106 research outputs found
Five-Year Denosumab Treatment of Postmenopausal Women with Osteoporosis: Results from the first two Years of the Freedom Trial Extension
No full textObjectives : The FREEDOM trial1 open-label extension is designed to evaluate the long-term efficacy and safety of denosumab for up to 10 years. We report the results from the first 2 years of the extension, representing up to 5 years of denosumab exposure.Materials/Methods : Postmenopausal women enrolled in the extension previously completed FREEDOM. During the extension, all women receive denosumab (60 mg) every 6 months and calcium and vitamin D daily. For the FREEDOM denosumab group, the data reflect 5 years of denosumab treatment (long-term group). For the FREEDOM placebo group, the data reflect 2 years of denosumab treatment (de novo group). P-values are descriptive.Results : There were 4550 (70.2%) FREEDOM women enrolled in the extension (2343 long-term; 2207 de novo). During the 4th and 5th years of denosumab treatment, the long-term group had further 1.9% and 1.7% increases in lumbar spine BMD and further 0.7% and 0.6% increases in total hip BMD (all P<0.0001 compared with extension baseline). Total BMD increases with 5-year denosumab treatment were 13.7% (lumbar spine) and 7.0% (total hip). In the de novo group, BMD increased during the first 2 years of denosumab treatment by 7.9% (lumbar spine) and 4.1% (total hip) (all P<0.0001 compared with extension baseline). After denosumab administration, serum CTX was rapidly and maximally reduced in both groups with the characteristic attenuation observed at the end of the dosing interval, as previously reported.2 Incidences of new vertebral and nonvertebral fractures were low and below rates observed in the FREEDOM placebo group. Adverse event reports were similar for both groups: in the long-term group, 83.4% reported AEs and 18.9% were serious. In the de novo group, the percentages were 82.8% and 19.4%, respectively. In FREEDOM, the respective percentages were 92.8% and 25.8% in the denosumab group and 93.1% and 25.1% in the placebo group. Two subjects in the de novo group had AEs adjudicated to ONJ which healed without further complications ; one resolved within the 6-month dosing interval and denosumab was continued. There were no atypical femoral fractures.Conclusions : Denosumab treatment for 5 years was well-tolerated and continued to significantly reduce CTX and significantly increase BMD. Reference: 1)Cummings;NEJM;2009;361:756, 2)Eastell;JBMR;2010; doi-10.1002/jbmr.251 Disclosure of Interest: This study was funded by Amgen; S Papapoulos: Consulting fees from Amgen, Merck, Novartis, Procter & Gamble, GSK, and Wyeth; R Chapurlat: Research grants and/or consulting fees from Amgen, Merck, Novartis, sanofi-aventis, Roche, Servier, and Warner Chilcott;ML Brandi: Research grants and/or consulting fees from Amgen, Eli Lily, GSK, MSD, NPS, Nycomed, Roche, Servier, and Stroder; JP Brown: Research grants and/or consulting or speaking fees from Abott, Amgen, Bristol Myers Squibb, Eli Lilly, Pfizer, Roche, Novartis, Merck, and Warner Chilcott; E Czerwinski: Research grants from Amgen, Astrazeneca, Danone Research, Eli Lilly, Merck Sharp & Dohme, Merck Serono, Novartis, Pfizer, Roche, SantoSolve AS, and Servier; N Daizadeh, A Grauer, C Libanati: Employed by Amgen and own Amgen stocks or stock options; M-A Krieg, D Mellstrom, H Resch: None; S Radominski: Research grants from Amgen, Pfizer, Novartis, Bristol-Myers Squibb, Roche, and Aventis; Z Man: Lecture fees and/or consulting fees from Merck, Novartis, Roche, and sanofi-aventis. Novartis steering committee member; JA Roman: Research grants from Roche; J-Y Reginster: Research grants, consulting fees, and/or lecture fees from Amgen, Analis, Bristol Myers Squibb, Ebewee Pharma, Genevrier, GSK, IBSA, Lilly, Merck Sharp & Dhome, Negma, Novartis, Novo-Nordisk, Nycomed, NPS, Roche, Rottapharm, Servier, Teijin, Teva, Theramex, UCB, Wyeth, and Zodiac; C Roux: Research grants and/or consulting fees from Amgen, MSD, Novartis, Servier, and Roche; SR Cummings: Research grants and/or consulting fees from Amgen, Eli Lilly, Novartis, and Merck; HG Bone: Research grants and/or consulting or speaking fees from Amgen, Eli Lilly, Merck, Nordic Bioscience, Novartis, Takeda, and Zelo
