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Previous Volume 357:2359-2370 December 6, 2007 Number 23 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Supplementary Material Editorial by Blackman, M. R. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background Visceral adipose tissue accumulates during antiretroviral therapy in many patients who are infected with the human immunodeficiency virus (HIV); this process is associated with an increased cardiovascular risk. We assessed the use of a growth hormone–releasing factor analogue, tesamorelin, to decrease visceral adiposity.

Methods We randomly assigned 412 patients with HIV (86% of whom were men) who had an accumulation of abdominal fat to receive a daily subcutaneous injection of either 2 mg of tesamorelin or placebo for 26 weeks. The primary end point was the percent change from baseline in visceral adipose tissue as shown on computed tomography. Secondary end points included triglyceride levels, the ratio of total cholesterol to high-density lipoprotein (HDL) cholesterol, the level of insulin-like growth factor I (IGF-I), and self-assessed body image. Glycemic measures included glucose and insulin levels.

Results The measure of visceral adipose tissue decreased by 15.2% in the tesamorelin group and increased by 5.0% in the placebo group; the levels of triglycerides decreased by 50 mg per deciliter and increased by 9 mg per deciliter, respectively, and the ratio of total cholesterol to HDL cholesterol decreased by 0.31 and increased by 0.21, respectively (P<0.001 for all comparisons). Levels of total cholesterol and HDL cholesterol also improved significantly in the tesamorelin group. Levels of IGF-I increased by 81.0% in the tesamorelin group and decreased by 5.0% in the placebo group (P<0.001). Adverse events did not differ significantly between the two study groups, but more patients in the tesamorelin group withdrew from the study because of an adverse event. No significant differences were observed in glycemic measures.

Conclusions Daily tesamorelin for 26 weeks decreased visceral fat and improved lipid profiles, effects that might be useful in HIV-infected patients who have treatment-associated central fat accumulation. (ClinicalTrials.gov number, NCT00123253 [ClinicalTrials.gov] .)

Source Information

From Montreal General Hospital, McGill University Health Centre (J. Falutz), and Theratechnologies (S.A., K.B., D.P.) — both in Montreal; St. Luke's–Roosevelt Hospital Center, Columbia University College of Physicians and Surgeons, New York (D.K.); Palm Springs, CA (M.S.); Northstar Health Care, Chicago (D.B.); AIDS Research Alliance, West Hollywood, CA (S.B.); Fort Lauderdale, FL (G.R.); Kaiser Foundation Research Institute, San Francisco (J. Fessel); Phase V Technologies, Wellesley Hills, MA (R.T.); and Massachusetts General Hospital and Harvard Medical School — both in Boston (S.G.).

Address reprint requests to Dr. Grinspoon at the Program in Nutritional Metabolism, Massachusetts General Hospital, LON 207, Boston, MA 02114, or at sgrinspoon{at}partners.org.

Full Text of this Article

Related Letters:

Effects of Growth Hormone–Releasing Factor in HIV-Infected Patients
Malgarini R. B., Pimpinella G., Falutz J., Grinspoon S.
Extract | Full Text | PDF  
N Engl J Med 2008; 358:969-970, Feb 28, 2008. Correspondence

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