The Indian registry on current patient profiles & treatment trends in hypertension (RECORD): One year interim analysis.

Background & objectives: In India, hypertension constitutes a significant health burden. This observational, non-interventional, prospective study was conducted in five centres across India to evaluate the current clinical practices for the management of hypertension. Methods: Participants were enrolled if they were newly diagnosed with essential hypertension or had pre-existing hypertension and were on the same therapeutic plan for the previous three months. At baseline, three months, six months, and one year, information on the patient and their treatment regimen was documented, and their quality of life (QoL) was evaluated. Results: A total of 2000 individuals were enrolled in this study, with a mean age of 54.45 yr. Of these, 55.7 per cent (n=1114) were males, and 957 (47.85%) were newly diagnosed with hypertension, while 1043 (52.15%) had pre-existing hypertension. Stage 2 hypertension (systolic blood pressure (BP) >140 or diastolic BP ≥90 mmHg) accounted for more than 70 per cent of the participants (70.76% of pre-existing and 76.29% of newly diagnosed); the average duration of pre-existing hypertension was 68.72 months. Diabetes (31.6%) and dyslipidaemia (15.8%) were the most common comorbidities. In 43.3 per cent of the participants, monotherapy was used, and in 56.7 per cent (70.55% fixed-dose combination), combination therapy was used. Telmisartan (31.6%), amlodipine (35.2%), and a combination of the two (27.1%) were the most commonly prescribed treatment regimens. At three months, six months, and one year, treatment modifications were observed in 1.4, 1.05, and 0.23 per cent of the participants receiving monotherapy and 2.74, 4.78 and 0.35 per cent receiving combination therapy, respectively. In both groups, the proportion of individuals with controlled hypertension (≤140/90 mmHg) increased by more than 30 per cent after a year. At one year, physical and emotional role functioning, social functioning, and health improved considerably. Interpretation & conclusions: Combination therapy for hypertension is increasingly preferred at the time of initial diagnosis. The efficacy, safety, and tolerance of the recommended medications were reflected by improvements in the QoL and the minimal changes in the therapeutic strategy required.

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.

The Indian REgistry on Current Patient PrOfiles and TReatment TrenDs in Hypertension (RECORD): Final Outcomes of the Real-world Observational Study.

Objectives: The Indian Registry on Current Patient Profiles and Treatment Trends in Hypertension (Record) evaluated the current trends and outcomes related to hypertension (HTN) management at 3, 6, 12, and 24 months in India. This study highlights and evaluates the outcomes and trends noted at 24 months. Materials and methods: The detailed study methodology is provided in the earlier publication (interim analysis at 12 months). Aspects such as changes in the quality of life (QOL), percentage of patients reaching target blood pressure (BP), treatment pattern among patients with comorbid conditions, and difference in treatment patterns between public and private healthcare settings, at 24 months, were evaluated in the current study. Results: The study population included 2,000 patients (55.7% males) with a mean age of 54.45 years. Telmisartan (43.7%) and amlodipine + telmisartan (16.4%) were the most prescribed monotherapy and combination therapy among patients with newly diagnosed HTN. A significant decrease in both systolic BP (SBP) and diastolic BP (DBP) was noted in the overall patient population at 24 months (p < 0.001). The mean change in SBP and DBP was slightly higher at 24 months compared to 12 months. This was more evident among patients on combination therapy. A significant improvement in QOL was noted at 24 months. Conclusion: Treatment strategies in HTN management are changing and are associated with effective HTN control and improvements in QOL. However, there is a further need for improved awareness regarding the optimal usage of combination therapy for better management of uncontrolled HTN. How to cite this article: Rajadhyaksha GC, Reddy H, Singh AK, et al. The Indian REgistry on Current Patient PrOfiles and TReatment TrenDs in Hypertension (RECORD): Final Outcomes of the Real-World Observational Study. J Assoc Physicians India 2023;71(11):43-49.

Suspecting and diagnosing transthyretin amyloid cardiomyopathy (ATTR-CM) in India: An Indian expert consensus.

