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 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 m 2), 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

Action and coping plans related to the behavior of adherence to drug therapy among coronary heart disease outpatients Planes de acción y de enfrentamiento de obstáculos relacionados al comportamiento de adhesión a la terapia medicamentosa en pacientes con coronariopatía Planos de ação e de enfrentamento de obstáculos relacionados ao comportamento de adesão à terapia medicamentosa em coronariopatas

OBJECTIVE: to analyze the action and coping plans related to the behavior of adhering to drug therapy, developed by coronary heart disease (CHD) outpatients, and to identify the barriers perceived to adopting this behavior. METHODS: the participants (n=59) were invited to formulate action plans and coping plans for the behavior of adhering to the cardio-protective medications and the symptom-relief medications. RESULTS: specific action plans for taking the medications associated with temporal markers and the sleep-wake cycle were shown. The most frequently reported obstacles were forgetfulness and absence of routine in daily living activities. The coping plans for overcoming forgetfulness were the most specific. CONCLUSION: this study's findings support the application of implementation intentions aimed at optimizing adherence to drug therapy among patients with CHD.<br>OBJETIVO: analizar los planes de acción y de enfrentamiento de obstáculos relacionados al comportamiento de adhesión a la terapia medicamentosa, elaborados por pacientes con coronariopatía en seguimiento de ambulatorio e identificar las barreras percibidas para adopción de este comportamiento. MÉTODO: los participantes (n=59) fueron invitados a elaborar planes de acción (action planning) y de enfrentamiento de obstáculos (coping planning) para el comportamiento de adhesión a los medicamentos cardio-protectores y de alivio de los síntomas. RESULTADOS: fueron evidenciados planes de acción específicos para la tomada de los medicamentos que asociaron el comportamiento a marcadores temporales y al ciclo vigilia sueño. Los obstáculos más frecuentemente relatados fueron el olvido y la ausencia de rutina en las actividades de vida diaria. Los planes de enfrentamiento elaborados para superar el olvido fueron los más específicos. CONCLUSIÓN: los hallazgos de este estudio subvencionan la aplicación de la implementación de la intención para optimizar la adhesión de pacientes con coronariopatía a la terapia medicamentosa.<br>OBJETIVO: analisar os planos de ação e de enfrentamento de obstáculos, relacionados ao comportamento de adesão à terapia medicamentosa, elaborados por pacientes coronariopatas, em seguimento ambulatorial, e identificar as barreiras percebidas para adoção desse comportamento. MÉTODO: os participantes (n=59) foram convidados a elaborar planos de ação (action planning) e de enfrentamento de obstáculos (coping planning) para o comportamento de adesão aos medicamentos cardioprotetores e de alívio dos sintomas. RESULTADOS: foram evidenciados planos de ação específicos para a tomada dos medicamentos que associaram o comportamento a marcadores temporais e ao ciclo vigília/sono. Os obstáculos mais frequentemente relatados foram o esquecimento e a ausência de rotina nas atividades de vida diária. Os planos de enfrentamento, elaborados para superar o esquecimento, foram os mais específicos. CONCLUSÃO: os achados deste estudo subsidiam a aplicação da implementação da intenção para otimizar a adesão de coronariopatas à terapia medicamentosa