TY - JOUR
T1 - Changes in glycoprotein IIb/IIIa inhibitor excess dosing with site-specific safety feedback in the can rapid risk stratification of Unstable angina patients suppress adverse outcomes with early implementation of the ACC/AHA guidelines (CRUSADE) initiative
AU - Mudrick, Daniel W.
AU - Chen, Anita Y.
AU - Roe, Matthew T.
AU - Newby, L. Kristin
AU - Gibler, W. Brian
AU - Ohman, E. Magnus
AU - Peterson, Eric D.
AU - Alexander, Karen P.
N1 - Funding Information:
CRUSADE was funded by the Schering-Plough Corporation. Bristol-Myers Squibb/Sanofi-Aventis Pharmaceuticals Partnership and Millennium Pharmaceuticals, Inc provided additional funding support. Dr Mudrick received support through a National Institutes of Health training grant T32 HLO69749. The authors are solely responsible for the design and conduct of this study, all study analyses, and the drafting and editing of the manuscript and its final contents.
PY - 2010/12
Y1 - 2010/12
N2 - Background: Glycoprotein (GP) IIb/IIIa inhibitors can improve outcomes in patients with non-ST-segment elevation acute coronary syndromes but raise the risk of bleeding, particularly if dosed in excess. The impact of GP IIb/IIIa dosing feedback on safety and major bleeding is unknown. Methods: Glycoprotein IIb/IIIa dosing feedback was added to the CRUSADE quarterly site reports in the first quarter of 2006. We describe GP IIb/IIIa use and dosing among 25,641 patients with non-ST-segment elevation acute coronary syndromes from the fourth quarter of 2005 to the fourth quarter of 2006. Results: Eleven thousand eight hundred forty-six patients received GP IIb/IIIa inhibitors, including 4,031 women and 2,609 elderly patients (age, ≥75 years). Among GP IIb/IIIa-treated patients, unadjusted rates of excess GP IIb/IIIa dosing declined overall (26.4%-22.4%, Ptrend = .01) and among the elderly (65.6%-52.1%, Ptrend < .001). After adjustment, declines in excess dosing remained significant only for the elderly, although more than half of GP IIb/IIIa-treated elderly patients continued to receive excess dosing at the end of the study period (64.1%-51.3%, Ptrend < .001). There were concurrent declines in unadjusted major bleeding rates overall (9.6%-8.0%, Ptrend = .02), but declines among women (14.4%-11.5%, P trend = .08) and the elderly (17.1%-11.0%, Ptrend = .05) did not reach statistical significance. After adjustment for baseline characteristics and excess dosing, declines in major bleeding rates were no longer significant overall or for any subgroup. Conclusion: Within 9 months of initiating a safety feedback program, we observed early decreases in excess GP IIb/IIIa dosing among the elderly but minimal changes in excess dosing overall. Further work is needed to promote safe and effective medication use in vulnerable patients who are most at risk of harm.
AB - Background: Glycoprotein (GP) IIb/IIIa inhibitors can improve outcomes in patients with non-ST-segment elevation acute coronary syndromes but raise the risk of bleeding, particularly if dosed in excess. The impact of GP IIb/IIIa dosing feedback on safety and major bleeding is unknown. Methods: Glycoprotein IIb/IIIa dosing feedback was added to the CRUSADE quarterly site reports in the first quarter of 2006. We describe GP IIb/IIIa use and dosing among 25,641 patients with non-ST-segment elevation acute coronary syndromes from the fourth quarter of 2005 to the fourth quarter of 2006. Results: Eleven thousand eight hundred forty-six patients received GP IIb/IIIa inhibitors, including 4,031 women and 2,609 elderly patients (age, ≥75 years). Among GP IIb/IIIa-treated patients, unadjusted rates of excess GP IIb/IIIa dosing declined overall (26.4%-22.4%, Ptrend = .01) and among the elderly (65.6%-52.1%, Ptrend < .001). After adjustment, declines in excess dosing remained significant only for the elderly, although more than half of GP IIb/IIIa-treated elderly patients continued to receive excess dosing at the end of the study period (64.1%-51.3%, Ptrend < .001). There were concurrent declines in unadjusted major bleeding rates overall (9.6%-8.0%, Ptrend = .02), but declines among women (14.4%-11.5%, P trend = .08) and the elderly (17.1%-11.0%, Ptrend = .05) did not reach statistical significance. After adjustment for baseline characteristics and excess dosing, declines in major bleeding rates were no longer significant overall or for any subgroup. Conclusion: Within 9 months of initiating a safety feedback program, we observed early decreases in excess GP IIb/IIIa dosing among the elderly but minimal changes in excess dosing overall. Further work is needed to promote safe and effective medication use in vulnerable patients who are most at risk of harm.
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U2 - 10.1016/j.ahj.2010.08.008
DO - 10.1016/j.ahj.2010.08.008
M3 - Article
C2 - 21146660
AN - SCOPUS:78650123866
SN - 0002-8703
VL - 160
SP - 1072
EP - 1078
JO - American heart journal
JF - American heart journal
IS - 6
ER -