Heidi Splete

Major Finding: The mean reductions in HbA_1c for patients on liraglutide ranged from 0.7% in the 7.5%-or-less category to 1.8% in the greater-than-9.0% category. The next best mean reduction in HbA_1c was seen among patients taking two other injectable therapies: insulin glargine and exenatide. Reductions in HbA_1c in patients taking insulin glargine ranged from 0.3% to 1.5%, and HbA_1c reductions in those taking exenatide ranged from 0.4% to 1.3%.

Data Source: A meta-analysis of seven phase III trials.

Disclosures: The study was sponsored by Novo Nordisk, which manufactures liraglutide. Dr. Henry has received research support from multiple pharmaceutical companies, including Amylin Pharmaceuticals, AstraZeneca, and Novartis. He has served as an adviser or consultant for, and has received consulting fees from, several companies, including Amylin, Eli Lilly, and Novo Nordisk.

SAN DIEGO – Type 2 diabetes patients achieved greater blood sugar control with once-daily liraglutide injections than with other standard type 2 diabetes medications, according to the findings from a meta-analysis of seven phase III studies.

“The progressive nature of type 2 diabetes makes it difficult for any single therapy to be effective long-term,” Dr. Robert Henry of the University of California, San Diego, said at the meeting.

Liraglutide (Victoza) was approved by the Food and Drug Administration in January 2010 to treat type 2 diabetes in adults as an adjunct therapy to a healthy diet and exercise.

To further evaluate the impact of liraglutide on blood sugar control, Dr. Henry and his colleagues consolidated data from the phase III clinical trials and divided the patients into five categories based on their baseline hemoglobin A_1c level: 7.5% or less (651 patients), 7.6%-8.0% (601), 8.1%-8.5% (538), 8.6%-9.0% (432), and greater than 9.0% (607).

They reviewed the mean changes in HbA_1c from baseline to 26 weeks of treatment. Overall, mean hemoglobin A_1c reductions with a once-daily 1.8-mg dose of liraglutide were greater than those achieved with standard regimens involving exenatide, insulin glargine, glimepiride, rosiglitazone, or sitagliptin. HbA_1c levels were significantly reduced in patients with a baseline HbA_1c of 7.5% or less in the liraglutide group compared with all other groups. The mean reductions in HbA_1c for patients on liraglutide ranged from 0.7% in the 7.5%-or- less category to 1.8% in the greater than 9.0% category. The next best mean reduction in HbA_1c was seen in patients taking insulin glargine and exenatide. Reductions in HbA_1c in patients taking insulin glargine ranged from 0.3% to 1.5%, and HbA_1c reductions in those taking exenatide ranged from 0.4% to 1.3%.

Patients on sulfonylureas, sitagliptin, or thiazolidinediones showed less improvement from baseline than did patients taking the injectables. The average reduction ranged from 0.0% to 1.1% in patients on sitagliptin, 0.4% to 1.4%, in those on sulfonylureas, and 0.4% to 0.8%. in those on thiazolidinediones.

Among 348 patients in the liraglutide group with baseline HbA_1c levels of 7.5% or less, 216 (63%) reached the AACE-recommended HbA_1c target of 6.5% or less, compared with less than half (20%-49%) of patients with a baseline HbA_1c of 7.5% or less in the other groups, Dr. Henry said.

Among 333 patients in the liraglutide group with HbA_1c levels greater than 9.0%, 33 (10%) reached the 6.5% or less target, compared with 4 (12%) of 34 patients in the insulin glargine group and 0%-5% of patients in the other groups.

Major Finding: The mean reductions in HbA_1c for patients on liraglutide ranged from 0.7% in the 7.5%-or-less category to 1.8% in the greater-than-9.0% category. The next best mean reduction in HbA_1c was seen among patients taking two other injectable therapies: insulin glargine and exenatide. Reductions in HbA_1c in patients taking insulin glargine ranged from 0.3% to 1.5%, and HbA_1c reductions in those taking exenatide ranged from 0.4% to 1.3%.

Data Source: A meta-analysis of seven phase III trials.

Disclosures: The study was sponsored by Novo Nordisk, which manufactures liraglutide. Dr. Henry has received research support from multiple pharmaceutical companies, including Amylin Pharmaceuticals, AstraZeneca, and Novartis. He has served as an adviser or consultant for, and has received consulting fees from, several companies, including Amylin, Eli Lilly, and Novo Nordisk.

SAN DIEGO – Type 2 diabetes patients achieved greater blood sugar control with once-daily liraglutide injections than with other standard type 2 diabetes medications, according to the findings from a meta-analysis of seven phase III studies.

“The progressive nature of type 2 diabetes makes it difficult for any single therapy to be effective long-term,” Dr. Robert Henry of the University of California, San Diego, said at the meeting.

Liraglutide (Victoza) was approved by the Food and Drug Administration in January 2010 to treat type 2 diabetes in adults as an adjunct therapy to a healthy diet and exercise.

To further evaluate the impact of liraglutide on blood sugar control, Dr. Henry and his colleagues consolidated data from the phase III clinical trials and divided the patients into five categories based on their baseline hemoglobin A_1c level: 7.5% or less (651 patients), 7.6%-8.0% (601), 8.1%-8.5% (538), 8.6%-9.0% (432), and greater than 9.0% (607).

They reviewed the mean changes in HbA_1c from baseline to 26 weeks of treatment. Overall, mean hemoglobin A_1c reductions with a once-daily 1.8-mg dose of liraglutide were greater than those achieved with standard regimens involving exenatide, insulin glargine, glimepiride, rosiglitazone, or sitagliptin. HbA_1c levels were significantly reduced in patients with a baseline HbA_1c of 7.5% or less in the liraglutide group compared with all other groups. The mean reductions in HbA_1c for patients on liraglutide ranged from 0.7% in the 7.5%-or- less category to 1.8% in the greater than 9.0% category. The next best mean reduction in HbA_1c was seen in patients taking insulin glargine and exenatide. Reductions in HbA_1c in patients taking insulin glargine ranged from 0.3% to 1.5%, and HbA_1c reductions in those taking exenatide ranged from 0.4% to 1.3%.

Patients on sulfonylureas, sitagliptin, or thiazolidinediones showed less improvement from baseline than did patients taking the injectables. The average reduction ranged from 0.0% to 1.1% in patients on sitagliptin, 0.4% to 1.4%, in those on sulfonylureas, and 0.4% to 0.8%. in those on thiazolidinediones.

Among 348 patients in the liraglutide group with baseline HbA_1c levels of 7.5% or less, 216 (63%) reached the AACE-recommended HbA_1c target of 6.5% or less, compared with less than half (20%-49%) of patients with a baseline HbA_1c of 7.5% or less in the other groups, Dr. Henry said.

Among 333 patients in the liraglutide group with HbA_1c levels greater than 9.0%, 33 (10%) reached the 6.5% or less target, compared with 4 (12%) of 34 patients in the insulin glargine group and 0%-5% of patients in the other groups.

Major Finding: The mean reductions in HbA_1c for patients on liraglutide ranged from 0.7% in the 7.5%-or-less category to 1.8% in the greater-than-9.0% category. The next best mean reduction in HbA_1c was seen among patients taking two other injectable therapies: insulin glargine and exenatide. Reductions in HbA_1c in patients taking insulin glargine ranged from 0.3% to 1.5%, and HbA_1c reductions in those taking exenatide ranged from 0.4% to 1.3%.

Data Source: A meta-analysis of seven phase III trials.

Disclosures: The study was sponsored by Novo Nordisk, which manufactures liraglutide. Dr. Henry has received research support from multiple pharmaceutical companies, including Amylin Pharmaceuticals, AstraZeneca, and Novartis. He has served as an adviser or consultant for, and has received consulting fees from, several companies, including Amylin, Eli Lilly, and Novo Nordisk.

SAN DIEGO – Type 2 diabetes patients achieved greater blood sugar control with once-daily liraglutide injections than with other standard type 2 diabetes medications, according to the findings from a meta-analysis of seven phase III studies.

“The progressive nature of type 2 diabetes makes it difficult for any single therapy to be effective long-term,” Dr. Robert Henry of the University of California, San Diego, said at the meeting.

Liraglutide (Victoza) was approved by the Food and Drug Administration in January 2010 to treat type 2 diabetes in adults as an adjunct therapy to a healthy diet and exercise.

To further evaluate the impact of liraglutide on blood sugar control, Dr. Henry and his colleagues consolidated data from the phase III clinical trials and divided the patients into five categories based on their baseline hemoglobin A_1c level: 7.5% or less (651 patients), 7.6%-8.0% (601), 8.1%-8.5% (538), 8.6%-9.0% (432), and greater than 9.0% (607).

They reviewed the mean changes in HbA_1c from baseline to 26 weeks of treatment. Overall, mean hemoglobin A_1c reductions with a once-daily 1.8-mg dose of liraglutide were greater than those achieved with standard regimens involving exenatide, insulin glargine, glimepiride, rosiglitazone, or sitagliptin. HbA_1c levels were significantly reduced in patients with a baseline HbA_1c of 7.5% or less in the liraglutide group compared with all other groups. The mean reductions in HbA_1c for patients on liraglutide ranged from 0.7% in the 7.5%-or- less category to 1.8% in the greater than 9.0% category. The next best mean reduction in HbA_1c was seen in patients taking insulin glargine and exenatide. Reductions in HbA_1c in patients taking insulin glargine ranged from 0.3% to 1.5%, and HbA_1c reductions in those taking exenatide ranged from 0.4% to 1.3%.

Patients on sulfonylureas, sitagliptin, or thiazolidinediones showed less improvement from baseline than did patients taking the injectables. The average reduction ranged from 0.0% to 1.1% in patients on sitagliptin, 0.4% to 1.4%, in those on sulfonylureas, and 0.4% to 0.8%. in those on thiazolidinediones.

Among 348 patients in the liraglutide group with baseline HbA_1c levels of 7.5% or less, 216 (63%) reached the AACE-recommended HbA_1c target of 6.5% or less, compared with less than half (20%-49%) of patients with a baseline HbA_1c of 7.5% or less in the other groups, Dr. Henry said.

Among 333 patients in the liraglutide group with HbA_1c levels greater than 9.0%, 33 (10%) reached the 6.5% or less target, compared with 4 (12%) of 34 patients in the insulin glargine group and 0%-5% of patients in the other groups.

