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

Continuous abstinence rates (CARs), defined as the percentage of participants remaining continuously abstinent from week 9 to each in-clinic visit through week 52. ORs shown are for CAR during weeks 9–12 (primary end point) and for CARs during weeks 9–24 and 9–52 (secondary end points). 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

fig2: Continuous abstinence rates (CARs), defined as the percentage of participants remaining continuously abstinent from week 9 to each in-clinic visit through week 52. ORs shown are for CAR during weeks 9–12 (primary end point) and for CARs during weeks 9–24 and 9–52 (secondary end points). CI, confidence interval; N, number of participants who received ≥1 dose, including partial doses, of randomized study drug; OR, odds ratio.

Mentions: The following results are for those participants who took at least one dose of study drug (varenicline n = 249; placebo n = 245). Participants retreated with varenicline had significantly greater continuous abstinence rates (CARs) than those treated with placebo for weeks 9–12 (45.0 vs. 11.8%; odds ratio (OR) = 7.08 (95% confidence interval (CI): 4.34, 11.55), P < 0.0001), weeks 9–24 (28.9 vs. 7.8%; OR = 5.83 (95% CI: 3.25, 10.44), P < 0.0001), and weeks 9–52 (20.1 vs. 3.3%; OR = 9.00 (95% CI: 3.97, 20.41), P < 0.0001; Figure 2). For the primary end point of CAR for weeks 9–12, there was no interaction effect of treatment by pooled study center (P = 0.8407).


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)

Continuous abstinence rates (CARs), defined as the percentage of participants remaining continuously abstinent from week 9 to each in-clinic visit through week 52. ORs shown are for CAR during weeks 9–12 (primary end point) and for CARs during weeks 9–24 and 9–52 (secondary end points). 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

fig2: Continuous abstinence rates (CARs), defined as the percentage of participants remaining continuously abstinent from week 9 to each in-clinic visit through week 52. ORs shown are for CAR during weeks 9–12 (primary end point) and for CARs during weeks 9–24 and 9–52 (secondary end points). CI, confidence interval; N, number of participants who received ≥1 dose, including partial doses, of randomized study drug; OR, odds ratio.
Mentions: The following results are for those participants who took at least one dose of study drug (varenicline n = 249; placebo n = 245). Participants retreated with varenicline had significantly greater continuous abstinence rates (CARs) than those treated with placebo for weeks 9–12 (45.0 vs. 11.8%; odds ratio (OR) = 7.08 (95% confidence interval (CI): 4.34, 11.55), P < 0.0001), weeks 9–24 (28.9 vs. 7.8%; OR = 5.83 (95% CI: 3.25, 10.44), P < 0.0001), and weeks 9–52 (20.1 vs. 3.3%; OR = 9.00 (95% CI: 3.97, 20.41), P < 0.0001; Figure 2). For the primary end point of CAR for weeks 9–12, there was no interaction effect of treatment by pooled study center (P = 0.8407).

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