Cerebrovascular Accident, Coronary Arteriosclerosis, Diabetes Mellitus, Type 2, Dyslipidemia, Peripheral Vascular Disease
Conditions
Brief summary
European physicians tend to always use the lowest dose of statins to initiate therapy even in subjects who require large reductions in cholesterol. The study evaluates if selecting the starting dose based on baseline and target LDL-C cholesterol would provide better results (ie proportion of subjects resching target)
Interventions
Sponsors
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* High cholesterol blood levels (LDL-cholesterol above 100 mg/dL up to 220 mg/dL. * Triglycerides up to 600 mg/dL. * History of coronary artery disease (ex.: heart attack, angina), stroke, diabetes or at high risk of such events.
Exclusion criteria
* Pregnancy or lactation, use of high statin doses (\>40mg) at baseline, liver or renal problems * Use of other drugs that would interfere with evaluation of efficacy or cause safety problems * Uncontrolled hypertension, diabetes or hypothyroidism * Recent cardiac event of procedure * High baseline CPK levels
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects achieving a LDL-C target of < 100 mg/dL (2.6 mmol/L) after 12 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| LDL-C target <100 mg/dL (<2.6 mmol/L) after 6 weeks of treatment. | — |
| Total cholesterol (TC)/HDL-C ratio target (<4.0) after 6 and 12 weeks of treatment. | — |
| Either the LDL-C <100mg/dL (<2.6 mmol/L) or TC/HDL-C ratio (<4.0) targets after 6 and 12 weeks of treatment. | — |
| Percentage of subjects achieving: | — |
| LDL-C <100mg/dL (<2.6 mmol/L) or TC/HDL-C ratio (<4.0) targets after 6 and 12 weeks of treatment by LDL-C strata. | — |
| LDL-C target (<100 mg/dL) by primary inclusion diagnosis (CHD, CHD-equivalent, diabetes or 10-year CHD risk-equivalent >20%). | — |
| The mean percent change in LDL-C, high density lipoprotein cholesterol (HDL-C),TC/HDL-C ratio, non HDL-C (in subjects with triglycerides [TG] ≥200 mg/dL or 2.3 mmol/L), TC and TG from baseline to 6 and 12 weeks of treatment. Change from baseline in apol | — |
| Both the LDL-C <100mg/dL (<2.6 mmol/L) and TC/HDL-C ratio (<4.0) targets after 6 and 12 weeks of treatment. | — |
Countries
Greece, Hungary, Ireland, Poland, Portugal, Russia, Slovakia, Switzerland
Outcome results
None listed