| Reference | 1. Ann Pharmacother. 2012 Feb;46(2):240-7. doi: 10.1345/aph.1Q629. Epub 2012 Jan 31. <br />
<br />
Tesamorelin: a growth hormone-releasing factor analogue for HIV-associated
lipodystrophy. <br />
<br />
Spooner LM(1), Olin JL. <br />
Author information: <br />
(1)School of Pharmacy-Worcester/Manchester, Massachusetts College of Pharmacy and
Health Sciences, USA. [email protected] <br />
OBJECTIVE: To evaluate the efficacy and safety of tesamorelin, a growth hormone
releasing factor analogue approved by the Food and Drug Administration in
November 2010 for the treatment of lipodystrophy associated with HIV infection.
DATA SOURCES: Literature was obtained through MEDLINE (1948-November 2011) and
International Pharmaceutical Abstracts (1970-October 2011) using the search terms
tesamorelin, TH9507, growth hormone releasing factor, and HIV-associated
lipodystrophy syndrome. Additional publications were obtained through review of
references within primary literature publications as well as pertinent Web sites.
STUDY SELECTION AND DATA EXTRACTION: All articles published in English identified
from the data sources were evaluated and all pertinent information was included.
All studies relevant to the evaluation of efficacy and safety of tesamorelin in
the management of HIV-associated lipodystrophy were included, with a focus on
trials completed in humans.
DATA SYNTHESIS: In 2 Phase 3 clinical trials and their pooled analyses,
tesamorelin was proven to significantly decrease waist circumference and visceral
adipose tissue (VAT) following 26 weeks of treatment. Both trials also
demonstrated significant improvements in some subjective body image parameters.
Both studies had 26-week extension phases that confirmed maintenance of VAT
improvements on treatment without adverse impact on blood glucose and lipid
parameters. Limited data support off-label uses of tesamorelin at this time.
CONCLUSIONS: Tesamorelin is effective in improving visceral adiposity and body
image in patients with HIV-associated lipodystrophy over 26-52 weeks of
treatment. Potential limitations for its use include high cost and lack of
long-term safety and adherence data. Tesamorelin provides a useful treatment
option for management of patients with significant lipodystrophy related to HIV
infection. <br />
<br />
2. Curr Opin Investig Drugs. 2006 Oct;7(10):936-45. <br />
<br />
Drug evaluation: tesamorelin, a synthetic human growth hormone releasing factor. <br />
<br />
Tomlinson B(1). <br />
Author information: <br />
(1)The Chinese University of Hong Kong, Division of Clinical Pharmacology,
Department of Medicine and Therapeutics, Prince of Wales Hospital, Shatin, New
Territories, Hong Kong SAR, China. [email protected] <br />
<br />
Theratechnologies, under license from Valeant, is developing tesamorelin as a
potential vaccine adjuvant and for the potential treatment of wasting, hip
fracture recovery, immune disorders, HIV-related lipodystrophy, sleep maintenance
insomnia and mild cognitive impairment. Phase III clinical trials for the
treatment of HIV-associated lipodystrophy and phase II clinical trials for sleep
disorder, chronic obstructive pulmonary disorder, hip fracture and immune system
dysfunction are underway. Phase II trials are also assessing the influenza
vaccination immune response and cognitive effects of tesamorelin.
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