TY - JOUR
T1 - Prescription behavior for gastroprotective drugs in new users as a result of communications regarding clopidogrel – proton pump inhibitor interaction
AU - Kruik-Kollöffel, Willemien J.
AU - van der Palen, Job
AU - Kruik, H. Joost
AU - van Herk-Sukel, Myrthe P.P.
AU - Movig, Kris L.L.
PY - 2016/8/1
Y1 - 2016/8/1
N2 - Abstract Safety concerns of the concomitant use of clopidogrel and proton pump inhibi- tors (PPIs) were published in 2009 and 2010 by the medicines regulatory agen- cies, including a direct healthcare professional communication. We examined the association between various safety statements and prescription behavior for gastroprotective drugs in na€ ıve patients in the Netherlands during the years 2008–2011. Data from the PHARMO Database Network were analyzed with interrupted time series analyses to estimate the impact of each communication on drug prescriptions. Dispensings were used as a proxy variable for prescrip- tion behavior. After the early communication in January 2009, 15.5% (95% CI 7.8, 23.4) more patients started concomitantly with (es)omeprazole and 13.8% (95% CI 6.5, 21.2) less with other PPIs. Directly after the first statement in June 2009, we found a steep increase in histamine 2-receptor antagonists (H2RA) peaking at 25%, placing those patients at risk for gastrointestinal events. This effect for H2RA faded away after a few months. In February 2010, when the official advice via an adjusted statement was to avoid (es)omeprazole, we found a decrease of 11.9% (95% CI 5.7, 18.2) for (es)omeprazole and an increase of +16.0% (95% CI 10.3, 21.7) for other PPIs. Still 22.6% (95% CI 19.5, 25.7) of patients started on (es)omeprazole in February 2010, placing them at risk for cardiovascular events. Advices of regulatory authorities were followed, however, reluctantly and not fully, probably partly because of the existing scientific doubt about the interaction
AB - Abstract Safety concerns of the concomitant use of clopidogrel and proton pump inhibi- tors (PPIs) were published in 2009 and 2010 by the medicines regulatory agen- cies, including a direct healthcare professional communication. We examined the association between various safety statements and prescription behavior for gastroprotective drugs in na€ ıve patients in the Netherlands during the years 2008–2011. Data from the PHARMO Database Network were analyzed with interrupted time series analyses to estimate the impact of each communication on drug prescriptions. Dispensings were used as a proxy variable for prescrip- tion behavior. After the early communication in January 2009, 15.5% (95% CI 7.8, 23.4) more patients started concomitantly with (es)omeprazole and 13.8% (95% CI 6.5, 21.2) less with other PPIs. Directly after the first statement in June 2009, we found a steep increase in histamine 2-receptor antagonists (H2RA) peaking at 25%, placing those patients at risk for gastrointestinal events. This effect for H2RA faded away after a few months. In February 2010, when the official advice via an adjusted statement was to avoid (es)omeprazole, we found a decrease of 11.9% (95% CI 5.7, 18.2) for (es)omeprazole and an increase of +16.0% (95% CI 10.3, 21.7) for other PPIs. Still 22.6% (95% CI 19.5, 25.7) of patients started on (es)omeprazole in February 2010, placing them at risk for cardiovascular events. Advices of regulatory authorities were followed, however, reluctantly and not fully, probably partly because of the existing scientific doubt about the interaction
KW - Antiulcer agents
KW - clopidogrel
KW - drug interactions
KW - drug safety
KW - histamine H2 antagonists
KW - pharmacoepidemiology
KW - pharmacovigilance
KW - proton pump inhibitors
KW - risk assessment
KW - risk factors
U2 - 10.1002/prp2.242
DO - 10.1002/prp2.242
M3 - Article
VL - 4
JO - Pharmacology Research & Perspectives
JF - Pharmacology Research & Perspectives
SN - 2052-1707
IS - 4
ER -