Real-World Observational Study on Vildagliptin With Insulin (VIL-INS) or Vildagliptin and Metformin With Insulin (VIL-MET-INS) Therapy in Indian Patients With Type 2 Diabetes Mellitus.

BACKGROUND AND OBJECTIVE:  The therapeutic use of vildagliptin and insulin (VIL-INS) or vildagliptin and metformin in combination with insulin (VIL-MET-INS) in the Indian scenario has yet to be explored by generating real-world evidence. Therefore, the present study aimed to evaluate the demographic, clinical characteristics, and treatment patterns of patients with type 2 diabetes mellitus (T2DM) in Indian settings in the above context. METHODOLOGY:  This observational study conducted at 600 healthcare centers in India retrospectively analyzed data of adult patients with T2DM who had been treated with either vildagliptin with insulin or a combination of vildagliptin and metformin with insulin. Data were collected from medical records and analyzed by appropriate statistical tests. RESULTS:  A total of 12,603 patients with T2DM were included with a mean age of 53.4 years of which 63.8% were males. The majority of patients (n=6511; 51.7%) received a combination of vildagliptin and metformin on top of insulin. A significantly high proportion of patients in the age group of 18-40 years received this treatment compared to patients who were initiated on insulin treatment after vildagliptin and metformin combination (11.6% vs. 9.7%; P<0.001). Of all the patients, 70.0% were able to achieve target glycemic control with either VIS-INS or VIL-MET-INS. After treatment with VIL-INS or VIL-MET-INS, the mean glycated hemoglobin (HbA1c) levels significantly decreased with a mean change of 1.46%. Out of all patients, 13.5% experienced weight changes during treatment, with 67.4% of them showing weight loss. A total of 68 patients reported hypoglycemic events and among them, 49 patients had mild hypoglycemic events. Physician global evaluation of efficacy and tolerability showed a majority of patients rated their experience as good to excellent (86.3% and 86.0%, respectively). CONCLUSION:  Both treatment regimens were effective in terms of reduced HbA1c to achieve glycemic control. Furthermore, it is well tolerated without an increase in the risk of hypoglycemia or weight gain. Hence, this therapy has favorable outcomes for T2DM management in Indian clinical settings.

Efficacy and Safety of a Fixed-Dose Combination of Vildagliptin and Pioglitazone in Indian Patients With Type 2 Diabetes Mellitus: A Randomized, Open-Label, Comparative, Phase III Study.

Background Type 2 diabetes mellitus (T2DM) arises due to a range of pathological abnormalities, necessitating a combination therapy to achieve optimal glycemic control. Vildagliptin, an effective and selective DPP-4 inhibitor, and pioglitazone, an insulin sensitizer, offer distinct mechanisms of action. Hence, the integration of these medications represents a logical and justified therapeutic strategy Objective To compare the efficacy, safety, and tolerability of vildagliptin and pioglitazone 50 mg/15 mg fixed-dose combination (FDC) tablets with individual monotherapy vildagliptin 50 mg and pioglitazone 15 mg tablets in Indian T2DM patients who were inadequately controlled on metformin monotherapy. Methods This was a randomized, open-label, comparative, multicenter, phase III study involving 195 T2DM patients with inadequate glycemic control on metformin ≥ 1000 mg/day. Patients were randomly assigned in a 1:1:1 ratio to the test product group (n=65) (vildagliptin 50 mg + pioglitazone 15 mg FDC tablets), reference product group 1 (n=65) (vildagliptin 50 mg tablet), or reference product group 2 (n=65) (pioglitazone 15 mg tablet reference product). The primary endpoint was the mean change in HbA1c levels from baseline to end of the study visit (12 weeks (84 days ±2)). The secondary endpoints were the mean change in fasting plasma glucose (FPG) and 2-hr postprandial plasma glucose (2-hr PPG) levels. Safety parameters were assessed till the end of the study. Results A total of 178 patients completed the study. At 12 weeks, the mean HbA1c level in the test group reduced to 6.85 ± 1.27%, in the reference product 1 group to 7.56 ± 1.72%, and in the reference product 2 groups to 7.37 ± 1.59%. The mean change in Hb1Ac from baseline in the test group was statistically significant compared to the reference groups (p=0.037). Similarly, the mean changes in the FPG and 2hr-PPG with the test product were statistically significant compared to reference products (p=0.041). The adverse events were comparable across all the treatment groups. Conclusion In Indian T2DM patients inadequately controlled on a daily maximum dose of metformin, treatment with vildagliptin and pioglitazone FDC showed better glycemic control than either vildagliptin or pioglitazone along with a good tolerability profile.

