Comparative Effectiveness of rofecoxib ( Vioxx)

Farrokh Alemi, Ph.D.

Compare effectiveness Low dose rofecoxib (Vioxx) High dose rofecoxib (Vioxx) Celecoxib Other medication

Data from Kaiser Permanente in California

All patients age 18–84 yearsTreated with the medication From Jan 1, 1999, to Dec 31, 20012,302,029 person-years of follow-up

8,143 cases of serious coronary heart disease

2,210 or 27% fatal.

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

1. Acute MI Code 410 (acute myocardial infarction) Code 411·1 (intermediate coronary

syndrome)▪ Raised creatine kinase MB fraction or troponin I

2. Sudden cardiac death From hypertensive heart disease, ischaemic

heart disease, conduction disorders, dysrhythmias, heart failure, atherosclerotic heart disease, sudden death

From an unknown cause

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

Logistic regression10 category score

12 fold increase in risk

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

Conclusions