Mitchel L. Zoler, PhD

LONDON – Strontium ranelate continued to safely and effectively prevent vertebral and nonvertebral fractures in postmenopausal women with osteoporosis during 5-10 years of continuous treatment, in a "modified" case-control study that included 233 women who maintained daily 2 g/day strontium dosing for 10 years.

"Strontium ranelate should not be considered a second-line alternative to bisphosphonates or to any other [osteoporosis] treatment," Dr. Jean-Yves Reginster said at the annual European Congress of Rheumatology. Treatment with strontium ranelate "gives you a chance to bring bone turnover back to premenopausal values," said Dr. Reginster, professor of epidemiology and chairman of the department of public health at the University of Liège in Belgium.

The ability of strontium ranelate to maintain a reduced rate of both vertebral and nonvertebral fractures over 10 years of continuous use in this study marks the first reported evidence of an antiosteoporotic drug exerting an unequivocal antifracture benefit for such a prolonged period. The only other report on 10-year treatment came from the Fracture Intervention Trial Long Term Extension, which included 1,099 women randomized to alendronate or placebo for 10 years (JAMA 2006;296:2927-38). Those results showed that 5-10 years of extended alendronate treatment did not result in a reduction of all clinical fractures or nonvertebral fracture, compared with women maintained on placebo during years 5-10, but extended alendronate did reduce the clinical vertebral fracture rate, compared with placebo.

"In our study [of strontium ranelate], we had no placebo group, but we showed that you can reduce fractures over 10 years with this drug." Strontium maintained its efficacy over 10 years "probably because of its mechanism of action, a dual action," Dr. Reginster said in an interview. "With bisphosphonates you reduce bone resorption. With strontium ranelate you reduce bone resorption by 20%-25%, and you increase bone formation by 20%-25%, so you bring the bone back to what you see in younger women. I think it is a more physiologic approach" than treatment with a bisphosphonate.

In addition, "safety is most important to me when you treat for 10 years. One of the biggest advantages of strontium ranelate is that it is a very safe drug, with little risk of adverse effects over time. I think that calculating the risk/benefit ratio of a drug over time is very important."

In his report, Dr. Reginster emphasized that the women maintained on the drug for 10 years did not have a single episode of atypical fracture, osteonecrosis of the jaw or atrial fibrillation, and their adverse-event profile showed better safety than in the original, pivotal trials of strontium ranelate. He also noted that while the extension only included 233 women on the drug, registry data on about one million patients who have taken the drug also show no reported cases of atypical fracture, osteonecrosis of the jaw, or atrial fibrillation.

The 233 women followed for 10 years on continuous strontium ranelate treatment came from either of the two pivotal, 5-year trials of the drug: the Treatment of Peripheral Osteoporosis Study (TROPOS) (J. Clin. Endocrinol. Met. 2005;90:2816-22), and the Spinal Osteoporosis Therapeutic Intervention (SOTI) trial (New. Engl. J. Med. 2004;350:459-68). They continued to receive 2 g/day strontium ranelate, and 73% of the women completed the full extension period. Their average duration of drug use was 9.8 years, and their average compliance with the regimen was 89%.

During their additional 5 years on the drug, average lumbar spine bone mineral density continued to rise, increasing from about 20% above baseline at the start of the extension to about 27% above baseline at 10 years.

To assess the efficacy of treatment for preventing vertebral and nonvertebral fractures, Dr. Reginster and his associates "rebuilt" a control population by selecting placebo patients from the TROPOS study who matched the 233 extended-treatment women based on their baseline Fracture Risk Assessment scores. The researchers matched two TROPOS placebo-group women with each women in the extension study, assembling a total of 458 controls.

The incidence of vertebral fractures during years 5-10 in the women on strontium ranelate was 21%, compared with a 28% rate in the rebuilt control group, a statistically significant difference. In addition, the 21% reduction during the 5-10 year period was statistically similar to the 19% vertebral fracture rate among women treated during 0-5 years in SOTI.

The incidence of nonvertebral fractures during years 5-10 with strontium ranelate was 14%, significantly less than the 20% rate in the derived placebo group and statistically similar to the 13% rate seen in TROPOS, Dr. Reginster reported.

The SOTI and TROPOS trials were funded by Servier, which markets strontium ranelate (Protelos). Dr. Reginster reported financial relationships with Amgen, Analis, Bristol-Myers Squibb, Ebewe, Genévrier, GlaxoSmithKline, IBSA, Eli Lilly, Merck Sharp & Dohme, Merckle, Negma, Novartis, Novo Nordisk, NPS Pharmaceuticals, Nycomed, Roche, Rottapharm, Servier, Teijin, Teva, Theramex, Wyeth, UCB, and Zodiac.

LONDON – Strontium ranelate continued to safely and effectively prevent vertebral and nonvertebral fractures in postmenopausal women with osteoporosis during 5-10 years of continuous treatment, in a "modified" case-control study that included 233 women who maintained daily 2 g/day strontium dosing for 10 years.

"Strontium ranelate should not be considered a second-line alternative to bisphosphonates or to any other [osteoporosis] treatment," Dr. Jean-Yves Reginster said at the annual European Congress of Rheumatology. Treatment with strontium ranelate "gives you a chance to bring bone turnover back to premenopausal values," said Dr. Reginster, professor of epidemiology and chairman of the department of public health at the University of Liège in Belgium.

The ability of strontium ranelate to maintain a reduced rate of both vertebral and nonvertebral fractures over 10 years of continuous use in this study marks the first reported evidence of an antiosteoporotic drug exerting an unequivocal antifracture benefit for such a prolonged period. The only other report on 10-year treatment came from the Fracture Intervention Trial Long Term Extension, which included 1,099 women randomized to alendronate or placebo for 10 years (JAMA 2006;296:2927-38). Those results showed that 5-10 years of extended alendronate treatment did not result in a reduction of all clinical fractures or nonvertebral fracture, compared with women maintained on placebo during years 5-10, but extended alendronate did reduce the clinical vertebral fracture rate, compared with placebo.

"In our study [of strontium ranelate], we had no placebo group, but we showed that you can reduce fractures over 10 years with this drug." Strontium maintained its efficacy over 10 years "probably because of its mechanism of action, a dual action," Dr. Reginster said in an interview. "With bisphosphonates you reduce bone resorption. With strontium ranelate you reduce bone resorption by 20%-25%, and you increase bone formation by 20%-25%, so you bring the bone back to what you see in younger women. I think it is a more physiologic approach" than treatment with a bisphosphonate.

In addition, "safety is most important to me when you treat for 10 years. One of the biggest advantages of strontium ranelate is that it is a very safe drug, with little risk of adverse effects over time. I think that calculating the risk/benefit ratio of a drug over time is very important."

In his report, Dr. Reginster emphasized that the women maintained on the drug for 10 years did not have a single episode of atypical fracture, osteonecrosis of the jaw or atrial fibrillation, and their adverse-event profile showed better safety than in the original, pivotal trials of strontium ranelate. He also noted that while the extension only included 233 women on the drug, registry data on about one million patients who have taken the drug also show no reported cases of atypical fracture, osteonecrosis of the jaw, or atrial fibrillation.

The 233 women followed for 10 years on continuous strontium ranelate treatment came from either of the two pivotal, 5-year trials of the drug: the Treatment of Peripheral Osteoporosis Study (TROPOS) (J. Clin. Endocrinol. Met. 2005;90:2816-22), and the Spinal Osteoporosis Therapeutic Intervention (SOTI) trial (New. Engl. J. Med. 2004;350:459-68). They continued to receive 2 g/day strontium ranelate, and 73% of the women completed the full extension period. Their average duration of drug use was 9.8 years, and their average compliance with the regimen was 89%.

During their additional 5 years on the drug, average lumbar spine bone mineral density continued to rise, increasing from about 20% above baseline at the start of the extension to about 27% above baseline at 10 years.

To assess the efficacy of treatment for preventing vertebral and nonvertebral fractures, Dr. Reginster and his associates "rebuilt" a control population by selecting placebo patients from the TROPOS study who matched the 233 extended-treatment women based on their baseline Fracture Risk Assessment scores. The researchers matched two TROPOS placebo-group women with each women in the extension study, assembling a total of 458 controls.

The incidence of vertebral fractures during years 5-10 in the women on strontium ranelate was 21%, compared with a 28% rate in the rebuilt control group, a statistically significant difference. In addition, the 21% reduction during the 5-10 year period was statistically similar to the 19% vertebral fracture rate among women treated during 0-5 years in SOTI.

The incidence of nonvertebral fractures during years 5-10 with strontium ranelate was 14%, significantly less than the 20% rate in the derived placebo group and statistically similar to the 13% rate seen in TROPOS, Dr. Reginster reported.

The SOTI and TROPOS trials were funded by Servier, which markets strontium ranelate (Protelos). Dr. Reginster reported financial relationships with Amgen, Analis, Bristol-Myers Squibb, Ebewe, Genévrier, GlaxoSmithKline, IBSA, Eli Lilly, Merck Sharp & Dohme, Merckle, Negma, Novartis, Novo Nordisk, NPS Pharmaceuticals, Nycomed, Roche, Rottapharm, Servier, Teijin, Teva, Theramex, Wyeth, UCB, and Zodiac.

LONDON – Strontium ranelate continued to safely and effectively prevent vertebral and nonvertebral fractures in postmenopausal women with osteoporosis during 5-10 years of continuous treatment, in a "modified" case-control study that included 233 women who maintained daily 2 g/day strontium dosing for 10 years.

"Strontium ranelate should not be considered a second-line alternative to bisphosphonates or to any other [osteoporosis] treatment," Dr. Jean-Yves Reginster said at the annual European Congress of Rheumatology. Treatment with strontium ranelate "gives you a chance to bring bone turnover back to premenopausal values," said Dr. Reginster, professor of epidemiology and chairman of the department of public health at the University of Liège in Belgium.

