Self-Assessment Method for Statin Side-effects Or Nocebo

• Status: Active, not recruiting
• Trial end date: 2020-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Front-line clinicians cannot currently test for an individual participant whether symptoms experienced are the pharmacological result of a statin or due to other phenomena. In this trial, participants who have previously ceased statins due to side effects will be offered the opportunity to undergo twelve randomly ordered 1-month periods. There will be four periods of no medication, four periods of placebo and four periods of statin. The placebo and the statin pills will be identical in appearance. Participants will record on a daily basis side-effects experienced. At the end of the study, the one-month sessions are sorted into the order shown above. The participant can then observe directly how much of the increase in symptoms seen with statin is also seen with placebo.

1. Hypothesis 1: that >30% of participants enrolling for the study will complete it.

2. Hypothesis 2: Overall >50% of symptom burden is nocebo rather than pharmacological

3. The investigators will define the Nocebo proportion of side effects.

4. Hypothesis 3: that the majority of participants, at 6 months after completion, will either be taking statins or have declined statins for reasons other than perceived side effects.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Imperial College London
• Treatments: Atorvastatin; Atorvastatin Calcium; Hydroxymethylglutaryl-CoA Reductase Inhibitors

Criteria

Inclusion Criteria:

• Aged 18 years or older

• Previously taken one or more statins

• Withdrawn from statins because of perceived side effects

• Developed side effects within 2 weeks of initiation

• Clinical indication for statins for primary or secondary prevention of cardiovascular disease or dyslipidaemia, on either no medication or non-statin lipid lowering therapy (e.g, ezetimibe)

Exclusion Criteria:

• History of neuropathy

• Regularly taking prescribed analgesia

• History of a chronic pain condition

• History of severe mental illness (as their experience of symptoms may already be altered)

• Current use of fibrates (because of the risk of interaction with statins but will not exclude participants taking ezetimibe).

• Severe previous reaction or reaction considered immunological, such as anaphylaxis, facial swelling, severe rash, muscle ache with rise in serum creatine kinase, inflammatory myopathy, rhabdomyolysis or liver function abnormalities (aspartate transaminase (AST) or alanine transaminase (ALT) greater than 3 times upper limit or normal).

• Side-effects taking longer than 2 weeks to develop (because in such participants much longer blocks of treatment would be required, if the present study is positive such studies will be planned for the future)*.

• History of statin intolerance with drug interaction to antiretroviral drugs.

• History of statin intolerance to any other drug.

• Pregnant or breast feeding.

• Side effects taking longer than 2 weeks to present.

• In clinical judgement of study doctor, participant should not participate.