Transthyretin cardiac amyloidosis (ATTR-CM) is a rare and under-recognized disorder characterized by the aggregation of transthyretin-derived insoluble amyloid fibrils in the myocardium. Heterogeneity of symptoms at presentation, makes its diagnosis often delayed. An expert panel gathered on a virtual platform across India to conduct a meeting for developing a guiding tool for ATTR-CM diagnosis. The panel recommended younger age (≥40 years) for suspecting ATTR-CM and thick-walled non-dilated hypokinetic ventricle was considered as one of the important red flags. Electrocardiogram (ECG) and echocardiography (ECHO) findings were recommended as primary tests to raise the suspicion while nuclear scintigraphy and hematological tests were recommended to confirm the diagnosis and rule out amyloid light-chain (AL) amyloidosis. Cardiac magnetic resonance (CMR) and biopsy were recommended in case of ambiguity in the presence of red flags. Considering the lack of expert guidelines in the Indian scenario, a standardized diagnostic algorithm was also proposed.

Heart Failure with Preserved Ejection Fraction: Management Guidelines (From Heart Failure Association of India, Endorsed by Association of Physicians of India).

Heart failure with preserved ejection fraction (HFpEF) accounts for 15-20% of patients with heart failure (HF) in India. Diagnosis is by clinical features supported by biomarkers and echocardiography. Lifestyle modifications, control of risk factors to optimum levels, and treatment of comorbidities are essential in the management of HFpEF. Spironolactone and sacubitril-valsartan [angiotensin receptor neprilysin inhibitor (ARNI)] are beneficial in subsets of HFpEF, especially with lower range of ejection fraction (EF). Sodium-glucose co-transporter-2 inhibitors (SGLT2i)-empagliflozin and dapagliflozin and probably sotagliflozin are the only currently available drugs which have shown benefits in HFpEF, mostly by reducing hospitalizations. The benefit of SGLT2i is evident in both diabetic and nondiabetic subsets.

Clinical recommendations to diagnose and monitor patients with transthyretin amyloid cardiomyopathy in Asia.

Transthyretin amyloid cardiomyopathy (ATTR-CM) is a debilitating and life-threatening condition with a heterogeneous clinical presentation. Recent guidelines from the United States and Europe have been published to guide clinical practice and to facilitate management conformity by covering current diagnostic and treatment strategies for patients with ATTR-CM. These guidelines highlight the importance of an early diagnosis to optimize therapeutic outcomes, specifying the use of tests and imaging techniques to allow accurate, noninvasive diagnosis of ATTR-CM. However, as regional practice variations across Asia may limit access to healthcare, availability of specific tests, and expertise in assessing diagnostic images, there is an ongoing need to provide an Asian perspective on these clinical guidelines. This review article provides practical recommendations for the diagnosis and monitoring of patients with ATTR-CM in Asia, highlighting the need for additional guidelines to support a broad and diverse population, consider differing healthcare systems and diagnostic testing availability, and provide a flexible yet robust algorithm.

Coronary thrombo-embolic events after Covid-19 vaccination- a single centre study.

