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Comparative Effectiveness of rofecoxib ( Vioxx)

Farrokh Alemi, Ph.D. Comparative Effectiveness of rofecoxib ( Vioxx). Source. Objectives. Compare effectiveness Low dose rofecoxib (Vioxx) High dose rofecoxib (Vioxx) Celecoxib Other medication. Based on Large Amount of Data. Data from Kaiser Permanente in California

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Comparative Effectiveness of rofecoxib ( Vioxx)

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  1. Farrokh Alemi, Ph.D. Comparative Effectiveness of rofecoxib ( Vioxx)

  2. Source

  3. Objectives • Compare effectiveness • Low dose rofecoxib (Vioxx) • High dose rofecoxib (Vioxx) • Celecoxib • Other medication

  4. Based on Large Amount of Data • Data from Kaiser Permanente in California • All patients age 18–84 years • Treated with the medication • From Jan 1, 1999, to Dec 31, 2001 • 2,302,029 person-years of follow-up • 8,143 cases of serious coronary heart disease • 2,210 or 27% fatal.

  5. Study Design • Study group • 18 to 84 years old • At least one prescription • At least 12 months of health plan membership • No diagnosis of other serious diseases • Nested Control Group • Intervention group of high or low dose rofecoxib • Matched control of patients on celecoxib

  6. Study Outcomes • Acute MI • Code 410 (acute myocardial infarction) • Code 411·1 (intermediate coronary syndrome) • Raised creatinekinase MB fraction or troponin I • Sudden cardiac death • From hypertensive heart disease, ischaemic heart disease, conduction disorders, dysrhythmias, heart failure, atherosclerotic heart disease, sudden death • From an unknown cause

  7. Risk Factors Used for Matching • From ICD-9-CM claims data • Cardiovascular admissions • Emergency room visits for cardiovascular reasons • Outpatient diagnoses for tobacco use • Non-cardiovascular admissions and emergency room visits • Same-day admissions for medical procedures • Outpatient diagnoses of alcohol dependence • Rheumatoid arthritis • From prescription data • Cardiovascular prescription drug use • Hormone replacement therapy • Oral prednisone • Antirheumatic drugs

  8. Cardiovascular Risk Score • Logistic regression • 10 category score • 12 fold increase in risk

  9. Characteristics of Controls • Rofecoxib vs celecoxib exposed cases • Older • More likely to be women • More likely to be treated by a rheumatologist • More likely to have used: • anticoagulants • oral prednisone • Lower cardiovascular risk scores compared to patients treated with celecoxib

  10. Odds of Cardiac Events Compared to Remote NSAID use

  11. Conclusions rofecoxib increases the risk of serious coronary heart disease

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