2017
Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review
Pease AM, Krumholz HM, Downing NS, Aminawung JA, Shah ND, Ross JS. Postapproval studies of drugs initially approved by the FDA on the basis of limited evidence: systematic review. The BMJ 2017, 357: j1680. PMID: 28468750, PMCID: PMC5421452, DOI: 10.1136/bmj.j1680.Peer-Reviewed Original ResearchMeSH KeywordsControlled Clinical Trials as TopicDrug ApprovalHumansProduct Surveillance, PostmarketingUnited StatesUnited States Food and Drug AdministrationConceptsSingle pivotal trialPivotal trialsPostapproval studiesSurrogate markerPrimary endpointNovel drugsClinical outcomesClinical studiesLimited evidenceSystematic reviewDouble-blind studyMedian total numberClinical evidenceSuperior efficacyBlind studyDrug AdministrationOriginal FDATrial approvalDiseaseTrialsDrugsFDAEndpointEfficacyMarkers
1997
Determinants of Appropriate Use of Angiotensin-Converting Enzyme Inhibitors After Acute Myocardial Infarction in Persons ≥65 Years of Age
Krumholz H, Vaccarino V, Ellerbeck E, Kiefe C, Hennen J, Kresowik T, Gold J, Jencks S, Radford M. Determinants of Appropriate Use of Angiotensin-Converting Enzyme Inhibitors After Acute Myocardial Infarction in Persons ≥65 Years of Age. The American Journal Of Cardiology 1997, 79: 581-586. PMID: 9068512, DOI: 10.1016/s0002-9149(96)00819-3.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAlabamaAngiotensin-Converting Enzyme InhibitorsConnecticutContraindicationsControlled Clinical Trials as TopicDecision MakingDiabetes ComplicationsDiureticsDrug PrescriptionsDrug UtilizationFemaleFollow-Up StudiesHeart FailureHospitalizationHumansIowaMaleMedicaidMultivariate AnalysisMyocardial InfarctionPatient DischargeRetrospective StudiesStroke VolumeTachycardia, VentricularUnited StatesVentricular Function, LeftWisconsinConceptsAcute myocardial infarctionACE inhibitorsMyocardial infarctionDischarge medicationsVentricular functionEnzyme inhibitorsLeft ventricular ejection fractionAngiotensin-converting enzyme inhibitorAngiotensin converting enzyme (ACE) inhibitorsVentricular Enlargement (SAVE) trialCongestive heart failureVentricular ejection fractionYears of ageEligible patientsPatient characteristicsAppropriate patientsDiabetes mellitusEjection fractionHeart failureLoop diureticsMultivariable analysisVentricular tachycardiaIdeal patientObservational studyPatients