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[PMID]:28968735
[Au] Autor:McInnes IB; Mease PJ; Ritchlin CT; Rahman P; Gottlieb AB; Kirkham B; Kajekar R; Delicha EM; Pricop L; Mpofu S
[Ad] Endereço:Institute of Infection Immunity and Inflammation, University of Glasgow, Glasgow, UK.
[Ti] Título:Secukinumab sustains improvement in signs and symptoms of psoriatic arthritis: 2 year results from the phase 3 FUTURE 2 study.
[So] Source:Rheumatology (Oxford);56(11):1993-2003, 2017 Nov 01.
[Is] ISSN:1462-0332
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:Objectives: To assess long-term efficacy, safety and tolerability of secukinumab up to 104 weeks in patients with active PsA. Methods: Patients with PsA (n = 397) were randomized to s.c. secukinumab 300, 150 or 75 mg or placebo at baseline, weeks 1, 2, 3 and 4 and every 4 weeks thereafter. Placebo-treated patients were re-randomized to receive secukinumab 300 or 150 mg s.c. from week 16 (placebo non-responders) or week 24 (placebo responders). Exploratory endpoints at week 104 included 20, 50 and 70% improvement in ACR criteria (ACR20, 50, 70); 75 and 90% improvement in the Psoriasis Area Severity Index, 28-joint DAS with CRP, presence of dactylitis and enthesitis and other patient-reported outcomes. For binary variables, missing values were imputed; continuous variables were analysed by a mixed-effects model for repeated measures. Results: A total of 86/100 (86%), 76/100 (76%) and 65/99 (66%) patients in the secukinumab 300, 150 and 75 mg groups, respectively, completed 104 weeks. At week 104, ACR20 response rates after multiple imputation in the 300, 150 and 75 mg groups were 69.4, 64.4 and 50.3%, respectively. Sustained clinical improvements were observed through week 104 with secukinumab across other clinically important domains of PsA. Responses were sustained through week 104 regardless of prior anti-TNF-α use. Over the entire treatment period the incidence, type and severity of adverse events were consistent with those reported previously. Conclusion: Secukinumab provided sustained improvements in signs and symptoms and multiple clinical domains in patients of active PsA through 2 years of therapy. Secukinumab was well tolerated, with a safety profile consistent with that reported previously. Trial registration: ClinicalTrials.gov (https://clinicaltrials.gov), NCT01752634.
[Mh] Termos MeSH primário: Anticorpos Monoclonais/uso terapêutico
Antirreumáticos/uso terapêutico
Artrite Psoriásica/tratamento farmacológico
[Mh] Termos MeSH secundário: Artrite Psoriásica/metabolismo
Artrite Psoriásica/fisiopatologia
Proteína C-Reativa/metabolismo
Diarreia/induzido quimicamente
Método Duplo-Cego
Quimioterapia Combinada
Glucocorticoides/uso terapêutico
Seres Humanos
Modelos Logísticos
Estudos Longitudinais
Metotrexato/uso terapêutico
Nasofaringite/induzido quimicamente
Medidas de Resultados Relatados pelo Paciente
Qualidade de Vida
Infecções Respiratórias/induzido quimicamente
Índice de Gravidade de Doença
Resultado do Tratamento
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE III; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Antibodies, Monoclonal); 0 (Antirheumatic Agents); 0 (Glucocorticoids); 9007-41-4 (C-Reactive Protein); DLG4EML025 (secukinumab); YL5FZ2Y5U1 (Methotrexate)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171106
[Lr] Data última revisão:
171106
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171003
[St] Status:MEDLINE
[do] DOI:10.1093/rheumatology/kex301


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[PMID]:28416342
[Au] Autor:Crowley J; Thaçi D; Joly P; Peris K; Papp KA; Goncalves J; Day RM; Chen R; Shah K; Ferrándiz C; Cather JC
[Ad] Endereço:Bakersfield Dermatology, Bakersfield, California. Electronic address: Crowley415@aol.com.
[Ti] Título:Long-term safety and tolerability of apremilast in patients with psoriasis: Pooled safety analysis for ≥156 weeks from 2 phase 3, randomized, controlled trials (ESTEEM 1 and 2).
[So] Source:J Am Acad Dermatol;77(2):310-317.e1, 2017 Aug.