Real-World Clinical Experience of Rosuvastatin as a Lipid-Lowering Therapy for Primary and Secondary Prevention of Cardiovascular Events (REAL ROSE).

Background Rosuvastatin effectively reduces endogenous cholesterol synthesis and low-density lipoprotein (LDL) cholesterol and increases high-density lipoprotein (HDL) cholesterol. This study aimed to evaluate the clinical characteristics of patients and treatment patterns of rosuvastatin as a lipid-lowering therapy for primary and secondary prevention of cardiovascular events in Indian settings. Methods This real-world, retrospective multi-centric observational study included patients aged >18 years who received treatment with a rosuvastatin/rosuvastatin-based combination. Demographic and data about concomitant diseases and medications were recorded. Results Out of 1,816 patients, the majority were men (66.2%); the mean age was 54.1 years. The patients prescribed rosuvastatin for primary and secondary prevention of cardiovascular events were 71.9% and 28.1%, respectively. Rosuvastatin 10 mg (56.8%) was the most commonly prescribed dose. For primary prevention, 10 mg (65.0%) was the most preferred dose, and for secondary prevention, 20 mg (54.3%) was the most preferred dose. Rosuvastatin treatment significantly (pre- vs. post-treatment) reduced the levels of total cholesterol (227.2 vs. 178.4 mg/dL), triglycerides (212.6 vs. 154.4 mg/dL), and LDL cholesterol (167.0 vs. 125.6 mg/dL), and increased HDL cholesterol levels (40.7 vs. 44.3 mg/dL) (p<0.0001). A total of 1,196 patients received combination therapy with rosuvastatin (aspirin, 34.0%, and fenofibrate, 21.9%). Adverse events were reported in 0.4% of the study population (leg pain, nausea, muscle cramps/pain, bleeding, and myalgia). Conclusion This study demonstrated the clinical effectiveness and safety of moderate- to high-intensity rosuvastatin (5-40 mg) for primary and secondary prevention of cardiovascular events in the Indian population. A primary prevention strategy with statins can reduce cardiovascular events and associated morbidity and mortality.

Management of polycystic ovary syndrome among Indian women using myo-inositol and D-chiro-inositol.

Myo-Inositol and D-chiro-inositol (MI-DCI) are used in the treatment of polycystic Ovary syndrome (PCOS) due to their insulin-sensitizing actions. Therefore, it is of interest to evaluate the treatment patterns, clinical effectiveness and safety of MI-DCI combination in anagement of PCOS in Indian women. Data from 50 healthcare centers across India was collected between September 2019 and February 2020 and was used in the study. Women aged 12-45 years diagnosed with PCOS, who had received MI-DCI (550-150 mg) were included. The outcome parameters were change in weight, luteinizing hormone (LH)/follicle stimulating hormone (FSH) ratio, hirsutism, blood glucose and insulin levels, HOMA-IR, and lipid profile. A total of 283 women were included (mean age: 27.74 years; body mass index: 26.89 kg/m2); of which 197 (69.61%) reported reduction in weight after treatment with MI-DCI. The hirsutism scores considerably improved after treatment and the proportion of patients with, no hirsutism increased from 31.07% to 50.51% and moderate hirsutism reduced from 32.52% to 6.12% while, there were no patients with severe hirsutism after the treatment. There was a significant reduction in LH:FSH ratio (mean difference: 0.25 mg/dL; p=0.021), free testosterone (mean difference: 1.49; p<0.001) and dehydroepiandrosterone (mean difference: 21.49; P<0.001) levels after regular use of MI-DCI tablets. Treatment with MI-DCI resulted in significant improvement in insulin levels, HOMA-IR score, Fasting plasma glucose (FPG), post-prandial plasma glucose (PPG) and lipid profile. The therapy restored menstruation and spontaneous ovulation and significantly attenuated the LH/FSH ratio. Thus, MI-DCI (550-150 mg) has shown multidimensional benefits in improving the hormonal, glycemic, and lipid profile of women with PCOS with considerable efficacy and tolerability.

