کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
5985124 | 1578169 | 2016 | 10 صفحه PDF | دانلود رایگان |
- Non-interventional 48-month follow-up cohort in 3215 hypercholesterolemic patients.
- NNT to prevent 1 non-fatal or fatal CV event was 143 patients treated for 5Â years.
- Exposure to ezetimibe plus statin provided the largest effect in LDL-C reduction.
- The MOBS methodology was shown to be effective at predicting CV event rates.
BackgroundTo evaluate the real-life impact of ezetimibe on cardiovascular (CV) morbidity and mortality in France.ObjectiveTo estimate the number of non-fatal and fatal CV events that could be prevented and corresponding number of patients needed to treat (NNT) with ezetimibe to prevent one CV event over 5 years.MethodsNon-interventional 48-month follow-up cohort conducted in hypercholesterolemic patients starting on ezetimibe <3Â months at study entry, either as monotherapy or combined with statins. Prediction modeling using discrete event simulation with calibrated Framingham CV risk equations was applied to data from pivotal clinical trials on ezetimibe and real-life data derived from the cohort.ResultsA total of 3215 patients in the cohort accumulated 9314 person-years of follow-up for an average of 2.9Â years. Mean age was 61.5 (standard deviation [SD]Â =Â 10.7), 54.6% were males, and 27.0% had a history of CV disease. Baseline LDL-cholesterol averaged 4.1Â mmol/L (159Â mg/dL; SDÂ =Â 1.0) and HDL-C 1.6Â mmol/L (62Â mg/dL; SDÂ =Â 0.5). LDL-C decreased in the first 12 months in ezetimibe-LLT (lipid-lowering therapy) initiators, switchers (monotherapy), and combination therapy with a statin by respectively 21.3%, 6.4%, and 29.1%. The corresponding predicted rate reductions of CV events (non-fatal and fatal) compared to no treatment or to a statin (combination therapy) were respectively 8, 2, and 12 per 1000 patients treated over 5Â years, with a global NNT of 143 patients over 5Â years.ConclusionThese results, accounting for observed CV event rates, risk factors evolution over time and adherence to treatment in real life, were consistent with those from clinical trials.
Journal: Journal of Clinical Lipidology - Volume 10, Issue 6, NovemberâDecember 2016, Pages 1379-1388