Web-based investigation of statin side-effects

Phase 4

Completed

• Conditions: Cardiovascular disease; Circulatory System

• Registration Number: ISRCTN30952488
• Lead Sponsor: ondon School of Hygiene and Tropical Medicine

Brief Summary

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/29197834 protocol 2021 Results article in https://doi.org/10.1136/bmj.n135 results (added 25/02/2021) 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33709907/ results (added 15/03/2021) 2019 Results article in https://doi.org/10.3390/healthcare7040134 (added 14/06/2023)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-05-12
• Study Completion: 2019-09-30
• Last Update Posted: 26 June 2023

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Adults (aged 16 and over)
2. Prescribed statin treatment in the last 3 years
3. Stopped OR considering stopping statin treatment due to muscle symptoms
4. Provided fully informed consent

Exclusion Criteria

1. Any previously documented serum alanine aminotransferase (ALT) levels at or above three times the upper limit of normal
2. Have persistent, generalised, unexplained muscle pain (whether associated or not with statin use) and have creatinine kinase (CK) levels greater than 5 times the upper limit of normal
3. Should not be using atorvastatin 20mg daily in the opinion of the general practitioner

Study & Design

• Study Type: Interventional
• Study Design: Not specified