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 total 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.

Management of Hypertension in Patients with Diabetes: A Comprehensive Review of the Perceptions and Practices of Health Care Providers in India.

OBJECTIVES: This study evaluated the perception and practices of health care providers (physicians, diabetologists, and endocrinologists) regarding the treatment of hypertension in patients with diabetes in India. METHODS: Health care providers throughout India who treated patients with diabetes and hypertension were invited to participate in an online survey and periodic 21 virtual meetings. They were questioned about their perception and practices in managing these patients, and strategies to improve blood pressure (BP). RESULTS: The online survey was completed by 2,513 health care providers, and 344 participated in virtual meetings. More than 50% reported that 31-50% of their patients with diabetes also had hypertension. Home BP monitoring was recommended by 88%, and lifestyle modifications were consistently recommended. Choice of antihypertensive treatment varied based on comorbidities, and a renin-angiotensin system blocker plus a calcium channel blocker (CCB) was the most common combination for dual antihypertensive therapy. Suggested strategies to improve BP control included patient awareness/education, lifestyle modifications, better follow-up/monitoring, and optimization of therapy. CONCLUSION: Indian health care providers were aware of clinical recommendations and practices regarding treatment of patients with diabetes and hypertension, and generally make clinical decisions consistent with current guidelines. Optimization of care for these patients is essential to reduce cardiovascular disease risk and improve patient outcomes.

Experts' Consensus on Use of Long-Acting Nitroglycerine in the Management of Angina and Chronic Coronary Syndrome in India.

AIM: To address the existing gaps in knowledge about long-acting nitroglycerine (LA-NTG) and provide recommendations to address these issues. METHODOLOGY: Approved LA-NTG questionnaire that included 17 questions related to the role of LA-NTG in the management of angina and chronic coronary syndrome (CCS) was shared with 150 expert cardiologists from different regions from India. Results of these survey questionnaires were further discussed in 12 regional level meetings. The opinions and suggestions from all the meetings were compiled and analyzed. Further, recommendations were made with the help of attending national cardiology experts and a consensus statement was derived. RESULTS: This is the first consensus on LA-NTG, summarizing the clinical evidence from India and suggesting recommendations based on these data. The experts recommended early use of LA-NTG as a first-line antianginal therapy in combination with beta-blocker since it improves exercise tolerance in patients with CCS. A strong consensus was observed for using LA-NTG in patients with co-morbid hypertension, diabetes, chronic kidney disease and post-percutaneous coronary intervention angina. As a part of cardiac rehabilitation, LA-NTG allows patients with angina to exercise to a greater functional capacity. CONCLUSIONS: A national consensus was observed for several aspects of LA-NTG in the management of angina and CCS. The clinical experience of the experts confirmed an extremely satisfied patient perception about the efficacy of LA-NTG.

Management of American Heart Association/American College of Cardiology-Defined Stage 2 Hypertension by Cardiologists in India.