The ability of strontium ranelate to maintain a reduced rate of both vertebral and nonvertebral fractures over 10 years of continuous use in this study marks the first reported evidence of an antiosteoporotic drug exerting an unequivocal antifracture benefit for such a prolonged period. The only other report on 10-year treatment came from the Fracture Intervention Trial Long Term Extension, which included 1,099 women randomized to alendronate or placebo for 10 years (JAMA 2006;296:2927-38). Those results showed that 5-10 years of extended alendronate treatment did not result in a reduction of all clinical fractures or nonvertebral fracture, compared with women maintained on placebo during years 5-10, but extended alendronate did reduce the clinical vertebral fracture rate, compared with placebo.

"In our study [of strontium ranelate], we had no placebo group, but we showed that you can reduce fractures over 10 years with this drug." Strontium maintained its efficacy over 10 years "probably because of its mechanism of action, a dual action," Dr. Reginster said in an interview. "With bisphosphonates you reduce bone resorption. With strontium ranelate you reduce bone resorption by 20%-25%, and you increase bone formation by 20%-25%, so you bring the bone back to what you see in younger women. I think it is a more physiologic approach" than treatment with a bisphosphonate.

In addition, "safety is most important to me when you treat for 10 years. One of the biggest advantages of strontium ranelate is that it is a very safe drug, with little risk of adverse effects over time. I think that calculating the risk/benefit ratio of a drug over time is very important."

In his report, Dr. Reginster emphasized that the women maintained on the drug for 10 years did not have a single episode of atypical fracture, osteonecrosis of the jaw or atrial fibrillation, and their adverse-event profile showed better safety than in the original, pivotal trials of strontium ranelate. He also noted that while the extension only included 233 women on the drug, registry data on about one million patients who have taken the drug also show no reported cases of atypical fracture, osteonecrosis of the jaw, or atrial fibrillation.

The 233 women followed for 10 years on continuous strontium ranelate treatment came from either of the two pivotal, 5-year trials of the drug: the Treatment of Peripheral Osteoporosis Study (TROPOS) (J. Clin. Endocrinol. Met. 2005;90:2816-22), and the Spinal Osteoporosis Therapeutic Intervention (SOTI) trial (New. Engl. J. Med. 2004;350:459-68). They continued to receive 2 g/day strontium ranelate, and 73% of the women completed the full extension period. Their average duration of drug use was 9.8 years, and their average compliance with the regimen was 89%.

During their additional 5 years on the drug, average lumbar spine bone mineral density continued to rise, increasing from about 20% above baseline at the start of the extension to about 27% above baseline at 10 years.

To assess the efficacy of treatment for preventing vertebral and nonvertebral fractures, Dr. Reginster and his associates "rebuilt" a control population by selecting placebo patients from the TROPOS study who matched the 233 extended-treatment women based on their baseline Fracture Risk Assessment scores. The researchers matched two TROPOS placebo-group women with each women in the extension study, assembling a total of 458 controls.

The incidence of vertebral fractures during years 5-10 in the women on strontium ranelate was 21%, compared with a 28% rate in the rebuilt control group, a statistically significant difference. In addition, the 21% reduction during the 5-10 year period was statistically similar to the 19% vertebral fracture rate among women treated during 0-5 years in SOTI.

The incidence of nonvertebral fractures during years 5-10 with strontium ranelate was 14%, significantly less than the 20% rate in the derived placebo group and statistically similar to the 13% rate seen in TROPOS, Dr. Reginster reported.

The SOTI and TROPOS trials were funded by Servier, which markets strontium ranelate (Protelos). Dr. Reginster reported financial relationships with Amgen, Analis, Bristol-Myers Squibb, Ebewe, Genévrier, GlaxoSmithKline, IBSA, Eli Lilly, Merck Sharp & Dohme, Merckle, Negma, Novartis, Novo Nordisk, NPS Pharmaceuticals, Nycomed, Roche, Rottapharm, Servier, Teijin, Teva, Theramex, Wyeth, UCB, and Zodiac.

LONDON – Strontium ranelate continued to safely and effectively prevent vertebral and nonvertebral fractures in postmenopausal women with osteoporosis during 5-10 years of continuous treatment, in a "modified" case-control study that included 233 women who maintained daily 2 g/day strontium dosing for 10 years.

"Strontium ranelate should not be considered a second-line alternative to bisphosphonates or to any other [osteoporosis] treatment," Dr. Jean-Yves Reginster said at the annual European Congress of Rheumatology. Treatment with strontium ranelate "gives you a chance to bring bone turnover back to premenopausal values," said Dr. Reginster, professor of epidemiology and chairman of the department of public health at the University of Liège in Belgium.

The ability of strontium ranelate to maintain a reduced rate of both vertebral and nonvertebral fractures over 10 years of continuous use in this study marks the first reported evidence of an antiosteoporotic drug exerting an unequivocal antifracture benefit for such a prolonged period. The only other report on 10-year treatment came from the Fracture Intervention Trial Long Term Extension, which included 1,099 women randomized to alendronate or placebo for 10 years (JAMA 2006;296:2927-38). Those results showed that 5-10 years of extended alendronate treatment did not result in a reduction of all clinical fractures or nonvertebral fracture, compared with women maintained on placebo during years 5-10, but extended alendronate did reduce the clinical vertebral fracture rate, compared with placebo.

"In our study [of strontium ranelate], we had no placebo group, but we showed that you can reduce fractures over 10 years with this drug." Strontium maintained its efficacy over 10 years "probably because of its mechanism of action, a dual action," Dr. Reginster said in an interview. "With bisphosphonates you reduce bone resorption. With strontium ranelate you reduce bone resorption by 20%-25%, and you increase bone formation by 20%-25%, so you bring the bone back to what you see in younger women. I think it is a more physiologic approach" than treatment with a bisphosphonate.

In addition, "safety is most important to me when you treat for 10 years. One of the biggest advantages of strontium ranelate is that it is a very safe drug, with little risk of adverse effects over time. I think that calculating the risk/benefit ratio of a drug over time is very important."

In his report, Dr. Reginster emphasized that the women maintained on the drug for 10 years did not have a single episode of atypical fracture, osteonecrosis of the jaw or atrial fibrillation, and their adverse-event profile showed better safety than in the original, pivotal trials of strontium ranelate. He also noted that while the extension only included 233 women on the drug, registry data on about one million patients who have taken the drug also show no reported cases of atypical fracture, osteonecrosis of the jaw, or atrial fibrillation.

The 233 women followed for 10 years on continuous strontium ranelate treatment came from either of the two pivotal, 5-year trials of the drug: the Treatment of Peripheral Osteoporosis Study (TROPOS) (J. Clin. Endocrinol. Met. 2005;90:2816-22), and the Spinal Osteoporosis Therapeutic Intervention (SOTI) trial (New. Engl. J. Med. 2004;350:459-68). They continued to receive 2 g/day strontium ranelate, and 73% of the women completed the full extension period. Their average duration of drug use was 9.8 years, and their average compliance with the regimen was 89%.

During their additional 5 years on the drug, average lumbar spine bone mineral density continued to rise, increasing from about 20% above baseline at the start of the extension to about 27% above baseline at 10 years.

To assess the efficacy of treatment for preventing vertebral and nonvertebral fractures, Dr. Reginster and his associates "rebuilt" a control population by selecting placebo patients from the TROPOS study who matched the 233 extended-treatment women based on their baseline Fracture Risk Assessment scores. The researchers matched two TROPOS placebo-group women with each women in the extension study, assembling a total of 458 controls.

The incidence of vertebral fractures during years 5-10 in the women on strontium ranelate was 21%, compared with a 28% rate in the rebuilt control group, a statistically significant difference. In addition, the 21% reduction during the 5-10 year period was statistically similar to the 19% vertebral fracture rate among women treated during 0-5 years in SOTI.

The incidence of nonvertebral fractures during years 5-10 with strontium ranelate was 14%, significantly less than the 20% rate in the derived placebo group and statistically similar to the 13% rate seen in TROPOS, Dr. Reginster reported.

The SOTI and TROPOS trials were funded by Servier, which markets strontium ranelate (Protelos). Dr. Reginster reported financial relationships with Amgen, Analis, Bristol-Myers Squibb, Ebewe, Genévrier, GlaxoSmithKline, IBSA, Eli Lilly, Merck Sharp & Dohme, Merckle, Negma, Novartis, Novo Nordisk, NPS Pharmaceuticals, Nycomed, Roche, Rottapharm, Servier, Teijin, Teva, Theramex, Wyeth, UCB, and Zodiac.

LONDON – Strontium ranelate continued to safely and effectively prevent vertebral and nonvertebral fractures in postmenopausal women with osteoporosis during 5-10 years of continuous treatment, in a "modified" case-control study that included 233 women who maintained daily 2 g/day strontium dosing for 10 years.

"Strontium ranelate should not be considered a second-line alternative to bisphosphonates or to any other [osteoporosis] treatment," Dr. Jean-Yves Reginster said at the annual European Congress of Rheumatology. Treatment with strontium ranelate "gives you a chance to bring bone turnover back to premenopausal values," said Dr. Reginster, professor of epidemiology and chairman of the department of public health at the University of Liège in Belgium.

The ability of strontium ranelate to maintain a reduced rate of both vertebral and nonvertebral fractures over 10 years of continuous use in this study marks the first reported evidence of an antiosteoporotic drug exerting an unequivocal antifracture benefit for such a prolonged period. The only other report on 10-year treatment came from the Fracture Intervention Trial Long Term Extension, which included 1,099 women randomized to alendronate or placebo for 10 years (JAMA 2006;296:2927-38). Those results showed that 5-10 years of extended alendronate treatment did not result in a reduction of all clinical fractures or nonvertebral fracture, compared with women maintained on placebo during years 5-10, but extended alendronate did reduce the clinical vertebral fracture rate, compared with placebo.

