Sara Freeman

LONDON – Neither the GLP-1 receptor agonist lixisenatide nor the DPP-4 inhibitor sitagliptin significantly increased the risk of heart failure or associated hospitalizations in patients with type 2 diabetes, according to data from two large cardiovascular safety trials.

Further analysis from ELIXA (Evaluation of Lixisenatide [Lyxumia] in Acute Coronary Syndrome) showed that the hazard ratios for several secondary heart failure endpoints were 1.00 or below. Although the risk for heart failure hospitalization was found to be nine times higher in patients who had a prior history of heart failure than in those who did not, there was there was no difference between treatment with the GLP-1 (glucagon-like peptide 1) agonist or placebo.

The findings add to those already presented in June at the annual scientific sessions of the American Diabetes Association from the 6,068-patient trial, which enrolled patients with type 2 diabetes who had experienced an acute coronary syndrome within the past 6 months.

Other reassuring data on the safety of newer diabetes medicines came from an updated analysis of TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin [Januvia]). The time to first hospitalization for heart failure did not differ between the placebo and sitagliptin arms, and there were no differences between the treatments in terms of hospitalization for heart failure or cardiovascular death or hospitalization for heart failure or all-cause death with the DPP-4 (dipeptyl peptidase 4) inhibitor. TECOS enrolled nearly 15,000 patients with type 2 diabetes and concurrent cardiovascular disease who were aged 50 years or older and the primary findings have been published (N Engl J Med. 2015 July 15;373:232-42).

These trials provide accumulating evidence that there is no heart failure risk with these particular diabetes medications, Dr. Lars Rydén, professor of cardiology at the Karolinska Institute in Stockholm, commented in an interview at the annual congress of the European Society of Cardiology. Dr. Rydén added that the trial results everyone is waiting to hear about concern the cardiovascular safety of the selective sodium–glucose cotransporter-2 (SGLT-2) inhibitor empagliflozin (Jardiance).

Advance information issued by manufacturer Boehringer-Ingelheim suggests that this drug actually may lower cardiovascular risk in patients at high risk for cardiovascular events, Dr. Rydén observed. “Now, if that is true, it is the only modern glucose-lowering drug to have shown such a capacity.” Results of the EMPA-REG OUTCOME study will be presented in September at the annual meeting of the European Association for the Study of Diabetes in Stockholm.

LONDON – Neither the GLP-1 receptor agonist lixisenatide nor the DPP-4 inhibitor sitagliptin significantly increased the risk of heart failure or associated hospitalizations in patients with type 2 diabetes, according to data from two large cardiovascular safety trials.

Further analysis from ELIXA (Evaluation of Lixisenatide [Lyxumia] in Acute Coronary Syndrome) showed that the hazard ratios for several secondary heart failure endpoints were 1.00 or below. Although the risk for heart failure hospitalization was found to be nine times higher in patients who had a prior history of heart failure than in those who did not, there was there was no difference between treatment with the GLP-1 (glucagon-like peptide 1) agonist or placebo.

The findings add to those already presented in June at the annual scientific sessions of the American Diabetes Association from the 6,068-patient trial, which enrolled patients with type 2 diabetes who had experienced an acute coronary syndrome within the past 6 months.

Other reassuring data on the safety of newer diabetes medicines came from an updated analysis of TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin [Januvia]). The time to first hospitalization for heart failure did not differ between the placebo and sitagliptin arms, and there were no differences between the treatments in terms of hospitalization for heart failure or cardiovascular death or hospitalization for heart failure or all-cause death with the DPP-4 (dipeptyl peptidase 4) inhibitor. TECOS enrolled nearly 15,000 patients with type 2 diabetes and concurrent cardiovascular disease who were aged 50 years or older and the primary findings have been published (N Engl J Med. 2015 July 15;373:232-42).

These trials provide accumulating evidence that there is no heart failure risk with these particular diabetes medications, Dr. Lars Rydén, professor of cardiology at the Karolinska Institute in Stockholm, commented in an interview at the annual congress of the European Society of Cardiology. Dr. Rydén added that the trial results everyone is waiting to hear about concern the cardiovascular safety of the selective sodium–glucose cotransporter-2 (SGLT-2) inhibitor empagliflozin (Jardiance).

Advance information issued by manufacturer Boehringer-Ingelheim suggests that this drug actually may lower cardiovascular risk in patients at high risk for cardiovascular events, Dr. Rydén observed. “Now, if that is true, it is the only modern glucose-lowering drug to have shown such a capacity.” Results of the EMPA-REG OUTCOME study will be presented in September at the annual meeting of the European Association for the Study of Diabetes in Stockholm.

LONDON – Neither the GLP-1 receptor agonist lixisenatide nor the DPP-4 inhibitor sitagliptin significantly increased the risk of heart failure or associated hospitalizations in patients with type 2 diabetes, according to data from two large cardiovascular safety trials.

Further analysis from ELIXA (Evaluation of Lixisenatide [Lyxumia] in Acute Coronary Syndrome) showed that the hazard ratios for several secondary heart failure endpoints were 1.00 or below. Although the risk for heart failure hospitalization was found to be nine times higher in patients who had a prior history of heart failure than in those who did not, there was there was no difference between treatment with the GLP-1 (glucagon-like peptide 1) agonist or placebo.

The findings add to those already presented in June at the annual scientific sessions of the American Diabetes Association from the 6,068-patient trial, which enrolled patients with type 2 diabetes who had experienced an acute coronary syndrome within the past 6 months.

Other reassuring data on the safety of newer diabetes medicines came from an updated analysis of TECOS (Trial Evaluating Cardiovascular Outcomes With Sitagliptin [Januvia]). The time to first hospitalization for heart failure did not differ between the placebo and sitagliptin arms, and there were no differences between the treatments in terms of hospitalization for heart failure or cardiovascular death or hospitalization for heart failure or all-cause death with the DPP-4 (dipeptyl peptidase 4) inhibitor. TECOS enrolled nearly 15,000 patients with type 2 diabetes and concurrent cardiovascular disease who were aged 50 years or older and the primary findings have been published (N Engl J Med. 2015 July 15;373:232-42).

These trials provide accumulating evidence that there is no heart failure risk with these particular diabetes medications, Dr. Lars Rydén, professor of cardiology at the Karolinska Institute in Stockholm, commented in an interview at the annual congress of the European Society of Cardiology. Dr. Rydén added that the trial results everyone is waiting to hear about concern the cardiovascular safety of the selective sodium–glucose cotransporter-2 (SGLT-2) inhibitor empagliflozin (Jardiance).

Advance information issued by manufacturer Boehringer-Ingelheim suggests that this drug actually may lower cardiovascular risk in patients at high risk for cardiovascular events, Dr. Rydén observed. “Now, if that is true, it is the only modern glucose-lowering drug to have shown such a capacity.” Results of the EMPA-REG OUTCOME study will be presented in September at the annual meeting of the European Association for the Study of Diabetes in Stockholm.

LONDON – A wireless pacemaker that is secured within the right ventricle of the heart proved both effective and safe in a prospective, nonrandomized, multicenter study.

Interim results obtained for 300 patients at 6 months’ follow-up in the LEADLESS II study showed that the primary efficacy endpoint of both an acceptable pacing threshold and an acceptable sensing amplitude was achieved in 90% of patients, and the primary safety endpoint of freedom from device-related serious adverse events was achieved in 93.3%.

Both of these findings exceeded the performance goal of 85% set in the study, said principal study investigator Dr. Vivek Reddy at the annual congress of the European Society of Cardiology.

“Regular pacemakers are very reliable devices; they’ve been around for half a century,” said Dr. Reddy, who is professor of medicine at Mount Sinai Hospital in New York. “Having said that, they are not perfect,” he observed.

Conventional pacemakers require surgical implantation in the chest, and the wires or leads that go from the device need to be embedded in the vasculature of the heart itself. While the risk of complications is low (around 4% of all implanted devices), when they do happen they usually occur around the site where the pacemaker is implanted or involve placement of the leads in veins.

In contrast, the small cylindrical Nanostim device used in the study is a fully self-contained leadless pacemaker that can be nonsurgically implanted and removed via a catheter threaded through the femoral vein and into the patient’s right ventricle. It is about the size of an AAA battery and, based on the study’s findings, has a potential battery life of 15 years. This is comparable to similar standard single-chamber ventricular pacemakers, according to the manufacturer, St. Jude Medical.

The feasibility of using the device was first shown in the LEADLESS study (Circulation 2014;129:1466-71) and are now confirmed in the LEADLESS II study, which has enrolled 526 patients to date, with successful implantation of the device in 504 patients.

The mean age of the mostly male (61.8%) study cohort was 76 years, with the primary indication for pacemaker placement being atrial fibrillation with atrioventricular block in 55.9%.

The study was performed in 56 centers in the United States, Canada, and Australia and involved 100 operators, only one of whom had prior experience with leadless pacing, Dr. Reddy observed. On average the leadless device was placed within a half hour, and the majority (70.2%) did not require repositioning of the device during the original procedure.

The rate of serious device-related adverse events, such as dislodgement warranting percutaneous retrieval or cardiac perforation, was low, at a rate of 6.7% overall and 1.7% and 1.3%, respectively, with just 1.3% of patients needing to have the device removed because of an increased pacing threshold. There were no device-related deaths, but two deaths occurred that were thought to be procedure related. This is comparable to traditional pacemakers, Dr. Reddy said, although he noted that he was referring to historical controls as this was not a randomized trial.

“The device was shown to be retrievable in a subgroup of seven patients who needed a replacement at a mean of 160 days after implantation,” he noted. Due to the relatively short duration of follow-up, however, “we really can’t talk about what happens with extended follow-up and what happens 5, 10, or 15 years down the line whether we retrieve the devices or simply abandon them and put in a second device.”

The study included patients who had an indication for a single-chamber pacemaker only. Dr. Reddy noted that one of the study limitations is that the device is not suitable for patients needing dual-chamber pacing. The observational nature of the trial also limits the conclusions that can be drawn, and the device does not provide electrocardiogram data.

The Nanostim device is one of two self-contained, miniature wireless pacemakers given marketing authorization in Europe, but both have yet to be approved by the Food and Drug Administration. The other device, Medtronic’s Micra Transcatheter Pacing System, is also placed in the right ventricle and is being studied in the Micra Transcatheter Pacing Study, with promising first-in-human results presented recently at Heart Rhythm 2015.

St. Jude Medical funded the study. Dr. Reddy has received grant support, acted as a consultant to, and received stock options in Nanostim from the company.

LONDON – A wireless pacemaker that is secured within the right ventricle of the heart proved both effective and safe in a prospective, nonrandomized, multicenter study.

Interim results obtained for 300 patients at 6 months’ follow-up in the LEADLESS II study showed that the primary efficacy endpoint of both an acceptable pacing threshold and an acceptable sensing amplitude was achieved in 90% of patients, and the primary safety endpoint of freedom from device-related serious adverse events was achieved in 93.3%.

