期刊
CLINICAL INFECTIOUS DISEASES
卷 54, 期 11, 页码 1642-1651出版社
OXFORD UNIV PRESS INC
DOI: 10.1093/cid/cis251
关键词
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资金
- Theratechnologies
- National Institute of Diabetes and Digestive and Kidney Diseases at the National Institutes of Health [K23 DK089910, K24 DK064545]
Background. Tesamorelin, a growth hormone-releasing hormone analogue, decreases visceral adipose tissue (VAT) by 15%-20% over 6-12 months in individuals with human immunodeficiency virus (HIV)-associated abdominal adiposity, but it is unknown whether VAT reduction is directly associated with endocrine and metabolic changes. Methods. In 2 phase III, randomized, double-blind studies, men and women with HIV-associated abdominal fat accumulation were randomly assigned (ratio, 2:1) to receive tesamorelin or placebo for 26 weeks. At week 26, patients initially receiving tesamorelin were randomly assigned to continue receiving tesamorelin or to receive placebo for an additional 26 weeks. In per-protocol analysis of 402 subjects initially randomly assigned to receive tesamorelin, those with >= 8% reduction in VAT were defined a priori as responders per the statistical analysis plan. Post hoc analyses were performed to assess differences between responders and nonresponders. Results. Compared with tesamorelin nonresponders, responders experienced greater mean (+/- SD) reduction in triglyceride levels (26 weeks: -0.6 +/- 1.7 mmol/L vs -0.1 +/- 1.2 mmol/L [P = .005]; 52 weeks: -0.8 +/- 1.8 mmol/L vs 0.0 +/- 1.1 mmol/L [P = .003]) and attenuated changes in fasting glucose levels (26 weeks: 1 +/- 16 mg/dL vs 5 +/- 14 mg/dL [P = .01]; 52 weeks: -1 +/- 14 mg/dL vs 8 +/- 17 mg/dL [P < .001]), hemoglobin A1c levels (26 weeks: 0.1 +/- 0.3% vs 0.3 +/- 0.4% [P < .001]; 52 weeks: 0.0 +/- 0.3% vs 0.2 +/- 0.5% [P = .003]), and other parameters of glucose homeostasis. Similar patterns were seen for adiponectin levels, with significant improvement in responders vs nonresponders. Changes in lipid levels and glucose homeostasis were significantly associated with percentage change in VAT. Conclusions. In contrast to nonresponders, HIV-infected patients receiving tesamorelin with >= 8% reduction in VAT have significantly improved triglyceride levels, adiponectin levels, and preservation of glucose homeostasis over 52 weeks of treatment. Clinicaltrials.gov Registration. NCT00123253, NCT00435136, NCT00608023.
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