Limits...
Retreatment with varenicline for smoking cessation in smokers who have previously taken varenicline: a randomized, placebo-controlled trial.

Gonzales D, Hajek P, Pliamm L, Nackaerts K, Tseng LJ, McRae TD, Treadow J - Clin. Pharmacol. Ther. (2014)

Bottom Line: The primary efficacy end point was the carbon monoxide-confirmed (≤ 10 ppm) continuous abstinence rate for weeks 9-12, which was 45.0% (varenicline; n = 249) vs. 11.8% (placebo; n = 245; odds ratio: 7.08; 95% confidence interval: 4.34, 11.55; P < 0.0001).Varenicline is efficacious and well tolerated in smokers who have previously taken it.Abstinence rates are comparable with rates reported for varenicline-naive smokers.

View Article: PubMed Central - PubMed

Affiliation: OHSU Smoking Cessation Center, Division of Pulmonary and Critical Care Medicine, Department of Medicine, Oregon Health & Science University, Portland, Oregon, USA.

ABSTRACT
The efficacy and safety of retreatment with varenicline in smokers attempting to quit were evaluated in this randomized, double-blind, placebo-controlled, multicenter trial (Australia, Belgium, Canada, the Czech Republic, France, Germany, the United Kingdom, and the United States). Participants were generally healthy adult smokers (≥ 10 cigarettes/day) with ≥ 1 prior quit attempt (≥ 2 weeks) using varenicline and no quit attempts in ≤ 3 months; they were randomly assigned (1:1) to 12 weeks' varenicline (n = 251) or placebo (n = 247) treatment, with individual counseling, plus 40 weeks' nontreatment follow-up. The primary efficacy end point was the carbon monoxide-confirmed (≤ 10 ppm) continuous abstinence rate for weeks 9-12, which was 45.0% (varenicline; n = 249) vs. 11.8% (placebo; n = 245; odds ratio: 7.08; 95% confidence interval: 4.34, 11.55; P < 0.0001). Common varenicline group adverse events were nausea, abnormal dreams, and headache, with no reported suicidal behavior. Varenicline is efficacious and well tolerated in smokers who have previously taken it. Abstinence rates are comparable with rates reported for varenicline-naive smokers.

Show MeSH

Related in: MedlinePlus

Mean 7-day point prevalence of abstinence, defined as the percentage of participants remaining abstinent from cigarette smoking and use of other nicotine and/or tobacco products in the previous 7 days. CI, confidence interval; N, number of participants who received ≥1 dose, including partial doses, of randomized study drug; OR, odds ratio.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4151018&req=5

fig3: Mean 7-day point prevalence of abstinence, defined as the percentage of participants remaining abstinent from cigarette smoking and use of other nicotine and/or tobacco products in the previous 7 days. CI, confidence interval; N, number of participants who received ≥1 dose, including partial doses, of randomized study drug; OR, odds ratio.

Mentions: The relapse curve after varenicline retreatment was similar to relapse curves observed in other trials that have included supportive counseling.15,16,17,18,23 Seven-day point prevalence abstinence rates were significantly greater for varenicline vs. placebo at all points. Abstinence peaked for varenicline at week 12 (last week of dosing) and then declined steadily to week 52, as observed in treatment-naive trials. Placebo point prevalence rates peaked earlier, at week 7, and remained somewhat flat until the end of the study (Figure 3). The varenicline CAR was sixfold greater than that for placebo at 52 weeks. Our data suggest that although retreatment with varenicline is effective in attaining and maintaining smoking abstinence (remission), the risk of relapse and the need for additional courses of treatment will likely continue for many chronic smokers. This retreatment paradigm provides an additional treatment approach to that provided by varenicline maintenance therapy, which extends continuous varenicline treatment from 3 to 6 months to aid in maintaining abstinence.34


Retreatment with varenicline for smoking cessation in smokers who have previously taken varenicline: a randomized, placebo-controlled trial.

Gonzales D, Hajek P, Pliamm L, Nackaerts K, Tseng LJ, McRae TD, Treadow J - Clin. Pharmacol. Ther. (2014)

Mean 7-day point prevalence of abstinence, defined as the percentage of participants remaining abstinent from cigarette smoking and use of other nicotine and/or tobacco products in the previous 7 days. CI, confidence interval; N, number of participants who received ≥1 dose, including partial doses, of randomized study drug; OR, odds ratio.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4151018&req=5

fig3: Mean 7-day point prevalence of abstinence, defined as the percentage of participants remaining abstinent from cigarette smoking and use of other nicotine and/or tobacco products in the previous 7 days. CI, confidence interval; N, number of participants who received ≥1 dose, including partial doses, of randomized study drug; OR, odds ratio.
Mentions: The relapse curve after varenicline retreatment was similar to relapse curves observed in other trials that have included supportive counseling.15,16,17,18,23 Seven-day point prevalence abstinence rates were significantly greater for varenicline vs. placebo at all points. Abstinence peaked for varenicline at week 12 (last week of dosing) and then declined steadily to week 52, as observed in treatment-naive trials. Placebo point prevalence rates peaked earlier, at week 7, and remained somewhat flat until the end of the study (Figure 3). The varenicline CAR was sixfold greater than that for placebo at 52 weeks. Our data suggest that although retreatment with varenicline is effective in attaining and maintaining smoking abstinence (remission), the risk of relapse and the need for additional courses of treatment will likely continue for many chronic smokers. This retreatment paradigm provides an additional treatment approach to that provided by varenicline maintenance therapy, which extends continuous varenicline treatment from 3 to 6 months to aid in maintaining abstinence.34

Bottom Line: The primary efficacy end point was the carbon monoxide-confirmed (≤ 10 ppm) continuous abstinence rate for weeks 9-12, which was 45.0% (varenicline; n = 249) vs. 11.8% (placebo; n = 245; odds ratio: 7.08; 95% confidence interval: 4.34, 11.55; P < 0.0001).Varenicline is efficacious and well tolerated in smokers who have previously taken it.Abstinence rates are comparable with rates reported for varenicline-naive smokers.

View Article: PubMed Central - PubMed

Affiliation: OHSU Smoking Cessation Center, Division of Pulmonary and Critical Care Medicine, Department of Medicine, Oregon Health & Science University, Portland, Oregon, USA.

ABSTRACT
The efficacy and safety of retreatment with varenicline in smokers attempting to quit were evaluated in this randomized, double-blind, placebo-controlled, multicenter trial (Australia, Belgium, Canada, the Czech Republic, France, Germany, the United Kingdom, and the United States). Participants were generally healthy adult smokers (≥ 10 cigarettes/day) with ≥ 1 prior quit attempt (≥ 2 weeks) using varenicline and no quit attempts in ≤ 3 months; they were randomly assigned (1:1) to 12 weeks' varenicline (n = 251) or placebo (n = 247) treatment, with individual counseling, plus 40 weeks' nontreatment follow-up. The primary efficacy end point was the carbon monoxide-confirmed (≤ 10 ppm) continuous abstinence rate for weeks 9-12, which was 45.0% (varenicline; n = 249) vs. 11.8% (placebo; n = 245; odds ratio: 7.08; 95% confidence interval: 4.34, 11.55; P < 0.0001). Common varenicline group adverse events were nausea, abnormal dreams, and headache, with no reported suicidal behavior. Varenicline is efficacious and well tolerated in smokers who have previously taken it. Abstinence rates are comparable with rates reported for varenicline-naive smokers.

Show MeSH
Related in: MedlinePlus