Lowering of LDL-C with rosuvastatin or single-pill combination rosuvastatin/ezetimibe in high/very high-risk patients with hyperlipidaemia – LEASH

Hyperlipidaemia

Proportion of patients achieving the LDL-C treatment goal* after 12 weeks of treatment (from baseline to Visit 5) in ARM 1 and ARM 2 separately. ______________________ *Patients at very high cardiovascular (CVD) risk: LDL-C reduction of ≥50 % from baseline AND LDL-C <1.4 mmol/L (<55 mg/dL); patients at high CVD risk: LDL-C reduction of ≥50 % from baseline AND LDL-C <1.8mmol/L (<70 mg/dL).

Proportion of patients achieving LDL-C treatment goal*, after 4 and 8 weeks of treatment (from baseline to Visit 3 and to Visit 4) in ARM 1 and ARM 2 separately. ______________________ *Patients at very high cardiovascular (CVD) risk: LDL-C reduction of ≥50 % from baseline AND LDL-C <1.4 mmol/L (<55 mg/dL); patients at high CVD risk: LDL-C reduction of ≥50 % from baseline AND LDL-C <1.8mmol/L (<70 mg/dL)., Proportion of patients achieving LDL-C reduction ≥50 % from baseline, after 4, 8 or 12 weeks of treatment (from baseline to Visit 3, to Visit 4 and to Visit 5) in ARM 1 and ARM 2 separately., Proportion of patients achieving LDL-C target values** after 4, 8 and 12 weeks of treatment (at Visit 3, Visit 4 and Visit 5, respectively) in ARM 1 and ARM 2 separately. _______________________ **LDL-C target value for patients at very high cardiovascular (CVD) risk: LDL-C <1.4mmol/L (<55 mg/dL); LDL-C target value patients at high CVD risk: <1.8mmol/L (<70 mg/dL)., Proportion of patients achieving target& non-HDL-C, after 4, 8 and 12 weeks of treatment (at Visit 3, Visit 4 and Visit 5) in ARM 1 and ARM 2 separately. _______________________ &Non-HDL-C target for patients at very high CVD risk: <2.2mmol/L (<85 mg/dL); non-HDL-C target for patients at high CVD risk: <2.6mmol/L (<100 mg/dL)., Mean absolute and relative changes in TC, LDL-C, non-HDL-C, HDL-C, and TG, after 4, 8 and 12 weeks of treatment (from baseline to Visit 3, to Visit 4 and to Visit 5) in ARM 1 and ARM 2 separately., Proportion of compliant# patients after 4, 8 and 12 weeks (at Visit 3, Visit 4 and Visit 5, respectively) of treatment in ARM 1 and ARM 2 separately. ________________________ #Patients are considered compliant to treatment, if ≥80 % of their prescribed doses were administered. One dose omission is defined as omission of 1 tablet of rosuvastatin or SPC rosuvastatin/ezetimibe per day in ARM 1 OR omission of 1 tablet of rosuvastatin or SPC rosuvastatin/ezetimibe per day in ARM 2., Proportion of patients achieving LDL-C treatment goal* after 4, 8 and 12 weeks of treatment in ARM1 in comparison with ARM2. ______________________ *Patients at very high cardiovascular (CVD) risk: LDL-C reduction of ≥50 % from baseline AND LDL-C <1.4 mmol/L (<55 mg/dL); patients at high CVD risk: LDL-C reduction of ≥50 % from baseline AND LDL-C <1.8mmol/L (<70 mg/dL).

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