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Tolerability and effectiveness of every-other-day atorvastatin dosing in patients with statin related muscle disease: a randomized controlled clinical trial
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SLCTR Registration Number
SLCTR/2015/010
Date of Registration
The date of last modification
Mar 11, 2020
Trial Status
Scientific Title of Trial
Tolerability and effectiveness of every-other-day atorvastatin dosing in patients with statin related muscle disease: a randomized controlled clinical trial
Public Title of Trial
Tolerability and effectiveness of every-other-day atorvastatin dosing in patients with statin related muscle disease
Disease or Health Condition(s) Studied
Statin related muscle disease
Scientific Acronym
None
Public Acronym
None
Brief title
None
Universal Trial Number
U 1111-1165-5194
Any other number(s) assigned to the trial and issuing authority
78/14 (University of Sri Jayewardenepura)
What is the research question being addressed?
Is alternate day atorvastatin therapy more tolerable and as effective as daily atorvastatin therapy in patients with statin related muscle disease?
Type of study
Interventional
Study design
Allocation
Randomized controlled trial
Masking
Single blinded
Control
Standard therapy/practice
Assignment
Parallel
Purpose
Treatment
Study Phase
Not Available
Intervention(s) planned
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 than 5 x ULN (upper limit of normal) with tolerable muscle symptoms will be randomized into two arms.
Patients in intervention arm will be given alternate day atorvastatin and patients in the control arm will be given daily atorvastatin. The dose used will be the original dose the patient was on when he/she developed muscle symptoms.
If CK > 5 x ULN and/or intolerable muscle symptoms are present, continue to withhold atorvastatin while monitoring symptoms and CK two weekly; when CK is equal or less than 5 x ULN with no or tolerable symptoms patient will be randomized to trial interventions.
Inclusion criteria
Exclusion criteria
Primary outcome(s)
|
1.
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 ] |
|
2.
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 ] |
|
3.
Mean LDL cholesterol level |
[ At baseline, at the end of 3 months and at the end of 6 months after recruitment ] |
|
4.
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 outcome(s)
|
1.
Mean CK level |
[ At baseline, at the end of 3 months and at the end of 6 months after recruitment ] |
|
2.
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 ] |
|
3.
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 ] |
|
4.
Mean atorvastatin dose |
[ At baseline, at the end of 3 months and at the end of 6 months after recruitment ] |
Target number/sample size
75 patients in to each arm (total 150)
Countries of recruitment
Sri Lanka
Anticipated start date
2015-05-15
Anticipated end date
2018-05-15
Date of first enrollment
2015-05-25
Date of study completion
Recruitment status
Complete: follow up complete
Funding source
Partially funded by the Ceylon College of Physicians Research Grant 2014
Regulatory approvals
Status
Approved
Date of Approval
2015-03-04
Approval number
78/14
Details of Ethics Review Committee
| Name: | Ethics Review Committee, Faculty of Medical Sciences, University of Sri Jayewardenepura |
| Institutional Address: | Gangodawila, Nugegoda Sri Lanka |
| Telephone: | +94-112758000 (Extension: 4075) |
| Email: | erc.fms.usjp@gmail.com |
Contact person for Scientific Queries/Principal Investigator
Dr. C. N. Wijekoon
Senior Lecturer in Pharmacology
Department of Pharmacology,
Faculty of Medical Sciences,
University of Sri Jayewardenepura,
Sri Lanka
Tel: +94 11 2758671
Mob: +94777738639
Fax: +94 11 2801480
nirmalawijekoon@yahoo.co.uk
Contact Person for Public Queries
Dr. P.W.M.C.S.B. Wijekoon
Senior Lecturer in Medicine and Specialist Physician
Department of Medicine
Faculty of Medical Sciences, University of Sri Jayewardenepura
Gangodawila
Nugegoda
Sri Lanka
Tel: +94112758000
Mob: +94772920900
sanjeewa_wijekoon@yahoo.co.uk
Primary study sponsor/organization
Department of Pharmacology
Faculty of Medical Sciences,
University of Sri Jayewardenepura,
Gangodawila, Nugegoda
Sri Lanka
Tel: +94 11 2758671
Fax: +94 11 2801480
pharmacologyfms2012@gmail.com
http://medical.sjp.ac.lk/
Secondary study sponsor (If any)
Ceylon College of Physicians
341/1, Kotte Road, Rajagiriya, Sri Lanka
Tel: + 94 (0)11 2888146, +94 (0) 113094140
Fax : + 94 (0)11 2888119
office@ccp.lk
https://www.ccp.lk
Do the investigators plan to share identified individual clinical trial participant-level data (IPD)?
IPD sharing plan description
Study protocol available
Protocol version and date
Not Available
Protocol URL
Not Available
Results summary available
No
Date of posting results
Date of study completion
Final sample size
Date of first publication
Link to results
Brief summary of results