Both of these findings exceeded the performance goal of 85% set in the study, said principal study investigator Dr. Vivek Reddy at the annual congress of the European Society of Cardiology.

“Regular pacemakers are very reliable devices; they’ve been around for half a century,” said Dr. Reddy, who is professor of medicine at Mount Sinai Hospital in New York. “Having said that, they are not perfect,” he observed.

Conventional pacemakers require surgical implantation in the chest, and the wires or leads that go from the device need to be embedded in the vasculature of the heart itself. While the risk of complications is low (around 4% of all implanted devices), when they do happen they usually occur around the site where the pacemaker is implanted or involve placement of the leads in veins.

In contrast, the small cylindrical Nanostim device used in the study is a fully self-contained leadless pacemaker that can be nonsurgically implanted and removed via a catheter threaded through the femoral vein and into the patient’s right ventricle. It is about the size of an AAA battery and, based on the study’s findings, has a potential battery life of 15 years. This is comparable to similar standard single-chamber ventricular pacemakers, according to the manufacturer, St. Jude Medical.

The feasibility of using the device was first shown in the LEADLESS study (Circulation 2014;129:1466-71) and are now confirmed in the LEADLESS II study, which has enrolled 526 patients to date, with successful implantation of the device in 504 patients.

The mean age of the mostly male (61.8%) study cohort was 76 years, with the primary indication for pacemaker placement being atrial fibrillation with atrioventricular block in 55.9%.

The study was performed in 56 centers in the United States, Canada, and Australia and involved 100 operators, only one of whom had prior experience with leadless pacing, Dr. Reddy observed. On average the leadless device was placed within a half hour, and the majority (70.2%) did not require repositioning of the device during the original procedure.

The rate of serious device-related adverse events, such as dislodgement warranting percutaneous retrieval or cardiac perforation, was low, at a rate of 6.7% overall and 1.7% and 1.3%, respectively, with just 1.3% of patients needing to have the device removed because of an increased pacing threshold. There were no device-related deaths, but two deaths occurred that were thought to be procedure related. This is comparable to traditional pacemakers, Dr. Reddy said, although he noted that he was referring to historical controls as this was not a randomized trial.

“The device was shown to be retrievable in a subgroup of seven patients who needed a replacement at a mean of 160 days after implantation,” he noted. Due to the relatively short duration of follow-up, however, “we really can’t talk about what happens with extended follow-up and what happens 5, 10, or 15 years down the line whether we retrieve the devices or simply abandon them and put in a second device.”

The study included patients who had an indication for a single-chamber pacemaker only. Dr. Reddy noted that one of the study limitations is that the device is not suitable for patients needing dual-chamber pacing. The observational nature of the trial also limits the conclusions that can be drawn, and the device does not provide electrocardiogram data.

The Nanostim device is one of two self-contained, miniature wireless pacemakers given marketing authorization in Europe, but both have yet to be approved by the Food and Drug Administration. The other device, Medtronic’s Micra Transcatheter Pacing System, is also placed in the right ventricle and is being studied in the Micra Transcatheter Pacing Study, with promising first-in-human results presented recently at Heart Rhythm 2015.

St. Jude Medical funded the study. Dr. Reddy has received grant support, acted as a consultant to, and received stock options in Nanostim from the company.

LONDON – A wireless pacemaker that is secured within the right ventricle of the heart proved both effective and safe in a prospective, nonrandomized, multicenter study.

Interim results obtained for 300 patients at 6 months’ follow-up in the LEADLESS II study showed that the primary efficacy endpoint of both an acceptable pacing threshold and an acceptable sensing amplitude was achieved in 90% of patients, and the primary safety endpoint of freedom from device-related serious adverse events was achieved in 93.3%.

Both of these findings exceeded the performance goal of 85% set in the study, said principal study investigator Dr. Vivek Reddy at the annual congress of the European Society of Cardiology.

“Regular pacemakers are very reliable devices; they’ve been around for half a century,” said Dr. Reddy, who is professor of medicine at Mount Sinai Hospital in New York. “Having said that, they are not perfect,” he observed.

Conventional pacemakers require surgical implantation in the chest, and the wires or leads that go from the device need to be embedded in the vasculature of the heart itself. While the risk of complications is low (around 4% of all implanted devices), when they do happen they usually occur around the site where the pacemaker is implanted or involve placement of the leads in veins.

In contrast, the small cylindrical Nanostim device used in the study is a fully self-contained leadless pacemaker that can be nonsurgically implanted and removed via a catheter threaded through the femoral vein and into the patient’s right ventricle. It is about the size of an AAA battery and, based on the study’s findings, has a potential battery life of 15 years. This is comparable to similar standard single-chamber ventricular pacemakers, according to the manufacturer, St. Jude Medical.

The feasibility of using the device was first shown in the LEADLESS study (Circulation 2014;129:1466-71) and are now confirmed in the LEADLESS II study, which has enrolled 526 patients to date, with successful implantation of the device in 504 patients.

The mean age of the mostly male (61.8%) study cohort was 76 years, with the primary indication for pacemaker placement being atrial fibrillation with atrioventricular block in 55.9%.

The study was performed in 56 centers in the United States, Canada, and Australia and involved 100 operators, only one of whom had prior experience with leadless pacing, Dr. Reddy observed. On average the leadless device was placed within a half hour, and the majority (70.2%) did not require repositioning of the device during the original procedure.

The rate of serious device-related adverse events, such as dislodgement warranting percutaneous retrieval or cardiac perforation, was low, at a rate of 6.7% overall and 1.7% and 1.3%, respectively, with just 1.3% of patients needing to have the device removed because of an increased pacing threshold. There were no device-related deaths, but two deaths occurred that were thought to be procedure related. This is comparable to traditional pacemakers, Dr. Reddy said, although he noted that he was referring to historical controls as this was not a randomized trial.

“The device was shown to be retrievable in a subgroup of seven patients who needed a replacement at a mean of 160 days after implantation,” he noted. Due to the relatively short duration of follow-up, however, “we really can’t talk about what happens with extended follow-up and what happens 5, 10, or 15 years down the line whether we retrieve the devices or simply abandon them and put in a second device.”

The study included patients who had an indication for a single-chamber pacemaker only. Dr. Reddy noted that one of the study limitations is that the device is not suitable for patients needing dual-chamber pacing. The observational nature of the trial also limits the conclusions that can be drawn, and the device does not provide electrocardiogram data.

The Nanostim device is one of two self-contained, miniature wireless pacemakers given marketing authorization in Europe, but both have yet to be approved by the Food and Drug Administration. The other device, Medtronic’s Micra Transcatheter Pacing System, is also placed in the right ventricle and is being studied in the Micra Transcatheter Pacing Study, with promising first-in-human results presented recently at Heart Rhythm 2015.

St. Jude Medical funded the study. Dr. Reddy has received grant support, acted as a consultant to, and received stock options in Nanostim from the company.

LONDON – Drinking more than three cups of coffee daily increased the risk of a cardiovascular event by 50% in a study of more than 1,000 adults aged 45 years or younger with mild, untreated hypertension.

The results of the Hypertension and Ambulatory Recording Venetia Study (HARVEST) also showed that even moderate coffee intake, defined as between one and three cups per day, could up the risk of a cardiovascular event when compared with non–coffee drinkers.

“Don’t drink a lot of coffee; reduce your intake,” Dr. Lucio Mos advised young to middle-aged hypertensive adults in a video interview at the annual congress of the European Society of Cardiology.

Heavy coffee drinking is a strong predictor of increasing blood pressure and rising blood glucose, said Dr. Mos of Hospital San Daniele del Friuli in Udine, Italy. In this study, which had a mean of 12.5 years of follow-up, there was a linear relationship between coffee intake and cardiovascular events such as heart attacks, with the risk increasing with higher coffee intake.

LONDON – Drinking more than three cups of coffee daily increased the risk of a cardiovascular event by 50% in a study of more than 1,000 adults aged 45 years or younger with mild, untreated hypertension.

The results of the Hypertension and Ambulatory Recording Venetia Study (HARVEST) also showed that even moderate coffee intake, defined as between one and three cups per day, could up the risk of a cardiovascular event when compared with non–coffee drinkers.

“Don’t drink a lot of coffee; reduce your intake,” Dr. Lucio Mos advised young to middle-aged hypertensive adults in a video interview at the annual congress of the European Society of Cardiology.

Heavy coffee drinking is a strong predictor of increasing blood pressure and rising blood glucose, said Dr. Mos of Hospital San Daniele del Friuli in Udine, Italy. In this study, which had a mean of 12.5 years of follow-up, there was a linear relationship between coffee intake and cardiovascular events such as heart attacks, with the risk increasing with higher coffee intake.

LONDON – Drinking more than three cups of coffee daily increased the risk of a cardiovascular event by 50% in a study of more than 1,000 adults aged 45 years or younger with mild, untreated hypertension.

The results of the Hypertension and Ambulatory Recording Venetia Study (HARVEST) also showed that even moderate coffee intake, defined as between one and three cups per day, could up the risk of a cardiovascular event when compared with non–coffee drinkers.

“Don’t drink a lot of coffee; reduce your intake,” Dr. Lucio Mos advised young to middle-aged hypertensive adults in a video interview at the annual congress of the European Society of Cardiology.

Heavy coffee drinking is a strong predictor of increasing blood pressure and rising blood glucose, said Dr. Mos of Hospital San Daniele del Friuli in Udine, Italy. In this study, which had a mean of 12.5 years of follow-up, there was a linear relationship between coffee intake and cardiovascular events such as heart attacks, with the risk increasing with higher coffee intake.

ROME – There was no advantage to individually prescribed exercises for knee osteoarthritis over usual physiotherapy in a multicenter, longitudinal, randomized study reported at the European Congress of Rheumatology.

Indeed, the results of the United Kingdom–based Benefits of Effective Exercise for knee Pain (BEEP) study showed that all of three of the interventions tested improved patients’ pain and physical function to a similar degree over the 18-month follow-up period.

“Clearer identification of those who respond to exercise, rather than changing the characteristics of exercise programs, is needed in future research,” suggested the presenting author Emma Healey, Ph.D., of Keele University, Staffordshire, England.

The aim of the BEEP was to see if changing the characteristics of exercise programs could improve patients’ outcomes when compared with usual physiotherapy. A total of 65 general practices, five National Health Service physiotherapy services, and 47 physiotherapists took part in the study and recruited 526 adults aged 45 years or older with knee osteoarthritis (OA) from a total of 1,530 who had been screened.

Three different interventions were compared: usual physiotherapy care consisting of up to four treatment sessions over 12 weeks (176 patients), an individually tailored and supervised exercise (ITE) program consisting of six to eight sessions over 12 weeks (178 patients), and a targeted exercise adherence (TEA) program consisting of 8-10 sessions over 6 months (172 patients). Data were collected at 3, 6, 9 and 18 months via postal questionnaires.

