Impact of Mineralocorticoid Receptor Antagonists in the Treatment of Heart Failure: Targeting the Heart Failure Cascade.

Epidemiological data from the Indian subcontinent on the burden of Heart failure (HF) is scarce. Mineralocorticoid receptor antagonists (MRAs) are usually used in the management of HF and hypertension. A consortium of experts reviewed and opined on the pathophysiological role of aldosterone in HF and its cascading effects on the heart in terms of cardiac fibrosis, cardiac hypertrophy, and remodeling, increased propensity to cause arrhythmias in addition to its effect on sodium and water retention. This expert opinion document highlights the various mechanisms of action of MRAs. It provides clinical experience and practice-based expert opinion on the use of spironolactone and eplerenone in patients with HF. The role of MRAs in diabetic patients with HF has also been profiled.

Bempedoic Acid for Lipid Management in the Indian Population: An Expert Opinion.

Lipid-lowering is a central theme in the management of patients with atherosclerotic cardiovascular disease (ASCVD) and heterozygous familial hypercholesterolemia (HeFH), with statins being currently used as the first-line lipid-lowering agent (LLAs). Bempedoic acid (BA) has been recently approved for lipid management in ASCVD/HeFH patients. This expert opinion paper brings out the essential concept to assess the current place of BA in the Indian population. Here we highlight that the majority of the patients with clinical ASCVD may not be receiving the optimal dose of statin, thereby failing to achieve their lipid targets. The addition of BA to statin results in a significant reduction in low-density lipoprotein cholesterol (LDL-C) along with substantial reductions in non-high-density lipoprotein cholesterol (non-HDL-C), apolipoprotein B (ApoB), and high-sensitivity C-reactive protein (hsCRP) levels. For patients who do not achieve LDL-C targets, BA can be an effective add-on alternative to choose among non-statin LLAs. BA is a good choice for statin-intolerant cases, especially in combination with ezetimibe. Given the lack of effect of worsening hyperglycemia or any increase in the occurrence of new-onset diabetes, BA can be used without hesitation in patients with diabetes. The small risk of hyperuricemia could be mitigated with appropriate patient selection and monitoring of serum uric acid levels in patients at high risk of hyperuricemia. We believe BA is an excellent non-statin therapy that is efficacious, well-tolerated, and cost-effective for lipid management in ASCVD, HeFH, and statin-intolerant patients in India.

Exploring the Need and Benefits of Digital Therapeutics (DTx) for the Management of Heart Failure in India.

Indian heart failure (HF) registries consistently indicate high hospital readmissions and increased mortality rates after HF diagnosis. The challenges of Indian cardiologists in HF management include limited longitudinal data, frequent readmissions, low medication adherence, inadequate monitoring and follow-up, insufficient patient education, and lack of standard guidelines on cardiac rehabilitation. This article outlines the adoption of digital therapeutics (DTx) in HF management as a potential solution to address these challenges. DTx services offer improved medication adherence, early symptom identification, remote vital monitoring, timely intervention, patient education on symptoms, self-awareness, and lifestyle. Overall, DTx for HF comprises a dedicated team of cardiologists, health coaches, care managers, and globally certified connected devices to provide comprehensive and proactive monitoring, personalized coaching and support, behavioral engagement to improve adherence, emergency response system, delivery of medications and diagnostic tests at home, and a dedicated application for caregivers. DTx has the potential to enhance HF management in India.

Sirolimus-Coated Balloon With a Microsphere-Based Technology for the Treatment of De Novo or Restenotic Coronary Lesions.

