A “Tune-Up” from Nesiritide?

A summary of this Week’s headlining NEJM article : Health Care Renewal: A "Tune-Up" from Nesiritide?.

Not a very good endorsement of this latest wonder drug:

Topol concluded, "in my view, nesiritide has not yet met the minimal criteria for safety and efficacy." So, "we need a tune-up of our procedures to eliminate indiscriminate use of drugs, such as nesiritide, when there is not proper evidence of their safety."

I wonder what he has in mind for that procedure?  I thought that was the FDA’s role.

But, that makes it easy.  Just Say No, at least for now.  (And, this again verifies the truism for new drug use: Never be the first to try it, never be the last to adopt it).  I wrote about this earlier, and, to my knowledge, none of my colleagues are using it now either.

via DB’s MedRants


Comments

  1. CardioNP says:

    I second the “never be the first one to try a drug” idea. My sister-in-law has been diagnosed with atypical MS (has 2 large demyelinating lesions in her brain). Her neurologist was pushing for her to take natalizumab (marketed as Tysabri) as soon as it was released. I told her, no way, she was clinically stable at the time and should hold off, wait at least 6 mos – let others be the guinea pigs since more adverse effects become apparent after more widespread use. And then of course, less than 6 months later PML was identified and the drug withdrawn from the market.

    Personally, have not found Nesiritide to be all it is touted to be. If CHF is diagnosed in a timely manner, and then there is implementation of appropriate therapy (frequently see pts with no ACE-I, no carvedilol or beta-blocker, no spironolactone) and EDUCATION about self titration of diuretics and need for Na and fluid restrictions, then a lot of CHF ER visits could be avoided. Alas, the education component is very time consuming and most practitioners don’t take the time to do it. Can’t tell you the number of times I have found that patients are clueless about their meds and how to take them.

    With the use of more ICDs we will be having more patients surviving SCD, but they will now develop pump failure and not really have much mortality benefit – just end up in the ED or ICU dying with endstage CHF. So be prepared. Time to brush off the advance directive info sheets and do some straight talk with your patients with CHF.

  2. I also (even in the ED) try to explain daily-weights and self-titration of diuretics with patients, usually those I’m sending home from a mild exacerbation, though.

    A few know about it, to many it’s a new idea. Some patients are decidedly uncomfortable titrating their own meds, so it’s not for everyone.

  3. The FDA doesn’t even post the prescribing information for all the drugs it has approved. The CDER website directs physicians to contact the manufacturer. I don’t think we’re going to see them raise the bar unless there’s some push back to make the drug companies bare more of the accountability burden in the New Drug Approval process.

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