"In our study [of strontium ranelate], we had no placebo group, but we showed that you can reduce fractures over 10 years with this drug." Strontium maintained its efficacy over 10 years "probably because of its mechanism of action, a dual action," Dr. Reginster said in an interview. "With bisphosphonates you reduce bone resorption. With strontium ranelate you reduce bone resorption by 20%-25%, and you increase bone formation by 20%-25%, so you bring the bone back to what you see in younger women. I think it is a more physiologic approach" than treatment with a bisphosphonate.

In addition, "safety is most important to me when you treat for 10 years. One of the biggest advantages of strontium ranelate is that it is a very safe drug, with little risk of adverse effects over time. I think that calculating the risk/benefit ratio of a drug over time is very important."

In his report, Dr. Reginster emphasized that the women maintained on the drug for 10 years did not have a single episode of atypical fracture, osteonecrosis of the jaw or atrial fibrillation, and their adverse-event profile showed better safety than in the original, pivotal trials of strontium ranelate. He also noted that while the extension only included 233 women on the drug, registry data on about one million patients who have taken the drug also show no reported cases of atypical fracture, osteonecrosis of the jaw, or atrial fibrillation.

The 233 women followed for 10 years on continuous strontium ranelate treatment came from either of the two pivotal, 5-year trials of the drug: the Treatment of Peripheral Osteoporosis Study (TROPOS) (J. Clin. Endocrinol. Met. 2005;90:2816-22), and the Spinal Osteoporosis Therapeutic Intervention (SOTI) trial (New. Engl. J. Med. 2004;350:459-68). They continued to receive 2 g/day strontium ranelate, and 73% of the women completed the full extension period. Their average duration of drug use was 9.8 years, and their average compliance with the regimen was 89%.

During their additional 5 years on the drug, average lumbar spine bone mineral density continued to rise, increasing from about 20% above baseline at the start of the extension to about 27% above baseline at 10 years.

To assess the efficacy of treatment for preventing vertebral and nonvertebral fractures, Dr. Reginster and his associates "rebuilt" a control population by selecting placebo patients from the TROPOS study who matched the 233 extended-treatment women based on their baseline Fracture Risk Assessment scores. The researchers matched two TROPOS placebo-group women with each women in the extension study, assembling a total of 458 controls.

The incidence of vertebral fractures during years 5-10 in the women on strontium ranelate was 21%, compared with a 28% rate in the rebuilt control group, a statistically significant difference. In addition, the 21% reduction during the 5-10 year period was statistically similar to the 19% vertebral fracture rate among women treated during 0-5 years in SOTI.

The incidence of nonvertebral fractures during years 5-10 with strontium ranelate was 14%, significantly less than the 20% rate in the derived placebo group and statistically similar to the 13% rate seen in TROPOS, Dr. Reginster reported.

The SOTI and TROPOS trials were funded by Servier, which markets strontium ranelate (Protelos). Dr. Reginster reported financial relationships with Amgen, Analis, Bristol-Myers Squibb, Ebewe, Genévrier, GlaxoSmithKline, IBSA, Eli Lilly, Merck Sharp & Dohme, Merckle, Negma, Novartis, Novo Nordisk, NPS Pharmaceuticals, Nycomed, Roche, Rottapharm, Servier, Teijin, Teva, Theramex, Wyeth, UCB, and Zodiac.

LONDON – Strontium ranelate continued to safely and effectively prevent vertebral and nonvertebral fractures in postmenopausal women with osteoporosis during 5-10 years of continuous treatment, in a "modified" case-control study that included 233 women who maintained daily 2 g/day strontium dosing for 10 years.

"Strontium ranelate should not be considered a second-line alternative to bisphosphonates or to any other [osteoporosis] treatment," Dr. Jean-Yves Reginster said at the annual European Congress of Rheumatology. Treatment with strontium ranelate "gives you a chance to bring bone turnover back to premenopausal values," said Dr. Reginster, professor of epidemiology and chairman of the department of public health at the University of Liège in Belgium.

The ability of strontium ranelate to maintain a reduced rate of both vertebral and nonvertebral fractures over 10 years of continuous use in this study marks the first reported evidence of an antiosteoporotic drug exerting an unequivocal antifracture benefit for such a prolonged period. The only other report on 10-year treatment came from the Fracture Intervention Trial Long Term Extension, which included 1,099 women randomized to alendronate or placebo for 10 years (JAMA 2006;296:2927-38). Those results showed that 5-10 years of extended alendronate treatment did not result in a reduction of all clinical fractures or nonvertebral fracture, compared with women maintained on placebo during years 5-10, but extended alendronate did reduce the clinical vertebral fracture rate, compared with placebo.

"In our study [of strontium ranelate], we had no placebo group, but we showed that you can reduce fractures over 10 years with this drug." Strontium maintained its efficacy over 10 years "probably because of its mechanism of action, a dual action," Dr. Reginster said in an interview. "With bisphosphonates you reduce bone resorption. With strontium ranelate you reduce bone resorption by 20%-25%, and you increase bone formation by 20%-25%, so you bring the bone back to what you see in younger women. I think it is a more physiologic approach" than treatment with a bisphosphonate.

In addition, "safety is most important to me when you treat for 10 years. One of the biggest advantages of strontium ranelate is that it is a very safe drug, with little risk of adverse effects over time. I think that calculating the risk/benefit ratio of a drug over time is very important."

In his report, Dr. Reginster emphasized that the women maintained on the drug for 10 years did not have a single episode of atypical fracture, osteonecrosis of the jaw or atrial fibrillation, and their adverse-event profile showed better safety than in the original, pivotal trials of strontium ranelate. He also noted that while the extension only included 233 women on the drug, registry data on about one million patients who have taken the drug also show no reported cases of atypical fracture, osteonecrosis of the jaw, or atrial fibrillation.

The 233 women followed for 10 years on continuous strontium ranelate treatment came from either of the two pivotal, 5-year trials of the drug: the Treatment of Peripheral Osteoporosis Study (TROPOS) (J. Clin. Endocrinol. Met. 2005;90:2816-22), and the Spinal Osteoporosis Therapeutic Intervention (SOTI) trial (New. Engl. J. Med. 2004;350:459-68). They continued to receive 2 g/day strontium ranelate, and 73% of the women completed the full extension period. Their average duration of drug use was 9.8 years, and their average compliance with the regimen was 89%.

During their additional 5 years on the drug, average lumbar spine bone mineral density continued to rise, increasing from about 20% above baseline at the start of the extension to about 27% above baseline at 10 years.

To assess the efficacy of treatment for preventing vertebral and nonvertebral fractures, Dr. Reginster and his associates "rebuilt" a control population by selecting placebo patients from the TROPOS study who matched the 233 extended-treatment women based on their baseline Fracture Risk Assessment scores. The researchers matched two TROPOS placebo-group women with each women in the extension study, assembling a total of 458 controls.

The incidence of vertebral fractures during years 5-10 in the women on strontium ranelate was 21%, compared with a 28% rate in the rebuilt control group, a statistically significant difference. In addition, the 21% reduction during the 5-10 year period was statistically similar to the 19% vertebral fracture rate among women treated during 0-5 years in SOTI.

The incidence of nonvertebral fractures during years 5-10 with strontium ranelate was 14%, significantly less than the 20% rate in the derived placebo group and statistically similar to the 13% rate seen in TROPOS, Dr. Reginster reported.

The SOTI and TROPOS trials were funded by Servier, which markets strontium ranelate (Protelos). Dr. Reginster reported financial relationships with Amgen, Analis, Bristol-Myers Squibb, Ebewe, Genévrier, GlaxoSmithKline, IBSA, Eli Lilly, Merck Sharp & Dohme, Merckle, Negma, Novartis, Novo Nordisk, NPS Pharmaceuticals, Nycomed, Roche, Rottapharm, Servier, Teijin, Teva, Theramex, Wyeth, UCB, and Zodiac.

AMSTERDAM – The International Association for the Study of Lung Cancer has issued a call for physicians to discuss lung cancer screening with patients who match the high-risk smoking history of the people enrolled in the landmark National Lung Screening Trial.

The National Lung Screening Trial (NLST) showed that an annual, low-dose CT chest scan can lead to significant reductions in lung cancer deaths and overall mortality in patients aged 55-74 years who smoked for at least 30 pack-years and, if former smokers, quit within the prior 15 years (New Engl. J. Med. 2011 [doi: 364:10.1056/NEJMoa1102873).

Based on these unprecedented findings, the International Association for the Study of Lung Cancer (IASLC)’s position-writing committee issued a call for physicians to discuss the data and its implications with such patients.

"It is appropriate for heavy smokers ages 55 to 74 to discuss relevant lung cancer screening information with their physicians to assist them in deciding whether to undergo spiral CT screening," said the statement, issued as IASLC started its world conference

Although some committee members, including the chairman, urged caution when routinely discussing screening with the target population before the cost effectiveness of this approach is proven, two of the Americans on the 10-member position-statement writing committee endorsed immediately offering screening to fully informed people who match the study’s screening profile.

"For patients with metastatic lung cancer the cure rate is essentially zero. Finding lung cancer early is the best way to deal with this disease, and that’s why this is such an extraordinary result," said Dr. Roy S. Herbst, a member of the task force and chief of medical oncology at Yale University in New Haven, Conn.

"Even with all the cautions, I think that in the United States at least you’ll see screening, especially since the NLST was largely sponsored by the National Cancer Institute. Assuming that the CMS [Centers for Medicare and Medicaid Services] and insurers will pick this up, I think [screening] is something we’re going to see. I think there will be great pressure in the United States for this to be covered, at a cost of about $300-$400 per scan.

"At Yale, we’ll start screening people who meet the enrollment criteria for the trial, as will several other U.S. centers. We’ll offer screening with all the caveats," including informing patients about the risks they will face from screening, their need to stop smoking, their need for ongoing screening, and the need to have a multidisciplinary team in place at the screening site to deal with all the possible consequences of screening, Dr. Herbst said.