Thrombo-embolic complications after Corona virus disease-19 (COVID-19) vaccination have been previously reported. We aimed to study the coronary thrombo-embolic complications (CTE) after COVID-19 vaccination in a single centre during the initial 3 months of vaccination drive in India. All patients admitted to our hospital between 1st March 2021 and 31st May 2021 with Acute coronary syndrome (ACS) were included. Of the 89 patients [Age 55 (47-64)y, 13f] with ACS and angiographic evidence of coronary thrombus, 37 (42%) had prior vaccination history. The timing from last vaccination dose to index event was <1, 1-2, 2-4 and >4 weeks in 9(24%), 4(11%), 15(41%) and 9 (24%) respectively. ChAdOx1 nCoV-19/AZD1222 (Covishield) was the most used vaccine- 28 (76%), while 9 (24%) had BBV152 (Covaxin). Baseline characteristics were similar in both vaccinated (VG) and non-vaccinated group (NVG), except for symptom to door time [8.5 (5.75-14) vs 14.5 (7.25-24) hrs, p = 0.003]. Thrombocytopenia was not noted in any of the VG patients, while 2 (3.8%) of NVG patient had thrombocytopenia (p = 0.51). The pre- Percutaneous Coronary Intervention (PCI) Thrombolysis in Myocardial Infarction (TIMI) flow was significantly lower [1 (0-3) vs2 (1-3), p = 0.03) and thrombus grade were significantly higher [4 (2.5-5) vs 2 (1-3), p = 0.0005] in VG. The in-hospital (2.7% vs 1.9%, p = 1.0) and 30-day mortality were also similar (5.4% vs 5.8%, p = 1.0). This is the first report of CTE after COVID-19 vaccination during the first 3 months of vaccination drive in India. We need further reports to identify the incidence of this rare but serious adverse events following COVID-19 vaccination.

Thrombolysis in Acute Pulmonary Embolism: Are we overdoing it?

AIM AND METHODS: We aimed to study the clinical data and outcome of patients admitted in our center with acute pulmonary embolism (PE) over a 5-year period from May 2013 to April 2018. The main outcome data included were: in - hospital bleeding, in - hospital right ventricular (RV) function improvement, pulmonary arterial hypertension improvement, duration of hospital stay, and 30- and 90-day mortality. RESULTS: A total of 114 (69 m, 55 f) patients with the mean age of 55 ± 15 years were included. Patients who had involvement of central pulmonary trunk called as "Central PE" group (n = 82) and others as "Peripheral PE" group (n = 32). There were more women in the peripheral PE group (53.1% vs. 34.1%, P = 0.05), while RBBB (22% vs. 3.1%, P = 0.02) and RV dysfunction (59.8% vs. 25%, P = 0.002) were noted more in the central PE group. Systemic thrombolysis was done in 53 patients (49 central, 4 peripheral), of which only 3 had hypotension and 28 patients were in the Intermediate-high risk group. The overall inhospital, 30-day, and 90-day mortalities were 3.6, 13.2, and 22.8%, respectively. Bleeding was significantly higher in the thrombolysis group compared to the nonthrombolysis group (18.9% vs. 0, P = 0.0003). However, improvement in pulmonary hypertension was noted more in thrombolysis group compared to nonthrombolytic group (49% vs. 21.2%, P = 0.01). CONCLUSION: This retrospective data from a tertiary center in South India showed that short- and mid-term mortality of patients with PE still remains high. The high nonguideline use of thrombolysis has been reflected in the increased bleeding noted in our study.

Correlation Between Ambulatory Blood Pressure Monitoring and Office Blood Pressure Measurement in Patients with Hypertension: A Community Study.

BACKGROUND: The current gold standard for blood pressure (BP) measurements is based on office BP measurements (OBPMs) by a sphygmomanometer or a digital device. Ambulatory BP measurement (ABPM) is a noninvasive method for continuous monitoring of BP over a period during routine activities of the patient. Thus, ABPM offers multiple BP readings during the patients' daily routine as compared to the single reading by OBPM at rest. A good correlation exists between mean 24-hour BP readings and the prediction of cardiovascular events. The present multicenter observational study was aimed to assess the correlation between ABPM and OBPM in patients with newly diagnosed, controlled, or uncontrolled hypertension in the community setting. Our hypothesis was to test if ABPM provides any further value in those hypertensive patients in whom the office blood pressure levels are controlled. A supplementary hypothesis was whether obtaining ABPM in patients with newly diagnosed or uncontrolled hypertension yields any value over and beyond OBPM. Another objective was to find out the applicability of ABPM in the community setting where the medical care is provided by primary care family physicians and not by specialists. MATERIALS AND METHODS: Materials and Methods A total of 1000 patients were analysed for this study. Those with controlled hypertension were assigned to Group A, and those with newly diagnosed/untreated hypertension comprised Group B. Group A was followed up during Visit 2 and Group B was followed up during Visit 2 and either Visit 3 or Visit 4 to assess the BP measurements by ABPM and OBPM. RESULTS: The correlation between ABPM and OBPM showed minimal variation in the BP readings of Group A subjects at Visit 2. A variation in BP readings was observed in Group B at Visit 2. Furthermore, the correlation was established between ABPM and OBPM noted for Group B subjects during Visit 3, and minimal variation was noted during Visit 4. CONCLUSIONS: Conclusions A good correlation was observed between ABPM and OBPM during both visits in patients in Groups A and B. However, a notable variation was noted in the diastolic BP readings. Thus, large-scale clinical studies are required to detect the prevalence of hypertension, masked hypertension, and dipping patterns associated with hypertension and other related medical co-morbidities.

