A dosage increase may provide longer-term benefit for smokers receiving varenicline or combination nicotine replacement therapy who are nonabstinent after six weeks, according to a study published online May 2 in the Journal of the American Medical Association.

Paul M. Cinciripini, Ph.D., from the University of Texas MD Anderson Cancer Center in Houston, and colleagues evaluated the best subsequent strategy for nonabstinence following initial treatment with varenicline (2 mg/day) or combined nicotine replacement therapy (CNRT; 21-mg patch plus 2-mg lozenge) for six weeks. Nonabstainers were re-randomly assigned to continue, switch treatments, or increase medication dosage for an additional six weeks.

The researchers reported that the end-of-treatment abstinence rate for the 191 phase 1 nonabstainers in the CNRT group was 8 percent for the 90 participants who continued at the dosage condition, 14 percent for the 50 who increased their dosage, and 14 percent for the 51 who switched to varenicline (absolute risk difference [RD], 6 percent), with >99 percent posterior probability that either strategy conferred benefit over continuing the initial dosage. The end-of-treatment abstinence rate for the 157 phase 1 nonabstainers in the varenicline group was 20 percent for the 39 who increased their varenicline dosage, 0 percent for the 41 who switched to CNRT, and 3 percent for the 77 who were assigned to the continued varenicline condition (absolute RD, −3 percent), with >99 percent posterior probability that continuing varenicline at the initial dosage was worse than switching to a higher dosage. Increasing the varenicline dosage had an absolute RD of 18 percent and >99 percent posterior probability of conferring benefit. Only increased dosages of the CNRT and varenicline provided benefit over continuation of the initial treatment dosages for the secondary outcome of continuous abstinence at six months.

“Relative to continuing the same medication, no evidence was found for increased risk of adverse events with the dosage increase for either medication,” the authors write.

Varenicline and matching placebo were provided by Pfizer.

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