2023
A Review of Incretin Therapies Approved and in Late-Stage Development for Overweight and Obesity Management
Chetty A, Rafi E, Bellini N, Buchholz N, Isaacs D. A Review of Incretin Therapies Approved and in Late-Stage Development for Overweight and Obesity Management. Endocrine Practice 2023, 30: 292-303. PMID: 38122931, DOI: 10.1016/j.eprac.2023.12.010.Peer-Reviewed Original ResearchConceptsWeight-related complicationsGlucose-dependent insulinotropic polypeptideReceptor agonistsIncretin therapiesGlucagon-like peptide-1Weight managementObesity managementLate-stage developmentOral GLP-1 receptor agonistSide effectsAssociated with weight regainReview clinical trial dataGLP-1 receptor agonistsDual GLP-1/GIP receptor agonistsGLP-1/GIP receptor agonistsWeeks of treatmentGastrointestinal side effectsClinical trial dataLevels of weight lossWeight reductionCombination therapyWeight regainClinical trialsTherapyPeptide-1Metformin inhibits digestive proteases and impairs protein digestion in mice
Kelly C, Verdegaal A, Anderson B, Shaw W, Bencivenga-Barry N, Folta-Stogniew E, Goodman A. Metformin inhibits digestive proteases and impairs protein digestion in mice. Journal Of Biological Chemistry 2023, 299: 105363. PMID: 37863262, PMCID: PMC10663847, DOI: 10.1016/j.jbc.2023.105363.Peer-Reviewed Original ResearchConceptsGastrointestinal side effectsSide effectsDrug concentrationsDaily metformin doseFirst-line therapyType 2 diabetesEnteropeptidase activityPrescribed medicationsMetformin doseIntestinal lumenGastrointestinal tissuesMice exhibitMetforminProtein maldigestionHuman duodenumProtein digestionTrypsin activityDigestive enzymesMedicationsDiabetesMaldigestionDuodenumTherapyActivityMice1704-P: Efficacy and Safety of Tirzepatide for Weight Loss—A Meta-analysis of Randomized Controlled Trials
MESQUITA Y, CALVI I, MARQUES I, CRUZ S, PADRAO E, CARDOSO R, MOURA F, RAFALSKIY V. 1704-P: Efficacy and Safety of Tirzepatide for Weight Loss—A Meta-analysis of Randomized Controlled Trials. Diabetes 2023, 72 DOI: 10.2337/db23-1704-p.Peer-Reviewed Original ResearchMean differenceDual glucose-dependent insulinotropic polypeptideOdds ratioGlucagon-like peptide-1 receptor agonistsMeta-analysis of randomized controlled trialsPeptide-1 receptor agonistsSafety of tirzepatideGlucose-dependent insulinotropic polypeptideCo-primary endpointsGastrointestinal side effectsWeight lossType 2 diabetesRandomized Controlled TrialsReceptor agonistsBody weight changesTherapeutic optionsAdverse eventsTirzepatidePooled analysisSide effectsPlaceboWeight managementControlled TrialsMeta-analysisBody weight
2022
Hepcidin-guided screen-and-treat interventions for young children with iron-deficiency anaemia in The Gambia: an individually randomised, three-arm, double-blind, controlled, proof-of-concept, non-inferiority trial
Wegmüller R, Bah A, Kendall L, Goheen M, Sanyang S, Danso E, Sise E, Jallow A, Verhoef H, Jallow M, Wathuo M, Armitage A, Drakesmith H, Pasricha S, Cross J, Cerami C, Prentice A. Hepcidin-guided screen-and-treat interventions for young children with iron-deficiency anaemia in The Gambia: an individually randomised, three-arm, double-blind, controlled, proof-of-concept, non-inferiority trial. The Lancet Global Health 2022, 11: e105-e116. PMID: 36521942, PMCID: PMC9764454, DOI: 10.1016/s2214-109x(22)00449-1.Peer-Reviewed Original ResearchConceptsMultiple micronutrient powdersPlasma hepcidin concentrationsRespiratory tract infectionsAdverse eventsHepcidin concentrationsIron supplementationNon-inferiority marginNon-inferiority trialDouble-blindTract infectionsControl groupIron deficiencyPrimary outcomeWHO standard of careAssociated with serious adverse outcomesLower respiratory tract infectionsUniversal iron supplementationUpper respiratory tract infectionPer-protocol populationIron deficiency anemiaDays of iron supplementationNon-serious adverse eventsGastrointestinal side effectsSerious adverse outcomesHemoglobin concentrationEffects of preconception lifestyle intervention in infertile women with obesity: The FIT-PLESE randomized controlled trial