[Is] ISSN:1097-6787
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Randomized, controlled trials demonstrated efficacy and safety of apremilast for moderate-to-severe plaque psoriasis and psoriatic arthritis. OBJECTIVE: Assess long-term safety of oral apremilast in psoriasis patients. METHODS: Safety findings are reported for 0 to ≥156 weeks from the Efficacy and Safety Trial Evaluating the Effects of Apremilast in Psoriasis (ESTEEM) 1 and 2. RESULTS: The 0 to ≥156-week apremilast-exposure period included 1184 patients treated twice daily with apremilast 30 mg (1902.2 patient-years). During 0 to ≤52 weeks, the adverse events (AEs) that occurred in ≥5% of patients included diarrhea, nausea, upper respiratory tract infection, nasopharyngitis, tension headache, and headache. From 0 to ≥156 weeks, no new AEs (affecting ≥5% of the population) were reported. AEs, serious AEs, and study drug discontinuations caused by AEs did not increase with long-term exposure. During the 0 to ≥156-week period, the rates of major cardiac events (exposure-adjusted incidence rate [EAIR] 0.5/100 patient-years), malignancies (EAIR 1.2/100 patient-years), depression (EAIR 1.8/100 patient-years), or suicide attempts (EAIR 0.1/100 patient-years) did not increase in comparison with the rates found during the 0 to ≤52-week period. No serious opportunistic infections, reactivation of tuberculosis, or clinically meaningful effects on laboratory measurements were reported. LIMITATIONS: This study had a high dropout rate (21% of patients ongoing >156 weeks); most were unrelated to safety concerns. CONCLUSIONS: Apremilast demonstrated an acceptable safety profile and was generally well tolerated for ≥156 weeks.
[Mh] Termos MeSH primário: Anti-Inflamatórios não Esteroides/efeitos adversos
Doenças Cardiovasculares/epidemiologia
Depressão/epidemiologia
Neoplasias/epidemiologia
Psoríase/tratamento farmacológico
Talidomida/análogos & derivados
[Mh] Termos MeSH secundário: Adulto
Diarreia/induzido quimicamente
Feminino
Cefaleia/induzido quimicamente
Seres Humanos
Incidência
Masculino
Meia-Idade
Nasofaringite/induzido quimicamente
Náusea/induzido quimicamente
Infecções Respiratórias/induzido quimicamente
Tentativa de Suicídio/estatística & dados numéricos
Cefaleia do Tipo Tensional/induzido quimicamente
Talidomida/efeitos adversos
Fatores de Tempo
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE III; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Anti-Inflammatory Agents, Non-Steroidal); 4Z8R6ORS6L (Thalidomide); UP7QBP99PN (apremilast)
[Em] Mês de entrada:1708
[Cu] Atualização por classe:170825
[Lr] Data última revisão:
170825
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170419
[St] Status:MEDLINE


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[PMID]:28390867
[Au] Autor:Sands BE; Chen J; Feagan BG; Penney M; Rees WA; Danese S; Higgins PDR; Newbold P; Faggioni R; Patra K; Li J; Klekotka P; Morehouse C; Pulkstenis E; Drappa J; van der Merwe R; Gasser RA
[Ad] Endereço:Icahn School of Medicine at Mount Sinai, New York, New York. Electronic address: bruce.sands@mssm.edu.
[Ti] Título:Efficacy and Safety of MEDI2070, an Antibody Against Interleukin 23, in Patients With Moderate to Severe Crohn's Disease: A Phase 2a Study.
[So] Source:Gastroenterology;153(1):77-86.e6, 2017 Jul.
[Is] ISSN:1528-0012
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND & AIMS: MEDI2070 is a human monoclonal antibody that selectively inhibits interleukin 23 (IL23), a cytokine implicated in the pathogenesis of Crohn's disease (CD). We analyzed its safety and efficacy in treatment of CD in a phase 2a study. METHODS: We conducted a double-blind, placebo-controlled study of 119 adults with moderate to severe CD failed by treatment with tumor necrosis factor antagonists. Patients were randomly assigned (1:1) to groups given MEDI2070 (700 mg) or placebo intravenously at weeks 0 and 4. Patients received open-label MEDI2070 (210 mg) subcutaneously every 4 weeks from weeks 12 to 112. The CD Activity Index was used to measure disease activity. RESULTS: The primary outcome, clinical response (either a 100-point decrease in CD Activity Index score from baseline or clinical remission, defined as CD Activity Index score <150) at week 8 occurred in 49.2% of patients receiving MEDI2070 (n = 59) compared with 26.7% receiving placebo (n = 60; absolute difference, 22.5%; 95% confidence interval, 5.6%-39.5%; P = .010). Clinical response at week 24 occurred in 53.8% of patients who continued to receive open-label MEDI2070 and in 57.7% of patients who had received placebo during the double-blind period and open-label MEDI2070 thereafter. The most common adverse events were headache and nasopharyngitis. Higher baseline serum concentrations of IL22, a cytokine whose expression is induced by IL23, were associated with greater likelihood of response to MEDI2070 compared with placebo. CONCLUSIONS: In a phase 2a trial of patients with moderate to severe Crohn's disease who had failed treatment with tumor necrosis factor antagonists, 8 and 24 weeks of treatment with MEDI2070 were associated with clinical improvement. ClinicalTrials.gov ID: NCT01714726.