Estado nutricional de pacientes em terapia nutricional enteral e a relaçao das necessidades energéticas com o valor energético total prescrito e recebido
No full textOrientadora: Rosana Bento RadominskiInclui apendiceDissertaçao (mestrado) - Universidade Federal do Paraná, Setor de Ciencias da Saúde, Programa de Pós-Graduaçao em Medicina Interna. Defesa: Curitiba, 2005Inclui bibliografia e anexoRESUMO: O estado nutricional tem um grande impacto na resposta individual à enfermidade e, portanto as deficiências devem ser detectadas precocemente. A terapia nutricional visa reconstituir ou manter o estado nutricional de um indivíduo, por meio da oferta de nutrientes. Tanto a manutenção como a repleção da composição corporal, dependem de uma provisão adequada e precisa de calorias e proteínas. OBJETIVO: Verificar o estado nutricional dos pacientes com indicação de nutrição enteral exclusiva e a relação entre as necessidades nutricionais, a prescrição dietética, a dieta consumida e a energia total recebida. CASUÍSTICA E MÉTODOS: Foram estudados 32 pacientes com idade superior a 18 anos internados em clínicas médicas e cirúrgicas com indicação do uso de nutrição enteral exclusiva por mais de 3 dias. Os pacientes foram avaliados nas primeiras doze horas após a indicação da nutrição enteral. O diagnóstico do estado nutricional foi considerando a presença de desnutrição quando havia diminuição da ingestão alimentar, albumina menor 3,5 g/dL, redução maior ou igual 10% do peso e ASG classificada como desnutrição. O GMR foi determinado por meio da Calorimetria Indireta. O valor energético total prescrito (VET-P), o valor energético recebido por sonda, (VET-S), os valores recebidos por sonda acrescido do soro glicosado infundido (VET- RS+SG ), os conteúdos protéicos prescritos e recebidos foram controlados diariamente. O nível de significância estabelecido foi p < 0,05. RESULTADOS: As doenças do aparelho digestivo predominaram em 59,4% dos casos, 18(56,25 %) pacientes estavam desnutridos ao iniciar com TNE. A proporção de desnutrição entre as mulheres 9(69%) foi maior do entre os homens 9(47%). O tempo de terapia nutricional exclusiva em 19 (59,38%) pacientes foi menos que 7 dias. Em relação ao GMR com o VET - P foi de 92%, o VET-S de 77%, significativamente menor (p<0,05), o VETRS+ SG representou 85% das necessidades para todos pacientes (p=0,001). A relação do VET-P com o VET-S teve uma diferença maior (p<0,0002) para todos os pacientes, porém, quando comparado o VET - P com o VET-RS+SG existe diferença significativa para as mulheres (p= 0,026). O VET-S foi significativamente menor que o VET-RS+SG, considerando o grupo geral (p=0,0035) e os homens (p=0,0019). A quantidade de proteínas prescritas para homens foi significativamente menor (p = 0,04) do que as necessidades. As proteínas prescritas para mulheres foram adequadas. O grupo geral (p<0,001), os homens e as mulheres receberam menor quantidade de proteína do que foi prescrito. A diarréia foi à complicação mais comum acometendo 10(31,1%) pacientes, prevalece como maior causa de suspensão da dieta. CONCLUSÃO Ao iniciar a terapia nutricional enteral mais de 50% dos pacientes apresenta-se desnutridos. As mulheres estavam mais desnutridas, com maior GMR do que nos homens. A prescrição da TNE foi adequada para as necessidades energéticas e de proteína. A energia e proteína recebida não preenchem as necessidades. A causa mais comum de suspensão da dieta foi a diarréia. Palavras-chave: Avaliação Nutricional, Gasto Metabólico de Repouso, Terapia Nutricional Enteral.ABSTRACT: Nutritional status (NS) has a significant impact on individual responses to the disease process and therefore, early detection of specific deficits is crucial. The main objectives of the nutritional therapy (NT) are to provide means and nutrients to restore and maintain an adequate NS. Both restoration and maintenance of body composition depend upon proper and precise prescription of calories and protein. OBJECTIVE: To assess NS of patients with formal indication of exclusive