2018
Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators
Bates J, Parzynski CS, Dhruva SS, Coppi A, Kuntz R, Li S, Marinac‐Dabic D, Masoudi FA, Shaw RE, Warner F, Krumholz HM, Ross JS. Quantifying the utilization of medical devices necessary to detect postmarket safety differences: A case study of implantable cardioverter defibrillators. Pharmacoepidemiology And Drug Safety 2018, 27: 848-856. PMID: 29896873, PMCID: PMC6436550, DOI: 10.1002/pds.4565.Peer-Reviewed Original ResearchConceptsAdverse event ratesSafety differencesEvent ratesMedical device utilizationICD utilizationRate ratioNational Cardiovascular Data RegistryICD modelsImplantable cardioverter defibrillatorEvent rate ratioMost patientsCardioverter defibrillatorProportion of individualsAmerican CollegeData registryRoutine surveillanceSample size estimatesAverage event rateDevice utilizationSignificance levelDifferencesPatientsRegistryDefibrillatorICD
2006
Risks Associated With Statin Therapy
Kashani A, Phillips CO, Foody JM, Wang Y, Mangalmurti S, Ko DT, Krumholz HM. Risks Associated With Statin Therapy. Circulation 2006, 114: 2788-2797. PMID: 17159064, DOI: 10.1161/circulationaha.106.624890.Peer-Reviewed Original ResearchConceptsCreatine kinase elevationStatin therapyTransaminase elevationClinical trialsStatin trialsAdverse eventsHigher statin dosesMajor statin trialsRandomized statin trialsReports of myalgiaRisk of myalgiaWithdrawal of therapySevere comorbid conditionsSmall excess riskSignificant absolute increaseEnglish-language reportsHepatic complicationsStatin monotherapyCardiovascular eventsStatin dosesMost patientsComorbid conditionsAbsolute riskExcess riskElectronic search