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Arena Pharmaceuticals, Inc. Message Board

  • jeremiahthirtythreeone jeremiahthirtythreeone Jul 18, 2012 3:06 AM Flag

    The significance, or rather insignificance, of Qsyemia approval

    I am not going to discuss immediate PPS values of VVUS vs. ARNA because there is no end to the speculation, and speculation is all that it is. I would rather discuss the eventual value of ARNA vs. VVUS when all the insanity has settled down.

    What I want to discuss is the significance of the restrictions on Qsyemia and its eventual market share. I will present objective data and not conjecture (except where there is high probability that the conjecture will translate into fact).

    First background:
    35.7% of adults are obese.
    31.9% of these are women in the reproductive age group of 20-39 (cdc.gov/obesity/data/adult.html/) the importance of this will be discussed below.

    Almost 1/3 of children and adolescents in the US are overweight or obese – with higher-weight categories with advancing age (Ogden CL; Carroll MD; Kit BK; Flegal KM. Prevalence of obesity and trends in body mass index among US children and adolescents, 1999-2010, JAMA 2012; 307 (5): 483.)
    Qsyemia is restricted from this patient population. They cannot perform and trials. Belviq will be performing clinical trials on this patient population - A POPULATION THAT IS NOT AVAILABLE NOR WILL IT EVER BE FOR Qsyemia.

    Another important obesity prevalence fact related to the restrictions on patients with cardiovascular disease:
    Non-hispanic blacks have the highest rates of obesity (44.1%) compared with Mexican-Americans (39.3%), all Hispanics (37.9%) and non-Hispanic whites (32.6%).

    The importance of this is:

    Hypertension tends to be both more common and more severe in blacks. Progression from prehypertension to hypertension is accelerated in blacks. Because of this they are at much greater risk of developing cardiovascular complications – by comparison, there is a three-fold increase in overall cardiovascular mortality, a six to seven fold increase in mortality under the age of 50, a 5-18 fold rise in the incidence of end-stage renal disease which is most common in the 25-45 year age group.

    Now add obesity which is associated with increased risks of coronary disease, heart failure, and cardiovascular mortality. Furthermore morbid obesity can cause changes in cardiac morphology that can alter the ECG – P, QRS, and t wave changes, left ventricular hypertrophy, and so on.
    Yet the FDA restricted qsyemia in patients with cardiovascular disease and suggested monitoring for it by checking BP, pulse, and ECG’s. Again, a very large segment of the population will be restricted from using Qsyemia both in black and white males.

    CONTINUED - the important stuff is coming up

    Daniel
    UCLA MD

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