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| Name | Class |
|---|---|
| University of Jena | OTHER |
| University Hospital Dresden | OTHER |
| Charite University, Berlin, Germany | OTHER |
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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.
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.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment adjustments | 3 years | |
| Change in LDL cholesterol level | 3 years |
| 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) |
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Inclusion Criteria:
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
Participants are ≧ 18 years old
Written declaration of consent is available
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:
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Patients with statin-intolerance
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| Name | Affiliation | Role |
|---|---|---|
| Ulrich Laufs | University of Leipzig | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniklinik Leipzig | Leipzig | Saxony | 04103 | Germany |
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| ID | Term |
|---|---|
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 3 years |