2024
Effects of Sotagliflozin on Health Status in Patients With Worsening Heart Failure Results From SOLOIST-WHF
Bhatt A, Bhatt D, Steg P, Szarek M, Cannon C, Leiter L, McGuire D, Lewis J, Riddle M, Voors A, Metra M, Lund L, Testani J, Wilcox C, Davies M, Pitt B, Kosiborod M. Effects of Sotagliflozin on Health Status in Patients With Worsening Heart Failure Results From SOLOIST-WHF. Journal Of The American College Of Cardiology 2024, 84: 1078-1088. PMID: 39260929, DOI: 10.1016/j.jacc.2024.06.036.Peer-Reviewed Original ResearchConceptsSodium-glucose cotransporter 2Effect of sotagliflozinKCCQ-12 scoreKCCQ-12Heart failureSOLOIST-WHFPrimary endpointSodium-glucose cotransporter 2 inhibitionLeft ventricular ejection fractionWorsening heart failureBaseline to monthVentricular ejection fractionHealth statusWorsening HFKansas City Cardiomyopathy Questionnaire-12Ejection fractionSecondary endpointsCotransporter 2Randomized patientsClinical characteristicsHF hospitalizationPlaceboCardiovascular deathHF episodeSotagliflozin
2015
Evaluation of Short-Term Changes in Serum Creatinine Level as a Meaningful End Point in Randomized Clinical Trials
Coca SG, Zabetian A, Ferket BS, Zhou J, Testani JM, Garg AX, Parikh CR. Evaluation of Short-Term Changes in Serum Creatinine Level as a Meaningful End Point in Randomized Clinical Trials. Journal Of The American Society Of Nephrology 2015, 27: 2529-2542. PMID: 26712525, PMCID: PMC4978048, DOI: 10.1681/asn.2015060642.Peer-Reviewed Original ResearchConceptsSerum creatinine levelsCreatinine levelsClinical trialsEnd pointAcute elevationRandomized trialsAcute changesPlacebo-controlled randomized trialSafety end pointRandomized clinical trialsStrong risk factorMeaningful clinical outcomesMeaningful end pointsClinical outcomesKidney functionPoor outcomeAcute increaseRisk factorsThorough literature searchObservational studyTemporary elevationMortality rateShort-term effectsPlaceboCKD