enteral feeding and the relation between nutritional requirements, diet prescribed, the amount of diet effectively consumed and total energy intake. METHODS: Thirty-two patients were evaluated, all were older than 18 years and were in-patients of internal medicine or surgical wards with indication of exclusive parenteral nutrition for a minimum of tree days consecutively. Patients were assessed during the first twelve hours after indication of the specific diet regimen. The NS was considered indicative of undernutrition by the presence of decreased food intake, serum albumin < 3,5 mg/dL, weight loss above or equal to 10% of expected body weight and global subjective assessment (GSA) indicative of undernutrition. The resting energy expenditure (REE) was determined by indirect calorimetry. Total energy intake prescribed (TEI-P), total energy intake received via tube feeding (TEI-T), intake via tube plus infusion media (glucosed serum 5%) (EI- Rt+im), protein amount prescribed and infused were also documented daily. Significance level for statistical analysis was p < 0,05. RESULTS: cases of gastrointestinal disorders were the most frequent (59,4%), 18 (56,2%) subjects were undernutrition at the beginning of enteral NT. The proportion of undernutrition among women (9, 69%) was higher than among men (9, 47%). Time on exclusive NT in 19 (59,38%) patients was less than 7 days. In regards to REE with TEI - P was 92%, significantly less than 77% for TEI-T (p<0,05), EI- Rt+im represented 85% of the requirements for all patients (p=0,001). Comparison of TEI-P with TEI-S revealed a more impressive difference (p<0,0002) for all patients, so, comparison of TEI - P with EI-Rt+im showed a significant difference for women (p= 0,026). The TEI-S was significantly inferior to EI-Rt+im, considering the whole group (p=0,0035) and male subjects (p=0,0019). The amount of prescribed protein for male subjects was significantly lees (p = 0,04) than requirements. Protein prescribed for female patients were adequate. As a whole (p<0,001), men and women received less protein than prescribed. Diarrhea was the most frequent complication affecting 10 (31,1%) patients, remaining as the most frequent cause for diet withdrawal. CONCLUSION Almost 50% of all patients started on enteral NT show signs of undernutrition. This was especially true for women, whose REE was higher than those of male patients. Prescription of enteral NT was considered adequate in regards to energy and protein content. Energy and protein amount received did not fulfill the requirements. Diarrhea was the most common cause of diet withdrawal. Key words: Nutritional assessment, resting metabolic rate, enteral nutritional therapy
Comprometimento otológico como manifestação inicial de granulomatose de wegener: relato de caso.
No full textTrabalho de Conclusão de Curso - Universidade Federal de Santa Catarina, Centro de Ciências da Saúde, Departamento de Clínica Cirúrgica, Curso de Medicina, Florianópolis, 199
The Role Of Biological Agents For Rheumatoid Arthritis: Best Evidence And Guidelines For Clinical Decision [uso De Agentes Biológicos Para O Tratamento Da Artrite Reumatóide: Melhores Evidências E Recomendações Para A Prática Clínica]
No full textRheumatoid arthritis (RA) is a chronic, systemic, autoimmune disease of unknown etiology, which predominantly involves small joints and is more common in women. It has a high degree of morbidity and is an important health problem. The treatment of RA includes DMARDs (disease-modifying anti-rheumatic drugs) and more recently the so-called biological agents. Carry out a structured literature review to determine the best existing evidences in medical literature regarding the diagnosis and treatment of rheumatoid arthritis. Six questions on RA were prepared: 1) What are the diagnostic criteria for initial rheumatoid arthritis diagnosis?; 2) For patients with diagnosis of rheumatoid arthritis what are the prognosis markers and what are their clinical implications?; 3) For patients with rheumatoid arthritis, when should DMARDs (MTX, sulfasalazine, among others) be introduced? What is the initial choice drug?; 4) For patients with