85 research outputs found
Uso de substâncias psicoativas e métodos contraceptivos pela população urbana brasileira, 2005
OBJETIVO: Analisar a relação entre os padrões de utilização de preservativos e outros métodos contraceptivos e o consumo de álcool e drogas. MÉTODOS: Estudo exploratório com base em dados de amostra probabilÃstica com 5.040 entrevistados residentes em grandes regiões urbanas do Brasil, com idades entre 16 e 65 anos, em 2005. Os dados foram coletados por meio de questionários. Empregou-se a técnica de árvores de classificação Chi-square Automatic Interaction para estudar o uso de preservativos por parte de entrevistados de ambos os sexos e de outros métodos contraceptivos entre as mulheres na última relação sexual vaginal. RESULTADOS: Entre adultos jovens e de meia idade, de ambos os sexos, e jovens do sexo masculino vivendo relacionamentos estáveis, o uso de preservativos foi menos freqüente entre os que disseram utilizar substâncias psicoativas (álcool e/ou drogas ilÃcitas). O possÃvel efeito modulador das substâncias psicoativas parece incidir de forma mais clara sobre as práticas anticoncepcionais de mulheres maduras, com inter-relações mais complexas, entre as mulheres mais jovens, onde a inserção em diferentes classes sociais parece desempenhar papel mais relevante. CONCLUSÕES: Apesar das limitações decorrentes de um estudo exploratório, o fato de se tratar de amostra representativa da população urbana brasileira, e não de populações vulneráveis, reforça a necessidade de implementar polÃticas públicas integradas dirigidas à população geral, referentes à prevenção do consumo de drogas, álcool, infecções sexualmente transmissÃveis e HIV/Aids e da gravidez indesejada nos marcos de promoção da saúde sexual e reprodutiva.OBJECTIVE: To analyze the relationship between utilization patterns for condoms and other contraceptive methods and the consumption of alcohol and drugs. METHODS: Exploratory study based on data from a probabilistic sample of 5,040 interviewees aged 16 to 65 years living in large urban regions of Brazil in 2005. The data were collected by means of questionnaires. The chi-square automatic interaction classification tree technique was used to study the use of condoms among interviewees of both sexes and other contraceptive methods among women, at the time of the last vaginal sexual intercourse. RESULTS: Among young and middle-aged adults of both sexes and young men in stable relationships, condom use was less frequent among those who said they used psychoactive substances (alcohol and/or illegal drugs). The possible modulating effect of psychoactive substances on contraceptive practices among mature women seems to be more straightforward, compared to the more subtle effects observed among younger women, for whom the different social classes they belonged to seemed to play a more important role. CONCLUSIONS: Despite the limitations resulting from an exploratory study, the fact that this was a representative sample of the urban population of Brazil and not from vulnerable populations, reinforces the need to implement integrated public policies directed towards the general population, with regard to preventing drug consumption, alcohol abuse, sexually transmitted infections, HIV/AIDS and unwanted pregnancy and promoting sexual and reproductive health
Sinais e sintomas associados à s doenças sexualmente transmissÃveis no Brasil, 2005
OBJECTIVE: Sexually transmitted infections (STIs) are a major determinant of population disease burden worldwide. The objective of the study was to assess self-reported morbidity associated to STIs according to gender. METHODS: The study data were obtained from a 2005 study consisting of a multistage probabilistic sample of 5,040 respondents, aged 16-65 years, living in urban areas in Brazil. These data were compared with those from a previous 1998 study. Bivariate analyses were carried out using Pearson's chi-square test and simple linear regression followed by logistic regression. RESULTS: In both men and women, the variables: previous HIV testing, personal belief in unfaithful love, and number of sexual partners in a lifetime were significantly associated to STIs. In women