Glenmark_ACC Conference Booklet_Apr 2021_Day 2_final - Smita

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ACC2021 ON-AIR th th May 15 -17 , 2021 Day-2 Day - 2 Sunday, 16th May 2021 REDUCTIONS IN TOTAL ISCHEMIC EVENTS WITH RIVAROXABAN IN PATIENTS WITH SYMPTOMATIC PAD AFTER REVASCULARIZATION: THE VOYAGER PAD TRIAL Bauersachs R, presented a study in a session at limb ischemia, major amputation due to a vascular the American College of Cardiology (ACC) 2021 aetiology, myocardial infarction, ischemic stroke, scientific sessions: virtual congress. Lower or CV mortality was the main objective. A shared extremity revascularization (LER) patients with log-normal frailty model was used to estimate peripheral arterial disease (PAD) are at a hazard ratios in the current total events study. significant risk of significant adverse limb and There were 1,092 initial and 522 subsequent cardiovascular (CV) events. In the vascular primary events among 6,564 randomised outcomes study of acetylsalicylic acid (ASA) individuals. Rivaroxaban reduced the number of along with Rivaroxaban in endovascular or initial incidents by 15% (HR 0.85, 95% CI 0.76 - surgical limb revascularization for peripheral 0.96, p=0.0085; 76 first events avoided). artery disease (VOYAGER PAD) trial, Rivaroxaban also decreased the total number of Rivaroxaban 2.5 mg twice daily plus Aspirin was incidents (HR 0.82, 95% CI 0.71 - 0.94, p=0.0049; found to lower first occurrences by 15% 124 total events avoided). The overall number of compared to Aspirin alone. events avoided with Rivaroxaban 2.5 mg twice day The VOYAGER PAD study assigned PAD patients with Aspirin in patients with symptomatic PAD receiving LER to Rivaroxaban 2.5 mg twice day undergoing LER was nearly double the number of or placebo on a background of Aspirin 100 mg initial events avoided. daily in a double-blind, placebo-controlled study. Time to first event in a composite of acute When compared to Aspirin alone, Rivaroxaban 2.5 mg twice daily with Aspirin lowers first and subsequent adverse limb and cardiovascular events, with an even higher overall benefit when all events are included. It should also be considered as an additional treatment following LER to lessen the severity of the first and recurrent unfavourable consequences. Day - 2 Sunday, 16th May 2021 EFFICACY AND SAFETY OF RIVAROXABAN IN ELDERLY PATIENTS WITH SYMPTOMATIC PAD UNDER GOING REVASCULARIZATION: INSIGHTS FROM VOYAGER PAD Krantz M, presented a study in a session at the Thrombolysis in Myocardial Infarction (TIMI) major American College of Cardiology (ACC) 2021 bleeding (TMB), were evaluated in people aged 75 scientific sessions: virtual congress. and up. Rivaroxaban 2.5 mg BID plus aspirin lowers 1330 (or 20%) of the 6564 people who were ischemic damage and improves bleeding in randomly assigned were over the age of 65. PEP patients with symptomatic peripheral artery (23.4% vs. 19.0%) and TMB (3.5% vs. 1.5%) ratios disease (PAD) who need revascularization (6:1 were higher in the elderly vs. non-elderly patients benefit-risk ratio). Both ischemic and bleeding randomised to placebo at 3 year KM. Rivaroxaban's cases are more common in elderly patients. PEP (p-interaction 0.83) benefits and TMB In this population, the risk-benefit ratio of low- protection (p-interaction 0.38) were similar across dose rivaroxaban combined with aspirin is age groups. PEP gains (absolute risk reduction uncertain. [ARR] 3.8%, number needed to treat [NNT] 26) The primary endpoint (PEP) of acute limb were not outweighed by TMB (absolute risk ischemia, major amputation, myocardial increase [ARI] 0.81%, number needed to harm infarction, ischemic stroke, or coronary [NNH] 123) in the elderly. mortality, as well as the principal safety result of Elderly patients did not experience any additional pain, but they did experience numerically larger absolute benefits. This suggests that, regardless of age, Rivaroxaban can be considered in PAD patients following revascularization. Day - 2 Sunday, 16th May 2021 SAFETY OF CLOPIDOGREL VERSUS TICAGRELOR IN STABILIZED PATIENTS WITH ACUTE MYOCARDIAL INFARCTION AFTER PERCUTANEOUS