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  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    The small bel-Phen study / poster is in the article. A link to a photo of the poster of the small study of bel- Phen lacking any control groups ( no drug, bel, or Phen) is in the article for the reader's convenience and analysis. Emphasis seemed to be more on efficacy rather than safety in the study.
    Oct 2 12:23 PM | 1 Like Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    ? Tramadol is a μ-opioid receptor agonist amongst other activities, however pain relief is only partially antagonized by naloxone (and presumably naltrzone). It's schedule IV, not "non-addictive". Agree on the contraindication obviously. The labeling includes tramadol in patients should be opiod free before starting Contrave.
    Oct 1 08:16 PM | 1 Like Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    Thx, but you shouldn't thank me for providing reinforcement, "all cause mortality", explain that concept to someone recovering from an MI.

    WOSCOPS and AFCAPS/TexCAPS show reductions in MI and other coronary events in the primary prevention (mostly) on reduction in non-fatal events. Not to mention the Jupiter study, as published showing reductions in events (which you say was "fudged" and others hold a similar view discounting the study because it was halted early and other reasons). Non fatal MIs are an important outcome with regard to statins.

    I can agree that Statin treatment should be stratified according to risk, but statins should not be excluded from primary prevention. The first link had some thoughts on CAC scans for risk stratification.

    The other point being glossed over is the Jupiter study was in patients with normal cholesterol levels, and high c reactive protein levels, which is affirmation in a large clinical study that stains have multiple mechanisms of action in reducing risk.
    Oct 1 08:07 PM | 1 Like Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    here's another supporting your view, since I never quite got the convoluted subtraction argument the first time around that makes non-fatal MIs of little importance. This one takes the all cause mortality approach.

    http://bit.ly/1wVUDB8

    and one that brings up the debate well

    http://bit.ly/1wVUDBb

    I think it would be more accurate to say the NNT is higher for primary prevention and the ratio of NNT to NNH needs to be considered more carefully for primary than secondary prevention. And that is why a tool used to measure risk needs to be correlated with outcomes, and the study we started this discussion on is important.

    Never?
    Sep 30 08:00 PM | Likes Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    Yes, the study shows that the new guidelines were a little better than the old in this patient population, which is a retrospective study of patient's getting angiograms. But meaningless? New vs old guidelines is a current controversial subject. And the last sentence excludes patients that don't meet the criteria for statin therapy.

    But that doesn't negate the prevailing view that statin benefit outweighs diabetes risk for primary prevention, of course according to risk which is why I mentioned guidelines, and definitely for secondary prevention.
    Sep 30 05:45 PM | Likes Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    Most conclude statin benefits outweigh diabetes risk. http://bit.ly/1nG7ZBC. New study shows the accuracy of matching statins to atherosclerotic burden with new guidelines are even better, I thnk very impressive. http://bit.ly/1nG7ZBE
    Sep 30 01:50 PM | Likes Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    Maybe he meant "advertise", interesting though, atypical antipyschotics are definitely advertised on TV as adjunct therapy, but phentermine is more the adjunct drug here. Would "marketing" the use of the combination be wise if the company decides to develop a patentable single formulation?
    Sep 30 12:26 PM | Likes Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    Yes, labeling change, thank you.

    You stated "If Eisai and Arena seek a labeling change, then the FDA may want another confirming study that does not have to be from a statistical standpoint any larger or longer than the current study."

    I doubt it. As you state "You don't know at all if the FDA will require another study". True enough, but for approval of a labeling change, it is a safe bet the FDA would require a larger trial. Future trials should be powered to rule out an increase in a low frequency of adverse events, I would speculate that MACE would be the primary outcome and valvulopathy as a secondary outcome just like CAMELLIA-TIMI. The current phentermine/belviq trial is 225 subjects in 3 arms. From clinicaltrials.gov, the current safety trial for Belviq (CAMELLIA-TIMI) with MACE as the primary outcome is recruiting "Approximately 12,000 subjects will be randomized to two treatment groups in a ratio of 1:1".

    That's a 50 fold difference!