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.

Acute Coronary Syndrome admissions and outcome during COVID-19 Pandemic-Report from large tertiary centre in India.

Few studies from various countries have reported decline in Acute Coronary Syndrome (ACS) admissions to hospital during COVID-19 pandemic. We studied the impact of COVID-19 strict lockdown on ACS admission in a tertiary referral hospital in India. This showed 43% decline in admissions (n = 104 vs mean n = 183) and even in those who got admitted, there was a delay in presentation compared to previous year, which was reflected in the outcome of patients. Government and health organizations should educate the public early-on during the pandemic about the consequences of ignoring other acute medical problems such as ACS.

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

BACKGROUND: Real-world data on the effectiveness of antihypertensive drugs (AHDs) in India is limited. The present study aims to provide updated evidence regarding the effectiveness of olmesartan as monotherapy or in combination with other AHDs in Indian patients with essential hypertension. METHODS: Electronic medical record data of adult patients who were diagnosed with essential hypertension (≥140/90 mmHg) and were prescribed olmesartan as mono- or add-on therapy were retrospectively analyzed. Patients were classified based on the number of AHD classes prescribed on initiation of olmesartan. Change in systolic and diastolic blood pressure (SBP and DBP) from baseline was the primary endpoint. Secondary endpoint was evaluation of proportion of patients who achieved treatment goals as per 2018 European Society of Cardiology/European Society of Hypertension guidelines. Readings were obtained before initiating olmesartan and after at least a month of therapy with olmesartan. RESULTS: Among the 459 included patients, majority were on olmesartan monotherapy or olmesartan+1AHD (91.7%). Mean (95% confidence interval [CI]) change in olmesartan monotherapy group was: SBP (-13.4 [-15.7, -11.1] mmHg) and DBP (-8.3 [-9.5, -7.1] mmHg) and mean (95% CI) change in olmesartan+1AHD group was: SBP (-11.7 [-15.1, -8.3] mmHg) and DBP (-6.6 [-8.3, -4.9] mmHg) (P<0.001 for all). SBP and DBP goals were achieved by 40.4% and 50.3% of patients on olmesartan monotherapy and by 36.1% and 46.2% of patients on olmesartan+1AHD. Among patients with comorbid diabetes, mean (95% CI) change in olmesartan monotherapy group was: SBP (-15.5 [-18.6, -12.4] mmHg) and DBP (-8.7 [-10.2, -7.2] mmHg) and mean (95% CI) change in olmesartan+1AHD group was: SBP (-13.5 [-18.3, -8.7] mmHg) and DBP (-7.6 [-9.8, -5.4] mmHg) (P<0.001 for all). SBP and DBP goals were achieved by 38.5% and 49.4% of patients on olmesartan monotherapy and by 31.7% and 42.9% of patients on olmesartan+1AHD. CONCLUSION: Olmesartan prescribed as mono- or add-on therapy during routine clinical practice significantly reduced blood pressure in Indian patients with essential hypertension as well as in patients with comorbid diabetes.

Early discharge of patients (within 24 h) after percutaneous coronary intervention is feasible and safe in Indian setup.

