Treatment of altered body composition in HIV-associated lipodystrophy: comparison of rosiglitazone, pravastatin, and recombinant human growth hormone.

Abstract

PURPOSE:

Treatment options for HIV-associated lipodystrophy syndrome (HALS) remain limited. The objective of this randomized open-label study was to compare three emerging therapies, rosiglitazone, pravastatin, and growth hormone alone and together, in men and women with HALS.

METHOD:

Sixty-four subjects received daily rosiglitazone (4 mg, n = 14), pravastatin (40 mg, n = 11), or rosiglitazone plus pravastatin (n = 13) for 48 weeks or recombinant human growth hormone (rhGH; Serostim 2 mg, 12 weeks, n = 13) alone or combined with rosiglitazone (n = 13). Primary endpoint was body composition change by dual X-ray absorptiometry (DXA) and computed tomography (CT).

RESULTS:

Rosiglitazone resulted in slow accrual of limb fat detected by DXA (+444 +/- 186 g; p < .05) but not CT. Pravastatin had no consistent significant effects on body composition, although it reduced total and LDL cholesterol. Negative interactions were observed between pravastatin and rosiglitazone. rhGH reduced abdominal fat by CT (-31 +/- 15 cm2, 26%; p < .05) and DXA (-1597 +/- 383 g, 27%; p < .05) and increased trunk and limb lean mass (+10% and +12%, respectively). However, effects largely disappeared within 12 weeks post treatment. rhGH alone impaired insulin sensitivity but not when combined with rosiglitazone.

CONCLUSION:

Prolonged rosiglitazone treatment slowly improves lipoatrophy. rhGH rapidly and selectively reduces visceral fat, although effects are short-lived; co-administered rosiglitazone abrogates rhGH-related insulin resistance.

• Authors: Derek C Macallan, Christine Baldwin, Sundihya Mandalia, Vjera Pandol-Kaljevic, Nadine Higgins, Alan Grundy, Graeme J Moyle
• Journal: HIV clinical trials (HIV Clin Trials) 2008 Jul-Aug Vol. 9 Issue 4 Pg. 254-68 ISSN: 1528-4336 [Print] England
• PMID: 18753120 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Fats
• Recombinant Proteins
• Thiazolidinediones
• Rosiglitazone
• Human Growth Hormone
• Pravastatin

Topics

• Absorptiometry, Photon
• Adult
• Body Composition (drug effects)
• Drug Therapy, Combination
• Endpoint Determination
• Fats (metabolism)
• Female
• HIV-1
• HIV-Associated Lipodystrophy Syndrome (drug therapy)
• Human Growth Hormone (therapeutic use)
• Humans
• London
• Male
• Pilot Projects
• Pravastatin (therapeutic use)
• Prospective Studies
• Recombinant Proteins (therapeutic use)
• Rosiglitazone
• Thiazolidinediones (therapeutic use)
• Tomography, X-Ray Computed
• Treatment Outcome