"We know there is effectiveness from screening, but is there cost effectiveness? Is there value?" asked Dr. Richard Gralla, another member of the statement-writing committee and chief of hematology-oncology at North Shore University Medical Center and Long Island Jewish Medical Center in New Hyde Park, N.Y.

"My prediction is that screening will not only be shown to be cost effective, but it will be very cost effective. It will also be very expensive" to run annual screens on the millions of middle-aged smokers who meet the trial’s screening profile, he added. The NLST report estimated that 7 million Americans match the age and smoking history of the people enrolled in the trial.

By thrusting medicine into a new era of routine lung cancer screening, these developments will trigger creation of a new system of quality oversight for lung cancer screening that will likely follow the model of breast cancer screening.

"There is a laundry list of requirements that will need to be established by the institutions that want to do CT screening," said Dr. Denise R. Aberle, professor of radiology at the University of California, Los Angeles, and a collaborator on the NLST. "That will likely evolve into a form of accreditation to better guarantee quality assurance, as with breast cancer screening." Dr. Aberle also noted that the NLST researchers collected cost-effectiveness data, and that they will soon release a report on their analysis of those data.

Routine lung cancer screening will also place new responsibilities on the thoracic surgeons who follow up on suspicious lung lesions found though screening, most of which will not be cancers.

"For surgeons it will be a very large challenge to offer correct treatment to patients with very small cancers," said Dr. Jesper Pedersen, a thoracic surgeon at Copenhagen University Hospital. "We’re planning on writing guidelines for surgeons, because they will be at risk by operating on so many patients without lung cancer." The NLST results showed that 96% of suspicious lesions identified by CT screening were not cancers.

"There is potential for physical and psychiatric harm from cancer screening, but the results from many studies of breast cancer screening have shown that the benefits of screening outweigh its harms," said IASLC president David R. Gandara, professor of medicine and director of the thoracic oncology program at the University of California, Davis, in Sacramento.

"We’re in the early days of screening for lung cancer, and we must do everything to make sure that screening is done appropriately and that follow-up is appropriate. But our message to patients about screening is positive. We can’t overemphasize that," Dr. Gandara said.

Dr. Herbst said that he has been a consultant to Genentech, Agennix, Allos Therapeutics, Boehringer Ingelheim, and OSI Pharmaceuticals. He has been on the advisory boards of Amgen, Biothera, Genetics Squared (now Everist Genomics), MedTrust, N-of-One, SunDev, Targeted Molecular Diagnostics, and DiaTech. He has received research grants from Genentech, Amgen, Bristol-Myers Squibb, AstraZeneca, Novartis, OSI, Oncothyreon, Geron, Sanofi-Aventis, Pfizer, and ImClone.

Dr. Gralla and Dr. Aberle had no relevant disclosures. Dr. Pedersen said that he has been on the speakers bureau for Eli Lilly and Roche and received grant support from AstraZeneca. Dr. Gandara said that he has been a consultant to Amgen, AstraZeneca, Biodesix, Bristol-Myers Squibb/ImClone, GlaxoSmithKline, Genentech, Merck, Novartis, Sanofi-Aventis, and Response Genetics; he has received research support from Abbott, Bristol-Myers Squibb/ImClone, Genentech, Lilly, Merck, Novartis, and Pfizer.

AMSTERDAM – The International Association for the Study of Lung Cancer has issued a call for physicians to discuss lung cancer screening with patients who match the high-risk smoking history of the people enrolled in the landmark National Lung Screening Trial.

The National Lung Screening Trial (NLST) showed that an annual, low-dose CT chest scan can lead to significant reductions in lung cancer deaths and overall mortality in patients aged 55-74 years who smoked for at least 30 pack-years and, if former smokers, quit within the prior 15 years (New Engl. J. Med. 2011 [doi: 364:10.1056/NEJMoa1102873).

Based on these unprecedented findings, the International Association for the Study of Lung Cancer (IASLC)’s position-writing committee issued a call for physicians to discuss the data and its implications with such patients.

"It is appropriate for heavy smokers ages 55 to 74 to discuss relevant lung cancer screening information with their physicians to assist them in deciding whether to undergo spiral CT screening," said the statement, issued as IASLC started its world conference

Although some committee members, including the chairman, urged caution when routinely discussing screening with the target population before the cost effectiveness of this approach is proven, two of the Americans on the 10-member position-statement writing committee endorsed immediately offering screening to fully informed people who match the study’s screening profile.

"For patients with metastatic lung cancer the cure rate is essentially zero. Finding lung cancer early is the best way to deal with this disease, and that’s why this is such an extraordinary result," said Dr. Roy S. Herbst, a member of the task force and chief of medical oncology at Yale University in New Haven, Conn.

"Even with all the cautions, I think that in the United States at least you’ll see screening, especially since the NLST was largely sponsored by the National Cancer Institute. Assuming that the CMS [Centers for Medicare and Medicaid Services] and insurers will pick this up, I think [screening] is something we’re going to see. I think there will be great pressure in the United States for this to be covered, at a cost of about $300-$400 per scan.

"At Yale, we’ll start screening people who meet the enrollment criteria for the trial, as will several other U.S. centers. We’ll offer screening with all the caveats," including informing patients about the risks they will face from screening, their need to stop smoking, their need for ongoing screening, and the need to have a multidisciplinary team in place at the screening site to deal with all the possible consequences of screening, Dr. Herbst said.

"We know there is effectiveness from screening, but is there cost effectiveness? Is there value?" asked Dr. Richard Gralla, another member of the statement-writing committee and chief of hematology-oncology at North Shore University Medical Center and Long Island Jewish Medical Center in New Hyde Park, N.Y.

"My prediction is that screening will not only be shown to be cost effective, but it will be very cost effective. It will also be very expensive" to run annual screens on the millions of middle-aged smokers who meet the trial’s screening profile, he added. The NLST report estimated that 7 million Americans match the age and smoking history of the people enrolled in the trial.

By thrusting medicine into a new era of routine lung cancer screening, these developments will trigger creation of a new system of quality oversight for lung cancer screening that will likely follow the model of breast cancer screening.

"There is a laundry list of requirements that will need to be established by the institutions that want to do CT screening," said Dr. Denise R. Aberle, professor of radiology at the University of California, Los Angeles, and a collaborator on the NLST. "That will likely evolve into a form of accreditation to better guarantee quality assurance, as with breast cancer screening." Dr. Aberle also noted that the NLST researchers collected cost-effectiveness data, and that they will soon release a report on their analysis of those data.

Routine lung cancer screening will also place new responsibilities on the thoracic surgeons who follow up on suspicious lung lesions found though screening, most of which will not be cancers.

"For surgeons it will be a very large challenge to offer correct treatment to patients with very small cancers," said Dr. Jesper Pedersen, a thoracic surgeon at Copenhagen University Hospital. "We’re planning on writing guidelines for surgeons, because they will be at risk by operating on so many patients without lung cancer." The NLST results showed that 96% of suspicious lesions identified by CT screening were not cancers.

"There is potential for physical and psychiatric harm from cancer screening, but the results from many studies of breast cancer screening have shown that the benefits of screening outweigh its harms," said IASLC president David R. Gandara, professor of medicine and director of the thoracic oncology program at the University of California, Davis, in Sacramento.

"We’re in the early days of screening for lung cancer, and we must do everything to make sure that screening is done appropriately and that follow-up is appropriate. But our message to patients about screening is positive. We can’t overemphasize that," Dr. Gandara said.

Dr. Herbst said that he has been a consultant to Genentech, Agennix, Allos Therapeutics, Boehringer Ingelheim, and OSI Pharmaceuticals. He has been on the advisory boards of Amgen, Biothera, Genetics Squared (now Everist Genomics), MedTrust, N-of-One, SunDev, Targeted Molecular Diagnostics, and DiaTech. He has received research grants from Genentech, Amgen, Bristol-Myers Squibb, AstraZeneca, Novartis, OSI, Oncothyreon, Geron, Sanofi-Aventis, Pfizer, and ImClone.

Dr. Gralla and Dr. Aberle had no relevant disclosures. Dr. Pedersen said that he has been on the speakers bureau for Eli Lilly and Roche and received grant support from AstraZeneca. Dr. Gandara said that he has been a consultant to Amgen, AstraZeneca, Biodesix, Bristol-Myers Squibb/ImClone, GlaxoSmithKline, Genentech, Merck, Novartis, Sanofi-Aventis, and Response Genetics; he has received research support from Abbott, Bristol-Myers Squibb/ImClone, Genentech, Lilly, Merck, Novartis, and Pfizer.

AMSTERDAM – The International Association for the Study of Lung Cancer has issued a call for physicians to discuss lung cancer screening with patients who match the high-risk smoking history of the people enrolled in the landmark National Lung Screening Trial.

The National Lung Screening Trial (NLST) showed that an annual, low-dose CT chest scan can lead to significant reductions in lung cancer deaths and overall mortality in patients aged 55-74 years who smoked for at least 30 pack-years and, if former smokers, quit within the prior 15 years (New Engl. J. Med. 2011 [doi: 364:10.1056/NEJMoa1102873).

Based on these unprecedented findings, the International Association for the Study of Lung Cancer (IASLC)’s position-writing committee issued a call for physicians to discuss the data and its implications with such patients.

"It is appropriate for heavy smokers ages 55 to 74 to discuss relevant lung cancer screening information with their physicians to assist them in deciding whether to undergo spiral CT screening," said the statement, issued as IASLC started its world conference

Although some committee members, including the chairman, urged caution when routinely discussing screening with the target population before the cost effectiveness of this approach is proven, two of the Americans on the 10-member position-statement writing committee endorsed immediately offering screening to fully informed people who match the study’s screening profile.

"For patients with metastatic lung cancer the cure rate is essentially zero. Finding lung cancer early is the best way to deal with this disease, and that’s why this is such an extraordinary result," said Dr. Roy S. Herbst, a member of the task force and chief of medical oncology at Yale University in New Haven, Conn.

