2016
Polypharmacy in the Aging Patient: A Review of Glycemic Control in Older Adults With Type 2 Diabetes
Lipska KJ, Krumholz H, Soones T, Lee SJ. Polypharmacy in the Aging Patient: A Review of Glycemic Control in Older Adults With Type 2 Diabetes. JAMA 2016, 315: 1034-1045. PMID: 26954412, PMCID: PMC4823136, DOI: 10.1001/jama.2016.0299.BooksConceptsRandomized clinical trialsIntensive glycemic controlGlycemic controlClinical trialsOlder adultsMicrovascular outcomesTreatment burdenPatient preferencesMost RCTsLarge randomized clinical trialsType 2 diabetes mellitusMajor macrovascular eventsStandard glycemic controlOptimal glycemic controlLower treatment burdenSurrogate end pointsHigh-quality evidenceType 2 diabetesLikelihood of benefitMajority of adultsGlycemic treatmentMacrovascular eventsDiabetes mellitusPatient factorsAging Patient
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
2010
Licensing drugs for diabetes
Lehman R, Yudkin JS, Krumholz H. Licensing drugs for diabetes. The BMJ 2010, 341: c4805. PMID: 20819887, DOI: 10.1136/bmj.c4805.Peer-Reviewed Original Research