2025
Uric Acid Stroke Cerebroprotection Transcended Sex, Age, and Comorbidities in a Multicenter Preclinical Trial
Patel R, Kumskova M, Kodali H, Budnik I, Kuznetsov V, Jain A, Jha A, Thedens D, Dhanesha N, Sutariya B, Nagarkatti K, Lamb J, Kamat P, Shi Y, Avery B, Imai T, Jin X, Chauhan A, Boisserand L, Khan M, Dhandapani K, Sanganahalli B, Sansing L, Hess D, Koehler R, McCullough L, Aronowski J, Ayata C, Diniz M, Lyden P, Planas A, Chamorro A, Chauhan A, Leira E, Investigators O. Uric Acid Stroke Cerebroprotection Transcended Sex, Age, and Comorbidities in a Multicenter Preclinical Trial. Stroke 2025, 56: 965-973. PMID: 40091742, PMCID: PMC11932773, DOI: 10.1161/strokeaha.124.048748.Peer-Reviewed Original ResearchConceptsUA-treated animalsPrimary functional outcomeFunctional outcomesMiddle cerebral artery filament occlusionModified intention-to-treat populationIntention-to-treat populationUric acidHuman clinical trialsImprove functional outcomesStudy drugIntravenous salineEffects of UARelevant to patientsClinical trialsPrimary outcomeSaline controlsSecondary outcomesPreclinical trialsDay 2Survival rateDay 7Filament occlusionGroups of animalsComorbiditiesDiverse comorbiditiesSafety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study
Antozzi C, Vu T, Ramchandren S, Nowak R, Farmakidis C, Bril V, De Bleecker J, Yang H, Minks E, Park J, Grudniak M, Smilowski M, Sevilla T, Hoffmann S, Sivakumar K, Suzuki Y, Youssef E, Sanga P, Karcher K, Zhu Y, Sheehan J, Sun H, Group T. Safety and efficacy of nipocalimab in adults with generalised myasthenia gravis (Vivacity-MG3): a phase 3, randomised, double-blind, placebo-controlled study. The Lancet Neurology 2025, 24: 105-116. PMID: 39862879, DOI: 10.1016/s1474-4422(24)00498-8.Peer-Reviewed Original ResearchConceptsStandard-of-care therapyLeast-squares mean changeOpen-label extension phaseDouble-blind phasePhase 3 studyPopulation of patientsMyasthenia gravisAdverse eventsAntibody-positivePlacebo groupDouble-blindStudy drugMG-ADLAssociated with dose-dependent reductionsDose of study drugLong-term disease controlMean changeIntention-to-treat populationIncidence of adverse eventsMG-ADL scoresPlacebo-controlled studyGeneralised myasthenia gravisPhase 2 studyBaseline to weekAnti-acetylcholine receptor155. Long-Acting Subcutaneous Lenacapavir in People with Multi-Drug Resistant HIV-1: 3-Year Results of the CAPELLA Study
Ogbuagu O, McGowan J, Stapleton A, Wiznia A, Berger D, Creticos C, Hagins D, Osiyemi O, Sims J, Wheeler D, Wang H, Margot N, Dvory-Sobol H, Rhee M, Segal-Maurer S. 155. Long-Acting Subcutaneous Lenacapavir in People with Multi-Drug Resistant HIV-1: 3-Year Results of the CAPELLA Study. Open Forum Infectious Diseases 2025, 12: ofae631.041. PMCID: PMC11776782, DOI: 10.1093/ofid/ofae631.041.Peer-Reviewed Original ResearchInjection site reactionsCD4 cell countHIV-1 RNAHIV-1Site reactionsMultidrug resistanceGilead SciencesVirologic suppressionCell countRates of virologic suppressionMulti-drug resistant HIV-1FDA snapshot algorithmResistant HIV-1Len resistanceTreatment-experiencedVirological outcomesGrade 1/2Study drugMedian ageLenacapavirLens toleranceSafety profileLonger-term dataAdverse eventsCD4P-1107. Oral Sulopenem/probenecid for Uncomplicated Urinary Tract Infections (uUTI): Results from the REASSURE Trial
