Indian Perspective on De-escalation from Dual Antiplatelet Therapy to Single Antiplatelet Therapy Study: A Knowledge, Attitude, and Practice Study among Indian Interventional Cardiologists.

BACKGROUND: Coronary artery disease (CAD) management is one of the most significant facets of interventional cardiology. Evidence from several clinical trials has redefined the drug management of CAD, including optimizing the duration of antiplatelet treatment regimens in the management of CAD, which is an intricate clinical issue. The available evidence indicates that East Asians have a higher bleeding risk. However, the Indian phenotype differs from that of East Asians, making this data confounding when applied to clinical decision-making among Indian patients. There is a need for a close understanding of Indian interventional cardiologists' perceptions of complex decision-making pertaining to antiplatelet agents among Indian CAD patients in real-world clinical settings. AIM: This Indian Perspective on De-escalation from Dual Antiplatelet Therapy to Single Antiplatelet Therapy (INDEPTH) study aims to assess the perspective of Indian interventional cardiologists regarding de-escalating from dual antiplatelet therapy (DAPT) to single antiplatelet therapy (SAPT), approach to decision-making, barriers, and related challenges in CAD management. METHODS: A cross-sectional knowledge, attitude, and practice (KAP) study survey was carried out among Indian interventional cardiologists practicing across different regions of India. A total of 209 responses were received. Descriptive statistics was used to summarize all the parameters. IBM Statistical Package for the Social Sciences (SPSS) statistics was used for biostatistical analysis. RESULTS: The study indicated that >90% of CAD patients received DAPT therapy immediately after percutaneous coronary intervention (PCI) (86.1%, p < 0.001). About 115 (55%) of the respondents reported using calculator-based scoring for evaluating bleeding risk in patients on DAPT therapy for the management of acute coronary syndrome (ACS) with post-PCI (p = 0.167). Regarding the usual duration of DAPT therapy post-ACS, nearly half of the respondents, 94 (45%), said that 6-12 months is the usual duration for DAPT therapy in post-ACS patients, followed by > 12 months 94 (45%) of the respondents; 17 (8.1%) of the respondents reported it is 3-6 months, and lastly up to 3 months as per four (1.9%) of the respondents (p < 0.001). A total of 128 (61%) of the respondents strongly believe that balancing bleeding with ischemic risk influenced the choice of antiplatelet agent when treating established CAD. As per interventional cardiologists surveyed, the perfect de-escalation time frame for Indian CAD patients with high bleeding risk (HBR) is up to 3 months (35.9%, p < 0.001), 6-12 months for medium bleeding risk (48.8%, p < 0.001), and >12 months for low bleeding risk (65.6%, p < 0.001). Regarding SAPT therapy, almost one-third of the respondents, 65 (31.1%), reported that they prescribed antiplatelet therapy other than aspirin in 20-40% of their SAPT-eligible patients. Furthermore, 69 (33%) of the respondents said that they preferred to prescribe clopidogrel in 50-75% of SAPT-eligible patients. While 64 (30.5%) prescribed in 25-50%, 53 (25.4%) prescribed in <25% and 23 (11%) of the respondents prescribed the drug in >75% of the SAPT-eligible patients. (p < 0.001). "Atorvastatin + clopidogrel" is the most preferred combination of SAPT primarily for the management of CAD among the majority of interventional cardiologists [33%, 95% confidence interval (CI): 1.97-2.24, p < 0.001]. The study respondents also indicated a need for Indian-specific guidelines on de-escalating from DAPT to SAPT in CAD management. CONCLUSION: The INDEPTH study indicated that the majority of CAD patients received DAPT immediately after PCI. The perfect de-escalation time frame for Indian CAD patients with "high-bleeding" risk is up to 3 and 6-12 months for "medium-bleeding" risk and >12 months for "low-bleeding" risk. One-third of respondents used clopidogrel as an antiplatelet agent in 50-75% of SAPT-eligible patients. Atorvastatin + clopidogrel is predominantly the most preferred combination of statin + SAPT for the management of CAD. Although the current international guidelines cover the Indian perspective to some extent, there is a need for Indian-specific guidelines on de-escalating from DAPT to SAPT.

Demographic characteristics of epilepsy patients and antiepileptic drug utilization in adult patients: Results of a cross-sectional survey.

