Patients who smoked and were hospitalized for chronic obstructive pulmonary disease (COPD) exacerbation had higher rates of continuous abstention when treated with both varenicline and intensive counseling compared with intensive counseling alone at 12 weeks, according to study results published in COPD.
Researchers conducted the SAVE clinical trial (Efficacy of Varenicline on Smoking Cessation at the Acute Phase of an Exacerbation of Chronic Obstructive Pulmonary Disease; ClinicalTrials.gov Identifier: NCT01694732) to determine whether early initiation of varenicline in patients who smoked and were hospitalized for a COPD exacerbation was associated with a higher rate of continuous abstention. These rates from smoking at Week 52 were measured in patients hospitalized for COPD exacerbations following treatment with either varenicline for 12 weeks and intensive counseling, or intensive counseling and placebo.
Continuous abstainers were defined as patients who achieved smoking cessation during the last weeks of treatment; who had exhaled carbon monoxide level <10 ppm at each clinic visit; smoked <6 cigarettes from Week 12 to 52; and achieved complete smoking cessation during the previous 7 days before Week 52.
Of the 1030 patients admitted to the emergency room of 10 hospitals for COPD exacerbation, 81 met the inclusion and exclusion criteria and were randomly assigned to either varenicline (n=42) or placebo (n=39) groups. At 12 weeks, 19 patients (50%) and 10 patients (27%) were abstainers in the varenicline and placebo groups, respectively. By Week 52 of follow-up, the same number of patients had achieved continuous abstention in each group (n=10; 25.6%). Therefore, the researchers concluded that the benefit was not sustained after varenicline discontinuation.
One major study limitation was the small sample size that resulted because of the premature interruption of pharmaceutical funding. Regardless, the primary outcome was similar between the 2 groups without any superiority trends.
According to the researchers, the optimal time to begin smoking cessation in COPD remains unclear.
Disclosure: This clinical trial was supported by Pfizer France. Please see the original reference for a full list of authors’ disclosures.
Le Mao R, Tromeur C, Paleiron N, et al. Effect of early initiation of varenicline on smoking cessation in COPD patients admitted for exacerbation: the Save randomized clinical trial [published online December 19, 2019]. COPD. doi:10.1080/15412555.2019.1703928