CORONARY INTERVENTION: TALOS-AMI TRIAL Chang K, presented a study in a session at the mortality, MI, stroke, or bleeding type 2, 3, or 5 American College of Cardiology (ACC) 2021 according to Bleeding Academic Research scientific sessions: virtual congress. Consortium (BARC) criteria. In the intention to The ischemic risk is higher in the early stages of treat population (ITT) population, a non-inferiority percutaneous coronary intervention (PCI) for test was conducted first, followed by a superiority acute myocardial infarction (AMI), although the test if the difference was substantial. bleeding risk is still significant throughout the A total of 2697 patients were allocated to one of maintenance phase. two groups: Clopidogrel (1349 patients) or Patients were randomly allocated to either Ticagrelor (1349 patients) (1348 patients). Aspirin 100 mg plus Clopidogrel 75 mg daily The main objectives were met in 59 patients (4.8%) Clopidogrel or aspirin 100 mg plus Ticagrelor 90 in the Clopidogrel group and 104 patients (8.5%) in mg twice daily in a 1:1 ratio in this multicentre, the Ticagrelor group after one year (p<0.001 for randomised, open-label trial enrolling AMI non-inferiority, p<0.001 for superiority). patients with no adverse events during the first The Ticagrelor group had a considerably higher risk month following an index PCI. From 1 to 12 of bleeding (p = 0.001), but there was no change in months following an index PCI, the main the ischemia risk (p = 0.149). outcome was a composite of cardiovascular The de-escalating DAPT method switching from Ticagrelor to Clopidogrel at 1 month significantly lowered the likelihood of net clinical outcomes in stable AMI patients, owing to a decrease in bleeding. Day - 2 Sunday, 16th May 2021 ENDOVASCULAR ULTRASOUND RENAL DENERVATION TO TREAT HYPERTENSION RESISTANT TO A FIXED DOSE TRIPLE MEDICATION PILL: THE RANDOMIZED SHAM-CONTROLLED RADIANCE-HTN TRIO TRIAL Kirtane A, presented a study in a session at the (N=67). At two months, urine samples revealed American College of Cardiology (ACC) 2021 that adherence to the combo tablet was above scientific sessions: virtual congress. 80%. In the ITT population, RDN (-8.0 mmHg vs. - Endovascular renal denervation (RDN) lowers 3.0 mmHg; median between-group difference -4.5 blood pressure (BP) in individuals with mild- mmHg; 95% CI -8.5 to -0.3 mmHg, adjusted moderate hypertension, but its BP-lowering p=0.022) lowered dASBP more than the sham efficacy in individuals with resistant treatment (-8.0 mmHg vs. -3.0 mmHg; median hypertension has yet to be shown. between-group difference -4.5 mmHg; 95% CI. The reduction in dASBP was -9.7 mmHg in the RDN In a multicenter, blinded, randomised, sham- group (n=63) vs. -3.0 mmHg in the sham group controlled trial, patients with resistant (n=67) among participants with ambulatory BP hypertension to at least three antihypertensive data at baseline and follow-up; median difference - medicines, including a diuretic, were included. 5.8 mmHg; 95% CI -9.7 to -1.6 mmHg, adjusted Subjects with daytime ambulatory BP of 135/85 p=0.005. In the ITT group, RDN lowered 24-hour mmHg were randomised to ultrasound RDN or SBP more than sham (median difference -4.2 a sham treatment after 4 weeks of this mmHg; 95% CI -8.3 to -0.3 mmHg, adjusted standardised treatment. The change in daytime p=0.016), with similar reductions in nighttime ambulatory systolic blood pressure (dASBP) in (p=0.044) and office (p=0.037). The RDN group had the intention-to-treat (ITT) group at 2 months one access site pseudo aneurysm, no renal artery was the main outcome. stenosis, and no change in renal function across A total of 136 people were randomly assigned groups after two months. to either the RDN (N=69) or the sham treatment In participants with resistant hypertension to a standardised single pill combination of 3 guideline-recommended medications, ultrasound RDN safely decreased BP when compared to a sham procedure. Day - 2 Sunday, 16th May 2021 A NOVEL PHYSICAL REHABILITATION INTERVENTION FOR OLDER PATIENTS WITH ACUTE DECOMPENSATED HEART FAILURE: THE REHAB-HF TRIAL Kitzman DW, presented a study