Participants in all groups received an advice booklet outlining the benefits of exercise and exercises to perform. Exercises were focused on the lower limb and selected from a template in the usual care group but individually prescribed and supervised in the other two groups. Patients in the TEA group also had exercises aimed at improving their overall fitness. An exercise diary was completed by those in the ITE group and an ‘adherence-enhancing toolkit’ was used by the TEA group.

The primary outcome measure used was change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scales at 6 months. On a scale of 0-20, no clinically or statistically significant differences were seen between the groups, with pain scores of 6.4, 6.4, and 6.2 for the usual care, ITE, and TEA groups, respectively. A similar pattern was seen for function scores (21.4, 22.3, 21.5, respectively) assessed on a scale of 0-68. These findings didn’t change over time, with all patients doing well with longer follow-up, Dr. Healey observed.

Clinical effectiveness was also evaluated according to Outcome Measures in Rheumatology–Osteoarthritis Research Society International (OMERACT-OARSI) responder criteria, but again no differences between the groups were found, with around half of the study population fitting responder criteria at 6 months.

Although patients’ self-reported adherence to their exercise was high at the 3-month assessment (75%-77%), it gradually declined over the course of the follow-up period. “Exercise behavior was back to baseline levels by 18 months,” Dr. Healey noted. Self-reported adherence appeared to remain higher for longer in the TEA group, but differences between treatment groups were again not statistically significant upon closer evaluation.

Usual physiotherapy had an edge over the other interventions in terms of both effectiveness measured in quality-adjusted life-years and knee OA–related resource use at 18 months’ follow-up, according to an economic evaluation.

“Economic analysis suggests usual care is ‘treatment of choice,’ ” Dr. Healey said.

The research was funded by the National Institute for Health Research and Arthritis UK. Dr. Healey reported having no financial disclosures.

ROME – There was no advantage to individually prescribed exercises for knee osteoarthritis over usual physiotherapy in a multicenter, longitudinal, randomized study reported at the European Congress of Rheumatology.

Indeed, the results of the United Kingdom–based Benefits of Effective Exercise for knee Pain (BEEP) study showed that all of three of the interventions tested improved patients’ pain and physical function to a similar degree over the 18-month follow-up period.

“Clearer identification of those who respond to exercise, rather than changing the characteristics of exercise programs, is needed in future research,” suggested the presenting author Emma Healey, Ph.D., of Keele University, Staffordshire, England.

The aim of the BEEP was to see if changing the characteristics of exercise programs could improve patients’ outcomes when compared with usual physiotherapy. A total of 65 general practices, five National Health Service physiotherapy services, and 47 physiotherapists took part in the study and recruited 526 adults aged 45 years or older with knee osteoarthritis (OA) from a total of 1,530 who had been screened.

Three different interventions were compared: usual physiotherapy care consisting of up to four treatment sessions over 12 weeks (176 patients), an individually tailored and supervised exercise (ITE) program consisting of six to eight sessions over 12 weeks (178 patients), and a targeted exercise adherence (TEA) program consisting of 8-10 sessions over 6 months (172 patients). Data were collected at 3, 6, 9 and 18 months via postal questionnaires.

Participants in all groups received an advice booklet outlining the benefits of exercise and exercises to perform. Exercises were focused on the lower limb and selected from a template in the usual care group but individually prescribed and supervised in the other two groups. Patients in the TEA group also had exercises aimed at improving their overall fitness. An exercise diary was completed by those in the ITE group and an ‘adherence-enhancing toolkit’ was used by the TEA group.

The primary outcome measure used was change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scales at 6 months. On a scale of 0-20, no clinically or statistically significant differences were seen between the groups, with pain scores of 6.4, 6.4, and 6.2 for the usual care, ITE, and TEA groups, respectively. A similar pattern was seen for function scores (21.4, 22.3, 21.5, respectively) assessed on a scale of 0-68. These findings didn’t change over time, with all patients doing well with longer follow-up, Dr. Healey observed.

Clinical effectiveness was also evaluated according to Outcome Measures in Rheumatology–Osteoarthritis Research Society International (OMERACT-OARSI) responder criteria, but again no differences between the groups were found, with around half of the study population fitting responder criteria at 6 months.

Although patients’ self-reported adherence to their exercise was high at the 3-month assessment (75%-77%), it gradually declined over the course of the follow-up period. “Exercise behavior was back to baseline levels by 18 months,” Dr. Healey noted. Self-reported adherence appeared to remain higher for longer in the TEA group, but differences between treatment groups were again not statistically significant upon closer evaluation.

Usual physiotherapy had an edge over the other interventions in terms of both effectiveness measured in quality-adjusted life-years and knee OA–related resource use at 18 months’ follow-up, according to an economic evaluation.

“Economic analysis suggests usual care is ‘treatment of choice,’ ” Dr. Healey said.

The research was funded by the National Institute for Health Research and Arthritis UK. Dr. Healey reported having no financial disclosures.

ROME – There was no advantage to individually prescribed exercises for knee osteoarthritis over usual physiotherapy in a multicenter, longitudinal, randomized study reported at the European Congress of Rheumatology.

Indeed, the results of the United Kingdom–based Benefits of Effective Exercise for knee Pain (BEEP) study showed that all of three of the interventions tested improved patients’ pain and physical function to a similar degree over the 18-month follow-up period.

“Clearer identification of those who respond to exercise, rather than changing the characteristics of exercise programs, is needed in future research,” suggested the presenting author Emma Healey, Ph.D., of Keele University, Staffordshire, England.

The aim of the BEEP was to see if changing the characteristics of exercise programs could improve patients’ outcomes when compared with usual physiotherapy. A total of 65 general practices, five National Health Service physiotherapy services, and 47 physiotherapists took part in the study and recruited 526 adults aged 45 years or older with knee osteoarthritis (OA) from a total of 1,530 who had been screened.

Three different interventions were compared: usual physiotherapy care consisting of up to four treatment sessions over 12 weeks (176 patients), an individually tailored and supervised exercise (ITE) program consisting of six to eight sessions over 12 weeks (178 patients), and a targeted exercise adherence (TEA) program consisting of 8-10 sessions over 6 months (172 patients). Data were collected at 3, 6, 9 and 18 months via postal questionnaires.

Participants in all groups received an advice booklet outlining the benefits of exercise and exercises to perform. Exercises were focused on the lower limb and selected from a template in the usual care group but individually prescribed and supervised in the other two groups. Patients in the TEA group also had exercises aimed at improving their overall fitness. An exercise diary was completed by those in the ITE group and an ‘adherence-enhancing toolkit’ was used by the TEA group.

The primary outcome measure used was change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain and function scales at 6 months. On a scale of 0-20, no clinically or statistically significant differences were seen between the groups, with pain scores of 6.4, 6.4, and 6.2 for the usual care, ITE, and TEA groups, respectively. A similar pattern was seen for function scores (21.4, 22.3, 21.5, respectively) assessed on a scale of 0-68. These findings didn’t change over time, with all patients doing well with longer follow-up, Dr. Healey observed.

Clinical effectiveness was also evaluated according to Outcome Measures in Rheumatology–Osteoarthritis Research Society International (OMERACT-OARSI) responder criteria, but again no differences between the groups were found, with around half of the study population fitting responder criteria at 6 months.

Although patients’ self-reported adherence to their exercise was high at the 3-month assessment (75%-77%), it gradually declined over the course of the follow-up period. “Exercise behavior was back to baseline levels by 18 months,” Dr. Healey noted. Self-reported adherence appeared to remain higher for longer in the TEA group, but differences between treatment groups were again not statistically significant upon closer evaluation.

Usual physiotherapy had an edge over the other interventions in terms of both effectiveness measured in quality-adjusted life-years and knee OA–related resource use at 18 months’ follow-up, according to an economic evaluation.

“Economic analysis suggests usual care is ‘treatment of choice,’ ” Dr. Healey said.

The research was funded by the National Institute for Health Research and Arthritis UK. Dr. Healey reported having no financial disclosures.

ROME – Erosive hand osteoarthritis (OA) is probably a more severe form of the disease, rather than a separate clinical entity, a team of Norwegian researchers has suggested.

Dr. Alexander Mathiessen and associates from Diakonhjemmet Hospital in Oslo found that synovial inflammation was more common in patients with erosive disease. However, when they stratified the 293 patients studied according to the degree of structural joint damage, they found that the differences disappeared.

“Modern imaging techniques such as MRI and ultrasound have shown high prevalence of synovitis in hand osteoarthritis,” they explained in a poster presentation at the European Congress of Rheumatology.

Although erosive hand OA is often considered a more inflammatory phenotype, with more pain and disability and a more aggressive disease course, “it has been debated whether erosive hand OA is an inflammatory subset with more synovitis than conventional OA, or just a severe form of the disease” they observed.

Although a recent study (Ann. Rheum. Dis. 2013;72:930-4) had found a higher frequency of inflammation in patients with erosive hand OA versus nonerosive hand OA, the study had not adjusted for the severity of structural damage. Dr. Mathiessen and coworkers therefore set out to examine whether the higher prevalence of synovitis that had been seen in patients with erosive hand OA was linked to the extent of joint disease according to the Kellgren-Lawrence (KL) scale.

The team used data from the Musculoskeletal Pain in Ullensaker Study (MUST) cohort (BMC Musculoskelet. Disord. 2013;14:201), an observational study comprising 630 participants with self-reported OA. Their analysis used data on 293 patients who reported having hand OA and who fulfilled American College of Rheumatology criteria, with no other inflammatory joint disease.

The majority (76%) of patients with hand OA studied were women, with a mean age of 64.9 years. There were over 4,000 joints examined using both ultrasonography and radiography of which 359 (7.9%) were erosive.

“We focused mainly on the proximal and distal interphalangeal joints, since radiographic erosions occur in these joints mainly,” the researchers said.

Just fewer than 30% (n = 86) participants had at least one erosive interphalangeal joint. The median number of these finger joints involved was five, ranging from 0 to 15.

Grey scale (GS) and power Doppler (PD) synovitis was seen in 18.9% and 1.8% of patients with erosive hand OA and 11.1% and 0.4% of those with nonerosive hand OA, respectively (P < .001 for both comparisons).

Patients with erosive disease were more likely to have greater joint damage on the KL scale than patients with nonerosive disease, with 41.7% versus 4.5%, respectively, having a KL grade of 3-4 and 26.7% versus 64% having a KL grade of 0­-1.

The team reported that the prevalence of both GS and PD synovitis increases with more structural joint damage irrespective of erosive status and that there was a similar level of joint inflammation when data were stratified according to KL grade.

Somewhat paradoxically, they said, “erosive joints actually have less inflammation than nonerosive joints.”

The investigators did not report having any disclosures.