SAN DIEGO – Bone density and fracture risk continued to improve from baseline in postmenopausal women taking denosumab for osteoporosis, based on data from a 2-year extension of the FREEDOM study in more than 4,000 women.

The original FREEDOM study (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) enrolled 7,808 postmenopausal women aged 60-80 years with osteoporosis to receive either a subcutaneous injection of denosumab (60 mg) or placebo along with daily calcium and vitamin D supplements every 6 months. All subjects had bone mineral density (BMD) T scores of less than −2.5 but not less than −4.0 at the lumbar spine or total hip. At 36 months, denosumab was associated with reductions of 68% in vertebral fracture and 40% in hip fracture (N. Engl. J. Med. 2009;361:756-65).

These results were the basis of the Food and Drug Administration's approval of denosumab in June 2010.

In the extension study, 2,343 patients from the original treatment group and 2,207 patients in the control group received the denosumab treatment for 2 years (as well as calcium and vitamin D), yielding follow-up data for up to 5 years of drug exposure, said Dr. Cesar Libanati at the meeting.

Women in the long-term group who received denosumab for 5 years showed significant BMD improvements from baseline, of 13.7% in the lumbar spine and 7.0% in the total hip. Women in crossover group showed significant BMD improvements from the start of the extension study, of 7.9% in the lumbar spine and 4.1% in the total hip.

Patients in the crossover group showed significant increase in BMD from the extension study baseline similar to those seen in the long-term patients during their first 2 years of denosumab use, noted Dr. Libanati, clinical research medical director at Amgen Pharmaceuticals, maker of denosumab (Prolia), in Newbury Park, Calif.

During years 4 and 5, the annualized yearly incidence of new vertebral fractures in the long-term patients was steady at 1.4%, compared with 1.1% at the end of the 3-year FREEDOM study. The yearly incidence in the crossover treatment group was 0.9% for their first 2 years of denosumab exposure, compared with 2.5% in the first 2 years of the FREEDOM study.

The yearly incidence of nonvertebral fractures in the long-term patients was 1.4% after 4 years and 1.1% after 5 years.

Denosumab remained well tolerated during the extension study. The adverse event profile was “similar in years 4 and 5 to that observed in the 3 years of the placebo-controlled FREEDOM study,” Dr. Libanati said. Long-term patients also maintained the reductions in bone turnover seen during the original FREEDOM study, he added.

SAN DIEGO – Bone density and fracture risk continued to improve from baseline in postmenopausal women taking denosumab for osteoporosis, based on data from a 2-year extension of the FREEDOM study in more than 4,000 women.

The original FREEDOM study (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) enrolled 7,808 postmenopausal women aged 60-80 years with osteoporosis to receive either a subcutaneous injection of denosumab (60 mg) or placebo along with daily calcium and vitamin D supplements every 6 months. All subjects had bone mineral density (BMD) T scores of less than −2.5 but not less than −4.0 at the lumbar spine or total hip. At 36 months, denosumab was associated with reductions of 68% in vertebral fracture and 40% in hip fracture (N. Engl. J. Med. 2009;361:756-65).

These results were the basis of the Food and Drug Administration's approval of denosumab in June 2010.

In the extension study, 2,343 patients from the original treatment group and 2,207 patients in the control group received the denosumab treatment for 2 years (as well as calcium and vitamin D), yielding follow-up data for up to 5 years of drug exposure, said Dr. Cesar Libanati at the meeting.

Women in the long-term group who received denosumab for 5 years showed significant BMD improvements from baseline, of 13.7% in the lumbar spine and 7.0% in the total hip. Women in crossover group showed significant BMD improvements from the start of the extension study, of 7.9% in the lumbar spine and 4.1% in the total hip.

Patients in the crossover group showed significant increase in BMD from the extension study baseline similar to those seen in the long-term patients during their first 2 years of denosumab use, noted Dr. Libanati, clinical research medical director at Amgen Pharmaceuticals, maker of denosumab (Prolia), in Newbury Park, Calif.

During years 4 and 5, the annualized yearly incidence of new vertebral fractures in the long-term patients was steady at 1.4%, compared with 1.1% at the end of the 3-year FREEDOM study. The yearly incidence in the crossover treatment group was 0.9% for their first 2 years of denosumab exposure, compared with 2.5% in the first 2 years of the FREEDOM study.

The yearly incidence of nonvertebral fractures in the long-term patients was 1.4% after 4 years and 1.1% after 5 years.

Denosumab remained well tolerated during the extension study. The adverse event profile was “similar in years 4 and 5 to that observed in the 3 years of the placebo-controlled FREEDOM study,” Dr. Libanati said. Long-term patients also maintained the reductions in bone turnover seen during the original FREEDOM study, he added.

SAN DIEGO – Bone density and fracture risk continued to improve from baseline in postmenopausal women taking denosumab for osteoporosis, based on data from a 2-year extension of the FREEDOM study in more than 4,000 women.

The original FREEDOM study (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) enrolled 7,808 postmenopausal women aged 60-80 years with osteoporosis to receive either a subcutaneous injection of denosumab (60 mg) or placebo along with daily calcium and vitamin D supplements every 6 months. All subjects had bone mineral density (BMD) T scores of less than −2.5 but not less than −4.0 at the lumbar spine or total hip. At 36 months, denosumab was associated with reductions of 68% in vertebral fracture and 40% in hip fracture (N. Engl. J. Med. 2009;361:756-65).

These results were the basis of the Food and Drug Administration's approval of denosumab in June 2010.

In the extension study, 2,343 patients from the original treatment group and 2,207 patients in the control group received the denosumab treatment for 2 years (as well as calcium and vitamin D), yielding follow-up data for up to 5 years of drug exposure, said Dr. Cesar Libanati at the meeting.

Women in the long-term group who received denosumab for 5 years showed significant BMD improvements from baseline, of 13.7% in the lumbar spine and 7.0% in the total hip. Women in crossover group showed significant BMD improvements from the start of the extension study, of 7.9% in the lumbar spine and 4.1% in the total hip.

Patients in the crossover group showed significant increase in BMD from the extension study baseline similar to those seen in the long-term patients during their first 2 years of denosumab use, noted Dr. Libanati, clinical research medical director at Amgen Pharmaceuticals, maker of denosumab (Prolia), in Newbury Park, Calif.

During years 4 and 5, the annualized yearly incidence of new vertebral fractures in the long-term patients was steady at 1.4%, compared with 1.1% at the end of the 3-year FREEDOM study. The yearly incidence in the crossover treatment group was 0.9% for their first 2 years of denosumab exposure, compared with 2.5% in the first 2 years of the FREEDOM study.

The yearly incidence of nonvertebral fractures in the long-term patients was 1.4% after 4 years and 1.1% after 5 years.

Denosumab remained well tolerated during the extension study. The adverse event profile was “similar in years 4 and 5 to that observed in the 3 years of the placebo-controlled FREEDOM study,” Dr. Libanati said. Long-term patients also maintained the reductions in bone turnover seen during the original FREEDOM study, he added.

SAN DIEGO – Bone density and fracture risk continued to improve from baseline in postmenopausal women taking denosumab for osteoporosis, according to data from a 2-year extension of the FREEDOM study in more than 4,000 women.

The original FREEDOM study (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) enrolled 7,808 postmenopausal women aged 60–80 years with osteoporosis to receive either a subcutaneous injection of denosumab (60 mg) or placebo along with daily calcium and vitamin D supplements every 6 months.

All subjects had bone mineral density (BMD) T scores of less than −2.5 but not less than −4.0 at the lumbar spine or total hip. At 36 months, denosumab was associated with reductions of 68% in vertebral fracture and 40% in hip fracture (N. Engl. J. Med. 2009;361:756–65).

The FREEDOM results were the basis of the Food and Drug Administration's approval of denosumab in June 2010. In the extension study, 2,343 patients from the original treatment group and 2,207 patients in the control group received the denosumab treatment for 2 years (as well as calcium and vitamin D), yielding follow-up data for up to 5 years of drug exposure, said Dr. Cesar Libanati at the meeting.

Women in the long-term group who received denosumab for 5 years showed significant BMD improvements from baseline, of 13.7% in the lumbar spine and 7.0% in the total hip. Women in crossover group showed significant BMD improvements from the start of the extension study, of 7.9% in the lumbar spine and 4.1% in the total hip.

Patients in the crossover group showed significant increased in BMD from the extension study baseline similar to those seen in the long-term patients during their first 2 years of denosumab use, noted Dr. Libanati, clinical research medical director at Amgen Pharmaceuticals, maker of denosumab (Prolia), in Newbury Park, Calif.

During years 4 and 5, the annualized yearly incidence of new vertebral fractures in the long-term patients was steady at 1.4%, compared with 1.1% at the end of the 3-year FREEDOM study.

The yearly incidence in the crossover treatment group was 0.9% for their first 2 years of denosumab exposure, compared with 2.5% in the first 2 years of the FREEDOM study.

The yearly incidence of nonvertebral fractures in the long-term patients was 1.4% after 4 years and 1.1% after 5 years.

Nonvertebral fracture data for the crossover patients were not presented.

Denosumab remained well tolerated during the extension study. The adverse event profile was “similar in years 4 and 5 to that observed in the 3 years of the placebo-controlled FREEDOM study,” Dr. Libanati said.

Long-term patients also maintained the reductions in bone turnover seen during the original FREEDOM study, he added.

Dr. Libanati is employed by Amgen.

SAN DIEGO – Bone density and fracture risk continued to improve from baseline in postmenopausal women taking denosumab for osteoporosis, according to data from a 2-year extension of the FREEDOM study in more than 4,000 women.

The original FREEDOM study (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) enrolled 7,808 postmenopausal women aged 60–80 years with osteoporosis to receive either a subcutaneous injection of denosumab (60 mg) or placebo along with daily calcium and vitamin D supplements every 6 months.

All subjects had bone mineral density (BMD) T scores of less than −2.5 but not less than −4.0 at the lumbar spine or total hip. At 36 months, denosumab was associated with reductions of 68% in vertebral fracture and 40% in hip fracture (N. Engl. J. Med. 2009;361:756–65).

The FREEDOM results were the basis of the Food and Drug Administration's approval of denosumab in June 2010. In the extension study, 2,343 patients from the original treatment group and 2,207 patients in the control group received the denosumab treatment for 2 years (as well as calcium and vitamin D), yielding follow-up data for up to 5 years of drug exposure, said Dr. Cesar Libanati at the meeting.

