Mark J Eisenberg1, Sarah B Windle2, Nathalie Roy2, Wayne Old2, François R Grondin2, Iqbal Bata2, Ayman Iskander2, Claude Lauzon2, Nalin Srivastava2, Adam Clarke2, Daniel Cassavar2, Danielle Dion2, Herbert Haught2, Shamir R Mehta2, Jean-François Baril2, Charles Lambert2, Mina Madan2, Beth L Abramson2, Payam Dehghani2. 1. From Jewish General Hospital/McGill University, Montréal, QC, Canada (M.J.E., S.B.W.); Centre de santé et de services sociaux de Chicoutimi, Chicoutimi, QC, Canada (N.R.); Sentara Cardiovascular Research Institute, Norfolk, VA (W.O.); CISSS Chaudière-Appalaches, Hôtel-Dieu de Lévis site, QC, Canada (F.R.G.); Queen Elizabeth II Health Sciences Centre, Halifax, NS, Canada (I.B.); SJH Cardiology Associates and St. Joseph's Hospital, Liverpool, NY (A.I.); CISSS - Chaudière-Appalaches, Thetford Mines, QC, Canada (C.L.); Spartanburg Regional Medical Center, Spartanburg, SC (N.S.); Valley Regional Hospital, Kentville, NS (A.C.); ProMedica Toledo Hospital, Toledo, OH (D.C.); CISSS de Chaudière Appalaches site Hôpital St-Georges, Beauce, QC, Canada (D.D.); Heart Center Research, Huntsville, AL (H.H.); McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada (S.R.M.); Dr. Georges-L.-Dumont University Hospital Centre, Moncton, NB, Canada (J.-F.B.); Florida Hospital Pepin Heart Institute, Tampa, FL (C.L.); Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada (M.M.);St. Michael's Hospital, Toronto, ON, Canada (B.L.A.); Prairie Vascular Research Network, University of Saskatchewan, Regina, SK, Canada (P.D.). mark.eisenberg@mcgill.ca. 2. From Jewish General Hospital/McGill University, Montréal, QC, Canada (M.J.E., S.B.W.); Centre de santé et de services sociaux de Chicoutimi, Chicoutimi, QC, Canada (N.R.); Sentara Cardiovascular Research Institute, Norfolk, VA (W.O.); CISSS Chaudière-Appalaches, Hôtel-Dieu de Lévis site, QC, Canada (F.R.G.); Queen Elizabeth II Health Sciences Centre, Halifax, NS, Canada (I.B.); SJH Cardiology Associates and St. Joseph's Hospital, Liverpool, NY (A.I.); CISSS - Chaudière-Appalaches, Thetford Mines, QC, Canada (C.L.); Spartanburg Regional Medical Center, Spartanburg, SC (N.S.); Valley Regional Hospital, Kentville, NS (A.C.); ProMedica Toledo Hospital, Toledo, OH (D.C.); CISSS de Chaudière Appalaches site Hôpital St-Georges, Beauce, QC, Canada (D.D.); Heart Center Research, Huntsville, AL (H.H.); McMaster University and Hamilton Health Sciences, Hamilton, ON, Canada (S.R.M.); Dr. Georges-L.-Dumont University Hospital Centre, Moncton, NB, Canada (J.-F.B.); Florida Hospital Pepin Heart Institute, Tampa, FL (C.L.); Sunnybrook Health Sciences Centre, University of Toronto, Toronto, ON, Canada (M.M.);St. Michael's Hospital, Toronto, ON, Canada (B.L.A.); Prairie Vascular Research Network, University of Saskatchewan, Regina, SK, Canada (P.D.).
Abstract
BACKGROUND: Less than one-third of smokers hospitalized with an acute coronary syndrome (ACS) remain abstinent following discharge. We assessed whether varenicline, begun in-hospital, is efficacious for smoking cessation following ACS. METHODS AND RESULTS: We conducted a multi-center, double-blind, randomized, placebo-controlled trial in which smokers hospitalized with an ACS were randomized to varenicline or placebo for 12 weeks. All patients received low-intensity counseling. The primary end point was point-prevalence smoking abstinence assessed at 24 weeks by 7-day recall and biochemical validation using expired carbon monoxide. A total of 302 patients were randomized (mean age 55±9 years; 75% male; 56% ST-segment elevation myocardial infarction; 38% non-ST-segment elevation myocardial infarction; 6% unstable angina). Patients smoked a mean of 21±11 cigarettes/d at the time of hospitalization and had been smoking for a mean of 36±12 years. At 24 weeks, patients randomized to varenicline had significantly higher rates of smoking abstinence and reduction than patients randomized to placebo. Point-prevalence abstinence rates were 47.3% in the varenicline group and 32.5% in the placebo group (P=0.012; number needed to treat=6.8). Continuous abstinence rates were 35.8% and 25.8%, respectively (P=0.081; number needed to treat=10.0), and rates of reduction ≥50% in daily cigarette consumption were 67.4% and 55.6%, respectively (P=0.05; number needed to treat=8.5). Adverse event rates within 30 days of study drug discontinuation were similar between groups (serious adverse events: varenicline 11.9%, placebo 11.3%; major adverse cardiovascular events: varenicline 4.0%, placebo 4.6%). CONCLUSIONS:Varenicline, initiated in-hospital following ACS, is efficacious for smoking cessation. Future studies are needed to establish safety in these patients. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00794573.
RCT Entities:
BACKGROUND: Less than one-third of smokers hospitalized with an acute coronary syndrome (ACS) remain abstinent following discharge. We assessed whether varenicline, begun in-hospital, is efficacious for smoking cessation following ACS. METHODS AND RESULTS: We conducted a multi-center, double-blind, randomized, placebo-controlled trial in which smokers hospitalized with an ACS were randomized to varenicline or placebo for 12 weeks. All patients received low-intensity counseling. The primary end point was point-prevalence smoking abstinence assessed at 24 weeks by 7-day recall and biochemical validation using expired carbon monoxide. A total of 302 patients were randomized (mean age 55±9 years; 75% male; 56% ST-segment elevation myocardial infarction; 38% non-ST-segment elevation myocardial infarction; 6% unstable angina). Patients smoked a mean of 21±11 cigarettes/d at the time of hospitalization and had been smoking for a mean of 36±12 years. At 24 weeks, patients randomized to varenicline had significantly higher rates of smoking abstinence and reduction than patients randomized to placebo. Point-prevalence abstinence rates were 47.3% in the varenicline group and 32.5% in the placebo group (P=0.012; number needed to treat=6.8). Continuous abstinence rates were 35.8% and 25.8%, respectively (P=0.081; number needed to treat=10.0), and rates of reduction ≥50% in daily cigarette consumption were 67.4% and 55.6%, respectively (P=0.05; number needed to treat=8.5). Adverse event rates within 30 days of study drug discontinuation were similar between groups (serious adverse events: varenicline 11.9%, placebo 11.3%; major adverse cardiovascular events: varenicline 4.0%, placebo 4.6%). CONCLUSIONS:Varenicline, initiated in-hospital following ACS, is efficacious for smoking cessation. Future studies are needed to establish safety in these patients. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00794573.
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