ROME – Erosive hand osteoarthritis (OA) is probably a more severe form of the disease, rather than a separate clinical entity, a team of Norwegian researchers has suggested.

Dr. Alexander Mathiessen and associates from Diakonhjemmet Hospital in Oslo found that synovial inflammation was more common in patients with erosive disease. However, when they stratified the 293 patients studied according to the degree of structural joint damage, they found that the differences disappeared.

“Modern imaging techniques such as MRI and ultrasound have shown high prevalence of synovitis in hand osteoarthritis,” they explained in a poster presentation at the European Congress of Rheumatology.

Although erosive hand OA is often considered a more inflammatory phenotype, with more pain and disability and a more aggressive disease course, “it has been debated whether erosive hand OA is an inflammatory subset with more synovitis than conventional OA, or just a severe form of the disease” they observed.

Although a recent study (Ann. Rheum. Dis. 2013;72:930-4) had found a higher frequency of inflammation in patients with erosive hand OA versus nonerosive hand OA, the study had not adjusted for the severity of structural damage. Dr. Mathiessen and coworkers therefore set out to examine whether the higher prevalence of synovitis that had been seen in patients with erosive hand OA was linked to the extent of joint disease according to the Kellgren-Lawrence (KL) scale.

The team used data from the Musculoskeletal Pain in Ullensaker Study (MUST) cohort (BMC Musculoskelet. Disord. 2013;14:201), an observational study comprising 630 participants with self-reported OA. Their analysis used data on 293 patients who reported having hand OA and who fulfilled American College of Rheumatology criteria, with no other inflammatory joint disease.

The majority (76%) of patients with hand OA studied were women, with a mean age of 64.9 years. There were over 4,000 joints examined using both ultrasonography and radiography of which 359 (7.9%) were erosive.

“We focused mainly on the proximal and distal interphalangeal joints, since radiographic erosions occur in these joints mainly,” the researchers said.

Just fewer than 30% (n = 86) participants had at least one erosive interphalangeal joint. The median number of these finger joints involved was five, ranging from 0 to 15.

Grey scale (GS) and power Doppler (PD) synovitis was seen in 18.9% and 1.8% of patients with erosive hand OA and 11.1% and 0.4% of those with nonerosive hand OA, respectively (P < .001 for both comparisons).

Patients with erosive disease were more likely to have greater joint damage on the KL scale than patients with nonerosive disease, with 41.7% versus 4.5%, respectively, having a KL grade of 3-4 and 26.7% versus 64% having a KL grade of 0­-1.

The team reported that the prevalence of both GS and PD synovitis increases with more structural joint damage irrespective of erosive status and that there was a similar level of joint inflammation when data were stratified according to KL grade.

Somewhat paradoxically, they said, “erosive joints actually have less inflammation than nonerosive joints.”

The investigators did not report having any disclosures.

ROME – Erosive hand osteoarthritis (OA) is probably a more severe form of the disease, rather than a separate clinical entity, a team of Norwegian researchers has suggested.

Dr. Alexander Mathiessen and associates from Diakonhjemmet Hospital in Oslo found that synovial inflammation was more common in patients with erosive disease. However, when they stratified the 293 patients studied according to the degree of structural joint damage, they found that the differences disappeared.

“Modern imaging techniques such as MRI and ultrasound have shown high prevalence of synovitis in hand osteoarthritis,” they explained in a poster presentation at the European Congress of Rheumatology.

Although erosive hand OA is often considered a more inflammatory phenotype, with more pain and disability and a more aggressive disease course, “it has been debated whether erosive hand OA is an inflammatory subset with more synovitis than conventional OA, or just a severe form of the disease” they observed.

Although a recent study (Ann. Rheum. Dis. 2013;72:930-4) had found a higher frequency of inflammation in patients with erosive hand OA versus nonerosive hand OA, the study had not adjusted for the severity of structural damage. Dr. Mathiessen and coworkers therefore set out to examine whether the higher prevalence of synovitis that had been seen in patients with erosive hand OA was linked to the extent of joint disease according to the Kellgren-Lawrence (KL) scale.

The team used data from the Musculoskeletal Pain in Ullensaker Study (MUST) cohort (BMC Musculoskelet. Disord. 2013;14:201), an observational study comprising 630 participants with self-reported OA. Their analysis used data on 293 patients who reported having hand OA and who fulfilled American College of Rheumatology criteria, with no other inflammatory joint disease.

The majority (76%) of patients with hand OA studied were women, with a mean age of 64.9 years. There were over 4,000 joints examined using both ultrasonography and radiography of which 359 (7.9%) were erosive.

“We focused mainly on the proximal and distal interphalangeal joints, since radiographic erosions occur in these joints mainly,” the researchers said.

Just fewer than 30% (n = 86) participants had at least one erosive interphalangeal joint. The median number of these finger joints involved was five, ranging from 0 to 15.

Grey scale (GS) and power Doppler (PD) synovitis was seen in 18.9% and 1.8% of patients with erosive hand OA and 11.1% and 0.4% of those with nonerosive hand OA, respectively (P < .001 for both comparisons).

Patients with erosive disease were more likely to have greater joint damage on the KL scale than patients with nonerosive disease, with 41.7% versus 4.5%, respectively, having a KL grade of 3-4 and 26.7% versus 64% having a KL grade of 0­-1.

The team reported that the prevalence of both GS and PD synovitis increases with more structural joint damage irrespective of erosive status and that there was a similar level of joint inflammation when data were stratified according to KL grade.

Somewhat paradoxically, they said, “erosive joints actually have less inflammation than nonerosive joints.”

The investigators did not report having any disclosures.

ROME – Combined intra-articular injections of Tr14 (Traumeel) and Ze14 (Zeel) provided statistically significant, clinically relevant, and long-lasting relief of knee osteoarthritis pain in a phase III, randomized, double-blind, placebo-controlled trial.

The size of the effect was consistent with that seen for other pain-relieving drugs used to manage knee osteoarthritis (OA), including intra-articular (IA) injections of hyaluronic acid and corticosteroids, and even oral administration of diclofenac, the study investigators reported.

“From a qualitative perspective, the risk-benefit relationship for Tr14&Ze14 appears favorable, particularly compared to oral NSAIDs,” noted Dr. Carlos Lozada and his associates in a poster presentation at the European Congress of Rheumatology.

Dr. Lozada of the University of Miami noted in an interview that, unlike oral NSAIDs, the safety profile of Tr14&Ze14 was “benign, with no signals of cardiovascular, gastrointestinal, or other concerning risks,” which might offer an advantage for patients who are unable to take NSAIDs but still need something to provide OA pain relief.

According to their individual prescribing information, Tr14 and Ze14 are two homeopathic medicines available for the management of various musculoskeletal disorders and, in combination, for inflammatory and degenerative conditions such as OA. They each contain 14 different components, such as arnica, belladonna, echinacea, and comfrey root, and can be given by subcutaneous, intradermal, intramuscular, IA, or intravenous administration.

The MOZART (Study of Intra-articular Injections vs. Placebo in Patients With Pain From Osteoarthritis of the Knee) trial was conducted at 30 clinical study sites in the United States and involved 232 patients with moderate to severe pain associated with knee OA. Patients were randomized to weekly IA injections of Tr14&Ze14 for 3 weeks or to intra-articular placebo injections.

The main results were presented at the annual meeting of the American College of Rheumatology in Boston last year (Arthritis Rheumatol. 2014;66:S1266[Abstr. 2896]) and showed that significantly improved knee OA pain – assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale – was achieved after 8 days with Tr14&Ze14 vs. IA placebo injections.

The current analysis looked at the size of the effect achieved using the Hedges’ g* statistical method, which is a calculation based on the difference between treatment means, divided by the estimated common standard deviation, and then multiplied by a correlation factor that adjusts for sample sizes. Comparing the size of the effect seen with Tr14&Ze14 vs. IA placebo injections for the WOMAC pain subscale over time showed a consistent pain-relieving benefit of 0.26 at 15 days’ assessment, 0.22 at 29 days, 0.30 at 43 days, 0.31 at 57 days, 0.30 at 71 days, 0.25 at 85 days, and 0.25 at 99 days, the final assessment point in the study.

These effect sizes were then compared with those seen with other treatments used for OA pain relief obtained from a recent meta-analysis of 129 trials (Ann. Intern. Med. 2015;162:46–54). In that meta-analysis, IA administration of anti-inflammatory medicines was found to be superior to oral NSAIDs for the relief of pain. While this may partly do due to an integrated placebo effect of having injections, small but robust differences were seen between the active treatments, the meta-analysis’ authors concluded.

Using IA placebo injections as the comparator, the meta-analysis found that the Hedges’ g* effect sizes at 3 months were 0.34 for IA injections of hyaluronic acid and 0.32 for IA injections of corticosteroids. Effect sizes for commonly used oral NSAIDs were 0.23 for diclofenac, 0.15 for ibuprofen, 0.09 for naproxen, and 0.04 for celecoxib.

Dr. Lozada noted that while the current trial data showed that a consistent and long-lasting pain-relieving effect could be achieved following just three weekly IA injections of Tr14&Ze14, they cannot provide information on when to re-treat patients.

“One reason the follow up was for 99 days was to try to get some notion of how long the effect would last,” he said. “It doesn’t answer the question at this point on when you have to re-treat, I think that will still have to be individualized according to the patient.”

The study was sponsored by Biologische Heilmittel Heel GmbH. Dr. Lozada is a consultant for Rio Pharmaceutical Services and Heel Inc.

ROME – Combined intra-articular injections of Tr14 (Traumeel) and Ze14 (Zeel) provided statistically significant, clinically relevant, and long-lasting relief of knee osteoarthritis pain in a phase III, randomized, double-blind, placebo-controlled trial.

The size of the effect was consistent with that seen for other pain-relieving drugs used to manage knee osteoarthritis (OA), including intra-articular (IA) injections of hyaluronic acid and corticosteroids, and even oral administration of diclofenac, the study investigators reported.

“From a qualitative perspective, the risk-benefit relationship for Tr14&Ze14 appears favorable, particularly compared to oral NSAIDs,” noted Dr. Carlos Lozada and his associates in a poster presentation at the European Congress of Rheumatology.

Dr. Lozada of the University of Miami noted in an interview that, unlike oral NSAIDs, the safety profile of Tr14&Ze14 was “benign, with no signals of cardiovascular, gastrointestinal, or other concerning risks,” which might offer an advantage for patients who are unable to take NSAIDs but still need something to provide OA pain relief.

According to their individual prescribing information, Tr14 and Ze14 are two homeopathic medicines available for the management of various musculoskeletal disorders and, in combination, for inflammatory and degenerative conditions such as OA. They each contain 14 different components, such as arnica, belladonna, echinacea, and comfrey root, and can be given by subcutaneous, intradermal, intramuscular, IA, or intravenous administration.

