Assessment of the number of cardio- and cerebrovascular events due to rofecoxib (Vioxx) in Germany between 2001 and 2004

Medizinische Klinik
Peter T SawickiSven Gutschmidt

Abstract

After the recall of rofecoxib (Vioxx), there was repeated national and international discussion on the potential number of patients harmed by causally related cardio- and cerebrovascular events. In individual cases, it cannot be determined whether a myocardial infarction or stroke that occurred during rofecoxib therapy was actually directly caused by this drug. On the basis of the results of the Vioxx Gastrointestinal Outcomes Research (VIGOR) trial and German prescription data provided by the Scientific Institute of the Local Health Care Fund, the authors therefore conservatively estimated the number of patients harmed by rofecoxib in Germany between 2001 and 2004. Under simplifying assumptions that, as in the VIGOR study, the risk of rofecoxib or naproxen therapy can be described by a Cox model with exponentially distributed event times, it is possible to calculate the daily risk of cardio- and cerebrovascular events in patients treated with these drugs. The estimated number of patients experiencing cardio- and cerebrovascular events under rofecoxib or naproxen therapy can be calculated by multiplying the daily risks by the defined daily doses prescribed in Germany. The difference between these numbers produces the estimated ...Continue Reading

Citations

Jul 14, 2011·Statistics in Medicine·Jonathan A L GelfondCraig M Klugman
Feb 25, 2009·Pharmacoepidemiology and Drug Safety·Falk Hoffmann
Aug 30, 2008·Pharmazie in unserer Zeit·Matthias S Pfannkuche, Gerd Glaeske
Jul 22, 2018·Bundesgesundheitsblatt, Gesundheitsforschung, Gesundheitsschutz·Ronja ForaitaIris Pigeot

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