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    Qnexa (Phentermine/Topamax) side effects dry mouth, tingling, constipation, altered taste, insomnia


    Posted by .(JavaScript must be enabled to view this email address)
    Wednesday, September 09, 2009 10:23 am Email this article
    The most common side effects reported by overweight and obese patients given the Qnexa (phentermine plus controlled-release Topamax (topiramate)) were dry mouth, tingling, constipation, altered taste and insomnia according to a press release from press release from Vivus, Inc, the company developing the drug. Qnexa Did Not Increase Depression

    Depression no more common in those given Qnexa as those given a placebo; 2% in both groups

    “Depression or depressed mood adverse events of a moderate to severe nature were less than 2% and were similar among patients in the Qnexa and placebo groups” the press release notes.

     

    No Suicide Attempts or Behaviors

    There were no suicide attempts or behaviors in those given Qnexa

    “There were no suicide attempts or suicidal behaviors, and there was no signal for suicidal ideation across all treatment groups including placebo” the press release notes.

     

    Comment: Topamax Increases Suicide Risk

    Topamax Increases Suicide Risk

    The US Food and Drug Administration (FDA) previously put out a warning that Topamax (topiramate) increases the risk of suicidal thoughts.

    The article is posted here.

     

    No Adverse Effects on Heart Rhythm

    No Effect on Heart Rhythm

    There was no effect on heart rhythm (“no signal for QT prolongation”).

    QT prolongation can lead to a potentially lethal arrythmia according to Wikipedia.

    Wikipedia

     

    Cognitive Function and Psychomotor Skills

    No Effect on Cognitive Function or Psychomotor Skills

    “Subjects taking Qnexa also underwent complex and extensive cognitive and psychomotor testing using validated, FDA accepted testing methodologies” the press release notes.

    “There was no clinically significant change in overall cognitive function or effect on psychomotor skills seen in patients taking Qnexa.”

     

    Subjects

    Subjects: 2487 overweight and obese patients

    “The CONQUER study included 2,487 overweight and obese patients (1,737 females and 750 males) with high blood pressure, high cholesterol or type 2 diabetes across 93 centers in the United States” the press release notes.

     

    Conclusions

    Dr. Michael Long’s Conclusion: Sustained weight loss and improved quality of life

    “I have seen dramatic and sustained weight loss with Qnexa as well as notable improvements in cardiovascular risk factors, diabetes, emotional well being and quality of life in my patients,” commented Michelle Look, M.D., FAAFP, of the San Diego Sports Medicine and Family Health Center and a lead investigator in the studies.

    “What is so striking for me is how many of my patients were able to achieve weight loss with Qnexa for the first time after many years of battling weight problems without success. The excellent tolerability of Qnexa allowed patients to stay on therapy for a year, as evidenced by the strong completer rates.”

     

    Conclusions

    Dr. Louis Aronne’s Conclusion: ‘I am encouraged by the efficacy and safety seen in these late stage Qnexa trials.’

    “These data are significant, and when coupled with my own experience treating patients with Qnexa, clearly demonstrate that it is one of the promising pharmaceutical therapies in development to assist patients in achieving significant weight loss,” stated Louis Aronne, MD, Clinical Professor of Medicine and Director of the Comprehensive Weight Control Program at New York-Presbyterian Hospital/Weill Cornell Medical Center and one of the investigators involved in the clinical trials.

    “People with weight problems have a truly biologic disease, and we are in desperate need of more options and effective tools to help our patients combat this disease and the other serious medical conditions that arise as a result of weight gain. I am encouraged by the efficacy and safety seen in these late stage Qnexa trials.”

    REFERENCE

    Vivus. Vivus announces positive results from two phase 3 studies; obese patients on qnexa achieve average weight loss up to 14.7% and significant improvements in co-morbidities. Press Release from Vivus Inc. 2009 Sept 09, http://ir.vivus.com/releasedetail.cfm?ReleaseID=407933

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