A double blind randomized controlled trial investigating efficacy and safety of varenicline for smoking cessation in patients with type 2 diabetes: study protocol

Russo, Cristina; Caponnetto, Pasquale; Cibella, Fabio; Maglia, Marilena; Alamo, Angela; Campagna, Davide; Frittitta, Lucia; Mauro, M. Di; Leotta, C; Mondati, Enrico; Krysinski, Arkadiusz; Franek, Edward; Polosa, Riccardo

doi:10.1007/s11739-021-02684-1

Cited by 3 publications

(2 citation statements)

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“…The 12-week treatment phase was followed by a 40-week nontreatment phase (Figure 2). Details of the trial design and protocol were described in a previous publication …”

Section: Methodsmentioning

confidence: 99%

“…Details of the trial design and protocol were described in a previous publication. 26 After screening, eligible patients were invited to attend the baseline visit (visit 1), during which the eligibility criteria were reviewed and patients were randomized 1:1 to either varenicline or placebo. The list for treatment randomization was generated using SAS software (SAS Institute).…”

Section: Trial Design and Study Visitsmentioning

confidence: 99%

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Efficacy and Safety of Varenicline for Smoking Cessation in Patients With Type 2 Diabetes

et al. 2022

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IMPORTANCEEvidence of effective smoking cessation interventions in patients with diabetes is limited. The unique behavioral and metabolic characteristics of smokers with type 2 diabetes warrants a randomized clinical trial of the smoking cessation drug varenicline. OBJECTIVE To evaluate the efficacy and safety of varenicline in patients with type 2 diabetes with an intention to quit smoking. DESIGN, SETTING, AND PARTICIPANTS This multicenter, double-blind, placebo-controlled randomized clinical trial recruited patients from 6 outpatient clinics in 5 hospitals in Catania, Italy.Patients with type 2 diabetes, who were smoking at least 10 cigarettes a day, and who intended to quit smoking were screened for eligibility. Eligible patients were randomized to either varenicline or placebo treatment. The trial consisted of a 12-week treatment phase followed by a 40-week follow-up, nontreatment phase. Intention-to-treat data analysis was performed from December 2020 to April 2021. INTERVENTIONSVarenicline, 1 mg, twice daily or matched placebo administered for 12 weeks.Patients in both treatment groups also received smoking cessation counseling. MAIN OUTCOMES AND MEASURESThe primary efficacy end point of the study was the continuous abstinence rate (CAR) at weeks 9 to 24. Secondary efficacy end points were the CAR at weeks 9 to 12 and weeks 9 to 52 as well as 7-day point prevalence of abstinence at weeks 12, 24, and 52. RESULTSA total of 300 patients (mean [SD] age, 57.4 [0.8] years; 117 men [78.0%] in varenicline group and 119 men [79.3%] in placebo group) were randomized to receive varenicline (n = 150) or placebo (n = 150). The CAR at weeks 9 to 24 was significantly higher for the varenicline than placebo group (24.0% vs 6.0%; odds ratio [OR], 4.95; 95% CI, 2.29-10.70; P < .001). The CARs at weeks 9 to 12 (31.3% vs 7.3%; OR, 5.77; 95% CI, 2.85-11.66; P < .001) and weeks 9 to 52 (18.7% vs 5.3%; OR, 4.07; 95% CI, 1.79-9.27; P < .001) as well as the 7-day point prevalence of abstinence at weeks 12, 24, and 52 were also significantly higher for the varenicline vs placebo group. The most frequent adverse events occurring in the varenicline group compared with the placebo group were nausea (41 [27.3%] vs 17 [11.4%]), insomnia (29 [19.4%] vs 19 [12.7%]), abnormal dreams (19 [12.7%] vs 5 [3.4%]), anxiety (17 [11.4%] vs 11 [7.3%]), and irritability (14 [9.4%] vs 8 [5.4%]). Serious adverse events were infrequent in both groups and not treatment-related. (continued) Key Points Question Is varenicline efficacious and safe in achieving long-term abstinence in patients with type 2 diabetes who are willing to quit smoking? Findings In this randomized clinical trial involving 300 patients with type 2 diabetes who smoked, varenicline was efficacious at weeks 12, 24, and 52 of the trial compared with placebo. Nausea, insomnia, abnormal dreams, anxiety, and irritability were reported at higher frequency among patients in the varenicline vs placebo group. No treatment-related serious adverse events were noted. Meaning Findings of this ...

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“…The 12-week treatment phase was followed by a 40-week nontreatment phase (Figure 2). Details of the trial design and protocol were described in a previous publication …”

Section: Methodsmentioning

confidence: 99%

Section: Trial Design and Study Visitsmentioning

confidence: 99%

Efficacy and Safety of Varenicline for Smoking Cessation in Patients With Type 2 Diabetes

et al. 2022

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Nicotine receptor partial agonists for smoking cessation

Livingstone‐Banks

Fanshawe

Thomas

et al. 2023

Cochrane Database of Systematic Reviews

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Background Nicotine receptor partial agonists may help people to stop smoking by a combination of maintaining moderate levels of dopamine to counteract withdrawal symptoms (acting as an agonist) and reducing smoking satisfaction (acting as an antagonist). This is an update of a Cochrane Review first published in 2007. Objectives To assess the effectiveness of nicotine receptor partial agonists, including varenicline and cytisine, for smoking cessation. Search methods We searched the Cochrane Tobacco Addiction Group's Specialised Register in April 2022 for trials, using relevant terms in the title or abstract, or as keywords. The register is compiled from searches of CENTRAL, MEDLINE, Embase, and PsycINFO. Selection criteria We included randomised controlled trials that compared the treatment drug with placebo, another smoking cessation drug, e‐cigarettes, or no medication. We excluded trials that did not report a minimum follow‐up period of six months from baseline. Data collection and analysis We followed standard Cochrane methods. Our main outcome was abstinence from smoking at longest follow‐up using the most rigorous definition of abstinence, preferring biochemically validated rates where reported. We pooled risk ratios (RRs), using the Mantel‐Haenszel fixed‐effect model. We also reported the number of people reporting serious adverse events (SAEs). Main results We included 75 trials of 45,049 people; 45 were new for this update. We rated 22 at low risk of bias, 18 at high risk, and 35 at unclear risk. We found moderate‐certainty evidence (limited by heterogeneity) that cytisine helps more people to quit smoking than placebo (RR 1.30, 95% confidence interval (CI) 1.15 to 1.47; I 2 = 83%; 4 studies, 4623 participants), and no evidence of a difference in the number reporting SAEs (RR 1.04, 95% CI 0.78 to 1.37; I 2 = 0%; 3 studies, 3781 participants; low‐certainty evidence). SAE evidence was limited by imprecision. We found no data on neuropsychiatric or cardiac SAEs. We found high‐certainty evidence that varenicline helps more people to quit than placebo (RR 2.32, 95% CI 2.15 to 2.51; I 2 = 60%, 41 studies, 17,395 participants), and moderate‐certainty evidence that people taking varenicline are more likely to report SAEs than those not taking it (RR 1.23, 95% CI 1.01 to 1.48; I 2 = 0%; 26 studies, 14,356 participants). While point estimates suggested increased risk of cardiac SAEs (RR 1.20, 95% CI 0.79 to 1.84; I 2 = 0%; 18 studies, 7151 participants; low‐certainty evidence), and decreased risk of neuropsychiatric SAEs (RR 0.89, 95% CI 0.61 to 1.29; I 2 = 0%; 22 studies, 7846 participants; low‐certainty evidence), in both cases evidence was limited ...

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