"Even with all the cautions, I think that in the United States at least you’ll see screening, especially since the NLST was largely sponsored by the National Cancer Institute. Assuming that the CMS [Centers for Medicare and Medicaid Services] and insurers will pick this up, I think [screening] is something we’re going to see. I think there will be great pressure in the United States for this to be covered, at a cost of about $300-$400 per scan.

"At Yale, we’ll start screening people who meet the enrollment criteria for the trial, as will several other U.S. centers. We’ll offer screening with all the caveats," including informing patients about the risks they will face from screening, their need to stop smoking, their need for ongoing screening, and the need to have a multidisciplinary team in place at the screening site to deal with all the possible consequences of screening, Dr. Herbst said.

"We know there is effectiveness from screening, but is there cost effectiveness? Is there value?" asked Dr. Richard Gralla, another member of the statement-writing committee and chief of hematology-oncology at North Shore University Medical Center and Long Island Jewish Medical Center in New Hyde Park, N.Y.

"My prediction is that screening will not only be shown to be cost effective, but it will be very cost effective. It will also be very expensive" to run annual screens on the millions of middle-aged smokers who meet the trial’s screening profile, he added. The NLST report estimated that 7 million Americans match the age and smoking history of the people enrolled in the trial.

By thrusting medicine into a new era of routine lung cancer screening, these developments will trigger creation of a new system of quality oversight for lung cancer screening that will likely follow the model of breast cancer screening.

"There is a laundry list of requirements that will need to be established by the institutions that want to do CT screening," said Dr. Denise R. Aberle, professor of radiology at the University of California, Los Angeles, and a collaborator on the NLST. "That will likely evolve into a form of accreditation to better guarantee quality assurance, as with breast cancer screening." Dr. Aberle also noted that the NLST researchers collected cost-effectiveness data, and that they will soon release a report on their analysis of those data.

Routine lung cancer screening will also place new responsibilities on the thoracic surgeons who follow up on suspicious lung lesions found though screening, most of which will not be cancers.

"For surgeons it will be a very large challenge to offer correct treatment to patients with very small cancers," said Dr. Jesper Pedersen, a thoracic surgeon at Copenhagen University Hospital. "We’re planning on writing guidelines for surgeons, because they will be at risk by operating on so many patients without lung cancer." The NLST results showed that 96% of suspicious lesions identified by CT screening were not cancers.

"There is potential for physical and psychiatric harm from cancer screening, but the results from many studies of breast cancer screening have shown that the benefits of screening outweigh its harms," said IASLC president David R. Gandara, professor of medicine and director of the thoracic oncology program at the University of California, Davis, in Sacramento.

"We’re in the early days of screening for lung cancer, and we must do everything to make sure that screening is done appropriately and that follow-up is appropriate. But our message to patients about screening is positive. We can’t overemphasize that," Dr. Gandara said.

Dr. Herbst said that he has been a consultant to Genentech, Agennix, Allos Therapeutics, Boehringer Ingelheim, and OSI Pharmaceuticals. He has been on the advisory boards of Amgen, Biothera, Genetics Squared (now Everist Genomics), MedTrust, N-of-One, SunDev, Targeted Molecular Diagnostics, and DiaTech. He has received research grants from Genentech, Amgen, Bristol-Myers Squibb, AstraZeneca, Novartis, OSI, Oncothyreon, Geron, Sanofi-Aventis, Pfizer, and ImClone.

Dr. Gralla and Dr. Aberle had no relevant disclosures. Dr. Pedersen said that he has been on the speakers bureau for Eli Lilly and Roche and received grant support from AstraZeneca. Dr. Gandara said that he has been a consultant to Amgen, AstraZeneca, Biodesix, Bristol-Myers Squibb/ImClone, GlaxoSmithKline, Genentech, Merck, Novartis, Sanofi-Aventis, and Response Genetics; he has received research support from Abbott, Bristol-Myers Squibb/ImClone, Genentech, Lilly, Merck, Novartis, and Pfizer.

LONDON – Women who give birth to a child face a twofold increased risk of incident ACPA-negative rheumatoid arthritis, compared with nulliparous women, but they have no increased risk for developing ACPA-positive disease, based on results from a Swedish epidemiologic study

The finding is consistent with a report last year from a Norwegian study that women face about a twofold increased risk for incident rheumatoid arthritis (RA) during the first 2 years after giving birth to a child, compared with their RA risk 2-4 years postpartum (Ann. Rheum. Dis. 2010;69:332-6). The reason why the new analysis, which included more than 1,200 cases and controls, showed a different relationship between partum and the onset of anticitrullinated peptide antibody (ACPA) –positive RH and ACPA-negative RA remains unclear, according to Camilla Bengtsson, Ph.D.

"Why there is only an association with ACPA-negative disease, and which biological mechanisms are involved remains to be elucidated," said Dr. Bengtsson, a researcher at the Karolinska Institute in Stockholm. The way in which this finding might apply to practice also remains unclear, she added.

Dr. Bengtsson’s analysis failed to show an increased incidence of any form of RA in women who were more than a year out from their delivery.

The study used data and blood specimens from Swedish women aged 18-50 years who were enrolled in the Epidemiological Investigation of RA (EIRA) study during 1996-2006. Among the women with incident RA enrolled in EIRA, 547 (95%) agreed to participate and provide blood specimens, and among the control women in the study, 658 (81%) provided blood. The analysis divided the cases and controls into subgroups based on their partum status. The 547 women with new-onset RA included 360 who had given birth and 187 who had not. The parous women included 226 with ACPA-positive RA and 134 with the ACPA-negative form. Among the nulliparous women with RA, 127 had the ACPA-positive form and 60 were ACPA negative.

Among the controls with no RA, 431 had given birth and 227 had never given birth.

The case-control analysis showed that among all women with incident RA, birth status during the year preceding a new RA diagnosis had no statistically significant relationship with RA onset. However, among women who developed ACPA-negative RA, their risk spiked by a statistically significant, 2.4-fold rate during the year following partum, compared with nulliparous women. In contrast, the incidence of ACPA-positive RA showed no significant relationship to partum status during the preceding year.

Further analysis examined the timing between delivery and onset of ACPA-negative RA more closely. Again, the analysis showed that, during the year following giving birth, women faced a statistically significant, 2.4-fold elevated risk for incident ACPA-negative RA, compared with nulliparous women. During the 2-10 years following giving birth, the rate of incident ACPA-negative RA dropped to a 50% higher risk, compared with nulliparous women, but this difference was not considered statistically significant. And women more than 10 years out from their most recent delivery had a risk for incident ACPA-negative RA identical to the nulliparous women, Dr. Bengtsson reported.

Dr. Bengtsson said that she had no disclosures.

LONDON – Women who give birth to a child face a twofold increased risk of incident ACPA-negative rheumatoid arthritis, compared with nulliparous women, but they have no increased risk for developing ACPA-positive disease, based on results from a Swedish epidemiologic study

The finding is consistent with a report last year from a Norwegian study that women face about a twofold increased risk for incident rheumatoid arthritis (RA) during the first 2 years after giving birth to a child, compared with their RA risk 2-4 years postpartum (Ann. Rheum. Dis. 2010;69:332-6). The reason why the new analysis, which included more than 1,200 cases and controls, showed a different relationship between partum and the onset of anticitrullinated peptide antibody (ACPA) –positive RH and ACPA-negative RA remains unclear, according to Camilla Bengtsson, Ph.D.

"Why there is only an association with ACPA-negative disease, and which biological mechanisms are involved remains to be elucidated," said Dr. Bengtsson, a researcher at the Karolinska Institute in Stockholm. The way in which this finding might apply to practice also remains unclear, she added.

Dr. Bengtsson’s analysis failed to show an increased incidence of any form of RA in women who were more than a year out from their delivery.

The study used data and blood specimens from Swedish women aged 18-50 years who were enrolled in the Epidemiological Investigation of RA (EIRA) study during 1996-2006. Among the women with incident RA enrolled in EIRA, 547 (95%) agreed to participate and provide blood specimens, and among the control women in the study, 658 (81%) provided blood. The analysis divided the cases and controls into subgroups based on their partum status. The 547 women with new-onset RA included 360 who had given birth and 187 who had not. The parous women included 226 with ACPA-positive RA and 134 with the ACPA-negative form. Among the nulliparous women with RA, 127 had the ACPA-positive form and 60 were ACPA negative.

Among the controls with no RA, 431 had given birth and 227 had never given birth.

The case-control analysis showed that among all women with incident RA, birth status during the year preceding a new RA diagnosis had no statistically significant relationship with RA onset. However, among women who developed ACPA-negative RA, their risk spiked by a statistically significant, 2.4-fold rate during the year following partum, compared with nulliparous women. In contrast, the incidence of ACPA-positive RA showed no significant relationship to partum status during the preceding year.

Further analysis examined the timing between delivery and onset of ACPA-negative RA more closely. Again, the analysis showed that, during the year following giving birth, women faced a statistically significant, 2.4-fold elevated risk for incident ACPA-negative RA, compared with nulliparous women. During the 2-10 years following giving birth, the rate of incident ACPA-negative RA dropped to a 50% higher risk, compared with nulliparous women, but this difference was not considered statistically significant. And women more than 10 years out from their most recent delivery had a risk for incident ACPA-negative RA identical to the nulliparous women, Dr. Bengtsson reported.

Dr. Bengtsson said that she had no disclosures.

LONDON – Women who give birth to a child face a twofold increased risk of incident ACPA-negative rheumatoid arthritis, compared with nulliparous women, but they have no increased risk for developing ACPA-positive disease, based on results from a Swedish epidemiologic study

The finding is consistent with a report last year from a Norwegian study that women face about a twofold increased risk for incident rheumatoid arthritis (RA) during the first 2 years after giving birth to a child, compared with their RA risk 2-4 years postpartum (Ann. Rheum. Dis. 2010;69:332-6). The reason why the new analysis, which included more than 1,200 cases and controls, showed a different relationship between partum and the onset of anticitrullinated peptide antibody (ACPA) –positive RH and ACPA-negative RA remains unclear, according to Camilla Bengtsson, Ph.D.