in a session at and were frail or pre-frail in 97% of cases. the American College of Cardiology (ACC) 2021 The intervention's adherence (87%) and retention scientific sessions: virtual congress. NIH-funded (91%) were both excellent. There were rather multi-center, randomised, controlled trial of a considerable gains in SPPB of 1.5+0.4 units unique, transitional, customised, progressive, (p<0.001) in the intervention group compared to multi-domain (strength, balance, mobility, the control group at 3-month follow-up, as well as endurance) rehabilitation intervention that other clinically significant outcomes: 6-minute begins soon after hospital admission for ADHF walk distance (+34+11 m; p=0.003), Fried frailty and lasts for 36 sessions beyond release. criteria (-0.3+0.1; p=0.03), Kansas City The primary outcome was the SPPB score, a Cardiomyopathy Questionnaire overall score standard, validated measure of physical (+7+3 units; p=0.007), and Geriatric Depression function in frail older people that was examined Survey-15 score (-0.7+0.3 units; p=0.018). by blinded observers after three months. 6- Both the maintained and lowered EFs showed month all-cause rehospitalizations were the significant improvements. There were no primary secondary outcome. significant differences in all-cause rehospitalizations (194 vs 213; p=0.32), HF A total of 349 patients were included, ranging in rehospitalizations (94 vs 110; p=0.69), or fatalities age from 60 to 99 years old, with 52% of them (21 vs 16; p=0.64) at 6-month follow-up compared being women, 49% being non-white, and 53% to control. Three potentially associated significant having a maintained ejection fraction (EF). adverse events occurred, all of which were self- Patients had severely reduced physical function limited. at the start, had an average of 5 co-morbidities, In a varied sample of older patients hospitalised for ADHF, independent of EF, a unique, early, tailored, progressive, multi-domain physical rehabilitation intervention was safe and resulted in considerable gains in physical function, frailty, quality of life, and depression. Day - 2 Sunday, 16th May 2021 FRACTIONAL FLOW RESERVE-GUIDED VERSUS ANGIO-GUIDED MULTIVESSEL REVASCULARIZATION IN ST-ELEVATION MYOCARDIAL INFARCTION PATIENTS: THE FLOWER-MI RANDOMIZED TRIAL Puymirat E, presented a study in a session at the revascularization. Secondary outcomes were cost- American College of Cardiology (ACC) 2021 effectiveness and cost utility after a year. scientific sessions: virtual congress. The average age was 62.11 years; with 83% of men A randomised, multicenter (40 locations in having diabetes and 16% having an anterior MI. France) experiment was done in 1171 patients PCI was performed on non-culprit lesions in 96.2% who had successful initial percutaneous of cases during a phased procedure. In the angio- coronary intervention (PCI) and 50% stenosis in guided group, the number of operations was 1 additional non-culprit lesion appropriate for 2.48±0.85, while in the FFR-guided group, it was PCI. 2.07±0.99. The average length of follow-up was 12 Patients were randomly assigned to have either months, with 6 patients (0.5%) missing out. Almost full revascularization of non-infarct-related 4.2 events of Major Adverse Cardiac Events arteries guided by fractional flow reserve (FFR) (MACE) were reported in the angio-guided group (590 patients) or angiography (581 patients). vs. 5.5 in the FFR-guided group. 1.7 events of MI Non-culprit lesions PCI was performed at the was reported in the angio-guided group vs. 3.1 in index operation or during a staged procedure the FFR-guided group. Angio-guided PCI provides before discharge (5 days). At 12 months, the higher benefit in cost effectiveness and cost utility primary outcome was a composite of all-cause than the FFR-guided group. mortality, nonfatal myocardial infarction (MI), and unexpected hospitalisation with urgent When compared to the angio-guided group, FFR-guided PCI of non-infarct-related lesions has no effect on the risk of mortality, reinfarction, or urgent revascularization after one year. Day - 2 Sunday, 16th May 2021 ASPIRIN