rheumatoid arthritis, when should biological agents be introduced? Should they be administered after the initial administration of methotrexate or at the time of diagnosis?; 5) What are the indications of the biological agents in early onset RA?; 6) Are biological agents effective and safe in the treatment of rheumatoid arthritis: Is there evidence of the relative superiority of any of the biological agents in terms of efficacy and safety? A structured literature review was carried out using different databases. In this review, the objective was to identify clinical studies which are methodologically more adequate that might respond to each of the questions. A committee of specialists evaluated literature data and prepared responses to each one of the questions. 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Extension of a one-year double-blind study in 174 patients (2002) Rheumatology (Oxford), 41 (2), pp. 196-204Van Aken, J., Lard, L.R., Le Cessie, S., Hazes, J.M., Breedveld, F.C., Huizinga, T.W., Radiological outcome after four years of early versus delayed treatment strategy in patients with recent onset rheumatoid arthritis (2004) Ann Rheum Dis, 63 (3), pp. 274-279Guidelines for the management of rheumatoid arthritis: 2002 Update (2002) Arthritis Rheum, 46 (2), pp. 328-346Gordon, P., West, J., Jones, H., Gibson, T., A 10 year prospective followup of patients with rheumatoid arthritis 1986-96 (2001) J Rheumatol, 28 (11), pp. 2409-2415Suarez-Almazor, M.E., Belseck, E., Shea, B., Homik, J., Wells, G., Tugwell, P., Antimalarials for treating rheumatoid arthritis (2000) Cochrane Database Syst Rev, (4). , CD000959Suarez-Almazor, M.E., Belseck, E., Shea, B., Wells, G., Tugwell, P., Sulfasalazine for rheumatoid arthritis (2000) Cochrane Database Syst Rev, (2). , CD000958Suarez-Almazor, M.E., Belseck, E., Shea, B., Wells, G., Tugwell, P., Methotrexate for rheumatoid arthritis (2000) Cochrane Database Syst Rev, (2). , CD000957Osiri, M., Shea, B., Robinson, V., Suarez-Almazor, M., Strand, V., Tugwell, P., Leflunomide for treating rheumatoid arthritis (2003) Cochrane Database Syst Rev, (1). , CD002047Suarez-Almazor, M.E., Spooner, C., Belseck, E., Azathioprine for treating rheumatoid arthritis (2000) Cochrane Database Syst Rev, (4). , CD001461Suarez-Almazor, M.E., Spooner, C., Belseck, E., Penicillamine for treating rheumatoid arthritis (2000) Cochrane Database Syst Rev, (4). , CD001460Clark, P., Tugwell, P., Bennet, K., Bombardier, C., Shea, B., Wells, G., Injectable gold for rheumatoid arthritis (2000) Cochrane Database Syst Rev, (2). , CD000520O'Dell, J.R., Paulsen, G., Haire, C.E., Blakely, K., Palmer, W., Wees, S., Treatment of early seropositive rheumatoid arthritis with minocycline: Four-year followup of a double-blind, placebo-controlled trial (1999) Arthritis Rheum, 42 (8), pp. 1691-1695Wells, G., Haguenauer, D., Shea, B., Suarez-Almazor, M.E., Welch, V.A., Tugwell, P., Cyclosporine for rheumatoid arthritis (2000) Cochrane Database Syst Rev, (2). , CD001083Quinn, M.A., Emery, P., Window of opportunity in early rheumatoid arthritis: Possibility of altering the disease process with early intervention (2003) Clin Exp Rheumatol, 21 (5 SUPPL. 31), pp. S154-S157Lard, L.R., Visser, H., Speyer, I., Vander Horst-Bruinsma, I.E., Zwinderman, A.H., Breedveld, F.C., Early versus delayed treatment in patients with recent-onset rheumatoid arthritis: Comparison of two cohorts who received different treatment strategies (2001) Am J Med, 111 (6), pp. 446-451Emery, P., Breedveld, F.C., Dougados, M., Kalden, J.R., Schiff, M.H., Smolen, J.S., Early referral recommendation for newly diagnosed rheumatoid arthritis: Evidence based development of a clinical guide (2002) Ann Rheum Dis, 61 (4), pp. 290-297Breedveld, F.C., Kalden, J.R., Appropriate and effective management of rheumatoid arthritis (2004) Ann Rheum Dis, 63 (6), pp. 627-633St. Clair, E.W., Disease-modifying anti-rheumatic drugs (2001) Primer on the Rheumatic Diseases. 12th Edition, pp. 599-602. , ed. Atlanta: The Arthritis FoundationSmolen, J.S., Sokka, T., Pincus, T., Breedveld, F.C., A proposed treatment algorithm for rheumatoid arthritis: Aggressive therapy, methotrexate, and quantitative measures (2003) Clin Exp Rheumatol, 21 (5 SUPPL. 