Table 1.
Evidentiary Basis for Strong Recommendation Favoring Varenicline over Nicotine Patch, with Moderate-Certainty Evidence
| Certainty Assessment |
Number (or Percent) |
Effect (95% CI) |
Certainty | Importance | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| No. of Studies | Study Design | Risk of Bias | Inconsistency | Indirectness | Imprecision | Other Considerations | Varenicline | Nicotine Patch | Relative | Absolute (per 1,000 Patients) | ||
|
Seven-day point-prevalence tobacco abstinence at 6 mo (follow-up: 6 mo; assessed with self-report + exhaled carbon-monoxide concentration verification) | ||||||||||||
| 11 | RCT | Not serious | Not serious | Not serious | Not serious | None | 1,081/3,743 (28.9%) | 20.2% | RR, 1.20 (1.09–1.32) | 40 more (↑18–↑65) | High | Critical |
|
Point-prevalence tobacco abstinence during the treatment period (follow-up: range, 10–12 wk; assessed with self-report + exhaled carbon monoxide) | ||||||||||||
| 9 | RCT | Not serious | Not serious | Not serious | Not serious | None | 1,449/3,640 (39.8%) | 25.4% | RR, 1.40 (1.31–1.49) | 101 more (↑79–↑124) | High | Important |
|
Quality of life, not reported | ||||||||||||
| — | — | — | — | — | — | — | — | — | — | — | — | Important |
|
Serious adverse events (follow-up: range, 4 wk to 3 mo) | ||||||||||||
| 10 | RCT | Not serious | Not serious | Not serious | Serious | None | 61/3,799 (1.6%) | 1.1% | RR, 0.72 (0.52–1.00) | 3 fewer (↓5–↓0) | Moderate | Critical |
|
Tobacco-use relapse measured at the end of the follow-up (follow-up: range, 8 wk to 6 mo) | ||||||||||||
| 2 | RCT | Serious | Not serious | Not serious | Serious | None | —/491 | —/314 | HR, 0.93 (0.78–1.11) | N/A | Low | Important |
|
Other substance abuse, alcohol (follow-up: 6 mo; assessed with alcohol test [breath alcohol ≤ 0.02 g/dl]) | ||||||||||||
| 1 | RCT | Serious | Not serious | Not serious | Very serious | None | 8/49 (16.3%) | 29.0% | RR, 0.56 (0.24–1.30) | 128 fewer (↓221–↑87) | Very low | Important |
|
Other substance abuse, any drug (follow-up: 6 mo) | ||||||||||||
| 1 | RCT | Serious | Not serious | Not serious | Very serious | None | 18/49 (36.7%) | 25.8% | RR, 1.42 (0.71–2.87) | 108 more (↓75–↑483) | Very low | Important |
|
Severity of withdrawal, MNWS total (follow-up: 12 wk; assessed with MNWS; lower score indicates better outcome) | ||||||||||||
| 1 | RCT | Serious | Not serious | Not serious | Very serious | None | 14 | 14 | — | MD, 0.08 higher (↓1.98–↑2.14) | Very low | Important |
|
Severity of withdrawal, MNWS urge to smoke (follow-up: 7–12 wk; assessed with MNWS; lower score indicates better outcome) | ||||||||||||
| 2 | RCT | Serious | Serious | Not serious | Not serious | None | 381 | 380 | — | MD, 0.32 lower (↓0.33–↓0.31) | Low | Important |
Definition of abbreviations: ↑ = increase of; ↓ = decrease of; CI = confidence interval; HR = hazard ratio; MD = mean difference; MNWS = Minnesota Nicotine Withdrawal Scale; N/A = not available; RCT = randomized controlled trial; RR = relative risk.
Varenicline treatment was found to be superior to the patch in achieving continuous long-term abstinence and was associated with fewer adverse events. For complete evidence tables, together with references, explanations of certainty assessments, and results of the Evidence-to-Decision process, see online supplement.