Evidence map›Paper›PMID 26223257›Full record

Trial reportCardiovascular diabetology2015

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.

Giuseppe Derosa, Amedeo Mugellini, Rosa M Pesce, Angela D'Angelo, Pamela Maffioli

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Cardiovascular diabetology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02064218 (Evaluation of Some Emerging Biomarkers of Cardiovascular Risk Stratification in Hypertensive Patients), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.7field-weighted citation impact, top 15% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02064218 unknown statusnot on this map

Evaluation of Some Emerging Biomarkers of Cardiovascular Risk Stratification in Hypertensive Patients: a 5-years Follow-up

TypeobservationalSponsorUniversity of PaviaRan2007ConditionsHypertensionArmsAnti-hypertensive drugs
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 10 citations in OpenAlex.

  1. Trial
  2. Article
  3. Review
  4. Article
  5. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

Giuseppe DerosaDepartment 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.
Amedeo MugelliniDepartment 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.
Rosa M PesceDepartment 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.
Angela D'AngeloDepartment 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.
Pamela MaffioliDepartment 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.
Istituti di Ricovero e Cura a Carattere Scientifico · ITUniversity of Pavia · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo evaluate the relevance of adding acetylsalicylic acid (ASA) in primary prevention in subjects with type 2 diabetes mellitus.

methods213 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).

resultsCompared 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.

conclusionAll 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 registrationClinicalTrials.gov: NCT02064218.

Indexed as

AgedAmlodipineAntihypertensive AgentsAspirinBiomarkersCalcium Channel BlockersCardiovascular DiseasesDiabetes Mellitus, Type 2Double-Blind MethodDrug Therapy, CombinationFemaleHumansHypertensionInflammation MediatorsItalyMaleAmlodipineAntihypertensive AgentsAspirinBiomarkersCalcium Channel BlockersInflammation MediatorsPlatelet Aggregation Inhibitors

Identifiers

PMID26223257
PMCPMC4518654
OpenAlexW2129877652

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.