31), pp. S209-S210Galindo-Rodriguez, G., Avina-Zubieta, J.A., Russell, A.S., Suarez-Almazor, M.E., Disappointing longterm results with disease modifying antirheumatic drugs. A practice based study (1999) J Rheumatol, 26 (11), pp. 2337-2343Aletaha, D., Smolen, J.S., Effectiveness profiles and dose dependent retention of traditional disease modifying antirheumatic drugs for rheumatoid arthritis. 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Aptidão cardiorrespiratória, perfil lipídico e metabólico em adolescentes obesos e não-obesos Cardiorespiratory fitness, lipid and metabolic profile in obese and non-obese adolescents
No full textO objetivo deste estudo foi investigar a relação entre o consumo máximo de oxigênio, perfil lipídico e metabólico em meninas e meninos obesos e não-obesos. Estudo transversal, descritivo e correlacional. A amostra foi composta por 91 obesos e 30 não-obesos, dos 10 aos 16 anos. Avaliou-se o índice de massa corporal (IMC) e a circunferência abdominal (CA). A aptidão cardiorrespiratória foi avaliada de forma direta através da análise do consumo máximo de oxigênio (O2max). Determinaram-se níveis de colesterol total (CT), lipoproteína de alta densidade (HDL-C), lipoproteína de baixa densidade (LDL-C), triglicérides (TG), glicemia e insulinemia após 12 horas de jejum. Analisaram-se os dados pelo teste "t" de student e correlação parcial controlada pela idade, com um nível de significância de pO2max com o IMC (r = -0,540; p O2max com a CT, a fração LDL-C e a glicemia.O menor VO2max correlacionou com maiores adiposidade, TG e insulinemia, bem como redução de HDL. O O2max não correlacionou com o CT, LDL-C e glicemia, sugerindo a importância do controle genético sobre estas variáveis e um menor tempo de influência do sedentarismo na população infanto-juvenil.The aim this study was investigates the relationship between maximum oxygen consumption, lipid and metabolic profile in obese and non-obese girls and boys. Transversal, descriptive and correlational study. 91 obese and 30 non-obese subjects participated, with 10 to 16 years. There were well overall adiposity by body mass index (BMI), and central adiposity by waist circumference (WC). The cardiorespiratory fitness was assessed by a direct analysis of maximum oxygen consumption (O2max). Are determined levels of total cholesterol (TC), high density lipoprotein (HDL-C), low density lipoprotein (LDL-C), triglycerides (TG), glucose and insulin after 12 hours of fasting. We analyzed the data by "t" student`s test and partial correlation controlled for age, with a significance level of p O2max and HDL-C than the obese (p O2max was no correlation with BMI (r = -0.50, p O2max with the TC, the fraction of LDL-C and glucose. The lowest VO2max correlated with increased adiposity, insulin and TG, and reduction of HDL. However, the O2max not correlated with TC, LDL-C and glucose, suggesting the importance of genetic control of these variables and a lower influence of time of inactivity in children and youth population
Efeito de um programa de exercício físico aeróbio na composição corporal, perfil lipídico e capacidade aeróbia em adolescentes com excesso de peso
No full textDissertação (mestrado) - Universidade Federal de Santa Catarina, Centro de Desportos, Programa de Pós-Graduação em Educação Física, Florianópolis, 2010O excesso de peso corporal entre os adolescentes, nas formas de sobrepeso e obesidade, vem aumentando nos países em desenvolvimento, o que acarreta preocupações aos órgãos de saúde, devido aos agravos e riscos provocados por essas condições. Associado ao excesso de peso, as alterações no perfil lipídico aumenta o risco de mortalidade na vida adulta. Uma das recomendações para diminuição do excesso de peso e dos fatores de risco associados é a prática de exercícios físicos aeróbios regulares, pois o aprimoramento da capacidade aeróbia resulta em alterações na composição corporal e no perfil lipídico. Assim, este estudo desenvolvido com adolescentes que apresentam excesso de peso teve como objetivos verificar o efeito de um programa de exercício físico