High abstinence likelihood with varenicline plus nicotine replacement therapy lozenges

Key takeaways:

• Varenicline plus oral nicotine replacement therapy led to high odds for self-reported abstinence at 6 and 12 months vs. varenicline only.
• Both groups had comparable treatment-related adverse events.

Hospitalized smokers who received varenicline plus nicotine replacement therapy lozenges had an increased likelihood for abstinence, according to a presentation at the European Respiratory Society International Congress.

“Varenicline may be used in combination with oral nicotine replacement for better cessation outcomes,” Michael J. Abramson, PhD, professor of clinical epidemiology, public health and preventive medicine at Monash University, said during his presentation. “Combination therapy was effective on the self-reported outcomes and well tolerated.”

In a randomized, double-blind, placebo-controlled trial, Abramson and colleagues analyzed 320 hospitalized adults (mean age, 52.5 years; 57.2% men) who had a smoking history of 10 or more cigarettes a day 1 month before being hospitalized to compare smoking abstinence rates between two treatments: varenicline plus nicotine replacement therapy lozenges vs. varenicline alone.

While hospitalized, every patient received a standard dose of varenicline which consisted of once-a-day 0.5 mg varenicline on day 1 to day 3, 0.5 mg twice a day on day 4 to day 7 and 1 mg twice a day on day 8 through 11 weeks. Researchers also gave nicotine replacement therapy lozenges (2 mg) to 160 patients (mean age, 53.4 years; 57.5% men) for when they felt like they wanted to smoke, whereas the remainder of patients (n = 160; mean age, 51.5 years; 56.9% men) had placebo lozenges.

For patients who succeeded in quitting, Abramson said they offered varenicline (1 mg twice a day) for an additional 12 weeks.

Regardless of treatment group, every adult received an offer for behavioral support, according to researchers.

At baseline, Abramson noted more patients receiving placebo had moderate nicotine dependence than patients receiving combination therapy (70.9% vs. 64.2%), and fewer patients in the placebo group tried quitting within the last 12 months (32.3% vs. 43.4%).

Using logistic regression models adjusted for heaviness of smoking index score at baseline, researchers found that patients receiving combination therapy had better self-reported and biochemically verified abstinence rates compared with patients receiving varenicline alone.

In terms of self-reporting, patients in the combination therapy group had higher odds for 7-day point prevalence smoking abstinence at 6 months (adjusted OR = 1.75; 95% CI, 1.06-2.87) and 12 months (aOR = 1.85; 95% CI, 1.1-3.13) vs. monotherapy. Researchers also observed significant increased odds for self-reported prolonged abstinence at 12 months with varenicline plus nicotine replacement therapy (aOR = 1.87; 95% CI, 1.1-3.18).

Despite not reaching statistical significance, patients receiving combination therapy vs. monotherapy demonstrated a trend toward a higher likelihood for biochemically verified prolonged abstinence at 12 months (aOR = 2.79; 95% CI, 0.97-8.08).

Patients from both groups reported comparable treatment-related adverse events, such as nausea, abnormal dreams and trouble sleeping at night, Abramson said.

In regard to limitations, Abramson highlighted two areas of the study.

“The limitations [of this study] were that the blinding of the intervention might not have been perfect; nicotine has a very distinctive taste,” Abramson said in his presentation. “And unfortunately, only a minority could have biochemical confirmation of their abstinence because of the restrictions imposed by the pandemic.

“Further studies of combination pharmacotherapy are required in other groups of patients,” Abramson concluded.