BACKGROUND: Through this cross-sectional study, we examined the demographic parameters, comorbidities, and antiepileptic drug (AED) utilization in patients with epilepsy. MATERIALS AND METHODS: We collected data of 973 adult patients with epilepsy and analysed AED utilization according to the epilepsy type, age group and gender. RESULTS: The study included 973 patients (males, 61.3%) with a mean age of 35.6 years. Only 3.6% patients were not educated whereas 45.3% patients were employed. Only 1.2% patients had a history of brain injury. The mean frequency of seizures during the previous 6 months was 24.0 ± 49.1 whereas the mean duration of epilepsy was 5.8 ± 5.8 years. Electroencephalogram was the most common (59.7%) investigation performed. A total of 109 (11.2%) patients had comorbid medical illness, with hypertension being observed in 3.3% patients. Levetiracetam was used in 583 (59.9%) patients whereas valproate, clobazam, and phenytoin were used in 16.3%, 14.8%, and 13.6% patients, respectively. Effectiveness and safety/tolerability profile were the two most important considerations for selecting the AED. A total of 924 (95%) patients had seizure control with the current therapy during the previous 6 months whereas the mean seizure-free interval was 7.1 ± 4.1 months. Levetiracetam was used in 34.9%, 45.7%, and 61.1% patients and valproate in 15.2%, 10.9%, and 4.6% patients in the age group of 18-30, 31-50 and 51-75 years, respectively. Levetiracetam was used in 57.7% and 63.4% whereas valproate was used in 19% and 12.2% male and female patients, respectively. The adverse event rate was only 0.1%. CONCLUSION: Epilepsy is common in adult patients. Hypertension is the most common comorbidity. Levetiracetam is the most commonly used AED across all studied age groups and both genders. Control of epilepsy with current treatment is satisfactory with no major adverse events.

Detection, Management Approach of Depression and Antidepressant Utilization in Adult Patients: Results of a Cross-Sectional Survey.

AIM: The study was conducted to understand the demographics, prevalence of co-morbid conditions and treatment modalities of depression. METHODS: A cross-sectional, nationwide observational study was conducted to understand the management pattern of depression in India. Depression was majorly diagnosed with DSM-IV TR criteria. RESULTS: The data of 2276 Indian patients across 18 states were collected through 135 mental health professionals. The study population was predominantly from urban (81.2%) area. The prevalence of uneducated and employed patients in the study was 7.2% and 54.6% respectively. The main co-morbidities observed were diabetes, hypertension, anxiety and insomnia. Overall, escitalopram monotherapy was used in 67.2% patients. Escitalopram was found to be the preferred antidepressant in patients with co-morbid conditions including hypertension and diabetes. Counseling was the most common non-pharmacological therapy practiced. CONCLUSIONS: This large cross sectional study in real life settings demonstrates high prevalence of depression among employed and educated adult Indian patients. Hypertension and diabetes are the two most common co-morbidites in patients with depression. Escitalopram is commonly used and preferred antidepressant in all studied age groups and even in co-morbid depression.

Impact of Partial Meal Replacement on Glycemic Levels and Body Weight in Indian Patients with Type 2 Diabetes (PRIDE): A Randomized Controlled Study.

INTRODUCTION: Partial meal replacement (PMR) offers potential glycemic and weight control benefits in type 2 diabetes mellitus (T2DM) patients. We evaluated the clinical impact of PMR (diabetes-specific nutritional supplement [DSNS]) in overweight/obese Indian patients with T2DM. METHODS: PRIDE, a 12-week, phase IV, open-label, multicenter study randomized (1:1) newly diagnosed T2DM patients (≤ 1 year) to either DSNS plus standard of care (SOC; diabetes treatment with dietary counseling) group (PMR) or SOC alone group (SOC). The primary endpoint was mean change in glycated hemoglobin (HbA1c) from baseline to week 12. Secondary endpoints were changes in glucose profiles, body weight, waist circumference, lipid profile, and factors impacting quality-of-life (QoL) at week 6 and 12 from baseline. Safety was assessed throughout the study. RESULTS: Of the 176 patients enrolled, 171 (n = 85 in PMR group; n = 86 in SOC group) were included in the modified intent-to-treat population. The mean reduction in HbA1c at week 12 from baseline in PMR group was significant compared to the SOC group (- 0.59 vs. - 0.21%, p = 0.002). At week 12, the PMR group showed significant reduction in mean body weight (- 2.19 vs. - 0.22 kg; p = 0.001) and waist circumference (- 2.34 vs. - 0.48 cm; p = 0.001) compared to SOC group. Mean fasting plasma glucose and post-prandial glucose significantly reduced from baseline at week 6 and 12 in each group (p < 0.05). No significant change was observed in lipid profile. QoL parameters (treatment adherence, general well-being, and energy fulfilment) in the PMR were significantly better than SOC group (p < 0.05). Patients were satisfied with the taste of DSNS. No serious adverse events were reported. CONCLUSIONS: DSNS is an encouraging option for PMR strategy, as it significantly improved HbA1c, body weight, waist circumference, and overall well-being among overweight/obese Indian T2DM patients. TRIAL IDENTIFICATION NO: CTRI/2019/10/021595.