[Mh] Termos MeSH primário: Anticorpos Monoclonais/uso terapêutico
Doença de Crohn/tratamento farmacológico
[Mh] Termos MeSH secundário: Adulto
Anticorpos Monoclonais/efeitos adversos
Método Duplo-Cego
Feminino
Cefaleia/induzido quimicamente
Seres Humanos
Interleucina-23/antagonistas & inibidores
Interleucinas/sangue
Masculino
Meia-Idade
Nasofaringite/induzido quimicamente
Retratamento
Índice de Gravidade de Doença
Resultado do Tratamento
Adulto Jovem
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE II; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Antibodies, Monoclonal); 0 (Interleukin-23); 0 (Interleukins); 0 (MEDI2070); 0 (interleukin-22)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170906
[Lr] Data última revisão:
170906
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:170410
[St] Status:MEDLINE


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[PMID]:28351345
[Au] Autor:Bojang E; Jafali J; Perreten V; Hart J; Harding-Esch EM; Sillah A; Mabey DC; Holland MJ; Bailey RL; Roca A; Burr SE
[Ad] Endereço:Disease Control and Elimination Theme, Medical Research Council Unit, The Gambia, Fajara, Banjul, The Gambia.
[Ti] Título:Short-term increase in prevalence of nasopharyngeal carriage of macrolide-resistant Staphylococcus aureus following mass drug administration with azithromycin for trachoma control.
[So] Source:BMC Microbiol;17(1):75, 2017 Mar 28.
[Is] ISSN:1471-2180
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Mass drug administration (MDA) with azithromycin is a corner-stone of trachoma control however it may drive the emergence of antimicrobial resistance. In a cluster-randomized trial (Clinical trial gov NCT00792922), we compared the reduction in the prevalence of active trachoma in communities that received three annual rounds of MDA to that in communities that received a single treatment round. We used the framework of this trial to carry out an opportunistic study to investigate if the increased rounds of treatment resulted in increased prevalence of nasopharyngeal carriage of macrolide-resistant Staphylococcus aureus. Three cross-sectional surveys were conducted in two villages receiving three annual rounds of MDA (3 × treatment arm). Surveys were conducted immediately before the third round of MDA (CSS-1) and at one (CSS-2) and six (CSS-3) months after MDA. The final survey also included six villages that had received only one round of MDA 30 months previously (1 × treatment arm). RESULTS: In the 3 × treatment arm, a short-term increase in prevalence of S. aureus carriage was seen following MDA from 24.6% at CSS-1 to 38.6% at CSS-2 (p < 0.001). Prevalence fell to 8.8% at CSS-3 (p < 0.001). A transient increase was also seen in prevalence of carriage of azithromycin resistant (Azm ) strains from 8.9% at CSS-1 to 34.1% (p < 0.001) in CSS-2 and down to 7.3% (p = 0.417) in CSS-3. A similar trend was observed for prevalence of carriage of macrolide-inducible-clindamycin resistant (iMLS ) strains. In CSS-3, prevalence of carriage of resistant strains was higher in the 3 × treatment arm than in the 1 × treatment (Azm 7.3% vs. 1.6%, p = 0.010; iMLS 5.8% vs. 0.8%, p < 0.001). Macrolide resistance was attributed to the presence of msr and erm genes. CONCLUSIONS: Three annual rounds of MDA with azithromycin were associated with a short-term increase in both the prevalence of nasopharyngeal carriage of S. aureus and prevalence of carriage of Azm and iMLS S. aureus. TRIAL REGISTRATION: This study was ancillary to the Partnership for the Rapid Elimination of Trachoma, ClinicalTrials.gov NCT00792922 , registration date November 17, 2008.