Percutaneous coronary intervention (PCI) is the commonest cardiac procedure in most centres in India. Unlike in most western countries, patients who undergo PCI in India are discharged after a few days. We undertook an observational study of 100 consecutive patients to evaluate the outcome of early discharge (within 24 h) after uncomplicated elective PCI. This showed that early discharge is feasible and safe; and most patients felt comfortable with early discharge. It is the responsibility of the interventional cardiologist to educate and reassure these uncomplicated PCI patients about the safety of this approach.

Cardiac Intensive Care Unit Admissions during COVID-19 Pandemic-A Single Center Experience.

AIM: The impact of coronavirus disease 2019 (COVID-19) lockdown on cardiac emergency admissions to hospitals has been reported previously. We aimed to study the emergency room (ER) admissions to cardiac intensive care unit (CICU) at a tertiary care center during that period and compare this with admissions during the same time frame in the previous years. MATERIALS AND METHODS: This is a retrospective observational study of patients admitted to the CICU during the pandemic period from March 22 to August 1 (inclusive) of 2020 and compared this with CICU admissions in the same time frame in the previous 2 years (2018 and 2019). RESULTS: During the study period in 2020, a total of 216 patients (age 59 ± 14 years) were admitted via ER, which is a 33% and 30% decline in admissions compared to 2019 (n = 322, age 63 ± 12 years) and 2018 (n = 307, age 62 ± 13), respectively. The decline in admissions with the primary diagnosis of acute coronary syndrome (ACS), acute decompensated heart failure, arrhythmia, and other diagnoses during the study period in 2020 were 27%, 38%, 62%, and 59%, respectively, while there was a 50% increase in acute pulmonary embolism admission compared to the mean admission in 2018 and 2019. Weekly admission rates gradually increased from less than 10 per week in the first 3 weeks to >15 by eighth week of the study period in 2020, while the trend was same throughout the study period in the previous 2 years. The CICU mortality rate in 2020 study period was 4.6% compared to 3.9% in 2018 (p = 0.83) and 5.6% in 2019 (p = 0.70). The in-hospital mortality of these patients was also similar in all 3 years (6.5%, 7.8%, and 7.9% in 2018, 2019, and 2020, respectively; p = 0.61). CONCLUSION: Our study showed that CICU admissions during COVID-19 lockdown had declined compared to the previous years in a large tertiary center in India. Government and health organizations should educate the public early on during the pandemic about the consequences of ignoring other acute medical problems such as ACS, provide various measures for them to reach hospital early, and give reassurance with the best practices adopted in hospitals to avoid contracting the virus from the hospital environment. HOW TO CITE THIS ARTICLE: Yalamanchi R, Dasari BC, Narra L, Oomman A, Kumar P, Nayak R, et al. Cardiac Intensive Care Unit Admissions during COVID-19 Pandemic-A Single Center Experience. Indian J Crit Care Med 2020;24(11):1103-1105.

Usefulness of ambulatory blood pressure measurement for hypertension management in India: the India ABPM study.

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.

Blood pressure related to age: The India ABPM study.

The present paper reports trends in office blood pressure (BP) measurement (OBPM) and ambulatory blood pressure measurement (ABPM) with age in a large multi-center 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 analyzed and compared. Individual differences between OBPM and ABPM patterns were compared for patients according to 10-year age categories. Results showed that systolic (S) BP values started to increase with age from the age of 40, BP variability (SD) increased from the age of 30 years. Diastolic (D) BP values started to decrease from the age of 50 years. Mean OBPM values were higher than daytime ABPM values (all P < .001) in all age-groups. The prevalence of white coat hypertension (WCH) and masked hypertension (MH) was based on OBPM and daytime, 24-hour, and nighttime average BPs together. WCH decreased with age from 15.1% and 12.4% in treated and untreated subjects at the youngest age to 7.2% and 6.9% in the oldest age, respectively. MH prevalence was higher for untreated than for treated subjects but remained similar for all age-groups (range of 18.6%-21.3%). The prevalence of reverse dippers increased with age from the youngest to oldest group with 7.3%-34.2% (P < .001 for trend). Dippers prevalence decreased from 42.5% to 17.9% from the youngest to oldest age-groups, respectively (P < .001 for trend). These findings confirm that BP patterns show clear differences in trends with age, particularly regarding nighttime BP.

