A nurse-led, family-based preventive cardiology program in high-risk patients that included the use of varenicline (Chantix, Pfizer) cut smoking rates in half when compared with usual care, according to the results of a new study . In addition, patients also improved their diet, exercised more, and did not gain any weight when treated with varenicline on top of usual care.
The study, known as EUROACTION PLUS, is a follow-up to a similar study known as EUROACTION, with the exception that the patients from the 20 general practices enrolled in the newest study had the option of receiving varenicline at the discretion of the treating physician. In all, 95% of those in the intervention arm received the smoking-cessation medication.
“We started this study because the first EUROACTION study was not successful in terms of smoking cessation,” Dr Kornelia Kotseva (Imperial College London, UK) told heartwire. “We included a specially designed smoking-cessation program with the option of using varenicline, which, for the time being, has been shown to have the best effect in terms of smoking cessation. The results are similar to the other clinical trials with varenicline, but the advantage of EUROACTION PLUS is that we actually showed this can be done in everyday clinical practice.”
Presented at EuroPrevent 2012, EUROACTION PLUS included 696 patients with vascular disease or those at high risk for vascular events as well as their partners. The mean patient age was 60 years old, and roughly 40% of participants in the study were women. Varenicline was given one week before the patient’s selected quit date and titrated up to 1 mg twice per day. In addition to the focused attention on smoking cessation, the family-based program included assistance with healthy eating habits, weight management, and physical activity.
At 16 weeks, 51% of the smokers had stopped smoking (validated by breath carbon monoxide <10 ppm) compared with 19% of subjects randomized to usual care. Patients treated with varenicline in the family-based program were nearly five times more likely to quit smoking compared with their usual-care counterparts (odds ratio 4.52; 95% CI 3.20-6.39). In addition, smoking-cessation rates were also significantly higher in the partners of treated patients. Excluding randomized patients who chose not to participate in the study or who dropped out, 62% of patients in the intervention arm quit smoking at 16 weeks. The benefit of treatment was observed across all subgroups, including patients with vascular disease and those at high risk for vascular events.
In addition to quitting smoking, the varenicline-treated patients were significantly more likely to adhere to the Mediterranean diet; eat the recommended daily servings of fish, fruits, and vegetables; and achieve blood pressures of <140/90 mm Hg (or <130/80 for vascular-disease patients).
In EUROACTION PLUS, There was no observed increase in depression, an important finding given previous concerns about the neuropsychiatric effects of the drug. In October 2011, the US Food and Drug Administration published a review of two epidemiological studies evaluating the risk of neuropsychiatric adverse events associated with varenicline and nicotine-replacement therapy and concluded there was no difference between the two smoking-cessation therapies. It still urged caution, however, stating that healthcare professionals should continue to follow the recommendations in the physician label and to monitor for neuropsychiatric symptoms when prescribing varenicline.
To heartwire, Kotseva said that simply prescribing pharmacotherapy is not sufficient and that all patients should be part of a preventive cardiology-type program that will allow them access to psychological and physical support to aid their quitting attempt. “Pharmacotherapy is important because smoking is quite a difficult behavior to change,” added Kotseva. “It’s very difficult for smokers to stop smoking, and in most cases they need some sort of comprehensive program, one that includes behavioral therapy and education.”
She added that as many as 50% of patients will return to smoking within the year. The EUROACTION PLUS researchers intend to follow patients out to one year, depending on funding, but two countries involved in the study, Italy and Spain, have resources committed for long-term follow-up.