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Konu: Tıpta Devrim Lorcaserin Mucize Zayıflama İlacı İle İlgili Son Haberler Zayıflama Hapı

                  
   
  1. #1
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    Katılım Tarihi
    Apr 2011
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    Tıpta Devrim Lorcaserin Mucize Zayıflama İlacı İle İlgili Son Haberler Zayıflama Hapı




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    İstanbul'da geçen çarşamba günü başlayan ve dün sona eren 18’inci Avrupa Obezite Kongresi’nden obez hastalarına müthiş bir haber çıktı. 3 bine yakın delegenin katıldığı kongrede ABD’li bilim insanları, yüzde 40’a varan oranda kilo kaybı sağlayan ilaçla ilgili çalışmalarını sundu. “Mucize diyet ilacını” anlatan çalışma, 7 bin 500’den fazla kişinin gönüllü olarak katıldığı üç ayrı araştırmanın analizlerinden oluşturuldu.

    Californialı Arena isimli şirketin üzerinde çalıştığı iştah kesici “Lorcaserin” adlı ilacı, bir yıldan fazla bir süre kullanan obez kadın ve erkeklerde, yüzde 8 oranında kilo kaybı gözlendi. Bu 76 kilo ağırlığındaki bir kadın için 6.3 kilo vermesine, bir beden de zayıflamasına eş değer. Bazı hastalar ise, rekor kırarak yüzde 40 oranında kilo kaybetti. Hastalar tüm fazla kilolarını ilk birkaç ayda eritti. İlaç bir grup hastada ise etkili olmadı.


    Bilim insanları serotonine etki ederek açlık isteğini azaltan ilacın küçük ama önemli yararları olduğunu da açıkladı. Buna göre, “Lorcaserin” hastalarda kolesterolü, kan basıncını düşürdü, bel genişliğini azalttı. Ancak ilacı kullanan kişilerde baş ağrısı, baş dönmesi gibi geçici yan etkiler de gözlendi.


    MEME TÜMÖRÜNÜ ARTIRABİLİR
    Şirketin Başkan Yardımcısı Dr. Christen Anderson, Avrupa’da gelecek yıl ilacın onay alması için başvuruların yapılacağını, olumlu sonuç çıkması halinde ilacın 2013’te piyasaya sürüleceğini açıkladı. Ancak aynı ilaç, geçen sene Amerikan Gıda ve İlaç Dairesi FDA’dan onay alamamıştı. ABD ilacın fareler üzerinde yapılan deneylerinde meme tümörünün arttığı bulgularını gerekçe göstermişti. İlacın fiyatı da henüz belli değil.

    Firmanın Kendi Sitesinden İlaçla İlgili Bilgiler

    Our most advanced drug candidate, lorcaserin, is for weight management, including weight loss and maintenance of weight loss. In December 2009, after completing a pivotal Phase 3 clinical trial program, we submitted a New Drug Application, or NDA, for lorcaserin to the FDA. The NDA submission is based on a data package from lorcaserin’s clinical development program that includes 18 clinical trials totaling 8,576 patients. In February 2010, the FDA accepted our lorcaserin NDA for filing and assigned a Prescription Drug User Fee Act, or PDUFA, date of October 22, 2010, for the review of our application.
    The lorcaserin Phase 3 pivotal program consists of the BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management) and BLOSSOM (Behavioral modification and LOrcaserin Second Study for Obesity Management) trials, which evaluated 7,190 patients for up to two years. In addition to the pivotal program, we are evaluating the safety and efficacy of lorcaserin for weight management in obese and overweight patients with type 2 diabetes in our Phase 3 BLOOM-DM (Behavioral modification and Lorcaserin for Overweight and Obesity Management in Diabetes Mellitus) trial. We plan to file the results of BLOOM-DM as a supplement to the NDA.
    The pivotal program showed that lorcaserin consistently produced statistically significant weight loss with excellent tolerability. The BLOOM and BLOSSOM results were comparable, and demonstrated the following key lorcaserin effects after one year of treatment:

    • About two-thirds of patients achieved at least 5% weight loss and over one-third achieved at least 10% weight loss;
    • On average, patients lost 17 to 18 pounds or about 8% of their weight;
    • Secondary endpoints, including body composition, lipids, cardiovascular risk factors and glycemic parameters improved compared to placebo;
    • Heart rate and blood pressure went down;
    • Lorcaserin improved quality of life, and there was no signal for depression or suicidal ideation;
    • The only adverse event that exceeded the placebo rate by 5% was generally mild or moderate, transient headache.