[Mh] Termos MeSH primário: Azitromicina/administração & dosagem
Azitromicina/uso terapêutico
Macrolídeos/uso terapêutico
Staphylococcus aureus Resistente à Meticilina/efeitos dos fármacos
Staphylococcus aureus Resistente à Meticilina/patogenicidade
Nasofaringe/microbiologia
Prevalência
Tracoma/tratamento farmacológico
[Mh] Termos MeSH secundário: Administração Oral
Adolescente
Antibacterianos/uso terapêutico
Portador Sadio/epidemiologia
Portador Sadio/microbiologia
Criança
Estudos Transversais
Farmacorresistência Bacteriana
Feminino
Gâmbia/epidemiologia
Seres Humanos
Programas de Imunização
Masculino
Testes de Sensibilidade Microbiana
Nasofaringite/tratamento farmacológico
Nasofaringite/microbiologia
Fatores de Risco
Manejo de Espécimes/métodos
Infecções Estafilocócicas/complicações
Infecções Estafilocócicas/tratamento farmacológico
Infecções Estafilocócicas/epidemiologia
Streptococcus pneumoniae/efeitos dos fármacos
Tracoma/complicações
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anti-Bacterial Agents); 0 (Macrolides); 83905-01-5 (Azithromycin)
[Em] Mês de entrada:1709
[Cu] Atualização por classe:170925
[Lr] Data última revisão:
170925
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170330
[St] Status:MEDLINE
[do] DOI:10.1186/s12866-017-0982-x


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[PMID]:28292927
[Au] Autor:Nilsson AG; Bergthorsdottir R; Burman P; Dahlqvist P; Ekman B; Engström BE; Ragnarsson O; Skrtic S; Wahlberg J; Achenbach H; Uddin S; Marelli C; Johannsson G
[Ad] Endereço:Department of EndocrinologySahlgrenska University Hospital and Institute of Medicine, Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden.
[Ti] Título:Long-term safety of once-daily, dual-release hydrocortisone in patients with adrenal insufficiency: a phase 3b, open-label, extension study.
[So] Source:Eur J Endocrinol;176(6):715-725, 2017 Jun.
[Is] ISSN:1479-683X
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:OBJECTIVE: To investigate the long-term safety and tolerability of a once-daily, dual-release hydrocortisone (DR-HC) tablet as oral glucocorticoid replacement therapy in patients with primary adrenal insufficiency (AI). DESIGN: Prospective, open-label, multicenter, 5-year extension study of DR-HC conducted at five university clinics in Sweden. METHODS: Seventy-one adult patients diagnosed with primary AI who were receiving stable glucocorticoid replacement therapy were recruited. Safety and tolerability outcomes included adverse events (AEs), intercurrent illness episodes, laboratory parameters and vital signs. Quality of life (QoL) was evaluated using generic questionnaires. RESULTS: Total DR-HC exposure was 328 patient-treatment years. Seventy patients reported 1060 AEs (323 per 100 patient-years); 85% were considered unrelated to DR-HC by the investigator. The most common AEs were nasopharyngitis (70%), fatigue (52%) and gastroenteritis (48%). Of 65 serious AEs reported by 32 patients (20 per 100 patient-years), four were considered to be possibly related to DR-HC: acute AI ( = 2), gastritis ( = 1) and syncope ( = 1). Two deaths were reported (fall from height and subarachnoid hemorrhage), both considered to be unrelated to DR-HC. From baseline to 5 years, intercurrent illness episodes remained relatively stable (mean 2.6-5.4 episodes per patient per year), fasting plasma glucose (0.7 mmol/L; < 0.0001) and HDL cholesterol (0.2 mmol/L; < 0.0001) increased and patient-/investigator-assessed tolerability improved. QoL total scores were unchanged but worsening physical functioning was recorded ( = 0.008). CONCLUSIONS: In the first prospective study evaluating the long-term safety of glucocorticoid replacement therapy in patients with primary AI, DR-HC was well tolerated with no safety concerns observed during 5-year treatment.
[Mh] Termos MeSH primário: Doença de Addison/tratamento farmacológico
Glucocorticoides/uso terapêutico
Terapia de Reposição Hormonal/métodos
Hidrocortisona/uso terapêutico
[Mh] Termos MeSH secundário: Adulto
Idoso
Preparações de Ação Retardada
Fadiga/induzido quimicamente
Feminino
Gastroenterite/induzido quimicamente
Terapia de Reposição Hormonal/efeitos adversos
Seres Humanos
Estudos Longitudinais
Masculino
Meia-Idade
Nasofaringite/induzido quimicamente
Qualidade de Vida
Suécia
Resultado do Tratamento
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE III; JOURNAL ARTICLE; MULTICENTER STUDY
[Nm] Nome de substância:
0 (Delayed-Action Preparations); 0 (Glucocorticoids); WI4X0X7BPJ (Hydrocortisone)
[Em] Mês de entrada:1704
[Cu] Atualização por classe:170516
[Lr] Data última revisão:
170516
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170316
[St] Status:MEDLINE
[do] DOI:10.1530/EJE-17-0067


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[PMID]:27891757
[Au] Autor:Kaku K; Sumino S; Katou M; Nishiyama Y; Kinugawa Y
[Ad] Endereço:Department of Internal Medicine, Kawasaki Medical School, Okayama, Japan.
