Mitchel L. Zoler, PhD

Major Finding: In patients undergoing periodontal surgery, daily 20-mcg injections of teriparatide for 6 weeks led to an average 29% bone gain at the surgery site after 1 year, compared with an average 3% gain in the placebo group.

Data Source: A randomized, single-center pilot study of 40 patients with severe periodontal disease.

Disclosures: The investigator-initiated study received partial funding from Eli Lilly & Co., the company that markets teriparatide (Forteo). Dr. McCauley has received research grants and transportation support from Lilly. She has also received research grants and has been a consultant to Amgen, but has not received any honoraria or consulting fees. Dr. Bashutski said she has received travel expenses from the Colgate-Palmolive Co. Dr. Grey said that he has received travel expenses from Merck Sharp & Dohme (NZ) Ltd.

Treatment for 6 weeks with teriparatide, a U.S.-approved drug that stimulates bone remodeling, led to significant, 1-year improvements in alveolar bone formation and clinical outcomes in a controlled pilot study of 40 patients undergoing periodontal surgery.

Bone gain in the osseous defects of the 20 patients who were randomized to receive daily teriparatide injections became detectable early after treatment began and continued to improve during 12 months of follow-up, leading to a highly significant improvement in overall alveolar bone gain, compared with the 20 patients on placebo, Jill D. Bashutski, D.D.S., and her associates reported online (N. Engl. J. Med. 2010 Oct. 16 [doi:10.1056/NEJMoa1005361]).

The patients who were treated with teriparatide also demonstrated significantly better 1-year improvements in periodontal probing depth and clinical attachment, reported Dr. Bashutski, a periodontist at the University of Michigan in Ann Arbor.

The article's online publication was timed to coincide with Dr. Bashutski's presentation of the study findings at the annual meeting of the American Society for Bone and Mineral Research in Toronto.

She and her coinvestigators used teriparatide, a recombinant agent that contains the first 34 amino acids of parathyroid hormone, because of its activity as an anabolic agent and evidence from prior studies that it enhances bone remodeling and wound healing in areas of high bone turnover, such as fractures and surgical sites.

“We know that parathyroid hormone stimulates formation of preosteoblast cells, and these cells go on to eventually form bone,” said Dr. Bashutski.

The 6-week regimen consists of daily teriparatide injections, which produce “an initial incentive for bone formation to occur” during subsequent months, said Dr. Laurie K. McCauley, the principal investigator of the study and professor and chair of periodontics and oral medicine at the University of Michigan, in an interview.

The positive effects that teriparatide treatment had on the study outcomes of bone gain, probing depth, and clinical attachment were also all clinically significant, according to Dr. McCauley. Teriparatide increased 1-year bone gain at a rate that was 10-fold higher than placebo.

“That's huge,” she said.

The long-term sequence of events that teriparatide triggers likely explains how a 6-week course produced significant differences after 1 year, she said.

“We know that most connective tissue healing goes on during the first 6 weeks,” according to Dr. McCauley. “The thought was to augment that healing with this agent.”

The outcome from “this small trial provides preliminary evidence that an agent that stimulates bone formation might confer additional benefit over that achieved with standard care in patients with periodontitis,” commented Dr. Andrew Grey in an editorial that accompanied the article (N. Engl. J. Med. 2010 Oct. 16 [doi:10.1056/NEJMe1010459]).

But many questions about this treatment remain, he said. “How durable is the effect of teriparatide? What is the optimal dosing regimen? Does teriparatide alter important end points] such as tooth loss or the need for further operative intervention? Do antiresorptive agents, which cost considerably less than teriparatide, confer similar benefits?” asked Dr. Grey, an endocrinologist at the University of Auckland (New Zealand).

The study enrolled patients (aged 30–65 years) with severe periodontal disease at the University of Michigan from January 2005 to June 2009. All patients in the study had normal levels of calcium and parathyroid hormone, a minimum vitamin D level of 16 ng/mL, and no osteoporosis.

All patients underwent conventional surgery on an osseous defect. Starting 3 days before surgery, patients began daily treatment with either 20 mcg of teriparatide or placebo, administered daily by subcutaneous injection, for 6 weeks. All patients also received a daily supplement of calcium and vitamin D.

Patients who were treated with teriparatide had significantly better resolution of their periodontal bone defects at 6, 9, and 12 months following baseline, compared with the placebo patients.

At 12 months, the teriparatide-treated patients averaged a bone gain of 1.86 mm (29%), compared with baseline, whereas the placebo patients averaged a 0.16-mm (3%) gain from baseline.

Teriparatide treatment was also associated with a 2.42-mm (33%) average reduction in probing depth at the surgical site after a period of 12 months, compared with baseline. The placebo group averaged a 1.32-mm (20%) reduction in probing depth from baseline, a statistically significant difference.

Clinical attachment improved by an average of 1.58 mm (22%) at 1-year follow-up, compared with baseline, in the teriparatide patients, significantly better than the average value of 0.42 mm (7%) for attachment improvement in the placebo group.

No improvements in probing depth occurred in the teriparatide and placebo patients in areas of severe, chronic periodontitis that did not undergo surgery.

At entry to the study, five patients in the teriparatide arm and nine in the placebo group had osteopenia on dual x-ray absorptiometry examinations. At the 12-month follow-up, patients in both of the study arms showed no significant changes in bone density scores or in quality of life scores.

Teriparatide treatment was not associated with any pattern of adverse events that differed from the placebo group.

Although teriparatide is available in the United States for treating osteoporosis, its widespread use in patients who are undergoing periodontal surgery should await results from studies involving larger numbers of patients, Dr. McCauley said. She also cautioned against extrapolating the results to other types of bone surgery.

Dr. McCauley said she would like to run studies on a delayed-release, topical formulation of teriparatide that would be implanted during surgery and would then release over the subsequent 6 weeks. Such a mode of delivery would precludeithe necessity of administering daily injections. Teriparatide formulations of this type now exist, but they have not reached the clinical-testing stage.

Parathyroid hormone stimulates formation of preosteoblast cells and bone.

Source DR. BASHUTSKI

Teriparatide increased 1-year bone gain at a rate that was 10-fold higher than placebo.

Source DR. MCCAULEY

Major Finding: In patients undergoing periodontal surgery, daily 20-mcg injections of teriparatide for 6 weeks led to an average 29% bone gain at the surgery site after 1 year, compared with an average 3% gain in the placebo group.

Data Source: A randomized, single-center pilot study of 40 patients with severe periodontal disease.

Disclosures: The investigator-initiated study received partial funding from Eli Lilly & Co., the company that markets teriparatide (Forteo). Dr. McCauley has received research grants and transportation support from Lilly. She has also received research grants and has been a consultant to Amgen, but has not received any honoraria or consulting fees. Dr. Bashutski said she has received travel expenses from the Colgate-Palmolive Co. Dr. Grey said that he has received travel expenses from Merck Sharp & Dohme (NZ) Ltd.

Treatment for 6 weeks with teriparatide, a U.S.-approved drug that stimulates bone remodeling, led to significant, 1-year improvements in alveolar bone formation and clinical outcomes in a controlled pilot study of 40 patients undergoing periodontal surgery.

Bone gain in the osseous defects of the 20 patients who were randomized to receive daily teriparatide injections became detectable early after treatment began and continued to improve during 12 months of follow-up, leading to a highly significant improvement in overall alveolar bone gain, compared with the 20 patients on placebo, Jill D. Bashutski, D.D.S., and her associates reported online (N. Engl. J. Med. 2010 Oct. 16 [doi:10.1056/NEJMoa1005361]).

The patients who were treated with teriparatide also demonstrated significantly better 1-year improvements in periodontal probing depth and clinical attachment, reported Dr. Bashutski, a periodontist at the University of Michigan in Ann Arbor.

The article's online publication was timed to coincide with Dr. Bashutski's presentation of the study findings at the annual meeting of the American Society for Bone and Mineral Research in Toronto.

She and her coinvestigators used teriparatide, a recombinant agent that contains the first 34 amino acids of parathyroid hormone, because of its activity as an anabolic agent and evidence from prior studies that it enhances bone remodeling and wound healing in areas of high bone turnover, such as fractures and surgical sites.

“We know that parathyroid hormone stimulates formation of preosteoblast cells, and these cells go on to eventually form bone,” said Dr. Bashutski.

The 6-week regimen consists of daily teriparatide injections, which produce “an initial incentive for bone formation to occur” during subsequent months, said Dr. Laurie K. McCauley, the principal investigator of the study and professor and chair of periodontics and oral medicine at the University of Michigan, in an interview.

The positive effects that teriparatide treatment had on the study outcomes of bone gain, probing depth, and clinical attachment were also all clinically significant, according to Dr. McCauley. Teriparatide increased 1-year bone gain at a rate that was 10-fold higher than placebo.

“That's huge,” she said.

The long-term sequence of events that teriparatide triggers likely explains how a 6-week course produced significant differences after 1 year, she said.

“We know that most connective tissue healing goes on during the first 6 weeks,” according to Dr. McCauley. “The thought was to augment that healing with this agent.”

The outcome from “this small trial provides preliminary evidence that an agent that stimulates bone formation might confer additional benefit over that achieved with standard care in patients with periodontitis,” commented Dr. Andrew Grey in an editorial that accompanied the article (N. Engl. J. Med. 2010 Oct. 16 [doi:10.1056/NEJMe1010459]).

But many questions about this treatment remain, he said. “How durable is the effect of teriparatide? What is the optimal dosing regimen? Does teriparatide alter important end points] such as tooth loss or the need for further operative intervention? Do antiresorptive agents, which cost considerably less than teriparatide, confer similar benefits?” asked Dr. Grey, an endocrinologist at the University of Auckland (New Zealand).

The study enrolled patients (aged 30–65 years) with severe periodontal disease at the University of Michigan from January 2005 to June 2009. All patients in the study had normal levels of calcium and parathyroid hormone, a minimum vitamin D level of 16 ng/mL, and no osteoporosis.

All patients underwent conventional surgery on an osseous defect. Starting 3 days before surgery, patients began daily treatment with either 20 mcg of teriparatide or placebo, administered daily by subcutaneous injection, for 6 weeks. All patients also received a daily supplement of calcium and vitamin D.

Patients who were treated with teriparatide had significantly better resolution of their periodontal bone defects at 6, 9, and 12 months following baseline, compared with the placebo patients.

At 12 months, the teriparatide-treated patients averaged a bone gain of 1.86 mm (29%), compared with baseline, whereas the placebo patients averaged a 0.16-mm (3%) gain from baseline.

Teriparatide treatment was also associated with a 2.42-mm (33%) average reduction in probing depth at the surgical site after a period of 12 months, compared with baseline. The placebo group averaged a 1.32-mm (20%) reduction in probing depth from baseline, a statistically significant difference.

Clinical attachment improved by an average of 1.58 mm (22%) at 1-year follow-up, compared with baseline, in the teriparatide patients, significantly better than the average value of 0.42 mm (7%) for attachment improvement in the placebo group.

No improvements in probing depth occurred in the teriparatide and placebo patients in areas of severe, chronic periodontitis that did not undergo surgery.

At entry to the study, five patients in the teriparatide arm and nine in the placebo group had osteopenia on dual x-ray absorptiometry examinations. At the 12-month follow-up, patients in both of the study arms showed no significant changes in bone density scores or in quality of life scores.

Teriparatide treatment was not associated with any pattern of adverse events that differed from the placebo group.

Although teriparatide is available in the United States for treating osteoporosis, its widespread use in patients who are undergoing periodontal surgery should await results from studies involving larger numbers of patients, Dr. McCauley said. She also cautioned against extrapolating the results to other types of bone surgery.

Dr. McCauley said she would like to run studies on a delayed-release, topical formulation of teriparatide that would be implanted during surgery and would then release over the subsequent 6 weeks. Such a mode of delivery would precludeithe necessity of administering daily injections. Teriparatide formulations of this type now exist, but they have not reached the clinical-testing stage.

Parathyroid hormone stimulates formation of preosteoblast cells and bone.

Source DR. BASHUTSKI

Teriparatide increased 1-year bone gain at a rate that was 10-fold higher than placebo.

Source DR. MCCAULEY

Major Finding: In patients undergoing periodontal surgery, daily 20-mcg injections of teriparatide for 6 weeks led to an average 29% bone gain at the surgery site after 1 year, compared with an average 3% gain in the placebo group.

Data Source: A randomized, single-center pilot study of 40 patients with severe periodontal disease.

Disclosures: The investigator-initiated study received partial funding from Eli Lilly & Co., the company that markets teriparatide (Forteo). Dr. McCauley has received research grants and transportation support from Lilly. She has also received research grants and has been a consultant to Amgen, but has not received any honoraria or consulting fees. Dr. Bashutski said she has received travel expenses from the Colgate-Palmolive Co. Dr. Grey said that he has received travel expenses from Merck Sharp & Dohme (NZ) Ltd.