    Post-hoc analyses of data from the individual pivotal trials also demonstrate lorcaserin’s efficacy:

    • Based on a normal BMI of 25, lorcaserin patients in the BLOOM trial lost an average of one-third of their excess body weight;
    • The top quartile of lorcaserin patients in the BLOSSOM trial lost an average of 16%, or 35 pounds, of their body weight.

    About Lorcaserin

    Lorcaserin is a novel single agent that represents the first in a new class of selective serotonin 2C receptor agonists. The serotonin 2C receptor is expressed in the brain, including the hypothalamus, an area involved in the control of appetite and metabolism. Stimulation of this receptor is strongly associated with feeding behavior and satiety. We have patents that cover lorcaserin in the U.S. and other jurisdictions, which in most cases are capable of continuing into 2023 without taking into account any patent term extensions or other exclusivity we might obtain.
    About Weight Management

    The National Institutes of Health reported in 2007 that about 65% of U.S. adults are overweight or obese. A 2009 publication in Health Affairs estimated the annual medical burden of obesity in the U.S. to be $147 billion in 2008. Studies have shown that weight loss of 5% to 10% is medically significant and results in meaningful improvements in cardiovascular risk factors and a significant reduction in the incidence of type 2 diabetes in patients with glucose intolerance.
    The FDA draft guidance document “Developing Products for Weight Management,” dated February 2007, provides recommendations regarding the development of drugs for the indication of weight management. It contains two alternate efficacy benchmarks. The guidance provides that, in general, a product can be considered effective for weight management if after one year of treatment either of the following occurs: (1) the difference in mean weight loss between the active-product and placebo-treated groups is at least 5% and the difference is statistically significant, or (2) the proportion of subjects who lose greater than or equal to 5% of baseline body weight in the active-product group is at least 35%, is approximately double the proportion in the placebo-treated group, and the difference between groups is statistically significant.
    Our drug candidates have not been approved by the U.S. Food and Drug Administration or any international regulatory agency.


    Phase 3 Results: BLOOM


    In BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), lorcaserin patients achieved highly statistically significant categorical and absolute weight loss in Year 1, and over two-thirds of lorcaserin patients that achieved at least 5% weight loss in Year 1 and continued lorcaserin treatment in Year 2 maintained at least 5% weight loss. Treatment with lorcaserin also resulted in statistically significant improvements as compared to placebo in multiple secondary endpoints associated with cardiovascular risk.
    Efficacy

    Patients who completed the one-year trial according to the trial’s protocol demonstrated the benefits of long-term treatment with lorcaserin:

    • 66.4% of lorcaserin patients lost at least 5% of their body weight, compared to 32.1% for placebo, and the average weight loss in this responder population was 26 pounds.
    • 36.2% of lorcaserin patients lost at least 10% of their body weight, compared to 13.6% for placebo.
    • Lorcaserin patients achieved an average weight loss of 8.2% of their body weight, or 17.9 pounds, compared to 3.4%, or 7.3 pounds, for placebo.

    Measurements of efficacy using an intent-to-treat last observation carried forward, or ITT-LOCF, analysis showed that lorcaserin met all primary endpoints. Lorcaserin patients achieved highly statistically significant categorical and average weight loss after one year:

    • 47.5% of lorcaserin patients lost at least 5% of their body weight, compared to 20.3% for placebo. This result satisfies one of two alternate efficacy benchmarks in the most recent FDA draft guidance, which provides that a weight-management product can be considered effective if after one year of treatment the proportion of subjects who lose greater than or equal to 5% of baseline body weight in the active-product group is at least 35%, is approximately double the proportion in the placebo-treated group, and the difference between groups is statistically significant.
    • 22.6% of lorcaserin patients lost at least 10% of their body weight, compared to 7.7% for placebo.
    • Lorcaserin patients achieved an average weight loss of 5.8% of their body weight, or 12.7 pounds, compared to 2.2%, or 4.7 pounds, for placebo.

