Statin related muscle disease
Conditions
Interventions
Patients with statin related muscle disease will be recruited from medical clinics of Colombo South Teaching Hospital. Consenting participants meeting inclusion/exclusion criteria and CK equal or less
when CK is equal or less than 5 x ULN with no or tolerable symptoms patient will be randomized to trial interventions.
Sponsors
Department of Pharmacology
Ceylon College of Physicians
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with myositis (muscle symptoms with Creatine Kinase [CK] elevation) [At baseline, at the end of 3 months and at the end of 6 months after recruitment] Proportion of patients with myalgia (muscle symptoms with no CK elevation) [At baseline, at the end of 3 months and at the end of 6 months after recruitment ] Mean LDL cholesterol level [At baseline, at the end of 3 months and at the end of 6 months after recruitment ] Percentage reduction of mean LDL cholesterol level as compared with the baseline [At baseline, at the end of 3 months and at the end of 6 months after recruitment ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean CK level [At baseline, at the end of 3 months and at the end of 6 months after recruitment] Mean score for discomfort due to muscle problems using visual analogue scale [At baseline, at the end of 3 months and at the end of 6 months after recruitment ] Mean quality of life score for Physical Component Summary and Mental Component Summary of SF-36 [At baseline, at the end of 3 months and at the end of 6 months after recruitment ] Mean atorvastatin dose [At baseline, at the end of 3 months and at the end of 6 months after recruitment ] | — |
Countries
Sri Lanka
Contacts
Public ContactDr. C. N. Wijekoon
Senior Lecturer in Pharmacology
Outcome results
None listed