Varenicline and bupropion sustained-release combination therapy for smoking cessation.
BACKGROUND
Varenicline and bupropion sustained release (SR) are both safe and effective for the treatment of tobacco dependence and have different mechanisms of action. Combination pharmacotherapy with these agents may increase long-term smoking abstinence rates above what is observed with single-agent therapy.


METHODS
We enrolled cigarettes smokers in an open-label, one-arm, Phase II clinical trial to obtain preliminary data on the potential effectiveness and safety of combination therapy with varenicline and bupropion SR for the treatment of tobacco dependence. Eligible subjects received varenicline titrated to 1.0 mg by mouth twice daily and bupropion SR titrated to 150 mg by mouth twice daily for a total of 12 weeks along with behavioral therapy. Self-reported smoking abstinence was biochemically confirmed with expired carbon monoxide. A total of 38 smokers with a mean age of 49.1 years (SD = 12.4) who smoked an average of 19.9 cigarettes/day (SD = 7.8) for 30 years (SD = 12.3) were enrolled.


RESULTS
Seven-day point-prevalent smoking abstinence rates were 71% (95% CI = 54%-85%) at 3 months and 58% (95% CI = 41%-74%) at 6 months. Mean weight change during the medication phase among smoking-abstinent subjects was 1.6 kg (SD = 2.4). For both medications, 74% of subjects took at least 90% of the prescribed doses. The most common side effects were sleep disturbance (26%) and nausea (24%). No increase in depressive symptoms was observed, and no subjects reported suicidal ideation.


CONCLUSIONS
Combination therapy with varenicline and bupropion SR may be effective for increasing smoking abstinence rates above that observed with monotherapy.
Ebbert
Jon O
JO
Mayo Clinic College of Medicine, 200 1st Street Southwest, Rochester, MN 55905, USA. ebbert.jon@mayo.edu
Croghan
Ivana T
IT
Sood
Amit
A
Schroeder
Darrell R
DR
Hays
J Taylor
JT
Hurt
Richard D
RD
D000328:Adult; D000368:Aged; D001552:Benzazepines / Q000008:administration & dosage / Q000627:therapeutic use*; D016642:Bupropion / Q000008:administration & dosage / Q000627:therapeutic use*; D003692:Delayed-Action Preparations; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011810:Quinoxalines / Q000008:administration & dosage / Q000627:therapeutic use*; D012907:Smoking / Q000188:drug therapy*; D016540:Smoking Cessation / Q000379:methods*; D000068580:Varenicline; D055815:Young Adult
D001552:Benzazepines; D003692:Delayed-Action Preparations; D011810:Quinoxalines; D016642:Bupropion; D000068580:Varenicline