Real-world clinical experience of ticagrelor in Indian patients with acute coronary syndrome after discharge from a tertiary setting

Background: To understand the usage pattern of ticagrelor in real-life clinical experience in Indian patients with the acute coronary syndrome (ACS) after discharge from a tertiary care setting. Methods: A retrospective multicentric observational study conducted across Indian healthcare centers having medical records of adult patients with ACS. Patients prescribed with ticagrelor post-discharge for at least 1 month were included. The study endpoints were to determine the clinical effectiveness of ticagrelor in post-ACS patients and adverse events reported during the study period. Results: A total of 1910 patients with ACS with a mean (SD) age of 58.2 (11.3) years were enrolled in this study. The median (IQR) duration of treatment was 30.0 (30.0-90.0) days. More than half of the patients (n=1115, 58.4%) were managed with interventional therapy. The most common comorbid conditions were type-2 diabetes mellitus (46.9%), followed by hypertension (36.8%). A total of 9.7% of patients reported complaints after treatment with ticagrelor. Among them, weakness, giddiness, and body pain were the most common (3.2%). Conclusions: This real-world study revealed that ticagrelor had been used widely in patients who underwent different management strategies. History of diabetes and hypertension were the most common risk factors. There were no major adverse events reported during the follow-up, indicating ticagrelor is well-tolerated in Indian patients with ACS

Real-world experience of metformin 1000 mg/day in patients with type 2 diabetes mellitus and comorbidities from Myanmar

Background: The study was conducted to assess the efficacy and safety of 1000 (mg/day) metformin in patients with type 2 diabetes (T2DM) with comorbidities and special reference to elderly people in Myanmar.Methods: This was a retrospective, post surveillance study conducted in patients diagnosed with T2DM receiving treatment of metformin (1000 mg/day). Baseline characteristics, comorbidities, random blood sugar level (RBS) and RBS changes pre- and post-therapy were retrieved from patient’s medical records. A paired sample t-test was used for comparing the pre- and post-treatment RBS levels.Results: A total of 303 patients with T2DM were included. A total of 88, 115 and 100 patients belonged to age groups ≤50, >50-≤60 and >61 years, respectively. Duration of T2DM was significantly higher in elderly patients (>61 years) compared to ≤50 and >50-≤60 age group. Hypertension was the most common comorbid condition observed in all age groups followed by cardiovascular disease. However, both hypertension and cardiovascular disease were significantly higher among elderly patients (>61 years) compared to ≤50 and >50-≤60 age group (p50-≤60 years, 86.2 mg/dL and >61 years, 97.2 mg/dL). Metformin was well tolerated with minimal gastrointestinal adverse events (n=27).Conclusions: In this post marketing surveillance study, metformin (1000 mg/day) was found to be effective in reducing RBS in T2DM patients with comorbidities especially older adults and well tolerated with no risk of hypoglycemia

Hypertension clinical care in the era of coronavirus disease 2019: Practical insights from India

Objective: The objective of this study was to seek the opinion of Indian health-care professionals (HCPs) about hypertension (HTN) care during coronavirus disease 2019 (COVID-19) era. Methods: HCPs' opinions (n = 2832) were recorded based on survey and round table meetings. Standard questionnaire consisting of nine questions pertaining to HTN care in COVID-19 was prepared, discussed, and evaluated by experts who treat patients with HTN during COVID-19 era. Results: Smoking/tobacco use, obesity, and comorbidities (diabetes/dyslipidemia) were ranked as the top three modifiable risk factors. A total of 37% and 33% of HCPs reported an increase in blood pressure (BP) during the lockdown period in 10%–20% and 20%–40% of hypertensive patients, respectively, who were on monotherapy. Around 35% of HCPs reported that 20%–30% of their patients with HTN showed uncontrolled BP (>150/100 mmHg). Dual-drug therapy in patients with uncontrolled BP was preferred by 56% of HCPs. Nearly 71% preferred dual combination for HTN management. In dual combination, 27% preferred angiotensin receptor blockers (ARBs) + diuretic, 26% preferred ARB + calcium channel blockers, and 18% preferred ARB + beta-blockers. The majority of HCPs (44%) consider that <30% of their patients with HTN check BP at home. A total of 47% of HCPs reported acute coronary syndrome as the most common HTN-related complication. The majority of HCPs (57%) considered that avoiding contamination during BP measurement is the challenging parameter. Around 32% considered self-BP monitoring (SBPM) as the best method to improve medication adherence. Conclusion: SBPM, combination therapies, and digital connect with patients are critical aspects of HTN management during COVID-19 pandemic