Uncontrolled hypertension is an important cardiovascular risk factor and therefore requires effective approaches to patient management. This study assessed approaches to the management of patients with Stage 2 hypertension by cardiologists in India. This was a retrospective, multicenter, observational, case-based questionnaire study. Data on demographic characteristics, risk factors associated with Stage 2 hypertension, use of antihypertensive medications, side effects, and approaches to education for 2,540 patients were extracted from questionnaire responses provided by 508 cardiologists. The study population of patients with Stage 2 hypertension had a mean age of 55.0 years. Most of the patients (62.6%) were aged 30 to 60 years and diabetes mellitus was the most prevalent comorbidity (48.9%). Triple antihypertensive therapy was being used by 760 patients, and 634 and 1,146 patients were receiving 4 and 5 different antihypertensive medications, respectively. Telmisartan, amlodipine, chlorthalidone, hydrochlorothiazide, spironolactone, metoprolol, and prazosin were the commonly prescribed drugs. Ankle edema (27.7%) was the most frequent side effect of therapy. Pharmacotherapy was supported by patient education and lifestyle modifications for better blood pressure control. The standardized approach to the collection and assessment of these contemporary data provides useful insights into the characteristics and treatment of patients with Stage 2 hypertension in India.

REAL-world evidence of risk factors and comorbidities in YOUNG Indian adults with type 2 diabetes mellitus: A REAL YOUNG (diabetes) study.

OBJECTIVE: To assess the clinical characteristics, risk factors, and comorbidities associated with type 2 diabetes mellitus (T2DM) in young adult patients. METHODS: This is a retrospective, multicentric real-world study that included young adults (18-45 years) with T2DM. Primary information including demographics, medical and family history, biochemical measures (pre-and post-prandial blood glucose levels, glycosylated hemoglobin [HbA1c] and blood pressure, and lipid parameters) smoking and drinking habits were collected retrospectively from the medical records of the respective hospitals/clinics. Data were analyzed using descriptive and appropriate comparative statistics. RESULTS: A total of 22,921 patients from 623 sites were included. The median age was 37.0 years and the majority were men (61.6%). The proportion of patients from the age group >35-≤45 years was 62.7%. Among all patients, 46.9% had only T2DM; however, 53.1% of patients had T2DM with other comorbidities (T2DM with hypertension, dyslipidemia, and both). The majority of patients had elevated body mass index (BMI) (overweight, 46.6%; and obese, 22.9%). Family history of T2DM (68.1%) was most common in overall population. Sedentary lifestyle (63.1%), alcohol consumption (38.9%), and regular smoking (23.1%) were the most common associations in patients with T2DM with dyslipidemia and hypertension. Uncontrolled HbA1c level (≥7%) were observed in 79.2% of patients. The level of HbA1c was significantly increased with the duration of T2DM and sedentary lifestyle (p < 0.001). CONCLUSION: Higher BMI, family history of T2DM, sedentary lifestyle, alcohol consumption, and smoking were the most common risk facors, while hypertension and dyslipidemia were the most prevalent comorbidities associated with T2DM in young Indian adults.

Real-World Clinical Experience on the Usage of High-Dose Metformin (1500-2500 mg/day) in Type 2 Diabetes Management.

BACKGROUND: To evaluate the clinical characteristics, treatment patterns, and clinical effectiveness and safety of high doses of metformin (1500-2500 mg/day) in Indian adults with type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS: A retrospective, multicentric (n = 241), real-world study included patients with T2DM (aged >18 years) receiving high doses of metformin. Details were retrieved from patient's medical records. RESULTS: Out of 5695 patients, 62.7% were men with median age was 50.0 years. Hypertension (67.5%) and dyslipidemia (48.7%) were the prevalent comorbidities. Doses of 2000 mg (57.4%) and 1500 mg (29.1%) were the most commonly used doses of metformin and median duration of high-dose metformin therapy was 24.0 months. Metformin twice daily was the most frequently used dosage pattern (94.2%). Up-titration of doses was done in 96.8% of patients. The mean HbA1c levels were significantly decreased post-treatment (mean change: 1.08%; P < .001). The target glycemic control was achieved in 91.2% patients. A total of 83.0% had decreased weight. Adverse events were reported in 156 patients. Physician global evaluation of efficacy and tolerability showed majority of patients on a good to excellent scale (98.2% and 97.7%). CONCLUSION: Clinical effectiveness and safety of a high-dose metformin was demonstrated through significant improvement in HbA1c levels and weight reduction.

