Statin Immune Study

Phase 4

Completed

• Conditions: Drug Intolerance
• Interventions: Drug: Atorvastatin; Drug: Placebo

• Registration Number: NCT02984293
• Lead Sponsor: University of Dundee

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-12-02
• Study First Submitted QC: 2016-12-02
• Study First Posted: 2016-12-06
• Study Start: 2017-04-17
• Primary Completion: 2017-11-03
• Study Completion: 2017-11-03
• Status Verified: 2018-03
• Last Update Submitted: 2018-11-29
• Last Update Posted: 2018-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Atorvastatin	Atorvastatin	The participants will receive atorvastatin (80 mg) orally once daily for 28 days.
Placebo	Placebo	The participants will receive matched placebo orally once daily for 28 days.

Primary Outcome Measures

Name	Time	Method
The primary outcome will be the change in CK levels at the end of the treatment from baseline in both treatment periods.	Measured at baseline (day 0) and day 29 of both treatment periods.

Trial Locations

Locations (1)

University of Dundee; 🇬🇧 Dundee, United Kingdom