Treatment for 6 weeks with teriparatide, a U.S.-approved drug that stimulates bone remodeling, led to significant, 1-year improvements in alveolar bone formation and clinical outcomes in a controlled pilot study of 40 patients undergoing periodontal surgery.

Bone gain in the osseous defects of the 20 patients who were randomized to receive daily teriparatide injections became detectable early after treatment began and continued to improve during 12 months of follow-up, leading to a highly significant improvement in overall alveolar bone gain, compared with the 20 patients on placebo, Jill D. Bashutski, D.D.S., and her associates reported online (N. Engl. J. Med. 2010 Oct. 16 [doi:10.1056/NEJMoa1005361]).

The patients who were treated with teriparatide also demonstrated significantly better 1-year improvements in periodontal probing depth and clinical attachment, reported Dr. Bashutski, a periodontist at the University of Michigan in Ann Arbor.

The article's online publication was timed to coincide with Dr. Bashutski's presentation of the study findings at the annual meeting of the American Society for Bone and Mineral Research in Toronto.

She and her coinvestigators used teriparatide, a recombinant agent that contains the first 34 amino acids of parathyroid hormone, because of its activity as an anabolic agent and evidence from prior studies that it enhances bone remodeling and wound healing in areas of high bone turnover, such as fractures and surgical sites.

“We know that parathyroid hormone stimulates formation of preosteoblast cells, and these cells go on to eventually form bone,” said Dr. Bashutski.

The 6-week regimen consists of daily teriparatide injections, which produce “an initial incentive for bone formation to occur” during subsequent months, said Dr. Laurie K. McCauley, the principal investigator of the study and professor and chair of periodontics and oral medicine at the University of Michigan, in an interview.

The positive effects that teriparatide treatment had on the study outcomes of bone gain, probing depth, and clinical attachment were also all clinically significant, according to Dr. McCauley. Teriparatide increased 1-year bone gain at a rate that was 10-fold higher than placebo.

“That's huge,” she said.

The long-term sequence of events that teriparatide triggers likely explains how a 6-week course produced significant differences after 1 year, she said.

“We know that most connective tissue healing goes on during the first 6 weeks,” according to Dr. McCauley. “The thought was to augment that healing with this agent.”

The outcome from “this small trial provides preliminary evidence that an agent that stimulates bone formation might confer additional benefit over that achieved with standard care in patients with periodontitis,” commented Dr. Andrew Grey in an editorial that accompanied the article (N. Engl. J. Med. 2010 Oct. 16 [doi:10.1056/NEJMe1010459]).

But many questions about this treatment remain, he said. “How durable is the effect of teriparatide? What is the optimal dosing regimen? Does teriparatide alter important end points] such as tooth loss or the need for further operative intervention? Do antiresorptive agents, which cost considerably less than teriparatide, confer similar benefits?” asked Dr. Grey, an endocrinologist at the University of Auckland (New Zealand).

The study enrolled patients (aged 30–65 years) with severe periodontal disease at the University of Michigan from January 2005 to June 2009. All patients in the study had normal levels of calcium and parathyroid hormone, a minimum vitamin D level of 16 ng/mL, and no osteoporosis.

All patients underwent conventional surgery on an osseous defect. Starting 3 days before surgery, patients began daily treatment with either 20 mcg of teriparatide or placebo, administered daily by subcutaneous injection, for 6 weeks. All patients also received a daily supplement of calcium and vitamin D.

Patients who were treated with teriparatide had significantly better resolution of their periodontal bone defects at 6, 9, and 12 months following baseline, compared with the placebo patients.

At 12 months, the teriparatide-treated patients averaged a bone gain of 1.86 mm (29%), compared with baseline, whereas the placebo patients averaged a 0.16-mm (3%) gain from baseline.

Teriparatide treatment was also associated with a 2.42-mm (33%) average reduction in probing depth at the surgical site after a period of 12 months, compared with baseline. The placebo group averaged a 1.32-mm (20%) reduction in probing depth from baseline, a statistically significant difference.

Clinical attachment improved by an average of 1.58 mm (22%) at 1-year follow-up, compared with baseline, in the teriparatide patients, significantly better than the average value of 0.42 mm (7%) for attachment improvement in the placebo group.

No improvements in probing depth occurred in the teriparatide and placebo patients in areas of severe, chronic periodontitis that did not undergo surgery.

At entry to the study, five patients in the teriparatide arm and nine in the placebo group had osteopenia on dual x-ray absorptiometry examinations. At the 12-month follow-up, patients in both of the study arms showed no significant changes in bone density scores or in quality of life scores.

Teriparatide treatment was not associated with any pattern of adverse events that differed from the placebo group.

Although teriparatide is available in the United States for treating osteoporosis, its widespread use in patients who are undergoing periodontal surgery should await results from studies involving larger numbers of patients, Dr. McCauley said. She also cautioned against extrapolating the results to other types of bone surgery.

Dr. McCauley said she would like to run studies on a delayed-release, topical formulation of teriparatide that would be implanted during surgery and would then release over the subsequent 6 weeks. Such a mode of delivery would precludeithe necessity of administering daily injections. Teriparatide formulations of this type now exist, but they have not reached the clinical-testing stage.

Parathyroid hormone stimulates formation of preosteoblast cells and bone.

Source DR. BASHUTSKI

Teriparatide increased 1-year bone gain at a rate that was 10-fold higher than placebo.

Source DR. MCCAULEY

A star-based system for rating the performance of more than 200 U.S. thoracic surgery programs doing isolated coronary artery bypass surgery went live on the Consumer Reports Health Web site on Sept. 7, using data collected and analyzed by the Society of Thoracic Surgeons.

On a subscription-only site, Consumer Reports Health lists the names, locations, and a one- to three-star rating for 221 U.S. cardiothoracic surgery practices that perform coronary artery bypass grafting (CABG), participate in the Society of Thoracic Surgeons (STS) database, and agreed to have their rating released to the public. About 90% of the more than 1,000 U.S. thoracic surgery practices that perform CABG participate in the STS database.

The 221 listed practices included 50 with a three-star rating (defined as above-average performance on several process and outcomes measures); 166 with a two-star (average) rating; and 5 with a one-star (a below-average performance) rating. The October issue of Consumer Reports also published the names and locations of the 50 three-star practices.

The launch of this ranking of CABG programs culminates an effort begun by STS officials in early 2009, when they approached the Consumers Union, publisher of Consumer Reports Health, to map out a strategy to create the listing. The STS promoted the program during its annual meeting in January, aiming to list more than 300 practices. The 221 initial participants – fewer than a quarter of the U.S. programs offering CABG – falls short of that number and notably runs short on one-star (below average) programs.

The STS members who developed the data assessment methodology used an approach that produced roughly equal numbers of high and low outliers, the above- and below-average subgroups. The current analysis designated about 10%-15% of the CABG programs as above average, and a similar percentage as below average, with roughly three-quarters tagged as two stars (average), said Dr. David M. Shahian, professor of surgery at Harvard Medical School, Boston, and chairman of the society's national database workforce. Now that the inaugural report is out, several practices not yet involved will feel “pressure to participate” from both patients and payers, and will sign on to be part of next year's list, Dr. Shahian said in an interview.

“I think it's pretty remarkable” that 22% were willing to participate in the initial listing, he said. “I have done several conference calls to answer questions [about the listing], and I did not hear a single comment that this is philosophically wrong.” Many programs opted to wait to see how the initial list rolled out, he added.

The methods he and his associates developed to distinguish the three tiers of programs will result in smaller percentages of above- and below-average designations if several low-scoring programs improve. The analysis method has a high level of sensitivity to detect high and low outliers, and high specificity so outlier groups truly deserved their designations. The method has a 99% probability that the three- and one-star programs truly differ from the programs that got two stars.

The list included an overall practice assessment based on four domains of CABG care, and each individual domain received a one- to three-star rating (Ann. Thorac. Surg. 2007;83[suppl. 4]:S3-12).

The four domains of care are:

▸ Operative care focused on whether patients received at least one internal mammary-artery graft.

▸ Risk-adjusted operative mortality.

▸ Perioperative medical care focused on preoperative beta-blocker use and on discharge prescribing of aspirin, a beta-blocker, and a lipid-lowering regimen.

▸ Postoperative morbidity, including renal insufficiency, deep sternal wound infection, and reexploration for any cause, as well as stroke or prolonged ventilation.

Dr. Shahian said he had no conflicts of interest to disclose.

A star-based system for rating the performance of more than 200 U.S. thoracic surgery programs doing isolated coronary artery bypass surgery went live on the Consumer Reports Health Web site on Sept. 7, using data collected and analyzed by the Society of Thoracic Surgeons.

On a subscription-only site, Consumer Reports Health lists the names, locations, and a one- to three-star rating for 221 U.S. cardiothoracic surgery practices that perform coronary artery bypass grafting (CABG), participate in the Society of Thoracic Surgeons (STS) database, and agreed to have their rating released to the public. About 90% of the more than 1,000 U.S. thoracic surgery practices that perform CABG participate in the STS database.

The 221 listed practices included 50 with a three-star rating (defined as above-average performance on several process and outcomes measures); 166 with a two-star (average) rating; and 5 with a one-star (a below-average performance) rating. The October issue of Consumer Reports also published the names and locations of the 50 three-star practices.

The launch of this ranking of CABG programs culminates an effort begun by STS officials in early 2009, when they approached the Consumers Union, publisher of Consumer Reports Health, to map out a strategy to create the listing. The STS promoted the program during its annual meeting in January, aiming to list more than 300 practices. The 221 initial participants – fewer than a quarter of the U.S. programs offering CABG – falls short of that number and notably runs short on one-star (below average) programs.

The STS members who developed the data assessment methodology used an approach that produced roughly equal numbers of high and low outliers, the above- and below-average subgroups. The current analysis designated about 10%-15% of the CABG programs as above average, and a similar percentage as below average, with roughly three-quarters tagged as two stars (average), said Dr. David M. Shahian, professor of surgery at Harvard Medical School, Boston, and chairman of the society's national database workforce. Now that the inaugural report is out, several practices not yet involved will feel “pressure to participate” from both patients and payers, and will sign on to be part of next year's list, Dr. Shahian said in an interview.

“I think it's pretty remarkable” that 22% were willing to participate in the initial listing, he said. “I have done several conference calls to answer questions [about the listing], and I did not hear a single comment that this is philosophically wrong.” Many programs opted to wait to see how the initial list rolled out, he added.

The methods he and his associates developed to distinguish the three tiers of programs will result in smaller percentages of above- and below-average designations if several low-scoring programs improve. The analysis method has a high level of sensitivity to detect high and low outliers, and high specificity so outlier groups truly deserved their designations. The method has a 99% probability that the three- and one-star programs truly differ from the programs that got two stars.

The list included an overall practice assessment based on four domains of CABG care, and each individual domain received a one- to three-star rating (Ann. Thorac. Surg. 2007;83[suppl. 4]:S3-12).

The four domains of care are:

▸ Operative care focused on whether patients received at least one internal mammary-artery graft.

▸ Risk-adjusted operative mortality.

▸ Perioperative medical care focused on preoperative beta-blocker use and on discharge prescribing of aspirin, a beta-blocker, and a lipid-lowering regimen.

▸ Postoperative morbidity, including renal insufficiency, deep sternal wound infection, and reexploration for any cause, as well as stroke or prolonged ventilation.

Dr. Shahian said he had no conflicts of interest to disclose.

A star-based system for rating the performance of more than 200 U.S. thoracic surgery programs doing isolated coronary artery bypass surgery went live on the Consumer Reports Health Web site on Sept. 7, using data collected and analyzed by the Society of Thoracic Surgeons.

On a subscription-only site, Consumer Reports Health lists the names, locations, and a one- to three-star rating for 221 U.S. cardiothoracic surgery practices that perform coronary artery bypass grafting (CABG), participate in the Society of Thoracic Surgeons (STS) database, and agreed to have their rating released to the public. About 90% of the more than 1,000 U.S. thoracic surgery practices that perform CABG participate in the STS database.

The 221 listed practices included 50 with a three-star rating (defined as above-average performance on several process and outcomes measures); 166 with a two-star (average) rating; and 5 with a one-star (a below-average performance) rating. The October issue of Consumer Reports also published the names and locations of the 50 three-star practices.

The launch of this ranking of CABG programs culminates an effort begun by STS officials in early 2009, when they approached the Consumers Union, publisher of Consumer Reports Health, to map out a strategy to create the listing. The STS promoted the program during its annual meeting in January, aiming to list more than 300 practices. The 221 initial participants – fewer than a quarter of the U.S. programs offering CABG – falls short of that number and notably runs short on one-star (below average) programs.

The STS members who developed the data assessment methodology used an approach that produced roughly equal numbers of high and low outliers, the above- and below-average subgroups. The current analysis designated about 10%-15% of the CABG programs as above average, and a similar percentage as below average, with roughly three-quarters tagged as two stars (average), said Dr. David M. Shahian, professor of surgery at Harvard Medical School, Boston, and chairman of the society's national database workforce. Now that the inaugural report is out, several practices not yet involved will feel “pressure to participate” from both patients and payers, and will sign on to be part of next year's list, Dr. Shahian said in an interview.

