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Tesamorelin 5MG
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Tesamorelin 5mg Properties
Chemical Formula: C223H370N72O69S
Molecular Mass: 5196 g/mol
Synonyms: Tesamorelin acetate, TH9507, UNII-LGW5H38VE3, Tesamorelin acetate [USAN]
CAS Number: 901758-09-6
PubChem: 44147413
Total Amount of the Active Ingredient: 5mg (1 vial)
Shelf Life: 36 months
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Peer-Reviewed Studies
Tesamorelin: a growth hormone-releasing factor analogue for HIV-associated lipodystrophy
Abstract
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.
Abstract
Context: HIV patients treated with antiretroviral therapy (ART) often develop increased visceral adipose tissue (VAT).
Objective: Our objective was to perform a pooled analysis of two phase-3 studies of tesamorelin in ART-treated HIV patients with excess abdominal fat.
Design and setting: Two multicenter, international studies were conducted; a 26-wk randomized, placebo-controlled primary intervention phase was followed by a 26-wk safety extension.
Patients: A total of 806 ART-treated HIV patients with excess abdominal fat were randomized in a 2:1 fashion to receive tesamorelin 2 mg (n = 543) or placebo (n = 263) sc daily. At wk 26, patients initially on tesamorelin were rerandomized to 2 mg tesamorelin (T-T group, n = 246) or placebo (T-P, n = 135) for an additional 26 wk, whereas patients on placebo were switched to tesamorelin (P-T, n = 197).
Interventions: Tesamorelin (GHRH(1-44)) at a dose of 2 mg or identical placebo, sc, was given daily.
Main outcome measure: We evaluated percent change in VAT by computed tomography scan at wk 26.
Results: At wk 26, VAT decreased significantly in tesamorelin-treated patients (-24 +/- 41 vs. 2 +/- 35 cm(2), tesamorelin vs. placebo, P < 0.001; treatment effect, -15.4%). No significant changes were observed in abdominal sc adipose tissue (-2 +/- 32 vs. 2 +/- 29 cm(2), P = 0.08; treatment effect, -0.6%). Treatment with tesamorelin resulted in significant decreases in triglycerides (-37 +/- 139 vs. 6 +/- 112 mg/dl, P < 0.001; treatment effect, -12.3%) and cholesterol to high-density lipoprotein ratio (-0.18 +/- 1.00 vs. 0.18 +/- 0.94, P < 0.001; treatment effect, -7.2%) vs. placebo. Tesamorelin improved body image [belly appearance distress (P = 0.002)], patient rating of belly profile (P = 0.003), and physician rating of belly profile (P < 0.001). Mean IGF-I increased 108 +/- 112 vs.-7 +/- 64 ng/ml (P < 0.001 vs. placebo). At wk 52, decreases in VAT [-35 +/- 50 cm(2) (-17.5 +/- 23.3%)], waist circumference (-3.4 +/- 6.0 cm), triglycerides (-48 +/- 182 mg/dl), cholesterol (-8 +/- 38 mg/dl), and non-high-density lipoprotein (-7 +/- 38 mg/dl) were maintained (all P < 0.001 vs. original baseline) in the T-T group. Treatment with tesamorelin was generally well tolerated. No clinically meaningful differences were observed between groups in glucose parameters at wk 26 and 52.
Conclusions: Treatment with tesamorelin reduces VAT and maintains the reduction for up to 52 wk, preserves abdominal sc adipose tissue, improves body image and lipids, and is overall well tolerated without clinically meaningful changes in glucose parameters.
Abstract
Objective: Use of growth hormone is associated with side effects, including insulin resistance. The objective of this study was to determine whether tesamorelin, a stabilized growth hormone-releasing hormone analogue, would alter insulin sensitivity or control of diabetes.
Design: A 12-week randomized, placebo-controlled study of 53 patients with type 2 diabetes. Three treatment groups: placebo, 1 and 2 mg tesamorelin.
Measurements: Fasting glucose, glucose and insulin from oral glucose tolerance test, glycosylated hemoglobin (HbA1c), home blood glucose, insulin-like growth factor-1, and lipids.
Main outcome measure: Relative insulin response following oral ingestion of glucose.
Results: No significant differences were observed between groups in relative insulin response over the 12-week treatment period. At Week 12, fasting glucose, HbA1c and overall diabetes control were not significantly different between groups. In addition, relevant modifications in diabetes medications were similar between groups. Total cholesterol (-0.3±0.6 mmol/L) and non-HDL cholesterol (-0.3±0.5 mmol/L) significantly decreased from baseline to Week 12 in the tesamorelin 2 mg group (p<0.05 vs. placebo). No patient discontinued the study due to loss of diabetes control.
Conclusions: Treatment of type 2 diabetic patients with tesamorelin for 12 weeks did not alter insulin response or glycemic control.
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Disclaimer
The information provided above is not intended to substitute medical advice, diagnosis, or treatment. Should you have any questions regarding a medical condition, seek the advice of your physician or a qualified healthcare provider.
In no case should medical advice be disregarded or delayed because of what you have read or seen. We bear no responsibility or liability for your use of any of our research compounds and products. Please note that they are being sold for research purposes ONLY. We do NOT condone any personal use.
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ALL ARTICLES AND PRODUCT INFORMATION PROVIDED ON THIS WEBSITE ARE FOR INFORMATIONAL AND EDUCATIONAL PURPOSES ONLY.
The products offered on this website are furnished for in-vitro studies only. In-vitro studies (Latin: “in glass”) are performed outside the body. These products are not medicines or drugs and have not been approved by the FDA to prevent, treat and/or cure any medical condition, ailment or disease. Bodily introduction of any kind into animals or human is strictly prohibited by law.
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FAQ
Tesamorelin 5mg Vials
How to reconstitute Tesamorelin 5mg vials?
Tesamorelin 5mg vials contain a peptide powder, which is typically a puck or loose bits due to shipping. To reconstitute a Tesamorelin 5mg vials, researchers typically use bacteriostatic water, combining it with the peptide powder according to the specific requirements of their research protocols.
How to dose Tesamorelin 5mg?
The dosing of Tesamorelin 5mg in vials form will vary according to the experiment being conducted. We do not provide dosage recommendations as our products are intended for research purposes only.
How to administer Tesamorelin 5mg?
There are multiple methods of administering research products that are under investigation in various studies. The choice of administration technique should align with the specific goals and design of the researcher’s study. We provide products solely for research use, we do not offer advice on administration methods.
