RESUMO
INTRODUCTION: Studies have shown that T2DM is an inflammatory disease. Thus, the present study was aimed at evaluating whether diacerein could improve the metabolic and inflammatory profile among patients with T2DM under long-term treatment with glucose-lowering agents. METHODS: This is a double-blind, parallel, placebo-controlled trial with 72 participants randomly assigned to diacerein 50 mg or placebo for 12 weeks. The primary endpoint was the between-group difference in change in HbA1c. Secondary endpoints included the proportion of patients achieving metabolic control [HbA1c ≤ 7.0% (53 mmol/mol)] and change in inflammatory mediators. RESULTS: Participants in the diacerein group had greater reductions in mean HbA1c level in comparison to placebo (-0.98; 95% CI: -2.02 to 0.05, P = 0.06), independently of confounding factors. The difference in HbA1c level was -1.3 (95% CI: -2.3 to -0.4) in favor of diacerein (P = 0.007) in those with <14 years of diabetes duration versus 0.05 (-0.7 to 0.8; P = 0.9) in those with longer duration. The diacerein group had a 50% increase in the number of participants at the lowest TNF-α level (≤1.46 pg/mL). CONCLUSIONS: In patients with long-established T2DM under long-term treatment with glucose-lowering agents, diacerein improves metabolic control as measured by HbA1c level and has a favorable impact on inflammatory profile. CLINICAL TRIAL REGISTRY: This trial is registered with Brazilian Clinical Trials Registry (ReBEC) number RBR-29j956.
Assuntos
Antraquinonas/uso terapêutico , Anti-Inflamatórios/uso terapêutico , Diabetes Mellitus Tipo 2/tratamento farmacológico , Hipoglicemiantes/uso terapêutico , Inflamação/tratamento farmacológico , Idoso , Glicemia/metabolismo , Diabetes Mellitus Tipo 2/sangue , Método Duplo-Cego , Feminino , Hemoglobinas Glicadas/metabolismo , Humanos , Inflamação/sangue , Masculino , Pessoa de Meia-Idade , Resultado do TratamentoRESUMO
Diacerein seems to improve metabolic control and reduce inflammatory marker levels in individuals with type 2 diabetes mellitus (Type 2 DM), but for participants with chronic kidney disease (CKD) its effect is unknown. This study aimed to evaluate the effect of diacerein vs. placebo on urinary albumin/creatinine ratio (ACR), glomerular filtration rate (GFR), and inflammatory cytokines in type 2 DM participants with CKD. Blood pressure (BP) and metabolic control were secondary outcomes. This randomized, placebo-controlled, parallel trial of adjuvant treatment of type 2 DM with diacerein enrolled seventy-two participants with CKD, aged 30-80 years, with glycated hemoglobin levels from 53-97 mmol/mol (7.0-11.0%), receiving angiotensin-converting enzyme inhibitors or angiotensin receptor blockers and antidiabetic agents. Participants randomized to diacerein or placebo were followed-up up to 90 days. Both groups had a marked reduction in ACR, but there was no effect on glomerular filtration rate. While the diacerein group had reduced TNF-α levels at the 75th percentile with a borderline significance (P = 0.05), there were no changes in the IL levels at the 75th percentile. Diacerein prevented the increase in blood glucose to the level observed in the placebo group (P = 0.04), improving metabolic control by 74%, reducing 24-hour diastolic BP, nighttime systolic and diastolic BP compared to the placebo group. In conclusion, among patients with type 2 DM and CKD, diacerein does not have an effect on ACR or GFR, but slows metabolic control deterioration and is associated with lower nighttime systolic and diastolic blood pressure. TRIAL REGISTRATION: Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clinicos; ReBeC) U1111-1156-0255.
Assuntos
Antraquinonas/farmacologia , Citocinas/metabolismo , Diabetes Mellitus Tipo 2/metabolismo , Mediadores da Inflamação/metabolismo , Falência Renal Crônica/metabolismo , Rim/efeitos dos fármacos , Idoso , Feminino , Humanos , Rim/fisiopatologia , Masculino , Pessoa de Meia-Idade , PlacebosRESUMO
Este trabalho estudou o perfil clínico e laboratorial de quarenta pacientes diabéticos näo insulino-dependentes atendidos no ambulatório de endocrinologia do Hospital Säo Vicente de Paulo, Passo Fundo (RS), no período de seis meses. Nesta amostra predominou a raça branca, baixo nível de escolaridade, idade média de 46 anos e o diagnóstico de diabetes há cerca de 5 anos. A maioria dos pacientes usava dieta e hipoglicemiante oral, apresentava peso excessivo, obesidade androgênica e hipertensäo arterial sistêmica. A neuropatia periférica foi a complicaçäo crônica mais freqüente. Prevaleceu o mau controle glicêmico e a hipertrigliceridemia foi a displipidemia mais observada neste grupo