Puttagunta S, Aronin S, Gupta J, Das A, Gupta K, Dunne M. P-1107. Oral Sulopenem/probenecid for Uncomplicated Urinary Tract Infections (uUTI): Results from the REASSURE Trial. Open Forum Infectious Diseases 2025, 12: ofae631.1295. PMCID: PMC11777793, DOI: 10.1093/ofid/ofae631.1295.Peer-Reviewed Original ResearchUncomplicated urinary tract infectionsTreatment-emergent adverse eventsTreatment of uncomplicated urinary tract infectionsSusceptible to amoxicillin/clavulanateMMITT populationAdverse eventsFrequent treatment-emergent adverse eventsTreatment of multidrug-resistant infectionsBaseline urine cultureOral antibiotic optionsEmergent adverse eventsUrinary tract infectionMultidrug-resistant infectionsAdult womenTreatment of adult womenAmoxicillin/clavulanate groupDouble-dummyActive controlled trialAntibiotic optionsUrine cultureOral antibioticsResistant uropathogensDouble-blindStudy drugPrimary endpoint
2024
Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Heavily Treatment-Experienced People with Multidrug-Resistant HIV-1: Week 104 Results of a Phase 2/3 Trial
Ogbuagu O, Molina J, Chetchotisakd P, Ramgopal M, Sanchez W, Brunetta J, Castelli F, Crofoot G, Hung C, Ronot-Bregigeon S, Margot N, Wang H, Dvory-Sobol H, Rhee M, Segal-Maurer S. Efficacy and Safety of Long-Acting Subcutaneous Lenacapavir in Heavily Treatment-Experienced People with Multidrug-Resistant HIV-1: Week 104 Results of a Phase 2/3 Trial. Clinical Infectious Diseases 2024, 80: 566-574. PMID: 39206943, DOI: 10.1093/cid/ciae423.Peer-Reviewed Original ResearchMultidrug-resistant HIV-1Optimized background regimenHIV-1 RNA <CD4 cell countHIV-1Food & Drug AdministrationAdverse eventsTreatment of HIV-1 infectionRates of virologic suppressionCD4 cell count <Treatment-related adverse eventsMulti-drug resistant HIV-1Cell countTreatment-experienced peopleCell count <HIV-1 infectionHIV-1 RNAPhase 2/3 trialsImportant treatment optionInjection site reactionsResistant HIV-1US Food & Drug AdministrationBackground regimenVirologic suppressionStudy drugGuselkumab for Pityriasis Rubra Pilaris and Dysregulation of IL-23/IL-17 and NFkB Signaling
Velasco R, Shao C, Cutler B, Strunck J, Kent G, Cassidy P, Choate K, Greiling T. Guselkumab for Pityriasis Rubra Pilaris and Dysregulation of IL-23/IL-17 and NFkB Signaling. JAMA Dermatology 2024, 160: 641-645. PMID: 38598229, PMCID: PMC11007649, DOI: 10.1001/jamadermatol.2024.0257.Peer-Reviewed Original ResearchPsoriasis Area Severity IndexPityriasis rubra pilarisDermatology Life Quality Index scoresInvolvement of interleukinsQuality Index scoreFood and Drug Administration-approved treatmentPrimary outcomeUS Food and Drug Administration-approved treatmentPsoriasis area severity index scoreSex-matched healthy controlsIL-23p19 inhibitorsP19 subunit of IL-23Index scoreArea Severity IndexIL-23/IL-17Subunit of IL-23Per-protocol analysisClinical responseStudy drugDosing scheduleClinical respondersClinical improvementMale patientsIL-23GuselkumabA phase I study of ATR inhibitor BAY1895344 (elimusertib) plus topotecan (ETCTN 10402): Results of dose escalation.
