RESUMO
BACKGROUND: In many patients, the risk of cardiovascular (CV) events persists despite statin treatment and attaining target LDL-c levels. This residual risk is in part attributed to atherogenic dyslipidemia (AD). We studied the clinical effectiveness of the CNIC-polypill in improving the lipid profile, and lipid ratios and indices indicative of AD that are more accurate in predicting lipid-related CV risk. METHODS: Post-hoc analysis of a multicenter, observational, non-comparative, prospective registry in 533 patients in Mexico. We evaluated blood lipids at baseline (usual care) and after 12 months of treatment with the CNIC-polypill (Sincronium®), including total cholesterol (TC), triglycerides (TG), cholesterol low-density lipoproteins (LDL-c), cholesterol high-density lipoproteins (HDL-c), and cholesterol non-high-density lipoproteins (non-HDL-c). We also calculated and compared AD-related lipid ratios and indices, including remnant cholesterol (RC), Castelli's risk index-I (CRI-I), atherogenic index (AI), atherogenic coefficient (AC), a surrogate of insulin resistance (IRS), atherogenic index of plasma (AIP), and lipoprotein combined index (LCI). RESULTS: At 1 year of treatment, there was a significant reduction in the levels of TC (-22.6%), TG (-29.2%), LDL-c (-13.8%), and non-HDL-c (-29.2%) (all p < 0.001). The likelihood that patients attained their corresponding target LDL-c and TG levels was almost three-fold and seven-fold higher, respectively (p < 0.001). The values of the AD-related ratios RC, CRI-I, AI, AC, AIP, and LCI were all significantly lower (p < 0.001) after one year of treatment. CONCLUSIONS: In patients with or at high risk of CVD, one-year treatment with the CNIC-polypill significantly lowered lipid ratios indicative of AD compared to baseline.
RESUMO
BACKGROUND: The cardiovascular disease pandemic has promoted the cardiovascular polypill as one of the most scalable public health strategies to improve cardiovascular risk by increasing accessibility and adherence to treatments. Data from randomized clinical trials has shown that the polypill strategy significantly improves adherence as well as risk factor control (cholesterol and blood pressure), however, to date, no information from phase IV registries has been available. METHODS: We conducted a multicentre, observational and prospective registry of a polypill-based treatment strategy. A total of 1193 patients in Mexico were included. Patient demographics, clinical history, blood pressure, analysis of blood lipids and the Framingham risk score were measured at baseline and after 12 months of treatment with the CNIC-Ferrer polypill. RESULTS: At one year with the polypill, systolic blood pressure (SBP) and diastolic blood pressure (DBP) levels changed from mean 146.9 mmHg to 128 mmHg (p <0.001), and from 89.1 mmHg to 80.4 mmHg (p <0.001) respectively. LDLc levels were significantly reduced 132.5-107.6 mg/dL (p <0.001). The 10 year Framingham cardiovascular disease risk was also reduced in the high-risk group (33.7 + 22.0 vs. 21.2 + 14.8; p <0.001) and in the intermediate risk group (23.7 + 14.8 vs. 12.7 + 11.4; p <0.001). CONCLUSIONS: To our knowledge, the results of the current study constitute the first real life data on the impact of a polypill therapy on cardiovascular risk factor control. The results show major improvements on the primary outcome, above and beyond those presented previously in the setting of randomized clinical trials.