The MOZART (Study of Intra-articular Injections vs. Placebo in Patients With Pain From Osteoarthritis of the Knee) trial was conducted at 30 clinical study sites in the United States and involved 232 patients with moderate to severe pain associated with knee OA. Patients were randomized to weekly IA injections of Tr14&Ze14 for 3 weeks or to intra-articular placebo injections.

The main results were presented at the annual meeting of the American College of Rheumatology in Boston last year (Arthritis Rheumatol. 2014;66:S1266[Abstr. 2896]) and showed that significantly improved knee OA pain – assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale – was achieved after 8 days with Tr14&Ze14 vs. IA placebo injections.

The current analysis looked at the size of the effect achieved using the Hedges’ g* statistical method, which is a calculation based on the difference between treatment means, divided by the estimated common standard deviation, and then multiplied by a correlation factor that adjusts for sample sizes. Comparing the size of the effect seen with Tr14&Ze14 vs. IA placebo injections for the WOMAC pain subscale over time showed a consistent pain-relieving benefit of 0.26 at 15 days’ assessment, 0.22 at 29 days, 0.30 at 43 days, 0.31 at 57 days, 0.30 at 71 days, 0.25 at 85 days, and 0.25 at 99 days, the final assessment point in the study.

These effect sizes were then compared with those seen with other treatments used for OA pain relief obtained from a recent meta-analysis of 129 trials (Ann. Intern. Med. 2015;162:46–54). In that meta-analysis, IA administration of anti-inflammatory medicines was found to be superior to oral NSAIDs for the relief of pain. While this may partly do due to an integrated placebo effect of having injections, small but robust differences were seen between the active treatments, the meta-analysis’ authors concluded.

Using IA placebo injections as the comparator, the meta-analysis found that the Hedges’ g* effect sizes at 3 months were 0.34 for IA injections of hyaluronic acid and 0.32 for IA injections of corticosteroids. Effect sizes for commonly used oral NSAIDs were 0.23 for diclofenac, 0.15 for ibuprofen, 0.09 for naproxen, and 0.04 for celecoxib.

Dr. Lozada noted that while the current trial data showed that a consistent and long-lasting pain-relieving effect could be achieved following just three weekly IA injections of Tr14&Ze14, they cannot provide information on when to re-treat patients.

“One reason the follow up was for 99 days was to try to get some notion of how long the effect would last,” he said. “It doesn’t answer the question at this point on when you have to re-treat, I think that will still have to be individualized according to the patient.”

The study was sponsored by Biologische Heilmittel Heel GmbH. Dr. Lozada is a consultant for Rio Pharmaceutical Services and Heel Inc.

ROME – Combined intra-articular injections of Tr14 (Traumeel) and Ze14 (Zeel) provided statistically significant, clinically relevant, and long-lasting relief of knee osteoarthritis pain in a phase III, randomized, double-blind, placebo-controlled trial.

The size of the effect was consistent with that seen for other pain-relieving drugs used to manage knee osteoarthritis (OA), including intra-articular (IA) injections of hyaluronic acid and corticosteroids, and even oral administration of diclofenac, the study investigators reported.

“From a qualitative perspective, the risk-benefit relationship for Tr14&Ze14 appears favorable, particularly compared to oral NSAIDs,” noted Dr. Carlos Lozada and his associates in a poster presentation at the European Congress of Rheumatology.

Dr. Lozada of the University of Miami noted in an interview that, unlike oral NSAIDs, the safety profile of Tr14&Ze14 was “benign, with no signals of cardiovascular, gastrointestinal, or other concerning risks,” which might offer an advantage for patients who are unable to take NSAIDs but still need something to provide OA pain relief.

According to their individual prescribing information, Tr14 and Ze14 are two homeopathic medicines available for the management of various musculoskeletal disorders and, in combination, for inflammatory and degenerative conditions such as OA. They each contain 14 different components, such as arnica, belladonna, echinacea, and comfrey root, and can be given by subcutaneous, intradermal, intramuscular, IA, or intravenous administration.

The MOZART (Study of Intra-articular Injections vs. Placebo in Patients With Pain From Osteoarthritis of the Knee) trial was conducted at 30 clinical study sites in the United States and involved 232 patients with moderate to severe pain associated with knee OA. Patients were randomized to weekly IA injections of Tr14&Ze14 for 3 weeks or to intra-articular placebo injections.

The main results were presented at the annual meeting of the American College of Rheumatology in Boston last year (Arthritis Rheumatol. 2014;66:S1266[Abstr. 2896]) and showed that significantly improved knee OA pain – assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale – was achieved after 8 days with Tr14&Ze14 vs. IA placebo injections.

The current analysis looked at the size of the effect achieved using the Hedges’ g* statistical method, which is a calculation based on the difference between treatment means, divided by the estimated common standard deviation, and then multiplied by a correlation factor that adjusts for sample sizes. Comparing the size of the effect seen with Tr14&Ze14 vs. IA placebo injections for the WOMAC pain subscale over time showed a consistent pain-relieving benefit of 0.26 at 15 days’ assessment, 0.22 at 29 days, 0.30 at 43 days, 0.31 at 57 days, 0.30 at 71 days, 0.25 at 85 days, and 0.25 at 99 days, the final assessment point in the study.

These effect sizes were then compared with those seen with other treatments used for OA pain relief obtained from a recent meta-analysis of 129 trials (Ann. Intern. Med. 2015;162:46–54). In that meta-analysis, IA administration of anti-inflammatory medicines was found to be superior to oral NSAIDs for the relief of pain. While this may partly do due to an integrated placebo effect of having injections, small but robust differences were seen between the active treatments, the meta-analysis’ authors concluded.

Using IA placebo injections as the comparator, the meta-analysis found that the Hedges’ g* effect sizes at 3 months were 0.34 for IA injections of hyaluronic acid and 0.32 for IA injections of corticosteroids. Effect sizes for commonly used oral NSAIDs were 0.23 for diclofenac, 0.15 for ibuprofen, 0.09 for naproxen, and 0.04 for celecoxib.

Dr. Lozada noted that while the current trial data showed that a consistent and long-lasting pain-relieving effect could be achieved following just three weekly IA injections of Tr14&Ze14, they cannot provide information on when to re-treat patients.

“One reason the follow up was for 99 days was to try to get some notion of how long the effect would last,” he said. “It doesn’t answer the question at this point on when you have to re-treat, I think that will still have to be individualized according to the patient.”

The study was sponsored by Biologische Heilmittel Heel GmbH. Dr. Lozada is a consultant for Rio Pharmaceutical Services and Heel Inc.

ROME – Ensuring that intra-articular injections are correctly placed does not appear to result in better pain management for knee osteoarthritis, according to research presented at the European Congress of Rheumatology.

“Accurate injection neither resulted in higher rate of response to treatment than inaccurate injection nor greater mean pain reduction,” said George Hirsch, Ph.D., of the Institute of Inflammation and Repair at the University of Manchester (England) and the Dudley Group NHS Foundation Trust.

Courtesy National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Dr. Hirsch and his associates defined response to treatment as at least a 40% reduction in pain on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the percentages who met that definition were similar among patients who had their injections correctly placed and those who did not at 3 weeks (57.7% vs. 63.4%, respectively; P = .0355) and 9 weeks (39.3% vs. 51.4%; P = .0148).

There also were no differences between mean pain reduction at 3 weeks (–110.7 mm vs. –116.9 mm on a visual analogue scale; P = .781) and 9 weeks (–65.2 mm vs. –92.8 mm; P = .247) between the patients with accurate and inaccurate intra-articular injection placement.

The researchers aimed to determine if injecting accurately into the knee could have an effect on patients’ pain outcomes because, despite the effectiveness of intra-articular corticosteroid injections (IACIs) for pain in knee OA, “responses to treatment vary.” In the poster presentation, Dr. Hirsch noted that uncertainty remained as to whether structural factors including accurate intra-articular placement mattered in regards to pain reduction.

The practical, prospective, observational study included 141 men and women with a mean age of 63.8 years who had been referred for IACI for their knee OA in a routine practice setting.

Before aspiration and injection into the affected knee(s) based on clinical examination, patients underwent careful x-ray and ultrasound assessment. Following injection, an air arthrosonogram was used to see if injections had entered the joint cavity.

Overall, just over half (53%) of patients were classed as responders at 3 weeks and 44% at 9 weeks, and a positive arthrosonogram was seen in 98 (70%).

In addition to no advantage for accurate injection placement on pain outcomes, there was no indication that individual physical factors mattered either. Mean measurements of sonographic effusion and synovial hypertrophy did not differ between responders and nonresponders at either time point assessed.

Similar findings also were seen for mean scores for power Doppler signal and individual radiographic features of osteoarthritis that included joint-space narrowing and presence of bone spurs.

“These results raise potential questions about the routine use of [ultrasound] to enhance or predict response to IACI in knee OA,” Dr. Hirsch said.

The authors reported having no financial disclosures.

ROME – Ensuring that intra-articular injections are correctly placed does not appear to result in better pain management for knee osteoarthritis, according to research presented at the European Congress of Rheumatology.

“Accurate injection neither resulted in higher rate of response to treatment than inaccurate injection nor greater mean pain reduction,” said George Hirsch, Ph.D., of the Institute of Inflammation and Repair at the University of Manchester (England) and the Dudley Group NHS Foundation Trust.

Courtesy National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Dr. Hirsch and his associates defined response to treatment as at least a 40% reduction in pain on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the percentages who met that definition were similar among patients who had their injections correctly placed and those who did not at 3 weeks (57.7% vs. 63.4%, respectively; P = .0355) and 9 weeks (39.3% vs. 51.4%; P = .0148).

There also were no differences between mean pain reduction at 3 weeks (–110.7 mm vs. –116.9 mm on a visual analogue scale; P = .781) and 9 weeks (–65.2 mm vs. –92.8 mm; P = .247) between the patients with accurate and inaccurate intra-articular injection placement.

The researchers aimed to determine if injecting accurately into the knee could have an effect on patients’ pain outcomes because, despite the effectiveness of intra-articular corticosteroid injections (IACIs) for pain in knee OA, “responses to treatment vary.” In the poster presentation, Dr. Hirsch noted that uncertainty remained as to whether structural factors including accurate intra-articular placement mattered in regards to pain reduction.

The practical, prospective, observational study included 141 men and women with a mean age of 63.8 years who had been referred for IACI for their knee OA in a routine practice setting.

Before aspiration and injection into the affected knee(s) based on clinical examination, patients underwent careful x-ray and ultrasound assessment. Following injection, an air arthrosonogram was used to see if injections had entered the joint cavity.

Overall, just over half (53%) of patients were classed as responders at 3 weeks and 44% at 9 weeks, and a positive arthrosonogram was seen in 98 (70%).

In addition to no advantage for accurate injection placement on pain outcomes, there was no indication that individual physical factors mattered either. Mean measurements of sonographic effusion and synovial hypertrophy did not differ between responders and nonresponders at either time point assessed.

