Three weeks ago I wrote about the growing dominance of the new oral anticoagulant (NOAC) drugs for stroke prevention in patients with atrial fibrillation. (Another common name for these drugs is direct acting oral anticoagulants or DOACs.)
The post generated many comments–some privately and some on the blog.
Your responses induced me to think a bit more about the warfarin-substitute drugs. Thanks for that.
More thinking led to my most recent post on theHeart.org, which is titled: NOACs Are Favored Over Warfarin: I’m (Almost) Okay With That
In this column, which is written for a medical audience, I start by noting the many positives of the new drugs. Then I discuss our collective experience with drugs–also quite positive.
But then I cite reasons for caution.
It turns out there is a lot of nuance to see in the industry-sponsored warfarin vs NOAC studies. Enthusiasm makes it harder to see nuance. What’s more, the dabigatran (RELY), rivaroxaban (ROCKET-AF) and apixaban (ARISTOTLE) trials each suffered from “irregularities.” None of these blemishes were enough to stop FDA approval.
But the NOAC trials have not been independently confirmed. Given the closeness of the results, the complexity of the data and the trials’ irregularities, independent analysis of the data would increase my level of certainty on these new drugs.
Here is a teaser from the column. My editor and I went back and forth on whether this comparison was appropriate.
“My (probabilistic) guess is that time will prove our embrace of the new anticoagulants was the right call. It’s a good bet, but it’s not a sure bet. Many clinicians were quite sure that treating depression in adolescents with paroxetine or high-dose imipramine was beneficial. That was until independent researchers reanalyzed the famous Study 329 and found no evidence of efficacy of the drugs and an increase in harm.[17]
You can decide.
JMM
Ritva Valavaara says
Very important post and concerns. Too many problems of new medicines have occured postmarketing. Developing new medicines is expensive but honesty in reporting the results is of utmost importance. Thank you !
Paul says
John, your ending comment; ” You can decide. ” is unrealistic optimism in lieu of such skepticism involving those studies.
James Gaulte says
So what exactly are some of the
“irregularities”, knowing what they are is important to decide for ourselves.
Eliza says
Thank you for this update. However I am still wondering why no one is investigating how the new blood thinners, in particular pradaxa or dabigatran affect the immune system before declaring them to be safe and of benefit? There are studies that show there are great effects on the immune system. Can you please address this?
Thanks kindly.