Women in the long-term group who received denosumab for 5 years showed significant BMD improvements from baseline, of 13.7% in the lumbar spine and 7.0% in the total hip. Women in crossover group showed significant BMD improvements from the start of the extension study, of 7.9% in the lumbar spine and 4.1% in the total hip.

Patients in the crossover group showed significant increased in BMD from the extension study baseline similar to those seen in the long-term patients during their first 2 years of denosumab use, noted Dr. Libanati, clinical research medical director at Amgen Pharmaceuticals, maker of denosumab (Prolia), in Newbury Park, Calif.

During years 4 and 5, the annualized yearly incidence of new vertebral fractures in the long-term patients was steady at 1.4%, compared with 1.1% at the end of the 3-year FREEDOM study.

The yearly incidence in the crossover treatment group was 0.9% for their first 2 years of denosumab exposure, compared with 2.5% in the first 2 years of the FREEDOM study.

The yearly incidence of nonvertebral fractures in the long-term patients was 1.4% after 4 years and 1.1% after 5 years.

Nonvertebral fracture data for the crossover patients were not presented.

Denosumab remained well tolerated during the extension study. The adverse event profile was “similar in years 4 and 5 to that observed in the 3 years of the placebo-controlled FREEDOM study,” Dr. Libanati said.

Long-term patients also maintained the reductions in bone turnover seen during the original FREEDOM study, he added.

Dr. Libanati is employed by Amgen.

SAN DIEGO – Bone density and fracture risk continued to improve from baseline in postmenopausal women taking denosumab for osteoporosis, according to data from a 2-year extension of the FREEDOM study in more than 4,000 women.

The original FREEDOM study (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) enrolled 7,808 postmenopausal women aged 60–80 years with osteoporosis to receive either a subcutaneous injection of denosumab (60 mg) or placebo along with daily calcium and vitamin D supplements every 6 months.

All subjects had bone mineral density (BMD) T scores of less than −2.5 but not less than −4.0 at the lumbar spine or total hip. At 36 months, denosumab was associated with reductions of 68% in vertebral fracture and 40% in hip fracture (N. Engl. J. Med. 2009;361:756–65).

The FREEDOM results were the basis of the Food and Drug Administration's approval of denosumab in June 2010. In the extension study, 2,343 patients from the original treatment group and 2,207 patients in the control group received the denosumab treatment for 2 years (as well as calcium and vitamin D), yielding follow-up data for up to 5 years of drug exposure, said Dr. Cesar Libanati at the meeting.

Women in the long-term group who received denosumab for 5 years showed significant BMD improvements from baseline, of 13.7% in the lumbar spine and 7.0% in the total hip. Women in crossover group showed significant BMD improvements from the start of the extension study, of 7.9% in the lumbar spine and 4.1% in the total hip.

Patients in the crossover group showed significant increased in BMD from the extension study baseline similar to those seen in the long-term patients during their first 2 years of denosumab use, noted Dr. Libanati, clinical research medical director at Amgen Pharmaceuticals, maker of denosumab (Prolia), in Newbury Park, Calif.

During years 4 and 5, the annualized yearly incidence of new vertebral fractures in the long-term patients was steady at 1.4%, compared with 1.1% at the end of the 3-year FREEDOM study.

The yearly incidence in the crossover treatment group was 0.9% for their first 2 years of denosumab exposure, compared with 2.5% in the first 2 years of the FREEDOM study.

The yearly incidence of nonvertebral fractures in the long-term patients was 1.4% after 4 years and 1.1% after 5 years.

Nonvertebral fracture data for the crossover patients were not presented.

Denosumab remained well tolerated during the extension study. The adverse event profile was “similar in years 4 and 5 to that observed in the 3 years of the placebo-controlled FREEDOM study,” Dr. Libanati said.

Long-term patients also maintained the reductions in bone turnover seen during the original FREEDOM study, he added.

Dr. Libanati is employed by Amgen.

Major Finding: Overall, 28 of 789 women with goiter also had breast cancer, for a prevalence of 3.6%.

Data Source: A review of 789 women with nontoxic goiter.

Disclosures: Dr. Sanghvi reported having no financial conflicts to disclose.

SAN DIEGO – Women with nontoxic goiter were more than twice as likely to have breast cancer compared with women in the general population, according to a review of data from 789 women with nontoxic, multinodular goiter, uninodular goiter, or simple goiter.

Data from previous studies of a potential link between thyroid disorders and breast cancer are inconclusive, said Sarika Patel Sanghvi, D.O., of Robert Wood Johnson Medical School in New Brunswick, N.J.

In this study, Dr. Sanghvi and her colleagues compared breast cancer incidence in women with nontoxic goiter with breast cancer incidence in the general population of New Jersey. Breast cancer history was obtained from each patient's medical history.

Overall, 28 of 789 women with goiter also had breast cancer, for a prevalence of 3.6%. By contrast, the prevalence of breast cancer in the general population, based on data from the New Jersey Department of Health and Senior Services, was significantly lower at 1.6%.

Two of the 28 patients with breast cancer had low TSH levels, but one had a free T4 within normal limits and the other had a total T4 within normal limits, said Dr. Sanghvi. Four of the 28 patients had serum thyroid peroxidase (TPO) antibodies, only one level of which was elevated, but this patient had normal TSH and free T4 levels, Dr. Sanghvi said.

The association between breast cancer and nontoxic goiter is unclear, she said. Possible mechanisms include the role of iodine, thyroid-stimulating hormone, and estrogen.

“Iodine has been theorized as being a causative factor, because it is utilized by both breast and thyroid tissues,” and these are the only two organs in which iodine is stored. Dr. Sanghvi explained. However, epidemiologic studies are needed to explore the association between iodine and breast cancer.

The results were limited by the retrospective nature of the study, and the lack of a standard medical history questionnaire. But they underscore the important of breast cancer screening in women with benign thyroid disease until larger, prospective studies provide additional information, Dr. Sanghvi said.

In the study population as a whole, the average age was 51 years, the average body mass index was 29.2 kg/m

One of the patients with breast cancer had ductal carcinoma in situ; the breast cancer types in the other 27 patients were not specified.

Major Finding: Overall, 28 of 789 women with goiter also had breast cancer, for a prevalence of 3.6%.

Data Source: A review of 789 women with nontoxic goiter.

Disclosures: Dr. Sanghvi reported having no financial conflicts to disclose.

SAN DIEGO – Women with nontoxic goiter were more than twice as likely to have breast cancer compared with women in the general population, according to a review of data from 789 women with nontoxic, multinodular goiter, uninodular goiter, or simple goiter.

Data from previous studies of a potential link between thyroid disorders and breast cancer are inconclusive, said Sarika Patel Sanghvi, D.O., of Robert Wood Johnson Medical School in New Brunswick, N.J.

In this study, Dr. Sanghvi and her colleagues compared breast cancer incidence in women with nontoxic goiter with breast cancer incidence in the general population of New Jersey. Breast cancer history was obtained from each patient's medical history.

Overall, 28 of 789 women with goiter also had breast cancer, for a prevalence of 3.6%. By contrast, the prevalence of breast cancer in the general population, based on data from the New Jersey Department of Health and Senior Services, was significantly lower at 1.6%.

Two of the 28 patients with breast cancer had low TSH levels, but one had a free T4 within normal limits and the other had a total T4 within normal limits, said Dr. Sanghvi. Four of the 28 patients had serum thyroid peroxidase (TPO) antibodies, only one level of which was elevated, but this patient had normal TSH and free T4 levels, Dr. Sanghvi said.

The association between breast cancer and nontoxic goiter is unclear, she said. Possible mechanisms include the role of iodine, thyroid-stimulating hormone, and estrogen.

“Iodine has been theorized as being a causative factor, because it is utilized by both breast and thyroid tissues,” and these are the only two organs in which iodine is stored. Dr. Sanghvi explained. However, epidemiologic studies are needed to explore the association between iodine and breast cancer.

The results were limited by the retrospective nature of the study, and the lack of a standard medical history questionnaire. But they underscore the important of breast cancer screening in women with benign thyroid disease until larger, prospective studies provide additional information, Dr. Sanghvi said.

In the study population as a whole, the average age was 51 years, the average body mass index was 29.2 kg/m

One of the patients with breast cancer had ductal carcinoma in situ; the breast cancer types in the other 27 patients were not specified.

Major Finding: Overall, 28 of 789 women with goiter also had breast cancer, for a prevalence of 3.6%.

Data Source: A review of 789 women with nontoxic goiter.

Disclosures: Dr. Sanghvi reported having no financial conflicts to disclose.

SAN DIEGO – Women with nontoxic goiter were more than twice as likely to have breast cancer compared with women in the general population, according to a review of data from 789 women with nontoxic, multinodular goiter, uninodular goiter, or simple goiter.

Data from previous studies of a potential link between thyroid disorders and breast cancer are inconclusive, said Sarika Patel Sanghvi, D.O., of Robert Wood Johnson Medical School in New Brunswick, N.J.

In this study, Dr. Sanghvi and her colleagues compared breast cancer incidence in women with nontoxic goiter with breast cancer incidence in the general population of New Jersey. Breast cancer history was obtained from each patient's medical history.

Overall, 28 of 789 women with goiter also had breast cancer, for a prevalence of 3.6%. By contrast, the prevalence of breast cancer in the general population, based on data from the New Jersey Department of Health and Senior Services, was significantly lower at 1.6%.

Two of the 28 patients with breast cancer had low TSH levels, but one had a free T4 within normal limits and the other had a total T4 within normal limits, said Dr. Sanghvi. Four of the 28 patients had serum thyroid peroxidase (TPO) antibodies, only one level of which was elevated, but this patient had normal TSH and free T4 levels, Dr. Sanghvi said.

The association between breast cancer and nontoxic goiter is unclear, she said. Possible mechanisms include the role of iodine, thyroid-stimulating hormone, and estrogen.

“Iodine has been theorized as being a causative factor, because it is utilized by both breast and thyroid tissues,” and these are the only two organs in which iodine is stored. Dr. Sanghvi explained. However, epidemiologic studies are needed to explore the association between iodine and breast cancer.