Similar findings also were seen for mean scores for power Doppler signal and individual radiographic features of osteoarthritis that included joint-space narrowing and presence of bone spurs.

“These results raise potential questions about the routine use of [ultrasound] to enhance or predict response to IACI in knee OA,” Dr. Hirsch said.

The authors reported having no financial disclosures.

ROME – Ensuring that intra-articular injections are correctly placed does not appear to result in better pain management for knee osteoarthritis, according to research presented at the European Congress of Rheumatology.

“Accurate injection neither resulted in higher rate of response to treatment than inaccurate injection nor greater mean pain reduction,” said George Hirsch, Ph.D., of the Institute of Inflammation and Repair at the University of Manchester (England) and the Dudley Group NHS Foundation Trust.

Courtesy National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Dr. Hirsch and his associates defined response to treatment as at least a 40% reduction in pain on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the percentages who met that definition were similar among patients who had their injections correctly placed and those who did not at 3 weeks (57.7% vs. 63.4%, respectively; P = .0355) and 9 weeks (39.3% vs. 51.4%; P = .0148).

There also were no differences between mean pain reduction at 3 weeks (–110.7 mm vs. –116.9 mm on a visual analogue scale; P = .781) and 9 weeks (–65.2 mm vs. –92.8 mm; P = .247) between the patients with accurate and inaccurate intra-articular injection placement.

The researchers aimed to determine if injecting accurately into the knee could have an effect on patients’ pain outcomes because, despite the effectiveness of intra-articular corticosteroid injections (IACIs) for pain in knee OA, “responses to treatment vary.” In the poster presentation, Dr. Hirsch noted that uncertainty remained as to whether structural factors including accurate intra-articular placement mattered in regards to pain reduction.

The practical, prospective, observational study included 141 men and women with a mean age of 63.8 years who had been referred for IACI for their knee OA in a routine practice setting.

Before aspiration and injection into the affected knee(s) based on clinical examination, patients underwent careful x-ray and ultrasound assessment. Following injection, an air arthrosonogram was used to see if injections had entered the joint cavity.

Overall, just over half (53%) of patients were classed as responders at 3 weeks and 44% at 9 weeks, and a positive arthrosonogram was seen in 98 (70%).

In addition to no advantage for accurate injection placement on pain outcomes, there was no indication that individual physical factors mattered either. Mean measurements of sonographic effusion and synovial hypertrophy did not differ between responders and nonresponders at either time point assessed.

Similar findings also were seen for mean scores for power Doppler signal and individual radiographic features of osteoarthritis that included joint-space narrowing and presence of bone spurs.

“These results raise potential questions about the routine use of [ultrasound] to enhance or predict response to IACI in knee OA,” Dr. Hirsch said.

The authors reported having no financial disclosures.

ROME – Tai chi is as effective as standard physical therapy in reducing pain and improving physical function and quality of life in patients with knee osteoarthritis, according to the results of a randomized, single-blind study reported at the European Congress of Rheumatology.

The primary outcome of change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score from baseline to 12 weeks was –167.2 mm in the patients randomized to the tai chi group vs. –143.0 mm in those who completed a standard physiotherapy program (P = .16).

©bloodstone/iStockphoto.com

“Future studies of ‘Eastern’ complementary medicine will further inform ‘Western’ medical treatment guidelines,” said Dr. Chenchen Wang, director of the Center for Complementary and Integrative Medicine at Tufts Medical Center in Boston. She noted that the study findings showed that tai chi could be a viable alternative to physical therapy for knee osteoarthritis (OA), which she called “a chronic disabling disease.”

Dr. Wang andher associates have previously shown that the classic Yang-style tai chi results in clinically important improvements in patients with fibromyalgia (N. Engl. J. Med. 2010;363:743-54). They have also previously reported beneficial effects in small numbers of patients with knee OA (Arthritis Rheum. 2009;61:1545–53). The present study findings replicate these results in a larger group of patients followed up for a longer period of time.

“This is the longest follow-up of tai chi for knee osteoarthritis to date,” Dr. Wang observed. It is also representative of a racially diverse population, she said. The study is ongoing but not recruiting participants and will continue to compare the effectiveness and cost-effectiveness of the Chinese martial art vs. standard-of-care physiotherapy for 1 year (BMC Complement. Altern. Med. 2014;14:333).Of 204 randomized patients with a mean age of 60 years and disease duration of 8 years, 167 (82%) completed the tai chi sessions and 12-week evaluation for the primary end point. In addition, three-quarters of patients completed 24 weeks and 69% completed 1 year of the intervention, showing the sustainability of the exercise program. Overall attendance was similar between the groups, at 74% for tai chi and 81% for physical therapy.

The 106 patients randomized to the tai chi group performed the martial art twice a week for 12 weeks while the 98 patients in the physical therapy group underwent twice-weekly sessions for the first 6 weeks, then continued with ”rigorously monitored” exercises at home for 12 additional weeks. Patients knew to which group they had been randomly assigned, but the study physician and outcomes assessments were blinded to the treatment allocation.

Similar benefits were seen for with both strategies for the secondary end points of physical function subscale of the WOMAC (P = .08), Patients’ Global Assessment (P = .06), and chronic pain self-efficacy (P = .22). There were also similar improvements in 6-minute (P = .76) and 20-meter (P = .40) walking tests.

Health-related quality of life measured using the Short Form 36 suggested a possible statistical advantage of tai chi over physical therapy for the physical but not mental component summary, with mean differences between the groups of 3.2 (P < .01) and 1.6 (P = .08), respectively. There was also a statistical difference in depression scores between the groups, but this may not be clinically significant, Dr. Wang observed.

“This study provides evidence to support both tai chi and physical therapy improve pain and physical function for patients with knee osteoarthritis,” she said. “Interestingly, we didn’t see any differences in effectiveness attributable to the four individual tai chi instructors.”

The National Center for Complementary and Integrative Health of the National Institutes of Health supported the study. Dr. Wang reported no relevant conflicts.

ROME – Tai chi is as effective as standard physical therapy in reducing pain and improving physical function and quality of life in patients with knee osteoarthritis, according to the results of a randomized, single-blind study reported at the European Congress of Rheumatology.

The primary outcome of change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score from baseline to 12 weeks was –167.2 mm in the patients randomized to the tai chi group vs. –143.0 mm in those who completed a standard physiotherapy program (P = .16).

©bloodstone/iStockphoto.com

“Future studies of ‘Eastern’ complementary medicine will further inform ‘Western’ medical treatment guidelines,” said Dr. Chenchen Wang, director of the Center for Complementary and Integrative Medicine at Tufts Medical Center in Boston. She noted that the study findings showed that tai chi could be a viable alternative to physical therapy for knee osteoarthritis (OA), which she called “a chronic disabling disease.”

Dr. Wang andher associates have previously shown that the classic Yang-style tai chi results in clinically important improvements in patients with fibromyalgia (N. Engl. J. Med. 2010;363:743-54). They have also previously reported beneficial effects in small numbers of patients with knee OA (Arthritis Rheum. 2009;61:1545–53). The present study findings replicate these results in a larger group of patients followed up for a longer period of time.

“This is the longest follow-up of tai chi for knee osteoarthritis to date,” Dr. Wang observed. It is also representative of a racially diverse population, she said. The study is ongoing but not recruiting participants and will continue to compare the effectiveness and cost-effectiveness of the Chinese martial art vs. standard-of-care physiotherapy for 1 year (BMC Complement. Altern. Med. 2014;14:333).Of 204 randomized patients with a mean age of 60 years and disease duration of 8 years, 167 (82%) completed the tai chi sessions and 12-week evaluation for the primary end point. In addition, three-quarters of patients completed 24 weeks and 69% completed 1 year of the intervention, showing the sustainability of the exercise program. Overall attendance was similar between the groups, at 74% for tai chi and 81% for physical therapy.

The 106 patients randomized to the tai chi group performed the martial art twice a week for 12 weeks while the 98 patients in the physical therapy group underwent twice-weekly sessions for the first 6 weeks, then continued with ”rigorously monitored” exercises at home for 12 additional weeks. Patients knew to which group they had been randomly assigned, but the study physician and outcomes assessments were blinded to the treatment allocation.

Similar benefits were seen for with both strategies for the secondary end points of physical function subscale of the WOMAC (P = .08), Patients’ Global Assessment (P = .06), and chronic pain self-efficacy (P = .22). There were also similar improvements in 6-minute (P = .76) and 20-meter (P = .40) walking tests.

Health-related quality of life measured using the Short Form 36 suggested a possible statistical advantage of tai chi over physical therapy for the physical but not mental component summary, with mean differences between the groups of 3.2 (P < .01) and 1.6 (P = .08), respectively. There was also a statistical difference in depression scores between the groups, but this may not be clinically significant, Dr. Wang observed.

“This study provides evidence to support both tai chi and physical therapy improve pain and physical function for patients with knee osteoarthritis,” she said. “Interestingly, we didn’t see any differences in effectiveness attributable to the four individual tai chi instructors.”

The National Center for Complementary and Integrative Health of the National Institutes of Health supported the study. Dr. Wang reported no relevant conflicts.

ROME – Tai chi is as effective as standard physical therapy in reducing pain and improving physical function and quality of life in patients with knee osteoarthritis, according to the results of a randomized, single-blind study reported at the European Congress of Rheumatology.

The primary outcome of change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale score from baseline to 12 weeks was –167.2 mm in the patients randomized to the tai chi group vs. –143.0 mm in those who completed a standard physiotherapy program (P = .16).

©bloodstone/iStockphoto.com

“Future studies of ‘Eastern’ complementary medicine will further inform ‘Western’ medical treatment guidelines,” said Dr. Chenchen Wang, director of the Center for Complementary and Integrative Medicine at Tufts Medical Center in Boston. She noted that the study findings showed that tai chi could be a viable alternative to physical therapy for knee osteoarthritis (OA), which she called “a chronic disabling disease.”

Dr. Wang andher associates have previously shown that the classic Yang-style tai chi results in clinically important improvements in patients with fibromyalgia (N. Engl. J. Med. 2010;363:743-54). They have also previously reported beneficial effects in small numbers of patients with knee OA (Arthritis Rheum. 2009;61:1545–53). The present study findings replicate these results in a larger group of patients followed up for a longer period of time.

“This is the longest follow-up of tai chi for knee osteoarthritis to date,” Dr. Wang observed. It is also representative of a racially diverse population, she said. The study is ongoing but not recruiting participants and will continue to compare the effectiveness and cost-effectiveness of the Chinese martial art vs. standard-of-care physiotherapy for 1 year (BMC Complement. Altern. Med. 2014;14:333).Of 204 randomized patients with a mean age of 60 years and disease duration of 8 years, 167 (82%) completed the tai chi sessions and 12-week evaluation for the primary end point. In addition, three-quarters of patients completed 24 weeks and 69% completed 1 year of the intervention, showing the sustainability of the exercise program. Overall attendance was similar between the groups, at 74% for tai chi and 81% for physical therapy.

