|
Safety profile of varenicline as used in general practice in England: interim results from a prescription-event monitoring study
Rachna Kasliwal, Clinical Research Fellow, Drug Safety Research Unit,
Southampton, UK
Abstract
A post-marketing safety study is being conducted, on varenicline, using the observational cohort technique of Modified Prescription-Event Monitoring. Patients are identified from dispensed prescriptions issued by general practitioners (GPs). Demographic and clinical-event data (events during course or 1 month after stopping varenicline, reasons for discontinuing and suspected adverse drug reactions [ADRs] to varenicline) are collected from questionnaires posted to GPs at least 4 months after the date of 1st prescription for each patient.
Interim cohort: 2,682 patients, median age 47 years; 60.7% females (1,627).
Most frequent events (causality not implied) reported during the course of varenicline included (n; % of cohort): nausea/vomiting (217; 8.1%), headache/migraine (48; 1.8%), sleep disorder (45; 1.7%), malaise/lassitude (44; 1.6%), anxiety and depression (both 28; 1.0%). Two cases of suicidal attempt were reported during treatment with varenicline (both patients had previous history of psychiatric illness).
Nausea/vomiting was the most frequent clinical reason for stopping varenicline (n=90; 35.3% of clinical reasons) and the most frequently reported suspected ADR to varenicline (n=59, 50.9% of patients for whom an ADR was reported).
This study examined the ‘real life’ use of varenicline. Results presented are expected to change as the cohort size increases. Further evaluation of events of interest is ongoing.
|