only, the covariates: low family income, living in the Center-West, Southeast and South regions, and reporting of physical violence were independently associated to STIs. In men, the variables associated were: age group (35 years or more), living in the South region and in the state of São Paulo, and self-perceived HIV infection risk. CONCLUSIONS: Signs and symptoms associated to STIs have strong gender differences in the general population and education interventions should be specifically targeted to either men or women.OBJETIVO: As doenças sexualmente transmissÃveis (DST) constituem um dos principais determinantes da carga de doença das populações em todo o mundo. O objetivo do estudo foi avaliar a morbidade auto-referida associada à ocorrência de DST, segundo gênero. MÉTODOS: Os dados analisados referem-se à pesquisa realizada em 2005 e foram obtidos a partir de amostra probabilÃstica em múltiplos estágios de 5.040 entrevistados, com 16-65 anos de idade, moradores nas regiões urbanas do Brasil. Esses dados foram cotejados com aqueles de pesquisa anterior, de 1998. Realizaram-se análises bivariadas, utilizando teste qui-quadrado de Pearson e regressão linear simples, seguidas por regressão logÃstica. RESULTADOS: Tanto para homens quanto para mulheres as variáveis: testagem anterior para o HIV, crença pessoal de que pode haver amor sem fidelidade e número de pessoas com quem teve relações sexuais na vida mostraram-se significativamente associadas ao desfecho. Porém, somente entre as mulheres as covariáveis a seguir se mostraram independentemente associadas ao desfecho: renda familiar baixa, residência na Região Centro-Oeste, Sudeste e Sul, e relato de violência fÃsica. Para os homens, as variáveis independentemente associadas foram: faixa etária (35 anos ou mais), residência na Região Sul e Estado de São Paulo, e auto-avaliação de risco de se infectar com o HIV. CONCLUSÕES: Sinais e sintomas associados à s DST apresentam forte diferencial de gênero na população geral, devendo ser objeto de intervenções educativas claramente distintas
Participation of women in HIV clinical trials: the IPEC-FIOCRUZ experience
Jordan E Lake1, Ruth K Friedman2, Cynthia B Cunha2, Sandra W Cardoso2, Valdilea G Veloso2, Judith S Currier1, Beatriz Grinsztejn21Division of Infectious Diseases, University of California at Los Angeles, Los Angeles, CA, USA; 2Fundação Oswaldo Cruz – Instituto de Pesquisa Clínica Evandro Chagas/IPEC, Rio de Janeiro, State of Rio de Janeiro, BrazilBackground: Fifty percent of people living with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) worldwide are female. In Brazil, for example, 240,000 women are infected with HIV, rates of infection in women have increased over the last two decades, and addressing HIV prevention and treatment for women at risk for, or living with, HIV/AIDS remains a challenge. To better address the needs of women living with HIV in Brazil, the Instituto de Pesquisa Clínica Evandro Chagas – Fundação Oswaldo Cruz (IPEC-FIOCRUZ) HIV Women’s Cohort was established in 1996 to study the natural history of women seeking HIV care. This analysis describes the characteristics of women in the cohort who participated in HIV clinical trials between 1999 and 2008.Methods: A total of 736 Women’s Cohort participants were in active follow-up and 665 participants from the Women’s Cohort were included in univariable and multivariable analyses to determine socioeconomic and sociodemographic factors associated with women’s participation in HIV clinical trials at our site.Results: Of the complete cohort, 23% participated in a clinical trial between January 1999 and July 2008. Odds of participation decreased for women who were younger than 35 years old, currently employed, had an HIV-positive sexual partner, and/or who reported a lifetime history of illicit drug use. Alternatively, the odds of participation increased for women who had more than 8 years of formal education, were living independently, and/or were married or cohabitating.Conclusion: The rate of participation in HIV clinical trials by women in the IPEC-Fiocruz Cohort was similar to other published cohorts, but identification of local risk factors and barriers to participation remains important. Our analysis offers a novel description of the factors associated with participation in HIV clinical trials among women in care at IPEC-FIOCRUZ in Rio de Janeiro, Brazil.Keywords: AIDS, Brazil, South America, clinical trial participation&nbsp
