2022
Health State Utility Mapping of Rimegepant for the Preventive Treatment of Migraine: Double-Blind Treatment Phase and Open Label Extension (BHV3000-305)
Powell L, L’Italien G, Popoff E, Johnston K, O’Sullivan F, Harris L, Croop R, Coric V, Lipton R. Health State Utility Mapping of Rimegepant for the Preventive Treatment of Migraine: Double-Blind Treatment Phase and Open Label Extension (BHV3000-305). Advances In Therapy 2022, 40: 585-600. PMID: 36417057, PMCID: PMC9898331, DOI: 10.1007/s12325-022-02369-x.Peer-Reviewed Original ResearchConceptsOpen-label extensionEQ-5D utilitiesWeek 12EQ-5DLong-term health-related qualityDouble-blind treatment phaseDouble-blind treatmentPrevention of migraineHealth-related qualityLife Questionnaire version 2.1Migraine-Specific QualityInfluence of treatmentHRQoL improvementResultsBaseline dataIntroductionThe objectiveAdult patientsPoint patientsActive treatmentTrial armsHRQOL measuresPreventive effectPreventive treatmentPlaceboLabel extensionTreatment phase
2020
Naltrexone + Bupropion Combination for the Treatment of Binge-eating Disorder with Obesity: A Randomized, Controlled Pilot Study
Grilo CM, Lydecker JA, Morgan PT, Gueorguieva R. Naltrexone + Bupropion Combination for the Treatment of Binge-eating Disorder with Obesity: A Randomized, Controlled Pilot Study. Clinical Therapeutics 2020, 43: 112-122.e1. PMID: 33218742, PMCID: PMC7902424, DOI: 10.1016/j.clinthera.2020.10.010.Peer-Reviewed Original ResearchConceptsBinge-eating disorderEating-disorder psychopathologyPilot RCTTreatment of BEDOutcome time pointDouble-blind treatmentPercentage of patientsControlled Pilot StudyDiscontinuation of medicationTreatment of bingeEvidence-based treatmentsBinge-eating frequencyBupropion combinationAdult patientsAdverse eventsComorbid obesitySecondary outcomesPrimary outcomeAcute effectsFunctional impairmentPlaceboLong-term effectsPatientsMost outcomesObesity170 Efficacy and Safety of Dasotraline in Adults with Binge-Eating Disorder: A Randomized, Double-blind, Fixed-dose Trial
Tsai J, Navia B, McElroy S, Hudson J, Grilo C, Goldman R, Deng L, Kent J, Loebel A. 170 Efficacy and Safety of Dasotraline in Adults with Binge-Eating Disorder: A Randomized, Double-blind, Fixed-dose Trial. CNS Spectrums 2020, 25: 308-309. DOI: 10.1017/s1092852920000863.Peer-Reviewed Original ResearchBinge-eating disorderEfficacy endpointWeek 12Dopamine/norepinephrine reuptake inhibitorFlexible-dose studySafety of dasotralineDouble-blind treatmentFixed-dose studyPrimary efficacy endpointProportion of patientsSecondary efficacy endpointsClinical Global ImpressionNorepinephrine reuptake inhibitorsWeeks of treatmentTreatment of patientsCompulsive Scale ModifiedBinge-eating episodesDSM-5 criteriaYale-Brown ObsessiveITT populationReuptake inhibitorsGlobal ImpressionDose studySignificant efficacySeverity Scale
2019
Dipeptidyl Peptidase 4 Inhibition Increases Postprandial Norepinephrine via Substance P (NK1 Receptor) During RAAS Inhibition
Wilson JR, Kerman SJ, Hubers SA, Yu C, Nian H, Grouzmann E, Eugster PJ, Mayfield DS, Brown NJ. Dipeptidyl Peptidase 4 Inhibition Increases Postprandial Norepinephrine via Substance P (NK1 Receptor) During RAAS Inhibition. Journal Of The Endocrine Society 2019, 3: 1784-1798. PMID: 31528826, PMCID: PMC6734191, DOI: 10.1210/js.2019-00185.Peer-Reviewed Original ResearchPostprandial blood pressureDPP4 inhibitionNPY 1Blood pressureHeart failureACE inhibitionSubstance PVasoactive peptidesPostprandial glucagon-like peptide-1Substance P receptor blockadeDipeptidyl peptidase-4 inhibitorsGlucagon-like peptide-1Mixed-meal studyAngiotensin receptor blockersDouble-blind treatmentPeptidase-4 inhibitorsType 2 diabetesReceptor-dependent mechanismAntihypertensive groupNPY 3Y1 agonistRAAS inhibitionReceptor blockersReceptor blockadeACE inhibitors