[Ti] Título:Randomized, double-blind, phase III study to evaluate the efficacy and safety of once-daily treatment with alogliptin and metformin hydrochloride in Japanese patients with type 2 diabetes.
[So] Source:Diabetes Obes Metab;19(3):463-467, 2017 Mar.
[Is] ISSN:1463-1326
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:This randomized, double-blind, phase III study evaluated the efficacy and safety of once-daily treatment with alogliptin (25 mg once daily), alone or with metformin hydrochloride (500 mg once daily or 250 mg twice daily), in Japanese patients with type 2 diabetes. The primary endpoint was change in glycated haemoglobin (HbA1c) from baseline to the end of treatment (week 24). The least squares (LS) mean (standard error) change in HbA1c from baseline to the end of treatment (week 24) was 0.16 (0.072)% in alogliptin alone, -0.49 (0.049)% in alogliptin/metformin once daily, and -0.60 (0.049)% in alogliptin/metformin twice daily. The LS mean difference in HbA1c change from baseline between alogliptin/metformin once daily and alogliptin alone (alogliptin/metformin once daily minus alogliptin alone) was -0.65% (95% confidence interval [CI] -0.821, -0.480) and between alogliptin/metformin once daily and twice daily (once daily minus twice daily) was 0.11% (95% CI -0.026, 0.247). The overall frequency of adverse events was similar among the groups. This study showed that the efficacy of alogliptin/metformin once daily was superior to alogliptin alone and non-inferior to alogliptin/metformin twice daily, and that alogliptin/metformin once daily was safe and well tolerated in Japanese patients with type 2 diabetes.
[Mh] Termos MeSH primário: Diabetes Mellitus Tipo 2/tratamento farmacológico
Hipoglicemiantes/uso terapêutico
Metformina/uso terapêutico
Piperidinas/uso terapêutico
Uracila/análogos & derivados
[Mh] Termos MeSH secundário: Doença Aguda
Idoso
Glicemia/metabolismo
Diabetes Mellitus Tipo 2/metabolismo
Método Duplo-Cego
Esquema de Medicação
Quimioterapia Combinada
Feminino
Hemoglobina A Glicada/metabolismo
Seres Humanos
Hipoglicemia/induzido quimicamente
Japão
Masculino
Meia-Idade
Nasofaringite/induzido quimicamente
Pancreatite/induzido quimicamente
Resultado do Tratamento
Uracila/uso terapêutico
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE III; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Blood Glucose); 0 (Glycated Hemoglobin A); 0 (Hypoglycemic Agents); 0 (Piperidines); 0 (hemoglobin A1c protein, human); 56HH86ZVCT (Uracil); 9100L32L2N (Metformin); JHC049LO86 (alogliptin)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161129
[St] Status:MEDLINE
[do] DOI:10.1111/dom.12837


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[PMID]:27768242
[Au] Autor:Reich K; Gooderham M; Green L; Bewley A; Zhang Z; Khanskaya I; Day RM; Goncalves J; Shah K; Piguet V; Soung J
[Ad] Endereço:SCIderm Research Institute and Dermatologikum Hamburg, Hamburg, Germany.
[Ti] Título:The efficacy and safety of apremilast, etanercept and placebo in patients with moderate-to-severe plaque psoriasis: 52-week results from a phase IIIb, randomized, placebo-controlled trial (LIBERATE).
[So] Source:J Eur Acad Dermatol Venereol;31(3):507-517, 2017 Mar.
[Is] ISSN:1468-3083
[Cp] País de publicação:England
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Apremilast, an oral, small-molecule phosphodiesterase 4 inhibitor, has demonstrated efficacy in patients with moderate-to-severe psoriasis. OBJECTIVE: Evaluate efficacy and safety of apremilast vs. placebo in biologic-naive patients with moderate-to-severe plaque psoriasis and safety of switching from etanercept to apremilast in a phase IIIb, randomized, double-blind, placebo-controlled study (NCT01690299). METHODS: Two hundred and fifty patients were randomized to placebo (n = 84), apremilast 30 mg BID (n = 83) or etanercept 50 mg QW (n = 83) through Week 16; thereafter, all patients continued or switched to apremilast through Week 104. The primary efficacy endpoint was achievement of PASI-75 at Week 16 with apremilast vs. placebo. Secondary endpoints included achievement of PASI-75 at Week 16 with etanercept vs. placebo and improvements in other clinical endpoints vs. placebo at Week 16. Outcomes were assessed through Week 52. This study was not designed for apremilast vs. etanercept comparisons. RESULTS: At Week 16, PASI-75 achievement was greater with apremilast (39.8%) vs. placebo (11.9%; P < 0.0001); 48.2% of patients achieved PASI-75 with etanercept (P < 0.0001 vs. placebo). PASI-75 response was maintained in 47.3% (apremilast/apremilast), 49.4% (etanercept/apremilast) and 47.9% (placebo/apremilast) of patients at Week 52. Most common adverse events (≥5%) with apremilast, including nausea, diarrhoea, upper respiratory tract infection, nasopharyngitis, tension headache and headache, were mild or moderate in severity; diarrhoea and nausea generally resolved in the first month. No new safety or tolerability issues were observed through Week 52 with apremilast. CONCLUSION: Apremilast demonstrated significant efficacy vs. placebo at Week 16 in biologic-naive patients with psoriasis, which was sustained over 52 weeks, and demonstrated safety consistent with the known safety profile of apremilast. Switching from etanercept to apremilast did not result in any new or clinically significant safety findings, and efficacy was maintained with apremilast through Week 52.