Optimized extraction of a lectin from Crataeva tapia bark using AOT in isooctane reversed micelles
Crataeva tapia bark lectin was extracted from a crude extract into a reversed micelle phase of the anionic
surfactant AOT in isooctane and back-extracted, to a final aqueous phase by addition of butanol. The
effects of pH, ionic strength and surfactant concentration on the protein transfer process from the
aqueous to the organic phase were characterized, being the best results obtained after 5 min of contact,
under agitation, between the two phases, at pH 5.5 (10 mM citrate-phosphate buffer), 30 mM NaCl, and
5 mM AOT. Recovery to a new aqueous phase was performed with 5 min of contact, under agitation,
10 mM citrate-phosphate buffer at pH 5.5, 500 mM KCl and 5% of butanol. The overall yield obtained for
the process was 80% for lectin activity and 56% for protein recovery. The efficiency of the process was
confirmed by SDS-PAGE analysis.ALFA/VALNATURA; CNPq
Qualidade da assistência ao trabalho de parto pelo Sistema Único de Saúde, Rio de Janeiro (RJ), 1999-2001
OBJECTIVE: Quality of labor care has been recognized as a major factor for prevention of obstetric complications which can lead to maternal, perinatal and neonatal morbidity and mortality. The objective of the study was to assess quality of labor care by gestational risk and type of health provider. METHODS: Observational, cross-sectional study of labor care provided to 574 pregnant women. Stratified sampling in 20 Unified Health System maternity hospitals in Rio de Janeiro, Brazil, was carried out between 1999 and 2001. Quality of labor care was assessed by gestational risk and type of health provider. Statistical analyses consisted of variance analysis and the analysis of difference between proportions. RESULTS: Of all women studied, 29.6% were classified at obstetric risk. Although hypertension is the main cause of maternal death in Brazil, 71.6% did not have their prelabor blood pressure measured. Five measures were taken on average per parturient and the lowest rate was found in privately insured hospitals (average of 2.9). As to humanized health care, only 21.4% of the parturients had an accompanying person on their side during labor, 75.7% were submitted to intravenous hydration and 24.3% to amniotomy. The single care-related factor that varied by obstetric risk was frequency of blood pressure measures: high-risk parturients had their blood pressure measured twice as much as those low-risk women (mean 0.36 vs. 0.18 measures/h, p=0.006). CONCLUSIONS: In general, low-risk parturients were submitted to unnecessary interventions while high-risk women did not receive adequate care. As a result, there are poor perinatal outcomes, high cesarean rates and high maternal mortality rates, which do not reflect health care investments and technology available.OBJETIVO: La calidad de asistencia en el trabajo de parto ha sido reconocida en la prevención de complicaciones obstétricas que pueden llevar a la morbi-mortalidad maternal, perinatal y neonatal. El objetivo del estudio fue analizar la calidad de la asistencia en el trabajo de parto de acuerdo con el riesgo gestacional y tipo de asistencia médica. MÉTODOS: Se realizó estudio transversal de observación de la asistencia en el trabajo de parto de 574 mujeres, seleccionadas por muestra estratificada en 20 maternidades del Sistema Único de Salud de Rio de Janerio (Sureste de Brasil), entre 1999 y 2001. La calidad de asistencia fue analizada de acuerdo con el riesgo gestacional y tipo de asistencia médica. Se utilizaron procedimientos estadÃsticos de análisis de varianza y de diferencia de proporciones. RESULTADOS: Del total de la muestra, 29,6% de las gestantes fueron clasificadas como de riesgo. A pesar de la hipertensión ser una de las causas más importantes de la muerte materna en Brasil, la presión arterial no fue evaluada en 71,6% de las gestantes durante la observación