HMG COA Reductase Inhibitor Adverse Reaction
Conditions
Keywords
Statin, HMG COA Reductase Inhibitor, myalgia, vitamin D
Brief summary
Pretreating people with replacement doses of vitamin D will allow them to tolerate Statin medications that have caused muscle pain for them in the past.
Detailed description
Patients who have been unable to tolerate statin medications due to muscle pain will be randomly assigned to receive vitamin D or placebo for 6 weeks before reintroducing their statin medication. The investigators will judge whether vitamin D in the manner administered in the study reduces the myalgia with statins and allows patients to remain on these important medications.
Interventions
10,000 IU tablets. 50,000 initial dose, followed by weekly doses of 10,000 IU
DRUGPlacebo
Standard Placebo made of Lactose 100 mg
Sponsors
McGill University Health Centre/Research Institute of the McGill University Health Centre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* male and female adults * identified by their physician as having myalgia with their statin medication.
Exclusion criteria
* Unexplained CK \> 4X upper limit of normal, at study entry, or on a statin medication in the past. * Severe myositis * Consumption in excess of 14 alcoholic beverages per week * Situations which will cause difficulty in interpreting the vitamin D and / or PTH. examples: * Present consumption of vitamin D supplements \> 1000 iu daily * Renal impairment (Estimated creatinine clearance \< 70 ± 14 mL/min/m2 in Males; and \< 60 ± 10 mL/min/m2 in Females) * Chronic liver disease or impaired liver function * Any contraindication for statin re-challenge Example: rhabdomyolysis or allergy to statins
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| lack of need to stop statin medication due to myalgia | 12 weeks | Ability to tolerate a statin at the same dosage that previously caused the individuals to stop due to myalgia |
Secondary
| Measure | Time frame |
|---|---|
| reduction of visual analog pain score | 12 weeks |
Countries
Canada
Outcome results
None listed