Bhavesh Kotak

An observational, cross-sectional study to assess the prevalence of chronic kidney disease in type 2 diabetes patients in India (START -India).

Objective: The primary objective of this study is to estimate the prevalence of chronic kidney disease (CKD) among type 2 diabetes mellitus (T2DM) patients in India. Materials and Methods: This cross-sectional, observational, epidemiological, multi-center, study is enrolling T2DM patients of either gender aged 30 years or above. This study aimed to enroll a total of 3000 T2DM patients at 30 participating hospitals/clinics across India and the data from a planned interim analysis of 1500 patients are presented here. The primary endpoint of the study is to estimate proportion of T2DM patients with CKD (glomerular filtration rate [GFR] <60 ml/min/1.73 m2 or albumin creatinine ratio [ACR] ≥30 mg/g or ≥3 mg/mmol or both). Routine treatment, as administered by the treating physician, was continued without any study specific intervention. Patients’ data pertaining to demographic characteristics, medical history, current medication and physical examination were recorded. The blood/plasma and urine samples, were collected for estimation of hemoglobin A1c, microalbuminuria, serum creatinine, urine creatinine, and routine urine analysis. ACR was calculated from urine creatinine and albumin while GFR was estimated by using a modification of diet in the renal disease equation. Results: Study recruited 1500 patients from 18 centers across India. The study population included 840 (56.05%) males. Mean age, body mass index and systolic blood pressure were 55.1 years, 27.4 kg/m2 and 134.5 mmHg respectively. The mean duration of diabetes was 102.2 months. History of co-morbid diseases such as dyslipidemia, hypertension, microvascular complications and macrovascular complications was present in 657 (43.8%), 655 (43.7%), 268 (17.9%) and 104 (6.93%), respectively. This interim analysis revealed that about 46% of the T2DM patients had CKD (urinary albumin creatinine ratio (UACR) ≥30 mg/g and/or estimated GFR [eGFR] <60 mL/min/1.73 m2). The renal dysfunction as per eGFR criteria (<60 mL/min/1.73 m2) was reported in about 23% while as per UACR criteria (≥30 mg/g) it was reported in about 35% patients. Conclusion: This interim analysis results suggests that over 40% of T2DM patients have CKD. Despite this high number of T2DM patients with CKD, eGFR analysis shows there are almost 80% of T2DM patients still have reasonably good renal function (eGFR above 60 ml/min), which ensures less restrictions in selecting oral anti-diabetic drugs. Full study results from Start-India study will provide detail insights into the occurrence of CKD in patients with T2DM in India.

Prevalence of Chronic Kidney Disease (CKD) in Type 2 Diabetes Mellitus Patients: START-India Study

Objective: Despite rising incidence of diabetes in India, we currently lack country wide data on the prevalence of CKD in T2DM patients. Hence this nationwide study was planned. Methods: This was a nationwide, cross-sectional, observational, multi-centric study to assess prevalence of CKD among T2DM patients. The primary endpoint of the study was to estimate proportion of T2DM patients with CKD (glomerular filtration rate [GFR] <60 ml/min/1.73 m2or albumin creatinine ratio [ACR] ≥ 30 mg/g or ≥ 3 mg/mmol or both). The blood/plasma and urine samples, were collected for estimation of hemoglobin A1c, microalbuminuria, serum creatinine, urine creatinine, and routine urine analysis. Results: Of the 3043 screened subjects, 3000 eligible subjects were enrolled, out of which 46% were females. The mean age was 53.4 (± 11.9) years, with a mean body mass index of 27.3 (± 4.8) kg/m2. Both micro and macro vascular complications were reported. In the studied population with T2DM, 47.8% had mildly decreased, 15.1% had mild to moderately decreased, and 1.8% had severely decreased GFR respectively. As per ACR categorization, 61.3% had normal to mildly increased ACR, 25.6% with moderately increased and 7.2% with severely increased ACR were seen. We observed a significant (p<0.0001) weak negative correlation (-0.23069) between eGFR< 60 mL/ min/1.73 m² and urinary ACR in over six hundred patients. We found 48.4% prevalence of CKD in T2DM patients. The results on analysis of HbA1c goal achievement showed that the patients without CKD had a better success rate to achieve the target <7% goal of HbA1c compared to those who had CKD (29.6% vs. 23.4%). Conclusion: Study reported higher prevalence of CKD which was driven by the ACR levels and majority of the patients had reasonable eGFR. This can be a guide to select drug and dosage of diabetes drug as it depends on kidney function.

