Statin-Intolerance Registry (SIR)

The Statin-Intolerance Registry will characterize the patient population suffering from statin-intolerance which is a frequent but incompletely understood patient condition with important clinical implications for atherosclerotic cardiovascular disease (ASCVD) prevention.

Patients will be systematically and prospectively included and followed by the registry.

Study Overview

• Status: Active, not recruiting
• Conditions: Dyslipidemias

Detailed Description

This non-interventional registry based on routine clinical practice will collect data under real-life conditions. The treatment of patients will not be changed by this study.

Data on patient characteristics and the treatment history will be collected via questionnaires at study entree. Yearly follow up visits will re-assess the baseline parameters and document cardiovascular events.

The data will be analyzed using descriptive statistics.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• Germany
  • Saxony
    • Leipzig, Saxony, Germany, 04103
      • Uniklinik Leipzig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with statin-intolerance

Description

Inclusion Criteria:

1. Patients with dyslipidemia and statin intolerance, defined as:

   Use of 2 or more statins and intolerance of these drugs in any dose or inability to tolerate dosage increasement beyond a maximum weekly dose of 70 mg atorvastatin, 140 mg Simvastatin, pravastatin, or lovastatin, 35 mg rosuvastatin, 280 mg of Fluvastatin and symptoms improve or disappear when statin is reduced in dosage or discontinued

2. Participants are ≧ 18 years old
3. Written declaration of consent is available
4. The patient is cognitively, linguistically and organizationally capable to meet the study requirements. The possibility of 1 year follow-up is very likely.

Exclusion Criteria:

1. Use of any experimental or investigational drugs within 30 days prior to screening.
2. An employee or contractor of the facility conducting the study, or a family member of the principal investigator, co-Investigator, or sponsor.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of treatment adjustments	3 years
Change in LDL cholesterol level	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in quality of life	by EQ-5D	3 years
Development of muscle symptoms over time that initially lead to discontinuation of statin therapy	based on the "Statin-Associated Muscle Symptom Clinical Index" (SAMS-CI)	3 years

Collaborators and Investigators

• Sponsor: University of Leipzig
• Collaborators: Charite University, Berlin, Germany; University of Jena; University Hospital Dresden
• Investigators: Study Director: Ulrich Laufs, University of Leipzig

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: June 14, 2021
• First Submitted That Met QC Criteria: July 14, 2021
• First Posted (Actual): July 23, 2021

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 15, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Cardiovascular; Statins; Lipid Metabolism Disorders; Muscle symptoms
• Additional Relevant MeSH Terms: Metabolic Diseases; Nutritional and Metabolic Diseases; Dyslipidemias; Lipid Metabolism Disorders
• Other Study ID Numbers: SIR-2021/05-UKL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No