[Mh] Termos MeSH primário: Anti-Inflamatórios não Esteroides/uso terapêutico
Etanercepte/uso terapêutico
Psoríase/tratamento farmacológico
Talidomida/análogos & derivados
[Mh] Termos MeSH secundário: Adulto
Anti-Inflamatórios não Esteroides/efeitos adversos
Diarreia/induzido quimicamente
Método Duplo-Cego
Etanercepte/efeitos adversos
Feminino
Cefaleia/induzido quimicamente
Seres Humanos
Masculino
Meia-Idade
Nasofaringite/induzido quimicamente
Náusea/induzido quimicamente
Dor/etiologia
Inibidores da Fosfodiesterase 4/uso terapêutico
Prurido/etiologia
Psoríase/complicações
Infecções Respiratórias/induzido quimicamente
Índice de Gravidade de Doença
Avaliação de Sintomas
Cefaleia do Tipo Tensional/induzido quimicamente
Talidomida/efeitos adversos
Talidomida/uso terapêutico
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE III; JOURNAL ARTICLE; MULTICENTER STUDY; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Anti-Inflammatory Agents, Non-Steroidal); 0 (Phosphodiesterase 4 Inhibitors); 4Z8R6ORS6L (Thalidomide); OP401G7OJC (Etanercept); UP7QBP99PN (apremilast)
[Em] Mês de entrada:1710
[Cu] Atualização por classe:171019
[Lr] Data última revisão:
171019
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161022
[St] Status:MEDLINE
[do] DOI:10.1111/jdv.14015


  8 / 310 MEDLINE  
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[PMID]:27695944
[Au] Autor:Torretta S; Marchisio P; Rinaldi V; Carioli D; Nazzari E; Pignataro L
[Ad] Endereço:Department of Clinical Sciences and Community Health, Università degli Studi di Milano, Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico, Via F. Sforza 35, 20122, Milan, Italy. sara.torretta@gmail.com.
[Ti] Título:Endoscopic and clinical benefits of hyaluronic acid in children with chronic adenoiditis and middle ear disease.
[So] Source:Eur Arch Otorhinolaryngol;274(3):1423-1429, 2017 Mar.
[Is] ISSN:1434-4726
[Cp] País de publicação:Germany
[La] Idioma:eng
[Ab] Resumo:Hyaluronic acid (HA) is involved in modulating inflammatory airway processes and mucociliary clearance. Some studies have tested the effectiveness of the topical administration of HA in patients with upper airway diseases with positive preliminary results. A prospective, single-blind, 1:1 randomised controlled study was performed to assess the efficacy and safety of the daily topical administration of 9 mg of sodium hyaluronate in 3 mL of a 0.9 % sodium saline solution on the basis of endoscopic and clinical parameters in children with chronic adenoiditis associated with recurrent acute otitis media and otitis media with effusion; age- and gender-matched children receiving normal 0.9 % sodium chloride saline solution were used as controls. Analysis was based on 103 (mean age 63.3 ± 18.2 months; 52 males, 50.5 %) children: 54 in the study group and 49 in the control group. A statistically significant reduction in the mean number of all acute otitis media episodes (AOME) (mean reduction 0.8 ± 0.4 per month; p value 0.05) and AOME without tympanic membrane perforation (mean reduction 0.6 ± 0.3 per month; p value 0.04) after recruitment was documented only in the study group. HA significantly improved all the endoscopic outcomes (p values ranging between 0.05 and <0.01) but one. Nasal washing with saline solution was effective on only three of them (p values ranging between 0.03 and <0.01). No untoward effects were documented. Our results confirm the safety and document the positive effect of topically administered HA solution on children with chronic adenoiditis associated with middle ear disease.