Data on vildagliptin and vildagliptin plus metformin combination in type-2 diabetes mellitus management.

It is of interest to evaluate the clinical effectiveness and safety of vildagliptin as monotherapy and combination therapy of vildagliptin and metformin for the management of type 2 diabetes mellitus (T2DM) patients in Indian settings. The study included patients with T2DM (aged >18 years) receiving vildagliptin monotherapy and vildagliptin in combination with metformin therapy of various strengths. Data related to demographics, risk factors, medical history, glycated hemoglobin (HbA1c) levels, and medical therapies were retrieved from medical records. Out of 9678 patients (median age, 52.0 years), 59.1% were men. A combination of vildagliptin and metformin (50/500 mg) was the most commonly used therapy (54.8%), and the median duration of therapy was 24.0 months. The predominant reason for selecting vildagliptin therapy was to improve HbA1c levels (87.8%). A total of 87.5% of patients required dosage up-titration. Vildagliptin therapy was used in patients with T2DM and associated complications (peripheral neuropathy, CAD, nephropathy, retinopathy, autonomous neuropathy, stroke/TIA, and peripheral artery disease). Among 5175 patients who experienced body weight changes, a majority of patients showed a loss of weight (68.6%). The target glycemic control was achieved in 95.3% of patients. The mean HbA1c levels were significantly decreased post-treatment (mean change: 1.34%; p<0.001). Adverse events were reported in 0.4% of patients. Physicians rated the majority of patients as good to excellent on the global evaluation of efficacy and tolerability scale (98.9%, each). Vildagliptin as monotherapy and combination therapy of vildagliptin and metformin was an effective therapy in reducing HbA1c helps in achieving target glycemic control, and was well tolerated in Indian patients with T2DM continuum.

Risk Factors and Comorbidities in Young Indian Patients with Hypertension: REAL YOUNG (Hypertension) Study.

PURPOSE: To analyze the risk factors and comorbidities among the young Indian adults with hypertension. PATIENTS AND METHODS: This was a retrospective, multicentric real-world study which included patients diagnosed with and receiving treatment for hypertension. Data were collected from the medical records of clinics/hospitals across 623 study sites in India. Patients of either sex and aged 18-45 years were included. Demographic details (age, sex, anthropometric measurement), medical and family history, sedentary lifestyle, smoking status and alcohol consumption data were extracted. Descriptive and comparative analysis (Mann-Whitney U and chi-squared test) was done. RESULTS: Out of 15,006 young patients diagnosed with hypertension (men=63.6%), 65.7% belonged to the age group of >35-45 years. The median body mass index was 27.0 kg/m2. Patients diagnosed with only hypertension were 29.1% while other predominant comorbidities with hypertension were diabetes mellitus (42.4%) and dyslipidemia (7.8%). Hypertension with diabetes mellitus were prevalent in the age group of >35-45 years (43.8%). More than half of the patients with hypertension (n=7656) had a sedentary lifestyle. Overall, 35.6%, 47.3%, and 56.7% of the patients were alcoholic, smokers (present and former), and had a family history of hypertension, respectively. CONCLUSION: The results showed that among the young population, hypertension was common in the age group of >35-45 years and diabetes mellitus and dyslipidemia were common comorbidities. Family history, sedentary lifestyle, smoking, alcohol consumption, and body mass index may also contribute to hypertension.

Clinical data analysis of telmisartan for hypertension management in Indian population.

