title: Adverse effects of pharmacological therapy for nicotine addiction in smokers following a smoking cessation program.
abstract: This multicenter, community-based, prospective, longitudinal study evaluated the safety of nicotine replacement therapy (NRT), bupropion, and combined therapy of NRT and bupropion for smokers seeking to quit, when these therapies were used under real-world conditions following a smoking cessation program. Participants were smokers aged 18 years or older who attended five smoking cessation clinics. Evaluations were made at 15, 30, 60, and 90 days. We investigated the possible existence of adverse effects as well as the severity of each adverse effect and its influence on the treatment course. The study included 904 smokers: 370 received NRT, 413 received bupropion, and 121 received combined therapy. At 15, 30, 60, and 90 days, adverse effects were reported by 43.8%, 33.1%, 22.3%, and 5.7% of subjects, respectively. Adverse effects were significantly more frequent in subjects receiving combined therapy or bupropion alone than in NRT-treated subjects at the 15-, 30-, and 60-day follow-ups. A total of 83 smokers (9.3%) withdrew from treatment and 116 (12.8%) stopped temporarily because of adverse effects. No differences were found in the percentages of discontinuation among the different treatment options. Adverse effects rarely were severe (n=10). Nevertheless, 41 subjects (4.5%) discontinued drug therapy indefinitely and 55 (6.1%) discontinued it temporarily because of mild adverse effects. Pharmacological therapies for smoking cessation are safe as long as they are appropriately prescribed and supervised by clinicians according to clinical practice guidelines. Adverse effects are primarily mild. Nonetheless, mild adverse effects may be perceived by patients as a serious enough problem to cause them to discontinue treatment.
authors.affiliation: Hospital Universitario de Salamanca, Spain. mibafe@telefonica.net
authors.forename: Miguel
authors.initials: M
authors.lastname: Barrueco
authors.forename: María José
authors.initials: MJ
authors.lastname: Otero
authors.forename: Luis
authors.initials: L
authors.lastname: Palomo
authors.forename: Carlos
authors.initials: C
authors.lastname: Jiménez-Ruiz
authors.forename: Miguel
authors.initials: M
authors.lastname: Torrecilla
authors.forename: Pedro
authors.initials: P
authors.lastname: Romero
authors.forename: Juan Antonio
authors.initials: JA
authors.lastname: Riesco
mesh_terms: D016642:Bupropion / Q000008:administration & dosage / Q000009:adverse effects*; D005260:Female; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D009538:Nicotine / Q000008:administration & dosage / Q000009:adverse effects*; D011446:Prospective Studies; D016540:Smoking Cessation; D014029:Tobacco Use Disorder / Q000188:drug therapy*
chemical_list: D016642:Bupropion; D009538:Nicotine