"Why there is only an association with ACPA-negative disease, and which biological mechanisms are involved remains to be elucidated," said Dr. Bengtsson, a researcher at the Karolinska Institute in Stockholm. The way in which this finding might apply to practice also remains unclear, she added.

Dr. Bengtsson’s analysis failed to show an increased incidence of any form of RA in women who were more than a year out from their delivery.

The study used data and blood specimens from Swedish women aged 18-50 years who were enrolled in the Epidemiological Investigation of RA (EIRA) study during 1996-2006. Among the women with incident RA enrolled in EIRA, 547 (95%) agreed to participate and provide blood specimens, and among the control women in the study, 658 (81%) provided blood. The analysis divided the cases and controls into subgroups based on their partum status. The 547 women with new-onset RA included 360 who had given birth and 187 who had not. The parous women included 226 with ACPA-positive RA and 134 with the ACPA-negative form. Among the nulliparous women with RA, 127 had the ACPA-positive form and 60 were ACPA negative.

Among the controls with no RA, 431 had given birth and 227 had never given birth.

The case-control analysis showed that among all women with incident RA, birth status during the year preceding a new RA diagnosis had no statistically significant relationship with RA onset. However, among women who developed ACPA-negative RA, their risk spiked by a statistically significant, 2.4-fold rate during the year following partum, compared with nulliparous women. In contrast, the incidence of ACPA-positive RA showed no significant relationship to partum status during the preceding year.

Further analysis examined the timing between delivery and onset of ACPA-negative RA more closely. Again, the analysis showed that, during the year following giving birth, women faced a statistically significant, 2.4-fold elevated risk for incident ACPA-negative RA, compared with nulliparous women. During the 2-10 years following giving birth, the rate of incident ACPA-negative RA dropped to a 50% higher risk, compared with nulliparous women, but this difference was not considered statistically significant. And women more than 10 years out from their most recent delivery had a risk for incident ACPA-negative RA identical to the nulliparous women, Dr. Bengtsson reported.

Dr. Bengtsson said that she had no disclosures.

LONDON – Women who give birth to a child face a twofold increased risk of incident ACPA-negative rheumatoid arthritis, compared with nulliparous women, but they have no increased risk for developing ACPA-positive disease, based on results from a Swedish epidemiologic study

The finding is consistent with a report last year from a Norwegian study that women face about a twofold increased risk for incident rheumatoid arthritis (RA) during the first 2 years after giving birth to a child, compared with their RA risk 2-4 years postpartum (Ann. Rheum. Dis. 2010;69:332-6). The reason why the new analysis, which included more than 1,200 cases and controls, showed a different relationship between partum and the onset of anticitrullinated peptide antibody (ACPA) –positive RH and ACPA-negative RA remains unclear, according to Camilla Bengtsson, Ph.D.

"Why there is only an association with ACPA-negative disease, and which biological mechanisms are involved remains to be elucidated," said Dr. Bengtsson, a researcher at the Karolinska Institute in Stockholm. The way in which this finding might apply to practice also remains unclear, she added.

Dr. Bengtsson’s analysis failed to show an increased incidence of any form of RA in women who were more than a year out from their delivery.

The study used data and blood specimens from Swedish women aged 18-50 years who were enrolled in the Epidemiological Investigation of RA (EIRA) study during 1996-2006. Among the women with incident RA enrolled in EIRA, 547 (95%) agreed to participate and provide blood specimens, and among the control women in the study, 658 (81%) provided blood. The analysis divided the cases and controls into subgroups based on their partum status. The 547 women with new-onset RA included 360 who had given birth and 187 who had not. The parous women included 226 with ACPA-positive RA and 134 with the ACPA-negative form. Among the nulliparous women with RA, 127 had the ACPA-positive form and 60 were ACPA negative.

Among the controls with no RA, 431 had given birth and 227 had never given birth.

The case-control analysis showed that among all women with incident RA, birth status during the year preceding a new RA diagnosis had no statistically significant relationship with RA onset. However, among women who developed ACPA-negative RA, their risk spiked by a statistically significant, 2.4-fold rate during the year following partum, compared with nulliparous women. In contrast, the incidence of ACPA-positive RA showed no significant relationship to partum status during the preceding year.

Further analysis examined the timing between delivery and onset of ACPA-negative RA more closely. Again, the analysis showed that, during the year following giving birth, women faced a statistically significant, 2.4-fold elevated risk for incident ACPA-negative RA, compared with nulliparous women. During the 2-10 years following giving birth, the rate of incident ACPA-negative RA dropped to a 50% higher risk, compared with nulliparous women, but this difference was not considered statistically significant. And women more than 10 years out from their most recent delivery had a risk for incident ACPA-negative RA identical to the nulliparous women, Dr. Bengtsson reported.

Dr. Bengtsson said that she had no disclosures.

LONDON – Women who give birth to a child face a twofold increased risk of incident ACPA-negative rheumatoid arthritis, compared with nulliparous women, but they have no increased risk for developing ACPA-positive disease, based on results from a Swedish epidemiologic study

The finding is consistent with a report last year from a Norwegian study that women face about a twofold increased risk for incident rheumatoid arthritis (RA) during the first 2 years after giving birth to a child, compared with their RA risk 2-4 years postpartum (Ann. Rheum. Dis. 2010;69:332-6). The reason why the new analysis, which included more than 1,200 cases and controls, showed a different relationship between partum and the onset of anticitrullinated peptide antibody (ACPA) –positive RH and ACPA-negative RA remains unclear, according to Camilla Bengtsson, Ph.D.

"Why there is only an association with ACPA-negative disease, and which biological mechanisms are involved remains to be elucidated," said Dr. Bengtsson, a researcher at the Karolinska Institute in Stockholm. The way in which this finding might apply to practice also remains unclear, she added.

Dr. Bengtsson’s analysis failed to show an increased incidence of any form of RA in women who were more than a year out from their delivery.

The study used data and blood specimens from Swedish women aged 18-50 years who were enrolled in the Epidemiological Investigation of RA (EIRA) study during 1996-2006. Among the women with incident RA enrolled in EIRA, 547 (95%) agreed to participate and provide blood specimens, and among the control women in the study, 658 (81%) provided blood. The analysis divided the cases and controls into subgroups based on their partum status. The 547 women with new-onset RA included 360 who had given birth and 187 who had not. The parous women included 226 with ACPA-positive RA and 134 with the ACPA-negative form. Among the nulliparous women with RA, 127 had the ACPA-positive form and 60 were ACPA negative.

Among the controls with no RA, 431 had given birth and 227 had never given birth.

The case-control analysis showed that among all women with incident RA, birth status during the year preceding a new RA diagnosis had no statistically significant relationship with RA onset. However, among women who developed ACPA-negative RA, their risk spiked by a statistically significant, 2.4-fold rate during the year following partum, compared with nulliparous women. In contrast, the incidence of ACPA-positive RA showed no significant relationship to partum status during the preceding year.

Further analysis examined the timing between delivery and onset of ACPA-negative RA more closely. Again, the analysis showed that, during the year following giving birth, women faced a statistically significant, 2.4-fold elevated risk for incident ACPA-negative RA, compared with nulliparous women. During the 2-10 years following giving birth, the rate of incident ACPA-negative RA dropped to a 50% higher risk, compared with nulliparous women, but this difference was not considered statistically significant. And women more than 10 years out from their most recent delivery had a risk for incident ACPA-negative RA identical to the nulliparous women, Dr. Bengtsson reported.

Dr. Bengtsson said that she had no disclosures.

LONDON – Women who give birth to a child face a twofold increased risk of incident ACPA-negative rheumatoid arthritis, compared with nulliparous women, but they have no increased risk for developing ACPA-positive disease, based on results from a Swedish epidemiologic study

The finding is consistent with a report last year from a Norwegian study that women face about a twofold increased risk for incident rheumatoid arthritis (RA) during the first 2 years after giving birth to a child, compared with their RA risk 2-4 years postpartum (Ann. Rheum. Dis. 2010;69:332-6). The reason why the new analysis, which included more than 1,200 cases and controls, showed a different relationship between partum and the onset of anticitrullinated peptide antibody (ACPA) –positive RH and ACPA-negative RA remains unclear, according to Camilla Bengtsson, Ph.D.

"Why there is only an association with ACPA-negative disease, and which biological mechanisms are involved remains to be elucidated," said Dr. Bengtsson, a researcher at the Karolinska Institute in Stockholm. The way in which this finding might apply to practice also remains unclear, she added.

Dr. Bengtsson’s analysis failed to show an increased incidence of any form of RA in women who were more than a year out from their delivery.

The study used data and blood specimens from Swedish women aged 18-50 years who were enrolled in the Epidemiological Investigation of RA (EIRA) study during 1996-2006. Among the women with incident RA enrolled in EIRA, 547 (95%) agreed to participate and provide blood specimens, and among the control women in the study, 658 (81%) provided blood. The analysis divided the cases and controls into subgroups based on their partum status. The 547 women with new-onset RA included 360 who had given birth and 187 who had not. The parous women included 226 with ACPA-positive RA and 134 with the ACPA-negative form. Among the nulliparous women with RA, 127 had the ACPA-positive form and 60 were ACPA negative.

Among the controls with no RA, 431 had given birth and 227 had never given birth.

The case-control analysis showed that among all women with incident RA, birth status during the year preceding a new RA diagnosis had no statistically significant relationship with RA onset. However, among women who developed ACPA-negative RA, their risk spiked by a statistically significant, 2.4-fold rate during the year following partum, compared with nulliparous women. In contrast, the incidence of ACPA-positive RA showed no significant relationship to partum status during the preceding year.