2017
Safety and efficacy of a Nav1.7 selective sodium channel blocker in patients with trigeminal neuralgia: a double-blind, placebo-controlled, randomised withdrawal phase 2a trial
Zakrzewska JM, Palmer J, Morisset V, Giblin GM, Obermann M, Ettlin DA, Cruccu G, Bendtsen L, Estacion M, Derjean D, Waxman SG, Layton G, Gunn K, Tate S, investigators S. Safety and efficacy of a Nav1.7 selective sodium channel blocker in patients with trigeminal neuralgia: a double-blind, placebo-controlled, randomised withdrawal phase 2a trial. The Lancet Neurology 2017, 16: 291-300. PMID: 28216232, DOI: 10.1016/s1474-4422(17)30005-4.Peer-Reviewed Original ResearchConceptsDouble-blind phaseFrequent adverse eventsOpen-label phaseSerious adverse eventsPhase 2a trialAdverse eventsTrigeminal neuralgiaSodium channel blockersTreatment failurePrimary endpointInteractive web response systemSelective sodium channel blockerPhase 2a studyCommon adverse eventsDouble-blind treatmentOpen-label treatmentSecondary care centresWeb response systemPhase 1 studyFuture clinical trialsSimilar adverse eventsNumber of patientsSodium channel blockers carbamazepineComputer-generated scheduleEligible patientsTrajectories of relapse in randomised, placebo-controlled trials of treatment discontinuation in major depressive disorder: an individual patient-level data meta-analysis
Gueorguieva R, Chekroud AM, Krystal JH. Trajectories of relapse in randomised, placebo-controlled trials of treatment discontinuation in major depressive disorder: an individual patient-level data meta-analysis. The Lancet Psychiatry 2017, 4: 230-237. PMID: 28189575, PMCID: PMC5340978, DOI: 10.1016/s2215-0366(17)30038-x.Peer-Reviewed Original ResearchConceptsActive medicationActive treatmentClinical trialsDepression severityHamilton Depression Rating Scale scoresDepression Rating Scale scoresClinical Global Impression scoresIndividual patient-level dataDouble-blind treatmentPlacebo-controlled trialPatterns of relapseGlobal Impression scoresIndividual patient dataPrevention of relapseTrajectory class membershipTreatment of depressionMajor depressive disorderRating Scale scoresPatient-level dataPost-traumatic stress disorderTreatment discontinuationAntidepressant treatmentClinical responseAlcohol Research CenterAntidepressant medication
2013
Randomized clinical trial of disulfiram for cocaine dependence or abuse during buprenorphine treatment
Schottenfeld RS, Chawarski MC, Cubells JF, George TP, Lappalainen J, Kosten TR. Randomized clinical trial of disulfiram for cocaine dependence or abuse during buprenorphine treatment. Drug And Alcohol Dependence 2013, 136: 36-42. PMID: 24462581, DOI: 10.1016/j.drugalcdep.2013.12.007.Peer-Reviewed Original ResearchMeSH KeywordsAdolescentAdultAlcohol DeterrentsAlcoholismAllelesBuprenorphineCocaine-Related DisordersData Interpretation, StatisticalDisulfiramDNADouble-Blind MethodDrug Therapy, CombinationFemaleGenotypeHumansMaleMiddle AgedNarcotic AntagonistsOpioid-Related DisordersPharmacogeneticsPolymerase Chain ReactionSample SizeTreatment OutcomeYoung AdultConceptsUrine testsCocaine useMechanism of actionCocaine dependenceClinical trialsWeeks abstinencePlacebo-controlled clinical trialEfficacy of disulfiramPharmacogenetics of responseDouble-blind treatmentBuprenorphine maintenance treatmentRandomized clinical trialsOpioid-dependent participantsT allele carriersFrequent cocaine useDopamine β-hydroxylaseBuprenorphine treatmentPrimary outcomeTreat comparisonMaintenance treatmentPharmacogenetic interactionsTreatment responseTT genotypeCocaine abstinenceConsecutive weeks