“I think it's pretty remarkable” that 22% were willing to participate in the initial listing, he said. “I have done several conference calls to answer questions [about the listing], and I did not hear a single comment that this is philosophically wrong.” Many programs opted to wait to see how the initial list rolled out, he added.

The methods he and his associates developed to distinguish the three tiers of programs will result in smaller percentages of above- and below-average designations if several low-scoring programs improve. The analysis method has a high level of sensitivity to detect high and low outliers, and high specificity so outlier groups truly deserved their designations. The method has a 99% probability that the three- and one-star programs truly differ from the programs that got two stars.

The list included an overall practice assessment based on four domains of CABG care, and each individual domain received a one- to three-star rating (Ann. Thorac. Surg. 2007;83[suppl. 4]:S3-12).

The four domains of care are:

▸ Operative care focused on whether patients received at least one internal mammary-artery graft.

▸ Risk-adjusted operative mortality.

▸ Perioperative medical care focused on preoperative beta-blocker use and on discharge prescribing of aspirin, a beta-blocker, and a lipid-lowering regimen.

▸ Postoperative morbidity, including renal insufficiency, deep sternal wound infection, and reexploration for any cause, as well as stroke or prolonged ventilation.

Dr. Shahian said he had no conflicts of interest to disclose.

Major Finding: Adding cilostazol, 100 mg twice daily, to a standard regimen of dual-antiplatelet therapy with aspirin and clopidogrel cut platelet reactivity by an average of 23% in patients with diabetes, and by an average of 15% in patients without diabetes, statistically significant differences.

Data Source: A single-center, crossover study of 40 patients with diabetes and 39 without diabetes, all with stable coronary artery disease.

Disclosures: Dr. Ferreiro said that he had no disclosures.

STOCKHOLM – Adding cilostazol to a standard, dual-antiplatelet therapy regimen significantly decreased platelet reactivity in patients, especially in those with diabetes, in a controlled study with 80 patients.

“Despite marked platelet inhibition, cilostazol does not change thrombin-mediated hemostasis, which may help explain its ischemic benefit without an increased risk of bleeding,” Dr. José Luis Ferreiro said at the congress.

Based on the new findings, cilostazol can have a role for “patients in whom you'd like more potent platelet inhibition who have a high risk for bleeding,” he said.

In addition, cilostazol treatment seems particularly appropriate for patients with diabetes, in whom it “works much better,” compared with patients without diabetes. It's also well suited as a third antiplatelet agent in patients on dual-antiplatelet therapy with aspirin and clopidogrel who have peripheral artery disease, an approved indication for cilostazol treatment, said Dr. Ferreiro, a cardiologist at the University Hospital of Bellvitge in Barcelona.

Cilostazol also has Food and Drug Administration approval to prevent thromboembolism in patients with coronary stents.

Despite data like these that show incremental value from adding cilostazol to a dual-antiplatelet regimen, the drug remains largely unused in Western countries, probably because most of the evidence supporting its efficacy comes from Asian studies, especially from Korean researchers, Dr. Ferreiro said. In addition, about a quarter of patients do not tolerate cilostazol treatment because of adverse effects, which commonly include headache and diarrhea.

Despite these drawbacks, cilostazol may be an attractive addition for antiplatelet therapy, compared with the new antiplatelet drugs prasugrel and ticagrelor, when drug cost is a consideration or for patients at high risk for bleeding complications, he said in an interview.

Dr. Ferreiro and his associates ran the new study to assess cilostazol's ability to reduce platelet reactivity in 40 patients with diabetes (including some with type 1 and some with type 2 disease), compared with 39 patients without diabetes. The patients all had stable coronary artery disease and averaged 61 years old; about two-thirds were men.

All enrolled patients had received 81-mg aspirin and 75-mg clopidogrel daily for a month, and remained on dual-antiplatelet therapy during the study. The researchers randomized the patients to either 100-mg cilostazol twice daily or placebo daily for 2 weeks, followed by a 1 week washout and then a crossover to another 2 weeks of treatment with the alternative agent. The study's primary end point was the difference in the reactivity of the platelet P2Y₁₂ receptor, measured in a vasodilator-stimulated phosphoprotein (VASP) flow-cytometry assay, at the end of 2 weeks of treatment with either cilostazol or placebo.

Patients with diabetes averaged 53% on the P2Y₁₂ reactivity index (PRI) while on placebo and 30% while on cilostazol, a 23% absolute, average drop in PRI attributable to cilostazol, a statistically significant effect. Patients without diabetes averaged 48% on placebo and 33% on cilostazol, a 15% absolute, average drop in their PRI attributable to cilostazol, also statistically significant. The difference in the average impact that cilostazol had on PRI between the patients with diabetes and those without diabetes (a 23% reduction vs. a 15% drop), also reached statistical significance, said Dr. Ferreiro.

Other assays of platelet reactivity used as secondary end points showed similar results. The study did not include enough patients to determine whether cilostazol had different effects in patients with type 1 and type 2 diabetes.

Cilostazol may be an attractive addition for antiplatelet therapy when drug cost is a consideration.

Source DR. FERREIRO

Major Finding: Adding cilostazol, 100 mg twice daily, to a standard regimen of dual-antiplatelet therapy with aspirin and clopidogrel cut platelet reactivity by an average of 23% in patients with diabetes, and by an average of 15% in patients without diabetes, statistically significant differences.

Data Source: A single-center, crossover study of 40 patients with diabetes and 39 without diabetes, all with stable coronary artery disease.

Disclosures: Dr. Ferreiro said that he had no disclosures.

STOCKHOLM – Adding cilostazol to a standard, dual-antiplatelet therapy regimen significantly decreased platelet reactivity in patients, especially in those with diabetes, in a controlled study with 80 patients.

“Despite marked platelet inhibition, cilostazol does not change thrombin-mediated hemostasis, which may help explain its ischemic benefit without an increased risk of bleeding,” Dr. José Luis Ferreiro said at the congress.

Based on the new findings, cilostazol can have a role for “patients in whom you'd like more potent platelet inhibition who have a high risk for bleeding,” he said.

In addition, cilostazol treatment seems particularly appropriate for patients with diabetes, in whom it “works much better,” compared with patients without diabetes. It's also well suited as a third antiplatelet agent in patients on dual-antiplatelet therapy with aspirin and clopidogrel who have peripheral artery disease, an approved indication for cilostazol treatment, said Dr. Ferreiro, a cardiologist at the University Hospital of Bellvitge in Barcelona.

Cilostazol also has Food and Drug Administration approval to prevent thromboembolism in patients with coronary stents.

Despite data like these that show incremental value from adding cilostazol to a dual-antiplatelet regimen, the drug remains largely unused in Western countries, probably because most of the evidence supporting its efficacy comes from Asian studies, especially from Korean researchers, Dr. Ferreiro said. In addition, about a quarter of patients do not tolerate cilostazol treatment because of adverse effects, which commonly include headache and diarrhea.

Despite these drawbacks, cilostazol may be an attractive addition for antiplatelet therapy, compared with the new antiplatelet drugs prasugrel and ticagrelor, when drug cost is a consideration or for patients at high risk for bleeding complications, he said in an interview.

Dr. Ferreiro and his associates ran the new study to assess cilostazol's ability to reduce platelet reactivity in 40 patients with diabetes (including some with type 1 and some with type 2 disease), compared with 39 patients without diabetes. The patients all had stable coronary artery disease and averaged 61 years old; about two-thirds were men.

All enrolled patients had received 81-mg aspirin and 75-mg clopidogrel daily for a month, and remained on dual-antiplatelet therapy during the study. The researchers randomized the patients to either 100-mg cilostazol twice daily or placebo daily for 2 weeks, followed by a 1 week washout and then a crossover to another 2 weeks of treatment with the alternative agent. The study's primary end point was the difference in the reactivity of the platelet P2Y₁₂ receptor, measured in a vasodilator-stimulated phosphoprotein (VASP) flow-cytometry assay, at the end of 2 weeks of treatment with either cilostazol or placebo.

Patients with diabetes averaged 53% on the P2Y₁₂ reactivity index (PRI) while on placebo and 30% while on cilostazol, a 23% absolute, average drop in PRI attributable to cilostazol, a statistically significant effect. Patients without diabetes averaged 48% on placebo and 33% on cilostazol, a 15% absolute, average drop in their PRI attributable to cilostazol, also statistically significant. The difference in the average impact that cilostazol had on PRI between the patients with diabetes and those without diabetes (a 23% reduction vs. a 15% drop), also reached statistical significance, said Dr. Ferreiro.

Other assays of platelet reactivity used as secondary end points showed similar results. The study did not include enough patients to determine whether cilostazol had different effects in patients with type 1 and type 2 diabetes.

Cilostazol may be an attractive addition for antiplatelet therapy when drug cost is a consideration.

Source DR. FERREIRO

Major Finding: Adding cilostazol, 100 mg twice daily, to a standard regimen of dual-antiplatelet therapy with aspirin and clopidogrel cut platelet reactivity by an average of 23% in patients with diabetes, and by an average of 15% in patients without diabetes, statistically significant differences.

Data Source: A single-center, crossover study of 40 patients with diabetes and 39 without diabetes, all with stable coronary artery disease.

Disclosures: Dr. Ferreiro said that he had no disclosures.

STOCKHOLM – Adding cilostazol to a standard, dual-antiplatelet therapy regimen significantly decreased platelet reactivity in patients, especially in those with diabetes, in a controlled study with 80 patients.

“Despite marked platelet inhibition, cilostazol does not change thrombin-mediated hemostasis, which may help explain its ischemic benefit without an increased risk of bleeding,” Dr. José Luis Ferreiro said at the congress.

Based on the new findings, cilostazol can have a role for “patients in whom you'd like more potent platelet inhibition who have a high risk for bleeding,” he said.

In addition, cilostazol treatment seems particularly appropriate for patients with diabetes, in whom it “works much better,” compared with patients without diabetes. It's also well suited as a third antiplatelet agent in patients on dual-antiplatelet therapy with aspirin and clopidogrel who have peripheral artery disease, an approved indication for cilostazol treatment, said Dr. Ferreiro, a cardiologist at the University Hospital of Bellvitge in Barcelona.

Cilostazol also has Food and Drug Administration approval to prevent thromboembolism in patients with coronary stents.

Despite data like these that show incremental value from adding cilostazol to a dual-antiplatelet regimen, the drug remains largely unused in Western countries, probably because most of the evidence supporting its efficacy comes from Asian studies, especially from Korean researchers, Dr. Ferreiro said. In addition, about a quarter of patients do not tolerate cilostazol treatment because of adverse effects, which commonly include headache and diarrhea.

Despite these drawbacks, cilostazol may be an attractive addition for antiplatelet therapy, compared with the new antiplatelet drugs prasugrel and ticagrelor, when drug cost is a consideration or for patients at high risk for bleeding complications, he said in an interview.

Dr. Ferreiro and his associates ran the new study to assess cilostazol's ability to reduce platelet reactivity in 40 patients with diabetes (including some with type 1 and some with type 2 disease), compared with 39 patients without diabetes. The patients all had stable coronary artery disease and averaged 61 years old; about two-thirds were men.

All enrolled patients had received 81-mg aspirin and 75-mg clopidogrel daily for a month, and remained on dual-antiplatelet therapy during the study. The researchers randomized the patients to either 100-mg cilostazol twice daily or placebo daily for 2 weeks, followed by a 1 week washout and then a crossover to another 2 weeks of treatment with the alternative agent. The study's primary end point was the difference in the reactivity of the platelet P2Y₁₂ receptor, measured in a vasodilator-stimulated phosphoprotein (VASP) flow-cytometry assay, at the end of 2 weeks of treatment with either cilostazol or placebo.

Patients with diabetes averaged 53% on the P2Y₁₂ reactivity index (PRI) while on placebo and 30% while on cilostazol, a 23% absolute, average drop in PRI attributable to cilostazol, a statistically significant effect. Patients without diabetes averaged 48% on placebo and 33% on cilostazol, a 15% absolute, average drop in their PRI attributable to cilostazol, also statistically significant. The difference in the average impact that cilostazol had on PRI between the patients with diabetes and those without diabetes (a 23% reduction vs. a 15% drop), also reached statistical significance, said Dr. Ferreiro.

Other assays of platelet reactivity used as secondary end points showed similar results. The study did not include enough patients to determine whether cilostazol had different effects in patients with type 1 and type 2 diabetes.

Cilostazol may be an attractive addition for antiplatelet therapy when drug cost is a consideration.

Source DR. FERREIRO

Major Finding: People who developed osteoarthritis in both knees during 30 months of follow-up had a twofold increased rate of vitamin K deficiency at baseline, compared with people who did not develop osteoarthritis, and a nearly threefold increased risk of vitamin K deficiency compared with those who developed osteoarthritis in one knee.

Data Source: The 1,180 people enrolled in the MOST study who did not have osteoarthritis at baseline.