BACKGROUND: Non stent-based local drug delivery with drug-coated balloon (DCB) is an alternative to drug-eluting stent with favorable clinical applicability in the treatment of selected coronary lesions. Our purpose was to report the initial performance, safety and efficacy evaluations of a novel sirolimus-coated balloon in the treatment of coronary lesions. METHODS: This was a phase I (first-in-man), prospective, multicenter, single-arm trial evaluating the novel SELUTION SLR™ DCB (M.A. Med Alliance SA, Nyon, Switzerland), which incorporates a polymeric microsphere-based technology for controlled and continuous release of sirolimus, in the treatment of de novo or restenotic lesions. RESULTS: A total of 56 patients/lesions were enrolled between November/2018 and March/2019. Diabetes was found in 46.6 %, and de novo lesions represented 79.6 % of cases. Device and procedural/clinical success were 100 % and 96.4 %, respectively. There was only one major adverse cardiac event (target lesion revascularization) reported at late follow-up. By quantitative coronary angiography analysis, mean % diameter stenosis was 30.5 ± 16.7 %, late lumen loss was 0.26 ± 0.45 mm and angiographic binary restenosis occurred in 4 of 45 cases at 6-month angiographic follow-up. CONCLUSION: The novel SELUTION sirolimus-coated balloon demonstrated safety and efficacy in the treatment of diseased coronary vessels, including absence of mortality and relatively low late lumen loss at late follow-up.

Sirolimus-coated balloon with a microsphere-based technology for the treatment of de novo or restenotic coronary lesions

BACKGROUND: Non stent-based local drug delivery with drug-coated balloon (DCB) is an alternative to drug-eluting stent with favorable clinical applicability in the treatment of selected coronary lesions. Our purpose was to report the initial performance, safety and efficacy evaluations of a novel sirolimus-coated balloon in the treatment of coronary lesions. METHODS: This was a phase I (first-in-man), prospective, multicenter, single-arm trial evaluating the novel SELUTION SLR™ DCB (M.A. Med Alliance SA, Nyon, Switzerland), which incorporates a polymeric microsphere-based technology for controlled and continuous release of sirolimus, in the treatment of de novo or restenotic lesions. RESULTS: A total of 56 patients/lesions were enrolled between November/2018 and March/2019. Diabetes was found in 46.6 %, and de novo lesions represented 79.6 % of cases. Device and procedural/clinical success were 100 % and 96.4 %, respectively. There was only one major adverse cardiac event (target lesion revascularization) reported at late follow-up. By quantitative coronary angiography analysis, mean % diameter stenosis was 30.5 ± 16.7 %, late lumen loss was 0.26 ± 0.45 mm and angiographic binary restenosis occurred in 4 of 45 cases at 6-month angiographic follow-up. CONCLUSION: The novel SELUTION sirolimus-coated balloon demonstrated safety and efficacy in the treatment of diseased coronary vessels, including absence of mortality and relatively low late lumen loss at late follow-up.

Effectiveness of Telmisartan on Blood Pressure Control in Hypertensive Patients in India: A Real-World Retrospective Study from Electronic Medical Records.

INTRODUCTION: The effectiveness of telmisartan has been reported in Indian clinical trials; however, real-world data are limited. We aimed to provide real-world evidence regarding the effectiveness of telmisartan as monotherapy or in combination with other antihypertensive drugs (AHDs) in Indian patients with essential hypertension. METHODS: Electronic medical record data of adult patients diagnosed with essential hypertension (≥ 140/90 mmHg) and who were prescribed telmisartan as mono- or add-on therapy were retrospectively analyzed. Patients were classified according to the number of AHD classes prescribed on initiating telmisartan. Change in systolic and diastolic blood pressure (SBP and DBP) after a month of treatment and the proportion of patients who achieved treatment goals according to the 2018 European Society of Cardiology/European Society of Hypertension guidelines were evaluated. RESULTS: A majority (90.6%) of the 1304 patients included in the study were on telmisartan monotherapy or telmisartan + 1 AHD. The mean (95% confidence interval [CI]) change in the telmisartan monotherapy group was SBP (-13.3 [-14.6, -12.0] mmHg) and DBP (-7.2 [-7.9, -6.5] mmHg), and the mean (95% CI) change in the telmisartan + 1 AHD group was SBP (-10.8 [-13.1, -8.5] mmHg) and DBP (-6.5 [-7.7, -5.3] mmHg) (P < 0.001 for all). SBP and DBP goals were achieved by 35.9% and 47.3% of patients on telmisartan monotherapy and by 35.9% and 46.8% of patients on telmisartan + 1 AHD. Among patients with comorbid diabetes, the mean (95% CI) change in the telmisartan monotherapy group was SBP (-13.3 [-15.0, -11.6] mmHg) and DBP (-7.3 [-8.2, -6.5] mmHg), and the mean (95% CI) change in the telmisartan + 1 AHD group was SBP (-13.0 [-16.5, -9.5] mmHg) and DBP (-6.9 [-8.7, -5.1] mmHg) (P < 0.001 for all). SBP and DBP goals were achieved by 31.7% and 39.7% of patients on telmisartan monotherapy and by 31.9% and 41.8% of patients on telmisartan + 1 AHD. CONCLUSION: Telmisartan may be a good candidate for blood pressure control in Indian patients with essential hypertension and comorbidities.

