Tolerability and effectiveness of every-other-day atorvastatin dosing in patients with statin related muscle disease: a randomized controlled clinical trial

Department of Pharmacology0 个研究点开始时间: 待定最近更新: 2024年8月20日

适应症

试验速览

暂无简介。

•1. Adult males and females(>18 years)
•2. On regular atorvastatin for >1 month
•3. Has one or more of the following muscle symptoms: pain, tenderness, stiffness, cramping, weakness
•4. Onset of muscle symptoms is after initiation of statin therapy
•5. No other possible cause for muscle symptoms
•6. Patient does not opt for switching to rosuvastatin and wishes to continue atorvastatin
•7. Meaningful consent

•1. Rhabdomyolysis [creatine kinase(CK) elevation >10 times upper limit of normal(ULN) with serum creatinine elevation +/- brown urine]
•2. Pre-existing thyroid dysfunction or abnormal TSH value
•3. Elevated ESR (>40mm 1st hour)
•4. Hypokalaemia and/or hyponatraemia
•5. Pre-existing chronic kidney disease or eGFR >45 ml/min/1.73m2
•6. Pre-existing chronic liver disease or abnormal liver profile or liver transaminases > 3 times ULN
•7. Epilepsy
•8. Regular alcohol consumption exceeding safe limit (males >21 units/week; females >14 units / week)
•9. Viral infection in preceding 2 weeks
•10. Unaccustomed physical exertion in preceding 2 weeks
•11. Major surgery within 1 month
•12. Major trauma within 1 month
•13. On concomitant therapy with steroids, antipsychotics, antiretroviral drugs, fibrates, cyclosporine, antifungals, macrolide antibiotics, amiodarone , verapamil, diltiazem or warfarin
•14. Breast-feeding women, pregnant women and women with potential to become pregnant
•15. Not available for follow-up (e.g. no fixed address, unable to come for regular clinic follow-ups)
•16. Any terminal disease (eg. advanced heart failure, advanced respiratory disease, malignancy)
•17. Participation in another clinical trial within 3 months

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