The results were limited by the retrospective nature of the study, and the lack of a standard medical history questionnaire. But they underscore the important of breast cancer screening in women with benign thyroid disease until larger, prospective studies provide additional information, Dr. Sanghvi said.

In the study population as a whole, the average age was 51 years, the average body mass index was 29.2 kg/m

One of the patients with breast cancer had ductal carcinoma in situ; the breast cancer types in the other 27 patients were not specified.

Teen birth rates in the United States fell by 37% over the past 2 decades, reaching the lowest rate ever recorded, according to data from the Centers for Disease Control and Prevention.

Despite those promising data, “we still have a ways to go to improve our teen birth rate to reflect what is seen in other parts of the world,” Ursula Bauer, Ph.D., director of the National Center for Chronic Disease Prevention and Health Promotion, said in a teleconference.

The birth rate for girls aged 15–19 years in 2008 and 2009 was 39 per 1,000 girls in the United States, Dr. Bauer and Dr. Wanda Barfield, director of the division of reproductive health, National Center for Chronic Disease Prevention and Health Promotion, wrote in the report, which was published in Morbidity and Mortality Weekly Report (2011;60:1–8).

However, teen birth rates in the United States are as much as nine times higher than in many other developed countries. Teen birth rates for 2008–2009 were 27 per 1,000 in Great Britain, 10 per 1,000 in Germany and France, and 6 per 1,000 in Sweden and Denmark.

The researchers, from the Centers for Disease Control and Prevention (CDC), reviewed National Vital Statistics System data from 1991 to 2009 on teen birth rates, as well as National Youth Risk Behavior Survey data on sexual activity and contraceptive use. They also reviewed data on sex education and the use of reproductive health services for teens aged 15–19 years from the 2006–2008 National Survey of Family Growth.

In 2009, teen birth rates were lowest in the Northeastern and upper Midwestern states and highest in the Southern states. The states with the lowest birth rates – Connecticut, Massachusetts, New Hampshire, New Jersey, and Vermont – posted rates ranging from 16 to 23 births per 1,000 girls aged 15–19 years. The states with the highest rates – Arkansas, Mississippi, New Mexico, Oklahoma, and Texas – had rates ranging from 59 to 64 births per 1,000 girls aged 15–19 years.

The number of teens having sex declined across white, black, and Hispanic ethnicities for both boys and girls, but black and Hispanic girls remained at least twice as likely as white girls to become teen mothers. Approximately 46% of teens in the United States have had sexual intercourse – down from 54% in 1991 – and 12% of those teens used no contraception, down from 16% in 1991.

“Health care providers have a key role to play in bringing down teen birth rates and teen pregnancy rates,” said Dr. Bauer. “Talking to teens, both boys and girls, about sexual health and reproductive health, and talking about available contraception, is very important for health care providers in their encounters with teens,” she said.

According to a CDC fact sheet, health care providers can help reduce the teen birth rate in the United States by making more birth control options available to sexually active teens, including long-acting methods such as IUDs, and by educating teens about the proper use of birth control options, including condoms and oral contraceptives.

For the complete MMWR Vital Signs report on teen birth rates, visit www.cdc.gov/vitalsigns

Vitals

Source Elsevier Global Medical News

Teen birth rates in the United States fell by 37% over the past 2 decades, reaching the lowest rate ever recorded, according to data from the Centers for Disease Control and Prevention.

Despite those promising data, “we still have a ways to go to improve our teen birth rate to reflect what is seen in other parts of the world,” Ursula Bauer, Ph.D., director of the National Center for Chronic Disease Prevention and Health Promotion, said in a teleconference.

The birth rate for girls aged 15–19 years in 2008 and 2009 was 39 per 1,000 girls in the United States, Dr. Bauer and Dr. Wanda Barfield, director of the division of reproductive health, National Center for Chronic Disease Prevention and Health Promotion, wrote in the report, which was published in Morbidity and Mortality Weekly Report (2011;60:1–8).

However, teen birth rates in the United States are as much as nine times higher than in many other developed countries. Teen birth rates for 2008–2009 were 27 per 1,000 in Great Britain, 10 per 1,000 in Germany and France, and 6 per 1,000 in Sweden and Denmark.

The researchers, from the Centers for Disease Control and Prevention (CDC), reviewed National Vital Statistics System data from 1991 to 2009 on teen birth rates, as well as National Youth Risk Behavior Survey data on sexual activity and contraceptive use. They also reviewed data on sex education and the use of reproductive health services for teens aged 15–19 years from the 2006–2008 National Survey of Family Growth.

In 2009, teen birth rates were lowest in the Northeastern and upper Midwestern states and highest in the Southern states. The states with the lowest birth rates – Connecticut, Massachusetts, New Hampshire, New Jersey, and Vermont – posted rates ranging from 16 to 23 births per 1,000 girls aged 15–19 years. The states with the highest rates – Arkansas, Mississippi, New Mexico, Oklahoma, and Texas – had rates ranging from 59 to 64 births per 1,000 girls aged 15–19 years.

The number of teens having sex declined across white, black, and Hispanic ethnicities for both boys and girls, but black and Hispanic girls remained at least twice as likely as white girls to become teen mothers. Approximately 46% of teens in the United States have had sexual intercourse – down from 54% in 1991 – and 12% of those teens used no contraception, down from 16% in 1991.

“Health care providers have a key role to play in bringing down teen birth rates and teen pregnancy rates,” said Dr. Bauer. “Talking to teens, both boys and girls, about sexual health and reproductive health, and talking about available contraception, is very important for health care providers in their encounters with teens,” she said.

According to a CDC fact sheet, health care providers can help reduce the teen birth rate in the United States by making more birth control options available to sexually active teens, including long-acting methods such as IUDs, and by educating teens about the proper use of birth control options, including condoms and oral contraceptives.

For the complete MMWR Vital Signs report on teen birth rates, visit www.cdc.gov/vitalsigns

Vitals

Source Elsevier Global Medical News

Teen birth rates in the United States fell by 37% over the past 2 decades, reaching the lowest rate ever recorded, according to data from the Centers for Disease Control and Prevention.

Despite those promising data, “we still have a ways to go to improve our teen birth rate to reflect what is seen in other parts of the world,” Ursula Bauer, Ph.D., director of the National Center for Chronic Disease Prevention and Health Promotion, said in a teleconference.

The birth rate for girls aged 15–19 years in 2008 and 2009 was 39 per 1,000 girls in the United States, Dr. Bauer and Dr. Wanda Barfield, director of the division of reproductive health, National Center for Chronic Disease Prevention and Health Promotion, wrote in the report, which was published in Morbidity and Mortality Weekly Report (2011;60:1–8).

However, teen birth rates in the United States are as much as nine times higher than in many other developed countries. Teen birth rates for 2008–2009 were 27 per 1,000 in Great Britain, 10 per 1,000 in Germany and France, and 6 per 1,000 in Sweden and Denmark.

The researchers, from the Centers for Disease Control and Prevention (CDC), reviewed National Vital Statistics System data from 1991 to 2009 on teen birth rates, as well as National Youth Risk Behavior Survey data on sexual activity and contraceptive use. They also reviewed data on sex education and the use of reproductive health services for teens aged 15–19 years from the 2006–2008 National Survey of Family Growth.

In 2009, teen birth rates were lowest in the Northeastern and upper Midwestern states and highest in the Southern states. The states with the lowest birth rates – Connecticut, Massachusetts, New Hampshire, New Jersey, and Vermont – posted rates ranging from 16 to 23 births per 1,000 girls aged 15–19 years. The states with the highest rates – Arkansas, Mississippi, New Mexico, Oklahoma, and Texas – had rates ranging from 59 to 64 births per 1,000 girls aged 15–19 years.

The number of teens having sex declined across white, black, and Hispanic ethnicities for both boys and girls, but black and Hispanic girls remained at least twice as likely as white girls to become teen mothers. Approximately 46% of teens in the United States have had sexual intercourse – down from 54% in 1991 – and 12% of those teens used no contraception, down from 16% in 1991.

“Health care providers have a key role to play in bringing down teen birth rates and teen pregnancy rates,” said Dr. Bauer. “Talking to teens, both boys and girls, about sexual health and reproductive health, and talking about available contraception, is very important for health care providers in their encounters with teens,” she said.

According to a CDC fact sheet, health care providers can help reduce the teen birth rate in the United States by making more birth control options available to sexually active teens, including long-acting methods such as IUDs, and by educating teens about the proper use of birth control options, including condoms and oral contraceptives.

For the complete MMWR Vital Signs report on teen birth rates, visit www.cdc.gov/vitalsigns

Vitals

Source Elsevier Global Medical News

SAN FRANCISCO – Children with recurrent, severe virus-induced wheezing during their first 3 years of life had significantly reduced prebronchodilator lung function at school age, compared with children with no history of wheezing, but no differences were seen on tests of postbronchodilator lung function, based on data from 215 children.

Previous studies have shown that early childhood is a vulnerable time for the development of lung function, and recurrent wheezing can be a major risk factor for reduced lung function when children reach school age, said Dr. Daniel Jackson of the University of Wisconsin, Madison, and his colleagues.

“This is particularly important because loss of lung function is associated with morbidity and limitation due to asthma,” Dr. Jackson said in an interview.

The researchers reviewed data from the Childhood Origins of Asthma (COAST) study, a prospective study of children at increased risk for allergies or asthma. They divided the children into four groups according to their wheezing history. The groups consisted of 101 children with no wheezing, 69 children with wheezing who received no oral corticosteroids, 23 children who received corticosteroids with one episode of wheezing, and 22 children who received corticosteroids with two or more episodes of wheezing. Pre- and postbronchodilator spirometry was performed each year to check lung function and compare lung volume among the groups, according to the researchers' poster, which was presented at the meeting.

Overall, prebronchodilator forced expiratory volume in 0.5 and 1 second (FEV_0.5 and FEV₁) obtained at age 5-8 years were significantly lower in children with histories of multiple wheezing episodes treated with oral steroids, compared with each of the other groups, after the investigators controlled for asthma, age, sex, height, weight, race, and smoke exposure. The children with two or more wheezing episodes treated with oral steroids had an average FEV₁ of 1.26 L, compared with 1.37 L in children with no episodes of wheezing, 1.34 L in children who had wheezing without oral steroid treatment, and 1.38 L in children who had wheezing with one oral steroid treatment.