VS. CLOPIDOGREL DURING CHRONIC MAINTENANCE MONOTHERAPY AFTER PERCUTANEOUS CORONARY INTERVENTION: THE HOST EXAM RANDOMIZED CONTROLLED TRIAL Kim H, presented a study in a session at the myocardial infarction, stroke, readmission owing American College of Cardiology (ACC) 2021 to acute coronary syndrome, and serious bleeding scientific sessions: virtual congress. After events (defined as Bleeding Academic Research percutaneous coronary intervention (PCI), Consortium class 3 events). guidelines recommend 6- to 12-months of dual From March 2014 to May 2018, a total of 5,436 antiplatelet treatment (DAPT). However, patients from 37 sites were randomly allocated beyond the DAPT length, the best single and had the following profiles: mean age antiplatelet drug is unknown. 63.5±10.7 years, 74.5% of whom were male, 34.2% This research is a multicenter, prospective, of whom had diabetes, and 12.7% of whom had randomised, open-label, comparative efficacy chronic renal disease. At 2 years, Group X had a experiment. Patients with no clinical events for lower rate of the major composite endpoint (6.1% 12 to 6 months after index PCI were randomly vs. 8.2 Hazard ratio 0.73, 95% confidence interval allocated to either the Aspirin or Clopidogrel 0.60 to 0.90, p=0.004) than Group Y 6.1% vs. 8.2%, monotherapy group in a 1:1 ratio. The working Hazard ratio 0.73, 95% confidence interval 0.60 to hypothesis is that in 1-year event-free patients 0.90, p=0.004). In Group X, both thrombotic and following PCI, long-term antiplatelet severe bleeding events (cardiac mortality, nonfatal monotherapy with Clopidogrel will have better myocardial infarction, stroke, readmission due to outcomes than Aspirin. acute coronary syndrome, and stent thrombosis) were considerably lower than in Group Y. At 2 years following randomization, the primary objective is composite clinical events, which are defined as all-cause mortality, non-fatal Clopidogrel monotherapy compared to Aspirin significantly decreased the risk of adverse clinical events in chronic maintenance monotherapy after 1 year of DAPT after PCI. Day - 2 Sunday, 16th May 2021 HUMAN VS. MACHINE LEARNING-BASED ECHOCARDIOGRAPHY ANALYSIS AS PREDICTOR OF OUTCOMES IN ACUTE COVID-19 PATIENTS: FROM THE WORLD ALLIANCE SOCIETIES OF ECHOCARDIOGRAPHY COVID STUDY Asch FM, presented a study in a session at the Volumes, ejection fraction, and global longitudinal American College of Cardiology (ACC) 2021 strain (GLS) of the left ventricle (LV), as well as GLS, scientific sessions: virtual congress. The goal of free wall strain (RVFWS), and dimensions of this multinational study is to investigate the the right ventricle (RV), were all examined. cardiac phenotype of COVID-19 individuals with The researchers used multivariate data to assess acute cardiac illness and to find clinical and echocardiographic factors that echocardiographic markers that predict clinical predicted mortality and LV/RV recovery. The echo- outcomes. Machine learning-derived cardiographers' reproducibility and predictive algorithms (ML) for automated echo analysis, value were compared to that of ML echo analysis. which have less reader variability, may give Almost 46.2% were in the intensive care unit, superior predictive value than expert readers, 27.1% were on a ventilator, and 22.2 % died in the according to the hypothesis. hospital. In-hospital mortality was predicted Researchers investigated at 870 individuals independently by age, prior lung illness, lactate with acute COVID-19 who had undergone dehydrogenase (LDH), LV global longitudinal transthoracic echocardiograms in four different systolic strain (LVGLS) and RVFWS (all p<0.05). globe areas (Asia, Europe, the United States, In-hospital all-cause mortality was reported by and Latin America) (echo). A 3-6 month follow- almost 21.6%. LV LS was linked to in-hospital death up was done, including echo in a subset. as compared to LVEF. All echoes were analysed twice by experienced echo-cardiographers, once using automated ML and once by professional echo- cardiographers. When the data were pooled, LV LS and RVFWS, as well as age, LDH, and prior lung illness, were