Abstract
Background: Measuring the effectiveness of pharmacovigilance activities is challenging but important. Objectives: To investigate the feasibility of measuring impact of pharmacovigilance activities based on publically available data in the Netherlands for the safety signal of cyproterone acetate/ ethinylestradiol (Diane-35) and the risk of developing venous thromboembolism, pergolide, and valvular heart fibrosis (VHF) and rosiglitazone and cardiovascular events. Methods: No public datasets were available on the prevalence of either VTEs, moderate-to-severe valvular heart fibrosis (VHF), or cardiovascular events in diabetic patients. For Diane-35, the amount of prevented VTE cases in users after the pharmacovigilance (PV) activity in 2013 was estimated, taking into account possible switching to other combined oral contraceptives (COCs). For pergolide and rosiglitazone, a trend analyses for exposure using segmented regression analysis model was performed to estimate the risk for developing VHF or cardiovascular events in the exposed before and after the signal and PV activities. Results: Estimation of the relative risk (RR) was based on estimates from the literature. An RR of 3.9, 3.8, and 2.8 for Diane-35, the 3rd/4th and 2nd COCs were used, respectively. The number of Diane-35 users decreased from 180 000 in 2012 to 44 000 users in 2015. 74 VTE cases/year were estimated as prevented due to overall change in hormonal contraceptive usage after 2013. The used RR of VHF for pergolide exposure was 2.3 and 29 915 pergolide users discontinuing treatment between 2003 and 2013, resulting in an estimated 2752 prevented moderate-to-severe VHF cases. For RGZ, the available literature gave conflicting results regarding the increased risk of CV events-in general as well as compared with alternative medications. Therefor no estimation of decreased risk could be made. Although all PV signals caused a decrease in utilization of RGZ, the measured PV signals did not significantly change the utilization immediately after the PV signals were distributed. Conclusions: Lack of data hampers assessment of the impact of PV signals for these three cases. A crude estimation of the impact was given for Diane-35 (74 VTE cases/year prevented) and Pergolide (2752 prevented moderate-to-severe VHF cases in 2003-2013), based on the RR from literature and change in use. For RGZ an estimation could not be made.
Original language | English |
---|---|
Pages (from-to) | 511-512 |
Number of pages | 2 |
Journal | Pharmacoepidemiology and Drug Safety |
Volume | 27 |
DOIs | |
Publication status | Published - 1 Aug 2018 |
Event | 34th International conference on Pharmacoepidemiology & Therapeutic Risk Management - Prague Congress Centre, Prague, Czech Republic Duration: 22 Aug 2018 → 26 Aug 2018 |
Keywords
- cyproterone acetate plus ethinylestradiol
- pergolide
- rosiglitazone
- adult
- case report
- clinical article
- conference abstract
- diabetic patient
- drug surveillance program
- female
- heart muscle fibrosis
- human
- male
- prevalence
- public health
- regression analysis
- risk assessment
- risk factor