In patients with diabetes mellitus and coronary artery disease undergoing PCI, paclitaxel-eluting stents were not shown to be noninferior to everolimus-eluting stents, and they resulted in higher rates of target-vessel failure, myocardial infarction, stent thrombosis, and target-vessel revascularization at 1 year. (Funded by Boston Scientific; TUXEDO-India Clinical Trials Registry-India number, CTRI/2011/06/001830).
Critical limb ischemia (CLI) is the end stage of lower extremity peripheral vascular disease (PVD) in which severe obstruction of blood flow results in ischemic rest pain, ulcers and/or gangrene, and a significant risk of limb loss. This open-label, single-arm feasibility study evaluated the safety and therapeutic effectiveness of autologous bone marrow cell (aBMC) concentrate in revascularization of CLI patients utilizing a rapid point-of-care device. Seventeen (17) no-option CLI patients with ischemic rest pain were enrolled in the study. Single dose of aBMC, prepared utilizing an intraoperative point-of-care device, the Res-Q™ 60 BMC system, was injected intramuscularly into the afflicted limb and patients were followed up at regular intervals for 12 months. A statistically significant improvement in Ankle Brachial Index (ABI), Transcutaneous Oxygen Pressure (TcPO2), mean rest pain and intermittent claudication pain scores, wound/ ulcer healing, and 6-minute walking distance was observed following aBMC treatment. Major amputation-free survival (mAFS) rate and amputation-free rates (AFR) at 12 months were 70.6% and 82.3%, respectively. In conclusion, aBMC injections were well tolerated with improved tissue perfusion, confirming the safety, feasibility, and preliminary effectiveness of aBMC treatment in CLI patients.
Objective: Diabetic dyslipidemia is highly atherogenic as it is associated with high triglyceride (TG), high small dense low-density lipoprotein (sd-LDL) particles and low High-Density Lipoprotein Cholesterol (HDL-C). Saroglitazar, a dual peroxisome proliferator activated receptor agonist (predominant PPAR-α agonist and modest PPAR-γ agonist), is approved in India for the management of diabetic dyslipidemia. The GLIDDER study was done to evaluate the effects of Saroglitazar 4 mg on non HDL-C as the primary endpoint and sd-LDL particles as a secondary endpoint in diabetic patients with dyslipidemia. Methods: This study was a 24 weeks, prospective, multicentre, single arm study conducted in 104 patients with diabetic dyslipidemia (TG ≥ 200 mg/dL) inadequately controlled with diet, exercise, and statins. It was conducted from April 2015 to November 2017 at three Indian centres. All the selected patients were given Saroglitazar 4 mg once daily before breakfast for 24 weeks. Efficacy evaluations of non HDL-C (calculated as Total Cholesterol (TC) minus HDL-C) (primary endpoint) and other lipid parameters (sd-LDL particles, TC, TG, HDL-C) and glycemic parameters (glycosylated hemoglobin (HbA1c), fasting plasma glucose (FPG)) were conducted after 24 weeks and compared to the baseline levels. Results: Total 104 patients (22% female) with mean age of 59.1 ± 11.4 years were enrolled in this study. In the perprotocol population, there was a significant reduction in non HDL-C (from 142.3 ± 59.3 mg/dL (baseline) to 109.9 ± 45.5 mg/dL (week-24); p<0.0001) and sd-LDL (from 32.5 ± 11.3 mg/dL (baseline) to 25.9 ± 11.8 mg/dL (week-24); p<0.0001). There was a significant reduction in TG, TC, HbA1c, and FPG with a significant increase in HDL-C at week-24 from baseline levels (p<0.05). Conclusion: Saroglitazar effectively reduces non HDL-C and sd-LDL particles in patients with diabetic dyslipidemia.
The present paper reports differences between office blood pressure (BP) measurement (OBPM) and ambulatory blood pressure measurement (ABPM) in a large multi-centre Indian all comers' population visiting primary care physicians. ABPM and OBPM data from 27,472 subjects (aged 51 ± 14 years, males 68.2%, treated 45.5%) were analysed and compared. Patients were classified based on the following hypertension thresholds: systolic BP (SBP) ≥ 140 and/or diastolic BP (DBP) ≥90 mmHg for OBPM, and SBP ≥ 130 and/or DBP ≥ 80 mmHg for 24-h ABPM, and SBP ≥ 120 and/or DBP ≥ 70 mmHg for night-time ABPM and SBP ≥ 135 and/or DBP ≥ 85 mmHg for daytime ABPM, all together. White coat hypertension (WCH) was seen in 12.0% (n = 3304), masked hypertension (MH) in 19.3% (n = 5293) and 55.5% (n = 15,246) had sustained hypertension. Isolated night-time hypertension (INH) was diagnosed in 11.9% (n = 3256). Untreated subjects had MH relatively more often than treated subjects (23.0% vs. 14.8%, p < 0.0001; respectively). Females had higher relative risk (RR) of having WCH than males (RR 1.16 [CI 95, 1.07-1.25], p < 0.0001). Whereas, males had higher RR of MH than females (RR 1.09 [CI 95, 1.02-1.17] p < 0.01). INH subjects had lower average systolic and diastolic dipping percentages (0.7 ± 6.6/ 2.2 ± 7.9 vs. 9.0 ± 7.3/11.9 ± 8.5, p < 0.001) than those without INH. In conclusion, for diagnosis of hypertension there was a contradiction between OBPM and ABPM in approximately one-third of all patients, and a substantial number of patients had INH. Using ABPM in routine hypertension management can lead to a reduction in burden and associated costs for Indian healthcare.
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