Drug class
HMG-CoA reductase inhibitor (statin)" - a "reversible inhibitor of 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase," the enzyme that catalyzes "the conversion of HMG-CoA to mevalonate, an early and rate limiting step in the biosynthetic pathway for cholesterol." The drug also "reduces VLDL and TG and increases HDL-C.
Uses
Pravastatin is indicated to reduce the risk of MI, revascularization, and cardiovascular mortality in hypercholesterolemic patients without clinically evident coronary heart disease, and in patients with existing coronary heart disease to reduce "the risk of total mortality by reducing coronary death, MI, revascularization, stroke/TIA, and the progression of coronary atherosclerosis." Also indicated as an adjunct to diet for elevated total cholesterol, LDL-C, and triglycerides, and for "heterozygous familial hypercholesterolemia" in pediatric patients 8 years and older who fail diet therapy.
Warnings
No boxed warning. Contraindications include "hypersensitivity to any component of this medication," "active liver disease or unexplained, persistent elevations of serum transaminases," and use during pregnancy and lactation. Key warnings cover skeletal muscle effects - patients should report "unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever" - with rare cases of "rhabdomyolysis with acute renal failure secondary to myoglobinuria," and rare immune-mediated necrotizing myopathy (IMNM) with "proximal muscle weakness and elevated serum creatine kinase, which persist despite discontinuation of statin treatment."
Side effects
In short-term trials, the most frequent reactions were "musculoskeletal pain, nausea/vomiting, upper respiratory infection, diarrhea, and headache." Long-term data reported musculoskeletal pain in 24.9% of patients, fatigue in 8.4%, and upper respiratory tract infection in 21.2%. Postmarketing reports include myopathy, rhabdomyolysis, tendon disorder, polymyositis, and rare cognitive impairment ("memory loss, forgetfulness, amnesia, memory impairment, confusion").