2010
Clinical and Cytological Effects of Pimecrolimus Cream 1% after Resolution of Active Atopic Dermatitis Lesions by Topical Corticosteroids: A Randomized Controlled Trial
Bangert C, Strober B, Cork M, Ortonne J, Luger T, Bieber T, Ferguson A, Ecker R, Kopp T, Weise-Riccardi S, Guettner A, Stingl G. Clinical and Cytological Effects of Pimecrolimus Cream 1% after Resolution of Active Atopic Dermatitis Lesions by Topical Corticosteroids: A Randomized Controlled Trial. Dermatology 2010, 222: 36-48. PMID: 21150167, DOI: 10.1159/000321711.Peer-Reviewed Original ResearchConceptsPimecrolimus cream 1End of studyCream 1Vehicle creamTopical pimecrolimusAD lesionsAtopic dermatitisDouble-blind treatmentDermal dendritic cellsProportion of patientsAtopic dermatitis lesionsNumber of leukocytesAD remissionEczema AreaPlacebo creamSubclinical inflammationTopical corticosteroidsControlled TrialsDendritic cellsInflammatory infiltrateLangerhans cellsNonsignificant reductionSkin biopsiesT cellsOutcome measures
2007
Baseline characteristics in the Avoiding Cardiovascular events through Combination therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) trial: A hypertensive population at high cardiovascular risk
Weber MA, Bakris GL, Dahlöf B, Pitt B, Velazquez E, Gupte J, Lefkowitz M, Hester A, Shi V, Weir M, Kjeldsen S, Massie B, Nesbitt S, Ofili E, Jamerson K, Investigators F. Baseline characteristics in the Avoiding Cardiovascular events through Combination therapy in Patients Living with Systolic Hypertension (ACCOMPLISH) trial: A hypertensive population at high cardiovascular risk. Blood Pressure 2007, 16: 13-19. PMID: 17453747, DOI: 10.1080/08037050701217643.Peer-Reviewed Original ResearchConceptsBody mass indexHigh cardiovascular riskCardiovascular eventsHypertensive patientsCardiovascular riskDiabetes mellitusCombination therapyNon-fatal cardiovascular endpointsCoronary artery bypass graftMean body mass indexAnti-lipid therapyAvoiding Cardiovascular EventsOral diabetes therapyPrevious antihypertensive treatmentSystolic Hypertension (ACCOMPLISH) trialDouble-blind treatmentAcute coronary syndromeArtery bypass graftAntihypertensive combination therapyHistory of strokePercutaneous coronary interventionAnti-platelet agentsACCOMPLISH trialAntihypertensive treatmentCardiovascular morbidity
2006
Effectiveness of Olanzapine, Quetiapine, Risperidone, and Ziprasidone in Patients With Chronic Schizophrenia Following Discontinuation of a Previous Atypical Antipsychotic
Stroup T, Lieberman J, McEvoy J, Swartz M, Davis S, Rosenheck R, Perkins D, Keefe R, Davis C, Severe J, Hsiao J. Effectiveness of Olanzapine, Quetiapine, Risperidone, and Ziprasidone in Patients With Chronic Schizophrenia Following Discontinuation of a Previous Atypical Antipsychotic. FOCUS The Journal Of Lifelong Learning In Psychiatry 2006, 4: 539-552. DOI: 10.1176/foc.4.4.539.Peer-Reviewed Original ResearchAtypical antipsychoticsChronic schizophreniaDouble-blind treatmentDouble-blind studyGroup of patientsDifferent atypical antipsychoticsEffectiveness of olanzapineTreatment of schizophreniaClinical Antipsychotic TrialsTreatment discontinuationPrevious antipsychoticDifferent antipsychoticsAntipsychotic TrialsAntipsychoticsQuetiapineDiscontinuationPatientsOlanzapineRisperidoneZiprasidonePrevious treatmentSchizophreniaTreatmentSignificant differencesPrimary aim