Stockton S, Shyr C, Cecchini M, Aljumaily R, Halfdanarson T, Sonbol M, Whisenant J, Ivy S, LoRusso P, Das S, Gore S, Berlin J, Beumer J, Heumann T. A phase I study of ATR inhibitor BAY1895344 (elimusertib) plus topotecan (ETCTN 10402): Results of dose escalation. Journal Of Clinical Oncology 2024, 42: 3076-3076. DOI: 10.1200/jco.2024.42.16_suppl.3076.Peer-Reviewed Original ResearchMaximum tolerated doseDose escalationDose levelsMedian progression-free survivalRecommended phase 2 doseRefractory advanced solid tumorsResults of dose escalationTreatment-related adverse eventsSmall cell lung cancerDisease control ratePhase 2 dosePhase Ia studyDose-limiting toxicityProgression-free survivalAdvanced solid tumorsPhase I studyCell lung cancerAnti-tumor activityExpansion cohortPartial responseTolerated doseTopotecan exposureStudy drugCancer xenograftsRespiratory failureThe PAX LC Trial: A Decentralized, Phase 2, Randomized, Double-Blind Study of Nirmatrelvir/Ritonavir Compared with Placebo/Ritonavir for Long COVID
Krumholz H, Sawano M, Bhattacharjee B, Caraballo C, Khera R, Li S, Herrin J, Coppi A, Holub J, Henriquez Y, Johnson M, Goddard T, Rocco E, Hummel A, Al Mouslmani M, Putrino D, Carr K, Carvajal-Gonzalez S, Charnas L, De Jesus M, Ziegler F, Iwasaki A. The PAX LC Trial: A Decentralized, Phase 2, Randomized, Double-Blind Study of Nirmatrelvir/Ritonavir Compared with Placebo/Ritonavir for Long COVID. The American Journal Of Medicine 2024, 138: 884-892.e4. PMID: 38735354, DOI: 10.1016/j.amjmed.2024.04.030.Peer-Reviewed Original ResearchLC trialPROMIS-29Participants' homesTargeting viral persistencePlacebo-controlled trialDouble-blind studyElectronic health recordsCore Outcome MeasuresLong COVIDEQ-5D-5LRepeated measures analysisEvidence-based treatmentsPhase 2Double-blindParticipant-centred approachStudy drugPrimary endpointSecondary endpointsCommunity-dwellingHealth recordsHealthcare utilizationContiguous US statesViral persistencePatient groupDrug treatmentFruquintinib plus paclitaxel versus paclitaxel as second-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma (FRUTIGA): A randomized, multicenter, double-blind, placebo-controlled, phase 3 study.
Xu R, Wang F, Shen L, Guo W, Liu T, Li J, Qin S, Bai Y, Chen Z, Wang J, Pan Y, Shu Y, Zhao F, Cheng Y, Ye F, Gu K, Zhang T, Pan H, Zhong H, Su W. Fruquintinib plus paclitaxel versus paclitaxel as second-line therapy for patients with advanced gastric or gastroesophageal junction adenocarcinoma (FRUTIGA): A randomized, multicenter, double-blind, placebo-controlled, phase 3 study. Journal Of Clinical Oncology 2024, 42: 438780-438780. DOI: 10.1200/jco.2024.42.36_suppl.438780.Peer-Reviewed Original ResearchPhase 3 studyAntitumor therapyMedian OSDouble-blindPrimary endpointInhibitor of VEGFR-1Dose of study drugSecond-line treatment optionDual primary endpointsPlacebo (PBO)-controlledFirst-line chemotherapyGastroesophageal junction adenocarcinomaMetastatic colorectal cancerSecond-line therapyLymph node metastasisTreatment of paclitaxelStatistical significanceCox proportional hazards modelsPost hoc analysisOral inhibitorJunction adenocarcinomaEligible ptsPlacebo-controlledStudy drugStatistically significant improvement
2023
Bacillus Calmette-Guérin vaccination for protection against recurrent herpes labialis: a nested randomised controlled trial
