A study about the relevance of adding acetylsalicylic acid in primary prevention in subjects with type 2 diabetes mellitus: effects on some new emerging biomarkers of cardiovascular risk

Cardiovasc Diabetol. 2015 Jul 30;14:95. doi: 10.1186/s12933-015-0254-8.

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.

Publication types

  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Amlodipine / therapeutic use
  • Antihypertensive Agents / therapeutic use
  • Aspirin / adverse effects
  • Aspirin / therapeutic use*
  • Biomarkers / blood
  • Calcium Channel Blockers / therapeutic use
  • Cardiovascular Diseases / blood
  • Cardiovascular Diseases / diagnosis
  • Cardiovascular Diseases / etiology
  • Cardiovascular Diseases / prevention & control*
  • Diabetes Mellitus, Type 2 / blood
  • Diabetes Mellitus, Type 2 / complications
  • Diabetes Mellitus, Type 2 / diagnosis
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Double-Blind Method
  • Drug Therapy, Combination
  • Female
  • Humans
  • Hypertension / blood
  • Hypertension / complications
  • Hypertension / diagnosis
  • Hypertension / drug therapy
  • Inflammation Mediators / blood
  • Italy
  • Male
  • Middle Aged
  • Platelet Aggregation Inhibitors / adverse effects
  • Platelet Aggregation Inhibitors / therapeutic use*
  • Predictive Value of Tests
  • Primary Prevention / methods*
  • Risk Factors
  • Time Factors
  • Treatment Outcome

Substances

  • Antihypertensive Agents
  • Biomarkers
  • Calcium Channel Blockers
  • Inflammation Mediators
  • Platelet Aggregation Inhibitors
  • Amlodipine
  • Aspirin

Associated data

  • ClinicalTrials.gov/NCT02064218