    But on the flip side and in support of your position, the safety hurdle for approval of obesity drugs regarding cardiovascular risk was lower than the hurdle for current new diabetes drugs, at least for Arena and Vivus, not as much so for Orexigen.
    Sep 30 12:22 PM | 1 Like Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    Nothing to do with investing, but in the prescribing information, it states that patients may be more responsive to opiates immediately after stopping Contrave (presumably to take opiate pain meds), so lower opiate doses may be appropriate.
    Sep 29 11:55 AM | Likes Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    Yes, I meant to say thanks, Rod27. thank you healthythoughts.

    worth considering, there is likely overlap in patient populations requiring chronic pain relief and candidates for obesity drugs, but how much?
    Sep 29 11:21 AM | 1 Like Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    Nice examples, overly restrictive labeling (liver function testing), which created the perception that these drugs may not have an excellent safety profile, may well have slowed the implementation of the most effective class of drugs for reducing risk from atherosclerosis. But Baycol (Cerivastatin) use, many cases involving co-administration with gemfibrozil, is attributed with 52 deaths. Caution on combination use, in retrospect, was warranted for fibrates, but probably not so much for Niacin. Niacin efficacy, well that became controversial recently as you note. Your comment "So go with the best information you have, make your best choice, and be prepared to change." addresses Niacin well indeed.

    Your approach to informed consent, more when risk is unknown or greater, is commendable. You wrote "There's always informed consent. This is true with any medication. A little more informed consent for sure when you're waiting on the safety study on B+P. A discussion of risk and benefits always required. "

    But clinical trials require informed consent in a fashion meeting standards and approved by an Institutional Review Board (IRB) for the explicit protection of human subjects. Prescribing drugs, informed consent is up to the prescribing physician, nurse practitioner, or Physician's assistant.

    Prospective clinical trials are less likely to result in economically devastating lawsuits like other serious drug safety problems picked up in other ways.
    Sep 28 06:43 PM | Likes Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    Yes, drugs are used in combination without adequate evidence (trials). But, for large markets, trials are sometimes done to increase labeling indications. For example, use of diabetes drugs in combination (http://prn.to/1rmwhRR).

    "B+P" is in the first pilot trial, and the potential, if warranted, could be formulate it as a single patentable drug.

    Safety of different dosages is important, especially with Phentermine. Qsymia is difficult to replace by prescribing Topiramate and Phentermine independently. Safety could be an issue. The single formulation reduces the dose of both drugs from the previous indications for epilepsy or obesity. The "B+P" trial is investigating two dosages of Phentermine.
    Sep 28 06:01 PM | 1 Like Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    not "will", but is contraindicated, from the prescribing info " CONTRAVE is contraindicated in ...
    Chronic opioid or opiate agonist (e.g., methadone) or partial agonists (e.g., buprenorphine) use, or acute opiate withdrawal [see Warnings and Precautions (5.4) and Drug Interactions (7.2)] "

    But, will this impact sales? What portion of the potential market for Contrave are patients being treated with opiates? Albeit, Contrave ia an opioid antagonist, but are Lorcaserin or Qsymia appropriate for these patients?
    Sep 28 05:38 PM | 1 Like Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    Yes, there are four secondary outcomes involving weight, BMI, etc., primary outcome is serotonergic adverse effects. Also, the trial is not recruiting patients, so presumably the patients have been enrolled and the trial is only 12 weeks, but I could not find a press release on when they will report anything. I suggest keeping in mind this is termed a pilot study, three arms of 75 patients so other studies will be required before submitting to the FDA for a new indication. Admittedly, any safety ( and efficacy) data could impact premature prescription of Bel-Phen. Speculation on ARNA share valuation because of Bel-Phen is fine, the article points out that premature prescribing may present an Investment risk because a safety signal may be picked up outside of a trial. Spencer's points on smoking cessation, also " just starting" are appropriate for speculation.
    Sep 28 02:59 PM | 1 Like Like |Link to Comment
  • Premature Combination Use Of Belviq And Phentermine Is A Risk [View article]
    I think my point, relevant to investors, is that picking up safety problems outside of clinical trials has investment risk. Baycol, a statin, was withdrawn because of Rhabdomyolysis. To some extent, it was because Baycol was used in combination with Gemfibrozil. The risk is higher with Baycol than others, although it is a risk with all statins. Thank you, the clarity may not have come through on that point.
    Sep 28 01:43 PM | 1 Like Like |Link to Comment
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