[Mh] Termos MeSH primário: Tonsila Faríngea
Adjuvantes Imunológicos/uso terapêutico
Ácido Hialurônico/uso terapêutico
Nasofaringite/tratamento farmacológico
Otite Média/tratamento farmacológico
[Mh] Termos MeSH secundário: Administração Tópica
Pré-Escolar
Doença Crônica
Endoscopia
Feminino
Seres Humanos
Hipertrofia/tratamento farmacológico
Lactente
Masculino
Estudos Prospectivos
Método Simples-Cego
Conchas Nasais/patologia
[Pt] Tipo de publicação:JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Adjuvants, Immunologic); 9004-61-9 (Hyaluronic Acid)
[Em] Mês de entrada:1705
[Cu] Atualização por classe:170928
[Lr] Data última revisão:
170928
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161004
[St] Status:MEDLINE
[do] DOI:10.1007/s00405-016-4327-4


  9 / 310 MEDLINE  
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[PMID]:27059529
[Au] Autor:Taneda S; Hyllested-Winge J; Gall MA; Kaneko S; Hirao K
[Ad] Endereço:Diabetes Center, Manda Memorial Hospital, Hokkaido, Japan.
[Ti] Título:Insulin degludec/insulin aspart versus biphasic insulin aspart 30 twice daily in insulin-experienced Japanese subjects with uncontrolled type 2 diabetes: Subgroup analysis of a Pan-Asian, treat-to-target Phase 3 Trial.
[Ti] Título:在既往使用胰岛素治疗血糖未得到控制的日本2型糖尿病受试者中比较德谷胰岛素/门冬胰岛素与每日2次双相门冬胰岛素30:泛亚达标治疗3期试验亚组分析..
[So] Source:J Diabetes;9(3):243-247, 2017 Mar.
[Is] ISSN:1753-0407
[Cp] País de publicação:Australia
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: The present study was a subgroup analysis of a Pan-Asian Phase 3 open-label randomized treat-to-target trial evaluating insulin degludec/insulin aspart (IDegAsp) and biphasic insulin aspart 30 (BIAsp 30) in Japanese subjects with type 2 diabetes inadequately controlled on insulin. METHODS: Eligible subjects (n = 178) were randomized (2: 1) to twice-daily (b.i.d.) IDegAsp or BIAsp 30 with or without metformin for 26 weeks, titrated to a blood glucose target of between 3.9 and <5.0 mmol/L. Changes in HbA , the proportion of responders reaching the HbA target, and changes in fasting plasma glucose, nine-point self-monitored plasma glucose profiles, and body weight were assessed. RESULTS: At 26 weeks, the decrease in HbA was similar in both groups. Fasting plasma glucose was lower with IDegAsp than BIAsp 30 (estimated treatment difference -1.50 mmol/L; 95 % confidence interval [CI] -1.98, -1.01). Overall confirmed hypoglycemia rates were similar; the nocturnal confirmed hypoglycemia rate was lower with IDegAsp than BIAsp 30 (estimated rate ratio 0.44; 95 % CI 0.20, 0.99). No severe hypoglycemic episodes were reported. CONCLUSIONS: The results indicate that IDegAsp b.i.d. improves glycemic control and, compared with BIAsp 30, lowers the rate of nocturnal confirmed hypoglycemia.
[Mh] Termos MeSH primário: Insulinas Bifásicas/uso terapêutico
Diabetes Mellitus Tipo 2/tratamento farmacológico
Insulina Aspart/uso terapêutico
Insulina Isófana/uso terapêutico
Insulina de Ação Prolongada/uso terapêutico
[Mh] Termos MeSH secundário: Idoso
Grupo com Ancestrais do Continente Asiático
Insulinas Bifásicas/efeitos adversos
Glicemia/metabolismo
Diabetes Mellitus Tipo 2/sangue
Diabetes Mellitus Tipo 2/etnologia
Retinopatia Diabética/induzido quimicamente
Esquema de Medicação
Quimioterapia Combinada
Feminino
Hemoglobina A Glicada/metabolismo
Seres Humanos
Hipertensão/induzido quimicamente
Hipoglicemiantes/efeitos adversos
Hipoglicemiantes/uso terapêutico
Insulina Aspart/efeitos adversos
Insulina Isófana/efeitos adversos
Insulina de Ação Prolongada/efeitos adversos
Masculino
Metformina/efeitos adversos
Metformina/uso terapêutico
Meia-Idade
Nasofaringite/induzido quimicamente
Resultado do Tratamento
[Pt] Tipo de publicação:CLINICAL TRIAL, PHASE III; JOURNAL ARTICLE; RANDOMIZED CONTROLLED TRIAL
[Nm] Nome de substância:
0 (Biphasic Insulins); 0 (Blood Glucose); 0 (Glycated Hemoglobin A); 0 (Hypoglycemic Agents); 0 (Insulin, Long-Acting); 0 (insulin aspart, insulin aspart protamine drug combination 30:70); 53027-39-7 (Insulin, Isophane); 54Q18076QB (insulin degludec); 9100L32L2N (Metformin); D933668QVX (Insulin Aspart)
[Em] Mês de entrada:1706
[Cu] Atualização por classe:171116
[Lr] Data última revisão:
171116
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:160410
[St] Status:MEDLINE
[do] DOI:10.1111/1753-0407.12407


  10 / 310 MEDLINE  
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[PMID]:27876743
[Au] Autor:Karpova EP; Kharina DV
[Ad] Endereço:Russian Medical Academy of Post-Graduate Education, Moscow, Russia, 123242.
