Date of Award

2012

Degree Type

Selective Evidence-Based Medicine Review

Degree Name

Master of Science in Health Sciences - Physician Assistant

Department

Physician Assistant Studies

Department Chair

John Cavenagh, PhD, PA-C

Abstract

Objective: The objective of this selective EBM review is to determine whether or not Tesamorelin is a safe and effective drug to treat lipodystrophy in HIV patients.

Study Design: Review of three English language primary randomized controlled trials published between 2005-2010.

Data Sources: Randomized, placebo-controlled, double-blind clinical trials comparing Tesamorelin to a visually matched placebo were found using PubMed.

Outcome(s) Measured: Each of the three clinical trials assessed the improvement of lipodystrophy (accumulation of visceral adipose tissue) in HIV patients. In addition, they noted how the improvement in lipodystrophy would impact patient's self body image and quality of life. Prior to the study, all patients received a CT scan in order to get a visceral adipose tissue baseline, this allowed researchers to note patient's percent change from baseline. Furthermore, patients also completed a self-perceived body image questionnaire. Patients rated their “belly size” comparing their current appearance to their perceived healthy look with scores from -100 (much thinner) to +100 (much bigger). Similarly, they rated their “belly image distress” from 0 (extremely upsetting and distressing) to 100 (extremely encouraging); and “belly profile” by choosing from six silhouettes scored from 0 (normal) to 5 (very dysmorphic).

Results: Three randomized-controlled trials were included in this review. Results from each study reveals that Tesamorelin (2 mg) is a safe and effective drug to treat lipodystrophy in HIV patients. Similarly, patient's self body image and quality of life also improved due to the reduction in their visceral adipose tissue. Although all three trials reported similar adverse events, for two of the trials, headache was the most common; while injection site erythema was the most common for the other trial.

Conclusion: The three randomized-controlled trials have proven that Tesamorelin is a safe and effective treatment for lipodystrophy in HIV patients. It is because of these clinical trials that Tesamorelin was approved by the FDA on November 10, 2010 and it is currently the only alternative treatment for lipodystrophy in HIV patients besides surgery or diet and exercise.

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