Disclosures: Dr. Neogi had no disclosures.

BRUSSELS – Vitamin K deficiency may increase the risk for developing knee osteoarthritis and for forming knee cartilage lesions, judging from the findings of a 30-month study of nearly 1,200 people at risk for knee osteoarthritis.

This apparent role of vitamin K in susceptibility to knee pathology raised the question of whether vitamin K supplementation for deficient individuals might be a “simple, effective preventive agent,” said Dr. Tuhina Neogi, a rheumatologist at Boston University.

Results from prior studies showed that low vitamin K intake and low blood levels were linked with prevalent radiographic features of hand and knee osteoarthritis. The new study made the first longitudinal examination of a potential link between plasma levels of vitamin K at baseline and incident osteoarthritis (OA) and associated pathology.

The investigators examined data that was collected from more than 3,000 people enrolled in the Multicenter Osteoarthritis (MOST) study who had an elevated risk for knee osteoarthritis at entry but had not yet developed the disease. The 1,180 people included in the current study averaged 62 years of age; 62% were women. Dr. Neogi and her associates defined vitamin K deficiency as a plasma level of phylloquinone less than 0.5 nmol/L. (Normal is 0.5-1.2 nmol/L.) At baseline, 9% of the study participants without OA had vitamin K deficiency.

The researchers made incident OA the primary end point, defined as development of a knee Kellgren-Lawrence (KL) grade of 2 or higher (including knee replacement). All people included in the analysis had a KL grade less than 2 at baseline. During 30 months of follow-up, 15% of the participants developed osteoarthritis.

In an analysis of whether or not participants developed knee OA, those with vitamin K deficiency at baseline had a 43% increased risk after adjustment. This increased risk just missed statistical significance, Dr. Neogi noted.

An additional analysis that took into account the extent of knee osteoarthritis showed that those who developed OA in both knees had a significant, nearly threefold increased risk of having vitamin K deficiency at baseline, compared with those who developed OA in one knee during follow-up. Those who had both knees affected at follow-up had a significant, twofold increased risk of vitamin deficiency, compared with people who did not develop any knee OA, she said at the congress, organized by the Osteoarthritis Research Society International.

The vitamin K–deficient participants also had a statistically significant, nearly threefold increased risk of developing new cartilage lesions on their knee MRI scans that were consistent with developing OA. They also had a 77% increased risk for showing osteophytes on their follow-up MRI scans, but this difference was not statistically significant.

Those with vitamin K deficiency had a 43% increased risk of developing knee OA, after adjustment.

Source DR. NEOGI

Major Finding: People who developed osteoarthritis in both knees during 30 months of follow-up had a twofold increased rate of vitamin K deficiency at baseline, compared with people who did not develop osteoarthritis, and a nearly threefold increased risk of vitamin K deficiency compared with those who developed osteoarthritis in one knee.

Data Source: The 1,180 people enrolled in the MOST study who did not have osteoarthritis at baseline.

Disclosures: Dr. Neogi had no disclosures.

BRUSSELS – Vitamin K deficiency may increase the risk for developing knee osteoarthritis and for forming knee cartilage lesions, judging from the findings of a 30-month study of nearly 1,200 people at risk for knee osteoarthritis.

This apparent role of vitamin K in susceptibility to knee pathology raised the question of whether vitamin K supplementation for deficient individuals might be a “simple, effective preventive agent,” said Dr. Tuhina Neogi, a rheumatologist at Boston University.

Results from prior studies showed that low vitamin K intake and low blood levels were linked with prevalent radiographic features of hand and knee osteoarthritis. The new study made the first longitudinal examination of a potential link between plasma levels of vitamin K at baseline and incident osteoarthritis (OA) and associated pathology.

The investigators examined data that was collected from more than 3,000 people enrolled in the Multicenter Osteoarthritis (MOST) study who had an elevated risk for knee osteoarthritis at entry but had not yet developed the disease. The 1,180 people included in the current study averaged 62 years of age; 62% were women. Dr. Neogi and her associates defined vitamin K deficiency as a plasma level of phylloquinone less than 0.5 nmol/L. (Normal is 0.5-1.2 nmol/L.) At baseline, 9% of the study participants without OA had vitamin K deficiency.

The researchers made incident OA the primary end point, defined as development of a knee Kellgren-Lawrence (KL) grade of 2 or higher (including knee replacement). All people included in the analysis had a KL grade less than 2 at baseline. During 30 months of follow-up, 15% of the participants developed osteoarthritis.

In an analysis of whether or not participants developed knee OA, those with vitamin K deficiency at baseline had a 43% increased risk after adjustment. This increased risk just missed statistical significance, Dr. Neogi noted.

An additional analysis that took into account the extent of knee osteoarthritis showed that those who developed OA in both knees had a significant, nearly threefold increased risk of having vitamin K deficiency at baseline, compared with those who developed OA in one knee during follow-up. Those who had both knees affected at follow-up had a significant, twofold increased risk of vitamin deficiency, compared with people who did not develop any knee OA, she said at the congress, organized by the Osteoarthritis Research Society International.

The vitamin K–deficient participants also had a statistically significant, nearly threefold increased risk of developing new cartilage lesions on their knee MRI scans that were consistent with developing OA. They also had a 77% increased risk for showing osteophytes on their follow-up MRI scans, but this difference was not statistically significant.

Those with vitamin K deficiency had a 43% increased risk of developing knee OA, after adjustment.

Source DR. NEOGI

Major Finding: People who developed osteoarthritis in both knees during 30 months of follow-up had a twofold increased rate of vitamin K deficiency at baseline, compared with people who did not develop osteoarthritis, and a nearly threefold increased risk of vitamin K deficiency compared with those who developed osteoarthritis in one knee.

Data Source: The 1,180 people enrolled in the MOST study who did not have osteoarthritis at baseline.

Disclosures: Dr. Neogi had no disclosures.

BRUSSELS – Vitamin K deficiency may increase the risk for developing knee osteoarthritis and for forming knee cartilage lesions, judging from the findings of a 30-month study of nearly 1,200 people at risk for knee osteoarthritis.

This apparent role of vitamin K in susceptibility to knee pathology raised the question of whether vitamin K supplementation for deficient individuals might be a “simple, effective preventive agent,” said Dr. Tuhina Neogi, a rheumatologist at Boston University.

Results from prior studies showed that low vitamin K intake and low blood levels were linked with prevalent radiographic features of hand and knee osteoarthritis. The new study made the first longitudinal examination of a potential link between plasma levels of vitamin K at baseline and incident osteoarthritis (OA) and associated pathology.

The investigators examined data that was collected from more than 3,000 people enrolled in the Multicenter Osteoarthritis (MOST) study who had an elevated risk for knee osteoarthritis at entry but had not yet developed the disease. The 1,180 people included in the current study averaged 62 years of age; 62% were women. Dr. Neogi and her associates defined vitamin K deficiency as a plasma level of phylloquinone less than 0.5 nmol/L. (Normal is 0.5-1.2 nmol/L.) At baseline, 9% of the study participants without OA had vitamin K deficiency.

The researchers made incident OA the primary end point, defined as development of a knee Kellgren-Lawrence (KL) grade of 2 or higher (including knee replacement). All people included in the analysis had a KL grade less than 2 at baseline. During 30 months of follow-up, 15% of the participants developed osteoarthritis.

In an analysis of whether or not participants developed knee OA, those with vitamin K deficiency at baseline had a 43% increased risk after adjustment. This increased risk just missed statistical significance, Dr. Neogi noted.

An additional analysis that took into account the extent of knee osteoarthritis showed that those who developed OA in both knees had a significant, nearly threefold increased risk of having vitamin K deficiency at baseline, compared with those who developed OA in one knee during follow-up. Those who had both knees affected at follow-up had a significant, twofold increased risk of vitamin deficiency, compared with people who did not develop any knee OA, she said at the congress, organized by the Osteoarthritis Research Society International.

The vitamin K–deficient participants also had a statistically significant, nearly threefold increased risk of developing new cartilage lesions on their knee MRI scans that were consistent with developing OA. They also had a 77% increased risk for showing osteophytes on their follow-up MRI scans, but this difference was not statistically significant.

Those with vitamin K deficiency had a 43% increased risk of developing knee OA, after adjustment.

Source DR. NEOGI

VIENNA – Rilpivirine, an investigational non-nucleoside reverse transcriptase inhibitor for treating HIV, matched the efficacy of the benchmark agent in the class, efavirenz, and edged efavirenz for safety in a pair of phase III studies with more than 1,300 patients combined.

The results showed virologic failure to be the only parameter by which rilpivirine fell short of efavirenz, with rilpivirine's rate nearly twice that of efavirenz, Dr. Calvin J. Cohen said at the meeting.

Despite that, rilpivirine “had significant tolerability advantages over efavirenz,” said Dr. Cohen, research director of the Community Research Initiative of New England in Boston. The HIV-infected patients randomized to 25 mg of oral rilpivirine once daily had a lower rate of discontinuations for adverse events; half the rate of grade 2-4 adverse events; and reduced rates of dizziness, rash, abnormal dreams and nightmares, and grade 3 and 4 lipid abnormalities, compared with those randomized to 600 mg of efavirenz once daily.

“These studies provide valuable information on the safety and tolerability of TMC278 [rilpivirine] and specifically its metabolic and CNS side effect profiles,” Dr. Cohen said in a written statement.

The study was sponsored by Tibotec Pharmaceuticals, a subsidiary of Johnson & Johnson that is developing the drug. Tibotec has filed a New Drug Application with the Food and Drug Administration based on the data Dr. Cohen presented.

The Efficacy Comparison in Treatment-Naive HIV-Infected Subjects of TMC278 and EFV (ECHO) study and the TMC278 Against HIV in a Once Daily Regimen vs. Efavirenz (THRIVE) study had very similar results, differing only in the type of treatment added to each of the two study agents.

In ECHO, all patients also received the standard initial combination of tenofovir and emtricitabine. In THRIVE, each participating physician could decide which dual nucleoside reverse transcriptase inhibitors to prescribe. Their choice was tenofovir and emtricitabine in 60% of the THRIVE patients, zidovudine and lamivudine in 30%, and abacavir and lamivudine in 10%. Both trials enrolled treatment-naive patients with a baseline viral load of more than 5,000 copies/mL.

The median age of all patients in both trials was 36 years, and three-quarters were men. About half of the patients had viral loads greater than 100,000 copies/mL, and their average CD4 cell count was roughly 250 cells/mm

The primary end point of both studies was the percentage of patients with an undetectable viral load (fewer than 50 copies/mL) after 48 weeks on treatment. The end point occurred in 84% of the 686 rilpivirine patients and 82% of the 682 patients who got efavirenz, showing rilpivirine's noninferiority. Curves depicting the rate at which patients attained undetectable viral loads during 48 weeks of treatment showed virtually identical kinetics, Dr. Cohen said. Virologic failure occurred in 9% of the rilpivirine patients and 5% of those on efavirenz.

Discontinuation of treatment for an adverse event occurred in 3% of those on rilpivirine and 8% of those on efavirenz. A grade 2-4 adverse event at least possibly related to treatment occurred in 16% of patients on rilpivirine and 31% of those on efavirenz. Neurologic adverse events appeared in 17% of the rilpivirine patients and 38% of those on efavirenz. Dizziness incidence was 8% with rilpivirine and 26% with efavirenz.

Tibotec also announced that it is collaborating with Gilead Sciences in developing a single-pill, once-daily formulation that combines rilpivirine, tenofovir, and emtricitabine.

Dr. Cohen has received research support from, has served on the speakers bureau for, and has been a consultant to Tibotec, Bristol-Myers Squibb, Gilead Sciences (maker of tenofovir and emtricitabine), and Merck. He has also been a consultant to Abbott.

VIENNA – Rilpivirine, an investigational non-nucleoside reverse transcriptase inhibitor for treating HIV, matched the efficacy of the benchmark agent in the class, efavirenz, and edged efavirenz for safety in a pair of phase III studies with more than 1,300 patients combined.

The results showed virologic failure to be the only parameter by which rilpivirine fell short of efavirenz, with rilpivirine's rate nearly twice that of efavirenz, Dr. Calvin J. Cohen said at the meeting.

Despite that, rilpivirine “had significant tolerability advantages over efavirenz,” said Dr. Cohen, research director of the Community Research Initiative of New England in Boston. The HIV-infected patients randomized to 25 mg of oral rilpivirine once daily had a lower rate of discontinuations for adverse events; half the rate of grade 2-4 adverse events; and reduced rates of dizziness, rash, abnormal dreams and nightmares, and grade 3 and 4 lipid abnormalities, compared with those randomized to 600 mg of efavirenz once daily.

“These studies provide valuable information on the safety and tolerability of TMC278 [rilpivirine] and specifically its metabolic and CNS side effect profiles,” Dr. Cohen said in a written statement.

The study was sponsored by Tibotec Pharmaceuticals, a subsidiary of Johnson & Johnson that is developing the drug. Tibotec has filed a New Drug Application with the Food and Drug Administration based on the data Dr. Cohen presented.

