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Tesamorelin

  1. #1
    Community Veteran Zeek's Avatar
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    Tesamorelin
    This is all a copy and paste job on my part but it is very interesting. What are your thoughts?



    November 12, 2010 — The US Food and Drug Administration (FDA) has approved tesamorelin acetate injection (Egrifta; Theratechnologies, Inc, and marketed by EMD Serono) as the first and only treatment indicated to reduce excess abdominal fat in HIV-infected patients with lipodystrophy.

    Tesamorelin is a synthetic analog of growth hormone–releasing factor — a hypothalamic peptide that acts on pituitary cells in the brain to stimulate the production and release of endogenous growth hormone.

    "The FDA recognizes the need for therapies to treat patients with HIV-lipodystrophy," said Curtis Rosebraugh, MD, MPH, director of the Office of Drug Evaluation II in the FDA's Center for Drug Evaluation and Research, in an agency news release. "The presence of excess fat with this condition may contribute to other health problems as well as affect a patient's quality of life, so treatments that demonstrate they are safe and effective at treating these symptoms are important."

    FDA approval followed a positive endorsement from the Endocrinologic and ********* Drugs Advisory Committee and was based on data from 2 multicenter, randomized, double-blind, placebo-controlled phase 3 studies of 816 patients, showing that once-daily treatment with tesamorelin significantly reduced visceral adipose tissue (VAT) at 26 weeks.

    Mean VAT at baseline ranged from 178 cm2 to 186 cm2 for the active-treatment group and 171 cm2 to 195 cm2 for patients randomly assigned to placebo, as assessed by computed tomography scan at the L4–L5 vertebral level.

    Computed tomography scan results of the first study showed that tesamorelin therapy yielded an 18% least-squares mean decrease from baseline in VAT compared with an increase of 2% for placebo (***916;, ***8722;20%; 95% confidence interval [CI], ***8722;24% to ***8722;15%). In the second study, tesamorelin-treated patients experienced a likewise significant 14% decrease from baseline in VAT compared with a 2% decrease among those given placebo (***916;, ***8722;12%; 95% CI, ***8722;16% to ***8722;7%).

    Both studies also showed significant decreases in VAT as measured by least-squares mean decreases from baseline in waist circumference (study 1, ***8722;3 cm vs ***8722;1 cm; ***916;, ***8722;2 cm; 95% CI, ***8722;2.8 cm to ***8722;0.9 cm; study 2, ***8722;2 cm vs ***8722;1 cm; ***916;, ***8722;1 cm; 95% CI, ***8722;2.5 cm to ***8722;0.3 cm).

    The decreases in VAT and waist circumference were sustained in patients who received extended therapy with tesamorelin for 52 weeks.

    The recommended dose of tesamorelin is 2 mg (2 vials) injected subcutaneously once daily in the abdomen. Adverse events most commonly reported in tesamorelin-treated study patients included arthralgia (13% vs placebo, 11%), pain in extremity (6.1% vs 4.6%), myalgia (5.5% vs 1.9%), injection-site erythema (8.5% vs 2.7%), injection-site pruritus (7.6% vs 0.%), and peripheral edema (6.1% vs 2.3%).

    FDA officials note that the long-term cardiovascular benefit and safety of tesamorelin have not been studied, and there are no data to support improved compliance with antiretroviral therapies. Also, tesamorelin should not be used for weight-loss management.

    "As HIV-infected patients are living longer, a substantial number may develop ********* complications associated with HIV, such as abdominal lipohypertrophy," said Morris Schambelan, MD, professor of medicine from the University of California–San Francisco, in a company news release. "With the approval of Egrifta, doctors are now able to provide appropriately selected patients with a treatment option shown to reduce [VAT]."

    Because tesamorelin induces the release of endogenous growth hormone, it should not be used in patients with active malignancy, whether newly diagnosed or recurrent. Tesamorelin increases serum levels of insulin-like growth factor 1 (IGF-1), which has an unknown effect on the development or progression of malignancies. Discontinuation of therapy should be considered in patients with persistent IGF-1 elevations greater than 3 standard deviations, particularly if the efficacy response is not robust. In clinical trials, IGF-1 levels were measured every 3 months.

    Tesamorelin therapy may also result in glucose intolerance and an increased risk for diabetes mellitus. Glucose status should be carefully evaluated before initiating therapy and monitored periodically thereafter. Caution is advised when treating patients who develop glucose intolerance or diabetes, and discontinuation of therapy should be considered in those who do not demonstrate a clear efficacy response. Diabetic patients should be monitored at regular intervals for the potential development or worsening of retinopathy.

    Treatment with tesamorelin is contraindicated in patients with disruption of the hypothalamic–pituitary axis resulting from hypophysectomy, hypopituitarism, or pituitary tumor/surgery; active malignancy; or pregnancy and in patients with known hypersensitivity to tesamorelin and/or mannitol.

    The safety and efficacy of tesamorelin have not been established in pediatric patients and in those with renal or hepatic impairment; discontinuation of therapy should be considered in critically ill patients.

    As a condition of approval, the company is required to conduct a clinical trial to assess whether tesamorelin has an effect on diabetic retinopathy, and a long-term observational safety study for a single-vial formulation of the drug (tesamorelin).

