“Aspirin isn’t effective in primary prevention of heart attacks or strokes”–you may have seen that statement this past week (it was in every daily newspaper I saw on August 26th, 2018) or heard it (CNN, CNBC gave it headlines plus, as did NBC,CBS, and ABC nightly newscasts—I know, patients sent me quotes from those sources). You may nothave heard the last part of that report of non-effectiveness —“in intention to treat analysis”.
Even in replay of those newscasts I couldn’t hear anyone say that phrase or that “for those that actually followed the protocol (took aspirin in the active group, and didn’t take it in the control group), there was a 47% reduction in heart attacks by taking 100mg of aspirin.” Which is why patients (and some other docs) I have advised to take a baby aspirin morning and night (with half a glass of warm water before and after) emailed me.
The reason for that recommendation was (and still is –read on) simple: in randomized and epidemiologic studies, people who take a baby aspirin or more a day (and there is a benefit to morning and night) have a 10 to 40 percent decrease in 9 cancers (including breast, colon, esophageal, rectal, etc.,) and 10 to 35% reduction in recurrent heart attacks or strokes. But yes, aspirin has a bleeding risk, so everyone should check with their doc before starting on one, especially if they do extreme sports. The benefit in my opinion and analysis is generally greater than the risk for men who do not do extreme sports and are over age 40, and women over age 50—but check with your doc.
Like statins, and blood pressure (BP) pills I warn patients they can’t forget more than one tablet or there will be a rebound increase in LDL, or BP, or clotting leading to an increase in heart attacks and strokes. As my co-staff member, Dr Sukol, in Cleveland Clinic’s executive health program (She and I and others see patients there—we are available) says: ”Hooray for OCD patients”
So when I heard the headline, and was sent the url’s to the newscasts by so many patients, I did what I always do: get and read the paper to see if the telereporters got it right (they actually do an amazing percent of the time).
Huh? You might ask…how can that be –a 47% reduction in heart attacks reported as no benefit? Let me explain as only a science nerd might (okay I’m guilty). The short answer is a lot of patients who were supposed to take the 100mg aspirin a day in the study didn’t take it even as much as 60% of the time (the criteria for following the aspirin regimen), and many who were randomly allocated to the group of patients in this study who were not supposed to take aspirin did take it (a criteria for being in the “not taking” group). In “Intention to treat analysis”, the researchers gather all outcomes over about 10 years of those people randomly allocated to the group supposed to take aspirin (even it they didn’t take the aspirin—they were “intended to take it”) , to statistically contrast with the outcomes of the group of patients who were supposed to not take aspirin even if they did take it.
What did the study find? Of about 12,550 people randomly allocated to the aspirin or no-aspirin groups, only 7800 actually did what they were supposed to do. So that is why the report is misleading and why Dr Sukol says “Hooray for OCD patients”. (By the way, these data fit with another primary prevention studies that shows a very strong benefit of those who take aspirin compared to those who do not. But key for study results is for those in the take group to do so, and those in the not take group to not do so. As I remember it more than 30% in another study of primary prevention, the Physician’s Health Study, who were in the control group started taking a daily aspirin on their own. When they were excluded or put into the right group the primary prevention benefit of aspirin was highly significant in that study too.
So my response to people who emailed me went like this: “of those who followed the protocol, took the aspirin or didn’t, there was a 47% reduction in heart attacks if they took the aspirin (table 2 per protocol population), (significant) and a 19% reduction in all CV events —they needed more patients to make that finding statistically significant. Of note, those who broke protocol and didn’t follow the group they were assigned, had higher risk (by about 20% in those assigned to the aspirin group who didn’t take it at least 60% of time. This may be most important point as rebound from irregular aspirin use has been shown to increase clotting risk in all studies I have read of that risk. People should either take aspirin or not. Taking it irregularly is hazardous — not sure if our patients are more compliant than those in study in general or not, but I suspect you ( a patient who emailed me) is very diligent in aspirin taking.”
Now you might ask why did the reporters only tell about the “Intention to Treat Analysis”, and why do scientists report that anyway? Scientists report it because that is a real life scenario—many patients aren’t OCD with regard to medications (only 30% take BP pills as prescribed in large studies). So this “Intention to Treat Analysis” is supposed to be more valid for most patients. Why they didn’t tell about the 75+% of patients who were OCD about aspirin? I do not know. But you read the results here, and can judge whether you are good enough in pill taking to at least remember one of your two baby aspirins every day.
Our basic premise in these columns and in my practice: your body is amazing: until permanent structural dysfunction occurs, You get a do over: it doesn’t take that long, and isn’t that hard if you know what to do. Since this series started we’ve given you 152 or so easy to adopt tips to Staying Young. Our aspirin tip was one of these. My take now on ARRIVE and what I will do and advise my patients who were advised to take aspirin before: keep taking a baby aspirin morning and another at night with half a glass of water before and after as long as you do not do extreme sports or some other activity that increases the risk or decreases the benefits of the aspirin.
Thanks for reading. Feel free to send questions—to [email protected]
You can follow Dr Roizen on twitter @YoungDrMike (and get updates on the latest and most important medical stories of the week).
Michael F. Roizen, M.D., is chief wellness officer at the Cleveland Clinic.