#71 Varenicline and Cardiovascular Risk – Is the Cure Worse than the Affliction?
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- Pooled event rates: Varenicline 1.06%, placebo 0.82%.
- Meta-analysis of 38 RCTs (12,706 patients):4 Relative risk 1.03, 0.72-1.49
- Pooled event rates: Varenicline 0.79% versus placebo 0.78%.
- Meta-analysis5 of CVD risk with smoking cessation therapies found \
- No increase in major CVD events with bupropion, nicotine replacement therapy (NRT), or varenicline versus placebo
- An increased risk of CVD events of any severity with NRT (mostly low-risk events like transient tachycardia): NRT 2.8% versus placebo 1.6%.
- Few CVD events limiting power
- CVD outcomes not systematically recorded in most RCTs
- High drop-out rates (up to 30%).
- RCT of smoking cessation (counselling plus bupropion or nicotine replacement) after coronary care unit admission:9
- 9% absolute reduction in mortality at 2 years despite <40% abstinent.
- Varenicline may be the most effective smoking cessation drug.10 Number needed to treat (NNT) for different meds after 1 year, based on 10% cessation with placebo versus placebo
- Varenicline NNT=8, Nortriptyline NNT=10, bupropion NNT=10
- Concerns were also raised about an association between varenicline and an increased risk of depression and self-harm
- Multiple RCTs and observational studies, including patients with stable psychiatric disoders,11 show no increased risk of adverse neuropsychiatric events.12,13