Varenicline 1mg tablets

AimsTo assess whether combining nicotine replacement therapy (NRT) with varenicline improves long-term smoking cessation rates compared with varenicline or NRT alone.MethodSystematic review and meta-analysis of randomized controlled trials (RCTs) or quasi-RCTs, conducted according to PRISMA guidelines. A comprehensive literature search of PubMed, MEDLINE, EMBASE, Web of Science and the Cochrane Central Register of Controlled Trials was conducted through June 2025. The primary outcome was smoking abstinence at the longest follow-up (≥6 months). Secondary outcomes included adverse events (AEs) and serious adverse events (SAEs). Risk ratios (RRs) with 95% confidence intervals (CIs) were pooled using random-effects meta-analyses. The certainty of evidence was assessed using the GRADE approach. Risk of bias was assessed using the Cochrane RoB 2.0 tool. The protocol was pre-registered in the PROSPERO (registration number CRD42024600510).ResultsSeven trials including 2631 participants met inclusion criteria. Compared with varenicline alone, combination therapy was associated with statistically significantly higher abstinence rates at the longest follow-up (RR = 1.33, 95% CI = 1.04-1.69; 5 studies; I2 = 51%). A sensitivity analysis including trials with ≥3 months of follow-up yielded similar results (RR = 1.31, 95% CI = 1.06-1.62; 6 studies). However, when excluding the trial at high risk of bias, the result was not statistically significant (RR = 1.26, 95% CI = 0.94-1.68). Compared with NRT alone, only one RCT was included, and the effect of combination therapy on abstinence was not statistically significant (RR = 0.94, 95% CI = 0.51-1.72). AEs were more common with combination therapy compared with varenicline alone (RR = 1.11, 95% CI = 1.02-1.20). Specifically, skin reactions were significantly increased with NRT patch plus varenicline (RR = 1.67; 95% CI = 1.29-2.16). Compared with NRT alone, combination therapy was associated with increased AEs (RR = 1.23; 95% CI = 1.07-1.41). SAEs were infrequent and generally unrelated to treatment.ConclusionsLow-certainty evidence indicates that combining varenicline with nicotine replacement therapy may improve long-term smoking cessation rates compared with varenicline alone and is generally well tolerated.

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ObjectiveTo evaluate the comparative effectiveness and safety of pharmacological and non-pharmacological smoking cessation interventions in people with severe mental illness.DesignSystematic review and network meta-analysis.Data sourcesMedline, Embase, Scopus, Cochrane Central Register of Controlled Trials (CENTRAL), and Web of Science, from inception to 19 September 2024.Eligibility criteria for selecting studiesTrials enrolling adults who had established diagnoses of schizophrenia, bipolar disorder, recurrent or current severe major depressive disorder, or post-traumatic stress disorder, randomised to a smoking cessation intervention versus another active treatment, placebo, standard care, or no treatment.Results74 randomised controlled trials (11 023 participants) evaluating nine smoking cessation interventions were included in the study. Compared with placebo or minimal care, varenicline (10 more per 100 achieving long term smoking abstinence, 95% confidence interval (CI) 5 to 16; high certainty evidence) and bupropion (5 more per 100, 1 to 10; moderate certainty evidence) increased long term abstinence. Effects on short term smoking abstinence were similar. Nicotine replacement therapy improved short term abstinence but with little or no long term abstinence benefit (moderate certainty evidence). Combination interventions (pharmacological with non-pharmacological interventions) may increase long term abstinence (6 more per 100, 95% CI 3 to 11; low certainty evidence). The certainty of evidence for other interventions was very low. Serious adverse event data were highly uncertain. Dropout from a trial because of harms was possibly no different for varenicline, bupropion, and nicotine replacement therapy compared with placebo or minimal care.ConclusionsVarenicline, bupropion, and nicotine replacement therapy likely improved smoking abstinence in people with severe mental illness compared with placebo or minimal care (moderate to high certainty evidence). Combined pharmacological and non-pharmacological approaches may offer more benefit (low certainty evidence), but the risk of serious adverse events for all interventions was very uncertain.Systematic review registrationPROSPERO CRD42022349498.

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