However, postbronchodilator measures taken at 6-8 years were not significantly different in children with repeated wheezing episodes, compared with children with fewer or no wheezing episodes.

The findings suggest that reduced lung function in school-aged children at high risk for asthma is at least partially reversible, the researchers noted. “Whether these severe wheezing episodes caused progressive lung function or were due to low baseline lung function is not known,” they wrote. But the results also suggest that preventing severe wheezing in early childhood could reduce later problems caused by a loss of lung function, and new therapeutic strategies are needed to prevent virus-induced wheezing in high-risk children, they added.

SAN FRANCISCO – Children with recurrent, severe virus-induced wheezing during their first 3 years of life had significantly reduced prebronchodilator lung function at school age, compared with children with no history of wheezing, but no differences were seen on tests of postbronchodilator lung function, based on data from 215 children.

Previous studies have shown that early childhood is a vulnerable time for the development of lung function, and recurrent wheezing can be a major risk factor for reduced lung function when children reach school age, said Dr. Daniel Jackson of the University of Wisconsin, Madison, and his colleagues.

“This is particularly important because loss of lung function is associated with morbidity and limitation due to asthma,” Dr. Jackson said in an interview.

The researchers reviewed data from the Childhood Origins of Asthma (COAST) study, a prospective study of children at increased risk for allergies or asthma. They divided the children into four groups according to their wheezing history. The groups consisted of 101 children with no wheezing, 69 children with wheezing who received no oral corticosteroids, 23 children who received corticosteroids with one episode of wheezing, and 22 children who received corticosteroids with two or more episodes of wheezing. Pre- and postbronchodilator spirometry was performed each year to check lung function and compare lung volume among the groups, according to the researchers' poster, which was presented at the meeting.

Overall, prebronchodilator forced expiratory volume in 0.5 and 1 second (FEV_0.5 and FEV₁) obtained at age 5-8 years were significantly lower in children with histories of multiple wheezing episodes treated with oral steroids, compared with each of the other groups, after the investigators controlled for asthma, age, sex, height, weight, race, and smoke exposure. The children with two or more wheezing episodes treated with oral steroids had an average FEV₁ of 1.26 L, compared with 1.37 L in children with no episodes of wheezing, 1.34 L in children who had wheezing without oral steroid treatment, and 1.38 L in children who had wheezing with one oral steroid treatment.

However, postbronchodilator measures taken at 6-8 years were not significantly different in children with repeated wheezing episodes, compared with children with fewer or no wheezing episodes.

The findings suggest that reduced lung function in school-aged children at high risk for asthma is at least partially reversible, the researchers noted. “Whether these severe wheezing episodes caused progressive lung function or were due to low baseline lung function is not known,” they wrote. But the results also suggest that preventing severe wheezing in early childhood could reduce later problems caused by a loss of lung function, and new therapeutic strategies are needed to prevent virus-induced wheezing in high-risk children, they added.

SAN FRANCISCO – Children with recurrent, severe virus-induced wheezing during their first 3 years of life had significantly reduced prebronchodilator lung function at school age, compared with children with no history of wheezing, but no differences were seen on tests of postbronchodilator lung function, based on data from 215 children.

Previous studies have shown that early childhood is a vulnerable time for the development of lung function, and recurrent wheezing can be a major risk factor for reduced lung function when children reach school age, said Dr. Daniel Jackson of the University of Wisconsin, Madison, and his colleagues.

“This is particularly important because loss of lung function is associated with morbidity and limitation due to asthma,” Dr. Jackson said in an interview.

The researchers reviewed data from the Childhood Origins of Asthma (COAST) study, a prospective study of children at increased risk for allergies or asthma. They divided the children into four groups according to their wheezing history. The groups consisted of 101 children with no wheezing, 69 children with wheezing who received no oral corticosteroids, 23 children who received corticosteroids with one episode of wheezing, and 22 children who received corticosteroids with two or more episodes of wheezing. Pre- and postbronchodilator spirometry was performed each year to check lung function and compare lung volume among the groups, according to the researchers' poster, which was presented at the meeting.

Overall, prebronchodilator forced expiratory volume in 0.5 and 1 second (FEV_0.5 and FEV₁) obtained at age 5-8 years were significantly lower in children with histories of multiple wheezing episodes treated with oral steroids, compared with each of the other groups, after the investigators controlled for asthma, age, sex, height, weight, race, and smoke exposure. The children with two or more wheezing episodes treated with oral steroids had an average FEV₁ of 1.26 L, compared with 1.37 L in children with no episodes of wheezing, 1.34 L in children who had wheezing without oral steroid treatment, and 1.38 L in children who had wheezing with one oral steroid treatment.

However, postbronchodilator measures taken at 6-8 years were not significantly different in children with repeated wheezing episodes, compared with children with fewer or no wheezing episodes.

The findings suggest that reduced lung function in school-aged children at high risk for asthma is at least partially reversible, the researchers noted. “Whether these severe wheezing episodes caused progressive lung function or were due to low baseline lung function is not known,” they wrote. But the results also suggest that preventing severe wheezing in early childhood could reduce later problems caused by a loss of lung function, and new therapeutic strategies are needed to prevent virus-induced wheezing in high-risk children, they added.

Age-related macular degeneration improved equally in patients treated with monthly bevacizumab or monthly ranibizumab, and as-needed dosing was almost as effective as monthly injections, according to data from 1-year results of a 2-year clinical trial. The findings were published online April 28 in the New England Journal of Medicine.

After 1 year of treatment, the two drugs were "equivalent for visual acuity at all time points when administered at the same dosing regimen," Dr. Daniel Martin of the Cleveland Clinic said in a teleconference.

Bevacizumab (Avastin) has been used off label for age-related macular degeneration (AMD), but formal efficacy data were lacking, said Dr. Paul Sieving, director of the National Eye Institute, which sponsored the study.

In addition, "both drugs produced an immediate and substantial decrease in the amount of fluid in the retina," Dr. Martin said.

As-needed dosing resulted in a lower treatment burden for patients, with "an average of 4 to 5 fewer injections over 1 year than patients assigned to monthly dosing," Dr. Martin noted. As-needed dosing yielded slightly less improvement, but "the results were still excellent," he said (N. Engl. J. Med. 2011 April 28 [doi: 10.1056/NEJM0a1102673]).

In the Comparison of AMD Treatments Trial (CATT), Dr. Martin and the CATT Research Group enrolled 1,208 adults aged 50 years or older with AMD at 44 clinical sites between February 2008 and December 2009. Patients were randomized into four groups: monthly ranibizumab, monthly bevacizumab, ranibizumab as needed, and bevacizumab as needed.

The ranibizumab dose was 0.50 mg in 0.05 mL of solution, and the bevacizumab dose was 1.25 mg in 0.50 mL of solution.

After 23 patients at one center were eliminated because of protocol noncompliance, 1-year results were available for 1,185 patients.

After 1 year of treatment, visual acuity (defined as number of letters the patients could read on an eye chart) improved across all four groups. The changes in visual acuity scores from baseline in the ranibizumab monthly, bevacizumab monthly, ranibizumab as needed, and bevacizumab as needed groups were 8.5, 8.0, 6.8, and 5.9, respectively. Ranibizumab was statistically equivalent to bevacizumab both when the drugs were given monthly and when they were given as needed.

In all four groups, the greatest improvements occurred during the first 3 months of treatment, the researchers noted.

In a longitudinal analysis, the mean increases in number of letters, compared with baseline in the four groups were 7.2, 7.3, 6.4, and 6.1, respectively.

The baseline demographics were similar across all four groups. The average age ranged from 78 to 80 years, approximately two-thirds of patients in each group were women, and at least 98% of each group was white.

The incidence of serious systemic adverse events was 18% in the ranibizumab monthly group, 22% in the bevacizumab monthly group, 21% in the ranibizumab as-needed group, and 26% in the bevacizumab as-needed group. These differences were not significant.

The difference in the cost of the two medications remains a factor in drug choice, the researchers noted. "A single dose of ranibizumab costs 40 times as much as a single dose of bevacizumab," they wrote. The average cost of the medications per patient for 1 year was $23,400 in the ranibizumab monthly group, $13,800 in the ranibizumab as-needed group, $595 in the bevacizumab monthly group, and $385 in the bevacizumab as-needed group.

Currently, most AMD patients in the United States receive bevacizumab, and the study "provides data to support what is the dominant practice pattern in the United States," said Dr. Martin. Both drugs could be considered standard of care, and both are viable options, he said. "Clinicians may choose one or the other, and this study has informed that choice," he added.

The CATT study is ongoing, and additional results will be published at the end of 2 years.

The study was funded by a grant from the National Eye Institute. Dr. Martin had no additional financial conflicts to disclose.

Age-related macular degeneration improved equally in patients treated with monthly bevacizumab or monthly ranibizumab, and as-needed dosing was almost as effective as monthly injections, according to data from 1-year results of a 2-year clinical trial. The findings were published online April 28 in the New England Journal of Medicine.

After 1 year of treatment, the two drugs were "equivalent for visual acuity at all time points when administered at the same dosing regimen," Dr. Daniel Martin of the Cleveland Clinic said in a teleconference.

Bevacizumab (Avastin) has been used off label for age-related macular degeneration (AMD), but formal efficacy data were lacking, said Dr. Paul Sieving, director of the National Eye Institute, which sponsored the study.

In addition, "both drugs produced an immediate and substantial decrease in the amount of fluid in the retina," Dr. Martin said.

As-needed dosing resulted in a lower treatment burden for patients, with "an average of 4 to 5 fewer injections over 1 year than patients assigned to monthly dosing," Dr. Martin noted. As-needed dosing yielded slightly less improvement, but "the results were still excellent," he said (N. Engl. J. Med. 2011 April 28 [doi: 10.1056/NEJM0a1102673]).

In the Comparison of AMD Treatments Trial (CATT), Dr. Martin and the CATT Research Group enrolled 1,208 adults aged 50 years or older with AMD at 44 clinical sites between February 2008 and December 2009. Patients were randomized into four groups: monthly ranibizumab, monthly bevacizumab, ranibizumab as needed, and bevacizumab as needed.

The ranibizumab dose was 0.50 mg in 0.05 mL of solution, and the bevacizumab dose was 1.25 mg in 0.50 mL of solution.

After 23 patients at one center were eliminated because of protocol noncompliance, 1-year results were available for 1,185 patients.

