Tackling Statin Intolerance with N-of-1 trials (TASINI)
Research type
Research Study
Full title
Tackling Statin Intolerance with N-of-1 trials in primary care (TASINI): testing the feasibility of a GP delivered behavioural intervention to increase statin adherence.
IRAS ID
255410
Contact name
Kate Tudor
Contact email
Sponsor organisation
University of Oxford /Clinical Trials and Research Governance
ISRCTN Number
ISRCTN11142694
Clinicaltrials.gov Identifier
0000, 0000
Duration of Study in the UK
1 years, 0 months, 18 days
Research summary
Statins reduce cardiovascular mortality by 25%. Treatment is cheap, effective, and safe and randomised trials show that it is well-tolerated causing few adverse effects. However, half of all patients prescribed statins have stopped them one year later, primarily due to the perceived side-effects. One explanation for this is that people are experiencing adverse events that they misattribute to the statin and stop the medication. \n\nWe propose to harness individuals’ tendency to experiment with medication and create a coalition between doctor and patient that legitimizes and affirms experimentation in a way that will allow both to make inferences about the cause of adverse events that are more likely to be correct than currently is the case. This could prevent people discarding a safe and effective means of prevention unnecessarily, reduce stand-offs between doctor and patient, prevent waste of medication and prescribing of more expensive alternatives, and prevent patients suffering unnecessary side-effects. \n\nWe will encourage participants to assess whether the statin causes side-effects by deploying a series of n-of-1 crossover designs. There is evidence that blinded n-of-1 trials of statin help people with intolerance realise that the side-effects were not caused by medication and subsequently restart medication. However, blinded trials are impractical in routine practice. Thus we are proposing to test an open-label design alongside a blinded design, comparing both to usual care. Participants will be randomised to one of three arms: usual care, blinded n-of-1 experiment, and open-label n-of-1 experiment. Participants will be supported to monitor adverse events and draw sound inferences about their cause using symptom diaries, 4-week on-off periods of medication use, and a review from their GP. We will then test the feasibility of this approach to assess whether GPs deliver the intervention as planned, whether patients engage with this, and whether it improves adherence to statins.\n
REC name
North of Scotland Research Ethics Committee 1
REC reference
19/NS/0014
Date of REC Opinion
22 Feb 2019
REC opinion
Further Information Favourable Opinion