en pre-parto. En promedio se realizaron cinco estimaciones por parturienta, siendo el menor número en los hospitales con convenios privados (promedio 2,9). Con relación a la humanización de la asistencia, se observó que apenas 21,4% de las parturientas tuvieron la presencia de acompañante en el pre-parto, 75,7% fueron sometidas a hidratación venosa y 24,3% a amniotomÃa. El único tipo de cuidado que varió según el riesgo obstétrico fue la frecuencia de estimación de la presión arterial, en el que las gestantes de riesgo fueron monitoreadas doblemente con relación a las demás (promedio de 0,36 x 0,18 estimaciones/h respectivamente, p=0,006). CONCLUSIONES: De modo general, las gestantes de bajo riesgo son sometidas a intervenciones innecesarias y las de alto riesgo no reciben el cuidado adecuado. En consecuencia, los resultados perinatales son desfavorables y las tasas de cesáreas y de mortalidad materna son incompatibles con las inversiones y la tecnologÃa disponible.OBJETIVO: A qualidade da assistência ao trabalho de parto tem sido reconhecida na prevenção de complicações obstétricas que podem levar à morbi-mortalidade materna, perinatal e neonatal. O objetivo do estudo foi analisar a qualidade da assistência ao trabalho de parto segundo o risco gestacional e tipo de prestador. MÉTODOS: Estudo transversal de observação da assistência ao trabalho de parto de 574 mulheres, selecionadas por amostra estratificada em 20 maternidades do Sistema Único de Saúde do Rio de Janeiro (RJ), entre 1999 e 2001. A qualidade da assistência foi analisada segundo o risco gestacional e o tipo de prestador. Utilizaram-se procedimentos estatÃsticos de análise de variância e de diferença de proporções. RESULTADOS: Do total da amostra, 29,6% das gestantes foram classificadas como de risco. Apesar da hipertensão ser a causa mais importante de morte materna no Brasil, a pressão arterial não foi aferida em 71,6% das gestantes durante a observação no pré-parto. Em média foram feitas cinco aferições por parturiente, sendo o menor número nos hospitais conveniados privados (média de 2,9). Quanto à humanização da assistência, observou-se que apenas 21,4% das parturientes tiveram a presença de acompanhante no pré-parto, 75,7% foram submetidas à hidratação venosa e 24,3% à amniotomia. O único tipo de cuidado que variou segundo o risco obstétrico foi a freqüência da aferição da pressão arterial, em que as gestantes de risco foram monitoradas o dobro de vezes em relação à s demais (média de 0,36 x 0,18 aferições/h respectivamente, p=0,006). CONCLUSÕES: De modo geral, as gestantes de baixo risco são submetidas a intervenções desnecessárias e as de alto risco não recebem cuidado adequado. Como conseqüência, os resultados perinatais são desfavoráveis e as taxas de cesariana e de mortalidade materna são incompatÃveis com os investimentos e a tecnologia disponÃvel
Liver imaging : it is time to adopt standardized terminology
Liver imaging plays a vital role in the management of patients at risk for hepatocellular carcinoma (HCC); however, progress in the field is challenged by nonuniform and inconsistent terminology in the published literature. The Steering Committee of the American College of Radiology (ACR)’s Liver Imaging Reporting And Data System (LI-RADS), in conjunction with the LI-RADS Lexicon Writing Group and the LI-RADS International Working Group, present this consensus document to establish a single universal liver imaging lexicon. The lexicon is intended for use in research, education, and clinical care of patients at risk for HCC (i.e., the LI-RADS population) and in the general population (i.e., even when LI-RADS algorithms are not applicable). We anticipate that the universal adoption of this lexicon will provide research, educational, and clinical benefits
Purification of a lectin from Cratylia mollis crude extract seed by a single step PEG/phosphate aqueous two-phase system
