IngentaConnect A double-blind study evaluating the long-term safety of varenicli...

Authors: Williams, Kathryn E.¹; Reeves, Karen R.¹; Billing, Clare B.¹; Pennington, Ann M.¹; Gong, Jason¹

Source: Current Medical Research and Opinion, Volume 23, Number 4, April 2007 , pp. 793-801(9)

Abstract:

Objective: We assessed the safety of long-term varenicline administration for smoking cessation.

Methods: In this randomized, double-blind, multicenter trial, eligible adult smokers (18-75 years) who smoked an average of ≥10 cigarettes/day were randomized to either varenicline 1 mg twice daily (BID) or placebo for 52 weeks. Subjects made weekly clinic visits until week 8, and then every 4 weeks until week 52, with a follow-up visit at week 53. The target quit date was the morning of the week 1 clinic visit. Brief counseling was provided at each visit, and vital signs, adverse events (AEs), and smoking status were documented. Other laboratory measures were collected at specified visits.

Results: A total of 251 subjects were randomized to varenicline and 126 to placebo. Approximately half of the subjects in each arm completed the study (53.8% varenicline; 46.8% placebo). Treatment-emergent AEs were observed in 96.4% of varenicline- and 82.5% of placebo-treated subjects during the study. Common varenicline-associated AEs were nausea (40.2%), abnormal dreams (22.7%), and insomnia (19.1%). Most AEs were considered mild or moderate in intensity. AEs leading to discontinuation of varenicline treatment included nausea (7.6%), insomnia (3.2%), and abnormal dreams (2.4%). A single varenicline-related serious AE, bilateral subcapsular cataracts, was observed. At week 52, 7-day point prevalence abstinence rates were 36.7% (varenicline) and 7.9% (placebo).

Conclusions: Varenicline 1 mg BID can be safely administered for up to 1 year. Varenicline was also a more effective smoking cessation aid than placebo throughout the study, supporting both its short- (12-week) and long-term (52-week) efficacy.

Keywords: LONG-TERM; POINT PREVALENCE; RANDOMIZED CONTROLLED TRIAL; SAFETY; SMOKING CESSATION; VARENICLINE

Document Type: Research article

DOI: 10.1185/030079907X182185

Affiliations: 1: Pfizer Global Research & Development, Groton, CT, USA

Your trusted access to this article has expired.

The full text electronic article is available for purchase. You will be able to download the full text electronic article after payment.

$51.50 plus tax

A double-blind study evaluating the long-term safety of varenicline for smoking cessation