Transcatheter aortic valve replacement in India-Early experience, challenges, and outcomes from a single center.

BACKGROUND: Despite the increasing popularity of transcatheter aortic valve replacement (TAVR), only about 10,000 TAVR cases have been performed in Asia to date. The procedure is still in a nascent stage in India with very few centers offering this state-of-art technique. Here, we present the early results of TAVR experience at our center. METHODS: Forty-nine patients with severe symptomatic aortic stenosis (AS) were referred to our center for TAVR from November 2015 to February 2018. Twenty-five patients underwent TAVR at our conventional cardiac catheterization laboratory under local or general anesthesia, with standby surgical team support. RESULTS: The mean age of the patients was 72.0 ± 8.1 years. The mean Society of Thoracic Surgeons score was 13.8 ± 10.2. Baseline mean ejection fraction was 50.3 ± 14.8%. Baseline mean aortic valve gradient was 55.8 ± 24.7 mmHg. There was one procedural-related death. Two of the patients required urgent surgery: one for contained annular rupture and one underwent vascular repair for femoral artery occlusion. Mild and moderate paravalvular leak was seen in 11 and 3 patients, respectively. Four patients (16%) required permanent pacemaker. Eighty percent were in New York Heart Association class I-II at discharge. One-year all-cause mortality was 8%, with no hospitalizations or major adverse cardiac event during the 1-year follow-up. CONCLUSION: Our early data clearly shows that in our country, TAVR is a good alternative for symptomatic severe AS for high surgical risk cases. Large-scale multicenter studies are required to study the real impact of TAVR in the Indian scenario. During initial years of implementation of a nationwide TAVR program, it may be prudent to focus on creating TAVR Centers of Excellence by developing an ideal hub and spokes model.

Comparative Evaluation of Safety and Efficacy of Glimepiride and Sitagliptin in Combination with Metformin in Patients with Type 2 Diabetes Mellitus: Indian Multicentric Randomized Trial - START Study.

BACKGROUND AND OBJECTIVE: Modern sulfonylureas like glimepiride offer effective glycemic control with extrapancreatic benefits and good tolerability. The objective of the present study was to evaluate and compare safety and efficacy of glimepiride and sitagliptin in combination with metformin in patients with type 2 diabetes mellitus (T2DM). METHODS: In this open-label, randomized, comparative, multicenter study, a total of 305 T2DM patients who were either drug naïve or uncontrolled on metformin were randomized to glimepiride 1 or 2 mg/sustained-release metformin 1000 mg once daily (glimepiride group, n = 202) or sitagliptin 50 mg/metformin 500 mg twice daily (sitagliptin group, n = 103) for 12 weeks. Primary endpoint was change in glycosylated hemoglobin (HbA1c). Secondary endpoints were change in fasting plasma glucose (FPG), postprandial plasma glucose (PPG), body mass index (BMI) and to assess overall safety profile. RESULTS: At 12 weeks, there was a statistically significant difference in the mean HbA1c reduction in glimepiride group (0.42%) as compared to sitagliptin group (0.30%) (P = 0.001). Mean reduction in FPG and PPG was also statistically significant in the glimepiride group as compared to the sitagliptin group (P = 0.008). There was no significant difference in terms of change in BMI (0.07 ± 0.39 kg/m2 vs. 0.08 ± 0.31 kg/m2) in glimepiride and sitagliptin groups, respectively, (P = 0.644) between both the groups. The incidences of hypoglycemic events were also comparable among both the groups. CONCLUSION: In T2DM patients, glimepiride/metformin combination exhibited significant reduction in glycemic parameters as compared to sitagliptin/metformin combination. Moreover, there was no significant difference between both the groups in terms of change in BMI and incidence of hypoglycemia.