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Kalra S.,Karnal Bharti Hospital | Deepak M.C.,Madhav Diabetes Center | Narang P.,MSD Pharmaceuticals Pvt. Ltd. | Singh V.,MSD Pty. Ltd. | And 2 more authors.
Diabetes Technology and Therapeutics | Year: 2013

Background: Individual sulfonylurea agents differ in pharmacokinetic properties and clinical effects. This study aimed to describe the usage pattern, glycemic improvement, hypoglycemia, and change in body mass index (BMI) observed with commonly used sulfonylureas. Subjects and Methods: Patients of either gender with type 2 diabetes mellitus (T2DM), between 18 and 75 years old and requiring addition of a sulfonylurea to an ongoing regimen of oral antihyperglycemic agent(s), were enrolled. Glycosylated hemoglobin (HbA1c) and BMI were assessed at both baseline and the end of 12 weeks of follow-up. The hypoglycemia score was assessed at the end of follow-up only. Results: In total, 1,069 patients were enrolled in the study, of whom 950 were considered evaluable. After a mean follow-up of 14.34±2.80 weeks, the HbA1c level decreased by 0.86±2.28%, BMI increased by 0.13±0.78 kg/m 2, and mean hypoglycemia score was 0.98±1.42. A weak negative, statistically significant correlation (r=-0.093; P=0.0044) between hypoglycemic scores and increase in BMI was observed. No correlation was observed between change in HbA1c level and change in BMI. Glimepiride was the most commonly prescribed sulfonylurea (75.3%). For patients on glimepiride, a weak positive, statistically significant correlation (r=0.098; P=0.0082) between its dose and the hypoglycemic score was observed. Conclusions: Various sulfonylurea agents appear to differ in their effect on glycemic control, tendency to cause hypoglycemia, and gain in BMI. Hypoglycemia caused by these agents appears not only to be dose related, but also correlates inversely with gain in BMI. © Copyright 2013, Mary Ann Liebert, Inc. 2013.

Namjoshi G.S.,MSD Pharmaceuticals Pvt Ltd | Mitra M.,Institute of Child Health | Lalwani S.K.,Bharati Vidyapeeth Medical College and Hospital | Sachdeva A.,Sir Gangaram Hospital | And 6 more authors.
Vaccine | Year: 2014

Burden of rotavirus gastroenteritis (RVGE) in outpatient setting in India is not fully understood. A prospective study was undertaken to describe RVGE among Indian children less than 5 years of age presenting in outpatient departments with acute gastroenteritis (AGE). This study was conducted at 11 outpatient departments (OPDs) of private pediatric clinics in urban areas of India. A total of 605 eligible children were enrolled at OPDs. Stool samples of the subjects were collected and tested for presence of rotavirus antigen by enzyme immune assay (EIA) and were typed by reverse-transcriptase polymerase chain reaction (RT-PCR). Physician examined the children and documented the disease particulars. In addition, parents/guardians were interviewed for AGE related symptoms, health care utilization and cost incurred due to AGE, and parental stress associated with AGE. After OPD, parents/guardians completed diary cards and questionnaires to capture the information for 14 days following the enrollment. Complete data for analysis including stool sample results was available from 552 subjects. 23% (127/552; [CI 19.5, 26.5]) of stool samples were rotavirus (RV) positive. RT-PCR was done for 85.8% (109/127) of RV positive samples. G1, G2, G9, and G12 types were identified in 34.9% (38/109), 37.6% (41/109), 8.3% (9/109), and 6.4% (7/109) stool samples, respectively. P[4] and P[8] were identified in 36.7% (40/109) stool samples each, followed by P[6] identified in 15.6% (17/109) stool samples. At the time of enrollment, all three symptoms (vomiting, diarrhea, and fever) were observed concurrently in higher proportion of RV positive subjects compared to RV negative subjects (60.6% [77/127] vs. 42.8% [182/425], p= 0.0004). Healthcare resource utilization, costs incurred due to disease, and parental stress were higher for RV positive subjects compared to RV negative subjects. In conclusion, RVGE was found to be a definite burden in AGE cases attending pediatric outpatient clinics in urban areas and it was associated with substantial economic and psychological burden. Introduction of rotavirus vaccine in India may help in reducing this disease burden. © 2014.