The partitioning and purification of lectins from the crude extract of Cratylia mollis seeds (Cramoll 1,4) was investigated in aqueous two-phase systems (ATPS). A factorial design model (24) was used to evaluate the influence of polyethylene glycol (PEG) molar mass (15008000g/mol), PEG concentration (12.517.5% w/w), phosphate (1015% w/w) concentration, and pH (68) on the differential partitioning, purification factor, and yield of the lectin. Polymer and salt concentration were the most important variables affecting partition of lectin and used to find optimum purification factor by experimental BoxBehnken design together with the response surface methodology (RSM). ATPS showed best conditions composed by 13.9% PEG1500, 15.3% phosphate buffer at pH 6, which ensured purification factor of 4.70. Sodium dodecyl sulfatepolyacrylamide gel electrophoresis showed a single band of protein with 26.1kDa. Furthermore, results demonstrated a thermostable lectin presenting activity until 60°C and lost hemagglutinating activity at 80°C. According to the obtained data it can be inferred that the ATPS optimization using RSM approach can be applied for recovery and purification of lectins.We are grateful to the following bodies for the grants awarded: CAPES (Coordination for the Improvement of Level Personnel Superior); FACEPE (Pernambuco Science and Technology Foundation): Researcher's scholarship grant: BFP-0017-5.05/18 CNPq (National Council for Scientific Development and Technological) process: 427153/2016-6 and we also thank the reviewers for their valuable comments and suggestions as these helped us to improve the manuscript.info:eu-repo/semantics/publishedVersio
Teste rápido para o HIV como estratégia de prevenção da transmissão vertical no Brasil
OBJECTIVE: To assess the feasibility of HIV rapid testing for pregnant women at maternity hospital admission and of subsequent interventions to reduce perinatal HIV transmission. METHODS: Study based on a convenience sample of women unaware of their HIV serostatus when they were admitted to delivery in public maternity hospitals in Rio de Janeiro and Porto Alegre, Brazil, between March 2000 and April 2002. Women were counseled and tested using the Determine HIV1/2 Rapid Test. HIV infection was confirmed using the Brazilian algorithm for HIV infection diagnosis. In utero transmission of HIV was determined using HIV-DNA-PCR. There were performed descriptive analyses of sociodemographic data, number of previous pregnancies and abortions, number of prenatal care visits, timing of HIV testing, HIV rapid test result, neonatal and mother-to-child transmission interventions, by city studied. RESULTS: HIV prevalence in women was 6.5% (N=1,439) in Porto Alegre and 1.3% (N=3.778) in Rio de Janeiro. In Porto Alegre most of women were tested during labor (88.7%), while in Rio de Janeiro most were tested in the postpartum (67.5%). One hundred and forty-four infants were born to 143 HIV-infected women. All newborns but one in each city received at least prophylaxis with oral zidovudine. It was possible to completely avoid newborn exposure to breast milk in 96.8% and 51.1% of the cases in Porto Alegre and Rio de Janeiro, respectively. Injectable intravenous zidovudine was administered during labor to 68.8% and 27.7% newborns in Porto Alegre and Rio de Janeiro, respectively. Among those from whom blood samples were collected within 48 hours of birth, in utero transmission of HIV was confirmed in 4 cases in Rio de Janeiro (4/47) and 6 cases in Porto Alegre (6/79). CONCLUSIONS: The strategy proved feasible in maternity hospitals in Rio de Janeiro and Porto Alegre. Efforts must be taken to maximize HIV testing during labor. There is a need of strong social support to provide this population access to health care services after hospital discharge.OBJETIVO: Analizar la viabilidad de evaluación rápida del HIV entre gestantes en la admisión en la maternidad y de intervenciones para reducir la transmisión perinatal del HIV. MÉTODOS: Muestra de conveniencia de mujeres que desconocÃan su situación serológica para el HIV al ser admitidas para el parto en maternidades públicas de Rio de Janeiro (Sureste) y de Porto alegre (Sur de Brasil), entre marzo de 2000 y abril de 2002. Las mujeres fueron aconsejadas y evaluadas con prueba rápida Determine HIV1/2 en la maternidad. Infección por el HIV fue confirmada por el algoritmo brasilero para el diagnóstico de la infección por el HIV. La transmisión intra- útero fue determinada