all shown to be independently linked with in-hospital mortality, although LVEF was not. Day - 2 Sunday, 16th May 2021 IMPACT OF TICAGRELOR MONOTHERAPY AFTER 3-MONTH DUAL ANTIPLATELET THERAPY IN ACUTE CORONARY SYNDROME BY HIGH BLEEDING RISK: A POST HOC ANALYSIS OF THE RANDOMIZED TICO TRIAL Lee Y, presented a study in a session at the 453 (15.2%) of the 2980 patients with acute American College of Cardiology (ACC) 2021 coronary syndrome (ACS) who had no adverse scientific sessions: virtual congress. When events in the first three months following choosing an antiplatelet therapy approach, it's operation were HBR by ARC-HBR criterion, and 504 important to identify patients with a high (16.9%) were HBR by PRECISE-DAPT ranking. bleeding risk (HBR). HBR patients had a higher primary outcome rate than non-HBR patients (HR=2.87, 95% CI=1.76- HBR was described as meeting ARC-HBR 4.69, p<0.001; by PRECISE-DAPT score: HR=3.09, (Academic Research Consortium for High 95% CI=1.92-4.98, p<0.001). Ticagrelor Bleeding Risk) criteria or having a PRECISE-DAPT monotherapy after 3- month dual antiplatelet (Predicting Bleeding Complications in Patients therapy (DAPT) was superior to ticagrelor-based U n d e rg o i n g S t e nt I m p l a nta t i o n a n d 12-month DAPT regardless of HBR by ARC-HBR Subsequent Dual Antiplatelet Therapy) score of criteria, with similar magnitudes of therapy effect 25 in this post hoc review of the TICO trial. (p=0.400) for HBR and non-HBR patients. A 3-12 month net adverse health occurrence The PRECISE-DAPT score (p=0.178) verified the was the primary outcome (composite of findings. major bleeding and adverse cardiac and cerebrovascular events). Ticagrelor monotherapy after 3-month DAPT was associated with better clinical results in ACS patients, independent of HBR, with no difference in the magnitudes of therapy impact between HBR and non-HBR. Day - 2 Sunday, 16th May 2021 TICAGRELOR MONOTHERAPY AFTER PERCUTANEOUS CORONARY INTERVENTION IN HIGH-RISK PATIENTS WITH OR WITHOUT HISTORY OF MYOCARDIAL INFARCTION: A PRESPECIFIED TWILIGHT SUBSTUDY Chiarito M, presented a study in a session at the ratio (HR) 0.50; 95% confidence interval (CI) 0.33- American College of Cardiology (ACC) 2021 0.76) to a consistent extent as that seen without scientific sessions: virtual congress. Patients prior MI (n = 4595, 4.2% vs. 7.0%; HR 0.58; 95% CI who have had an acute myocardial infarction 0.45-0.76; p = 0.54). Rates of death, MI, or stroke (MI) are more likely to have another ischemic among those with (5.9% vs. 5.5%; HR 1.07; 95% CI occurrence. The best antithrombotic 0.74-1.55) and without prior MI (3.0% vs. 3.4%; HR treatments for these patients are still unknown. 0.89; 95% CI 0.64-1.23) were similar between The impact of prior MI on the treatment effect treatment arms (p = 0.47). of Ticagrelor monotherapy versus Ticagrelor Patients with a previous MI (n= 1937; 29.7%) had a plus Aspirin in terms of Bleeding Academic higher risk of ischemic incidents than those Research Consortium (BARC) type 2, 3, 5 without (5.7 vs. 3.2%, p<0.001) for 6532 (primary outcome) and the composite of all- randomised patients. Ticagrelor monotherapy cause death, MI, or stroke was assessed in this reduced BARC 2, 3, or 5 bleeding to the same pre-specified sub analysis from the Ticagrelor degree in patients with prior MI (3.4% vs. 6.7%; With Aspirin or Alone in High Risk Patients After hazard ratio (HR) 0.50; 95% Cl 0.33-0.76) as in Coronary Intervention (TWILIGHT) trial (key those without prior MI (n = 4595, 4.2% vs. 7.0%; secondary outcome). HR 0.58; 95% Cl 0.45-0.76; p = 0.54). Death, MI, Among 6532 randomized patients, patients and stroke rates were close between care arms with a prior MI (n= 1937; 29.7%) had a higher (p = 0.47), with (5.9% vs. 5.5%; HR 1.07; 95% CI rate of ischemic events compared to those 0.74-1.55) and without previous MI (3.0% vs. 3.4%; without (5.7 vs. 3.2%, p<0.001). Ticagrelor HR 0.89; 95% CI 0.64-1.23). monotherapy reduced BARC 2, 3, or 5 bleeding in patients with prior MI (3.4% vs. 6.7%; hazard In patients with and without previous MI, Ticagrelor monotherapy greatly decreased