Fixed-dose Combination of Metoprolol, Telmisartan, and Chlorthalidone for Essential Hypertension in Adults with Stable Coronary Artery Disease: Phase III Study.

INTRODUCTION: The aim of the study was to evaluate the efficacy and safety of fixed-dose combination (FDC) of metoprolol, telmisartan, and chlorthalidone in patients with essential hypertension and stable coronary artery disease (CAD) who showed inadequate response to dual therapy. METHODS: In this phase III, open-label, multicenter study, 254 adults with stable CAD having uncontrolled hypertension despite being treated with FDC of metoprolol (25/50 mg) and telmisartan (40 mg) were included. Patients received either of the following FDC for 24 weeks: metoprolol (25 mg), telmisartan (40 mg), and chlorthalidone (12.5 mg) (FDC1; n = 139) or metoprolol (50 mg), telmisartan (40 mg), and chlorthalidone (12.5 mg) (FDC2; n = 115) tablets once daily. The FDCs were developed using the novel Wrap Matrix™ platform technology. Primary endpoint assessed the mean change in seated diastolic blood pressure (SeDBP) and seated systolic blood pressure (SeSBP) from baseline to 24 weeks. Secondary efficacy endpoints included proportion of patients achieving < 90 mmHg SeDBP (SeDBP responder) and < 140 mmHg SeSBP (SeSBP responder) at weeks 12, 16, 20, and 24. Safety was assessed throughout the study. RESULTS: A total of 243 (95.70%) patients completed study. The mean change in BP from baseline (FDC1, 155/96 mmHg; FDC2, 165/98 mmHg) to week 24 (FDC1, 128/82 mmHg; FDC2, 131/83 mmHg) was statistically significant (both groups p < 0.0001). Within FDC1 and FDC2, the mean change from baseline to week 24 in SeDBP (82.60 mmHg and 83.09 mmHg) and SeSBP (128.07 mmHg and 131.29 mmHg) was statistically significant (both groups p < 0.0001). At week 24, in FDC1, 80.15% and 84.73% were SeDBP and SeSBP responders, respectively; in FDC2, 79.46% and 74.11% were SeDBP and SeSBP responders, respectively. No serious adverse events or deaths were reported. CONCLUSION: Triple FDCs of metoprolol, telmisartan, and chlorthalidone were considered effective and well tolerated in patients with hypertension who respond inadequately to dual therapy. CLINICAL TRIAL REGISTRATION: CTRI/2016/11/007491.

The increasing prevalence of hypertension in India requires immediate attention. To adequately manage blood pressure and ensure compliance to medications, innovative treatment options involving combination therapy with three or more drugs to treat hypertension need to be explored. Fixed-dose combination (FDC) of three antihypertension drugs, viz., metoprolol, telmisartan, and chlorthalidone, were tested in Indian patients who could not respond adequately to dual treatment. The rationale behind using a combination of three drug types was to take advantage of the complementary actions of each drug class for an enhanced treatment effect. The two variants of FDCs were tested in 254 adults with the most common form of heart disease, i.e., stable coronary artery disease. Changes in seated diastolic and systolic blood pressure (SeDBP and SeSBP) were measured to assess the effectiveness of the FDC. The mean changes in SeDBP and SeSBP were statistically significant by the end of the study, i.e., it determined that results are not explainable by chance alone. A greater proportion of patients (range 74­84%) achieved their target BPs with the FDC used in the study. The FDC variants were well tolerated without any reports of serious adverse events or deaths. Overall, this triple combination therapy option was effective and considered safe to be administered to hypertensive Indian adults with stable coronary artery disease who did not respond adequately to dual antihypertension therapy.