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The DISCOVERY PENTA study: a DIrect Statin COmparison of LDL-C Value--an Evaluation of Rosuvastatin therapY compared
Francisco A H Fonseca1, Alvaro Ruiz, Ernesto G Cardona-Muñoz
1Disciplina de Cardiologia, Universidade Federal de São Paulo, São Paulo, Brazil. fahfonseca@terra.com.br
Insights
Rosuvastatin 10 mg significantly improved low-density lipoprotein cholesterol (LDL-C) goal achievement more than atorvastatin 10 mg in patients with hypercholesterolemia. Both statins demonstrated comparable safety and tolerability profiles.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Trials
Background:
- International guidelines recommend low-density lipoprotein cholesterol (LDL-C) reduction for coronary heart disease (CHD) risk mitigation.
- Many hypercholesterolemia patients do not reach target LDL-C levels with current treatments.
Purpose of the Study:
- To compare the efficacy of rosuvastatin 10 mg versus atorvastatin 10 mg in achieving LDL-C goals.
- To evaluate secondary objectives including European LDL-C goal attainment, lipid profile changes, and safety.
Main Methods:
- A 12-week, randomized, open-label trial involving 1124 statin-naïve or switched patients.
- Participants were from Brazil, Colombia, Mexico, Portugal, and Venezuela with primary hypercholesterolemia.
Main Results:
- Rosuvastatin 10 mg achieved significantly higher rates of NCEP ATP III and European LDL-C goals compared to atorvastatin 10 mg.
- Rosuvastatin led to greater reductions in LDL-C and total cholesterol (TC), and increased HDL-C in statin-naïve patients.
- Both drugs were well-tolerated with similar adverse event profiles.
Conclusions:
- Rosuvastatin 10 mg is more effective than atorvastatin 10 mg for achieving LDL-C goals and improving lipid profiles.
- The study highlights rosuvastatin's superior efficacy in specific populations while maintaining a similar safety profile.
Background:
International guidelines emphasize the need to achieve recommended low-density lipoprotein cholesterol (LDL-C) levels in order to reduce morbidity and mortality associated with coronary heart disease (CHD). However, many patients with hypercholesterolemia fail to achieve LDL-C goals on treatment.
Objective:
The primary objective was to compare the efficacy of rosuvastatin and atorvastatin for enabling patients to achieve National Cholesterol Education Program Adult Treatment Panel III (NCEP ATP III) LDL-C goals. Secondary objectives were European LDL-C goal achievement, changes in the lipid profile, and safety.
Research Design And Methods:
This 12-week, multicenter, multinational, randomized, open-label trial compared the efficacy and safety of rosuvastatin 10 mg with atorvastatin 10 mg in statin-naïve and switched patients with primary hypercholesterolemia from Brazil, Colombia, Mexico, Portugal, and Venezuela.
Results:
A total of 1124 patients with similar baseline characteristics were randomized to the two treatment groups. After 12 weeks of treatment, a significantly greater percentage of patients receiving rosuvastatin 10 mg compared with atorvastatin 10 mg achieved NCEP ATP III LDL-C goals (71.2% vs 61.4%, p < 0.001), 1998 European LDL-C goals (73.5% vs 59.2%, p < 0.001) and 2003 European LDL-C goals (58.9% vs 44.6%, p < 0.001). Rosuvastatin treatment was associated with significant reductions in LDL-C and total cholesterol (TC) and, in statin-naïve patients, a significant increase in high-density lipoprotein cholesterol (HDL-C) compared with atorvastatin treatment. Both treatments were well tolerated with a similar incidence of adverse events. Clinically significant elevations in creatinine, creatine kinase or hepatic transaminases were low and similar between treatment groups.
Conclusions:
Rosuvastatin 10 mg is significantly more effective at achieving NCEP ATP III and European LDL-C goals, lowering LDL-C and TC in both naïve and switched patients and increasing HDL-C in naïve patients than atorvastatin 10mg, with a similar safety and tolerability profile. This study also provides evidence regarding the comparative effects of rosuvastatin versus atorvastatin in Latin American and Portuguese populations.
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