After 1 year of treatment, visual acuity (defined as number of letters the patients could read on an eye chart) improved across all four groups. The changes in visual acuity scores from baseline in the ranibizumab monthly, bevacizumab monthly, ranibizumab as needed, and bevacizumab as needed groups were 8.5, 8.0, 6.8, and 5.9, respectively. Ranibizumab was statistically equivalent to bevacizumab both when the drugs were given monthly and when they were given as needed.

In all four groups, the greatest improvements occurred during the first 3 months of treatment, the researchers noted.

In a longitudinal analysis, the mean increases in number of letters, compared with baseline in the four groups were 7.2, 7.3, 6.4, and 6.1, respectively.

The baseline demographics were similar across all four groups. The average age ranged from 78 to 80 years, approximately two-thirds of patients in each group were women, and at least 98% of each group was white.

The incidence of serious systemic adverse events was 18% in the ranibizumab monthly group, 22% in the bevacizumab monthly group, 21% in the ranibizumab as-needed group, and 26% in the bevacizumab as-needed group. These differences were not significant.

The difference in the cost of the two medications remains a factor in drug choice, the researchers noted. "A single dose of ranibizumab costs 40 times as much as a single dose of bevacizumab," they wrote. The average cost of the medications per patient for 1 year was $23,400 in the ranibizumab monthly group, $13,800 in the ranibizumab as-needed group, $595 in the bevacizumab monthly group, and $385 in the bevacizumab as-needed group.

Currently, most AMD patients in the United States receive bevacizumab, and the study "provides data to support what is the dominant practice pattern in the United States," said Dr. Martin. Both drugs could be considered standard of care, and both are viable options, he said. "Clinicians may choose one or the other, and this study has informed that choice," he added.

The CATT study is ongoing, and additional results will be published at the end of 2 years.

The study was funded by a grant from the National Eye Institute. Dr. Martin had no additional financial conflicts to disclose.

Age-related macular degeneration improved equally in patients treated with monthly bevacizumab or monthly ranibizumab, and as-needed dosing was almost as effective as monthly injections, according to data from 1-year results of a 2-year clinical trial. The findings were published online April 28 in the New England Journal of Medicine.

After 1 year of treatment, the two drugs were "equivalent for visual acuity at all time points when administered at the same dosing regimen," Dr. Daniel Martin of the Cleveland Clinic said in a teleconference.

Bevacizumab (Avastin) has been used off label for age-related macular degeneration (AMD), but formal efficacy data were lacking, said Dr. Paul Sieving, director of the National Eye Institute, which sponsored the study.

In addition, "both drugs produced an immediate and substantial decrease in the amount of fluid in the retina," Dr. Martin said.

As-needed dosing resulted in a lower treatment burden for patients, with "an average of 4 to 5 fewer injections over 1 year than patients assigned to monthly dosing," Dr. Martin noted. As-needed dosing yielded slightly less improvement, but "the results were still excellent," he said (N. Engl. J. Med. 2011 April 28 [doi: 10.1056/NEJM0a1102673]).

In the Comparison of AMD Treatments Trial (CATT), Dr. Martin and the CATT Research Group enrolled 1,208 adults aged 50 years or older with AMD at 44 clinical sites between February 2008 and December 2009. Patients were randomized into four groups: monthly ranibizumab, monthly bevacizumab, ranibizumab as needed, and bevacizumab as needed.

The ranibizumab dose was 0.50 mg in 0.05 mL of solution, and the bevacizumab dose was 1.25 mg in 0.50 mL of solution.

After 23 patients at one center were eliminated because of protocol noncompliance, 1-year results were available for 1,185 patients.

After 1 year of treatment, visual acuity (defined as number of letters the patients could read on an eye chart) improved across all four groups. The changes in visual acuity scores from baseline in the ranibizumab monthly, bevacizumab monthly, ranibizumab as needed, and bevacizumab as needed groups were 8.5, 8.0, 6.8, and 5.9, respectively. Ranibizumab was statistically equivalent to bevacizumab both when the drugs were given monthly and when they were given as needed.

In all four groups, the greatest improvements occurred during the first 3 months of treatment, the researchers noted.

In a longitudinal analysis, the mean increases in number of letters, compared with baseline in the four groups were 7.2, 7.3, 6.4, and 6.1, respectively.

The baseline demographics were similar across all four groups. The average age ranged from 78 to 80 years, approximately two-thirds of patients in each group were women, and at least 98% of each group was white.

The incidence of serious systemic adverse events was 18% in the ranibizumab monthly group, 22% in the bevacizumab monthly group, 21% in the ranibizumab as-needed group, and 26% in the bevacizumab as-needed group. These differences were not significant.

The difference in the cost of the two medications remains a factor in drug choice, the researchers noted. "A single dose of ranibizumab costs 40 times as much as a single dose of bevacizumab," they wrote. The average cost of the medications per patient for 1 year was $23,400 in the ranibizumab monthly group, $13,800 in the ranibizumab as-needed group, $595 in the bevacizumab monthly group, and $385 in the bevacizumab as-needed group.

Currently, most AMD patients in the United States receive bevacizumab, and the study "provides data to support what is the dominant practice pattern in the United States," said Dr. Martin. Both drugs could be considered standard of care, and both are viable options, he said. "Clinicians may choose one or the other, and this study has informed that choice," he added.

The CATT study is ongoing, and additional results will be published at the end of 2 years.

The study was funded by a grant from the National Eye Institute. Dr. Martin had no additional financial conflicts to disclose.

Age-related macular degeneration improved equally in patients treated with monthly bevacizumab or monthly ranibizumab, and as-needed dosing was almost as effective as monthly injections, according to data from 1-year results of a 2-year clinical trial. The findings were published online April 28 in the New England Journal of Medicine.

After 1 year of treatment, the two drugs were "equivalent for visual acuity at all time points when administered at the same dosing regimen," Dr. Daniel Martin of the Cleveland Clinic said in a teleconference.

Bevacizumab (Avastin) has been used off label for age-related macular degeneration (AMD), but formal efficacy data were lacking, said Dr. Paul Sieving, director of the National Eye Institute, which sponsored the study.

In addition, "both drugs produced an immediate and substantial decrease in the amount of fluid in the retina," Dr. Martin said.

As-needed dosing resulted in a lower treatment burden for patients, with "an average of 4 to 5 fewer injections over 1 year than patients assigned to monthly dosing," Dr. Martin noted. As-needed dosing yielded slightly less improvement, but "the results were still excellent," he said (N. Engl. J. Med. 2011 April 28 [doi: 10.1056/NEJM0a1102673]).

In the Comparison of AMD Treatments Trial (CATT), Dr. Martin and the CATT Research Group enrolled 1,208 adults aged 50 years or older with AMD at 44 clinical sites between February 2008 and December 2009. Patients were randomized into four groups: monthly ranibizumab, monthly bevacizumab, ranibizumab as needed, and bevacizumab as needed.

The ranibizumab dose was 0.50 mg in 0.05 mL of solution, and the bevacizumab dose was 1.25 mg in 0.50 mL of solution.

After 23 patients at one center were eliminated because of protocol noncompliance, 1-year results were available for 1,185 patients.

After 1 year of treatment, visual acuity (defined as number of letters the patients could read on an eye chart) improved across all four groups. The changes in visual acuity scores from baseline in the ranibizumab monthly, bevacizumab monthly, ranibizumab as needed, and bevacizumab as needed groups were 8.5, 8.0, 6.8, and 5.9, respectively. Ranibizumab was statistically equivalent to bevacizumab both when the drugs were given monthly and when they were given as needed.

In all four groups, the greatest improvements occurred during the first 3 months of treatment, the researchers noted.

In a longitudinal analysis, the mean increases in number of letters, compared with baseline in the four groups were 7.2, 7.3, 6.4, and 6.1, respectively.

The baseline demographics were similar across all four groups. The average age ranged from 78 to 80 years, approximately two-thirds of patients in each group were women, and at least 98% of each group was white.

The incidence of serious systemic adverse events was 18% in the ranibizumab monthly group, 22% in the bevacizumab monthly group, 21% in the ranibizumab as-needed group, and 26% in the bevacizumab as-needed group. These differences were not significant.

The difference in the cost of the two medications remains a factor in drug choice, the researchers noted. "A single dose of ranibizumab costs 40 times as much as a single dose of bevacizumab," they wrote. The average cost of the medications per patient for 1 year was $23,400 in the ranibizumab monthly group, $13,800 in the ranibizumab as-needed group, $595 in the bevacizumab monthly group, and $385 in the bevacizumab as-needed group.

Currently, most AMD patients in the United States receive bevacizumab, and the study "provides data to support what is the dominant practice pattern in the United States," said Dr. Martin. Both drugs could be considered standard of care, and both are viable options, he said. "Clinicians may choose one or the other, and this study has informed that choice," he added.

The CATT study is ongoing, and additional results will be published at the end of 2 years.

The study was funded by a grant from the National Eye Institute. Dr. Martin had no additional financial conflicts to disclose.

Age-related macular degeneration improved equally in patients treated with monthly bevacizumab or monthly ranibizumab, and as-needed dosing was almost as effective as monthly injections, according to data from 1-year results of a 2-year clinical trial. The findings were published online April 28 in the New England Journal of Medicine.

After 1 year of treatment, the two drugs were "equivalent for visual acuity at all time points when administered at the same dosing regimen," Dr. Daniel Martin of the Cleveland Clinic said in a teleconference.

Bevacizumab (Avastin) has been used off label for age-related macular degeneration (AMD), but formal efficacy data were lacking, said Dr. Paul Sieving, director of the National Eye Institute, which sponsored the study.

In addition, "both drugs produced an immediate and substantial decrease in the amount of fluid in the retina," Dr. Martin said.

As-needed dosing resulted in a lower treatment burden for patients, with "an average of 4 to 5 fewer injections over 1 year than patients assigned to monthly dosing," Dr. Martin noted. As-needed dosing yielded slightly less improvement, but "the results were still excellent," he said (N. Engl. J. Med. 2011 April 28 [doi: 10.1056/NEJM0a1102673]).

In the Comparison of AMD Treatments Trial (CATT), Dr. Martin and the CATT Research Group enrolled 1,208 adults aged 50 years or older with AMD at 44 clinical sites between February 2008 and December 2009. Patients were randomized into four groups: monthly ranibizumab, monthly bevacizumab, ranibizumab as needed, and bevacizumab as needed.

