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  • Zimerman, AndreDuke Med, Duke Clin Res Inst, Durham, NC USA. (författare)

Pooled analysis of adverse event collection from 4 acute coronary syndrome trials

  • Artikel/kapitelEngelska2016

Förlag, utgivningsår, omfång ...

  • Elsevier BV,2016
  • printrdacarrier

Nummerbeteckningar

  • LIBRIS-ID:oai:DiVA.org:uu-293002
  • https://urn.kb.se/resolve?urn=urn:nbn:se:uu:diva-293002URI
  • https://doi.org/10.1016/j.ahj.2016.01.003DOI

Kompletterande språkuppgifter

  • Språk:engelska
  • Sammanfattning på:engelska

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  • Ämneskategori:ref swepub-contenttype
  • Ämneskategori:art swepub-publicationtype

Anmärkningar

  • Background: Adverse event collection in randomized clinical trials establishes drug safety. Although costly and regulated, it is rarely studied.Methods: Adverse event data from 4 clinical trials (APPRAISE-2, PLATO, TRACER, TRILOGY ACS) comprising 48,118 participants with acute coronary syndromes were pooled to compare patterns and determinants of reporting. Events were classified as serious (SAE) or nonserious (AE) from hospital discharge to 1 year; study end points were excluded.Results: In total, 84,901 events were reported. Of those, 12,266 (14.4%) were SAEs and 72,635 (85.6%) were AEs. Of all participants, 7,823 (16.3%) had SAEs, 18,124 (37.7%) had only AEs, and 22,171 (46.1%) had neither. Nonserious adverse events were distributed across system organ classes: general disorders (11%), infection (10%), gastrointestinal (10%), respiratory (9%), cardiovascular (8.4%), and other (35%). Serious adverse events had a higher proportion of cardiovascular causes (14.0%). Event reporting was highest after hospital discharge, decreasing rapidly during the following 3 months. In a Cox proportional hazards model, chronic obstructive pulmonary disease (hazard ratio 1.58, 95% CI 1.44-1.74), heart failure (1.55, 1.40-1.70), older age, and female sex were independent predictors of more SAEs, whereas enrollment in Eastern Europe (0.63, 0.58-0.69) or Asia (0.84, 0.75-0.94) were independent predictors of fewer SAEs.Conclusions: Half of all participants reported adverse events in the year after acute coronary syndrome; most were AEs and occurred within 3 months. The high volume of events, as well as the variation in SAE reporting by characteristics and enrollment region, indicates that efforts to refine event collection in large trials are warranted.

Ämnesord och genrebeteckningar

Biuppslag (personer, institutioner, konferenser, titlar ...)

  • Lopes, Renato D.Duke Med, Duke Clin Res Inst, Durham, NC USA. (författare)
  • Stebbins, Amanda L.Duke Med, Duke Clin Res Inst, Durham, NC USA. (författare)
  • Guimaraes, Patricia O.Duke Med, Duke Clin Res Inst, Durham, NC USA. (författare)
  • Haque, GhazalaDuke Med, Duke Clin Res Inst, Durham, NC USA. (författare)
  • Melloni, ChiaraDuke Med, Duke Clin Res Inst, Durham, NC USA. (författare)
  • Trollinger, KathleenDuke Med, Duke Clin Res Inst, Durham, NC USA. (författare)
  • James, Stefan K.Uppsala universitet,Uppsala kliniska forskningscentrum (UCR)(Swepub:uu)stjam367 (författare)
  • Alexander, John H.Duke Med, Duke Clin Res Inst, Durham, NC USA. (författare)
  • Tricoci, PierluigiDuke Med, Duke Clin Res Inst, Durham, NC USA. (författare)
  • Roe, Matthew T.Duke Med, Duke Clin Res Inst, Durham, NC USA. (författare)
  • Ohman, Erik MagnusDuke Med, Duke Clin Res Inst, Durham, NC USA. (författare)
  • Mahaffey, Kenneth W.Stanford Univ, Dept Med, Stanford, CA 94305 USA. (författare)
  • Held, ClaesUppsala universitet,Uppsala kliniska forskningscentrum (UCR)(Swepub:uu)clahe947 (författare)
  • Tinga, BrianDuke Med, Duke Clin Res Inst, Durham, NC USA. (författare)
  • Pieper, Karen S.Duke Med, Duke Clin Res Inst, Durham, NC USA. (författare)
  • Alexander, Karen P.Duke Med, Duke Clin Res Inst, Durham, NC USA. (författare)
  • Duke Med, Duke Clin Res Inst, Durham, NC USA.Uppsala kliniska forskningscentrum (UCR) (creator_code:org_t)

Sammanhörande titlar

  • Ingår i:American Heart Journal: Elsevier BV174, s. 60-670002-87031097-6744

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