Further analysis examined the timing between delivery and onset of ACPA-negative RA more closely. Again, the analysis showed that, during the year following giving birth, women faced a statistically significant, 2.4-fold elevated risk for incident ACPA-negative RA, compared with nulliparous women. During the 2-10 years following giving birth, the rate of incident ACPA-negative RA dropped to a 50% higher risk, compared with nulliparous women, but this difference was not considered statistically significant. And women more than 10 years out from their most recent delivery had a risk for incident ACPA-negative RA identical to the nulliparous women, Dr. Bengtsson reported.

Dr. Bengtsson said that she had no disclosures.

ORLANDO – The American Society for Metabolic and Bariatric Surgery has opted to defer making recommendations on the use of the laparoscopically placed gastric band for class I obesity patients, according to Dr. Stacy A. Brethauer at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

The stage was set for the position statement after the Food and Drug Administration’s approval last February of a laparoscopically placed gastric band for patients with class I obesity and a related comorbidity. The society opted to wait, pending availability of level I evidence on the safety and efficacy of at least one alternative surgical option, such as laparoscopic gastric bypass.

"We decided to wait until we had adequate data on at least the bypass," which should take about another 2 years, given the status of controlled trials now in progress, he said. Safety and efficacy data from randomized, controlled trials of the gastrectomy sleeve will likely take even longer, he added.

"We could issue a statement based just on the band data. There are enough data to say that it’s safe and effective. The FDA has spoken, and approved bands for patients with a body mass index (BMI) of 30- 34 kg/m² and at least one obesity-related comorbidity. But the society’s committee seeks to produce a broader assessment of the treatment options, said Dr. Brethauer, a surgeon in the Bariatric and Metabolic Institute of the Cleveland Clinic.

His committee’s decision to wait parallels the slow approach that Dr. Brethauer and many of his colleagues have taken on placing bands in the expanded patient population following the agency’s decision last February. This cautious approach reflects both medical insurance coverage issues, and the skeptical view of bariatric surgery that many physicians still have, which limits patient referrals.

Despite the FDA’s action, class I obesity patients with an obesity-related comorbidity generally still do not receive insurance coverage for band placement, so the only patients of this type getting bands are those who pay for the procedure themselves. "At the Cleveland Clinic, about 5% of our practice is self-pay. We don’t see many patients who say, ‘I have a BMI of 33 [kg/m²], here is $15,000, please put in a band.’ That may happen elsewhere, but not in our practice," Dr. Brethauer said in an interview.

Also, "primary care physicians ... still see bariatric surgery as carrying a lot of risk, even for patients with a BMI of more than 35." As a result, most patients Dr. Brethauer sees about bariatric surgery are self-referred or sent by endocrinologists.

At least some endocrinologists "have realized that there are benefits to patients from bariatric surgery that they can’t offer. The endocrinologists will be the [linchpin] for changing the paradigm and for getting patients in for surgery sooner. The primary care physicians will hopefully follow. Our job [as bariatric surgeons] is to give [these physicians] the evidence so that they can feel comfortable making referrals. Right now, we only see patients with a BMI of 30-35 for entry into trials. We work with endocrinologists" as co-principal investigators of studies in this BMI group.

"The FDA’s approval of bands for these patients was based on evidence, but many physicians either don’t believe the evidence or don’t pay attention to it. There has been strong evidence to support bariatric surgery for treating diabetes in patients with BMIs of 35 or higher for decades, but some physicians still don’t believe it. It’s an ongoing challenge to convince physicians that for most patients it’s a low-risk surgery that gives a high benefit."

Dr. Brethauer said that he has received consulting fees from Bard/Davol, Baxter Healthcare, Cardinal Health, Ethicon Endo- Surgery, and Stryker Endoscopy. He also has received honoraria and served on an advisory committee for Ethicon Endo-Surgery, has been a proctor for Bard/Davol, and had received teaching honoraria from Covidien.

ORLANDO – The American Society for Metabolic and Bariatric Surgery has opted to defer making recommendations on the use of the laparoscopically placed gastric band for class I obesity patients, according to Dr. Stacy A. Brethauer at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

The stage was set for the position statement after the Food and Drug Administration’s approval last February of a laparoscopically placed gastric band for patients with class I obesity and a related comorbidity. The society opted to wait, pending availability of level I evidence on the safety and efficacy of at least one alternative surgical option, such as laparoscopic gastric bypass.

"We decided to wait until we had adequate data on at least the bypass," which should take about another 2 years, given the status of controlled trials now in progress, he said. Safety and efficacy data from randomized, controlled trials of the gastrectomy sleeve will likely take even longer, he added.

"We could issue a statement based just on the band data. There are enough data to say that it’s safe and effective. The FDA has spoken, and approved bands for patients with a body mass index (BMI) of 30- 34 kg/m² and at least one obesity-related comorbidity. But the society’s committee seeks to produce a broader assessment of the treatment options, said Dr. Brethauer, a surgeon in the Bariatric and Metabolic Institute of the Cleveland Clinic.

His committee’s decision to wait parallels the slow approach that Dr. Brethauer and many of his colleagues have taken on placing bands in the expanded patient population following the agency’s decision last February. This cautious approach reflects both medical insurance coverage issues, and the skeptical view of bariatric surgery that many physicians still have, which limits patient referrals.

Despite the FDA’s action, class I obesity patients with an obesity-related comorbidity generally still do not receive insurance coverage for band placement, so the only patients of this type getting bands are those who pay for the procedure themselves. "At the Cleveland Clinic, about 5% of our practice is self-pay. We don’t see many patients who say, ‘I have a BMI of 33 [kg/m²], here is $15,000, please put in a band.’ That may happen elsewhere, but not in our practice," Dr. Brethauer said in an interview.

Also, "primary care physicians ... still see bariatric surgery as carrying a lot of risk, even for patients with a BMI of more than 35." As a result, most patients Dr. Brethauer sees about bariatric surgery are self-referred or sent by endocrinologists.

At least some endocrinologists "have realized that there are benefits to patients from bariatric surgery that they can’t offer. The endocrinologists will be the [linchpin] for changing the paradigm and for getting patients in for surgery sooner. The primary care physicians will hopefully follow. Our job [as bariatric surgeons] is to give [these physicians] the evidence so that they can feel comfortable making referrals. Right now, we only see patients with a BMI of 30-35 for entry into trials. We work with endocrinologists" as co-principal investigators of studies in this BMI group.

"The FDA’s approval of bands for these patients was based on evidence, but many physicians either don’t believe the evidence or don’t pay attention to it. There has been strong evidence to support bariatric surgery for treating diabetes in patients with BMIs of 35 or higher for decades, but some physicians still don’t believe it. It’s an ongoing challenge to convince physicians that for most patients it’s a low-risk surgery that gives a high benefit."

Dr. Brethauer said that he has received consulting fees from Bard/Davol, Baxter Healthcare, Cardinal Health, Ethicon Endo- Surgery, and Stryker Endoscopy. He also has received honoraria and served on an advisory committee for Ethicon Endo-Surgery, has been a proctor for Bard/Davol, and had received teaching honoraria from Covidien.

ORLANDO – The American Society for Metabolic and Bariatric Surgery has opted to defer making recommendations on the use of the laparoscopically placed gastric band for class I obesity patients, according to Dr. Stacy A. Brethauer at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

The stage was set for the position statement after the Food and Drug Administration’s approval last February of a laparoscopically placed gastric band for patients with class I obesity and a related comorbidity. The society opted to wait, pending availability of level I evidence on the safety and efficacy of at least one alternative surgical option, such as laparoscopic gastric bypass.

"We decided to wait until we had adequate data on at least the bypass," which should take about another 2 years, given the status of controlled trials now in progress, he said. Safety and efficacy data from randomized, controlled trials of the gastrectomy sleeve will likely take even longer, he added.

"We could issue a statement based just on the band data. There are enough data to say that it’s safe and effective. The FDA has spoken, and approved bands for patients with a body mass index (BMI) of 30- 34 kg/m² and at least one obesity-related comorbidity. But the society’s committee seeks to produce a broader assessment of the treatment options, said Dr. Brethauer, a surgeon in the Bariatric and Metabolic Institute of the Cleveland Clinic.

His committee’s decision to wait parallels the slow approach that Dr. Brethauer and many of his colleagues have taken on placing bands in the expanded patient population following the agency’s decision last February. This cautious approach reflects both medical insurance coverage issues, and the skeptical view of bariatric surgery that many physicians still have, which limits patient referrals.

Despite the FDA’s action, class I obesity patients with an obesity-related comorbidity generally still do not receive insurance coverage for band placement, so the only patients of this type getting bands are those who pay for the procedure themselves. "At the Cleveland Clinic, about 5% of our practice is self-pay. We don’t see many patients who say, ‘I have a BMI of 33 [kg/m²], here is $15,000, please put in a band.’ That may happen elsewhere, but not in our practice," Dr. Brethauer said in an interview.

Also, "primary care physicians ... still see bariatric surgery as carrying a lot of risk, even for patients with a BMI of more than 35." As a result, most patients Dr. Brethauer sees about bariatric surgery are self-referred or sent by endocrinologists.

At least some endocrinologists "have realized that there are benefits to patients from bariatric surgery that they can’t offer. The endocrinologists will be the [linchpin] for changing the paradigm and for getting patients in for surgery sooner. The primary care physicians will hopefully follow. Our job [as bariatric surgeons] is to give [these physicians] the evidence so that they can feel comfortable making referrals. Right now, we only see patients with a BMI of 30-35 for entry into trials. We work with endocrinologists" as co-principal investigators of studies in this BMI group.

"The FDA’s approval of bands for these patients was based on evidence, but many physicians either don’t believe the evidence or don’t pay attention to it. There has been strong evidence to support bariatric surgery for treating diabetes in patients with BMIs of 35 or higher for decades, but some physicians still don’t believe it. It’s an ongoing challenge to convince physicians that for most patients it’s a low-risk surgery that gives a high benefit."

Dr. Brethauer said that he has received consulting fees from Bard/Davol, Baxter Healthcare, Cardinal Health, Ethicon Endo- Surgery, and Stryker Endoscopy. He also has received honoraria and served on an advisory committee for Ethicon Endo-Surgery, has been a proctor for Bard/Davol, and had received teaching honoraria from Covidien.

