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Efficacy of Rosuvastatin and Fenofibric acid combination therapy in the Management of dyslipidemia

Rosevast F (Rosuvastatin + fenofibric acid

Efficacy of rosuvastatin and fenofibric acid combination therapy in the management of dyslipidemia

The aim of the study was to evaluate the efficacy and safety of rosuvastatin in combination with fenofibric acid in a group of patients treated for 12 weeks with rosuvastatin 10 mg + fenofibric acid 135 mg and consequently treated for up to 52 weeks with rosuvastatin 20 mg + fenofibric acid 135 mg. The patients included in the study were men and women ≥18 years of age with mixed dyslipidemia, determined as TG ≥150 mg/dL, LDL-C ≥130 mg/dL, and HDL-C <40>

  • Out of 261 patients primarily randomized to rosuvastatin 10 mg + fenofibric acid 135 mg, 220 completed the controlled study and 187 sustained to the treatment with rosuvastatin 20 mg + fenofibric acid 135 mg in the extension study
  • Raising the rosuvastatin dose from 10 mg to 20 mg in combination with fenofibric acid 135 mg for up to 52 weeks ensued in considerable mean percentage changes from baseline in LDL-C (-9.5%), non-HDL-C (-6.0%), ApoB (-8.5%), and HDL-C (3.6%), while median TG levels remained largely unchanged (0.8%) at the end of week 52
  • Massive percentage of patients attained their risk-stratified lipid goals at week 52 compared with baseline for LDL-C (89% versus 84%), non-HDL-C (50% versus 25%), and both LDL-C and non-HDL-C (50% versus 19%)
  • The combination therapy was well tolerated and the incidence of muscle-, hepatic-, and renal-related adverse effects and laboratory values were within the anticipated range.

    • The investigators therefore concluded that combination therapy with rosuvastatin and fenofibric acid was well tolerated and raising the rosuvastatin dose from 10 mg to 20 mg in the combination results in further beneficial effects on key lipid parameters in patients with mixed dyslipidemia.

    Source: Ferdinand KC, Davidson MH, Kelly MT, Setze CM. One-year efficacy and safety of rosuvastatin + fenofibric acid combination therapy in patients with mixed dyslipidemia: evaluation of dose response. Am J Cardiovasc Drugs. 2012 Apr 1;12(2):117-25.