[Ti] Título:[The possibilities for the rational pharmacotherapy of adenoiditis in the children].
[Ti] Título:Vozmozhnosti ratsional'noi farmakoterapii adenoidita u detei..
[So] Source:Vestn Otorinolaringol;81(5):73-76, 2016.
[Is] ISSN:0042-4668
[Cp] País de publicação:Russia (Federation)
[La] Idioma:rus
[Ab] Resumo:The available literature data give evidence that viral infection is the main cause underlying the development of inflammatory nasopharyngeal pathology in the children. According to ICD-10, nether acute nor chronic adenoiditis should be considered as a self-consistent nosological entity. Acute adenoiditis is usually regarded as a form of acute nasopharyngitis (J02) or acute respiratory viral infection (J06.9) whereas chronic adenoiditis is commonly referred to as representing other chronic diseases of the tonsils and adenoids (J 35.8). The reactive changes in the nasopharyngeal tonsils begin to be manifested on days 3-5 after the onset of acute respiratory viral infection; thereafter, they persist and gradually disappear within the next 2-3 weeks. In the majority of the cases, acute adenoiditis is actually a physiological reaction of the nasopharyngeal tonsils as the organs of regional mucosal immunity to antigenic stimulation. There is no universally accepted opinion as regards the duration of the inflammatory process which would allow these pathological changes to be considered as turned into chronic ones. This condition is actually not a serious pathology provided it is not associated with the concomitant complications and produces no clinically significant effect on the child's quality of life. Under practical conditions, such children are most frequently treated with the use of irrigation therapy. Taking into account that otorhinolaryngologists all over the world do not consider chronic adenoiditis as an independent nosological entity but distinguish only hypertrophy of adenoid vegetations or chronic rhinosinusitis (in the presence of inflammatory changes in the nasopharynx), it appears correct to speak about chronic adenoiditis provided the clinical manifestations of the disease persist for more than 12 weeks. Based on the predominant etiological component, the viral, bacterial, and allergic forms of nasopharyngeal adenoiditis can be distinguished even though it is rather difficult to actually determine which etiological factor prevails in each concrete case. The aforedescribed situation poses a large number of questions pertaining to the choice of either systemic or topical antibacterial therapy.
[Mh] Termos MeSH primário: Tonsila Faríngea/efeitos dos fármacos
Dexametasona/administração & dosagem
Nasofaringite
Fenilefrina/administração & dosagem
Polimixina B/administração & dosagem
Qualidade de Vida
[Mh] Termos MeSH secundário: Tonsila Faríngea/patologia
Tonsila Faríngea/fisiopatologia
Antibacterianos/administração & dosagem
Criança
Combinação de Medicamentos
Monitoramento de Medicamentos
Feminino
Glucocorticoides/administração & dosagem
Seres Humanos
Masculino
Descongestionantes Nasais/administração & dosagem
Sprays Nasais
Nasofaringite/tratamento farmacológico
Nasofaringite/etiologia
Nasofaringite/fisiopatologia
Nasofaringite/psicologia
Resultado do Tratamento
[Pt] Tipo de publicação:CLINICAL TRIAL; JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anti-Bacterial Agents); 0 (Drug Combinations); 0 (Glucocorticoids); 0 (Nasal Decongestants); 0 (Nasal Sprays); 1404-26-8 (Polymyxin B); 1WS297W6MV (Phenylephrine); 7S5I7G3JQL (Dexamethasone)
[Em] Mês de entrada:1703
[Cu] Atualização por classe:170621
[Lr] Data última revisão:
170621
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161124
[St] Status:MEDLINE
[do] DOI:10.17116/otorino201681573-76



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