The 106 patients randomized to the tai chi group performed the martial art twice a week for 12 weeks while the 98 patients in the physical therapy group underwent twice-weekly sessions for the first 6 weeks, then continued with ”rigorously monitored” exercises at home for 12 additional weeks. Patients knew to which group they had been randomly assigned, but the study physician and outcomes assessments were blinded to the treatment allocation.

Similar benefits were seen for with both strategies for the secondary end points of physical function subscale of the WOMAC (P = .08), Patients’ Global Assessment (P = .06), and chronic pain self-efficacy (P = .22). There were also similar improvements in 6-minute (P = .76) and 20-meter (P = .40) walking tests.

Health-related quality of life measured using the Short Form 36 suggested a possible statistical advantage of tai chi over physical therapy for the physical but not mental component summary, with mean differences between the groups of 3.2 (P < .01) and 1.6 (P = .08), respectively. There was also a statistical difference in depression scores between the groups, but this may not be clinically significant, Dr. Wang observed.

“This study provides evidence to support both tai chi and physical therapy improve pain and physical function for patients with knee osteoarthritis,” she said. “Interestingly, we didn’t see any differences in effectiveness attributable to the four individual tai chi instructors.”

The National Center for Complementary and Integrative Health of the National Institutes of Health supported the study. Dr. Wang reported no relevant conflicts.

ROME – Vitamin D supplementation did not ease osteoarthritic knee pain measured using the Western Ontario and McMaster Universities Osteoarthritis Index in a 2-year, randomized, double-blind, placebo-controlled trial.

Results of the VIDEO (Vitamin D Effect on Osteoarthritis) study in patients with symptomatic knee osteoarthritis (OA) and low vitamin D levels also showed that replenishing vitamin D also had no effect on the loss of cartilage volume, although there might be a marginal benefit on bone marrow lesions (BMLs) and pain assessed using a visual analog scale (VAS).

“Vitamin D at 50,000 IU/month over 2 years did not meet the primary endpoint in this randomized, controlled trial,” said Jason Jin, a Ph.D. candidate at the Menzies Research Institute, University of Tasmania in Hobart, Australia, who presented the VIDEO study findings at the European Congress of Rheumatology.

He cited a recent commentary published in the Journal of the American Medical Association (JAMA 2015;313:1311-12) that looked at vitamin D research and clinical practice in which the authors said that “clinical enthusiasm for supplemental vitamin D has outpaced available evidence.” This seems to be true considering the results of this and other previous randomized trials, Mr. Jin observed.

“The background of this study is that, in the last decade, vitamin D has become a hot topic in osteoarthritis research and epidemiologic studies have found that vitamin D deficiency is very common in knee osteoarthritis patients,” he said. Low levels of vitamin D have been linked to increased knee pain, radiographic progression, and increased cartilage loss in OA.

Two prior randomized, controlled trials provided conflicting evidence, he highlighted, with one study showing that supplementation of 2,000 IU/day of vitamin D for 2 years had no effect on symptoms or knee structure (JAMA 2013;309:155-62) while another showed that a monthly dose of 60,000 IU for 1 year may be beneficial in terms of relieving pain and functional outcomes but longer follow-up was required (Clin. Orthop. Relat. Res. 2013;471:3556-62).

The VIDEO study was therefore designed to try to resolve some of the controversy and look at a larger group of patients for a longer period of time. The study’s hypothesis was that vitamin D might ease knee pain and perhaps have effect structural changes in patients with symptomatic knee OA who had low vitamin D levels. A low vitamin D level was defined as a serum measurement of 25(OH)D of 12.5-60 nmol/L (5-24 ng/mL) at baseline.

Of almost 600 patients screened, 413 were randomized, with 209 randomized to the oral vitamin D supplementation group and 204 to the matched placebo arm. Patients in each group had comparable characteristics at baseline, with a mean age of around 62 to ­63 years. Half the patients were female. Baseline serum vitamin D levels were about 43 nmol/L (17.2 ng/mL). Virtually all (96%) of patients had radiographic evidence of knee OA, 97% had cartilage defects, and 80% had bone marrow lesions.

While serum levels of 25(OH)D were successfully increased in the supplemented patients over the course of the study, this did not translate into an improvement in the coprimary endpoint of a change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) knee pain over 24 months. The difference in WOMAC pain between the vitamin D and placebo groups was a nonsignifcant –14.8 (–49.9 vs. –35.1; P = .102). Vitamin D–supplemented patients did, however, report marginally less VAS pain (–14.8 vs. –9.4; P = .038).

Total tibial cartilage volume loss, the second coprimary endpoint, was not significantly different between the vitamin D and placebo groups, at around 121 and 150 mm³ per annum, with 2-year changes of –3.44% vs. –4.23% per annum (P = .132). The secondary endpoints of changes in tibiofemoral cartilage defects (0.29 vs. 0.47; P = .159) and tibiofemoral BMLs (–0.59 vs. –0.21; P = .087) were also not significantly different, but patients randomized to vitamin D supplementation had fewer increases in BMLs (17% vs. 27%; P = .03).

There was no concern over the safety of vitamin D supplementation, although more general side effects were noted in the vitamin D vs. the placebo group.

Commenting on the strengths and weaknesses of the study, Mr. Jin noted it was a large, multicenter, randomized, double-blind, placebo-controlled trial with a reasonably long follow-up. The patient group studied has good generalizability to those seen in everyday practice, he suggested, noting that the main limitation was the number of patients lost to follow-up because of noncompliance: 21 patients in the vitamin D group vs. 8 patients in the placebo group.

ROME – Vitamin D supplementation did not ease osteoarthritic knee pain measured using the Western Ontario and McMaster Universities Osteoarthritis Index in a 2-year, randomized, double-blind, placebo-controlled trial.

Results of the VIDEO (Vitamin D Effect on Osteoarthritis) study in patients with symptomatic knee osteoarthritis (OA) and low vitamin D levels also showed that replenishing vitamin D also had no effect on the loss of cartilage volume, although there might be a marginal benefit on bone marrow lesions (BMLs) and pain assessed using a visual analog scale (VAS).

“Vitamin D at 50,000 IU/month over 2 years did not meet the primary endpoint in this randomized, controlled trial,” said Jason Jin, a Ph.D. candidate at the Menzies Research Institute, University of Tasmania in Hobart, Australia, who presented the VIDEO study findings at the European Congress of Rheumatology.

He cited a recent commentary published in the Journal of the American Medical Association (JAMA 2015;313:1311-12) that looked at vitamin D research and clinical practice in which the authors said that “clinical enthusiasm for supplemental vitamin D has outpaced available evidence.” This seems to be true considering the results of this and other previous randomized trials, Mr. Jin observed.

“The background of this study is that, in the last decade, vitamin D has become a hot topic in osteoarthritis research and epidemiologic studies have found that vitamin D deficiency is very common in knee osteoarthritis patients,” he said. Low levels of vitamin D have been linked to increased knee pain, radiographic progression, and increased cartilage loss in OA.

Two prior randomized, controlled trials provided conflicting evidence, he highlighted, with one study showing that supplementation of 2,000 IU/day of vitamin D for 2 years had no effect on symptoms or knee structure (JAMA 2013;309:155-62) while another showed that a monthly dose of 60,000 IU for 1 year may be beneficial in terms of relieving pain and functional outcomes but longer follow-up was required (Clin. Orthop. Relat. Res. 2013;471:3556-62).

The VIDEO study was therefore designed to try to resolve some of the controversy and look at a larger group of patients for a longer period of time. The study’s hypothesis was that vitamin D might ease knee pain and perhaps have effect structural changes in patients with symptomatic knee OA who had low vitamin D levels. A low vitamin D level was defined as a serum measurement of 25(OH)D of 12.5-60 nmol/L (5-24 ng/mL) at baseline.

Of almost 600 patients screened, 413 were randomized, with 209 randomized to the oral vitamin D supplementation group and 204 to the matched placebo arm. Patients in each group had comparable characteristics at baseline, with a mean age of around 62 to ­63 years. Half the patients were female. Baseline serum vitamin D levels were about 43 nmol/L (17.2 ng/mL). Virtually all (96%) of patients had radiographic evidence of knee OA, 97% had cartilage defects, and 80% had bone marrow lesions.

While serum levels of 25(OH)D were successfully increased in the supplemented patients over the course of the study, this did not translate into an improvement in the coprimary endpoint of a change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) knee pain over 24 months. The difference in WOMAC pain between the vitamin D and placebo groups was a nonsignifcant –14.8 (–49.9 vs. –35.1; P = .102). Vitamin D–supplemented patients did, however, report marginally less VAS pain (–14.8 vs. –9.4; P = .038).

Total tibial cartilage volume loss, the second coprimary endpoint, was not significantly different between the vitamin D and placebo groups, at around 121 and 150 mm³ per annum, with 2-year changes of –3.44% vs. –4.23% per annum (P = .132). The secondary endpoints of changes in tibiofemoral cartilage defects (0.29 vs. 0.47; P = .159) and tibiofemoral BMLs (–0.59 vs. –0.21; P = .087) were also not significantly different, but patients randomized to vitamin D supplementation had fewer increases in BMLs (17% vs. 27%; P = .03).

There was no concern over the safety of vitamin D supplementation, although more general side effects were noted in the vitamin D vs. the placebo group.

Commenting on the strengths and weaknesses of the study, Mr. Jin noted it was a large, multicenter, randomized, double-blind, placebo-controlled trial with a reasonably long follow-up. The patient group studied has good generalizability to those seen in everyday practice, he suggested, noting that the main limitation was the number of patients lost to follow-up because of noncompliance: 21 patients in the vitamin D group vs. 8 patients in the placebo group.

ROME – Vitamin D supplementation did not ease osteoarthritic knee pain measured using the Western Ontario and McMaster Universities Osteoarthritis Index in a 2-year, randomized, double-blind, placebo-controlled trial.

Results of the VIDEO (Vitamin D Effect on Osteoarthritis) study in patients with symptomatic knee osteoarthritis (OA) and low vitamin D levels also showed that replenishing vitamin D also had no effect on the loss of cartilage volume, although there might be a marginal benefit on bone marrow lesions (BMLs) and pain assessed using a visual analog scale (VAS).

“Vitamin D at 50,000 IU/month over 2 years did not meet the primary endpoint in this randomized, controlled trial,” said Jason Jin, a Ph.D. candidate at the Menzies Research Institute, University of Tasmania in Hobart, Australia, who presented the VIDEO study findings at the European Congress of Rheumatology.

He cited a recent commentary published in the Journal of the American Medical Association (JAMA 2015;313:1311-12) that looked at vitamin D research and clinical practice in which the authors said that “clinical enthusiasm for supplemental vitamin D has outpaced available evidence.” This seems to be true considering the results of this and other previous randomized trials, Mr. Jin observed.

