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Vioxx

Clinical Pharmacology
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Clinical Pharmacology

Vioxx

PUBs-symptomatic ulcers, upper GI perforation, obstruction, major or minor upper GI bleeding.

Complicated PUBs (a subset of PUBs)-upper GI perforation, obstruction or major upper GI bleeding.

Study Results

Gastrointestinal Safety in VIGOR

The VIGOR study showed a significant reduction in the risk of development of PUBs, including complicated PUBs in patients taking VIOXX compared to naproxen (see Table 3).

Table 3 VIGOR-Summary of Patients with Gastrointestinal Safety Events1 COMPARISON TO NAPROXEN

GI Safety Endpoints

VIOXX 50 mg daily (N=4047)2 n3 (Cumulative Rate4)

Naproxen 1000 mg daily (N=4029)2 n3 (Cumulative Rate4)

Relative Risk of VIOXX compared to naproxen5

95% CI5

PUBs

56 (1.80)

121 (3.87)

0.46*

(0.33, 0.64)

Complicated PUBs

16 (0.52)

37 (1.22)

0.43*

(0.24, 0.78)

1As confirmed by an independent committee blinded to treatment, 2N=Patients randomized, 3n=Patients with events, 4Kaplan-Meier cumulative rate at end of study when at least 500 patients remained (approx. 10 1/2 months), 5Based on Cox proportional hazard model

*p-value ≤ 0.005 for relative risk compared to naproxen

The risk reduction for PUBs and complicated PUBs for VIOXX compared to naproxen (approximately 50%) was maintained in patients with or without the following risk factors for developing a PUB (Kaplan-Meier cumulative rate of PUBs at approximately 10 1/2 months, VIOXX versus naproxen, respectively): with a prior PUB (5.12, 11.47); without a prior PUB (1.54, 3.27); age 65 or older (2.83, 6.49); or younger than 65 years of age (1.48, 3.01). A similar risk reduction for PUBs and complicated PUBs (approximately 50%) was also maintained in patients with or without Helicobacter pylori infection or concomitant corticosteroid use.

Other Safety Findings

Cardiovascular Safety

The VIGOR study showed a higher incidence of adjudicated serious cardiovascular thrombotic events in patients treated with VIOXX 50 mg once daily as compared to patients treated with naproxen 500 mg twice daily (see Table 4). This finding was largely due to a difference in the incidence of myocardial infarction between the groups. (See Table 5.) (See PRECAUTIONS, Cardiovascular Effects.) Adjudicated serious cardiovascular events (confirmed by a blinded adjudication committee) included: sudden death, myocardial infarction, unstable angina, ischemic stroke, transient ischemic attack and peripheral venous and arterial thromboses.

Table 4 VIGOR-Summary of Patients with Serious Cardiovascular Thrombotic Adverse Events1 Over Time COMPARISON TO NAPROXEN

Treatment Group

Patients Randomized

 

4 Months2

8 Months3

10 ½ months4

Brand Name: Vioxx
Generic Name: Rofecoxib

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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