Drug Intolerance Clinical Trial
Official title:
Impact of LILRB5 Genotype on Immune Response to Atorvastatin
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03052218 -
Evaluation of Pupillometry for cyp2d6 Phenotyping in Children Treated With Tramadol
|
N/A | |
| Completed |
NCT03280368 -
Adherence and Coagulation Assays in Dabigatran-treated Patients With Atrial Fibrillation
|