2004
NO Synthase Inhibition Increases Aldosterone in Humans
Muldowney JA, Davis SN, Vaughan DE, Brown NJ. NO Synthase Inhibition Increases Aldosterone in Humans. Hypertension 2004, 44: 739-745. PMID: 15381675, DOI: 10.1161/01.hyp.0000143852.48258.f1.Peer-Reviewed Original ResearchConceptsL-NAME infusionL-NAMEL-arginineAldosterone concentrationSerum potassiumNitro-L-arginine methyl esterNO precursor L-arginineEndogenous NO modulatesDouble-blind treatmentPlasma renin activityAngiotensin II concentrationEnzyme inhibitor ramiprilSystolic blood pressurePrecursor L-arginineRenin activityPlacebo pretreatmentBlood pressureSerum aldosteroneTreatment armsNO modulatesVehicle infusionHeart rateNormal subjectsSeparate daysCombined treatment
2001
Venlafaxine in the treatment of premenstrual dysphoric disorder.
Freeman E, Rickels K, Yonkers K, Kunz N, McPherson M, Upton G. Venlafaxine in the treatment of premenstrual dysphoric disorder. Obstetrics And Gynecology 2001, 98: 737-44. PMID: 11704162, DOI: 10.1016/s0029-7844(01)01530-7.Peer-Reviewed Original ResearchConceptsPremenstrual dysphoric disorderDaily symptom reportsTreatment of premenstrual dysphoric disorderDysphoric disorderHamilton Rating Scale for DepressionPremenstrual dysphoric disorder treatmentDSR scoresEfficacy of long-term maintenance treatmentSafety of venlafaxineFlexible-dose trialNew-generation antidepressantsLong-term maintenance treatmentDouble-blind treatmentTreatment cyclesPremenstrual symptom scoresVenlafaxine doseVenlafaxine treatmentSymptom reductionSymptom remissionInhibit serotoninNorepinephrine reuptakePMDD symptomsVenlafaxineSymptom reportingCyclic disorder
1998
Controlled‐release oxycodone compared with controlled‐release morphine in the treatment of cancer pain: A randomized, double‐blind, parallel‐group study
Mucci‐LoRusso P, Berman B, Silberstein P, Citron M, Bressler L, Weinstein S, Kaiko R, Buckley B, Reder R. Controlled‐release oxycodone compared with controlled‐release morphine in the treatment of cancer pain: A randomized, double‐blind, parallel‐group study. European Journal Of Pain 1998, 2: 239-249. PMID: 15102384, DOI: 10.1016/s1090-3801(98)90020-9.Peer-Reviewed Original ResearchControlled-release morphineControlled-release oxycodoneCancer-related painVisual analogue scorePlasma concentrationsStable analgesiaPain intensityAdverse experiencesChronic cancer-related painControlled-release oral formulationsSevere cancer-related painSteady-state plasma concentrationsCancer pain patientsDouble-blind treatmentParallel-group studyLess itchingMorphine patientSuitable analgesicCancer painAnalogue scorePain controlSevere painCreatinine levelsTrough fluctuationOral formulation
1993
Effects of Acute Buprenorphine on Responses to Intranasal Cocaine: A Pilot Study
Rosen M, Pearsall H, McDougle C, Price L, Woods S, Kosten T. Effects of Acute Buprenorphine on Responses to Intranasal Cocaine: A Pilot Study. The American Journal Of Drug And Alcohol Abuse 1993, 19: 451-464. PMID: 8273766, DOI: 10.3109/00952999309001634.Peer-Reviewed Original Research
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