Pittet L, Moore C, McDonald E, Barry S, Bonten M, Campbell J, Croda J, Dalcolmo M, Davidson A, Douglas M, Gardiner K, Gwee A, Jardim B, Lacerda M, Lucas M, Lynn D, Manning L, de Oliveira R, Perrett K, Prat-Aymerich C, Richmond P, Rocha J, Rodriguez-Baño J, Warris A, Wood N, Messina N, Curtis N, Curtis N, Davidson A, Gardiner K, Gwee A, Jamieson T, Messina N, Morawakage T, Perlen S, Perrett K, Pittet L, Sastry A, Teo J, Orsini F, Lee K, Moore C, Vidmar S, Pittet L, Ali R, Dunn R, Edler P, Gell G, Goodall C, Hall R, Krastev A, La N, McDonald E, McPhate N, Nguyen T, Ren J, Stevens L, Messina N, Alamrousi A, Bonnici R, Dang T, Germano S, Hua J, McElroy R, Razmovska M, Reddiex S, Wang X, Anderson J, Azzopardi K, Bennett-Wood V, Czajko A, Mazarakis N, McCafferty C, Oppedisano F, Ortika B, Pell C, Spry L, Toh R, Velagapudi S, Vlahos A, Wee-Hee A, Ramos P, De La Cruz K, Gamage D, Karunanayake A, Mezzetti I, Ong B, Singh R, Sooriyarachchi E, Nicholson S, Cain N, Brizuela R, Huang H, Abruzzo V, Bealing M, Bimboese P, Bowes K, Burrell E, Chan J, Cushnahan J, Elborough H, Elkington O, Fahey K, Fernandez M, Flynn C, Fowler S, Andrit M, Gladanac B, Hammond C, Ma N, Macalister S, Milojevic E, Mojeed J, Nguyen J, O'Donnell L, Olivier N, Ooi I, Reynolds S, Shen L, Sherry B, Spotswood J, Wedderburn J, Younes A, Legge D, Bell J, Cheah J, Cobbledick A, Lim K, Elia S, Addlem L, Bourke A, Brophy C, Henare N, Jenkins N, Machingaifa F, Miller S, Mitchell K, Pitkin S, Wall K, Villanueva P, Crawford N, Pittet L, Norton W, Tan N, Chengodu T, Dawson D, Gordon V, Korman T, O'Bryan J, Abruzzo V, Agius S, Bannister S, Bucholc J, Burns A, Camesella B, Carlin J, Ciaverella M, Curtis M, Firth S, Guo C, Hannan M, Hill E, Joshi S, Lieschke K, Mathers M, Odoi S, Rak A, Richards C, Steve L, Stewart C, Sudbury E, Thomson H, Watts E, Williams F, Young A, Glenn P, Kaynes A, De Floy A, Buchanan S, Sondag T, Xie I, Edmund H, Byrne B, Keeble T, Ngien B, Noonan F, Wearing-Smith M, Clarke A, Davies P, Eastwood O, Ellinghaus A, Ghieh R, Hilton Z, Jennings E, Kakkos A, Liang I, Nicol K, O'Callaghan S, Osman H, Rajaram G, Ratcliffe S, Rayner V, Salmon A, Scheppokat A, Stevens A, Street R, Toogood N, Wood N, Bahaduri T, Baulman T, Byrne J, Carter C, Corbett M, Dao A, Desylva M, Dunn A, Gardiner E, Joyce R, Kandasamy R, Munns C, Pelayo L, Sharma K, Sterling K, Uren C, Colaco C, Douglas M, Hamilton K, Bartlett A, McMullan B, Palasanthiran P, Williams P, Beardsley J, Bergant N, Lagunday R, Overton K, Post J, Al-Hindawi Y, Barney S, Byrne A, Mead L, Plit M, Lynn D, Benson S, Blake S, Botten R, Chern T, Eden G, Griffith L, James J, Lynn M, Markow A, Sacca D, Stevens N, Wesselingh S, Doran C, Barry S, Sawka A, Evans S, Goodchild L, Heath C, Krieg M, Marshall H, McMillan M, Walker M, Richmond P, Amenyogbe N, Anthony C, Arnold A, Arrowsmith B, Ben-Othman R, Clark S, Dunnill J, Eiffler N, Ewe K, Finucane C, Flynn L, Gibson C, Hartnell L, Hollams E, Hutton H, Jarvis L, Jones J, Jones J, Jones K, Kent J, Kollmann T, Lalich D, Lee W, Lim R, McAlister S, McDonald F, Meehan A, Minhaj A, Montgomery L, O'Donnell M, Ong J, Ong J, Parkin K, Perez G, Power C, Rezazadeh S, Richmond H, Rogers S, Schultz N, Shave M, Skut P, Stiglmayer L, Truelove A, Wadia U, Wallace R, Waring J, England M, Latkovic E, Manning L, Herrmann S, Lucas M, Lacerda M, Andrade P, Barbosa F, Barros D, Brasil L, Capella A, Castro R, Costa E, de Souza D, Dias M, Dias J, Ferreira K, Figueiredo P, Freitas T, Furtado A, Gama L, Godinho V, Gouy C, Hinojosa D, Jardim B, Jardim T, Junior J, Lima A, Maia