2022
Association Between Generic-to-Generic Levothyroxine Switching and Thyrotropin Levels Among US Adults
Brito JP, Deng Y, Ross JS, Choi NH, Graham DJ, Qiang Y, Rantou E, Wang Z, Zhao L, Shah ND, Lipska KJ. Association Between Generic-to-Generic Levothyroxine Switching and Thyrotropin Levels Among US Adults. JAMA Internal Medicine 2022, 182: 418-425. PMID: 35226058, PMCID: PMC8886450, DOI: 10.1001/jamainternmed.2022.0045.Peer-Reviewed Original ResearchConceptsComparative effectiveness research studyIndex dateProportion of patientsTSH levelsNormal TSH levelsMIU/LThyrotropin levelsLevothyroxine productsGeneric levothyroxineNational administrative claims databasePropensity-matched patient pairsBaseline TSH levelsMean TSH levelsThyroid replacement therapyAdministrative claims databaseCurrent guideline recommendationsSerum thyrotropin levelsOptumLabs Data WarehouseStandardized mean differenceLevothyroxine doseLevothyroxine prescriptionsPropensity matchingGuideline recommendationsClaims databaseReplacement therapy
2018
Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study
Wallach JD, Ciani O, Pease AM, Gonsalves GS, Krumholz HM, Taylor RS, Ross JS. Comparison of treatment effect sizes from pivotal and postapproval trials of novel therapeutics approved by the FDA based on surrogate markers of disease: a meta-epidemiological study. BMC Medicine 2018, 16: 45. PMID: 29562926, PMCID: PMC5863466, DOI: 10.1186/s12916-018-1023-9.Peer-Reviewed Original ResearchConceptsPostapproval trialsPivotal trialsActual clinical effectSurrogate markerTrial endpointsLarge treatment effectsPrimary endpointNovel therapeuticsNovel drugsTreatment effectsFDA approvalPatient-relevant outcomesMeta-epidemiological studyStandardized mean differenceTreatment effect sizeClinical effectsResultsBetween 2005Odds ratioDrug trialsSame indicationDrug AdministrationEvidence of differencesMean differenceU.S. FoodDisease