Legro RS, Hansen KR, Diamond MP, Steiner AZ, Coutifaris C, Cedars MI, Hoeger KM, Usadi R, Johnstone EB, Haisenleder DJ, Wild RA, Barnhart KT, Mersereau J, Trussell JC, Krawetz SA, Kris-Etherton PM, Sarwer DB, Santoro N, Eisenberg E, Huang H, Zhang H. Effects of preconception lifestyle intervention in infertile women with obesity: The FIT-PLESE randomized controlled trial. PLOS Medicine 2022, 19: e1003883. PMID: 35041662, PMCID: PMC8765626, DOI: 10.1371/journal.pmed.1003883.Peer-Reviewed Original ResearchConceptsHealthy live birthIntensive lifestyle interventionLifestyle interventionLive birthsWeight lossExercise interventionPrimary outcomeBirth outcomesMetabolic healthInfertility treatmentPhysical activityOvarian stimulation/intrauterine inseminationIntensive groupFirst trimester pregnancy lossIntensive lifestyle groupLifestyle modification groupPreconception lifestyle interventionStandard exercise interventionAcute weight lossTrimester pregnancy lossGastrointestinal side effectsSignificant weight lossLive birth incidenceLifestyle groupUnexplained infertility
2021
Risk of Intestinal Necrosis With Sodium Polystyrene Sulfonate: A Systematic Review and Meta‐analysis
Holleck JL, Roberts AE, Marhoffer EA, Grimshaw AA, Gunderson CG. Risk of Intestinal Necrosis With Sodium Polystyrene Sulfonate: A Systematic Review and Meta‐analysis. Journal Of Hospital Medicine 2021, 16: 489-494. PMID: 34328838, DOI: 10.12788/jhm.3655.Peer-Reviewed Original ResearchConceptsSevere gastrointestinal side effectsGastrointestinal side effectsIntestinal necrosisHazard ratioSide effectsComposite outcomeOdds ratioSodium polystyrene sulfonateSystematic reviewSevere gastrointestinal adverse eventsGastrointestinal adverse eventsPooled hazard ratioRisk of biasPooled odds ratioCase-control studyPrior systematic reviewsSystematic literature searchAdverse eventsAlternative medicationsCochrane LibraryDatabase inceptionClinical trialsNecrosis rateInclusion criteriaPotential confounding
2020
Combination Hydralazine and Isosorbide Dinitrate in Dialysis-Dependent ESRD (HIDE): A Randomized, Placebo-Controlled, Pilot Trial.
Charytan D, Hsu J, Mc Causland F, Waikar S, Ikizler T, Raj D, Landis J, Mehrotra R, Williams M, DiCarli M, Skali H, Kimmel P, Kliger A, Dember L, Himmelfarb J, Anderson A, Hung A, Sharma S, Weiner D. Combination Hydralazine and Isosorbide Dinitrate in Dialysis-Dependent ESRD (HIDE): A Randomized, Placebo-Controlled, Pilot Trial. Kidney360 2020, 1: 1380-1389. PMID: 35372900, PMCID: PMC8815530, DOI: 10.34067/kid.0004342020.Peer-Reviewed Original ResearchConceptsIsosorbide dinitrateCoronary flow reserveAdverse eventsMaintenance HDMitral annular e' velocityDouble-blind pilot trialFlow reserveRecurrent intradialytic hypotensionRandomized to placeboMaximum tolerated doseTissue Doppler echocardiographyParticipants discontinued therapyGastrointestinal side effectsDetect between-group differencesPilot trialIntra-dialytic hypotensionPlacebo-ControlledPositron emission tomographyDose escalationHeart failure mortalityDose reductionStudy medicationTolerated dosePlacebo groupCombination therapyMagnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer: Preliminary Experience from a Single Center in a Prospective, Multi-Center, Single-Arm Clinical Trial