A Study to derive distribution of carotid intima media thickness and to determine its COrrelation with cardiovascular Risk factors in asymptomatic nationwidE Indian population (SCORE-India)

Background There is presently no data to describe normal distribution of carotid intima-media thickness (CIMT), an established measure of subclinical atherosclerosis, in Indian subjects. Methods In this multi-centric study, 1229 subjects with age ≥30 years and no previous cardiovascular disease (CVD) underwent CVD risk factor assessment and CIMT measurement. Mean far wall common carotid artery IMT was measured on both sides and averaged. Results Mean age of the subjects was 48.0 ± 12.0 years and 54.2% were men. CIMT measurement was feasible in 1157 subjects. Mean, median and 75th percentile values of CIMT for different age-groups were derived for men and women separately. There was a progressive increase in CIMT with increasing age (P < 0.001) and men had higher CIMT values than women (0.608 ± 0.12 mm vs. 0.579 ± 0.11 mm, P < 0.001). The CIMT values were also higher in diabetics (0.635 ± 0.10 mm) and hypertensives (0.624 ± 0.10 mm) as compared to non-diabetics (0.589 ± 0.12 mm, P < 0.001) and non-hypertensives (0.592 ± 0.12, P 0.02) respectively. Among continuous variables, age, systolic blood pressure and fasting blood glucose had strong to modest correlation with CIMT (Pearsons r 0.524, 0.282 and 0.192 respectively, all P values <0.001), whereas body mass index, diastolic blood pressure and serum triglycerides exhibited weak but still statistically significant relationship (Pearsons r 0.069, P 0.019; Pearsons r 0.065, P 0.026; and Pearsons r 0.094, P 0.001, respectively). Conclusions This is the first study to provide age- and gender-specific distribution of CIMT in Indian subjects free from CVD. This information should help facilitate further research and clinical work involving CIMT in India.

A multicentre retrospective study to understand anti-platelet treatment patterns and outcomes of acute coronary syndrome patients in India (TRACE).

BACKGROUND There is limited available information for treatment of acute coronary syndrome (ACS) with respect to outcomes, therapeutic agents and treatment practices. Our retrospective registry study collected and evaluated varying anti-platelet treatment strategies and outcomes of ACS patients who were admitted to 9 different tertiary care hospitals in India. This study was carried out to provide an insight to anti-platelet treatment patterns and analyze outcomes of ACS patients in India. METHODS All the relevant data, including anti-platelet treatment strategies, outcomes and patient treatment compliance were collected from 500 ACS (defined as STEMI, NSTEMI and unstable angina [UA]) cases from January 2007 to December 2009. These ACS cases were randomly collected from the hospital records and included in the analysis. The patient follow up data was acquired either from the hospital records or via telephonic contact for a period of one year following the event. RESULTS Out of 500 ACS patients, 59.8% had UA/NSTEMI and 40.2% had STEMI. On hospital admission, aspirin, clopidogrel, statins, beta-blockers and angiotensin converting enzyme inhibitors (ACE-Is) were used by 83%, 83%, 68%, 43.2% and 31.6% patients, respectively. On discharge, aspirin, clopidogrel, statins and beta-blockers were used by 90.2%, 88%, 80.6%, and 59% patients, respectively. The average patient compliance to statins, clopidogrel and aspirin was recorded as 74.28%, 69.7% and 68.66%, respectively during discharge and follow-up visits. Greater than 50% of ACS patients after discharge were lost to follow-up and as a result there was significant drop in the number of clinical events reported. CONCLUSION This pilot study conducted in tertiary care centers in India showed that patients with ACS were more often diagnosed with UA/NSTEMI as compared to STEMI and reported maximum compliance to statins, clopidogrel and aspirin after discharge over 1 year follow-up. More ACS patients were lost to follow up that resulted in low reporting of clinical outcomes, following discharge upto 1 year.