Whilst some of the data in this paper have been submitted to Medsafe (NZ Ministry of Health) and the NZ Medicines Adverse Reactions Committee (MARC) for confidential review, this report has not been published elsewhere nor submitted anywhere else for consideration of publication.
Article first published online: 2 JUL 2010
Copyright © 2010 John Wiley & Sons, Ltd.
Pharmacoepidemiology and Drug Safety
Volume 19, Issue 9, pages 949–953, September 2010
How to Cite
Harrison-Woolrych, M. and Ashton, J. (2010), Utilization of the smoking cessation medicine varenicline: an intensive post-marketing study in New Zealand. Pharmacoepidem. Drug Safe., 19: 949–953. doi: 10.1002/pds.2003
Authors declare no conflict of interest.
- Issue published online: 25 AUG 2010
- Article first published online: 2 JUL 2010
- Manuscript Accepted: 27 MAY 2010
- Manuscript Revised: 25 MAY 2010
- Manuscript Received: 14 APR 2010
- smoking cessation medicines;
- post-marketing use
To examine the utilization of varenicline during the first year of marketing in New Zealand (NZ) and to examine how this compares with the dosing instructions recommended in the Champix® product information.
Dispensing records for all NZ patients prescribed varenicline were collected by the Intensive Medicines Monitoring Programme (IMMP) during the first year this medicine was available in this country. Analyses of these data included patient characteristics and patterns of usage—in particular the duration of treatment dispensed as the first course. An assessment of the effectiveness of varenicline in post-marketing use was also performed on a sub-group of the cohort for whom follow-up information was available.
Of 3415 patients in the first year IMMP cohort, only 125 patients (4%) were dispensed the recommended 12 weeks varenicline treatment. 1299 (38%) were dispensed 14 days treatment (most often as a Starter Pack), 766 (22%) were dispensed 6 weeks, 411 (12%) were dispensed 4 weeks and 332 (8%) patients were dispensed more than 12 weeks treatment as a continuous course. The most common reasons for stopping varenicline prematurely were adverse reactions and cost of treatment. In a subgroup of 1299 patients, varenicline was reported to have been effective for 359 (28%) patients.
In ‘real-life’ post-marketing use, most patients did not receive 12 weeks varenicline treatment as recommended in the Champix product information. This observation may have implications for the effectiveness of this smoking cessation medicine. Copyright © 2010 John Wiley & Sons, Ltd.