Smoking in Cancer Care (PDQ®): Supportive care - Health Professional Information [NCI] - Pharmacological Treatment
Table 4. Nicotine Patches continued...
In June 2011, the FDA updated the prescribing information label for varenicline to warn that the drug may increase the risk of cardiovascular adverse events in patients who have cardiovascular disease. In December 2012, the FDA updated the drug safety information for varenicline to include the results of a large meta-analysis that evaluated cardiovascular adverse events in patients who received either varenicline or placebo. Although a higher occurrence of adverse cardiovascular events that was not statistically significant was reported, there was an increased risk in patients using varenicline over those treated with placebo.
In a pooled analysis of two randomized studies (total N = 2,052) in which varenicline was directly tested against bupropion SR and a placebo, results showed continuous abstinence rates of 44% with varenicline, 29.7% with bupropion SR, and 17.7% with placebo at weeks 9 through 12. Abstinence rates were followed through week 52 at study end, with varenicline at 22.4%, bupropion SR at 15.4%, and placebo at 9.3%. Factors found in previous studies to predict better quit rates—such as being older, being male, having a lower level of nicotine dependence, smoking fewer baseline cigarettes, and having the first cigarette of the day at a later time—were not found to be predictive of higher quit rates in this pooled analysis.
Table 5. Varenicline
|bid = twice a day; Rx = prescription.|
|a It is recommended that clinicians closely monitor all patients taking varenicline and bupropion hydrochloride (HCl). The premarketing smoking cessation studies of these medications excluded patients with serious psychiatric illness (e.g., schizophrenia, bipolar disorder, and major depressive disorder), suggesting that the safety of these medications for these patients has not been investigated.[15,18]Therefore, during smoking cessation, it is important to especially monitor patients with preexisting psychiatric illness who are receiving varenicline and bupropion HCl for smoking cessation.|
|Rx||Chantix||0.5 mg/d, days 1–3; 0.5 mg bid, days 4–7; then 1.0 mg bid through week 12||Nausea, insomnia||Risk of toxicity higher in patients with impaired renal function.|
|Not tested in children and pregnant women.|