por el PCR-DNA-HIV. Fueron realizados análisis descriptivos de los datos sociodemográficos, número de gestaciones y de abortos previos, número de visitas de prenatal, momento de la evaluación para el HIV, resultado de la prueba rápida para el HIV, intervenciones recibidas por los recién nacidos y de transmisión vertical del HIV, de acuerdo con cada ciudad. RESULTADOS: La prevalencia de HIV entre las mujeres fue de 6,5% (N=1.439) en Porto Alegre y 1,3% (N=3,778) en Rio de Janeiro. La mayorÃa fue evaluada durante el trabajo de parto en Porto Alegre y en el postparto, en Rio de Janeiro. Ciento y cuarenta y cuatro niños nacieron de 143 mujeres infectadas por el HIV. Todos los recién nacidos recibieron al menos la profilaxia con zidovudina oral, excepto uno en cada ciudad. Fue posible evitar cualquier exposición a la leche materna en 96,8% y 51,1% de los recién nacidos en Porto Alegre y en Rio de Janeiro, respectivamente. La zidovudina inyectable fue administrada durante el trabajo de parto a 68,8% de los recién nacidos en Porto Alegre y 27,7% en Rio de Janeiro. Entre aquellos con muestras de sangre colectadas hasta 48 horas de nacimiento, la transmisión intra-útero fue confirmada en cuatro casos en Rio de Janeiro (4/47) y en seis casos en Porto Alegre (6/79). CONCLUSIONES: La estrategia se mostró factible en las maternidades de Rio de Janeiro y de Porto Alegre. Esfuerzos deben ser emprendidos para maximizar la evaluación durante el trabajo de parto. Fuerte soporte social precisa ser acoplado a esa estrategia para garantizar el acceso de dicha población al sistema de salud posterior a ser dado de alta de la maternidad.OBJETIVO: Analisar a viabilidade da testagem rápida para o HIV entre gestantes na admissão à maternidade e de intervenções para reduzir a transmissão perinatal do HIV. MÉTODOS: Amostra de conveniência de mulheres que desconheciam sua situação sorológica para o HIV quando admitidas para o parto em maternidades públicas do Rio de Janeiro, RJ, e de Porto Alegre, RS, entre março de 2000 e abril de 2002. As mulheres foram aconselhadas e testadas com teste rápido Determine HIV1/2 na maternidade. Infecção pelo HIV foi confirmada pelo algoritmo brasileiro para o diagnóstico da infecção pelo HIV. A transmissão intra-útero foi determinada pelo PCR-DNA-HIV. Foram realizadas análises descritivas dos dados sociodemográficos, número de gestações e de abortos prévios, número de visitas de pré-natal, momento da testagem para o HIV, resultado do teste rápido para o HIV, intervenções recebidas pelos recém-natos e de transmissão vertical do HIV, de acordo com cada cidade. RESULTADOS: A prevalência de HIV entre as mulheres foi 6,5% (N=1.439) em Porto Alegre e 1,3% (N=3.778) no Rio de Janeiro. A maioria foi testada durante o trabalho de parto em Porto Alegre e no pós-parto, no Rio de Janeiro. Cento e quarenta e quatro crianças nasceram de 143 mulheres infectadas pelo HIV. Todos os recém-natos receberam ao menos a profilaxia com zidovudina oral, exceto um em cada cidade. Foi possÃvel evitar qualquer exposição ao leite materno em 96,8% e 51,1% dos recém-natos em Porto Alegre e no Rio de Janeiro, respectivamente. A zidovudina injetável foi administrada durante o trabalho de parto para 68,8% dos recém-natos em Porto Alegre e 27,7% no Rio de Janeiro. Entre aqueles com amostras de sangue coletadas até 48 horas do nascimento, a transmissão intra-útero foi confirmada em quatro casos no Rio de Janeiro (4/47) e em seis casos em Porto Alegre (6/79). CONCLUSÕES: A estratégia mostrou-se factÃvel nas maternidades do Rio de Janeiro e de Porto Alegre. Esforços devem ser empreendidos para maximizar a testagem durante o trabalho de parto. Forte suporte social precisa ser acoplado a essa estratégia para garantir o acesso dessa população ao sistema de saúde após a alta da maternidade
Evaluation of MCM-2 Expression in TMA Cervical Specimens
Background:Minichromosome maintenance proteins (MCM) are highly expressed in actively replicating cells. The need for
biological markers for cervical carcinoma and its precursor lesions is emerging. Our main aim was to determine the
immunohistochemical expression of MCM-2 in HIV-positive and -negative dysplastic cervical specimens.
