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A Phase 3 Randomized Controlled Trial to Evaluate Efficacy and Safety of New-Formulation Zenon
Alberico L Catapano1, Michal Vrablik2, Yuri Karpov3
1Department of Pharmacological and Biomolecular Sciences, University of Milan and IRCCS Multimedica, Milan, Italy.
Insights
Fixed-dose combination rosuvastatin/ezetimibe (R/E) significantly improved LDL-C reduction in high-risk patients with primary hypercholesterolemia. This combination therapy offers a promising option for patients not achieving goals with statins alone.
Area of Science:
- Cardiology
- Pharmacology
- Metabolic Disorders
Background:
- Primary hypercholesterolemia poses a significant cardiovascular disease (CVD) risk.
- Many patients on statin therapy do not achieve target low-density lipoprotein cholesterol (LDL-C) levels.
- Suboptimal LDL-C control increases the risk of cardiovascular events.
Purpose of the Study:
- To evaluate the efficacy and safety of a fixed-dose combination (FDC) of rosuvastatin/ezetimibe (R/E).
- To assess the effectiveness of R/E FDC in primary hypercholesterolemia patients inadequately controlled by statins.
- To compare R/E FDC against uptitrated rosuvastatin monotherapy.
Main Methods:
- A multicenter, randomized, double-blind, active-controlled study.
- Involved patients with primary hypercholesterolemia at very high (VHR) or high (HR) risk of CVD.
- Primary endpoint: LDL-C reduction at 6 weeks comparing FDC R/E versus rosuvastatin monotherapy.
Main Results:
- In VHR participants, R/E FDC (R40/E10 and R20/E10) demonstrated superiority over R40 in LDL-C reduction.
- Least squares mean differences (LSMD) showed significant reductions for R40/E10 (-19.66%) and R20/E10 (-12.28%) versus R40.
- In HR participants, R10/E10 did not show superiority over R20, though clinically relevant LDL-C reduction was observed.
Conclusions:
- R/E FDCs effectively improve LDL-C reduction in patients with primary hypercholesterolemia.
- This combination therapy enhances LDL-C goal achievement in high-risk individuals.
- No unexpected safety concerns were reported with the R/E FDC formulations.
Objective:
In primary hypercholesterolemia many people treated with statins do not reach their plasma LDL-C goals and are at increased risk of cardiovascular disease (CVD). This study aimed to evaluate efficacy and safety of a new fixed-dose combination (FDC) formulation of rosuvastatin/ezetimibe (R/E) in this population.
Methods:
This was a multicenter, multinational, randomized, double-blind, double-dummy, active-controlled, parallel-arm study of FDC R/E in people with primary hypercholesterolemia at very high risk (VHR) or high risk (HR) of CVD, inadequately controlled with 20 mg or 10 mg stable daily dose of rosuvastatin or equipotent dose of another statin. The primary objective was to demonstrate superiority of FDC R/E versus rosuvastatin monotherapy uptitrated to 40 mg (R40) or 20 mg (R20) in reduction of LDL-C after 6 weeks.
Results:
Randomized VHR participants (n = 244) were treated with R40, R40/E10, or R20/E10; randomized HR participants (n = 208) received R10/E10 or R20. In VHR participants, superiority of R40/E10 and R20/E10 versus R40 was demonstrated on LDL-C percent change from baseline to Week 6 with least squares mean differences (LSMD) of -19.66% (95% CI: -29.48% to -9.84%; P < .001) and -12.28% (95% CI: -22.12% to -2.44%; P = .015), respectively. In HR participants, superiority of R10/E10 over R20 was not demonstrated (LSMD -5.20%; 95% CI: -15.18% to 4.78%; P = .306), despite clinically relevant LDL-C reduction with R10/E10. No unexpected safety findings were reported.
Conclusions:
The results from this study suggest that R/E FDCs improve LDL-C reduction and goal achievement in people with primary hypercholesterolemia inadequately controlled with statins and at VHR/HR of CVD.
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