The Efficacy Comparison in Treatment-Naive HIV-Infected Subjects of TMC278 and EFV (ECHO) study and the TMC278 Against HIV in a Once Daily Regimen vs. Efavirenz (THRIVE) study had very similar results, differing only in the type of treatment added to each of the two study agents.

In ECHO, all patients also received the standard initial combination of tenofovir and emtricitabine. In THRIVE, each participating physician could decide which dual nucleoside reverse transcriptase inhibitors to prescribe. Their choice was tenofovir and emtricitabine in 60% of the THRIVE patients, zidovudine and lamivudine in 30%, and abacavir and lamivudine in 10%. Both trials enrolled treatment-naive patients with a baseline viral load of more than 5,000 copies/mL.

The median age of all patients in both trials was 36 years, and three-quarters were men. About half of the patients had viral loads greater than 100,000 copies/mL, and their average CD4 cell count was roughly 250 cells/mm

The primary end point of both studies was the percentage of patients with an undetectable viral load (fewer than 50 copies/mL) after 48 weeks on treatment. The end point occurred in 84% of the 686 rilpivirine patients and 82% of the 682 patients who got efavirenz, showing rilpivirine's noninferiority. Curves depicting the rate at which patients attained undetectable viral loads during 48 weeks of treatment showed virtually identical kinetics, Dr. Cohen said. Virologic failure occurred in 9% of the rilpivirine patients and 5% of those on efavirenz.

Discontinuation of treatment for an adverse event occurred in 3% of those on rilpivirine and 8% of those on efavirenz. A grade 2-4 adverse event at least possibly related to treatment occurred in 16% of patients on rilpivirine and 31% of those on efavirenz. Neurologic adverse events appeared in 17% of the rilpivirine patients and 38% of those on efavirenz. Dizziness incidence was 8% with rilpivirine and 26% with efavirenz.

Tibotec also announced that it is collaborating with Gilead Sciences in developing a single-pill, once-daily formulation that combines rilpivirine, tenofovir, and emtricitabine.

Dr. Cohen has received research support from, has served on the speakers bureau for, and has been a consultant to Tibotec, Bristol-Myers Squibb, Gilead Sciences (maker of tenofovir and emtricitabine), and Merck. He has also been a consultant to Abbott.

VIENNA – Rilpivirine, an investigational non-nucleoside reverse transcriptase inhibitor for treating HIV, matched the efficacy of the benchmark agent in the class, efavirenz, and edged efavirenz for safety in a pair of phase III studies with more than 1,300 patients combined.

The results showed virologic failure to be the only parameter by which rilpivirine fell short of efavirenz, with rilpivirine's rate nearly twice that of efavirenz, Dr. Calvin J. Cohen said at the meeting.

Despite that, rilpivirine “had significant tolerability advantages over efavirenz,” said Dr. Cohen, research director of the Community Research Initiative of New England in Boston. The HIV-infected patients randomized to 25 mg of oral rilpivirine once daily had a lower rate of discontinuations for adverse events; half the rate of grade 2-4 adverse events; and reduced rates of dizziness, rash, abnormal dreams and nightmares, and grade 3 and 4 lipid abnormalities, compared with those randomized to 600 mg of efavirenz once daily.

“These studies provide valuable information on the safety and tolerability of TMC278 [rilpivirine] and specifically its metabolic and CNS side effect profiles,” Dr. Cohen said in a written statement.

The study was sponsored by Tibotec Pharmaceuticals, a subsidiary of Johnson & Johnson that is developing the drug. Tibotec has filed a New Drug Application with the Food and Drug Administration based on the data Dr. Cohen presented.

The Efficacy Comparison in Treatment-Naive HIV-Infected Subjects of TMC278 and EFV (ECHO) study and the TMC278 Against HIV in a Once Daily Regimen vs. Efavirenz (THRIVE) study had very similar results, differing only in the type of treatment added to each of the two study agents.

In ECHO, all patients also received the standard initial combination of tenofovir and emtricitabine. In THRIVE, each participating physician could decide which dual nucleoside reverse transcriptase inhibitors to prescribe. Their choice was tenofovir and emtricitabine in 60% of the THRIVE patients, zidovudine and lamivudine in 30%, and abacavir and lamivudine in 10%. Both trials enrolled treatment-naive patients with a baseline viral load of more than 5,000 copies/mL.

The median age of all patients in both trials was 36 years, and three-quarters were men. About half of the patients had viral loads greater than 100,000 copies/mL, and their average CD4 cell count was roughly 250 cells/mm

The primary end point of both studies was the percentage of patients with an undetectable viral load (fewer than 50 copies/mL) after 48 weeks on treatment. The end point occurred in 84% of the 686 rilpivirine patients and 82% of the 682 patients who got efavirenz, showing rilpivirine's noninferiority. Curves depicting the rate at which patients attained undetectable viral loads during 48 weeks of treatment showed virtually identical kinetics, Dr. Cohen said. Virologic failure occurred in 9% of the rilpivirine patients and 5% of those on efavirenz.

Discontinuation of treatment for an adverse event occurred in 3% of those on rilpivirine and 8% of those on efavirenz. A grade 2-4 adverse event at least possibly related to treatment occurred in 16% of patients on rilpivirine and 31% of those on efavirenz. Neurologic adverse events appeared in 17% of the rilpivirine patients and 38% of those on efavirenz. Dizziness incidence was 8% with rilpivirine and 26% with efavirenz.

Tibotec also announced that it is collaborating with Gilead Sciences in developing a single-pill, once-daily formulation that combines rilpivirine, tenofovir, and emtricitabine.

Dr. Cohen has received research support from, has served on the speakers bureau for, and has been a consultant to Tibotec, Bristol-Myers Squibb, Gilead Sciences (maker of tenofovir and emtricitabine), and Merck. He has also been a consultant to Abbott.

Major Finding: American young adults with hyperactive-impulsive symptoms of attention-deficit/hyperactivity disorder had a 63% increased risk of being obese, compared with those without any ADHD symptoms in a multivariate analysis.

Data Source: Data from the fourth wave of the National Longitudinal Study of Adolescent Health, which included a representative sample of 11,666 Americans with an average age of 29.

Disclosures: The National Longitudinal Study of Adolescent Health is sponsored by several branches of the National Institutes of Health. Dr. Fuemmeler said he has served as a consultant to or received research funding from Addrenex, Otsuka, and Shire.

STOCKHOLM – Young adults with hyperactive-impulsive symptoms of attention-deficit/hyperactivity disorder had a significantly increased risk for obesity in a U.S. national sample of nearly 12,000 people.

“This is the first population-based study to examine the association between ADHD symptoms as dimensional predictors of adult BMI [body mass index], changes in BMI, and risk of adult obesity and hypertension,” Bernard F. Fuemmeler, Ph.D., wrote in a poster at the meeting. “Our findings show a dose-response increase in risk of obesity associated with increasing ADHD symptoms, especially hyperactive-impulsive symptoms.”

Based on these findings, “it may be clinically relevant to screen patients with ADHD who are at risk for obesity to develop appropriate treatment strategies,” suggested Dr. Fuemmeler, a clinical psychologist at Duke University in Durham, N.C.

“The effectiveness of obesity treatment may be diminished, and relapse may be greater among those with more ADHD symptoms,” he added.

The biologic plausibility of a link between ADHD symptoms and obesity is based on results from positron emission tomography studies showing a reduced availability of dopamine receptors in people with ADHD and in people who are obese. Better understanding of the link may improve understanding of the etiology of obesity and may help identify better treatments.

Dr. Fuemmeler and his coinvestigators used data collected during the fourth wave of the National Longitudinal Study of Adolescent Health, a recurring national survey begun in 1994 sponsored by the National Institute of Child Health and Human Development and several other branches of the National Institutes of Health.

At the onset, the representative sample of adolescents in the survey had an average age of 16. The fourth round of longitudinal data collection occurred in 2007 and 2008 at an average age of 29, and included 11,666 people, 49% women; among the sample, 66% were white, 15% African American, 12% Hispanic, and 7% other.

Average BMI for the entire sample was 29 kg/m

In a multivariate analysis that controlled for age, sex, race, ethnicity, education, depression, alcohol use, smoking, and physical activity, survey participants with hyperactive-impulsive symptoms of ADHD had a statistically significant 63% increased risk of being obese compared with survey participants without these symptoms.

People with ADHD symptoms of inattention had a smaller increased obesity risk, 23%. The data showed the link between ADHD symptoms and hypertension was weaker than the link between ADHD and obesity.

Although even people with one hyperactive-impulsive symptom had a modestly increased obesity risk, the risk was highest among people with three to eight hyperactive-impulsive symptoms, which linked with a 50% increased risk in the multivariate analysis.

In contrast, people with inattentive symptoms showed an increased obesity risk in only those with three to nine symptoms, a 21% increased risk, the investigators found.

Analysis of the longitudinal data, collected from participants at four times during the course of the survey to date, showed hyperactive-impulsive symptoms linked with increasing BMI over the course of adolescence and into adulthood.

Major Finding: American young adults with hyperactive-impulsive symptoms of attention-deficit/hyperactivity disorder had a 63% increased risk of being obese, compared with those without any ADHD symptoms in a multivariate analysis.

Data Source: Data from the fourth wave of the National Longitudinal Study of Adolescent Health, which included a representative sample of 11,666 Americans with an average age of 29.

Disclosures: The National Longitudinal Study of Adolescent Health is sponsored by several branches of the National Institutes of Health. Dr. Fuemmeler said he has served as a consultant to or received research funding from Addrenex, Otsuka, and Shire.

STOCKHOLM – Young adults with hyperactive-impulsive symptoms of attention-deficit/hyperactivity disorder had a significantly increased risk for obesity in a U.S. national sample of nearly 12,000 people.

“This is the first population-based study to examine the association between ADHD symptoms as dimensional predictors of adult BMI [body mass index], changes in BMI, and risk of adult obesity and hypertension,” Bernard F. Fuemmeler, Ph.D., wrote in a poster at the meeting. “Our findings show a dose-response increase in risk of obesity associated with increasing ADHD symptoms, especially hyperactive-impulsive symptoms.”

Based on these findings, “it may be clinically relevant to screen patients with ADHD who are at risk for obesity to develop appropriate treatment strategies,” suggested Dr. Fuemmeler, a clinical psychologist at Duke University in Durham, N.C.

“The effectiveness of obesity treatment may be diminished, and relapse may be greater among those with more ADHD symptoms,” he added.

The biologic plausibility of a link between ADHD symptoms and obesity is based on results from positron emission tomography studies showing a reduced availability of dopamine receptors in people with ADHD and in people who are obese. Better understanding of the link may improve understanding of the etiology of obesity and may help identify better treatments.

Dr. Fuemmeler and his coinvestigators used data collected during the fourth wave of the National Longitudinal Study of Adolescent Health, a recurring national survey begun in 1994 sponsored by the National Institute of Child Health and Human Development and several other branches of the National Institutes of Health.

At the onset, the representative sample of adolescents in the survey had an average age of 16. The fourth round of longitudinal data collection occurred in 2007 and 2008 at an average age of 29, and included 11,666 people, 49% women; among the sample, 66% were white, 15% African American, 12% Hispanic, and 7% other.

Average BMI for the entire sample was 29 kg/m

In a multivariate analysis that controlled for age, sex, race, ethnicity, education, depression, alcohol use, smoking, and physical activity, survey participants with hyperactive-impulsive symptoms of ADHD had a statistically significant 63% increased risk of being obese compared with survey participants without these symptoms.

People with ADHD symptoms of inattention had a smaller increased obesity risk, 23%. The data showed the link between ADHD symptoms and hypertension was weaker than the link between ADHD and obesity.

Although even people with one hyperactive-impulsive symptom had a modestly increased obesity risk, the risk was highest among people with three to eight hyperactive-impulsive symptoms, which linked with a 50% increased risk in the multivariate analysis.

In contrast, people with inattentive symptoms showed an increased obesity risk in only those with three to nine symptoms, a 21% increased risk, the investigators found.

Analysis of the longitudinal data, collected from participants at four times during the course of the survey to date, showed hyperactive-impulsive symptoms linked with increasing BMI over the course of adolescence and into adulthood.

Major Finding: American young adults with hyperactive-impulsive symptoms of attention-deficit/hyperactivity disorder had a 63% increased risk of being obese, compared with those without any ADHD symptoms in a multivariate analysis.

Data Source: Data from the fourth wave of the National Longitudinal Study of Adolescent Health, which included a representative sample of 11,666 Americans with an average age of 29.

Disclosures: The National Longitudinal Study of Adolescent Health is sponsored by several branches of the National Institutes of Health. Dr. Fuemmeler said he has served as a consultant to or received research funding from Addrenex, Otsuka, and Shire.

STOCKHOLM – Young adults with hyperactive-impulsive symptoms of attention-deficit/hyperactivity disorder had a significantly increased risk for obesity in a U.S. national sample of nearly 12,000 people.

