RESUMO
Background: Non-alcoholic fatty liver disease (NAFLD) is closely associated with metabolic syndrome. NAFLD is considered a disease of no consequence. Data on the effect of NAFLD on renal dysfunction in T2DM is sparse. Author aimed to study the association of NAFLD with CKD in Indian T2DM subjects.Methods: In an observational cross-sectional study at Mahatma Gandhi Medical College and Hospital, Jaipur, Rajasthan, India from February 2017 to March 2018. 197 out of 268 randomly selected type 2 diabetes mellitus (T2DM) subjects were selected for the study after considering the inclusion and exclusion criteria. CKD was defined as estimated GFR <60 ml/min per 1.73 m2 and/or albumin to creatinine ratio ≥30 mg/g. NAFLD was diagnosed using ultrasonography. The association between NAFLD and CKD was analyzed using SPSS (version 24.0).Results: On ultrasonography 133 (67.5%) T2DM subjects had NAFLD. Diabetic with NAFLD (133, 67.51%) had significantly more history of hypertension (p 0.006), higher systolic (p 0.03) and diastolic BP (p 0.009), higher BMI (p <0.001), waist circumference (p <0.001), fasting glucose (p 0.03), triglyceride (p<0.001) and higher urinary albumin-to-creatinine ratio (p <0.001). Diabetics with CKD (61, 30.96%), were older (p 0.03), hypertensive (p <0.001) and had higher fasting glucose (p 0.003). Subjects with CKD had a higher prevalence of underlying NAFLD (78.69% vs 62.5%, p 0.03) as compared with diabetics with no CKD. T2DM subjects with NAFLD had more than two times (OR 2.88 (1.1-6.78), p 0.03) the risk of developing CKD after multivariate analysis as compared to subjects without NAFLD.Conclusions: NAFLD is a risk factor for development of CKD in patients of type 2 diabetes mellitus. Screening and early preventive measures may go long way in reducing morbidity.
RESUMO
Prokinetics are commonly used for Functional Dyspepsia (FD) and GastroEsophageal Reflux Disease (GERD). Aims and Objectives: To evaluate the safety and efficacy of cinitapride Extended-Release (ER) tablets versus conventional cinitapride Immediate-Release (IR) tablets for the treatment of FD and GERD. Materials and Methods: Patients with FD and GERD received either cinitapride ER 3 mg tablets OD or cinitapride IR 1 mg tablets TID for 4 weeks in this randomized, multicentre study. Change in the mean intensity score of gastrointestinal (GI) symptoms (overall and individual) at the end of the study and at each weekly follow up visit as compared to baseline, patients with complete resolution of GI symptoms, patients with > 50% reduction from baseline in overall intensity score, rescue medication use and overall efficacy were recorded. The safety variables were reported adverse events (AEs), laboratory parameters, electrocardiogram, and overall tolerability. Unpaired t test, chi square test or Fisher’s exact test were used for analysis. p < 0.05 was considered significant. Results: Total 218 patients were enrolled Cinitapride ER tablets were non-inferior (non-inferiority margin -2.5) to cinitapride IR tablets for the change in the mean overall GI symptom intensity score at the end of the study as compared to the baseline (treatment difference - 0.2 (95% CI: -2.2, 1.7)); also, no significant difference was found for other efficacy variables (p > 0.05). Eight AEs of mild-to-moderate intensity were reported. There was also no difference in the overall tolerability between the study groups (p = 0.875). Conclusions : Both the study treatments were comparable in terms of safety and efficacy for the treatment of FD and GERD.