B, Marins A, Mazurega K, Medeiros T, Melo R, Moraes M, Nascimento E, Neves J, Oliveira M, Oliveira T, Oliveira I, Otsuka A, Paes R, Pereira H, Pereira G, Prado C, Queiroz E, Rodrigues L, Rodrigues B, Sampaio V, Santos A, Santos D, Santos T, Santos E, Sartim A, Silva A, Silva J, Silva E, Simão M, Soares C, Sousa A, Trindade A, Val F, Vasconcelos A, Vasconcelos H, Croda J, Abreu C, Almeida K, de Andrade C, Angelo J, de Araújo Arcanjo G, Arruda B, Ayala W, Barbosa A, Batista F, de Morais Batista F, de Jesus Costa M, Croda M, da Cruz L, Diogo R, Escobar R, Fernandes I, Figueiredo L, Gonçalves L, Lahdo S, dos Santos Lencina J, de Lima G, Matos L, Meireles B, Moreira D, Muranaka L, de Oliveira A, de Oliveira K, de Oliveira M, de Oliveira R, dos Reis Pereira A, Puga M, Ramos C, da Rosa T, dos Santos K, dos Santos C, dos Santos D, Santos K, da Silva P, da Silva P, dos Santos Silva D, da Silva P, da Rosa Soares B, Sperotto M, Tadokoro M, Tsuha D, Vieira H, Dalcolmo M, da Paixão C, Castro G, Collopy S, da Costa Silva R, da Silveira S, Da-Cruz A, de Carvalho A, de Cássia Batista R, De Freitas M, de Oliveira Ferreira A, de Souza A, Doblas P, dos Santos A, dos Santos V, dos Santos Gomes D, Fortunato A, Gomes-Silva A, Gonçalves M, Meireless P, da Costa Carvalho E, do Couto Motta F, de Mendonça L, dos Santos Pandine G, Pereira R, Maia I, da Rocha J, Romano J, dos Santos G, da Silva E, de Siqueira M, Soares Á, Bonten M, Arroyo S, Besten H, Boon A, Brakke K, Janssen A, Koopmans M, Lemmens T, Leurink T, Prat-Aymerich C, Septer-Bijleveld E, Stadhouders K, Troeman D, van der Waal M, van Opdorp M, van Sluis N, Wolters B, Kluytmans J, Romme J, van den Bijllaardt W, van Mook L, van Rijen M, Filius P, Gisolf J, Greven F, Huijbens D, Hassing R, Pon R, Preijers L, van Leusen J, Verheij H, Boersma W, Brans E, Kloeg P, Molenaar-Groot K, Nguyen N, Paternotte N, Rol A, Stooper L, Dijkstra H, Eggenhuizen E, Huijs L, Moorlag S, Netea M, Pranger E, Taks E, Oever J, Heine R, Blauwendraat K, Meek B, Erkaya I, Harbech H, Roescher N, Peeters R, Riele M, Zhou C, Calbo E, Marti C, Palomares E, Porcuna T, Barriocanal A, Barriocanal A, Casas I, Dominguez J, Esteve M, Lacoma A, Latorre I, Molina G, Molina B, Rosell A, Vidal S, Barrera L, Bustos N, Calderón I, Campos D, Carretero J, Castellano A, Compagnone R, de Arellano E, de la Serna A, del Toro Lopez M, Espindola M, Gutierrez A, Hernandez A, Jiménez V, Moreno E, Navarrete N, Paño T, Rodríguez-Baño J, Tristán E, Villegas M, Garces A, Amo E, Guerrero R, Goikoetxea J, Jorge L, Perez C, Álvarez M, Cuadra M, de las Revillas Almajano F, Garcia P, Poderos T, Rico C, Sanchez B, Valero O, Vega N, Campbell J, Barnes A, Catterick H, Cranston T, Dawe P, Fletcher E, Fouracre L, Gifford A, Kirkwood J, Martin C, McAnew A, Mitchell M, Newman G, O'Connell A, Onysk J, Quinn L, Rhodes S, Stone S, Symons L, Tripp H, Warris A, Watkins D, Whale B, Harding A, Lockhart G, Sidaway-Lee K, Campbell J, Hilton S, Manton S, Webber-Rookes D, Winder R, Moore J, Bateman F, Gibbons M, Knight B, Moss J, Statton S, Studham J, Hall L, Moyle W, Venton T. Bacillus Calmette-Guérin vaccination for protection against recurrent herpes labialis: a nested randomised controlled trial. EClinicalMedicine 2023, 64: 102203. PMID: 37719417, PMCID: PMC10500555, DOI: 10.1016/j.eclinm.2023.102203.Peer-Reviewed Original ResearchBacille Calmette-GuerinRecurrent herpes labialisHerpes simplex virusBCG-DenmarkHerpes labialisCold soresRandomised controlled trialsRecurrence of herpes simplex virusDose of study drugEffects of Bacille Calmette-GuerinControlled trialsAs-treated populationBacillus Calmette-Guerin vaccineRecurrent cold soresControl groupBurden of recurrenceMean survival timeIntention-to-treatNested randomised controlled trialImpact quality-of-lifeStudy drugLive attenuated vaccinesIntradermal doseOrofacial regionProportion of participantsDapagliflozin in Patients With Heart Failure and Deterioration in Renal Function