    Safety and Tolerability Profile

    Treatment with lorcaserin was very well tolerated, resulting in few adverse events with greater frequency than the placebo group. The most frequent adverse events reported in Year 1 and their rates for lorcaserin and placebo patients, respectively, were as follows: headache (18.0% vs. 11.0%), upper respiratory tract infection (14.8% vs. 11.9%), nasopharyngitis (13.4% vs. 12.0%), sinusitis (7.2% vs. 8.2%) and nausea (7.5% vs. 5.4%). Adverse events of depression, anxiety and suicidal ideation were infrequent and were reported at a similar rate in each treatment group.
    Rates of new FDA-defined valvulopathy in BLOOM were as follows: lorcaserin 10 mg twice daily (2.7%) and placebo (2.3%) at Week 52 and lorcaserin 10 mg twice daily (2.6%) and placebo (2.7%) at Week 104.
    Secondary Endpoints

    Treatment with lorcaserin over one year was associated with statistically significant improvements compared to placebo in multiple secondary endpoints, including:

    • Blood Pressure: systolic blood pressure, diastolic blood pressure and heart rate
    • Lipids: total cholesterol, LDL cholesterol and triglycerides
    • Glycemic Parameters: fasting glucose, fasting insulin and insulin resistance
    • Inflammatory Markers of Cardiovascular Risk: high-sensitivity CRP and fibrinogen

    Patient Disposition

    BLOOM evaluated 3,182 patients with an average Body Mass Index, or BMI, of 36.2 and baseline weight of 220 pounds. The Week 52 completion rate was higher for patients on lorcaserin (54.9%) compared to patients on placebo (45.1%). Discontinuation rates for adverse events were similar in the lorcaserin and placebo groups for Year 1 (7.1% vs. 6.7%) and were the same in Year 2 (3.0% vs. 3.0%).
    BLOOM Trial Design

    We initiated BLOOM in September 2006, and completed enrollment in February 2007 in about 100 centers in the United States. BLOOM was a randomized, double-blind and placebo-controlled trial evaluating 10 mg of lorcaserin dosed twice daily versus placebo over a two-year treatment period in obese patients (BMI of 30 to 45) with or without co-morbid conditions and overweight patients (BMI of 27 to less than 30) with at least one co-morbid condition. BLOOM did not include a dose titration or run-in period. Patients were randomized in a 1:1 ratio to lorcaserin or placebo at baseline. At Week 52, 856 patients taking lorcaserin were re-randomized in a 2:1 ratio to continue lorcaserin or to switch to placebo, and 697 patients on placebo were continued on placebo. All patients received echocardiograms at baseline, Months 6, 12 and 18, and at the end of the trial to assess heart valve function and other parameters over time. Patients with FDA-defined valvulopathy were excluded from enrolling in the trial.


    Our drug candidates have not been approved by the U.S. Food and Drug Administration or any international regulatory agency.





  2. #2
    Er
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    Jun 2011
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    paylaşımlarınızın devamını bekliyorum..



  3. #3
    Er
    Katılım Tarihi
    Oct 2011
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    Zayıflama ve doğal zayıflama ile zayıflama hapı gibi konuların yer aldığı sağlık portalı Zayıflama Online www.zayiflamaonline.com


    Last edited by sinan; 23-12-2011 at 04:23 PM.

  4. #4
    Er
    Katılım Tarihi
    Oct 2011
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    merhaba Acai | Acai Berry | A burdan almıştım çok memnun kaldım fakat sadece düzenli kullanımda etkisini gösteriyor. ve orjinal olmasına dikkat ediniz.



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