Sundaram KM, Staruch R, Burtnyk M, Lane JS, Penson DF, Arora SS. Magnetic Resonance Imaging-Guided Transurethral Ultrasound Ablation of Localized Prostate Cancer: Preliminary Experience from a Single Center in a Prospective, Multi-Center, Single-Arm Clinical Trial. Journal Of Vascular And Interventional Radiology 2020, 31: 740-746.e4. PMID: 32307311, DOI: 10.1016/j.jvir.2019.12.802.Peer-Reviewed Original ResearchMeSH KeywordsAblation TechniquesAgedAged, 80 and overHumansMagnetic Resonance Imaging, InterventionalMaleMiddle AgedNeoplasm GradingNeoplasm StagingOntarioPreliminary DataProspective StudiesProstatic NeoplasmsTime FactorsTransurethral Resection of ProstateTreatment OutcomeUltrasonic Surgical ProceduresConceptsTransurethral ultrasound ablationProstate cancerMagnetic resonance imaging-guided transurethral ultrasound ablationIntermediate-risk prostate cancerUltrasound ablationIntermediate-risk diseaseSingle-center experienceGastrointestinal side effectsLocalized prostate cancerArm clinical trialMagnetic resonance imagingHistologic benefitPostprocedural changesPrimary endpointSingle centerClinical trialsMulti-centerSide effectsPreliminary experienceResonance imagingPatientsProstate treatmentCancerAblationBiopsyEvaluating the clinical effectiveness and safety of various HER2-targeted regimens after prior taxane/trastuzumab in patients with previously treated, unresectable, or metastatic HER2-positive breast cancer: a systematic review and network meta-analysis
Paracha N, Reyes A, Diéras V, Krop I, Pivot X, Urruticoechea A. Evaluating the clinical effectiveness and safety of various HER2-targeted regimens after prior taxane/trastuzumab in patients with previously treated, unresectable, or metastatic HER2-positive breast cancer: a systematic review and network meta-analysis. Breast Cancer Research And Treatment 2020, 180: 597-609. PMID: 32100144, PMCID: PMC7103014, DOI: 10.1007/s10549-020-05577-7.Peer-Reviewed Original ResearchConceptsMetastatic HER2-positive breast cancerHER2-positive breast cancerOverall response rateProgression-free survivalT-DM1Breast cancerHazard ratioOverall survivalHead trial dataElevated liver transaminasesGastrointestinal side effectsTrial of treatmentAbsence of headRandom-effects NMAAdjuvant therapyEfficacy outcomesLiver transaminasesSafety endpointTolerability profileAdverse eventsEarly relapseMethodsSystematic reviewClinical effectivenessTrastuzumab emtansineConclusionsThe efficacyIntegrated safety profile of selinexor in multiple myeloma: experience from 437 patients enrolled in clinical trials
Gavriatopoulou M, Chari A, Chen C, Bahlis N, Vogl DT, Jakubowiak A, Dingli D, Cornell RF, Hofmeister CC, Siegel D, Berdeja JG, Reece D, White D, Lentzsch S, Gasparetto C, Huff CA, Jagannath S, Baz R, Nooka AK, Richter J, Abonour R, Parker TL, Yee AJ, Moreau P, Lonial S, Tuchman S, Weisel KC, Mohty M, Choquet S, Unger TJ, Li K, Chai Y, Li L, Shah J, Shacham S, Kauffman MG, Dimopoulos MA. Integrated safety profile of selinexor in multiple myeloma: experience from 437 patients enrolled in clinical trials. Leukemia 2020, 34: 2430-2440. PMID: 32094461, PMCID: PMC7449872, DOI: 10.1038/s41375-020-0756-6.Peer-Reviewed Original ResearchConceptsWeeks of treatmentSide effectsMultiple myelomaNuclear export protein exportin 1Integrated safety profileSupportive care measuresThrombopoietin receptor agonistsGastrointestinal side effectsGranulocyte-colony stimulating factorConstitutional side effectsColony-stimulating factorAdverse eventsSupportive carePlatelet transfusionsSafety profileReceptor antagonistCare measuresReceptor agonistSolid malignanciesClinical trialsSmall molecule inhibitorsSelinexorDemonstrated activityStimulating factorWeight loss
2015
Tapentadol extended release in the management of peripheral diabetic neuropathic pain
Vadivelu N, Kai A, Maslin B, Kodumudi G, Legler A, Berger JM. Tapentadol extended release in the management of peripheral diabetic neuropathic pain. Therapeutics And Clinical Risk Management 2015, 11: 95-105. PMID: 25609974, PMCID: PMC4298300, DOI: 10.2147/tcrm.s32193.Peer-Reviewed Original ResearchPainful diabetic neuropathyDiabetic neuropathyOpioid-based therapyCancer-related painDiabetic neuropathic painChronic pain conditionsGastrointestinal side effectsNorepinephrine reuptake inhibitorsΜ-opioid agonistMechanism of actionNeuropathic painPain conditionsReuptake inhibitorsBack painArthritic painClinical efficacyEffective medicationsClinical studiesSide effectsPainTapentadolNeuropathyOne-thirdMedicationsDiabetes