Left atrial appendage occlusion for ischemic stroke prevention in patients with non-valvular atrial fibrillation: clinical expert opinion and consensus statement for the Asian-Pacific region.

PURPOSE: To develop a consensus statement for left atrial appendage occlusion (LAAO) in Asian-Pacific patients with non-valvular atrial fibrillation (NVAF) at risk of ischemic stroke. The need for such a region-specific consensus was indicated by the relative paucity of clinical evidence for LAAO and oral anticoagulation therapy obtained in Asian-Pacific populations and the specific stroke and bleeding characteristics of this population. METHODS: Consensus was developed by discussion and evaluation of available evidence and expert opinions during a 2-day meeting attended by clinical experts from the Asian-Pacific regions. RESULTS: The consensus statement arrived at provides recommendations based on available evidence and expert opinions regarding LAAO in Asian-Pacific patients. Gaps in the evidence and other areas requiring further research were identified. CONCLUSION: LAAO is an alternative device-based therapy in carefully selected patients with NVAF at risk of ischemic stroke. However, evidence for LAAO is primarily obtained from Caucasian populations, and data on LAAO in Asian-Pacific patients are scarce. While the present consensus statement addresses several therapy-related aspects based on careful interpretation of available evidence and expert opinions, other areas require additional evidence derived from Asian-Pacific populations.

Consensus document: management of heart failure in type 2 diabetes mellitus.

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.

A questionnaire survey for improving awareness of rheumatic heart disease among school-aged children in India.

OBJECTIVES: We examined the level of awareness about Rheumatic Heart Disease (RHD) among school-aged children in a rural district of India and evaluated the effects of a questionnaire-based survey in improving the level of awareness. METHODS: The study involved 8,646 students aged 10-16 years from 20 schools in West Midnapore, India which was conducted in August 2017. We examined changes in the level of awareness of RHD using a 29-point scoring system in seven domains. The baseline questionnaire survey assessed students' knowledge and was followed by a multimedia presentation about RHD and a post-intervention survey using the same questionnaire. The questionnaire included 9 questions on different aspects of RHD including prevalence, nature of disease, symptoms, determinants, treatment options, impact of the disease and diagnosis. RESULTS: The mean age of the study population was 13 years and 46% were boys. At baseline, the mean level of knowledge about RHD was 42% (12.2 out of 29 points). After the school-based presentation, the score improved to a mean of 55% (15.9 points on the 29-point scale), a 31% relative improvement. Improvement in students' knowledge was noted across all seven domains, individually and combined (p < 0.001). CONCLUSIONS: Awareness among children in rural India about RHD is modest. A school-based intervention could help in improving awareness about this chronic condition and may promote secondary prophylaxis to reduce the morbidity and mortality from RHD.

Evaluation of the efficacy and safety of fexofenadine in the management of chronic idiopathic urticaria: a prospective study with 512 patients.

Five hundred and twelve patients with chronic idiopathic urticaria (CIU) were treated with fexofenadine at a dose on 180 mg/day. Maximum number of patients were between 20 to 40 years of age and female to male ratio was 1.45:1. The severity of itching was calculated on a scale of 0 to 4 and was recorded by the patients. The mean daily total symptom score (TSS) was measured as sum of the patients' pruritus and number of wheal scores (0 to 7). A mean TSS was determined for each week. Baseline TSS came down to '0' by 4 weeks in all groups except those with TSS 4. There was no correlation between the baseline TSS and degree of improvement. Of 512, 14 (2.73%) patients did not complete the study. The commonest adverse effect was headache (9.04%). There was no report of drowsiness or cardiac arrhythmia. In no patient fexofenadine had to be withdrawn because of its adverse effects.