Chatur S, Vaduganathan M, Claggett B, Mc Causland F, Desai A, Jhund P, de Boer R, Hernandez A, Inzucchi S, Kosiborod M, Lam C, Martinez F, Shah S, Sabatine M, Kober L, Ponikowski P, Merkely B, Petersson M, Langkilde A, McMurray J, Solomon S. Dapagliflozin in Patients With Heart Failure and Deterioration in Renal Function. Journal Of The American College Of Cardiology 2023, 82: 1854-1863. PMID: 37634707, DOI: 10.1016/j.jacc.2023.08.026.Peer-Reviewed Original ResearchConceptsDeterioration of eGFRHeart failureSafety outcomesKidney functionTreatment groupsTime-updated Cox proportional hazards modelsSodium-glucose cotransporter 2 inhibitorsComorbid chronic kidney diseaseCox proportional hazards modelPrimary composite outcomeChronic kidney diseaseCotransporter 2 inhibitorsEffect of dapagliflozinGlomerular filtration rateProportional hazards modelLives of patientsDAPA-HFDrug discontinuationCardiovascular deathCardiovascular outcomesStudy drugChronic heartComposite outcomeDapagliflozin treatmentPrimary outcomeSickle Cell Disease Treatment with Arginine Therapy (STArT): study protocol for a phase 3 randomized controlled trial
Rees C, Brousseau D, Cohen D, Villella A, Dampier C, Brown K, Campbell A, Chumpitazi C, Airewele G, Chang T, Denton C, Ellison A, Thompson A, Ahmad F, Bakshi N, Coleman K, Leibovich S, Leake D, Hatabah D, Wilkinson H, Robinson M, Casper T, Vichinsky E, Morris C. Sickle Cell Disease Treatment with Arginine Therapy (STArT): study protocol for a phase 3 randomized controlled trial. Trials 2023, 24: 538. PMID: 37587492, PMCID: PMC10433602, DOI: 10.1186/s13063-023-07538-z.Peer-Reviewed Original ResearchConceptsPediatric Emergency Care Applied Research NetworkSickle cell disease treatmentVaso-occlusive episodesSickle cell diseaseSTART trialArginine therapyIntravenous arginineLoading doseNormal saline three timesYoung adultsBlood Institute guidelinesParental opioid usePlacebo loading doseSubstantial illness burdenDisease-modifying therapiesPatient-reported outcomesDisease treatmentPhase 3Emergency medicine providersSaline three timesMulticenter research networkResearch NetworkIntravenous opioidsLast doseStudy drugComparative effectiveness of second line glucose lowering drug treatments using real world data: emulation of a target trial
Deng Y, Polley E, Wallach J, Herrin J, Ross J, McCoy R. Comparative effectiveness of second line glucose lowering drug treatments using real world data: emulation of a target trial. BMJ Medicine 2023, 2: e000419. PMID: 37577025, PMCID: PMC10414064, DOI: 10.1136/bmjmed-2022-000419.Peer-Reviewed Original ResearchYear cumulative incidence rateCumulative incidence rateType 2 diabetesLiraglutide armMetabolic failureSitagliptin armGlycaemic controlInsulin glargineMedian timeIncidence rateComparative effectivenessCox proportional hazards regressionPropensity scoreTarget trialsInsulin glargine armProportional hazards regressionOptumLabs Data WarehouseTarget trial emulationStatistical analysis planMetformin monotherapyMacrovascular complicationsMicrovascular outcomesStudy drugStudy armsTrial emulationEffect of Sotagliflozin on Early Mortality and Heart Failure-Related Events A Post Hoc Analysis of SOLOIST-WHF
