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Side effect of statins11/30/2023 ![]() ![]() All of the excess (ten vs no cases) with more intensive therapy occurred in the two trials of 80 mg versus 20 mg simvastatin daily these two trials have also reported definite excesses in the incidence of myopathy with 80 mg simvastatin daily. Overall, the observed excess of rhabdomyolysis was 4 per 10,000 in the five trials of more versus less intensive statin therapy (14 vs six cases) compared with 1 per 10,000 in the 21 trials of standard statin regimens versus control (14 vs nine cases). The leading cause of death in rhabdomyolysis is acute renal failure (18).Ī recent meta-analysis made the following considerations: only cases of myopathy that had progressed to rhabdomyolysis were sought from the individual trials. The greatest risk was with the use of cerivastatin, which was withdrawn from the market in 2001, after 31 rhabdomyolysis deaths reported in elderly patients who used it in association with the gemfibrozil. In the United States, deaths from rhabdomyolysis induced by statins occur in about 0.15 per million prescriptions (17). Special caution must be taken in conditions that can lead to toxicity during statin use, such as advanced age, small body size, female gender, renal and hepatic dysfunction, perioperative periods, hypothyroidism, multisystem disease and alcohol abuse. After the withdrawal of the drug, clinical and laboratory improvements can occur between 3 and 30 days. Symptoms can start a week before treatment onset and can occur at any time during treatment.The definition of a tolerable elevation has been a rise of five times the upper normal limit of of this enzyme measured on two occasions - to levels about 2,000 IU/L.However, myalgia (without CK elevation) occurs in 5-10% of patients in clinical practice. Creatine phosphokinase elevation has become the primary marker for ongoing muscle cell death and destruction. An elevation of CK is the best indicator of statin-induced myopathy (myositis).The myopathies - diseases of the muscles usually characterised by weakness - associated with the use of statin drugs range from discreet muscle pains to rhabdomyolysis. ![]() If, after 2 months without statin treatment, muscle symptoms or elevated CK levels do not resolve completely, consider other causes of muscle symptoms (16).If a causal relationship exists, 1) discontinue the original statin 2) Once muscle symptoms resolve, use a low dose of a different statin 3) Once a low dose of a statin is tolerated, gradually increase the dose as tolerated.If muscle symptoms resolve, and if no contraindication exists, give the patient the original or a lower dose of the same statin to establish a causal relationship between the muscle symptoms and statin therapy.If unexplained severe muscle symptoms or fatigue develop during statin therapy, discontinue the statin and address the possibility of rhabdomyolysis by evaluating creatinine kinase activity (CK), creatinine, and a urinalysis for myoglobinuria.If mild to moderate muscle symptoms develop during statin therapy, discontinue the statin, evaluate the patient for other conditions that might increase the risk for muscle symptoms (e.g., hypothyroidism, reduced renal or hepatic function, rheumatologic disorders such as polymyalgia rheumatica, steroid myopathy, vitamin D deficiency, or primary muscle diseases).The emergence of myalgia, although of small magnitude, with loss of kidney function and high muscle enzyme and liver damage markers should always suggest rhabdomyolysis (15).Take a history of prior or current muscle symptoms (pain, weakness and stiffness) to establish a baseline before initiating statin therapy.Here are some aspects to consider in prevention of rhabdomyolysis - the association of muscle and renal damage and acute renal failure resulting from in out-patient care: ![]() In the last guidelines the treatment goal is an LDL-cholesterol concentration of 10 ng/ml, CK-MB Mass 283 U (normal: 10 Major clinical trials (4S, WOSCOPS, CARE, LIPID) have shown that statins are important in reducing mortality from all causes, and especially cardiovascular mortality. Statin use for treatment and prevention of primary and secondary cardiovascular diseases has increased and lipid-lowering therapies have become more intense in complying with more aggressive targets after trials confirming safety and efficacy in high-risk patients (AVERT, HPS). For example, in those aged 45 years and older, statin use increased from 2% between 19 to 25% between 20 according to a 2010 center for disease control survey (1). ![]()
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