It is of interest to evaluate the clinical characteristics, treatment patterns, clinical effectiveness, and safety of telmisartan as a monotherapy or as part of combination therapy in Indian adults (>18 years old) with hypertension. All patients were receiving telmisartan as monotherapy, or as a combination therapy for hypertension management. Demographics, risk factors, existing comorbidity, and ongoing medical therapies were retrieved from the patients' medical records. A total of 8607 patients with hypertension (median age, 51.0 years) were part of the study. The gender distribution suggested, 5534(64.3%) patients were male, and 3073 (35.7%) were female patients. The excess salt intake (39.0%) was the most common risk factor according to the results. The analysis revealed telmisartan dual therapy (57.9%) as the most prescribed therapy, followed by monotherapy (32.5%), and triple therapy (9.6%). Further, telmisartan 40mg (21.3%) and telmisartan 40mg plus amlodipine 5mg (17.6%) were the most commonly prescribed therapies. The data suggested that only 17.2% of patients required dose titration. The mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) (mmHg) were significantly decreased with monotherapy (mean change: 19.8 [15.1] mmHg and 8.8[8.2] mmHg), dual therapy (mean change: 23.7 [16.6] mmHg and 10.3[8.5] mmHg), and triple therapy (mean change: 28.6 [19.0] mmHg and 12.1[10.8] mmHg) after the treatment (P<0.001). A total of 98.4% of the patients were compliant, and 97.6% achieved the target blood pressure goal with telmisartan-based therapy. There were 157 adverse events reported altogether. The Physicians' global evaluation of efficacy and tolerability showed the majority of the patients receiving telmisartan-based therapy on a good to excellent scale. Telmisartan used as a monotherapeutic agent or as a part of combination therapy was successful and effective in reducing blood pressure and achieving the blood pressure target. Irrespective of the patient's age, duration, and stages of hypertension, the study resulted in a good to excellent scale in efficacy and tolerability in the Indian patients having hypertension.

Risk factors, comorbiditiEs and Atherogenic dysLipidaemia in Indian YOUNG patients with dyslipidaemia attending hospital/clinic: REAL YOUNG (dyslipidaemia) study.

OBJECTIVE: To evaluate the pattern of dyslipidaemia, risk factors, and comorbidities in young Indian adults with dyslipidaemia. METHODS: A retrospective, multi-centric real-world study included individuals with dyslipidaemia, aged 18 - 45 years, attending to 623 hospitals/clinics across India. Data were collected retrospectively from medical records to note demographics, risk factors (smoking, alcohol consumption, sedentary lifestyle, family history of dyslipidaemia, diabetes mellitus, and hypertension), and clinical details (height, weight, waist circumference, body mass index (BMI), blood pressure, blood sugar, glycated hemoglobin (HbA1c), triglycerides (TG), total cholesterol (TC), low-density lipoproteins (LDL-C), and high-density lipoprotein (HDL-C)).A descriptive analysis and comparative analysis (Mann-Whitney U test and Chi-square test) were done. RESULTS: Of the total 8135 patients, the majority were men (65.0%). Overall, 87.1% of population had one or multiple comorbidities which included the presence of dyslipidaemia alone (12.9%), dyslipidaemia with diabetes and hypertension (39.1%), dyslipidaemia with diabetes (33.6%), and dyslipidaemia with hypertension (14.4%). Sedentary lifestyle was prevalent observation in >50% of the population. Youngest age (18 - 25) group had higher prevalence of hypertriglyceridemia (63.2%), high LDL-C levels (56.8%), and low HDL-C levels (64.6%), while patients from the age group >25 to ≤35 years had the highest incidence of hypercholesterolemia (66.6%). Atherogenic dyslipidaemia was observed in 41.9%, 25.5%, and 23.2% of patients from age groups of ≥18 to ≤25, >25 to ≤35, and >35 to ≤45 years, respectively. Patients with HbA1c ≥6.5% had significantly higher levels of TG, TC, LDL-C, and lower HDL-C compared to those with HbA1c <6.5%. CONCLUSION: Hypertriglyceridemia, high LDL-C, low HDL-C, and atherogenic dyslipidaemia were prevalent in the young Indian cohort and sedentary lifestyle, and HbA1c ≥ 6.5% were the predominant risk factors of dyslipidaemia.