title: 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.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov: NCT02064218.
authors.affiliation: Department of Internal Medicine and Therapeutics, University of Pavia, and Fondazione IRCCS Policlinico San Matteo, P.le C. Golgi, 2, 27100, Pavia, Italy. giuseppe.derosa@unipv.it.|Center for the Study of Endocrine-Metabolic Pathophysiology and Clinical Research, University of Pavia, Pavia, Italy. giuseppe.derosa@unipv.it.|Laboratory of Molecular Medicine, University of Pavia, Pavia, Italy. giuseppe.derosa@unipv.it.
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Derosa
authors.affiliation: Department of Internal Medicine and Therapeutics, University of Pavia, and Fondazione IRCCS Policlinico San Matteo, P.le C. Golgi, 2, 27100, Pavia, Italy. amedeo.mugellini@unipv.it.
authors.forename: Amedeo
authors.initials: A
authors.lastname: Mugellini
authors.affiliation: Department of Internal Medicine and Therapeutics, University of Pavia, and Fondazione IRCCS Policlinico San Matteo, P.le C. Golgi, 2, 27100, Pavia, Italy. dott.rmpesce@tiscali.it.
authors.forename: Rosa M
authors.initials: RM
authors.lastname: Pesce
authors.affiliation: Department of Internal Medicine and Therapeutics, University of Pavia, and Fondazione IRCCS Policlinico San Matteo, P.le C. Golgi, 2, 27100, Pavia, Italy. labmedmol@smatteo.pv.it.|Laboratory of Molecular Medicine, University of Pavia, Pavia, Italy. labmedmol@smatteo.pv.it.
authors.forename: Angela
authors.initials: A
authors.lastname: D'Angelo
authors.affiliation: Department of Internal Medicine and Therapeutics, University of Pavia, and Fondazione IRCCS Policlinico San Matteo, P.le C. Golgi, 2, 27100, Pavia, Italy. pamelamaffioli@hotmail.it.|PhD School in Experimental Medicine, University of Pavia, Pavia, Italy. pamelamaffioli@hotmail.it.
authors.forename: Pamela
authors.initials: P
authors.lastname: Maffioli
mesh_terms: D000368:Aged; D017311:Amlodipine / Q000627:therapeutic use; D000959:Antihypertensive Agents / Q000627:therapeutic use; D001241:Aspirin / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000097:blood; D002121:Calcium Channel Blockers / Q000627:therapeutic use; D002318:Cardiovascular Diseases / Q000097:blood / Q000175:diagnosis / Q000209:etiology / Q000517:prevention & control*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006973:Hypertension / Q000097:blood / Q000150:complications / Q000175:diagnosis / Q000188:drug therapy; D018836:Inflammation Mediators / Q000097:blood; D007558:Italy; D008297:Male; D008875:Middle Aged; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D011237:Predictive Value of Tests; D011322:Primary Prevention / Q000379:methods*; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000959:Antihypertensive Agents; D015415:Biomarkers; D002121:Calcium Channel Blockers; D018836:Inflammation Mediators; D010975:Platelet Aggregation Inhibitors; D017311:Amlodipine; D001241:Aspirin