ORLANDO – The American Society for Metabolic and Bariatric Surgery has opted to defer making recommendations on the use of the laparoscopically placed gastric band for class I obesity patients, according to Dr. Stacy A. Brethauer at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

The stage was set for the position statement after the Food and Drug Administration’s approval last February of a laparoscopically placed gastric band for patients with class I obesity and a related comorbidity. The society opted to wait, pending availability of level I evidence on the safety and efficacy of at least one alternative surgical option, such as laparoscopic gastric bypass.

"We decided to wait until we had adequate data on at least the bypass," which should take about another 2 years, given the status of controlled trials now in progress, he said. Safety and efficacy data from randomized, controlled trials of the gastrectomy sleeve will likely take even longer, he added.

"We could issue a statement based just on the band data. There are enough data to say that it’s safe and effective. The FDA has spoken, and approved bands for patients with a body mass index (BMI) of 30- 34 kg/m² and at least one obesity-related comorbidity. But the society’s committee seeks to produce a broader assessment of the treatment options, said Dr. Brethauer, a surgeon in the Bariatric and Metabolic Institute of the Cleveland Clinic.

His committee’s decision to wait parallels the slow approach that Dr. Brethauer and many of his colleagues have taken on placing bands in the expanded patient population following the agency’s decision last February. This cautious approach reflects both medical insurance coverage issues, and the skeptical view of bariatric surgery that many physicians still have, which limits patient referrals.

Despite the FDA’s action, class I obesity patients with an obesity-related comorbidity generally still do not receive insurance coverage for band placement, so the only patients of this type getting bands are those who pay for the procedure themselves. "At the Cleveland Clinic, about 5% of our practice is self-pay. We don’t see many patients who say, ‘I have a BMI of 33 [kg/m²], here is $15,000, please put in a band.’ That may happen elsewhere, but not in our practice," Dr. Brethauer said in an interview.

Also, "primary care physicians ... still see bariatric surgery as carrying a lot of risk, even for patients with a BMI of more than 35." As a result, most patients Dr. Brethauer sees about bariatric surgery are self-referred or sent by endocrinologists.

At least some endocrinologists "have realized that there are benefits to patients from bariatric surgery that they can’t offer. The endocrinologists will be the [linchpin] for changing the paradigm and for getting patients in for surgery sooner. The primary care physicians will hopefully follow. Our job [as bariatric surgeons] is to give [these physicians] the evidence so that they can feel comfortable making referrals. Right now, we only see patients with a BMI of 30-35 for entry into trials. We work with endocrinologists" as co-principal investigators of studies in this BMI group.

"The FDA’s approval of bands for these patients was based on evidence, but many physicians either don’t believe the evidence or don’t pay attention to it. There has been strong evidence to support bariatric surgery for treating diabetes in patients with BMIs of 35 or higher for decades, but some physicians still don’t believe it. It’s an ongoing challenge to convince physicians that for most patients it’s a low-risk surgery that gives a high benefit."

Dr. Brethauer said that he has received consulting fees from Bard/Davol, Baxter Healthcare, Cardinal Health, Ethicon Endo- Surgery, and Stryker Endoscopy. He also has received honoraria and served on an advisory committee for Ethicon Endo-Surgery, has been a proctor for Bard/Davol, and had received teaching honoraria from Covidien.

ORLANDO – The American Society for Metabolic and Bariatric Surgery has opted to defer making recommendations on the use of the laparoscopically placed gastric band for class I obesity patients, according to Dr. Stacy A. Brethauer at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

The stage was set for the position statement after the Food and Drug Administration’s approval last February of a laparoscopically placed gastric band for patients with class I obesity and a related comorbidity. The society opted to wait, pending availability of level I evidence on the safety and efficacy of at least one alternative surgical option, such as laparoscopic gastric bypass.

"We decided to wait until we had adequate data on at least the bypass," which should take about another 2 years, given the status of controlled trials now in progress, he said. Safety and efficacy data from randomized, controlled trials of the gastrectomy sleeve will likely take even longer, he added.

"We could issue a statement based just on the band data. There are enough data to say that it’s safe and effective. The FDA has spoken, and approved bands for patients with a body mass index (BMI) of 30- 34 kg/m² and at least one obesity-related comorbidity. But the society’s committee seeks to produce a broader assessment of the treatment options, said Dr. Brethauer, a surgeon in the Bariatric and Metabolic Institute of the Cleveland Clinic.

His committee’s decision to wait parallels the slow approach that Dr. Brethauer and many of his colleagues have taken on placing bands in the expanded patient population following the agency’s decision last February. This cautious approach reflects both medical insurance coverage issues, and the skeptical view of bariatric surgery that many physicians still have, which limits patient referrals.

Despite the FDA’s action, class I obesity patients with an obesity-related comorbidity generally still do not receive insurance coverage for band placement, so the only patients of this type getting bands are those who pay for the procedure themselves. "At the Cleveland Clinic, about 5% of our practice is self-pay. We don’t see many patients who say, ‘I have a BMI of 33 [kg/m²], here is $15,000, please put in a band.’ That may happen elsewhere, but not in our practice," Dr. Brethauer said in an interview.

Also, "primary care physicians ... still see bariatric surgery as carrying a lot of risk, even for patients with a BMI of more than 35." As a result, most patients Dr. Brethauer sees about bariatric surgery are self-referred or sent by endocrinologists.

At least some endocrinologists "have realized that there are benefits to patients from bariatric surgery that they can’t offer. The endocrinologists will be the [linchpin] for changing the paradigm and for getting patients in for surgery sooner. The primary care physicians will hopefully follow. Our job [as bariatric surgeons] is to give [these physicians] the evidence so that they can feel comfortable making referrals. Right now, we only see patients with a BMI of 30-35 for entry into trials. We work with endocrinologists" as co-principal investigators of studies in this BMI group.

"The FDA’s approval of bands for these patients was based on evidence, but many physicians either don’t believe the evidence or don’t pay attention to it. There has been strong evidence to support bariatric surgery for treating diabetes in patients with BMIs of 35 or higher for decades, but some physicians still don’t believe it. It’s an ongoing challenge to convince physicians that for most patients it’s a low-risk surgery that gives a high benefit."

Dr. Brethauer said that he has received consulting fees from Bard/Davol, Baxter Healthcare, Cardinal Health, Ethicon Endo- Surgery, and Stryker Endoscopy. He also has received honoraria and served on an advisory committee for Ethicon Endo-Surgery, has been a proctor for Bard/Davol, and had received teaching honoraria from Covidien.

ORLANDO – The American Society for Metabolic and Bariatric Surgery has opted to defer making recommendations on the use of the laparoscopically placed gastric band for class I obesity patients, according to Dr. Stacy A. Brethauer at the annual meeting of the American Society for Metabolic and Bariatric Surgery.

The stage was set for the position statement after the Food and Drug Administration’s approval last February of a laparoscopically placed gastric band for patients with class I obesity and a related comorbidity. The society opted to wait, pending availability of level I evidence on the safety and efficacy of at least one alternative surgical option, such as laparoscopic gastric bypass.

"We decided to wait until we had adequate data on at least the bypass," which should take about another 2 years, given the status of controlled trials now in progress, he said. Safety and efficacy data from randomized, controlled trials of the gastrectomy sleeve will likely take even longer, he added.

"We could issue a statement based just on the band data. There are enough data to say that it’s safe and effective. The FDA has spoken, and approved bands for patients with a body mass index (BMI) of 30- 34 kg/m² and at least one obesity-related comorbidity. But the society’s committee seeks to produce a broader assessment of the treatment options, said Dr. Brethauer, a surgeon in the Bariatric and Metabolic Institute of the Cleveland Clinic.

His committee’s decision to wait parallels the slow approach that Dr. Brethauer and many of his colleagues have taken on placing bands in the expanded patient population following the agency’s decision last February. This cautious approach reflects both medical insurance coverage issues, and the skeptical view of bariatric surgery that many physicians still have, which limits patient referrals.

Despite the FDA’s action, class I obesity patients with an obesity-related comorbidity generally still do not receive insurance coverage for band placement, so the only patients of this type getting bands are those who pay for the procedure themselves. "At the Cleveland Clinic, about 5% of our practice is self-pay. We don’t see many patients who say, ‘I have a BMI of 33 [kg/m²], here is $15,000, please put in a band.’ That may happen elsewhere, but not in our practice," Dr. Brethauer said in an interview.

Also, "primary care physicians ... still see bariatric surgery as carrying a lot of risk, even for patients with a BMI of more than 35." As a result, most patients Dr. Brethauer sees about bariatric surgery are self-referred or sent by endocrinologists.

At least some endocrinologists "have realized that there are benefits to patients from bariatric surgery that they can’t offer. The endocrinologists will be the [linchpin] for changing the paradigm and for getting patients in for surgery sooner. The primary care physicians will hopefully follow. Our job [as bariatric surgeons] is to give [these physicians] the evidence so that they can feel comfortable making referrals. Right now, we only see patients with a BMI of 30-35 for entry into trials. We work with endocrinologists" as co-principal investigators of studies in this BMI group.

"The FDA’s approval of bands for these patients was based on evidence, but many physicians either don’t believe the evidence or don’t pay attention to it. There has been strong evidence to support bariatric surgery for treating diabetes in patients with BMIs of 35 or higher for decades, but some physicians still don’t believe it. It’s an ongoing challenge to convince physicians that for most patients it’s a low-risk surgery that gives a high benefit."

Dr. Brethauer said that he has received consulting fees from Bard/Davol, Baxter Healthcare, Cardinal Health, Ethicon Endo- Surgery, and Stryker Endoscopy. He also has received honoraria and served on an advisory committee for Ethicon Endo-Surgery, has been a proctor for Bard/Davol, and had received teaching honoraria from Covidien.