MUscle Side-Effects of Atorvastatin in Coronary Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-05

Study Completion Date

2019-12-12

Brief Summary

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The study aims to estimate the effect of atorvastatin on muscular symptom intensity in coronary patients with subjective statin-associated muscle symptoms (SAMS) and to determine the association with blood levels of atorvastatin and its metabolites, to obtain an objective marker for true SAMS. A randomized study will include 80 coronary patients with SAMS during ongoing atorvastatin therapy or previous muscle symptoms that led to discontinuation of atorvastatin. Patients will be randomized to 7-weeks treatment with atorvastatin 40 mg/day in the first period and matched placebo in the second 7-weeks period, or placebo in the first period and atorvastatin in the second period. A control group (n=40) without muscle symptoms will have 7 weeks open treatment with atorvastatin 40 mg/day. Blood samples will be collected at baseline and after each treatment period, and muscular symptom intensities will be rated by the patients weekly. The primary outcome is the difference in aggregated mean Visual Analogue Scale (VAS) scores between the last three weeks of atorvastatin treatment and of placebo treatment. The main purpose is to develop an objective marker for true SAMS, by comparing SAMS associated with blinded atorvastatin treatment with blood concentrations of atorvastatin and its metabolites. Diagnostic and discrimination performance will be determined. The study provides new clinical knowledge on SAMS in coronary patients and may contribute to more personalized statin treatment and monitoring, fewer side-effects and consequently improved adherence and lipid management in future practice.

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Detailed Description

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Conditions

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Statin Adverse Reaction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Prospective, randomized double-blinded placebo controlled cross-over phase 4 study.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention group

Atorvastatin 40 mg once daily

Group Type ACTIVE_COMPARATOR

Atorvastatin 40mg

Intervention Type DRUG

Oral tablet fabricated and labelled at Krageroe Tablettproduksjon AS

Placebo group

Matched placebo tablet once daily

Group Type PLACEBO_COMPARATOR

Placebo Oral Tablet

Intervention Type DRUG

Oral tablet fabricated and labelled at KrageroeTablettproduksjon AS

Interventions

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Atorvastatin 40mg

Oral tablet fabricated and labelled at Krageroe Tablettproduksjon AS

Intervention Type DRUG

Placebo Oral Tablet

Oral tablet fabricated and labelled at KrageroeTablettproduksjon AS

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 years or older
* First or recurrent diagnosis (myocardial infarction) or treatments (Percutaneous Coronary Intervention \[PCI\] or Coronary Artery Bypass Graft operation \[CABG\]) for a coronary heart disease (CHD) event at least 6 months prior to study start and prescribed atorvastatin (irrespective of dose)
* Reporting muscle complaints (i.e. pain, weakness, tenderness, stiffness or cramp) that they attribute to atorvastatin therapy or atorvastatin discontinuation due to muscle complains
* Signed informed consent and expected cooperation of the patient according to International Council for Harmonisation/Good Clinical Practice and national/local regulations

Exclusion Criteria

* First or recurrent diagnosis (myocardial infarction) or treatments (PCI or CABG) for a CHD event the a) 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) and b) 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 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/ Alanine Aminotransferase \> 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 Creatine Kinase \> 10 times upper limit of the normal range or Alanine Aminotransferase \> 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 (\<12 months) due to other medical conditions
* Not being able to understand Norwegian.
* Women of childbearing potential defined as all premenopausal female.
* Participation in another randomized clinical trial

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No