“This is the first population-based study to examine the association between ADHD symptoms as dimensional predictors of adult BMI [body mass index], changes in BMI, and risk of adult obesity and hypertension,” Bernard F. Fuemmeler, Ph.D., wrote in a poster at the meeting. “Our findings show a dose-response increase in risk of obesity associated with increasing ADHD symptoms, especially hyperactive-impulsive symptoms.”

Based on these findings, “it may be clinically relevant to screen patients with ADHD who are at risk for obesity to develop appropriate treatment strategies,” suggested Dr. Fuemmeler, a clinical psychologist at Duke University in Durham, N.C.

“The effectiveness of obesity treatment may be diminished, and relapse may be greater among those with more ADHD symptoms,” he added.

The biologic plausibility of a link between ADHD symptoms and obesity is based on results from positron emission tomography studies showing a reduced availability of dopamine receptors in people with ADHD and in people who are obese. Better understanding of the link may improve understanding of the etiology of obesity and may help identify better treatments.

Dr. Fuemmeler and his coinvestigators used data collected during the fourth wave of the National Longitudinal Study of Adolescent Health, a recurring national survey begun in 1994 sponsored by the National Institute of Child Health and Human Development and several other branches of the National Institutes of Health.

At the onset, the representative sample of adolescents in the survey had an average age of 16. The fourth round of longitudinal data collection occurred in 2007 and 2008 at an average age of 29, and included 11,666 people, 49% women; among the sample, 66% were white, 15% African American, 12% Hispanic, and 7% other.

Average BMI for the entire sample was 29 kg/m

In a multivariate analysis that controlled for age, sex, race, ethnicity, education, depression, alcohol use, smoking, and physical activity, survey participants with hyperactive-impulsive symptoms of ADHD had a statistically significant 63% increased risk of being obese compared with survey participants without these symptoms.

People with ADHD symptoms of inattention had a smaller increased obesity risk, 23%. The data showed the link between ADHD symptoms and hypertension was weaker than the link between ADHD and obesity.

Although even people with one hyperactive-impulsive symptom had a modestly increased obesity risk, the risk was highest among people with three to eight hyperactive-impulsive symptoms, which linked with a 50% increased risk in the multivariate analysis.

In contrast, people with inattentive symptoms showed an increased obesity risk in only those with three to nine symptoms, a 21% increased risk, the investigators found.

Analysis of the longitudinal data, collected from participants at four times during the course of the survey to date, showed hyperactive-impulsive symptoms linked with increasing BMI over the course of adolescence and into adulthood.

American high school students continued to engage in a variety of risky behaviors during 2009, although in many instances last year's levels ran significantly below rates previously recorded over the past 2 decades, according to results released by the Centers for Disease Control and Prevention from the 2009 National Youth Risk Behavior Survey.

These risky behaviors included riding in a car driven by someone who had recently consumed alcohol, an event that occurred within the prior 30 days for 28% of the high school respondents; carrying a weapon during the prior 30 days, reported by 18%; and participating in a physical fight in the prior year, reported by 32% (MMWR Surveillance Summaries 2010:59; No. SS-5).

In many cases, the 2009 numbers showed a continuation of improving trends. For example, the prevalence of high school students who never or rarely wore a seat belt in a car fell significantly from 26% in 1991 to 10% in 2009. The percentage of those who rarely or never wore a bicycle helmet fell from 96% in 1991 to 85% in 2009.

The prevalence of students who rode in a car driven by someone who had been consuming alcohol fell from 40% in 1991 to 28% in 2009. And carrying a weapon fell from 26% in 1991 to 18% in 2009.

In addition, current cigarette use dropped from 36% in 1997 to 20% in 2009. Among currently sexually active students, condom use during their last sexual intercourse increased from 46% in 1991 to 61% in 2009.

Notable exceptions to these improvements were in the areas of diet, exercise, and weight control. Obesity, defined as a body mass index at the 95th percentile or higher for age and gender, rose from 11% in 1999 to 12% in 2009, a significant increase.

Overweight, defined as a BMI between the 85th and 95th percentiles, rose from 14% in 1999 to 16% in 2009, also a significant increase. The percentage of students who said that they were trying to lose weight rose from 42% in 1991 to 44% in 2009, again a significant increase.

For the first time, the survey – conducted biannually by the CDC starting in 1991 – asked high school students about their prescription drug abuse, including use of OxyContin, Percocet, Vicodin, Adderall, Ritalin, or Xanax without a physician's prescription.

Overall, 20% of responding students admitted this type of abuse, with higher rates among all white students at 23%, all 12th-graders at 26%, and male 12th-graders at 27%.

The survey, which collected data from a weighted sample of more than 16,000 students with a 71% overall response rate, also showed stark regional differences in student behaviors based on the states and municipalities where they lived. For example, while overall 11% of U.S. high school students said they never or rarely wore a seat belt while riding in a car, the prevalence of this behavior ranged from a low of 4% in San Diego and 6% in Texas to highs of 19% in Arkansas and 29% in Milwaukee. The data also showed significant differences in several behaviors by gender, race, or ethnicity.

Notable risk-behavior findings included:

▸ Never or rarely wore a bicycle helmet while cycling: 85%.

▸ Had driven a car during the prior 30 days after drinking alcohol: 10%.

▸ Had carried a gun at least once during the prior 30 days: 6%.

▸ Had felt so sad or hopeless almost daily for 2 or more consecutive weeks that they had stopped some usual activities: 26%.

▸ Had attempted suicide at least once during the prior year: 6%.

▸ Had smoked a cigarette at least once during the prior 30 days: 20%; in addition, 26% said they currently used some type of tobacco (cigarettes, smokeless tobacco, or cigars).

▸ Had consumed at least five alcoholic drinks in a row on at least 1 day during the prior 30 days: 24%.

▸ Had used cocaine at least once: 6%.

▸ Had consumed a can, bottle, or glass of sugary soda at least once in the prior week: 29%.

▸ Did not participate in at least 60 minutes of any physical activity at least once in the prior week: 23%.

Dating violence was reported by 10% of survey participants, more often by black and Hispanic respondents than by white respondents.

For more information, go to www.cdc.gov/yrbs

American high school students continued to engage in a variety of risky behaviors during 2009, although in many instances last year's levels ran significantly below rates previously recorded over the past 2 decades, according to results released by the Centers for Disease Control and Prevention from the 2009 National Youth Risk Behavior Survey.

These risky behaviors included riding in a car driven by someone who had recently consumed alcohol, an event that occurred within the prior 30 days for 28% of the high school respondents; carrying a weapon during the prior 30 days, reported by 18%; and participating in a physical fight in the prior year, reported by 32% (MMWR Surveillance Summaries 2010:59; No. SS-5).

In many cases, the 2009 numbers showed a continuation of improving trends. For example, the prevalence of high school students who never or rarely wore a seat belt in a car fell significantly from 26% in 1991 to 10% in 2009. The percentage of those who rarely or never wore a bicycle helmet fell from 96% in 1991 to 85% in 2009.

The prevalence of students who rode in a car driven by someone who had been consuming alcohol fell from 40% in 1991 to 28% in 2009. And carrying a weapon fell from 26% in 1991 to 18% in 2009.

In addition, current cigarette use dropped from 36% in 1997 to 20% in 2009. Among currently sexually active students, condom use during their last sexual intercourse increased from 46% in 1991 to 61% in 2009.

Notable exceptions to these improvements were in the areas of diet, exercise, and weight control. Obesity, defined as a body mass index at the 95th percentile or higher for age and gender, rose from 11% in 1999 to 12% in 2009, a significant increase.

Overweight, defined as a BMI between the 85th and 95th percentiles, rose from 14% in 1999 to 16% in 2009, also a significant increase. The percentage of students who said that they were trying to lose weight rose from 42% in 1991 to 44% in 2009, again a significant increase.

For the first time, the survey – conducted biannually by the CDC starting in 1991 – asked high school students about their prescription drug abuse, including use of OxyContin, Percocet, Vicodin, Adderall, Ritalin, or Xanax without a physician's prescription.

Overall, 20% of responding students admitted this type of abuse, with higher rates among all white students at 23%, all 12th-graders at 26%, and male 12th-graders at 27%.

The survey, which collected data from a weighted sample of more than 16,000 students with a 71% overall response rate, also showed stark regional differences in student behaviors based on the states and municipalities where they lived. For example, while overall 11% of U.S. high school students said they never or rarely wore a seat belt while riding in a car, the prevalence of this behavior ranged from a low of 4% in San Diego and 6% in Texas to highs of 19% in Arkansas and 29% in Milwaukee. The data also showed significant differences in several behaviors by gender, race, or ethnicity.

Notable risk-behavior findings included:

▸ Never or rarely wore a bicycle helmet while cycling: 85%.

▸ Had driven a car during the prior 30 days after drinking alcohol: 10%.

▸ Had carried a gun at least once during the prior 30 days: 6%.

▸ Had felt so sad or hopeless almost daily for 2 or more consecutive weeks that they had stopped some usual activities: 26%.

▸ Had attempted suicide at least once during the prior year: 6%.

▸ Had smoked a cigarette at least once during the prior 30 days: 20%; in addition, 26% said they currently used some type of tobacco (cigarettes, smokeless tobacco, or cigars).

▸ Had consumed at least five alcoholic drinks in a row on at least 1 day during the prior 30 days: 24%.

▸ Had used cocaine at least once: 6%.

▸ Had consumed a can, bottle, or glass of sugary soda at least once in the prior week: 29%.

▸ Did not participate in at least 60 minutes of any physical activity at least once in the prior week: 23%.

Dating violence was reported by 10% of survey participants, more often by black and Hispanic respondents than by white respondents.

For more information, go to www.cdc.gov/yrbs

American high school students continued to engage in a variety of risky behaviors during 2009, although in many instances last year's levels ran significantly below rates previously recorded over the past 2 decades, according to results released by the Centers for Disease Control and Prevention from the 2009 National Youth Risk Behavior Survey.

These risky behaviors included riding in a car driven by someone who had recently consumed alcohol, an event that occurred within the prior 30 days for 28% of the high school respondents; carrying a weapon during the prior 30 days, reported by 18%; and participating in a physical fight in the prior year, reported by 32% (MMWR Surveillance Summaries 2010:59; No. SS-5).

In many cases, the 2009 numbers showed a continuation of improving trends. For example, the prevalence of high school students who never or rarely wore a seat belt in a car fell significantly from 26% in 1991 to 10% in 2009. The percentage of those who rarely or never wore a bicycle helmet fell from 96% in 1991 to 85% in 2009.

The prevalence of students who rode in a car driven by someone who had been consuming alcohol fell from 40% in 1991 to 28% in 2009. And carrying a weapon fell from 26% in 1991 to 18% in 2009.

In addition, current cigarette use dropped from 36% in 1997 to 20% in 2009. Among currently sexually active students, condom use during their last sexual intercourse increased from 46% in 1991 to 61% in 2009.

Notable exceptions to these improvements were in the areas of diet, exercise, and weight control. Obesity, defined as a body mass index at the 95th percentile or higher for age and gender, rose from 11% in 1999 to 12% in 2009, a significant increase.

Overweight, defined as a BMI between the 85th and 95th percentiles, rose from 14% in 1999 to 16% in 2009, also a significant increase. The percentage of students who said that they were trying to lose weight rose from 42% in 1991 to 44% in 2009, again a significant increase.

For the first time, the survey – conducted biannually by the CDC starting in 1991 – asked high school students about their prescription drug abuse, including use of OxyContin, Percocet, Vicodin, Adderall, Ritalin, or Xanax without a physician's prescription.

Overall, 20% of responding students admitted this type of abuse, with higher rates among all white students at 23%, all 12th-graders at 26%, and male 12th-graders at 27%.

The survey, which collected data from a weighted sample of more than 16,000 students with a 71% overall response rate, also showed stark regional differences in student behaviors based on the states and municipalities where they lived. For example, while overall 11% of U.S. high school students said they never or rarely wore a seat belt while riding in a car, the prevalence of this behavior ranged from a low of 4% in San Diego and 6% in Texas to highs of 19% in Arkansas and 29% in Milwaukee. The data also showed significant differences in several behaviors by gender, race, or ethnicity.

Notable risk-behavior findings included:

▸ Never or rarely wore a bicycle helmet while cycling: 85%.

▸ Had driven a car during the prior 30 days after drinking alcohol: 10%.

▸ Had carried a gun at least once during the prior 30 days: 6%.

▸ Had felt so sad or hopeless almost daily for 2 or more consecutive weeks that they had stopped some usual activities: 26%.

▸ Had attempted suicide at least once during the prior year: 6%.

▸ Had smoked a cigarette at least once during the prior 30 days: 20%; in addition, 26% said they currently used some type of tobacco (cigarettes, smokeless tobacco, or cigars).

▸ Had consumed at least five alcoholic drinks in a row on at least 1 day during the prior 30 days: 24%.

▸ Had used cocaine at least once: 6%.