2009
Mycophenolate Mofetil-induced Colitis in Children
Phatak UP, Seo-Mayer P, Jain D, Selbst M, Husain S, Pashankar DS. Mycophenolate Mofetil-induced Colitis in Children. Journal Of Clinical Gastroenterology 2009, 43: 967-969. PMID: 19609219, DOI: 10.1097/mcg.0b013e3181a8754d.Peer-Reviewed Original ResearchConceptsMycophenolate mofetilSevere colitisMild gastrointestinal side effectsPediatric renal transplant patientsWithdrawal of MMFMaintenance of immunosuppressionRenal transplant patientsInflammatory bowel diseaseGastrointestinal side effectsCause of diarrheaMMF therapyHost diseaseTransplant patientsBowel diseaseColonic biopsiesHistologic featuresPatient 1Patient 2Histologic findingsComplete resolutionSide effectsColitisPatientsCausal associationMofetil
2007
Clomiphene, Metformin, or Both for Infertility in the Polycystic Ovary Syndrome
Legro R, Barnhart H, Schlaff W, Carr B, Diamond M, Carson S, Steinkampf M, Coutifaris C, McGovern P, Cataldo N, Gosman G, Nestler J, Giudice L, Leppert P, Myers E. Clomiphene, Metformin, or Both for Infertility in the Polycystic Ovary Syndrome. Obstetrical & Gynecological Survey 2007, 62: 386-388. DOI: 10.1097/01.ogx.0000265909.61668.01.Peer-Reviewed Original ResearchPolycystic ovary syndromeExtended-release metforminMetformin groupLive birthsTreatment groupsClomiphene citrateOvary syndromeInfertile womenPregnancy lossSex hormone-binding globulin levelsAbstract Polycystic ovary syndromeHormone-binding globulin levelsFirst trimester pregnancy lossClomiphene-treated patientsDose of clomipheneMetformin-treated womenPlacebo-controlled trialSerious adverse eventsFirst-line treatmentFree androgen indexLive birth rateGastrointestinal side effectsBody mass indexEarly pregnancy lossSingle drug group
2002
Phase I Study of Perillyl Alcohol in Patients with Refractory Malignancies
Murren JR, Pizzorno G, DiStasio SA, McKeon A, Peccerillo K, Gollerkari A, McMurray W, Burtness BA, Rutherford T, Li X, Ho PT, Sartorelli A. Phase I Study of Perillyl Alcohol in Patients with Refractory Malignancies. Cancer Biology & Therapy 2002, 1: 130-135. PMID: 12170772, DOI: 10.4161/cbt.57.Peer-Reviewed Original ResearchConceptsPeak plasma concentrationPlasma concentrationsChronic basisDihydroperillic acidMean peak plasma concentrationLow-grade nauseaPerillyl alcoholStabilization of diseaseGastrointestinal side effectsH post ingestionPerillic acidMonoterpene perillyl alcoholStarting doseRefractory malignanciesPost ingestionSide effectsPatientsMajor metabolitePharmacokinetic studyDoseMicroMNauseaMalignancyAverage numberDisease
2000
Antiretroviral Prophylaxis of Health Care Workers at Two Urban Medical Centers
Russi M, Buitrago M, Goulet J, Calello D, Perlotto J, van Rhijn D, Nash E, Friedland G, Hierholzer W. Antiretroviral Prophylaxis of Health Care Workers at Two Urban Medical Centers. Journal Of Occupational And Environmental Medicine 2000, 42: 1092-1100. PMID: 11094788, DOI: 10.1097/00043764-200011000-00011.Peer-Reviewed Original ResearchMeSH KeywordsAdultAnti-HIV AgentsBlood-Borne PathogensChi-Square DistributionFemaleHealth PersonnelHepatitis BHepatitis CHIV InfectionsHospitals, UrbanHumansInfectious Disease Transmission, Patient-to-ProfessionalLogistic ModelsMaleMiddle AgedNeedlestick InjuriesOccupational ExposurePatient Acceptance of Health CareConceptsHealth care workersAntiretroviral prophylaxisCare workersBlood-borne pathogen exposureSource patient's HIV statusEarly drug discontinuationPatient's HIV statusGastrointestinal side effectsUrban medical centerDrug discontinuationSource patientsHIV statusMedical CenterProphylaxisSerological statusLicensed nursesSide effectsExposure typePathogen exposureJob categoriesExposureMedical studentsStatusDiscontinuationMedications
1999
5‐Fluorouracil‐induced small bowel toxicity in patients with colorectal carcinoma
