Abstract
Background
Although a concise overview of adverse drug reactions (ADRs) to varenicline is available, little is known about the use of varenicline in daily practice and time-related information about ADRs.
Objective
The aim of this study was to gain insight in the safety and use of varenicline in daily practice.
Methods
A prospective, observational, non-interventional cohort study was performed. The study population was defined as first-time users recruited through participating pharmacies between 1 December 2008 and 31 March 2012. Patients could sign up for the study on a dedicated website. Web-based questionnaires were sent after 1, 2 and 6 weeks, 3 months and 4 months after patients started to use varenicline. Questions were asked about drug use and ADRs. Information about the ADR, its seriousness and the action taken when experiencing an ADR was gathered.
Results
A total of 1,418 patients signed up for the study. The response rates for the various questionnaires varied from 31.3 to 62.5 %. At least one ADR was reported by 58.8 % of the patients. The most frequently reported ADRs were nausea (30.8 %), abdominal pain (11.2 %) and abnormal dreaming (10.4 %). Most patients did not stop taking varenicline when they experienced these ADRs. The median latency times for ADRs reported more than 50 times were 3–7 days, with an exception for depressed mood, which had a latency time of 10 days.
Conclusion
This prospective cohort study has given insight into latency time and action taken with varenicline when ADRs occur during treatment with varenicline in daily practice. It confirms the ADR pattern detected prior to marketing of the drug.
Similar content being viewed by others
References
Harmark L, van Grootheest K. Web-based intensive monitoring: from passive to active drug surveillance. Expert Opin Drug Saf. 2012;11(1):45–51.
Harmark L, van Puijenbroek E, Straus S, van Grootheest K. Intensive monitoring of pregabalin: results from an observational, Web-based, prospective cohort study in the Netherlands using patients as a source of information. Drug Saf. 2011;34(3):221–31.
Harmark L, van Puijenbroek E, van Grootheest K. Intensive monitoring of duloxetine: results of a web-based intensive monitoring study. Eur J Clin Pharmacol. 2013;69:209–15.
European summary of product characteristics for varenicline [in Dutch]. Version date 21 Jan 2014. http://www.ema.europa.eu/docs/nl_NL/document_library/EPAR-Product_Information/human/000699/WC500025251.pdf. Accessed 28 March 2014.
Kasliwal R, Wilton LV, Shakir SAW. Safety and drug utilization profile of varenicline as used in general practice in England: interim results from a prescription-event monitoring study. Drug Saf. 2009;32(6):499–507.
Stapleton JA, Watson L, Spirling LI, Smith R, Milbrandt A, Ratcliffe M, et al. Varenicline in the routine treatment of tobacco dependence: a pre-post comparison with nicotine replacement therapy and an evaluation in those with mental illness. Addiction. 2008;103(1):146–54.
CIOMS Working Group IV. Benefit-risk balance for marketed drugs: evaluating safety signals. Geneva: CIOMS; 1998. http://www.cioms.ch/publications/g4-benefit-risk.pdf. Accessed 20 Nov 2013.
MedDRA. http://www.meddra.org/. Accessed 28 March 2014.
Z-Index. http://www.z-index.nl/english. Accessed 28 March 2014.
Stichting Farmaceutische Kengetallen. http://www.sfk.nl/over-de-sfk. Accessed 28 March 2014.
Centraal Bureau voor de Statistiek. Smokers smoke for 24 years on average [in Dutch]. 2003. http://www.cbs.nl/nl-NL/menu/themas/gezondheid-welzijn/publicaties/artikelen/archief/2003/2003-1204-wm.htm. Accessed 20 Nov 2013.
Harmark L, Lie-Kwie M, Berm L, de Gier H, Van Grootheest K. Patients’ motives for participating in active post-marketing surveillance. Pharmacoepidemiol Drug Saf. 2013;22(1):70–6.
Varenicline. Procedural steps taken and scientific information after the authorisation. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Procedural_steps_taken_and_scientific_information_after_authorisation/human/000699/WC500025256.pdf. Accessed 28 March 2014.
Thomas KH, Martin RM, Davies NM, Metcalfe C, Windmeijer F, Gunnell D. Smoking cessation treatment and risk of depression, suicide, and self harm in the Clinical Practice Research Datalink: prospective cohort study. BMJ. 2013;347:f5704.
NHG standard M85. Quitting smoking; 2012 [in Dutch]. http://nhg.artsennet.nl/kenniscentrum/k_richtlijnen/k_nhgstandaarden/NHGStandaard/M85_std.htm#N65909. Accessed 28 March 2014.
Harmark L, Huls H, de Gier H, van Grootheest AC. Non-response in a pharmacy and patient based intensive monitoring system. PEDS. 2012;21(8):Supplement 212.
Borg JJ, Aislaitner G, Pirozynski M, Mifsud S. Strengthening and rationalizing pharmacovigilance in the EU: where is Europe heading to? A review of the new EU legislation on pharmacovigilance. Drug Saf. 2011;34(3):187–97.
Acknowledgments
The authors would like to thank all patients who participated in this study.
Funding and Conflicts of Interest
No sources of funding were used to conduct this study or prepare this manuscript. Ingrid Oosterhuis, Linda Härmark and Eugène van Puijenbroek have no conflicts of interest that are directly relevant to the content of this study.
Author information
Authors and Affiliations
Corresponding author
Electronic Supplementary Material
Below is the link to the electronic supplementary material.
Rights and permissions
About this article
Cite this article
Oosterhuis, I., Härmark, L. & van Puijenbroek, E. Experiences with the Use of Varenicline in Daily Practice in the Netherlands: A Prospective, Observational Cohort Study. Drug Saf 37, 449–457 (2014). https://doi.org/10.1007/s40264-014-0166-7
Published:
Issue Date:
DOI: https://doi.org/10.1007/s40264-014-0166-7