▸ Had consumed a can, bottle, or glass of sugary soda at least once in the prior week: 29%.

▸ Did not participate in at least 60 minutes of any physical activity at least once in the prior week: 23%.

Dating violence was reported by 10% of survey participants, more often by black and Hispanic respondents than by white respondents.

For more information, go to www.cdc.gov/yrbs

TORONTO – Patients who continued annual treatment with zoledronic acid for 6 years had significantly better bone mineral density and fewer morphometric vertebral fractures than did patients who received 3 years of treatment and then stopped, in a controlled study with more than 1,200 patients.

Six continuous years of annual zoledronic acid treatment also proved safe, making continued treatment with this bisphosphonate formulation an option for patients who might benefit, Dennis M. Black, Ph.D., said at the annual meeting of the American Society for Bone and Mineral Research.

“After 3 years, it might be beneficial for some women, particularly those at high vertebral fracture risk, to continue zoledronic acid for an additional 3 years,” said Dr. Black, professor of epidemiology and biostatistics at the University of California, San Francisco. “These new findings show that continued treatment with zoledronic acid for 6 years continues to maintain bone mass and reduced vertebral fracture risk with no change to its favorable safety profile compared with discontinuation of treatment after 3 years,” he said in a written statement.

On the other hand, the decision to continue bisphosphonate treatment long term must be individualized, he said. It may be possible to identify women who would benefit from a drug holiday.

With the new finding, zoledronic acid joins other bisphosphonates, such as alendronate, shown to prevent loss of bone density when the drug is continued after several years of treatment. In a prior report, continuing treatment with alendronate for 5 years following an initial 5 years of treatment led to less bone density loss than in patients who switched from alendronate to placebo (JAMA 2006;296:2927-38). The same alendronate study failed to show that continued bisphosphonate treatment led to a reduced rate of morphometric vertebral fractures, compared with stopping alendronate.

The new zoledronic acid findings came from an extension of the Health Outcomes and Reduced Incidence With Zoledronic Acid Once Yearly (HORIZON) Pivotal Fracture Trial, which compared a single, annual infusion of zoledronic acid with placebo in postmenopausal women with osteoporosis during 3 years of treatment (N. Engl. J. Med. 2007;356:1809-22).

Dr. Black and his associates randomized 1,233 women who completed the zoledronic acid arm of the study to either continue with another 3 years of annual infusions of 5 mg zoledronic acid or switch to placebo. Their average age was 76, and about 55% had a femoral neck T score of less than –2.5.

At the end of the study, the percent change in femoral neck bone mineral density, compared with the level at entry into the study, averaged 1% higher in patients treated with zoledronic acid, a statistically significant difference in the study’s primary end point. Femoral neck bone mineral density in the zoledronic acid–treated patients increased by an average of 1.4% over their baseline 6 years earlier (when they started on the drug), compared with those who switched off the bisphosphonate after 3 years, also a statistically significant difference.

The rate of morphometric vertebral fractures during the 3 years of the new study totaled 6% in the patients on placebo and 3% in those on zoledronic acid, a statistically significant difference. The two treatment arms showed no significant difference in their rates of nonvertebral fractures. Continued zoledronic acid treatment also led to reduced blood levels of a marker of bone turnover compared with the patients who received placebo injections.

Six years of annual zoledronic acid treatment appeared safe, with no excess of adverse events or serious adverse events compared with the patients on 3 years of placebo. The researchers looked especially closely at cardiovascular events; the only significant, between-treatment difference was in new hypertensive adverse events, which occurred significantly more often in the patients who received placebo for 3 years.

The HORIZON Pivotal Fracture Trial was funded by Novartis, which markets zoledronic acid (Aclasta). Dr. Black said that he has served as a consultant and done teaching for Amgen Inc. and Nycomed, and that he has received research contracts from Amgen, Merck & Co., Novartis, and Roche/Genentech.

TORONTO – Patients who continued annual treatment with zoledronic acid for 6 years had significantly better bone mineral density and fewer morphometric vertebral fractures than did patients who received 3 years of treatment and then stopped, in a controlled study with more than 1,200 patients.

Six continuous years of annual zoledronic acid treatment also proved safe, making continued treatment with this bisphosphonate formulation an option for patients who might benefit, Dennis M. Black, Ph.D., said at the annual meeting of the American Society for Bone and Mineral Research.

“After 3 years, it might be beneficial for some women, particularly those at high vertebral fracture risk, to continue zoledronic acid for an additional 3 years,” said Dr. Black, professor of epidemiology and biostatistics at the University of California, San Francisco. “These new findings show that continued treatment with zoledronic acid for 6 years continues to maintain bone mass and reduced vertebral fracture risk with no change to its favorable safety profile compared with discontinuation of treatment after 3 years,” he said in a written statement.

On the other hand, the decision to continue bisphosphonate treatment long term must be individualized, he said. It may be possible to identify women who would benefit from a drug holiday.

With the new finding, zoledronic acid joins other bisphosphonates, such as alendronate, shown to prevent loss of bone density when the drug is continued after several years of treatment. In a prior report, continuing treatment with alendronate for 5 years following an initial 5 years of treatment led to less bone density loss than in patients who switched from alendronate to placebo (JAMA 2006;296:2927-38). The same alendronate study failed to show that continued bisphosphonate treatment led to a reduced rate of morphometric vertebral fractures, compared with stopping alendronate.

The new zoledronic acid findings came from an extension of the Health Outcomes and Reduced Incidence With Zoledronic Acid Once Yearly (HORIZON) Pivotal Fracture Trial, which compared a single, annual infusion of zoledronic acid with placebo in postmenopausal women with osteoporosis during 3 years of treatment (N. Engl. J. Med. 2007;356:1809-22).

Dr. Black and his associates randomized 1,233 women who completed the zoledronic acid arm of the study to either continue with another 3 years of annual infusions of 5 mg zoledronic acid or switch to placebo. Their average age was 76, and about 55% had a femoral neck T score of less than –2.5.

At the end of the study, the percent change in femoral neck bone mineral density, compared with the level at entry into the study, averaged 1% higher in patients treated with zoledronic acid, a statistically significant difference in the study’s primary end point. Femoral neck bone mineral density in the zoledronic acid–treated patients increased by an average of 1.4% over their baseline 6 years earlier (when they started on the drug), compared with those who switched off the bisphosphonate after 3 years, also a statistically significant difference.

The rate of morphometric vertebral fractures during the 3 years of the new study totaled 6% in the patients on placebo and 3% in those on zoledronic acid, a statistically significant difference. The two treatment arms showed no significant difference in their rates of nonvertebral fractures. Continued zoledronic acid treatment also led to reduced blood levels of a marker of bone turnover compared with the patients who received placebo injections.

Six years of annual zoledronic acid treatment appeared safe, with no excess of adverse events or serious adverse events compared with the patients on 3 years of placebo. The researchers looked especially closely at cardiovascular events; the only significant, between-treatment difference was in new hypertensive adverse events, which occurred significantly more often in the patients who received placebo for 3 years.

The HORIZON Pivotal Fracture Trial was funded by Novartis, which markets zoledronic acid (Aclasta). Dr. Black said that he has served as a consultant and done teaching for Amgen Inc. and Nycomed, and that he has received research contracts from Amgen, Merck & Co., Novartis, and Roche/Genentech.

TORONTO – Patients who continued annual treatment with zoledronic acid for 6 years had significantly better bone mineral density and fewer morphometric vertebral fractures than did patients who received 3 years of treatment and then stopped, in a controlled study with more than 1,200 patients.

Six continuous years of annual zoledronic acid treatment also proved safe, making continued treatment with this bisphosphonate formulation an option for patients who might benefit, Dennis M. Black, Ph.D., said at the annual meeting of the American Society for Bone and Mineral Research.

“After 3 years, it might be beneficial for some women, particularly those at high vertebral fracture risk, to continue zoledronic acid for an additional 3 years,” said Dr. Black, professor of epidemiology and biostatistics at the University of California, San Francisco. “These new findings show that continued treatment with zoledronic acid for 6 years continues to maintain bone mass and reduced vertebral fracture risk with no change to its favorable safety profile compared with discontinuation of treatment after 3 years,” he said in a written statement.

On the other hand, the decision to continue bisphosphonate treatment long term must be individualized, he said. It may be possible to identify women who would benefit from a drug holiday.

With the new finding, zoledronic acid joins other bisphosphonates, such as alendronate, shown to prevent loss of bone density when the drug is continued after several years of treatment. In a prior report, continuing treatment with alendronate for 5 years following an initial 5 years of treatment led to less bone density loss than in patients who switched from alendronate to placebo (JAMA 2006;296:2927-38). The same alendronate study failed to show that continued bisphosphonate treatment led to a reduced rate of morphometric vertebral fractures, compared with stopping alendronate.

The new zoledronic acid findings came from an extension of the Health Outcomes and Reduced Incidence With Zoledronic Acid Once Yearly (HORIZON) Pivotal Fracture Trial, which compared a single, annual infusion of zoledronic acid with placebo in postmenopausal women with osteoporosis during 3 years of treatment (N. Engl. J. Med. 2007;356:1809-22).

Dr. Black and his associates randomized 1,233 women who completed the zoledronic acid arm of the study to either continue with another 3 years of annual infusions of 5 mg zoledronic acid or switch to placebo. Their average age was 76, and about 55% had a femoral neck T score of less than –2.5.

At the end of the study, the percent change in femoral neck bone mineral density, compared with the level at entry into the study, averaged 1% higher in patients treated with zoledronic acid, a statistically significant difference in the study’s primary end point. Femoral neck bone mineral density in the zoledronic acid–treated patients increased by an average of 1.4% over their baseline 6 years earlier (when they started on the drug), compared with those who switched off the bisphosphonate after 3 years, also a statistically significant difference.

The rate of morphometric vertebral fractures during the 3 years of the new study totaled 6% in the patients on placebo and 3% in those on zoledronic acid, a statistically significant difference. The two treatment arms showed no significant difference in their rates of nonvertebral fractures. Continued zoledronic acid treatment also led to reduced blood levels of a marker of bone turnover compared with the patients who received placebo injections.

Six years of annual zoledronic acid treatment appeared safe, with no excess of adverse events or serious adverse events compared with the patients on 3 years of placebo. The researchers looked especially closely at cardiovascular events; the only significant, between-treatment difference was in new hypertensive adverse events, which occurred significantly more often in the patients who received placebo for 3 years.

The HORIZON Pivotal Fracture Trial was funded by Novartis, which markets zoledronic acid (Aclasta). Dr. Black said that he has served as a consultant and done teaching for Amgen Inc. and Nycomed, and that he has received research contracts from Amgen, Merck & Co., Novartis, and Roche/Genentech.

TORONTO – A daily vitamin D dose of at least 792 IU was linked with significantly reduced rates of nonvertebral fractures and hip fractures in a meta-analysis of data from 11 randomized, controlled trials.

But the benefit from vitamin D appeared blunted when combined with a higher calcium dose, or when patients received vitamin D once yearly, Dr. Heike A. Bischoff-Ferrari reported.

Kaspri/Fotolia.com

In the meta-analysis, patients in the highest quartile for daily vitamin D intake, 792-2000 IU, had a statistically significant 14% reduced rate of any nonvertebral fracture, and a significant 30% reduced rate of hip fractures, in an analysis that adjusted for age, gender, and type of dwelling, said Dr. Bischoff-Ferrari, a rheumatologist at the University of Zurich.

Her meta-analysis pooled individual participant data from 12 double-blind, randomized, controlled trials that examined the impact of vitamin D supplements on fracture rate in people aged 65 years or older published through June 2010, and for which she could obtain individual participant data. The primary analysis focused on the 11 studies of the 12 in which participants received the supplement at least monthly, with 31,022 people enrolled. The twelfth study tested once annual dosing, and the researchers included those data in a separate analysis. The participants’ average age was 76 years, and about 90% were women.

The analysis divided the study subjects into the control group, with more than 15,000 people, and then into quartiles of their received amount of vitamin D, including both their study-treatment dose and any additional vitamin D intake. The analysis also took into account adherence to treatment. Each vitamin D quartile contained nearly 4,000 people, with a daily dose range of 792-2,000 mg forming the top quartile. Only the top quartile of vitamin intake linked with statistically significant differences, compared with the controls, for any nonvertebral fracture and for hip fracture.

Adding the data from the one trial that tested annual vitamin D treatment to the meta-analysis eliminated the statistically significant effect on fracture rates, suggesting that yearly administration of vitamin D produces a different effect than daily, weekly, or monthly treatment.

An additional analysis that looked at the interaction of calcium supplements along with vitamin D showed that with a daily calcium dose below 1,000 mg/day a high-dose vitamin D supplement (792-2,000 mg/day) linked with a statistically significant reduction in nonvertebral fractures, but when the daily calcium supplement delivered 1,000 mg or more, this amount of vitamin D did not associate with any significant change in fracture rate, suggesting an adverse effect from higher calcium intake.

