- « Previous
- Clinical Pharmacology
- Next »
Pravachol
Clinical Pharmacology
Pravachol
PRAVACHOL also significantly decreased the risk for undergoing myocardial revascularization procedures (coronary artery bypass graft [CABG] surgery or percutaneous transluminal coronary angioplasty [PTCA]) by 37% (80 vs 51 patients, p=0.009) and coronary angiography by 31% (128 vs 90, p=0.007). Cardiovascular deaths were decreased by 32% (73 vs 50, p=0.03) and there was no increase in death from non-cardiovascular causes.
Secondary Prevention of Cardiovascular Events
In the Long-term Intervention with Pravastatin in Ischemic Disease (LIPID)2 study, the effect of PRAVACHOL, 40 mg daily, was assessed in 9014 patients (7498 men; 1516 women; 3514 elderly patients [age ≥ 65 years]; 782 diabetic patients) who had experienced either an MI (5754 patients) or had been hospitalized for unstable angina pectoris (3260 patients) in the preceding 3-36 months. Patients in this multicenter, double-blind, placebo-controlled study participated for an average of 5.6 years (median of 5.9 years) and at randomization had total cholesterol between 114 and 563 mg/dL (mean 219 mg/dL), LDL-C between 46 and 274 mg/dL (mean 150 mg/dL), triglycerides between 35 and 2710 mg/dL (mean 160 mg/dL), and HDL-C between 1 and 103 mg/dL (mean 37 mg/dL). At baseline, 82% of patients were receiving aspirin and 76% were receiving antihypertensive medication. Treatment with PRAVACHOL significantly reduced the risk for total mortality by reducing coronary death (see Table 1). The risk reduction due to treatment with PRAVACHOL on CHD mortality was consistent regardless of age. PRAVACHOL significantly reduced the risk for total mortality (by reducing CHD death) and CHD events (CHD mortality or nonfatal MI) in patients who qualified with a history of either MI or hospitalization for unstable angina pectoris.
Table 1: LIPID - Primary and Secondary Endpoints
| Number (%) of Subjects | ||||
| Event | Pravastatin 40 mg (N=4512) |
Placebo (N=4502) |
Risk Reduction |
P-value |
| Primary Endpoint | ||||
| CHD mortality | 287 (6.4) | 373 (8.3) | 24% | 0.0004 |
| Secondary Endpoints | ||||
| Total mortality | 498 (11.0) | 633 (14.1) | 23% | < 0.0001 |
| CHD mortality or nonfatal MI | 557 (12.3) | 715 (15.9) | 24% | < 0.0001 |
| Myocardial revascularization procedures (CABG or PTCA) | 584 (12.9) | 706 (15.7) | 20% | < 0.0001 |
| Stroke | ||||
| All-cause | 169 (3.7) | 204 (4.5) | 19% | 0.0477 |
| Non-hemorrhagic | 154 (3.4) | 196 (4.4) | 23% | 0.0154 |
| Cardiovascular mortality | 331 (7.3) | 433 (9.6) | 25% | < 0.0001 |
In the Cholesterol and Recurrent Events (CARE)3 study the effect of PRAVACHOL, 40 mg daily, on coronary heart disease death and nonfatal MI was assessed in 4159 patients (3583 men and 576 women) who had experienced a myocardial infarction in the preceding 3-20 months and who had normal (below the 75th percentile of the general population) plasma total cholesterol levels. Patients in this double-blind, placebo-controlled study participated for an average of 4.9 years and had a mean baseline total cholesterol of 209 mg/dL. LDL-cholesterol levels in this patient population ranged from 101 mg/dL - 180 mg/dL (mean 139 mg/dL). At baseline, 84% of patients were receiving aspirin and 82% were taking antihypertensive medications. Median (25th, 75th percentile) percent changes from baseline after 6 months of pravastatin treatment in Total-C, LDL-C, TG, and HDL-C were -22.0 (-28.4, -14.9), -32.4 (-39.9, -23.7), -11.0 (-26.5, 8.6), and 5.1 (-2.9, 12.7), respectively. Treatment with PRAVACHOL significantly reduced the rate of first recurrent coronary events (either CHD death or nonfatal MI), the risk of undergoing revascularization procedures (PTCA, CABG), and the risk for stroke or transient ischemic attack (TIA) (see Table 2).
Table 2: CARE - Primary and Secondary Endpoints
| Number (%) of Subjects | ||||
| Event | Pravastatin 40 mg (N=2081) |
Placebo (N=2078) |
Risk Reduction |
P-value |
| Primary Endpoint | ||||
| CHD mortality or nonfatal MI* | 212 (10.2) | 274 (13.2) | 24% | 0.003 |
| Secondary Endpoints | ||||
| Myocardial revascularization procedures (CABG or PTCA) | 294 (14.1) | 391 (18.8) | 27% | < 0.001 |
| Stroke or TIA | 93 (4.5) | 124 (6.0) | 26% | 0.029 |
| *The risk reduction due to treatment with PRAVACHOL was consistent in both sexes. | ||||
Generic Name: Pravastatin Sodium
- « Previous
- Clinical Pharmacology
- Next »
Cholesterol Guidelines
Think you know all there is to know about cholesterol? Learn the cholesterol guidelines: the good, bad, and that other one. See more WebMD Videos »
Cholesterol Management
Tips to keep it under control.

