Plavix Clinical Pharmacology

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Plavix - Clinical Pharmacology [Clopidogrel]

Patients were randomized to receive PLAVIX (300 mg loading dose followed by 75 mg/day) or placebo, and were treated for up to one year. Patients also received aspirin (75-325 mg once daily) and other standard therapies such as heparin. The use of GPIIb/IIIa inhibitors was not permitted for three days prior to randomization.

The number of patients experiencing the primary outcome (CV death, MI, or stroke) was 582 (9.30%) in the PLAVIX-treated group and 719 (11.41%) in the placebo-treated group, a 20% relative risk reduction (95% CI of 10%-28%; p=0.00009) for the PLAVIX-treated group (see Table 2).

At the end of 12 months, the number of patients experiencing the co-primary outcome (CV death, MI, stroke or refractory ischemia) was 1035 (16.54%) in the PLAVIX-treated group and 1187 (18.83%) in the placebo-treated group, a 14% relative risk reduction (95% CI of 6%-21%, p=0.0005) for the PLAVIX-treated group (see Table 2).

In the PLAVIX-treated group, each component of the two primary endpoints (CV death, MI, stroke, refractory ischemia) occurred less frequently than in the placebo-treated group.

Table 2: Outcome Events in the CURE Primary Analysis

Outcome PLAVIX
(+aspirin)*

(n=6259)
Placebo
(+aspirin)*

(n=6303)
Relative Risk
Reduction (%)
(95% CI)

Primary outcome
(Cardiovascular death, MI, Stroke) 582
(9.3%) 719
(11.4%) 20%
(10.3, 27.9)
P=0.00009

Co-primary outcome
(Cardiovascular death, MI, Stroke, Refractory Ischemia) 1035
(16.5%) 1187
(18.8%) 14%
(6.2, 20.6)
P=0.00052

All Individual Outcome Events: ?
CV death 318
(5.1%) 345
(5.5%) 7%
(-7.7, 20.6)
MI 324
(5.2%) 419
(6.6%) 23%
(11.0, 33.4)
Stroke 75
(1.2%) 87
(1.4%) 14%
(-17.7, 36.6)
Refractory ischemia 544
(8.7%) 587
(9.3%) 7%
(-4.0, 18.0)

* Other standard therapies were used as appropriate.
? The individual components do not represent a breakdown of the primary and co-primary outcomes, but rather the total number of subjects experiencing an event during the course of the study.

The benefits of PLAVIX were maintained throughout the course of the trial (up to 12 months).