Dr. Bischoff-Ferrari said that she had no disclosures.

* The units of the dosage range were incorrect in the original story and have been corrected.

TORONTO – A daily vitamin D dose of at least 792 IU was linked with significantly reduced rates of nonvertebral fractures and hip fractures in a meta-analysis of data from 11 randomized, controlled trials.

But the benefit from vitamin D appeared blunted when combined with a higher calcium dose, or when patients received vitamin D once yearly, Dr. Heike A. Bischoff-Ferrari reported.

Kaspri/Fotolia.com

In the meta-analysis, patients in the highest quartile for daily vitamin D intake, 792-2000 IU, had a statistically significant 14% reduced rate of any nonvertebral fracture, and a significant 30% reduced rate of hip fractures, in an analysis that adjusted for age, gender, and type of dwelling, said Dr. Bischoff-Ferrari, a rheumatologist at the University of Zurich.

Her meta-analysis pooled individual participant data from 12 double-blind, randomized, controlled trials that examined the impact of vitamin D supplements on fracture rate in people aged 65 years or older published through June 2010, and for which she could obtain individual participant data. The primary analysis focused on the 11 studies of the 12 in which participants received the supplement at least monthly, with 31,022 people enrolled. The twelfth study tested once annual dosing, and the researchers included those data in a separate analysis. The participants’ average age was 76 years, and about 90% were women.

The analysis divided the study subjects into the control group, with more than 15,000 people, and then into quartiles of their received amount of vitamin D, including both their study-treatment dose and any additional vitamin D intake. The analysis also took into account adherence to treatment. Each vitamin D quartile contained nearly 4,000 people, with a daily dose range of 792-2,000 mg forming the top quartile. Only the top quartile of vitamin intake linked with statistically significant differences, compared with the controls, for any nonvertebral fracture and for hip fracture.

Adding the data from the one trial that tested annual vitamin D treatment to the meta-analysis eliminated the statistically significant effect on fracture rates, suggesting that yearly administration of vitamin D produces a different effect than daily, weekly, or monthly treatment.

An additional analysis that looked at the interaction of calcium supplements along with vitamin D showed that with a daily calcium dose below 1,000 mg/day a high-dose vitamin D supplement (792-2,000 mg/day) linked with a statistically significant reduction in nonvertebral fractures, but when the daily calcium supplement delivered 1,000 mg or more, this amount of vitamin D did not associate with any significant change in fracture rate, suggesting an adverse effect from higher calcium intake.

Dr. Bischoff-Ferrari said that she had no disclosures.

* The units of the dosage range were incorrect in the original story and have been corrected.

TORONTO – A daily vitamin D dose of at least 792 IU was linked with significantly reduced rates of nonvertebral fractures and hip fractures in a meta-analysis of data from 11 randomized, controlled trials.

But the benefit from vitamin D appeared blunted when combined with a higher calcium dose, or when patients received vitamin D once yearly, Dr. Heike A. Bischoff-Ferrari reported.

Kaspri/Fotolia.com

In the meta-analysis, patients in the highest quartile for daily vitamin D intake, 792-2000 IU, had a statistically significant 14% reduced rate of any nonvertebral fracture, and a significant 30% reduced rate of hip fractures, in an analysis that adjusted for age, gender, and type of dwelling, said Dr. Bischoff-Ferrari, a rheumatologist at the University of Zurich.

Her meta-analysis pooled individual participant data from 12 double-blind, randomized, controlled trials that examined the impact of vitamin D supplements on fracture rate in people aged 65 years or older published through June 2010, and for which she could obtain individual participant data. The primary analysis focused on the 11 studies of the 12 in which participants received the supplement at least monthly, with 31,022 people enrolled. The twelfth study tested once annual dosing, and the researchers included those data in a separate analysis. The participants’ average age was 76 years, and about 90% were women.

The analysis divided the study subjects into the control group, with more than 15,000 people, and then into quartiles of their received amount of vitamin D, including both their study-treatment dose and any additional vitamin D intake. The analysis also took into account adherence to treatment. Each vitamin D quartile contained nearly 4,000 people, with a daily dose range of 792-2,000 mg forming the top quartile. Only the top quartile of vitamin intake linked with statistically significant differences, compared with the controls, for any nonvertebral fracture and for hip fracture.

Adding the data from the one trial that tested annual vitamin D treatment to the meta-analysis eliminated the statistically significant effect on fracture rates, suggesting that yearly administration of vitamin D produces a different effect than daily, weekly, or monthly treatment.

An additional analysis that looked at the interaction of calcium supplements along with vitamin D showed that with a daily calcium dose below 1,000 mg/day a high-dose vitamin D supplement (792-2,000 mg/day) linked with a statistically significant reduction in nonvertebral fractures, but when the daily calcium supplement delivered 1,000 mg or more, this amount of vitamin D did not associate with any significant change in fracture rate, suggesting an adverse effect from higher calcium intake.

Dr. Bischoff-Ferrari said that she had no disclosures.

* The units of the dosage range were incorrect in the original story and have been corrected.

BRUSSELS – A carefully designed, 3-month program of rehabilitation exercise and education in patients with articular cartilage lesions who were scheduled for cartilage repair surgery led to significant improvements in knee function in a single-center study with 48 patients.

Following the 3-month rehabilitation intervention, 64% of the patients said they no longer needed immediate surgery, May Arna Risberg, Ph.D., said at the World Congress on Osteoarthritis.

“I believe this [rehabilitation] program works for these patients. We will publish the program, and continue to use it ourselves, and we hope others will use it,” said Dr. Risberg, professor of sports medicine at the Norwegian School of Sport Sciences in Oslo. Gradually increasing knee loading using an individualized schedule may explain the rehab program’s success, she said.

“Patients with cartilage lesions are very different from osteoarthritis patients. You need to go much slower with progression of their knee loading. Rehab for cartilage needs to be slow and long,” she said in an interview.

All 48 patients in the study had undergone prior rehab sessions run by other clinicians using different protocols. But aside from the focus on a gradual pace, an emphasis on using knee loading to guide the program’s intensity, and a strong education component, the rehab program tested by Dr. Risberg didn’t involve any novel approaches or exercise regimens.

Participating patients attended rehab sessions of the Oslo CARE (cartilage, active, rehab, and education) program an average of twice a week. Sessions included warm-up stretches, gait retraining, neuromuscular exercises, step-up and step-down exercises, and strength exercise for knee and hip muscles. Both the step and strength exercises featured gradually increasing loading over time. The program also included educational sessions and materials.

The study enrolled patients who had a focal femoral-condyle defect in the articular cartilage of one knee, diagnosed by arthroscopy, and who were scheduled for repair surgery. Their age averaged 34 years, (range, 17-50); 70% were men, and 84% had a medial femoral-condyle lesion. Participants had had their symptoms for an average of 47 months prior to the study.

Analysis of training diaries and responses in biweekly questionnaires showed that 79% of participants adhered to their rehab regimens, and 88% had follow-up assessments an average of 104 days after they entered the study.

At follow-up, participants averaged a 30% improvement over baseline in both extension and flexion of their injured knee, Dr. Risberg reported at the meeting, sponsored by the Osteoarthritis Research Society International. They also averaged improvements of 21%, 31%, and 37% in the triple, crossover, and one-leg hop tests, respectively, compared with baseline, all statistically significant increases.

They also had significant improvements in measures of pain, activity, and quality of life. Dr. Risberg cited the finding that nearly two-thirds of patients said they no longer needed immediate knee surgery as the best demonstration of their improvement.

She cautioned that despite completing the 3-month program, some patients had no significant response to their rehabilitation, and that additional studies should test the program in more patients with longer follow-up.

Dr. Risberg said she had no conflicts of interest.

BRUSSELS – A carefully designed, 3-month program of rehabilitation exercise and education in patients with articular cartilage lesions who were scheduled for cartilage repair surgery led to significant improvements in knee function in a single-center study with 48 patients.

Following the 3-month rehabilitation intervention, 64% of the patients said they no longer needed immediate surgery, May Arna Risberg, Ph.D., said at the World Congress on Osteoarthritis.

“I believe this [rehabilitation] program works for these patients. We will publish the program, and continue to use it ourselves, and we hope others will use it,” said Dr. Risberg, professor of sports medicine at the Norwegian School of Sport Sciences in Oslo. Gradually increasing knee loading using an individualized schedule may explain the rehab program’s success, she said.

“Patients with cartilage lesions are very different from osteoarthritis patients. You need to go much slower with progression of their knee loading. Rehab for cartilage needs to be slow and long,” she said in an interview.

All 48 patients in the study had undergone prior rehab sessions run by other clinicians using different protocols. But aside from the focus on a gradual pace, an emphasis on using knee loading to guide the program’s intensity, and a strong education component, the rehab program tested by Dr. Risberg didn’t involve any novel approaches or exercise regimens.

Participating patients attended rehab sessions of the Oslo CARE (cartilage, active, rehab, and education) program an average of twice a week. Sessions included warm-up stretches, gait retraining, neuromuscular exercises, step-up and step-down exercises, and strength exercise for knee and hip muscles. Both the step and strength exercises featured gradually increasing loading over time. The program also included educational sessions and materials.

The study enrolled patients who had a focal femoral-condyle defect in the articular cartilage of one knee, diagnosed by arthroscopy, and who were scheduled for repair surgery. Their age averaged 34 years, (range, 17-50); 70% were men, and 84% had a medial femoral-condyle lesion. Participants had had their symptoms for an average of 47 months prior to the study.

Analysis of training diaries and responses in biweekly questionnaires showed that 79% of participants adhered to their rehab regimens, and 88% had follow-up assessments an average of 104 days after they entered the study.

At follow-up, participants averaged a 30% improvement over baseline in both extension and flexion of their injured knee, Dr. Risberg reported at the meeting, sponsored by the Osteoarthritis Research Society International. They also averaged improvements of 21%, 31%, and 37% in the triple, crossover, and one-leg hop tests, respectively, compared with baseline, all statistically significant increases.

They also had significant improvements in measures of pain, activity, and quality of life. Dr. Risberg cited the finding that nearly two-thirds of patients said they no longer needed immediate knee surgery as the best demonstration of their improvement.

She cautioned that despite completing the 3-month program, some patients had no significant response to their rehabilitation, and that additional studies should test the program in more patients with longer follow-up.

Dr. Risberg said she had no conflicts of interest.

BRUSSELS – A carefully designed, 3-month program of rehabilitation exercise and education in patients with articular cartilage lesions who were scheduled for cartilage repair surgery led to significant improvements in knee function in a single-center study with 48 patients.

Following the 3-month rehabilitation intervention, 64% of the patients said they no longer needed immediate surgery, May Arna Risberg, Ph.D., said at the World Congress on Osteoarthritis.

“I believe this [rehabilitation] program works for these patients. We will publish the program, and continue to use it ourselves, and we hope others will use it,” said Dr. Risberg, professor of sports medicine at the Norwegian School of Sport Sciences in Oslo. Gradually increasing knee loading using an individualized schedule may explain the rehab program’s success, she said.

“Patients with cartilage lesions are very different from osteoarthritis patients. You need to go much slower with progression of their knee loading. Rehab for cartilage needs to be slow and long,” she said in an interview.

All 48 patients in the study had undergone prior rehab sessions run by other clinicians using different protocols. But aside from the focus on a gradual pace, an emphasis on using knee loading to guide the program’s intensity, and a strong education component, the rehab program tested by Dr. Risberg didn’t involve any novel approaches or exercise regimens.

Participating patients attended rehab sessions of the Oslo CARE (cartilage, active, rehab, and education) program an average of twice a week. Sessions included warm-up stretches, gait retraining, neuromuscular exercises, step-up and step-down exercises, and strength exercise for knee and hip muscles. Both the step and strength exercises featured gradually increasing loading over time. The program also included educational sessions and materials.

The study enrolled patients who had a focal femoral-condyle defect in the articular cartilage of one knee, diagnosed by arthroscopy, and who were scheduled for repair surgery. Their age averaged 34 years, (range, 17-50); 70% were men, and 84% had a medial femoral-condyle lesion. Participants had had their symptoms for an average of 47 months prior to the study.

Analysis of training diaries and responses in biweekly questionnaires showed that 79% of participants adhered to their rehab regimens, and 88% had follow-up assessments an average of 104 days after they entered the study.

At follow-up, participants averaged a 30% improvement over baseline in both extension and flexion of their injured knee, Dr. Risberg reported at the meeting, sponsored by the Osteoarthritis Research Society International. They also averaged improvements of 21%, 31%, and 37% in the triple, crossover, and one-leg hop tests, respectively, compared with baseline, all statistically significant increases.

They also had significant improvements in measures of pain, activity, and quality of life. Dr. Risberg cited the finding that nearly two-thirds of patients said they no longer needed immediate knee surgery as the best demonstration of their improvement.

She cautioned that despite completing the 3-month program, some patients had no significant response to their rehabilitation, and that additional studies should test the program in more patients with longer follow-up.

Dr. Risberg said she had no conflicts of interest.