nas seguintes variáveis: a) composição corporal; b) perfil lipídico; c) capacidade aeróbia. Este estudo experimental de delineamento de grupos randomizados com testes pré e pós-tratamento foi formado por adolescentes com excesso de peso, divididos aleatoriamente em grupos experimental - GE (n=9) e controle - GC (n=5). A intervenção teve duração de 12 semanas, na qual o GE realizou exercício aeróbio três vezes semanais, em cicloergômetro, com intensidades individuais referentes ao limiar de lactato (LL) e ao Onset of Blood Lactate Accumulation (OBLA), tendo a cada duas semanas um incremento de 10% na carga do ergômetro. Após o período de intervenção, diferentemente do GC, o GE teve uma melhora nas seguintes variáveis: a) composição corporal, diminuição da dobra cutânea tricipital (14,0%), percentual de gordura corporal (4,2%), massa de gordura (4,2%) e aumento da massa livre de gordura (1,7%); b) perfil lipídico, aumentando o HDL - colesterol (10,6%); c) capacidade aeróbia, aumento nas cargas do ergômetro referentes ao LL (33,3%) e OBLA (14,2%), além de se atingir o LL com uma freqüência cardíaca superior ao período inicial. O programa de exercício físico aeróbio em cicloergômetro, destinado aos adolescentes com excesso de peso, tendo uma intensidade elevada, prescrita com indicadores da resposta de lactato sanguíneo, provocou alterações positivas na composição corporal, perfil lipídico e capacidade aeróbia nos adolescentes que participaram do treinamento. Estes achados indicam, supostamente, que adolescentes com excesso de peso, inseridos em programas de exercício físico de intensidade elevada, podem diminuir o risco de desenvolvimento de doenças cardiovasculares na idade adulta
A Toolkit to assess health needs for congenital disorders in low- and middle-income countries: an instrument for public health action.
No full textBACKGROUND: In 2010 the World Health Assembly called for action to improve the care and prevention of congenital disorders, noting that technical guidance would be required for this task, especially in low- and middle-income countries. Responding to this call, we have developed a freely available web-accessible Toolkit for assessing health needs for congenital disorders. METHODS: Materials for the Toolkit website (http://toolkit.phgfoundation.org) were prepared by an iterative process of writing, discussion and modification by the project team, with advice from external experts. A customized database was developed using epidemiological, demographic, socio-economic and health-services data from a range of validated sources. Document-processing and data integration software combines data from the database with a template to generate topic- and country-specific Calculator documents for quantitative analysis. RESULTS: The Toolkit guides users through selection of topics (including both clinical conditions and relevant health services), assembly and evaluation of qualitative and quantitative information, assessment of the potential effects of selected interventions, and planning and prioritization of actions to reduce the risk or prevalence of congenital disorders. CONCLUSIONS: The Toolkit enables users without epidemiological or public health expertise to undertake health needs assessment as a prerequisite for strategic planning in relation to congenital disorders in their country or region
COPD in England: a comparison of expected, model-based prevalence and observed prevalence from general practice data
No full textBACKGROUND:
Primary care data show that 765 000 people in England have a general practice (GP) diagnosis of chronic obstructive pulmonary disease (COPD). We hypothesized that this underestimates actual prevalence, and compared expected prevalence of COPD for English local authority areas with prevalence of diagnosed COPD.
METHODS:
Cross-sectional comparison of GP observed and model-based prevalence estimates (using spirometry data without clinical diagnosis) from the Health Survey for England. Local underdiagnosis of COPD was estimated as the ratio of observed to expected cases. We investigated geographical patterns using classical and geographically weighted regression analysis.
