Real-World Effectiveness of Therapy With Rosuvastatin Combined With Fenofibric Acid in a Sample of Colombian Patients With Mixed Dyslipidemia

Abstract

Background Ischemic heart disease is the leading cause of death in the world and is associated with dyslipidemia, high blood pressure, diabetes mellitus, and other factors. Objective To determine the clinical effectiveness on the lipid profile of the rosuvastatin + fenofibric acid combination in Colombian patients with high cardiovascular risk and mixed dyslipidemia. Methods Longitudinal observational study in a random sample of patients with a diagnosis of mixed dyslipidemia and moderate, high, or very high cardiovascular risk who were treated with rosuvastatin + fenofibric acid. Anthropometric, clinical, laboratory, comorbidity, and pharmacological variables were identified. Effectiveness on the lipid profile was determined. Results A total of 386 patients were analyzed. They had a mean age of 60.8 ± 11.4 years, 53.1% were female, and 75.6% had high/very high cardiovascular risk. The initial evaluation showed a mean LDL cholesterol of 138.4 ± 67.1 mg/dL and triglycerides of 679.7 ± 573.6 mg/dL. At the end of follow-up, mean LDL cholesterol was 87.5 ± 41.2 mg/dL (reduced by 43.3%; P < .001), and triglycerides were 243.5 ± 170.5 mg/dL (reduced by 64.2%; P < .001). Only 35.4% (n = 73) of patients with very high risk reached the goal of metabolic control, compared to 61.6% (n = 53) with high risk and 55.4% (n = 46) with moderate risk. Belonging to the very high-risk group was associated with a lower probability of achieving the control goal (OR: 0.32; 95%CI: 0.192-0.539). Conclusion The combination of rosuvastatin + fenofibric acid is an effective option in patients with mixed dyslipidemia and high cardiovascular risk, providing a therapeutic alternative for those conditions that require it.

Effectiveness and Safety of Fenofibrate in Routine Treatment of Patients with Hypertriglyceridemia and Metabolic Syndrome

“…Machado-Duque et al (2020) have reported a real-world study of fenofibric acid effectiveness in patients with mixed dyslipidemia. Treatment for ≥3 months resulted in a 64.2% baseline TG level reduction [ 39 ]. Regarding bezafibrate, the results from a recent randomized study published by Nakamura et al (2023) indicated a 34.7% decrease in baseline TG levels at 6 months in patients with hypertriglyceridemia [ 40 ].…”

“…Regarding other drugs from the fibrate class, Machado-Duque et al (2020) reported that 1% of patients treated with a rosuvastatin/fenofibric acid combination had ADRs related to treatment in a real-world setting [ 39 ]. In a randomized study of pemafibrate and bezafibrate, adverse events were reported in 43 and 37% of patients, respectively [ 40 ].…”