Pitt B, Bhatt D, Szarek M, Cannon C, Leiter L, McGuire D, Lewis J, Riddle M, Voors A, Metra M, Lund L, Komajda M, Testani J, Wilcox C, Ponikowski P, Lopes R, Ezekowitz J, Sun F, Davies M, Verma S, Kosiborod M, Steg P, Investigators S. Effect of Sotagliflozin on Early Mortality and Heart Failure-Related Events A Post Hoc Analysis of SOLOIST-WHF. JACC Heart Failure 2023, 11: 879-889. PMID: 37558385, DOI: 10.1016/j.jchf.2023.05.026.Peer-Reviewed Original ResearchConceptsMain endpointCardiovascular deathHeart failureN-terminal pro-B-type natriuretic peptidePro-B-type natriuretic peptideEffect of sotagliflozinDate of dischargeGlomerular filtration rateVentricular ejection fractionType 2 diabetesProportional hazards modelPost Hoc AnalysisAgonist useCause mortalityIndex hospitalizationStudy drugEjection fractionEarly mortalityNatriuretic peptideStudy treatmentHF eventsSubgroup analysisFiltration rateHoc AnalysisHazards modelAntiretroviral Therapy Intensification for Neurocognitive Impairment in Human Immunodeficiency Virus
Letendre S, Chen H, McKhann A, Roa J, Vecchio A, Daar E, Berzins B, Hunt P, Marra C, Campbell T, Coombs R, Ma Q, Swaminathan S, Macatangay B, Morse G, Miller T, Rusin D, Greninger A, Ha B, Alston-Smith B, Robertson K, Paul R, Spudich S, Team T. Antiretroviral Therapy Intensification for Neurocognitive Impairment in Human Immunodeficiency Virus. Clinical Infectious Diseases 2023, 77: 866-874. PMID: 37183889, PMCID: PMC10506779, DOI: 10.1093/cid/ciad265.Peer-Reviewed Original ResearchConceptsAntiretroviral therapyART intensificationNeurocognitive impairmentWeek 48Z-scoreAntiretroviral therapy intensificationPersistent HIV replicationPlacebo-controlled trialPlasma HIV RNASuppressive antiretroviral therapyAge 52 yearsBody mass indexHuman immunodeficiency virusCopies/mLTotal Z-scoreBaseline z-scoresCentral nervous systemDual placeboEfavirenz useTherapy intensificationHIV RNAStudy drugAdverse eventsSymptomatic HIVPrimary outcome
2022
Pregnenolone effects on provoked alcohol craving, anxiety, HPA axis, and autonomic arousal in individuals with alcohol use disorder
Milivojevic V, Sullivan L, Tiber J, Fogelman N, Simpson C, Hermes G, Sinha R. Pregnenolone effects on provoked alcohol craving, anxiety, HPA axis, and autonomic arousal in individuals with alcohol use disorder. Psychopharmacology 2022, 240: 101-114. PMID: 36445398, PMCID: PMC10630889, DOI: 10.1007/s00213-022-06278-3.Peer-Reviewed Original ResearchConceptsAlcohol use disorderDiastolic blood pressureHeart rateGABAergic transmissionNeuroactive steroidsHPA axisRelapse riskUse disordersAlcohol cravingTreatment of AUDAlcohol cue-induced cravingPilot clinical trialStress-induced anxietyCue-induced cravingAutonomic arousalNeurosteroid systemPreg groupStudy drugDBP responseBlood pressureDay groupClinical trialsPregnenolone levelsWeek 2Cue-provoked cravingLinzagolix with and without hormonal add-back therapy for the treatment of symptomatic uterine fibroids: two randomised, placebo-controlled, phase 3 trials
Donnez J, Taylor HS, Stewart EA, Bradley L, Marsh E, Archer D, Al-Hendy A, Petraglia F, Watts N, Gotteland JP, Bestel E, Terrill P, Loumaye E, Humberstone A, Garner E. Linzagolix with and without hormonal add-back therapy for the treatment of symptomatic uterine fibroids: two randomised, placebo-controlled, phase 3 trials. The Lancet 2022, 400: 896-907. PMID: 36116480, DOI: 10.1016/s0140-6736(22)01475-1.Peer-Reviewed Original ResearchConceptsHeavy menstrual bleedingPhase 3 trialSymptomatic uterine fibroidsMenstrual bleedingUterine fibroidsTherapy groupPlacebo groupOral gonadotropin-releasing hormone receptor antagonistResponse rateGonadotropin-releasing hormone receptor antagonistCommon adverse eventsFull analysis setHormone receptor antagonistDose of treatmentMasked treatmentPrimary endpointStudy drugAdverse eventsEligible womenHot flushesChronic treatmentReceptor antagonistGonadal steroidsLinzagolixAnalysis setIncidence of Alopecia in Treatment of Women With Uterine Fibroids: Results of Two Phase 3 Trials of Linzagolix [A104]
Al-Hendy A, Taylor H, Catherino W, Stewart E, Bestel E, Garner E. Incidence of Alopecia in Treatment of Women With Uterine Fibroids: Results of Two Phase 3 Trials of Linzagolix [A104]. Obstetrics And Gynecology 2022, 139: 30s-30s. DOI: 10.1097/01.aog.0000826736.08037.1b.Peer-Reviewed Original ResearchPhase 3 trialUterine fibroidsGnRH antagonistHair lossPlacebo-controlled phase 3 trialUterine fibroid-related symptomsFibroid-related symptomsIncidence of alopeciaOral GnRH antagonistPooled safety analysisTreatment of womenConcomitant therapyTreatment discontinuationStudy drugWeek 52Mild alopeciaWeek 24Benign disorderSimilar incidenceLinzagolixSuppression dosesAlopeciaFibroidsTrialsTreatmentEfficacy of lower doses of pioglitazone after stroke or transient ischaemic attack in patients with insulin resistance
Spence JD, Viscoli C, Kernan WN, Young LH, Furie K, DeFronzo R, Abdul‐Ghani M, Dandona P, Inzucchi SE. Efficacy of lower doses of pioglitazone after stroke or transient ischaemic attack in patients with insulin resistance. Diabetes Obesity And Metabolism 2022, 24: 1150-1158. PMID: 35253334, DOI: 10.1111/dom.14687.Peer-Reviewed Original ResearchConceptsNew-onset diabetesAdjusted hazard ratioHazard ratioLow dosesAdverse effectsInsulin Resistance InterventionTransient ischemic attackSecondary prevention strategiesAnti-atherosclerotic propertiesInsulin-sensitizing drugsLess adverse effectsIschemic attackStudy drugHeart failureStroke trialsAdverse outcomesInsulin resistancePioglitazonePrevention strategiesHigh dosesResistance InterventionFull doseWeight gainDiabetesPatients
2021
A Double-Blind, Randomized, Placebo-Controlled Trial of Soluble Epoxide Hydrolase Inhibition in Patients with Aneurysmal Subarachnoid Hemorrhage
Martini RP, Siler D, Cetas J, Alkayed NJ, Allen E, Treggiari MM. A Double-Blind, Randomized, Placebo-Controlled Trial of Soluble Epoxide Hydrolase Inhibition in Patients with Aneurysmal Subarachnoid Hemorrhage. Neurocritical Care 2021, 36: 905-915. PMID: 34873674, DOI: 10.1007/s12028-021-01398-8.Peer-Reviewed Original ResearchConceptsSoluble epoxide hydrolaseAneurysmal subarachnoid hemorrhageSubarachnoid hemorrhageDHET ratiosEnd pointDay 7Day 10Primary study end pointSoluble epoxide hydrolase inhibitionCSF inflammatory cytokinesEET/DHET ratiosIncidence of DCIPrevention of DCITertiary end pointSecondary end pointsStudy end pointCerebral blood flowLength of stayEndothelial injury biomarkersEpoxide hydrolase inhibitionNeurovascular inflammationResultsTen patientsStudy drugAdverse eventsCytokine levels
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