The ranibizumab dose was 0.50 mg in 0.05 mL of solution, and the bevacizumab dose was 1.25 mg in 0.50 mL of solution.

After 23 patients at one center were eliminated because of protocol noncompliance, 1-year results were available for 1,185 patients.

After 1 year of treatment, visual acuity (defined as number of letters the patients could read on an eye chart) improved across all four groups. The changes in visual acuity scores from baseline in the ranibizumab monthly, bevacizumab monthly, ranibizumab as needed, and bevacizumab as needed groups were 8.5, 8.0, 6.8, and 5.9, respectively. Ranibizumab was statistically equivalent to bevacizumab both when the drugs were given monthly and when they were given as needed.

In all four groups, the greatest improvements occurred during the first 3 months of treatment, the researchers noted.

In a longitudinal analysis, the mean increases in number of letters, compared with baseline in the four groups were 7.2, 7.3, 6.4, and 6.1, respectively.

The baseline demographics were similar across all four groups. The average age ranged from 78 to 80 years, approximately two-thirds of patients in each group were women, and at least 98% of each group was white.

The incidence of serious systemic adverse events was 18% in the ranibizumab monthly group, 22% in the bevacizumab monthly group, 21% in the ranibizumab as-needed group, and 26% in the bevacizumab as-needed group. These differences were not significant.

The difference in the cost of the two medications remains a factor in drug choice, the researchers noted. "A single dose of ranibizumab costs 40 times as much as a single dose of bevacizumab," they wrote. The average cost of the medications per patient for 1 year was $23,400 in the ranibizumab monthly group, $13,800 in the ranibizumab as-needed group, $595 in the bevacizumab monthly group, and $385 in the bevacizumab as-needed group.

Currently, most AMD patients in the United States receive bevacizumab, and the study "provides data to support what is the dominant practice pattern in the United States," said Dr. Martin. Both drugs could be considered standard of care, and both are viable options, he said. "Clinicians may choose one or the other, and this study has informed that choice," he added.

The CATT study is ongoing, and additional results will be published at the end of 2 years.

The study was funded by a grant from the National Eye Institute. Dr. Martin had no additional financial conflicts to disclose.

Age-related macular degeneration improved equally in patients treated with monthly bevacizumab or monthly ranibizumab, and as-needed dosing was almost as effective as monthly injections, according to data from 1-year results of a 2-year clinical trial. The findings were published online April 28 in the New England Journal of Medicine.

After 1 year of treatment, the two drugs were "equivalent for visual acuity at all time points when administered at the same dosing regimen," Dr. Daniel Martin of the Cleveland Clinic said in a teleconference.

Bevacizumab (Avastin) has been used off label for age-related macular degeneration (AMD), but formal efficacy data were lacking, said Dr. Paul Sieving, director of the National Eye Institute, which sponsored the study.

In addition, "both drugs produced an immediate and substantial decrease in the amount of fluid in the retina," Dr. Martin said.

As-needed dosing resulted in a lower treatment burden for patients, with "an average of 4 to 5 fewer injections over 1 year than patients assigned to monthly dosing," Dr. Martin noted. As-needed dosing yielded slightly less improvement, but "the results were still excellent," he said (N. Engl. J. Med. 2011 April 28 [doi: 10.1056/NEJM0a1102673]).

In the Comparison of AMD Treatments Trial (CATT), Dr. Martin and the CATT Research Group enrolled 1,208 adults aged 50 years or older with AMD at 44 clinical sites between February 2008 and December 2009. Patients were randomized into four groups: monthly ranibizumab, monthly bevacizumab, ranibizumab as needed, and bevacizumab as needed.

The ranibizumab dose was 0.50 mg in 0.05 mL of solution, and the bevacizumab dose was 1.25 mg in 0.50 mL of solution.

After 23 patients at one center were eliminated because of protocol noncompliance, 1-year results were available for 1,185 patients.

After 1 year of treatment, visual acuity (defined as number of letters the patients could read on an eye chart) improved across all four groups. The changes in visual acuity scores from baseline in the ranibizumab monthly, bevacizumab monthly, ranibizumab as needed, and bevacizumab as needed groups were 8.5, 8.0, 6.8, and 5.9, respectively. Ranibizumab was statistically equivalent to bevacizumab both when the drugs were given monthly and when they were given as needed.

In all four groups, the greatest improvements occurred during the first 3 months of treatment, the researchers noted.

In a longitudinal analysis, the mean increases in number of letters, compared with baseline in the four groups were 7.2, 7.3, 6.4, and 6.1, respectively.

The baseline demographics were similar across all four groups. The average age ranged from 78 to 80 years, approximately two-thirds of patients in each group were women, and at least 98% of each group was white.

The incidence of serious systemic adverse events was 18% in the ranibizumab monthly group, 22% in the bevacizumab monthly group, 21% in the ranibizumab as-needed group, and 26% in the bevacizumab as-needed group. These differences were not significant.

The difference in the cost of the two medications remains a factor in drug choice, the researchers noted. "A single dose of ranibizumab costs 40 times as much as a single dose of bevacizumab," they wrote. The average cost of the medications per patient for 1 year was $23,400 in the ranibizumab monthly group, $13,800 in the ranibizumab as-needed group, $595 in the bevacizumab monthly group, and $385 in the bevacizumab as-needed group.

Currently, most AMD patients in the United States receive bevacizumab, and the study "provides data to support what is the dominant practice pattern in the United States," said Dr. Martin. Both drugs could be considered standard of care, and both are viable options, he said. "Clinicians may choose one or the other, and this study has informed that choice," he added.

The CATT study is ongoing, and additional results will be published at the end of 2 years.

The study was funded by a grant from the National Eye Institute. Dr. Martin had no additional financial conflicts to disclose.

SAN DIEGO – Bone density and fracture risk continued to improve from baseline in postmenopausal women taking denosumab for osteoporosis, according to data from a 2-year extension of the FREEDOM study in more than 4,000 women.

The original FREEDOM study (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) enrolled 7,808 postmenopausal women aged 60-80 years with osteoporosis to receive either a subcutaneous injection of denosumab (60 mg) or placebo along with daily calcium and vitamin D supplements every 6 months. All subjects had bone mineral density (BMD) T scores of less than –2.5 but not less than –4.0 at the lumbar spine or total hip. At 36 months, denosumab was associated with reductions of 68% in vertebral fracture and 40% in hip fracture (N. Engl. J. Med. 2009;361:756-65).

The FREEDOM results were the basis of the Food and Drug Administration’s approval of denosumab in June 2010. In the extension study, 2,343 patients from the original treatment group and 2,207 patients in the control group received the denosumab treatment for 2 years (as well as calcium and vitamin D), yielding follow-up data for up to 5 years of drug exposure, said Dr. Cesar Libanati at the annual meeting of the American Association of Clinical Endocrinologists.

Women in the long-term group who received denosumab for 5 years showed significant BMD improvements from baseline, of 13.7% in the lumbar spine and 7.0% in the total hip. Women in crossover group showed significant BMD improvements from the start of the extension study, of 7.9% in the lumbar spine and 4.1% in the total hip.

Patients in the crossover group showed significant increased in BMD from the extension study baseline similar to those seen in the long-term patients during their first 2 years of denosumab use, noted Dr. Libanati, clinical research medical director at Amgen Pharmaceuticals, maker of denosumab (Prolia), in Newbury Park, Calif.

During years 4 and 5, the annualized yearly incidence of new vertebral fractures in the long-term patients was steady at 1.4%, compared with 1.1% at the end of the 3-year FREEDOM study. The yearly incidence in the crossover treatment group was 0.9% for their first 2 years of denosumab exposure, compared with 2.5% in the first 2 years of the FREEDOM study.

The yearly incidence of nonvertebral fractures in the long-term patients was 1.4% after 4 years and 1.1% after 5 years. Nonvertebral fracture data for the crossover patients were not presented.

Denosumab remained well tolerated during the extension study. The adverse event profile was "similar in years 4 and 5 to that observed in the 3 years of the placebo-controlled FREEDOM study," Dr. Libanati said. Long-term patients also maintained the reductions in bone turnover seen during the original FREEDOM study, he added.

Dr. Libanati is employed by Amgen.

SAN DIEGO – Bone density and fracture risk continued to improve from baseline in postmenopausal women taking denosumab for osteoporosis, according to data from a 2-year extension of the FREEDOM study in more than 4,000 women.

The original FREEDOM study (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) enrolled 7,808 postmenopausal women aged 60-80 years with osteoporosis to receive either a subcutaneous injection of denosumab (60 mg) or placebo along with daily calcium and vitamin D supplements every 6 months. All subjects had bone mineral density (BMD) T scores of less than –2.5 but not less than –4.0 at the lumbar spine or total hip. At 36 months, denosumab was associated with reductions of 68% in vertebral fracture and 40% in hip fracture (N. Engl. J. Med. 2009;361:756-65).

The FREEDOM results were the basis of the Food and Drug Administration’s approval of denosumab in June 2010. In the extension study, 2,343 patients from the original treatment group and 2,207 patients in the control group received the denosumab treatment for 2 years (as well as calcium and vitamin D), yielding follow-up data for up to 5 years of drug exposure, said Dr. Cesar Libanati at the annual meeting of the American Association of Clinical Endocrinologists.

Women in the long-term group who received denosumab for 5 years showed significant BMD improvements from baseline, of 13.7% in the lumbar spine and 7.0% in the total hip. Women in crossover group showed significant BMD improvements from the start of the extension study, of 7.9% in the lumbar spine and 4.1% in the total hip.

Patients in the crossover group showed significant increased in BMD from the extension study baseline similar to those seen in the long-term patients during their first 2 years of denosumab use, noted Dr. Libanati, clinical research medical director at Amgen Pharmaceuticals, maker of denosumab (Prolia), in Newbury Park, Calif.

During years 4 and 5, the annualized yearly incidence of new vertebral fractures in the long-term patients was steady at 1.4%, compared with 1.1% at the end of the 3-year FREEDOM study. The yearly incidence in the crossover treatment group was 0.9% for their first 2 years of denosumab exposure, compared with 2.5% in the first 2 years of the FREEDOM study.

The yearly incidence of nonvertebral fractures in the long-term patients was 1.4% after 4 years and 1.1% after 5 years. Nonvertebral fracture data for the crossover patients were not presented.

