2014
Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012
Downing NS, Aminawung JA, Shah ND, Krumholz HM, Ross JS. Clinical Trial Evidence Supporting FDA Approval of Novel Therapeutic Agents, 2005-2012. JAMA 2014, 311: 368-377. PMID: 24449315, PMCID: PMC4144867, DOI: 10.1001/jama.2013.282034.Peer-Reviewed Original ResearchConceptsPivotal efficacy trialsNovel therapeutic agentsClinical trial evidencePivotal trialsEfficacy trialsTherapeutic agentsEnd pointTrial evidenceMedian numberAvailable FDA documentsSingle pivotal trialTrial end pointsSurrogate end pointsNumber of patientsLength of treatmentCross-sectional analysisPrimary outcomeClinical outcomesTrial completion ratesClinical benefitPlacebo comparatorSurrogate outcomesMAIN OUTCOMEDrug AdministrationUS Food
2011
Use of Fibrates in the United States and Canada
Jackevicius CA, Tu JV, Ross JS, Ko DT, Carreon D, Krumholz HM. Use of Fibrates in the United States and Canada. JAMA 2011, 305: 1217-1224. PMID: 21427374, PMCID: PMC3332101, DOI: 10.1001/jama.2011.353.Peer-Reviewed Original ResearchMeSH KeywordsCanadaCardiovascular DiseasesCohort StudiesCosts and Cost AnalysisDiabetes Mellitus, Type 2Drug CostsDrugs, GenericFenofibrateFibric AcidsHealth ExpendituresHumansHydroxymethylglutaryl-CoA Reductase InhibitorsHypolipidemic AgentsMedical AuditPractice Patterns, Physicians'PrescriptionsUnited StatesConceptsUse of fibratesRole of fibratesObservational cohort studyIMS Health dataFenofibrate useCardiovascular riskCohort studyDiabetes (ACCORD) trialClinical benefitFibratesMonthsPrescriptionUnited StatesPatientsNegative resultsFenofibrateHealth dataCurrent useGeneric formulationPopulationStatinsTherapyTrials
1997
When to start cholesterol-lowering therapy in patients with coronary heart disease. A statement for healthcare professionals from the American Heart Association Task Force on Risk Reduction.
Grundy S, Balady G, Criqui M, Fletcher G, Greenland P, Hiratzka L, Houston-Miller N, Kris-Etherton P, Krumholz H, LaRosa J, Ockene I, Pearson T, Reed J, Smith S, Washington R. When to start cholesterol-lowering therapy in patients with coronary heart disease. A statement for healthcare professionals from the American Heart Association Task Force on Risk Reduction. Circulation 1997, 95: 1683-5. PMID: 9118557, DOI: 10.1161/01.cir.95.6.1683.Peer-Reviewed Original ResearchConceptsCholesterol-lowering therapyAggressive cholesterol-lowering therapyAtherosclerotic diseaseCholesterol loweringAmerican Heart Association Task ForceCholesterol-lowering trialsClinical atherosclerotic diseaseFuture coronary eventsHigh-risk patientsSubstantial clinical benefitMajority of patientsCoronary heart diseaseLDL cholesterol loweringPrimary care physiciansBenefits of therapyRisk-reducing treatmentsNonpharmaceutical approachesRecurrent CHDCoronary eventsCare physiciansClinical benefitCholesterol managementClinical managementHeart diseaseCholesterol reduction