American Association of Clinical Endocrinologists, April 13-17, 2011

The American Association of Clinical Endocrinologists 20th Annual Meeting and Clinical Congress

The 20th Annual Meeting and Clinical Congress of the American Association of Clinical Endocrinologists (AACE) was held from April 13 to 17 in San Diego and attracted more than 1,450 participants from around the world, including clinicians, academicians, and allied health professionals. The conference highlighted recent advances in clinical endocrinology, with presentations focusing on endocrine disorders, diabetes, and metabolism.

In a post-hoc analysis, Harold Bays, M.D., of the Louisville Metabolic and Atherosclerosis Research Center in Kentucky, and colleagues reconfirmed earlier studies and demonstrated that colesevelam HCl added to a regimen of metformin has a positive effect on glycemic and lipid parameters in patients with type 2 diabetes who previously did not have adequate glucose control. The investigators pooled data on metformin-treated patients derived from three randomized, double-blind, placebo-controlled studies where colesevelam was added to background metformin-, insulin-, or sulfonylurea-based therapies in patients with poorly controlled type 2 diabetes.

"For clinical practitioners, the results of the study suggest the availability of another treatment approach for patients with diabetes mellitus who may benefit from not only better glucose control but improved low-density lipoprotein cholesterol lowering as well," Bays said.

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In another study, Robert R. Henry, M.D., of the University of California San Diego, and colleagues found that liraglutide significantly reduced glycosylated hemoglobin (HbA1c) levels compared to other commonly used anti-diabetes drugs. The investigators performed a meta-analysis across seven phase 3 studies to determine the observed mean changes in HbA1c from baseline to week 26 by baseline HbA1c category (≤7.5 percent, >7.5 to 8.0 percent, >8.0 to 8.5 percent, >8.5 to 9.0 percent, and >9.0 percent).

"Overall, A1C reductions achieved with liraglutide were greater than reductions observed with comparator therapies across all baseline A1C categories, ranging from 0.7 percent in patients with baseline HbA1c ≤7.5 percent to 1.8 percent in patients with baseline HbA1c >9.0 percent," said co-author Jason Brett, M.D., of Novo Nordisk Inc. in Princeton, N.J.

The investigators also found that more than 60 percent of the patients taking liraglutide 1.8 mg who had HbA1c ≤7.5 percent at baseline achieved the AACE target HbA1c ≤6.5 percent in comparison to only 20 to 49 percent of patients who were taking other anti-diabetes therapies.

"Many type 2 diabetes patients still struggle with blood sugar control. In fact, nearly half are not reaching the AACE recommended A1C target of ≤6.5 percent," Brett said. "This analysis should allow health care professionals to better assess the potential of an anti-diabetic agent in helping a patient reach target HbA1c based on starting HbA1c."

Several authors disclosed financial relationships with Novo Nordisk Inc., the manufacturer of liraglutide (Victoza).

Abstract No. 222

In the open-label extension of the Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) study, Henry G. Bone III, M.D., of the Michigan Bone and Mineral Clinic in Detroit, and colleagues found that the continued use of denosumab over five years among postmenopausal women with osteoporosis maintained significant reductions in bone turnover and continued to increase bone mineral density (BMD), with few adverse events.

The extension trial included 4,550 women (2,343 subjects in the long-term denosumab group and 2,207 subjects in the placebo [de novo] group) in the FREEDOM trial, with the results reflecting four doses of denosumab over the two-year extension study among those who originally received placebo, and up to 10 doses for those in the original denosumab treatment group.

During the fourth and fifth years of denosumab treatment, the investigators found that the long-term group continued to show significant annual BMD improvements of 1.9 and 1.7 percent (lumbar spine) and 0.7 and 0.6 percent (total hip), respectively. In addition, denosumab treatment for five years increased lumbar spine and total hip BMD by 13.7 and 7.0 percent, respectively. The de novo group had significant improvements in lumbar spine BMD (7.9 percent) and total hip BMD (4.1 percent) during the first two years of treatment. Serious adverse events and adverse events did not increase with denosumab treatment over the extension study.

"Five years of continuous denosumab treatment of postmenopausal women with osteoporosis remained well tolerated, maintained significant reductions in bone turnover, and continued to increase BMD," the authors write.

Abstract No. 503

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