Introduction:
Hypertension is reported to affect 35.5% of Indian adults. The telmisartan/amlodipine (T/A) fixed-dose combination (FDC) is widely prescribed, but limited real-world evidence has been documented regarding its safety and efficacy across different body mass index (BMI) categories in Indian patients.
Objective:
To evaluate the effectiveness and safety of T/A FDC in Indian patients with hypertension based on baseline BMI categories.
Methods:
- Design: Prospective, multicenter, observational real-world study.
- Participants: Adults ≥18 years with newly diagnosed or uncontrolled hypertension eligible for T/A FDC, n = 5363.
- BMI Subgroups:
- G1: BMI <25 kg/m² (n=2,603)
- G2: BMI 25–30 kg/m² (n=1,893)
- G3: BMI >30 kg/m² (n=867) Primary Endpoint: Change in systolic blood pressure (SBP) from baseline to week 8.
Results:
- Baseline Characteristics: Mean age ~57 years across groups; male representation ~46%.
- History of Hypertension: Present in 47.89% (G1), 35.45% (G2), and 16.66% (G3).
- Baseline SBP/DBP: Similar across all groups.
- Blood Pressure Reduction at Week 8:
|
Blood Pressure Parameter |
Group 1 (G1) |
Group 2 (G2) |
Group 3 (G3) |
P-value |
|
Systolic Blood Pressure (SBP) |
–19.16 mmHg |
–19.09 mmHg |
–19.15 mmHg |
<0.001 (all) |
|
Diastolic Blood Pressure (DBP) |
–15.86 mmHg |
–16.18 mmHg |
–16.17 mmHg |
<0.001 (all)
|
- BP Goal Achievement (<140/90 mmHg): G1: 70.53%, G2: 69.15%, G3: 70.13%
- Safety: 5 mild adverse events reported.
- Physician and Patient Feedback: >98% physicians found treatment effective and well-tolerated; >99% patients were satisfied.
Conclusion:
Significant and consistent blood pressure reductions across all BMI groups in Indian patients with hypertension were achieved with the telmisartan-amlodipine fixed-dose combination, and the treatment was well tolerated.
Body Mass Index among Individuals with T2DM uncontrolled on Monotherapy: Results from an Analysis of a Pan-India Conducted Real-World Study (NOVELTY)
Introduction:
Obesity is commonly observed as a comorbidity in type 2 diabetes mellitus (T2DM) and has been associated with multiple diabetes-related complications. Body mass index (BMI) is widely utilized to identify overweight and obesity status. The effectiveness and safety of vildagliptin sustained release (XR) 100 mg once daily added to metformin in patients with T2DM uncontrolled on monotherapy were assessed in the real-world NOVELTY study.
Objective:
To stratify individuals from the NOVELTY study by baseline BMI to understand the burden of obesity among Indian T2DM patients uncontrolled on metformin.
Methods:
- Observational, prospective, multicenter study in India.
- Included adults with T2DM uncontrolled on metformin XR (HbA1c >7.0%).
- Vildagliptin XR 100 mg added once daily.
- BMI categorized using WHO Asian cut-offs:
- Normal weight: <23 kg/m²
- Overweight: 23–24.9 kg/m²
- Obesity: ≥25 kg/m²
Results:
- Total patients: 1691 (mean age 53.1 years, mean diabetes duration 45.64 months, mean HbA1c 8.44%).
- Mean BMI: 27.57 kg/m², consistent across North, East, West, and South zones.
- BMI distribution:
- Normal weight: 14.23% (n=240)
- Overweight: 19.16% (n=323)
- Obese: 66.61% (n=1123) 25.03% had BMI ≥30 kg/m². BMI stratification was similar across geographic zones with minor variations.
Conclusion:
Comorbid obesity has been identified in two-thirds of Indian individuals with early-stage type 2 diabetes mellitus (T2DM) who are uncontrolled on monotherapy. Weight management should be addressed alongside glycemic control during the initial phase of diabetes treatment.
Impact of Baseline Body Mass Index on the Effectiveness and Safety of Torsemide-Spironolactone Fixed-Dose Combination in Indian Patients with Heart Failure: Subgroup Analysis from the Restore-HF Study
Introduction:
Obesity is recognized as a risk factor for heart failure (HF). The impact of baseline BMI on treatment effectiveness was evaluated to improve HF management. This analysis was conducted to assess the effectiveness and safety of a fixed-dose combination (FDC) of torsemide/spironolactone (T/S) in Indian HF patients based on baseline BMI.
Methods:
- Real-world prospective, multicenter observational study in India (Oct 2023–Jun 2024).
- Included adults aged 18–75 years with HF (NYHA class 2 & 3) on T/S FDC.
- BMI categories:
- G1: >30 kg/m²
- G2: 25–30 kg/m²
- G3: <25 kg/m² Primary endpoint: change in body weight from baseline to 3 weeks (end of study).
Results:
- Total patients analyzed: 1,520 (G1=369, G2=573, G3=578).
- Mean age (years): G1 = 59.05, G2 = 58.49, G3 = 58.45.
- Baseline mean weight (kg): G1 = 84.41, G2 = 74.58, G3 = 70.83.
- Mean weight reduction at EOS (kg): G1 = 2.85, G2 = 2.45, G3 = 2.09 (all P<0.001).
- Adverse events: 3 mild events reported, all in G2.
- Additional outcomes related to blood pressure and serum potassium are given below:
|
Parameter |
Timepoint |
G1 (BMI >30 kg/m2) (n=369) |
G2 (BMI 25–30 kg/m2) (n=573) |
G3 (BMI <25 kg/m2) (n=578) |
P-value |
|
SBP (mmHg), mean (SD) |
Baseline |
133.67 (2.94) |
133.43(3.13) |
133.27 (3.48) |
– |
|
End of Study |
128.79 (7.15) |
128.76 (6.46) |
128.43 (7.16) |
0.397 |
|
|
DBP (mmHg), mean (SD) |
Baseline |
86.09 (4.00) |
87.07 (4.07) |
87.43 (4.07) |
– |
|
End of Study |
84.95 (2.36) |
85.10 (2.39) |
84.92 (2.37) |
0.311 |
|
|
Serum Potassium (mEq/L), mean (SD) |
Baseline |
4.09 (0.49) |
4.09 (0.49) |
4.06 (0.46) |
– |
|
End of Study |
4.56 (0.59) |
4.58 (0.59) |
4.63 (0.58) |
0.467 |
- NYHA Class 3 patients significantly declined—from 127 to 19 in G1, 151 to 23 in G2, and 173 to 22 in G3—reflecting a major improvement in functional status.
- The number of patients with Grade 0 pitting oedema at the end of study in G1 was 60, in G2 was 132 and in G3 was 146, indicating marked reduction in fluid retention.
Conclusion:
Significant weight reduction across all baseline BMI categories was achieved by torsemide/spironolactone FDC in Indian patients with heart failure.
ECO, 11-14 May 205, Malaga, Spain
