Table 1.
Study Characteristics for Studies Included in the Meta-Analysis ( k = 16; Total n = 6710)
| First author | Data source | Sample a | % Female a | % Caucasian a | Varenicline duration (wk) | Study duration (wk) | Varenicline dose b | Outcomes | Study location(s) | Sample | Study notes |
|---|---|---|---|---|---|---|---|---|---|---|---|
| Gonzales et al. 20 | P | 696 | 48 | 78 | 12 | 52 | 1mg bid | PP-12,24,52; CA-12,24,52 | United States | Adults | — |
| Jorenby et al. 21 | P | 685 | 43 | 85 | 12 | 52 | 1mg bid | PP-12,24,52; CA-12,24,52 | United States | Adults | — |
| Nides et al. 47 | P | 254 | 49 | 86 | 6 | 52 | 0.3mg qd, 1.0mg qd, or 1.0mg bid | PP-12; CA-12 | United States | Adults | — |
| Oncken et al. 40 | P | 388 | 50 | 79 | 12 | 52 | 0.5mg bid or 1mg bid | PP-12, CA-12 | United States | Adults | — |
| Nakamura et al. 43 | P | 310 | 21 | — | 12 | 52 | 1mg bid | PP-12,24,52; CA-12,24,52 | Japan | Adults | — |
| Tsai et al. 42 | P | 250 | 11 | — | 12 | 24 | 1mg bid | PP-12,24; CA-12,24 | Korea, Taiwan | Adults | — |
| Williams et al. 48 | P | 377 | 50 | 89 | 52 | 53 | 1mg bid | PP-12 | United States | Adults | 1 |
| Niaura et al. 41 | P | 320 | 48 | 90 | 12 | 52 | 0.25–1.0mg bid | PP-12,24,52; CA-12,24,52 | United States | Adults | 2 |
| Wang et al. 45 | P | 333 | 3 | 0 | 12 | 24 | 1mg bid | PP-12,24; CA-12,24 | China, Singapore, Thailand | Adults | — |
| Fagerström et al. 46 | P | 431 | 11 | — | 12 | 26 | 1mg bid | PP-12; CA-12,24 | Norway, Sweden | Adults | 3 |
| Rigotti et al. 44 | P | 703 | 21 | 81 | 12 | 52 | 1mg bid | PP-12,24,52; CA-12,24,52 | 15 countries c | Adults with CVD | — |
| Bolliger et al. 32 | P | 593 | 40 | 30 | 12 | 26 | 1mg bid | PP-12,24; CA-12,24 | 11 countries d | Adults | — |
| Steinberg et al. 50 | A | 79 | 41 | 72 | 12 | 24 | 1mg bid | PP-12,24 | United States | Hospitalized adults | — |
| Tashkin et al. 29 | P | 504 | 38 | 83 | 12 | 52 | 1mg bid | PP-12,24,52; CA-12,24,52 | France, Italy, Spain, United States | Adults with COPD | — |
| Rennard et al. 33 | P | 659 | 40 | 68 | 12 | 24 | 1mg bid | PP-12,24; CA-12,24 | 14 countries e | Adults | 4 |
| Williams et al. 49 | P | 128 | 23 | 59 | 12 | 24 | 1mg bid | PP-12,24; CA-12 | United States | Adults with SZ/SZA | — |
AUD = alcohol use disorders, CVD = cardiovascular disease, COPD = chronic obstructive pulmonary disease, SZ = schizophrenia, SZA = schizoaffective disorder. Data source: A = author; P = Pfizer. Outcomes: PP-12 = point prevalence abstinence weeks 9–12, PP-24 = point prevalence abstinence weeks 9–24, PP-52 = point prevalence abstinence weeks 9–52, CA-12 = continuous abstinence weeks 9–12, CA-24 = continuous abstinence weeks 9–24, CA-52 = continuous abstinence weeks 9–52.
a Sample size, % female, and % Caucasian are presented for the sample included in the analyses. Participants in studies who were given a treatment other than varenicline or placebo (eg, bupropion) were not included in these estimates. As a result, numbers may differ from data published in the relevant citation. All studies analyzed intent-to-treat samples except 44,47,49 which analyzed starters.
b Dose reflects steady-state dose after titration.
c Argentina, Australia, Brazil, Canada, Czech Republic, Denmark, France, Germany, Greece, Mexico, the Netherlands, Republic of Korea, Taiwan, United Kingdom, and United States.
d Brazil, Colombia, Costa Rica, Egypt, Jordan, Lebanon, Mexico, Saudi Arabia, South Africa, United Arab Emirates, and Venezuela.
e Argentina, Brazil, Canada, China, Czech Republic, France, Germany, Hungary, Italy, Mexico, Republic of Korea, Taiwan, United Kingdom, and United States.
Study notes:
1. Long-term safety study where participants received 52 weeks of varenicline or placebo; only data from week 12 outcomes were included in analyses.
2. Flexible dosing study.
3. Smokeless tobacco study.
4. Flexible quit date study (ie, participants could choose to quit smoking any time from 8 to 35 days after starting the study medication).