Denosumab remained well tolerated during the extension study. The adverse event profile was "similar in years 4 and 5 to that observed in the 3 years of the placebo-controlled FREEDOM study," Dr. Libanati said. Long-term patients also maintained the reductions in bone turnover seen during the original FREEDOM study, he added.

Dr. Libanati is employed by Amgen.

SAN DIEGO – Bone density and fracture risk continued to improve from baseline in postmenopausal women taking denosumab for osteoporosis, according to data from a 2-year extension of the FREEDOM study in more than 4,000 women.

The original FREEDOM study (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) enrolled 7,808 postmenopausal women aged 60-80 years with osteoporosis to receive either a subcutaneous injection of denosumab (60 mg) or placebo along with daily calcium and vitamin D supplements every 6 months. All subjects had bone mineral density (BMD) T scores of less than –2.5 but not less than –4.0 at the lumbar spine or total hip. At 36 months, denosumab was associated with reductions of 68% in vertebral fracture and 40% in hip fracture (N. Engl. J. Med. 2009;361:756-65).

The FREEDOM results were the basis of the Food and Drug Administration’s approval of denosumab in June 2010. In the extension study, 2,343 patients from the original treatment group and 2,207 patients in the control group received the denosumab treatment for 2 years (as well as calcium and vitamin D), yielding follow-up data for up to 5 years of drug exposure, said Dr. Cesar Libanati at the annual meeting of the American Association of Clinical Endocrinologists.

Women in the long-term group who received denosumab for 5 years showed significant BMD improvements from baseline, of 13.7% in the lumbar spine and 7.0% in the total hip. Women in crossover group showed significant BMD improvements from the start of the extension study, of 7.9% in the lumbar spine and 4.1% in the total hip.

Patients in the crossover group showed significant increased in BMD from the extension study baseline similar to those seen in the long-term patients during their first 2 years of denosumab use, noted Dr. Libanati, clinical research medical director at Amgen Pharmaceuticals, maker of denosumab (Prolia), in Newbury Park, Calif.

During years 4 and 5, the annualized yearly incidence of new vertebral fractures in the long-term patients was steady at 1.4%, compared with 1.1% at the end of the 3-year FREEDOM study. The yearly incidence in the crossover treatment group was 0.9% for their first 2 years of denosumab exposure, compared with 2.5% in the first 2 years of the FREEDOM study.

The yearly incidence of nonvertebral fractures in the long-term patients was 1.4% after 4 years and 1.1% after 5 years. Nonvertebral fracture data for the crossover patients were not presented.

Denosumab remained well tolerated during the extension study. The adverse event profile was "similar in years 4 and 5 to that observed in the 3 years of the placebo-controlled FREEDOM study," Dr. Libanati said. Long-term patients also maintained the reductions in bone turnover seen during the original FREEDOM study, he added.

Dr. Libanati is employed by Amgen.

SAN DIEGO – Bone density and fracture risk continued to improve from baseline in postmenopausal women taking denosumab for osteoporosis, according to data from a 2-year extension of the FREEDOM study in more than 4,000 women.

The original FREEDOM study (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) enrolled 7,808 postmenopausal women aged 60-80 years with osteoporosis to receive either a subcutaneous injection of denosumab (60 mg) or placebo along with daily calcium and vitamin D supplements every 6 months. All subjects had bone mineral density (BMD) T scores of less than –2.5 but not less than –4.0 at the lumbar spine or total hip. At 36 months, denosumab was associated with reductions of 68% in vertebral fracture and 40% in hip fracture (N. Engl. J. Med. 2009;361:756-65).

The FREEDOM results were the basis of the Food and Drug Administration’s approval of denosumab in June 2010. In the extension study, 2,343 patients from the original treatment group and 2,207 patients in the control group received the denosumab treatment for 2 years (as well as calcium and vitamin D), yielding follow-up data for up to 5 years of drug exposure, said Dr. Cesar Libanati at the annual meeting of the American Association of Clinical Endocrinologists.

Women in the long-term group who received denosumab for 5 years showed significant BMD improvements from baseline, of 13.7% in the lumbar spine and 7.0% in the total hip. Women in crossover group showed significant BMD improvements from the start of the extension study, of 7.9% in the lumbar spine and 4.1% in the total hip.

Patients in the crossover group showed significant increased in BMD from the extension study baseline similar to those seen in the long-term patients during their first 2 years of denosumab use, noted Dr. Libanati, clinical research medical director at Amgen Pharmaceuticals, maker of denosumab (Prolia), in Newbury Park, Calif.

During years 4 and 5, the annualized yearly incidence of new vertebral fractures in the long-term patients was steady at 1.4%, compared with 1.1% at the end of the 3-year FREEDOM study. The yearly incidence in the crossover treatment group was 0.9% for their first 2 years of denosumab exposure, compared with 2.5% in the first 2 years of the FREEDOM study.

The yearly incidence of nonvertebral fractures in the long-term patients was 1.4% after 4 years and 1.1% after 5 years. Nonvertebral fracture data for the crossover patients were not presented.

Denosumab remained well tolerated during the extension study. The adverse event profile was "similar in years 4 and 5 to that observed in the 3 years of the placebo-controlled FREEDOM study," Dr. Libanati said. Long-term patients also maintained the reductions in bone turnover seen during the original FREEDOM study, he added.

Dr. Libanati is employed by Amgen.

SAN DIEGO – Bone density and fracture risk continued to improve from baseline in postmenopausal women taking denosumab for osteoporosis, according to data from a 2-year extension of the FREEDOM study in more than 4,000 women.

The original FREEDOM study (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) enrolled 7,808 postmenopausal women aged 60-80 years with osteoporosis to receive either a subcutaneous injection of denosumab (60 mg) or placebo along with daily calcium and vitamin D supplements every 6 months. All subjects had bone mineral density (BMD) T scores of less than –2.5 but not less than –4.0 at the lumbar spine or total hip. At 36 months, denosumab was associated with reductions of 68% in vertebral fracture and 40% in hip fracture (N. Engl. J. Med. 2009;361:756-65).

The FREEDOM results were the basis of the Food and Drug Administration’s approval of denosumab in June 2010. In the extension study, 2,343 patients from the original treatment group and 2,207 patients in the control group received the denosumab treatment for 2 years (as well as calcium and vitamin D), yielding follow-up data for up to 5 years of drug exposure, said Dr. Cesar Libanati at the annual meeting of the American Association of Clinical Endocrinologists.

Women in the long-term group who received denosumab for 5 years showed significant BMD improvements from baseline, of 13.7% in the lumbar spine and 7.0% in the total hip. Women in crossover group showed significant BMD improvements from the start of the extension study, of 7.9% in the lumbar spine and 4.1% in the total hip.

Patients in the crossover group showed significant increased in BMD from the extension study baseline similar to those seen in the long-term patients during their first 2 years of denosumab use, noted Dr. Libanati, clinical research medical director at Amgen Pharmaceuticals, maker of denosumab (Prolia), in Newbury Park, Calif.

During years 4 and 5, the annualized yearly incidence of new vertebral fractures in the long-term patients was steady at 1.4%, compared with 1.1% at the end of the 3-year FREEDOM study. The yearly incidence in the crossover treatment group was 0.9% for their first 2 years of denosumab exposure, compared with 2.5% in the first 2 years of the FREEDOM study.

The yearly incidence of nonvertebral fractures in the long-term patients was 1.4% after 4 years and 1.1% after 5 years. Nonvertebral fracture data for the crossover patients were not presented.

Denosumab remained well tolerated during the extension study. The adverse event profile was "similar in years 4 and 5 to that observed in the 3 years of the placebo-controlled FREEDOM study," Dr. Libanati said. Long-term patients also maintained the reductions in bone turnover seen during the original FREEDOM study, he added.

Dr. Libanati is employed by Amgen.

SAN DIEGO – Bone density and fracture risk continued to improve from baseline in postmenopausal women taking denosumab for osteoporosis, according to data from a 2-year extension of the FREEDOM study in more than 4,000 women.

The original FREEDOM study (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) enrolled 7,808 postmenopausal women aged 60-80 years with osteoporosis to receive either a subcutaneous injection of denosumab (60 mg) or placebo along with daily calcium and vitamin D supplements every 6 months. All subjects had bone mineral density (BMD) T scores of less than –2.5 but not less than –4.0 at the lumbar spine or total hip. At 36 months, denosumab was associated with reductions of 68% in vertebral fracture and 40% in hip fracture (N. Engl. J. Med. 2009;361:756-65).

The FREEDOM results were the basis of the Food and Drug Administration’s approval of denosumab in June 2010. In the extension study, 2,343 patients from the original treatment group and 2,207 patients in the control group received the denosumab treatment for 2 years (as well as calcium and vitamin D), yielding follow-up data for up to 5 years of drug exposure, said Dr. Cesar Libanati at the annual meeting of the American Association of Clinical Endocrinologists.

Women in the long-term group who received denosumab for 5 years showed significant BMD improvements from baseline, of 13.7% in the lumbar spine and 7.0% in the total hip. Women in crossover group showed significant BMD improvements from the start of the extension study, of 7.9% in the lumbar spine and 4.1% in the total hip.

Patients in the crossover group showed significant increased in BMD from the extension study baseline similar to those seen in the long-term patients during their first 2 years of denosumab use, noted Dr. Libanati, clinical research medical director at Amgen Pharmaceuticals, maker of denosumab (Prolia), in Newbury Park, Calif.

During years 4 and 5, the annualized yearly incidence of new vertebral fractures in the long-term patients was steady at 1.4%, compared with 1.1% at the end of the 3-year FREEDOM study. The yearly incidence in the crossover treatment group was 0.9% for their first 2 years of denosumab exposure, compared with 2.5% in the first 2 years of the FREEDOM study.

The yearly incidence of nonvertebral fractures in the long-term patients was 1.4% after 4 years and 1.1% after 5 years. Nonvertebral fracture data for the crossover patients were not presented.

Denosumab remained well tolerated during the extension study. The adverse event profile was "similar in years 4 and 5 to that observed in the 3 years of the placebo-controlled FREEDOM study," Dr. Libanati said. Long-term patients also maintained the reductions in bone turnover seen during the original FREEDOM study, he added.

Dr. Libanati is employed by Amgen.