  2. #2
    Community Veteran Zeek's Avatar
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    This peptide doesn't spark anyones interest?

    Let me break it down to you in what the copy and paste above might mean

    This peptide may prove to be superior to the current peps that induce GH release. It also apparently targets some of the most difficult to get rid of fatty areas on the male body. Abdominal fat specifically.

    And to top it all off, unless my eyes were playing tricks on me earlier , I thought I saw the company which just introduced this product as one of our own board sponsors :P

  3. #3
    stop fn staring! jimbo79's Avatar
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    Quote Originally Posted by Zeek View Post
    This peptide doesn't spark anyones interest?

    Let me break it down to you in what the copy and paste above might mean

    This peptide may prove to be superior to the current peps that induce GH release. It also apparently targets some of the most difficult to get rid of fatty areas on the male body. Abdominal fat specifically.

    And to top it all off, unless my eyes were playing tricks on me earlier , I thought I saw the company which just introduced this product as one of our own board sponsors :P
    Sounds perfect! You going to try it? Have to run it for atleast a year?

  4. #4
    Community Veteran Zeek's Avatar
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    Quote Originally Posted by jimbo79 View Post
    Sounds perfect! You going to try it? Have to run it for atleast a year?
    I'm never first in line to try the new products but since this one seems to have been around for many years at least in clinical trials I definitely will consider it for after the holidays. Cash flow till then won't allow me to dive into anything further than the bread and butter stuff that I really need.

    I'm dying to see what sort of IGF-1 numbers such a product can produce for people.

  5. #5
    Amateur Bodybuilder Osta-Marketing's Avatar
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    I would love to see some testimonials on this product.

  6. #6
    Community Veteran Zeek's Avatar
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    Quote Originally Posted by Osta-Marketing View Post
    I would love to see some testimonials on this product.
    I think you guys are the only show in town right now carrying it.

  7. #7
    Novice OSTA-GAIN's Avatar
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    Exclamation
    Quote Originally Posted by Zeek View Post
    I think you guys are the only show in town right now carrying it.
    TRUE... And TB500 is a peptide at a new level

  8. #8
    Novice liberate's Avatar
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    I'm very curious about this peptide. has anyone had any experience with it?

  9. #9
    Community Veteran Zeek's Avatar
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    Quote Originally Posted by liberate View Post
    I'm very curious about this peptide. has anyone had any experience with it?
    I've got my eyes open all over for some feed back on it. Have not found any yet

  10. #10
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    Anyone try this yet?

    Am I reading this right? dosage is 2mg per day?

  11. #11
    Community Veteran Zeek's Avatar
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    Quote Originally Posted by NeonKnight View Post
    Anyone try this yet?

    Am I reading this right? dosage is 2mg per day?
    Yes 2mg per day and I can't find a log on it anywhere! if anyone knows of one please PM a link my way.

  12. #12
    Amateur Bodybuilder alexus hensicus's Avatar
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    As much as I would love to lose stomach fat I don't think the HIV is worth it...... bad joke day

  13. #13
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    would this be considered a GHRH?
    And what would be the dif. between this and frag?

  14. #14
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    Don't know how I feel about this line here:

    Tesamorelin therapy may also result in glucose intolerance and an increased risk for diabetes mellitus. Glucose status should be carefully evaluated before initiating therapy and monitored periodically thereafter. Caution is advised when treating patients who develop glucose intolerance or diabetes, and discontinuation of therapy should be considered in those who do not demonstrate a clear efficacy response. Diabetic patients should be monitored at regular intervals for the potential development or worsening of retinopathy.
    Going to have to look around for more studies before I jump into saying I like something that may cause diabetes. Just a scary thought there since there is a history of diabetes in my family.

  15. #15
    Community Veteran Zeek's Avatar
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    Quote Originally Posted by Hawks58 View Post
    Don't know how I feel about this line here:



    Going to have to look around for more studies before I jump into saying I like something that may cause diabetes. Just a scary thought there since there is a history of diabetes in my family.
    Similar things have been said about HGH through the years and I don't know of anyone who developed issues like that from it.

    Not that I am downplaying any risks because I don't know. Just tossing that out there

  16. #16
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    Quote Originally Posted by Zeek View Post
    Similar things have been said about HGH through the years and I don't know of anyone who developed issues like that from it.

    Not that I am downplaying any risks because I don't know. Just tossing that out there
    This is true, actually right after I posted I thought about that. I did find this article:

    Some users of growth hormone have developed problems controlling their blood sugar levels. Tesamorelin has been tested in volunteers with diabetes and the drug did not make this condition worse.

    In a small study with HIV-negative people without diabetes, there was a slight increase in the proportion of people whose average blood sugar levels over three months were slightly abnormal***8212;2% among tesamorelin users vs. less than 1% among those taking placebo. But this difference, while statistically significant, was not clinically meaningful.
    http://www.catie.ca/en/treatmentupda...relin-overview
    I'm guessing if we/someone looked more into studies the people seeing a rise in blood sugar might have been predisposed to diabetes. Also could someone put the bold part into normal people terms? I know what statistically significant is but not sure how it can be statistically significant but not clinically meaningful?

  17. #17
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    Very intresting

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