ASSESSMENT OF SAFETY FOR BROMOCRIPTINE- COMPARISONS OF REPORTING SYSTEMS AND A RETROSPECTIVE COHORT STUDY
Author(s)
Wildon R Farwell, MD, MPH, Investigator1, Elizabeth Lawler, ScD, Associate Researcher2, Luke Boulanger, MA, MBA, Director of Health Economics3, Anthony H Cincotta, PhD, Investigator1, Richard E Scranton, MD, MPH, Investigator11VeroScience LLC, Tiverton, RI, USA; 2 VA Boston Healthcare System, Boston, MA, USA; 3 Abt Associates Inc, Lexington, MA, USA
Objective: Because of recent attention to public adverse event reporting systems, we assessed findings from published case reports and adverse drug reactions reported to the World Health Organization (WHO) Programme for International Drug Monitoring and findings from an analysis of patients in the General Practice Research Database (GPRD) regarding bromocriptine and risk of myocardial infarction and stroke (CVD). Methods: We tallied reports of adverse CVD events related to bromocriptine in the medical literature using PubMed (years 1950-2007) and from the WHO (years 1997-2006). Global person-year exposure to bromocriptine was estimated using data from IMS. Next, we conducted a retrospective matched cohort study using data from the GPRD (years 1990-2006). Age- and multivariate-adjusted Cox proportional hazard models were constructed to calculate a hazard ratio (HR) and 95% confidence interval (CI) of CVD events among bromocriptine users compared to controls. Results: We identified 24 CVD events published in the worldwide medical literature and 56 CVD events reported to the WHO over an estimated 19.3 million person-years of bromocriptine exposure. At least 92% of reported CVD events were among women in either data set. In our GPRD cohort, 88% of patients exposed to bromocriptine for any specified indication were women. After multivariate adjustment, patients exposed to bromocriptine appeared to have lower risk of a CVD event, although not statistically significant, HR 0.82 (95% CI 0.29 to 2.31). Gender was not a significant confounder in the multivariate model. Conclusion: Using public reporting systems, CVD events appear to occur infrequently among patients taking bromocriptine but predominately among women. Results from our GPRD analysis are not consistent with an increased risk of CVD events among patients taking bromocriptine; rather, they suggest a decreased risk. These findings highlight the need for careful epidemiologic study to consider the potential risks associated with bromocriptine specifically and medications in general.
Conference/Value in Health Info
2008-05, ISPOR 2008, Toronto, Ontario, Canada
Value in Health, Vol. 11, No. 3 (May/June 2008)
Code
PCV24
Topic
Epidemiology & Public Health
Topic Subcategory
Safety & Pharmacoepidemiology
Disease
Cardiovascular Disorders