“The background of this study is that, in the last decade, vitamin D has become a hot topic in osteoarthritis research and epidemiologic studies have found that vitamin D deficiency is very common in knee osteoarthritis patients,” he said. Low levels of vitamin D have been linked to increased knee pain, radiographic progression, and increased cartilage loss in OA.

Two prior randomized, controlled trials provided conflicting evidence, he highlighted, with one study showing that supplementation of 2,000 IU/day of vitamin D for 2 years had no effect on symptoms or knee structure (JAMA 2013;309:155-62) while another showed that a monthly dose of 60,000 IU for 1 year may be beneficial in terms of relieving pain and functional outcomes but longer follow-up was required (Clin. Orthop. Relat. Res. 2013;471:3556-62).

The VIDEO study was therefore designed to try to resolve some of the controversy and look at a larger group of patients for a longer period of time. The study’s hypothesis was that vitamin D might ease knee pain and perhaps have effect structural changes in patients with symptomatic knee OA who had low vitamin D levels. A low vitamin D level was defined as a serum measurement of 25(OH)D of 12.5-60 nmol/L (5-24 ng/mL) at baseline.

Of almost 600 patients screened, 413 were randomized, with 209 randomized to the oral vitamin D supplementation group and 204 to the matched placebo arm. Patients in each group had comparable characteristics at baseline, with a mean age of around 62 to ­63 years. Half the patients were female. Baseline serum vitamin D levels were about 43 nmol/L (17.2 ng/mL). Virtually all (96%) of patients had radiographic evidence of knee OA, 97% had cartilage defects, and 80% had bone marrow lesions.

While serum levels of 25(OH)D were successfully increased in the supplemented patients over the course of the study, this did not translate into an improvement in the coprimary endpoint of a change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) knee pain over 24 months. The difference in WOMAC pain between the vitamin D and placebo groups was a nonsignifcant –14.8 (–49.9 vs. –35.1; P = .102). Vitamin D–supplemented patients did, however, report marginally less VAS pain (–14.8 vs. –9.4; P = .038).

Total tibial cartilage volume loss, the second coprimary endpoint, was not significantly different between the vitamin D and placebo groups, at around 121 and 150 mm³ per annum, with 2-year changes of –3.44% vs. –4.23% per annum (P = .132). The secondary endpoints of changes in tibiofemoral cartilage defects (0.29 vs. 0.47; P = .159) and tibiofemoral BMLs (–0.59 vs. –0.21; P = .087) were also not significantly different, but patients randomized to vitamin D supplementation had fewer increases in BMLs (17% vs. 27%; P = .03).

There was no concern over the safety of vitamin D supplementation, although more general side effects were noted in the vitamin D vs. the placebo group.

Commenting on the strengths and weaknesses of the study, Mr. Jin noted it was a large, multicenter, randomized, double-blind, placebo-controlled trial with a reasonably long follow-up. The patient group studied has good generalizability to those seen in everyday practice, he suggested, noting that the main limitation was the number of patients lost to follow-up because of noncompliance: 21 patients in the vitamin D group vs. 8 patients in the placebo group.

Here are 7 articles in the July issue of Clinician Reviews (accreditation valid until January 1, 2016):

1. BSR: Multiple Benefits Seen With Intensive Psoriatic Arthritis Therapy
Multiple joint and skin benefits can be achieved by intensively treating patients with psoriatic arthritis (PsA) until they achieve a set of minimal disease activity (MDA) criteria (see Table), an expert said at the British Society for Rheumatology annual conference.

To take the posttest, go to: http://bit.ly/1KaikxW

2. Subclinical Hyperthyroidism Linked to Higher Fracture Risk
Individuals with subclinical hyperthyroidism are at increased risk for hip and other fractures, according to the authors of a meta-analysis. The researchers examined data from 70,298 individuals—4,092 with subclinical hypothyroidism and 2,219 with subclinical hyperthyroidism—enrolled in 13 prospective cohort studies.

To take the posttest, go to: http://bit.ly/1H13j0t

3. Newer Oral Contraceptives Pose Higher VTE Risk
The risk for venous thromboembolism (VTE) is generally greater for women using oral contraceptives with newer types of progestogen hormones than for those taking older, second-generation birth control pills, study results showed.

To take the posttest, go to: http://bit.ly/1AKQert

4. Statins, Fibrates Lower Stroke Risk in Elderly
Both statin and fibrate therapies taken to improve lipid profiles decreased risk for stroke by 30% in a community-dwelling population of elderly people, according to a prospective European study published online in the British Medical Journal.

To take the posttest, go to: http://bit.ly/1FuyYCb

5. Cystic Fibrosis–related Diabetes Requires Different Approach
Cystic fibrosis–related diabetes (CFRD) is a unique disease that requires a different mindset on the part of the treating clinician.

To take the posttest, go to: http://bit.ly/1BKGZCm

6. CVD Risk Persists for 40 Years in Hodgkin Survivors
People who survive Hodgkin lymphoma in adolescence or young adulthood remain at very high risk for cardiovascular disease (CVD) for at least 40 years—the longest period for which they have been followed, according to the results of a retrospective cohort study of more than 2,500 patients.

To take the posttest, go to: http://bit.ly/1M5ymYG

7. Asymptomatic Carotid Stenosis and Central Sleep Apnea Linked
More than two-thirds of patients with asymptomatic carotid stenosis are likely to have sleep apnea, according to an observational study. The polysomnography results of 96 patients with ­asymptomatic extracranial carotid stenosis revealed that 69% had sleep apnea: 42% had obstructive sleep apnea (OSA) and 27%, central sleep apnea (CSA).

To take the posttest, go to: http://bit.ly/1SWGPmb

Here are 7 articles in the July issue of Clinician Reviews (accreditation valid until January 1, 2016):

1. BSR: Multiple Benefits Seen With Intensive Psoriatic Arthritis Therapy
Multiple joint and skin benefits can be achieved by intensively treating patients with psoriatic arthritis (PsA) until they achieve a set of minimal disease activity (MDA) criteria (see Table), an expert said at the British Society for Rheumatology annual conference.

To take the posttest, go to: http://bit.ly/1KaikxW

2. Subclinical Hyperthyroidism Linked to Higher Fracture Risk
Individuals with subclinical hyperthyroidism are at increased risk for hip and other fractures, according to the authors of a meta-analysis. The researchers examined data from 70,298 individuals—4,092 with subclinical hypothyroidism and 2,219 with subclinical hyperthyroidism—enrolled in 13 prospective cohort studies.

To take the posttest, go to: http://bit.ly/1H13j0t

3. Newer Oral Contraceptives Pose Higher VTE Risk
The risk for venous thromboembolism (VTE) is generally greater for women using oral contraceptives with newer types of progestogen hormones than for those taking older, second-generation birth control pills, study results showed.

To take the posttest, go to: http://bit.ly/1AKQert

4. Statins, Fibrates Lower Stroke Risk in Elderly
Both statin and fibrate therapies taken to improve lipid profiles decreased risk for stroke by 30% in a community-dwelling population of elderly people, according to a prospective European study published online in the British Medical Journal.

To take the posttest, go to: http://bit.ly/1FuyYCb

5. Cystic Fibrosis–related Diabetes Requires Different Approach
Cystic fibrosis–related diabetes (CFRD) is a unique disease that requires a different mindset on the part of the treating clinician.

To take the posttest, go to: http://bit.ly/1BKGZCm

6. CVD Risk Persists for 40 Years in Hodgkin Survivors
People who survive Hodgkin lymphoma in adolescence or young adulthood remain at very high risk for cardiovascular disease (CVD) for at least 40 years—the longest period for which they have been followed, according to the results of a retrospective cohort study of more than 2,500 patients.

To take the posttest, go to: http://bit.ly/1M5ymYG

7. Asymptomatic Carotid Stenosis and Central Sleep Apnea Linked
More than two-thirds of patients with asymptomatic carotid stenosis are likely to have sleep apnea, according to an observational study. The polysomnography results of 96 patients with ­asymptomatic extracranial carotid stenosis revealed that 69% had sleep apnea: 42% had obstructive sleep apnea (OSA) and 27%, central sleep apnea (CSA).

To take the posttest, go to: http://bit.ly/1SWGPmb

Here are 7 articles in the July issue of Clinician Reviews (accreditation valid until January 1, 2016):

1. BSR: Multiple Benefits Seen With Intensive Psoriatic Arthritis Therapy
Multiple joint and skin benefits can be achieved by intensively treating patients with psoriatic arthritis (PsA) until they achieve a set of minimal disease activity (MDA) criteria (see Table), an expert said at the British Society for Rheumatology annual conference.

To take the posttest, go to: http://bit.ly/1KaikxW

2. Subclinical Hyperthyroidism Linked to Higher Fracture Risk
Individuals with subclinical hyperthyroidism are at increased risk for hip and other fractures, according to the authors of a meta-analysis. The researchers examined data from 70,298 individuals—4,092 with subclinical hypothyroidism and 2,219 with subclinical hyperthyroidism—enrolled in 13 prospective cohort studies.

To take the posttest, go to: http://bit.ly/1H13j0t

3. Newer Oral Contraceptives Pose Higher VTE Risk
The risk for venous thromboembolism (VTE) is generally greater for women using oral contraceptives with newer types of progestogen hormones than for those taking older, second-generation birth control pills, study results showed.

To take the posttest, go to: http://bit.ly/1AKQert

4. Statins, Fibrates Lower Stroke Risk in Elderly
Both statin and fibrate therapies taken to improve lipid profiles decreased risk for stroke by 30% in a community-dwelling population of elderly people, according to a prospective European study published online in the British Medical Journal.

To take the posttest, go to: http://bit.ly/1FuyYCb

5. Cystic Fibrosis–related Diabetes Requires Different Approach
Cystic fibrosis–related diabetes (CFRD) is a unique disease that requires a different mindset on the part of the treating clinician.

To take the posttest, go to: http://bit.ly/1BKGZCm

6. CVD Risk Persists for 40 Years in Hodgkin Survivors
People who survive Hodgkin lymphoma in adolescence or young adulthood remain at very high risk for cardiovascular disease (CVD) for at least 40 years—the longest period for which they have been followed, according to the results of a retrospective cohort study of more than 2,500 patients.

To take the posttest, go to: http://bit.ly/1M5ymYG

7. Asymptomatic Carotid Stenosis and Central Sleep Apnea Linked
More than two-thirds of patients with asymptomatic carotid stenosis are likely to have sleep apnea, according to an observational study. The polysomnography results of 96 patients with ­asymptomatic extracranial carotid stenosis revealed that 69% had sleep apnea: 42% had obstructive sleep apnea (OSA) and 27%, central sleep apnea (CSA).

To take the posttest, go to: http://bit.ly/1SWGPmb