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Abstract
Abstract Aim To evaluate the relevance of adding acetylsalicylic acid (ASA) in primary prevention in subjects with type 2 diabetes mellitus. Methods 213 patients with type 2 diabetes mellitus and hypertension were randomized to amlodipine 5 mg, or amlodipine 5 mg + ASA 100 mg for 3 months (Phase A); then, if adequate blood pressure control was reached patients terminated the study; otherwise, amlodipine was up-titrated to 10 mg/day for further 3 months and compared to amlodipine 10 mg + ASA 100 mg (Phase B). We assessed at baseline, at the end of Phase A, and at the end of Phase B the levels of some new emerging biomarkers of cardiovascular risk including: high sensitivity C-reactive protein (Hs-CRP), adiponectin (ADN), tumor necrosis factor-α (TNF-α), interleukin-1β (IL-1β), myeloperoxidase (MPO), soluble CD40 ligand (sCDL40). Results Compared to baseline, at the end of Phase A, patients treated with amlodipine 5 mg + ASA 100 mg showed a statistically significant reduction of Hs-CRP (−15.0%), TNF-α (−21.7%), MPO (−9.7%), and sCDL40 (−15.7%), and a statistically significant increase of ADN (+15.0%). These values were significantly better than the ones obtained with amlodipine alone. Similarly, at the end of Phase B, amlodipine 10 mg + ASA significantly lowered Hs-CRP (−18.8%), TNF-α (−15.0%), MPO (−9.2%), and sCDL40 (−20.0%) and increased ADN (+11.8%), with a better effect compared to amlodipine alone. Conclusion All biomarkers considered were significantly improved by ASA addition. These data suggest that the use of ASA in primary prevention could be useful in patients with type 2 diabetes mellitus and hypertension. Trial registration: ClinicalTrials.gov: NCT02064218