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Background Saroglitazar, a novel dual peroxisome proliferator activated receptor (PPAR) agonist, in clinical trials, has shown an improvement in lipid and glycemic parameters through the PPAR-α and γ agonist actions, respectively. It was granted marketing authorization in India in 2013 for diabetic dyslipidemia. This review was conducted to summarize the effects of Saroglitazar in patients with diabetic dyslipidemia in real world clinical studies conducted after marketing authorization in India. Methods In this review, we selected real world clinical studies of Saroglitazar published as manuscripts and abstracts presented at scientific conferences. In all these studies, patients with diabetic dyslipidemia were treated with Saroglitazar 4 mg once daily for at least 12 weeks and different lipid and glycemic parameters were measured at the baseline and end of the study. Results In 18 selected studies (5 published manuscripts and 13 abstracts), a total of 5824 patients with diabetic dyslipidemia were prescribed Saroglitazar 4 mg for a duration ranging from 12 to 58 weeks. Across all the studies, mean age of patients ranged from 49.6 to 59.1 years and the proportion of female patients ranged from 22% to 42%. Across all the studies, there was a consistent mean reduction in triglyceride levels (~ 45% to 62%), total cholesterol levels (~ 17% to 26%), non-high-density lipoprotein cholesterol levels (~ 21% to 36%), low-density lipoprotein cholesterol levels (~ 11% to 27%), and glycosylated hemoglobin levels (~ 0.7% to 1.6%) with an increase in mean high-density lipoprotein cholesterol levels (up to 9%) from baseline to end of the study. Saroglitazar also improved alanine aminotransferase levels and fatty liver (evaluated by FibroScan™) in non-alcoholic fatty liver disease patients with diabetic dyslipidemia. Body weight remained unchanged and no significant adverse events (AEs) were reported in the studies. Conclusion Saroglitazar effectively improved lipid and glycemic parameters without significant AEs in patients with diabetic dyslipidemia in real-world clinical studies of up to 58 weeks duration.

In this trial, 1830 patients undergoing PCI were assigned to receive a paclitaxel-eluting or an everolimus-eluting stent. At 1 year, rates of target-vessel failure, MI, stent thrombosis, and target-lesion and target-vessel revascularization were higher with paclitaxel. Diabetes mellitus is a highly prevalent medical condition globally and is frequently associated with symptomatic coronary artery disease necessitating percutaneous coronary intervention (PCI). 1 There is, however, controversy regarding the choice of a drug-eluting stent in patients with diabetes. Fundamental to this debate is the finding that there is attenuation of the mammalian target of rapamycin (mTOR) signaling pathway in patients with type 2 diabetes, which suggests that stents eluting rapamycin (now called sirolimus) or its analogues (everolimus or zotarolimus) — often termed “limus-eluting” stents — could be less effective in this cohort, potentially making paclitaxel-eluting stents an attractive option. 2 It . . .

Type 2 diabetes mellitus (T2DM) is a known predisposing factor for heart failure (HF). The growing burden of these two conditions and their impact on health of the individual and on society in general needs urgent attention from the health care professionals. Availability of multiple treatment choices for managing T2DM and HF may make therapeutic decisions more complex for clinicians. Recent cardiovascular outcome trials of antidiabetic drugs have added very robust evidence to effectively manage subjects with this dual condition. This consensus statement provides the prevalence trends and the impact of this dual burden on patients. In addition, it concisely narrates the types of HF, the different treatment algorithms, and recommendations for physicians to comprehensively manage such patients.

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.

Diabetic patients respond less favorably to revascularization and have poorer long-term outcomes. Our main aim was to evaluate the angiographic efficacy of XIENCE V (everolimus-eluting stent, or EES) in diabetic patients compared with TAXUS Liberté (paclitaxel-eluting stent, or PES). The SPIRIT V Diabetic Study was a prospective, single-blind, randomized study that enrolled 324 diabetic (insulin and non–insulin dependent) patients at 28 sites in Europe and Asia Pacific. Randomization was 2:1 between EES (n = 218) and PES (n = 106). The primary end point was sequential noninferiority and superiority of EES for in-stent late loss at 9 months. Secondary clinical end points included stent thrombosis, death, myocardial infarction, and revascularization rates up to 1 year. Everolimus-eluting stent was superior to PES for in-stent late loss at 9 months (0.19 mm vs 0.39 mm, respectively; Psuperiority = .0001). The composite rate of death, myocardial infarction, and target vessel revascularization was the same in the 2 groups at 1 year (16.3% vs 16.4%). No stent thromboses (Academic Research Consortium definite and probable) were seen through 1 year with EES compared with 2 of 104 (2%) with PES (P = .11). In this prospective, randomized trial in a high-risk group of diabetic patients, implantation of EES compared with PES resulted in significantly better inhibition of intimal hyperplasia with a comparable safety outcome.

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.

Abstract Background Several past clinical studies have demonstrated that frequent and unnecessary right ventricular pacing in patients with sick sinus syndrome and compromised atrio-ventricular conduction (AVC) produces long-term adverse effects. The safety and efficacy of two pacemaker algorithms, Ventricular Intrinsic Preference™ (VIP) and Ventricular AutoCapture (VAC), were evaluated in a multi-center study in pacemaker patients. Methods We evaluated 80 patients across 10 centers in India. Patients were enrolled within 15 days of dual chamber pacemaker (DDDR) implantation, and within 45 days thereafter were classified to either a compromised AVC (cAVC) arm or an intact AVC (iAVC) arm based on intrinsic paced/sensed (AV/PV) delays. In each arm, patients were then randomized (1:1) into the following groups: VIP OFF and VAC OFF (Control group; CG), or VIP ON and VAC ON (Treatment Group; TG). Subsequently, the AV/PV delays in the CG groups were mandatorily programmed at 180/150 ms, and to up to 350 ms in the TG groups. The percentage of right ventricular pacing (%RVp) evaluated at 12-month post-implantation follow-ups were compared between the two groups in each arm. Additionally, in-clinic time required for collecting device data was compared between patients programmed with the automated AutoCapture algorithm activated (VAC ON) vs. the manually programmed method (VAC OFF). Results Patients randomized to the TG with the VIP algorithm activated exhibited a significantly lower %RVp at 12 months than those in the CG in both the cAVC arm (39±41% vs. 97±3%; p =0.0004) and the iAVC arm (15±25% vs. 68±39%; p =0.0067). In-clinic time required to collect device data was less in patients with the VAC algorithm activated. No device-related adverse events were reported during the year-long study period. Conclusions In our study cohort, the use of the VIP algorithm significantly reduced the %RVp, while the VAC algorithm reduced in-clinic time needed to collect device data.

In this placebo-controlled trial, 7119 patients were randomly assigned at 3 months after PCI to either receive ticagrelor alone or continue dual therapy with ticagrelor plus aspirin. The trial evaluated bleeding and ischemic end points at 1 year.

At a median of 2.2 years, patients with stable coronary artery disease and advanced kidney disease who were treated with an invasive strategy of coronary angiography with revascularization if indicated did not have a lower risk of death or MI than those who were treated with a conservative strategy of medical therapy alone.