Bioequivalence study of ticagrelor in normal, healthy Indian subjects under fasting conditions: A randomized, blinded, crossover study

Objectives: The objectives of this study were to evaluate the bioequivalence and safety profiles of the test drug and reference drug of 90 mg ticagrelor tablets under fasting conditions. Methods: This was a randomized, blinded, balanced, two-treatment, two-period, two-sequence, single-dose, crossover bioequivalence study in normal, healthy adults. Subjects were randomized to receive a single dose of test or reference drug (ticagrelor 90 mg oral) under fasting conditions with a 16-day washout period. The primary pharmacokinetic variables were peak plasma concentration (Cmax), area under the plasma concentration (AUC) time curve measured to the last quantifiable concentration (AUCT), and time to maximum drug concentration (Tmax). Bioequivalence was concluded if 90% confidence intervals (CIs) of the geometric mean ratio of the test/reference drugs AUCT and Cmax are within the predefined range of 80%–125%. Adverse events (AEs) were also assessed. Results: Forty-two healthy adult males were enrolled, but 4 withdrew and 38 subjects successfully completed the study. There was no difference between the test and reference drugs regarding pharmacokinetic parameters. The median (range) Tmax was 1.67 h (1–4 h) and 2 h (1–4.5 h) for the test and reference products, respectively. The estimated 90% CIs of the geometric mean ratio for AUCT and Cmax satisfied the predefined bioequivalence criteria of 80%–125%. On analysis of variance, no significant “sequence” and “period” effects were observed for the pharmacokinetic parameters. No AEs were reported in the study. Conclusion: Our findings indicate that the test product is bioequivalent to the reference product and safe and well-tolerated in healthy Indian adults

Resurgence of hypertension and cardiovascular diseases in patients recovered from COVID-19: An Indian perspective

Objective: The aim of this study was to understand the prevalence, extent, clinical approach of hypertension and cardiovascular disease (CVD) in patients recovered from COVID-19. Methods: The round table meetings (RTMs) and survey convened a diverse panel of specialists including cardiologists, endocrinologists, diabetologists, consultant physicians, and family physicians from various geographical zones of India. A standard questionnaire including 10 questions was developed pertaining to the resurgence of hypertension and CVD in patients recovered from COVID-19. The RTMs and survey were held virtually. The collected opinions and recommendations were compiled to derive a consensus document. Results: A stotal of 3066 health-care practitioners (HCPs) participated. Hypertension was the most prevalent comorbidity in patients recovered from COVID-19 followed by diabetes, dyslipidemia, and coronary artery disease. Almost two-thirds of HCPs reported that 10%–30% newly diagnosed hypertension in patients recovered from COVID-19. Uncontrolled hypertension in 10-20% of COVID-19 recovered patients opined by 45% of the HCPs. About, 35% HCPs reported CV complications in 10-20% of Covid-19 recovered patients and 63% HCPs reported exacerbations of CAD in 10-30% of patients. Majority of HCPs preferred to switch to dual combination therapy from monotherapy for hypertension management (52.0%) and ARBs and its combination is most preferred combination for hypertension control (60%). Majority of the HCPs suggested follow-up after 1-2 weeks (39.0%). Close monitoring on symptoms including chest pain and breathlessness (45.0%), adherence to medication and regular monitoring of lab parameters (25%) is recommended for these patients. Conclusion: Overall observations indicate an increased incidence of hypertension and CVDs post recovery from COVID-19. A dual therapy of ARBs was the preferred choice for management of hypertension. Regular follow-up and close monitoring of symptoms to prevent further CV complications in COVID-19 recovered patients is recommended