2024
Tirzepatide and blood pressure reduction: stratified analyses of the SURMOUNT-1 randomised controlled trial
Krumholz H, de Lemos J, Sattar N, Linetzky B, Sharma P, Mast C, Ahmad N, Bunck M, Stefanski A. Tirzepatide and blood pressure reduction: stratified analyses of the SURMOUNT-1 randomised controlled trial. Heart 2024, 110: 1165-1171. PMID: 39084707, PMCID: PMC11420724, DOI: 10.1136/heartjnl-2024-324170.Peer-Reviewed Original ResearchBlood pressure reductionBlood pressure subgroupBlood pressurePost hoc analysisPressure reductionTirzepatide groupsAdverse eventsDiastolic blood pressure reductionHoc analysisAssociated with reduced blood pressureEffects of tirzepatideWeight-related complicationsOverall blood pressureLower blood pressure levelsWeight lossNormal blood pressureDiastolic blood pressureLower blood pressureBlood pressure levelsRandomised controlled trialsMediation analysisTirzepatideClinical subgroupsControlled hypertensionPlacebo
2023
Atorvastatin versus Placebo in ICU Patients with COVID-19: Ninety-day Results of the INSPIRATION-S Trial
Talasaz A, Sadeghipour P, Bakhshandeh H, Sharif-Kashani B, Rashidi F, Beigmohammadi M, Moghadam K, Rezaian S, Dabbagh A, Sezavar S, Farrokhpour M, Abedini A, Aliannejad R, Riahi T, Yadollahzadeh M, Lookzadeh S, Rezaeifar P, Matin S, Tahamtan O, Mohammadi K, Zoghi E, Rahmani H, Hosseini S, Mousavian S, Abri H, Sadeghipour P, Baghizadeh E, Rafiee F, Jamalkhani S, Amin A, Mohebbi B, Parhizgar S, Soleimanzadeh M, Aghakouchakzadeh M, Eslami V, Payandemehr P, Khalili H, Talakoob H, Tojari T, Shafaghi S, Tabrizi S, Kakavand H, Kashefizadeh A, Najafi A, Jimenez D, Gupta A, Madhavan M, Sethi S, Parikh S, Monreal M, Hadavand N, Hajighasemi A, Ansarin K, Maleki M, Sadeghian S, Barco S, Siegerink B, Spatz E, Piazza G, Kirtane A, Tassell B, Lip G, Klok F, Goldhaber S, Stone G, Krumholz H, Bikdeli B. Atorvastatin versus Placebo in ICU Patients with COVID-19: Ninety-day Results of the INSPIRATION-S Trial. Thrombosis And Haemostasis 2023, 123: 723-733. PMID: 36944357, DOI: 10.1055/a-2059-4844.Peer-Reviewed Original ResearchConceptsExtracorporeal membrane oxygenationArterial thrombosisMAIN OUTCOMEAtorvastatin 20Symptom onsetICU patientsFunctional statusIntensive care unit patientsCOVID-19Double-blind multicenterAdult ICU patientsCare unit patientsThrombo-inflammatory responseCoronavirus disease 2019Meaningful treatment effectPrespecified studyCause mortalityAtorvastatin useUnit patientsMembrane oxygenationFunctional outcomeDisease 2019Functional scalesPlaceboPatients
2009
Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data: Lessons for Postmarket Pharmaceutical Safety Surveillance
Ross JS, Madigan D, Hill KP, Egilman DS, Wang Y, Krumholz HM. Pooled Analysis of Rofecoxib Placebo-Controlled Clinical Trial Data: Lessons for Postmarket Pharmaceutical Safety Surveillance. JAMA Internal Medicine 2009, 169: 1976-1985. PMID: 19933959, PMCID: PMC2830805, DOI: 10.1001/archinternmed.2009.394.Peer-Reviewed Original ResearchMeSH KeywordsAdverse Drug Reaction Reporting SystemsCardiovascular SystemCyclooxygenase 2 InhibitorsDrug IndustryHumansIncidenceLactonesMyocardial InfarctionRandomized Controlled Trials as TopicRisk AssessmentSafety-Based Drug WithdrawalsSulfonesTime FactorsUnited StatesUnited States Food and Drug AdministrationConceptsPlacebo-controlled trialVoluntary market withdrawalAdverse eventsCardiovascular riskThromboembolic adverse eventsMain outcome measurementsClinical trial dataRofecoxib groupOutcome measurementsTrial dataPlaceboTrial durationSafety surveillanceTrialsMarket withdrawalDeathRiskP-valueSurveillance effortsSubjectsWithdrawalRofecoxibYearsIncidenceDose