Methods:Immunohistochemical analysis of MCM-2 was performed in a total of 352 cervical TMA specimens of normal
control, low-grade CIN, high-grade CIN and invasive tumor. 38 specimens were from HIV-positive women. A receiver
operating characteristic (ROC) curve was constructed to determine the best cutoff to diagnose high-grade CIN and invasive
cervical cancer.
Results:In the progression from normal epithelium to high-grade CIN and invasive tumor we found significant differences
in the MCM-2 expression (p,0.05). Based on the ROC curve of 80% with an area under the curve (AUC) of 0.78, expression of
MCM-2 to diagnose high-grade CIN and invasive tumor resulted in sensitivity of 81%, specificity of 66%, a positive predictive
value (PPV) of 86% and a negative predictive value (NPV) of 57%. HIV-positive cervices revealed a decreasing expression of
MCM-2 in both LGCIN and HGCIN compared with HIV-negative specimens (p,0.0001).
Conclusions:The present study suggests that immunohistochemical MCM-2 may not be a promising biomarker for
diagnosing high-grade CIN and invasive cance
Canagliflozin and renal outcomes in type 2 diabetes and nephropathy
BACKGROUND Type 2 diabetes mellitus is the leading cause of kidney failure worldwide, but few effective long-term treatments are available. In cardiovascular trials of inhibitors of sodium–glucose cotransporter 2 (SGLT2), exploratory results have suggested that such drugs may improve renal outcomes in patients with type 2 diabetes. METHODS In this double-blind, randomized trial, we assigned patients with type 2 diabetes and albuminuric chronic kidney disease to receive canagliflozin, an oral SGLT2 inhibitor, at a dose of 100 mg daily or placebo. All the patients had an estimated glomerular filtration rate (GFR) of 30 to <90 ml per minute per 1.73 m2 of body-surface area and albuminuria (ratio of albumin [mg] to creatinine [g], >300 to 5000) and were treated with renin–angiotensin system blockade. The primary outcome was a composite of end-stage kidney disease (dialysis, transplantation, or a sustained estimated GFR of <15 ml per minute per 1.73 m2), a doubling of the serum creatinine level, or death from renal or cardiovascular causes. Prespecified secondary outcomes were tested hierarchically. RESULTS The trial was stopped early after a planned interim analysis on the recommendation of the data and safety monitoring committee. At that time, 4401 patients had undergone randomization, with a median follow-up of 2.62 years. The relative risk of the primary outcome was 30% lower in the canagliflozin group than in the placebo group, with event rates of 43.2 and 61.2 per 1000 patient-years, respectively (hazard ratio, 0.70; 95% confidence interval [CI], 0.59 to 0.82; P=0.00001). The relative risk of the renal-specific composite of end-stage kidney disease, a doubling of the creatinine level, or death from renal causes was lower by 34% (hazard ratio, 0.66; 95% CI, 0.53 to 0.81; P<0.001), and the relative risk of end-stage kidney disease was lower by 32% (hazard ratio, 0.68; 95% CI, 0.54 to 0.86; P=0.002). The canagliflozin group also had a lower risk of cardiovascular death, myocardial infarction, or stroke (hazard ratio, 0.80; 95% CI, 0.67 to 0.95; P=0.01) and hospitalization for heart failure (hazard ratio, 0.61; 95% CI, 0.47 to 0.80; P<0.001). There were no significant differences in rates of amputation or fracture. CONCLUSIONS In patients with type 2 diabetes and kidney disease, the risk of kidney failure and cardiovascular events was lower in the canagliflozin group than in the placebo group at a median follow-up of 2.62 years
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