Kalra S.,Karnal Bharti Hospital | Deepak M.C.,Karnal Bharti Hospital | Deepak M.C.,Madhav Diabetes Center | Narang P.,Karnal Bharti Hospital | And 4 more authors.
Journal of Postgraduate Medicine | Year: 2014

Background: This study aimed to assess correlation between measures of hypoglycemia and glycemic control in patients with type 2 diabetes mellitus (T2DM) treated with sulfonylureas. Materials and Methods: T2DM patients being initiated on a sulfonylurea (SU) on background of a failing oral antihyperglycemic regimen were followed up for 12 weeks. (HbA1c) was measured at baseline and end of follow-up. Hypoglycemia was assessed using Stanford Hypoglycemia Questionnaire at week 12. Results: Of the total 1069 patients enrolled, 950 were considered evaluable. A weak negative correlation was observed between end of follow-up HbA1c values and hypoglycemia score, using both linear regression analysis (correlation coefficient -0.12; P = 0.0002) and negative binomial regression (β slope -0.09; P = 0.0010). A similar correlation was also observed between change in HbA1c from baseline and hypoglycemia score (β slope -0.07; P = 0.0048). Mean HbA1c reduction was lowest (0.65 ± 2.27%) in patients not reporting any hypoglycemia and highest (1.28 ± 2.40%) in patients with hypoglycemia score greater than median of 2 (P = 0.0031). There was no correlation between hypoglycemia frequency and end of follow-up HbA1c values (P = 0.4111). Conclusion: With addition of SU on a background of a failing oral anti-hyperglycemic regimen, the extent of glycemic control correlates directly with measures of patient reported hypoglycemia.

Shah D.,Gynaecworld and Gynaecworld Assisted Fertility Center | Puthran S.,MSD Pharmaceuticals Pvt. Ltd
Journal of Association of Physicians of India | Year: 2014

Context: Reference limits for diagnosing hyperinsulinaemia are currently derived from non-Indian cohorts and have not been validated in Indians even though it is acknowledged that different patterns of insulin secretion are seen across ethnicities. Aims: To develop ethnicity specific reference limits for insulin levels in a normoglycaemic healthy Indian cohort in order to derive a clinical cut off for hyperinsulinaemia as an effective screening tool for predicting future risk of metabolic and cardiovascular disease. Settings and Design: Prospective analysis of plasma insulin levels in healthy normoglycaemic volunteers availing diagnostic facilities at a central reference laboratory in Mumbai. Methods and Material: 122 normoglycaemic males between 19-73 years and 126 females between 19-55 years of age were selected based on a screening questionnaire as per the Clinical Laboratory and Standards Institute (CLSI) guidance document for deriving reference ranges. Fasting insulin levels were analysed using a Chemiluminescent Microparticle Immunoassay platform and derived results were analysed to determine reference limits for insulin. Statistical analysis used: A non- parametric method of statistical analysis was used to determine the 2.5 and 97.5% limits with 90% confidence intervals. Results: Reference range for insulin in a normoglycemic Indian cohort was derived as 2.7-17 uIU/ml which established 17 uIU/ml as the clinical cut off for diagnosing hyperinsulinemia in healthy Indians. Conclusions: Reference limits for insulin in normoglycemic Indians needs to be revised to 2.7-17 uIU/ ml. Clinical cut off for hyperinsulinemia needs to be lowered to 17 uIU/ml from currently used cut offs which range from 25-31 uIU/ml. Key Messages: Reference limits currently used for diagnosing hyperinsulinemia in healthy normoglycemic adults need to be revised and made specific for different ethnicities. In Indians the upper limit of the normal reference range for insulin levels needs to be brought down to 17 u IU/ml from the existing 25-31 u IU/ml. This modified cut off would help clinicians identify apparently healthy individuals who may need to be screened for a future risk of metabolic and cardiovascular disorders. © JAPI.

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