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October 27, 2011
Vancouver, BC – A rare trial looking at a smoking-cessation drug given to older, long-time smokers immediately post-AMI has found no benefits of bupropion (Wellbutrin/Zyban, GlaxoSmithKline) at one year in AMI survivors trying to kick the habit.
Dr Mark J Eisenberg
Presenting the results here at the late-breaking clinical-trials session of the Canadian Cardiovascular Congress 2011, Dr Mark J Eisenberg (Jewish General Hospital, Montreal, QC) called the study “disappointing,” saying it speaks to the need for a more in-depth, multifaceted approach to helping post-MI smokers quit than just giving them a drug.
“More intensive and behavioral therapy is likely to yield better results, but we were looking for something that could be done on a huge scale at discharge like handing out aspirin or handing out a beta blocker. It doesn’t look like bupropion is going to be like that.”
Eisenberg et al’s study was a randomized, multicenter, double-blind, placebo-controlled trial of bupropion in 392 smokers hospitalized post-AMI. Participants were mostly male and typically one-pack-a-day smokers who’d smoked for several decades. Participants received bupropion or placebo for nine weeks.
At four weeks, nine weeks, six months, and 12 months, abstinence was numerically higher in the smokers randomized to bupropion, but the difference between groups was never statistically significant, and the gap between groups became smaller and smaller over time. In a galling finding for physicians who tend to believe most of their patients will quit smoking after a momentous event like a heart attack, even within the first four weeks, 50% of patients in both groups had taken up the habit again. By one-year post-AMI, two-thirds of all patients had returned to smoking.
“That’s much better than what we’ve seen in trials of pharmacotherapy in young, healthier smokers without coronary disease, but it’s still really terrible,” Eisenberg said. He and his co-investigators had hoped the post-MI hospitalization would offer “a window of opportunity, when patients are in the hospital, to nab them, since the bang for the buck would be huge.” And it clearly wasn’t. “I would point out that we approached many, many patients for this study, and most didn’t even want to go into the trial, so these were actually patients who were motivated enough to try to quit.”
Dr John Mancini (St Paul’s Hospital, Vancouver, BC), one of the session moderators, agreed, calling the recidivism “atrocious.”
Dr Vladimir Dzavik
“As you correctly point out, we assume the MI is a life-changing event that will get the message through,” he lamented.
Of note, there were no safety issues with bupropion, an important finding, since nicotine-replacement therapies have been “relatively contraindicated” immediately following an AMI, Eisenberg noted.
Speaking with heartwire, Dr Vladimir Dzavik (University Health Network, Toronto, ON) pointed to the steady attrition rate in smoker abstinence rates over the 12 months, saying, “Investigators clearly were hoping that there’d be a magic-bullet drug that would induce patients to stop after this life-changing moment, their myocardial infarction, and it didn’t. The key message is that we need to focus not just on a drug. This seemed to help initially, and it can be safely prescribed to patients post-MI who have a physiological dependence, but it clearly needs to be augmented by rehab programs that are intensive, that are more than just pharmacological.”
Eisenberg disclosed receiving support from Pfizer, which makes a competing smoking-cessation drug, varenicline (Chantix).