Coronary heart disease patients With perceived statin Associated muscle symptoms or statin discontinuaton due to muscle symptoms
Conditions
Interventions
Trade Name: atorvastatin
Product Name: atorvastatin
Pharmaceutical Form: Tablet
Pharmaceutical form of the placebo: Tablet
Route of administration of the placebo: Oral use
Sponsors
Vestre Viken Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • First or recurrent diagnosis (myocardial infarction) or treatments (PCI or CABG) for a CHD event 6-36 months prior to study start and prescribed atorvastatin. • Self-reported muscle complaints (i.e. pain, weakness, tenderness, stiffness or cramp to the body of any intensity) that they attribute to atorvastatin therapy at study inclusion • Self-reported muscle complaints that has led to atorvastatin discontinuation at study inclusion. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: • First or recurrent diagnosis (myocardial infarction) or treatments (PCI or CABG) for a CHD event the past 12 months prior to study start in high risk patients (i.e. at least one of following comorbid conditions: systolic heart failure, >1 previous myocardial infarction, kidney failure, diabetes, and smokers) • First or recurrent diagnosis (myocardial infarction) or treatments (PCI or CABG) for a CHD event the past 6 months prior to study start in low risk patients without any of the co-morbid conditions mentioned above and in patients who are not taking a statin at all • Patients with residual stenosis on the major coronary arteries that were not revascularized at the time of the index event, patents with symptomatic peripheral artery disease and patients with familial hypercholesterolemia • Patient has any contraindications for atorvastatin listed in the Summary of Product Characteristics (i.e. known hypersensitivity to the ingredients, acute liver failure/ ALT > 3 times upper limit of the normal range in blood at study start, pregnancy and breastfeeding ) • History of previous rhabdomyolysis, myopathy or liver failure due to statin treatment with CK > 10 times upper limit of the normal range or ALT > 3 times upper limit of the normal range. • Any condition (e.g. psychiatric illness, dementia) or situation, that in the investigator’s opinion could put the subject at significant risk, confound the study results, interfere significantly with the subject participation in the study, or rendering informed consent unfeasible • Short life expectancy due to other medical conditions • Not being able to understand Norwegian. • Women of childbearing potential defined as a premenopausal female capable of becoming pregnant. • Participation in another randomized clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to estimate the effect of atorvastatin on muscular symptom intensity in coronary patients with subjective statin associated muscle symptoms (SAMS). ;Secondary Objective: The key secondary objectives are: •To determine the relationship between confirmed SAMS and blood concentrations of parent drug and the active metabolites of atorvastatin and SAMS in patients with confirmed SAMS •To determine the proportion of patients who report muscle symptoms on atorvastatin treatment and not on placebo (dichotomous SAMS classification) •To determine mean difference in the likelihood of statin discontinuation within and between the treatment periods •To characterize features ofcompare patients with and without confirmed SAMS and in the total sampleregarding muscle symptom charcteristics •To study statin adherence between the two study arms •To study sociodemographic, clinical, and psychosocial characteristics (PROMS and clinical data) between the two study arms ;Primary end point(s): The primary end-point will be assessed by the individual mean difference in muscular symptom intensity between treatment periods with statin and placebo, reported by the patients over the last three weeks (i.e. week 4-7) measured with aggregated VAS scores ;Timepoint(s) of evaluation of this end point: At study start, during the 7x2 weeks treatment period and at study end | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Assessment of the secondary study end-points will be ascertained through self-reported questionnaires, clinical examinations, and blood samples collected at baseline, during the treatment periods, and at study-end : • Levels of atorvastatin and its metabolites in blood plasma and white blood cells. • The proportion of patients who report muscle symptoms on atorvastatin treatment and not on placebo (dichotomous SAMS classification). • Likelihood of statin discontinuation measured on a 1-10 Likert scale. • Features of SAMS characterized by McGill Pain Questionnaire (SF-MPQ) and Brief Pain Inventory (BPI-SF). • Statin adherence measured with indirect (self-reported questionnaires and pill counts of returned packages) and direct (liquid chromatography-tandem mass spectrometry) methods. • Sociodemographic, clinical, and psychosocial factors ascertained through self-reported questionnaires, clinical examinations, and blood samples. ;Timepoint(s) of evaluation of this end point: At study start, during the 7x2 weeks treatment period and at study end | — |
Countries
Norway
Contacts
Public ContactJohn Munkhaugen
Vestre Viken Trust Drammen hospital
Outcome results
None listed