clinically related bleeding relative to Ticagrelor plus Aspirin without compromising ischemic case avoidance. Day - 2 Sunday, 16th May 2021 TRENDS IN ANTICOAGULATION PRESCRIPTION SPENDING AMONG MEDICARE PART D AND MEDICAID BENEFICIARIES BETWEEN 2014 AND 2018) Duvalyan A, presented a study in a session at DOAC usage grew dramatically in both Medicare the American College of Cardiology (ACC) 2021 and Medicaid between 2014 and 2018, with total scientific sessions: virtual congress. claims growing by 194% (5.5 to 16.1 million) and 405% (293,000 to 1.5 million) correspondingly. For many cardiovascular disorders, direct oral In Medicare, claims for Warfarin fell by 28% (17.1 anticoagulation (DOAC) has become the first- to 12.3 million) and by 21% (1.7 to 1.3 million) in line treatment. As a result, researchers look at Medicaid. Between 2014 and 2018, Medicare and current anticoagulant (AC) use and expense Medicaid paid $24.2 billion on AC, with $18 billion patterns in Medicare and Medicaid. going to DOACs. In 2018, Medicare spent $15 on Using the Medicare Part D Prescription Drug warfarin, $549 on Apixaban, $569 on Rivaroxaban, Event Dataset, Part D Prescriber Use File, and and $466 on Edoxaban per claim. The total out-of- Medicaid Spending and Utilization Dataset, a pocket payments for DOACs for Medicare patients retrospective research of 5 classes of AC grew from $228 million to $733 million between treatments covered by Medicare Part D and 2014 and 2017. Medicaid was conducted between 2014 and 2018. Changes in overall expenditures, claims, and average expenditure per claim were determined. DOACs are becoming increasingly popular, indicating a move toward higher-quality but more costly AC. These growing expenses may place a financial strain on the health-care system and consumers, necessitating further efforts to guarantee that access are not limited by cost. Day - 2 Sunday, 16th May 2021 COMPARISON OF STANDARDIZED TREATMENT EFFECT SIZES FOR INVASIVE ANDNON-INVASIVE ENDPOINTS IN PULMONARY ARTERIAL HYPERTENSION: INSIGHTS FROM THE REPAIR STUDY Kiely DG, presented a study in a session at the and cardiac index [RHC]; and weeks 26 and 52 in American College of Cardiology (ACC) 2021 6 minute walk distance (6MWD) and NT-proBNP scientific sessions: virtual congress. Invasive were all measured. and non-invasive measures can be used to The median age of the safety group (N=87) at track the progression of pulmonary arterial enrolment was 45 years, 81% of whom were hypertension (PAH). In the REPAIR trial, female, and 55% of whom had idiopathic PAH. researchers evaluate standardised treatment Macitentan was started as a monotherapy (25%) effect sizes (STES) of cardiac index (cMRI), or as a sequential combination (36%) on top of a hemodynamic, and functional outcomes. stable background phosphodiesterase type-5 REPAIR was a 52-week, multicenter, open-label, inhibitor (PDE5i) or as an initial combination with single-arm, phase 4 research that looked at the PDE5i (39%). At all timepoints tested, moderate effects of Macitentan 10 mg on right ventricular STES (Cohen's d 0.5-0.79) were seen for change (RV) remodelling in PAH patients. Changes in RV from baseline in 6MWD, and significant STES stroke volume, RV ejection fraction, left (Cohen's d =0.8) for all other parameters (Figure). ventricular (LV) stroke volume, and cardiac index [cMRI]; week 26 in PVR, stroke volume, The sensitivity to treatment impact of cMRI measures and NT-proBNP in the REPAIR research was equivalent to hemodynamic endpoints and larger than 6MWD change. At weeks 26 and 52, the changes were constant. The utility of non-invasive cMRI and NT-proBNP measures in assessing PAH treatments is supported by these findings. An Educational Initiative by ACC-2021/UPDATE/17052021/1425 For the use of a Registered Medical Practitioner or a Hospital or a Laboratory only. Developed and Designed by Disclaimer: The scientific content of this publication has been designed and developed by Carbon Brand Solutions for educational purpose through monetary assistance of Glenmark Pharmaceuticals Limited. 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