RESULTS:
Both observed and expected prevalence of COPD varied widely between areas. There was evidence of a 'north-south' divide, with both observed and modelled prevalence higher in the north. The ratio of diagnosed to expected prevalence varied from 0.20 to 0.95, with a mean of 0.52. Underdiagnosis was more pronounced in urban areas, and is particularly severe in London. The inclusion of GP numbers in the analysis yielded a stronger regression relationship, suggesting primary care supply affects diagnosis.
CONCLUSION:
Both observed and modelled COPD prevalence varies considerably across England. Cost-effective case-finding strategies should be evaluated, especially in areas where the ratio of observed to expected cases is low
Canakinumab in patients with systemic juvenile idiopathic arthritis and active systemic features:Results from the 5-year long-term extension of the phase III pivotal trials
No full textObjectives: To evaluate the long-term efficacy and safety of canakinumab in patients with active systemic juvenile idiopathic arthritis (JIA). Methods: Patients (2-19 years) entered two phase III studies and continued in the long-term extension (LTE) study. Efficacy assessments were performed every 3 months, including adapted JIA American College of Rheumatology (aJIA-ACR) criteria, Juvenile Arthritis Disease Activity Score (JADAS) and ACR clinical remission on medication criteria (CRACR). Efficacy analyses are reported as per the intent-to-treat population. Results: 144 of the 177 patients (81%) enrolled in the core study entered the LTE. Overall, 75 patients (42%) completed and 102 (58%) discontinued mainly for inefficacy (63/102, 62%), with higher discontinuation rates noted in the late responders group (n=25/31, 81%) versus early responders (n=11/38, 29%). At 2 years, aJIA-ACR 50/70/90 response rates were 62%, 61% and 54%, respectively. CRACR was achieved by 20% of patients at month 6; 32% at 2 years. A JADAS low disease activity score was achieved by 49% of patients at 2 years. Efficacy results were maintained up to 5 years. Of the 128/177 (72.3%) patients on glucocorticoids, 20 (15.6%) discontinued and 28 (22%) tapered to 0.150 mg/kg/day. Seven patients discontinued canakinumab due to CR. There were 13 macrophage activation syndrome (three previously reported) and no additional deaths (three previously reported). No new safety findings were observed. Conclusion: Response to canakinumab treatment was sustained and associated with substantial glucocorticoid dose reduction or discontinuation and a relatively low retention-on-treatment rate. No new safety findings were observed on long-term use of canakinumab. Trial registration numbers: NCT00886769, NCT00889863, NCT00426218 and NCT00891046.</p
Waist circumference as a determinant of hypertension and diabetes in Brazilian women: a population-based study.
No full textOBJECTIVE: To evaluate the role of central adiposity, as evaluated by the measurement of waist circumference (WC), as an independent risk factor for hypertension and type 2 diabetes mellitus in the setting of a developing country. DESIGN: Population-based, cross-sectional study. SETTING: A medium-sized town in southern Brazil. PARTICIPANTS: One thousand and ninety-five non-pregnant women, 20 to 69 years old, recruited by cluster random sampling between 1999 and 2000. Their mean WC was 85.3 cm (standard deviation 13.9 cm) and 23.3% (n=255) were obese (body mass index >30 kg m(-2)). The prevalence of hypertension and diabetes was 25.6% (n=280) and 6.2% (n=68), respectively. RESULTS: The risks of hypertension and diabetes were directly related to WC measurement. Women with WC>80 cm had increased risk of hypertension (odds ratio (OR)=6.2, P<0.001). The association remained significant (OR=1.04 per cm increase in WC, P=0.02) after adjusting for confounders. The effect of WC on diabetes was modified by age. The effect was stronger in women younger than 40 years old (OR=12.7, P=0.016) than in those over 40 years old (OR=2.8, P=0.013). In the multivariate analysis, the odds ratio was 5.7 (P=0.12) in those under 40 years old and 2.8 (P=0.008) in older women. CONCLUSIONS: Waist circumference is an independent determinant for hypertension and diabetes in women in this population. The stronger association between WC and diabetes in younger women suggests that the validity of this indicator to assess abdominal adiposity is age-specific. Further studies should validate the usefulness of WC measurement in different age groups
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