Christopher Giuliano, Internal Medicine clinical pharmacist, hosts this week’s episode of The Rounds Table alongside Amber Lanae Martirosov, clinical pharmacist in ambulatory care with a focus on pulmonology. Both guests join us from Wayne State University. In this episode they cover the use of apixaban in patients with atrial fibrillation and end-stage renal disease (ESRD) on hemodialysis, and the cardiovascular safety of medications used for smoking cessation.
Dabigatran and rivaroxaban, two direct oral anticoagulants (DOACs), can increase bleeding risk compared to warfarin in hemodialysis patients. Does apixaban have similar risks? Christopher walks listeners through a cohort study of patients with atrial fibrillation on hemodialysis receiving apixaban compared to warfarin. The study compares the risks of stroke, systemic embolism, bleeding, and mortality.
By prescribing agents for smoking cessation, physicians aim to lower patients’ overall cardiovascular risk. But what if the opposite occurs, and risk is increased with these medications? The EAGLES trial (Evaluating Adverse Events in a Global Smoking Cessation Study) was initially designed to study the neuropsychiatric effects smoking cessation agents. Amber reviews an extension of this trial, and covers the cardiovascular safety of varenicline, bupropion, and the nicotine patch in patients who smoke compared to placebo.
Finally, the Good Stuff segment. Christopher shares an article on bleeding risk with selective serotonin reuptake inhibitors (SSRI’s) and Amber shares an article on chronic versus as-needed inhaled corticosteroid/long-acting-beta-agonist (ICS/LABA) use for mild persistent asthma.
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The Papers
1. Apixaban in ESRD: https://www.ahajournals.org/doi/abs/10.1161/CIRCULATIONAHA.118.035418?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%3dpubmed
2. Safety of Smoking Cessation Agents: https://jamanetwork.com/journals/jamainternalmedicine/article-abstract/2677060
Good Stuff
1. SSRI’s and Bleeding Risk: http://journals.sagepub.com/doi/full/10.1177/1060028018794005
2. Mild Persistent Asthma:https://www.nejm.org/doi/full/10.1056/NEJMoa1715275
Music Credits
The Rounds Table Theme Music by Brendan Quinn, Creative Director and Composer, Vapor RMW
If smoking cessation therapy MACE are no different than placebo doesnt that reflect a failure of smoking cessation to exert the putative benefit for which it was originally prescribed.
One major limitation of this study is that with the lower number of events (0.5% overall), the study was under powered to detect a difference, despite enrolling 1000 patients in each group. Looking for a difference of 0.3 % in MACE would require more than 4000 patients in each group to detect a difference (alpha 0.05, beta 0.8), therefore it is hard to argue that smoking cessation failed at preventing MACE. Furthermore, varenicline demonstrated a HR of 0.29 and bupropion demonstrated a HR of 0.5 compared to placebo, although the confidence intervals were wide with the small number of events. If the study was longer, enrolled more patients, or was done in a higher risk population the question could be better answered.
Christopher Giuliano, PharmD, MPH