Fata F, Ron I, Kemeny N, O'Reilly E, Klimstra D, Kelsen D. 5‐Fluorouracil‐induced small bowel toxicity in patients with colorectal carcinoma. Cancer 1999, 86: 1129-1134. PMID: 10506695, DOI: 10.1002/(sici)1097-0142(19991001)86:7<1129::aid-cncr5>3.0.co;2-4.Peer-Reviewed Original ResearchConceptsSmall bowel toxicityBowel toxicityColorectal carcinomaColon carcinomaLow dose of 5-FUAcute small bowel toxicityDose of 5-FUAbdominal computed tomography scanAcute abdominal painRecurrence of symptomsGastrointestinal side effectsSmall bowel damageDecreased mucosal blood flowMucosal blood flowAcute toxicity episodesLower gastrointestinal tractGastrointestinal toxicityAbdominal painOral mucositisSchedule-dependentSevere toxicityTomography scanBowel damageClinical pictureLow dosesEfficacy and Safety of Delavirdine Mesylate With Zidovudine and Didanosine Compared With Two-Drug Combinations of These Agents in Persons With HIV Disease With CD4 Counts of 100 to 500 cells/mm3 (ACTG 261)
Friedland G, Pollard R, Griffith B, Hughes M, Morse G, Bassett R, Freimuth W, Demeter L, Connick E, Nevin T, Hirsch M, Fischl M. Efficacy and Safety of Delavirdine Mesylate With Zidovudine and Didanosine Compared With Two-Drug Combinations of These Agents in Persons With HIV Disease With CD4 Counts of 100 to 500 cells/mm3 (ACTG 261). JAIDS Journal Of Acquired Immune Deficiency Syndromes 1999, 21: 281-292. PMID: 10428106, DOI: 10.1097/00126334-199908010-00005.Peer-Reviewed Original ResearchConceptsCells/mm3CD4 cell countTwo-drug combinationsCell countHIV-1 RNA changesHIV-1 RNA levelsMonths of monotherapyThree-drug regimenTwo-drug armTwo-drug regimensGastrointestinal side effectsThree-drug combinationDelavirdine mesylateNon-nucleoside reverseCD4 countCD4 cellsHIV diseaseKey efficacyMulticenter trialCopies/Antiretroviral activityHIV-1Side effectsDidanosineZidovudineVinorelbine as first-line chemotherapy for advanced breast cancer in women 60 years of age or older
Vogel C, O’Rourke M, Winer E, Hochster H, Chang A, Adamkiewicz B, White R, McGuirt C. Vinorelbine as first-line chemotherapy for advanced breast cancer in women 60 years of age or older. Annals Of Oncology 1999, 10: 397-402. PMID: 10370781, DOI: 10.1023/a:1008364222793.Peer-Reviewed Original ResearchMeSH KeywordsAgedAged, 80 and overAgingAntineoplastic Agents, PhytogenicBreast NeoplasmsDisease-Free SurvivalDose-Response Relationship, DrugDrug Administration ScheduleFemaleFollow-Up StudiesHumansInfusions, IntravenousMiddle AgedProspective StudiesSeverity of Illness IndexTreatment OutcomeVinblastineVinorelbineConceptsAdvanced breast cancerDose-limiting toxicityBreast cancerSide effectsNonhematologic toxicityElderly patientsMeasurable advanced breast cancerMajor dose-limiting toxicityActivity of vinorelbineMedian dose intensityFirst-line chemotherapyObjective response rateFirst-line therapyPhase II trialSubjective side effectsInjection site reactionsWomen 60 yearsGastrointestinal side effectsGeneralized painIntravenous vinorelbinePrior chemotherapyAbdominal painChest painII trialCytotoxic chemotherapy
1996
Rectal suppositories of 8-methoxsalen produce fewer gastrointestinal side effects than the oral formulation
Bolognia J, Freije L, Amici L, Dellostritto J, Gasparro F. Rectal suppositories of 8-methoxsalen produce fewer gastrointestinal side effects than the oral formulation. Journal Of The American Academy Of Dermatology 1996, 35: 424-427. PMID: 8784281, DOI: 10.1016/s0190-9622(96)90609-x.Peer-Reviewed Original ResearchConceptsGastrointestinal side effectsAbdominal painRectal suppositoriesSide effectsOral formOral liquid formClinical severity scoreOpen pilot studyGroup of patientsEntire treatment periodRoute of administrationMean scoreGastrointestinal symptomsSignificant nauseaRectal formClinical efficacyPsoriasis vulgarisPlasma levelsSeverity scoreTreatment periodOral ingestionSuppository formOral formulationPatientsNausea
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