PRAVASTATIN SODIUM (Page 4 of 11)

Long-Term Controlled Morbidity and Mortality Trials

In the pravastatin sodium tablets placebo-controlled clinical trials database of 21,483 patients (age range 24 to 75 years, 10.3% women, 52.3% Caucasians, 0.8% Blacks, 0.5% Hispanics, 0.1% Asians, 0.1% Others, 46.1% Not Recorded) with a median treatment duration of 261 weeks, 8.1% of patients on pravastatin sodium tablets and 9.3% patients on placebo discontinued due to adverse events regardless of causality.

Adverse event data were pooled from 7 double-blind, placebo-controlled trials (West of Scotland Coronary Prevention Study [WOS]; Cholesterol and Recurrent Events study [CARE]; Long-term Intervention with Pravastatin in Ischemic Disease study [LIPID]; Pravastatin Limitation of Atherosclerosis in the Coronary Arteries study [PLAC I]; Pravastatin, Lipids and Atherosclerosis in the Carotids study [PLAC II]; Regression Growth Evaluation Statin Study [REGRESS]; and Kuopio Atherosclerosis Prevention Study [KAPS]) involving a total of 10,764 patients treated with pravastatin 40 mg and 10,719 patients treated with placebo. The safety and tolerability profile in the pravastatin group was comparable to that of the placebo group. Patients were exposed to pravastatin for a mean of 4.0 to 5.1 years in WOS, CARE, and LIPID and 1.9 to 2.9 years in PLAC I, PLAC II, KAPS, and REGRESS. In these long-term trials, the most common reasons for discontinuation were mild, non-specific gastrointestinal complaints. Collectively, these 7 trials represent 47,613 patient-years of exposure to pravastatin. All clinical adverse events (regardless of causality) occurring in ≥2% of patients treated with pravastatin in these studies are identified in Table 2.

Table 2: Adverse Events in ≥2% of Patients Treated with Pravastatin 40 mg and at an Incidence Greater Than Placebo in Long-Term Placebo-Controlled Trials
Body System/Event Pravastatin (N=10,764) % of patients Placebo (N=10,719) % of patients
Dermatologic Rash (including dermatitis) 7.2 7.1
General Edema Fatigue Chest Pain Fever Weight Gain Weight Loss 3.0 8.4 10.0 2.1 3.8 3.3 2.7 7.8 9.8 1.9 3.3 2.8
Musculoskeletal Musculoskeletal Pain Muscle Cramp Musculoskeletal Traumatism 24.9 5.1 10.2 24.4 4.6 9.6
Nervous System Dizziness Sleep Disturbance Anxiety/Nervousness Paresthesia 7.3 3.0 4.8 3.2 6.6 2.4 4.7 3.0
Renal/Genitourinary Urinary Tract Infection 2.7 2.6
Respiratory Upper Respiratory Tract Infection Cough Influenza Pulmonary Infection Sinus Abnormality Tracheobronchitis 21.2 8.2 9.2 3.8 7.0 3.4 20.2 7.4 9.0 3.5 6.7 3.1
Special Senses Vision Disturbance (includes blurred vision, diplopia) 3.4 3.3
Infections Viral Infection 3.2 2.9

In addition to the events listed above in the long-term trials table, events of probable, possible, or uncertain relationship to study drug that occurred in <2.0% of pravastatin-treated patients in the long-term trials included the following:

Dermatologic: scalp hair abnormality (including alopecia), urticaria.

Endocrine/Metabolic: sexual dysfunction, libido change.

General: flushing.

Immunologic: allergy, edema head/neck.

Musculoskeletal: muscle weakness.

Nervous System: vertigo, insomnia, memory impairment, neuropathy (including peripheral neuropathy).

Special Senses: taste disturbance.

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