Statin Immune Study

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-17

Study Completion Date

2017-11-03

Brief Summary

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Statins are widely used drugs to treat hypercholesterolaemia. In general, they are very safe drugs. However, up to one third of statin users can experience muscle symptoms, which are most commonly mild without any conventional laboratory signs of muscle damage. However, these muscle symptoms can often lead to poor compliance to the cholesterol-lowering therapy, reducing its effectiveness. Recent data has highlighted the potential role of immune system in development of statin-induced muscle pain. Variation in the LILRB5 gene has been associated with statin intolerance. We aim to investigate the impact of LILRB5 genetic variability in tolerability and immune response to atorvastatin in healthy volunteers.

The study is being undertaken at the Tayside Institute for Cardiovascular Research (TICR) in Ninewells Hospital, Dundee. We will recruit participants who have donated a sample to GoSHARE study. The participants will be healthy, and recruited according to their genotype of LILRB5 (information available from GoSHARE). The volunteers will then enter a randomised cross-over study with two treatment periods. During treatment period one, all participants will be commenced on atorvastatin or placebo (a dummy drug). Before and at the end of the treatment period, blood and urine samples will be taken and a muscle symptoms questionnaire will be completed to assess the tolerability and immune response to the study drug exposure. After four weeks, the study drug is stopped for a washout period of three weeks before cross-over commences. Thereafter, during treatment period two, the alternate study drug will be started, and tolerability will be assessed similar to that in period one. The study will last approximately 11 weeks. The volunteers have a total of 5 visits to the TICR.

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Detailed Description

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Conditions

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Drug Intolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Atorvastatin

The participants will receive atorvastatin (80 mg) orally once daily for 28 days.

Group Type ACTIVE_COMPARATOR

Atorvastatin

Intervention Type DRUG

Atorvastatin 80 mg once daily for 28 days.

Placebo

The participants will receive matched placebo orally once daily for 28 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo once daily for 28 days.

Interventions

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Atorvastatin

Atorvastatin 80 mg once daily for 28 days.

Intervention Type DRUG

Placebo

Placebo once daily for 28 days.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Age 40-69 years
* Statin-naïve
* White European
* Healthy
* Acceptable laboratory test results

Exclusion Criteria

* Significant disease
* Regular drug therapy
* Recent involvement (\<30 days) in a CTIMP
* Inability/unwillingness to comply with the protocol
* Carry the rare variant of the CKM polymorphism rs11559024
* Unable to consent
* Woman of childbearing potential (i.e. premenopausal female capable of becoming pregnant)

Minimum Eligible Age

40 Years

Maximum Eligible Age

69 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes