A real-world study of persistence and adherence to prescription medications in patients with chronic idiopathic constipation in the United States.
Cash B, Lu M, Lembo A, Feuerstadt P, Nguyen L, Terasawa E, Ayyagari R, Du S, Pi S, Westermeyer B, Terreri B, Boules M, Moshiree B. A real-world study of persistence and adherence to prescription medications in patients with chronic idiopathic constipation in the United States. Journal Of Managed Care & Specialty Pharmacy 2024, 30: 1136-1148. PMID: 39321115, PMCID: PMC11424913, DOI: 10.18553/jmcp.2024.30.10.1136.Peer-Reviewed Original ResearchConceptsChronic idiopathic constipationHazard ratioIdiopathic constipationTreatment of chronic idiopathic constipationHigher treatment persistencePrescription medicationsComparator medicationUS Food and Drug AdministrationProportion of patientsIBM MarketScan Commercial ClaimsObservational cohort studyFood and Drug AdministrationAdjusted hazard ratiosMarketScan Commercial ClaimsProportion of daysAssociated with lower oddsTreatment persistencePrucaloprideCohort studyOdds ratioPrescription fillsPrescription therapyDrug AdministrationCompare persistenceInclusion criteriaPUNCH CD3-OLS: a phase 3 prospective observational cohort study to evaluate the safety and efficacy of fecal microbiota, live-jslm (REBYOTA) in adults with recurrent Clostridioides difficile infection
Feuerstadt P, Chopra T, Knapple W, Van Hise N, Dubberke E, Baggott B, Guthmueller B, Bancke L, Gamborg M, Steiner T, Van Handel D, Khanna S. PUNCH CD3-OLS: a phase 3 prospective observational cohort study to evaluate the safety and efficacy of fecal microbiota, live-jslm (REBYOTA) in adults with recurrent Clostridioides difficile infection. Clinical Infectious Diseases 2024, ciae437. PMID: 39180326, DOI: 10.1093/cid/ciae437.Peer-Reviewed Original ResearchTreatment-emergent adverse eventsRecurrent Clostridioides difficile infectionPreventing recurrent Clostridioides difficile infectionStandard-of-careSerious treatment-emergent adverse eventsTreatment successSustained clinical response ratesStandard-of-care antibioticsSustained clinical responseClinical response rateOpen-label studyTreatment success rateClostridioides difficile infectionMicrobiota-basedBaseline characteristic subgroupsObservational cohort studyFood and Drug AdministrationInflammatory bowel diseaseAntibiotic completionClinical responseSingle-doseEfficacy ratePrimary endpointSecondary endpointsImmunocompromised conditionsRetrospective subgroup analysis of fecal microbiota, live-jslm (REBYOTA®) administered by colonoscopy under enforcement discretion for the prevention of recurrent Clostridioides difficile infection
Knapple W, Yoho D, Sheh A, Thul J, Feuerstadt P. Retrospective subgroup analysis of fecal microbiota, live-jslm (REBYOTA®) administered by colonoscopy under enforcement discretion for the prevention of recurrent Clostridioides difficile infection. Therapeutic Advances In Gastroenterology 2024, 17: 17562848241239547. PMID: 38529070, PMCID: PMC10962041, DOI: 10.1177/17562848241239547.Peer-Reviewed Original ResearchClostridioides difficile</i> infectionSustained clinical responseClinical responsePrevention of recurrent CDITreatment successRecurrent Clostridioides difficile infectionConsistent with clinical trialsAlternative routes of administrationRetrospective subgroup analysisClostridioides difficile infectionReal-world safetyRoute of administrationFood and Drug AdministrationAnalysis of fecal microbiotaCDI recurrenceSingle-doseFecal microbiotaDifficile infectionAdverse eventsRetrospective analysisLive biotherapeutic productsColonoscopyDrug AdministrationClinical interestTEAEs