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Effectiveness of Polypill for Prevention of Cardiovascular Disease (PolyPars): Protocol of a Randomized Controlled Trial.

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اقرأ على الانترنت اقرأ أكثر حفظ في قائمتي
  • معلومة اضافية
    • المصدر:
      Publisher: Academy of Medical Sciences of I.R. Iran Country of Publication: Iran NLM ID: 100889644 Publication Model: Electronic Cited Medium: Internet ISSN: 1735-3947 (Electronic) Linking ISSN: 10292977 NLM ISO Abbreviation: Arch Iran Med Subsets: MEDLINE
    • بيانات النشر:
      Original Publication: Tehran : Academy of Medical Sciences of I.R. Iran, [1998-
    • الموضوع:
      Antihypertensive Agents/*administration & dosage ; Aspirin/*administration & dosage ; Atorvastatin/*administration & dosage ; Cardiovascular Diseases/*prevention & control ; Hydrochlorothiazide/*administration & dosage; Drug Combinations ; Female ; Humans ; Iran ; Male ; Middle Aged ; Pragmatic Clinical Trials as Topic
    • نبذة مختصرة :
      Background: Cardiovascular diseases (CVDs) are the leading cause of death in Iran. A fixed-dose combination therapy (polypill) was proposed as a cost-effective strategy for CVD prevention, especially in lower-resource settings. We conducted the PolyPars trial to assess the effectiveness and safety of polypill for prevention of CVD.
      Methods: The PolyPars trial is a pragmatic cluster randomized controlled trial nested within the Pars Cohort Study. Participants were randomized to an intervention arm and a control arm. Participants in the control arm received minimal non-pharmacological care, while those in the intervention arm received polypill in addition to minimal care. The polypill comprises hydrochlorothiazide 12.5 mg, aspirin 81 mg, atorvastatin 20 mg, and either enalapril 5 mg or valsartan 40 mg. The primary outcome of the study is defined as the first occurrence of acute coronary syndrome (non-fatal myocardial infarction and unstable angina), fatal myocardial infarction, sudden cardiac death, new-onset heart failure, coronary artery revascularization procedures, transient ischemic attack, cerebrovascular accidents (fatal or non-fatal), and hospitalization due to any of the mentioned conditions. The secondary outcomes of the study include adverse events, compliance, non-cardiovascular mortality, changes in blood pressure, fasting blood sugar, and lipids after five years of follow-up.
      Results: From December 2014 to December 2015, 4415 participants (91 clusters) were recruited. Of those, 2200 were in the polypill arm and 2215 in the minimal care arm. The study is ongoing. This trial was registered with ClinicalTrials.gov number NCT03459560.
      Conclusion: Polypill may be effective for primary prevention of CVDs in developing countries.
      (© 2020 The Author(s). This is an open-access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.)
    • Comments:
      Erratum in: Arch Iran Med. 2021 Feb 01;24(2):166. doi: 10.34172/aim.2021.26. (PMID: 33636987)
    • Contributed Indexing:
      Keywords: Cardiovascular prevention; Non-communicable disease risk factors; Polypill
    • Molecular Sequence:
      ClinicalTrials.gov NCT03459560
    • الرقم المعرف:
      0 (Antihypertensive Agents)
      0 (Drug Combinations)
      0J48LPH2TH (Hydrochlorothiazide)
      A0JWA85V8F (Atorvastatin)
      R16CO5Y76E (Aspirin)
    • الموضوع:
      Date Created: 20200908 Date Completed: 20210701 Latest Revision: 20210701
    • الموضوع:
      20250114
    • الرقم المعرف:
      10.34172/aim.2020.58
    • الرقم المعرف:
      32894967