International journal of nephrology and renovascular disease · 2026
Effectiveness and Safety of Telmisartan Plus Amlodipine Compared to Telmisartan Plus Cilnidipine in Indian Patients with Hypertension and Renal Impairment: A Randomized, Open Label, Post Marketing Study (START Renal).
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Jadhav Uday, Guha Santanu, Mittal Harsh, Barik Chinmoy, Gillurkar Chandrashekhar S, Gupta Sandeep Kumar, Gupta Mukulesh, Saklecha Santosh, Jadhav Mayur, Choudhari Sanjay Y, Patil Saiprasad, Bhushan Sumit, A Divakar, Barkate Hanmant
Аннотация
PURPOSE: To assess the effectiveness and safety of telmisartan-amlodipine (TA) versus telmisartan-cilnidipine (TC) fixed-dose combinations (FDCs) in patients with hypertension and renal impairment.
PATIENTS AND METHODS: This open label, randomized, multicentric, post-marketing study was conducted in India. Adult patients with hypertension and renal impairment, receiving a stable dose of telmisartan and not on calcium channel blockers, were enrolled. Participants were randomized (1:1) to receive the TA or TC FDC for 12 months. The primary endpoint was change in the urine albumin-creatinine ratio (UACR) from baseline to 12 months. Secondary endpoints included changes in estimated glomerular filtration rate (eGFR), serum creatinine, and serum uric acid at 6 and 12 months, and office systolic blood pressure (SBP) and diastolic blood pressure (DBP) at 3, 6, 9, and 12 months. Similar parameters were assessed in the diabetic subpopulation. Adverse events were recorded and classified using system organ classification.
RESULTS: At 12 months, the TA and TC groups showed significant reductions in UACR by 119±157.7 mg/g and 97.5±128.6 mg/g, respectively (p<0.0001 for both). Improvements in eGFR and serum creatinine were comparable between groups (p>0.05). SBP reduction was significantly greater with TA at both 9 months (20.74±12.75 vs. 16.9±13.66) mmHg, (p=0.0430)] and 12 months (25.4±14.25 vs. 20.6±10.94) mmHg, (p=0.0397)], while DBP reductions were similar. The diabetic subgroup showed a superior SBP reduction favoring the TA group -24.5 (±13.75) mmHg (p≤.0001) Vs -18.9 (±10.68) mmHg (p≤.0001) while the renal parameters were similar between the two groups. A total of 17 mild drug-related adverse events were reported (TA: 8; TC: 9), with no serious events.
CONCLUSION: Both the TA and TC FDCs were effective and well tolerated when treating hypertension with renal impairment. The TA FDC may provide better BP reduction with similar reno-protective benefits than the TC FDC.
PATIENTS AND METHODS: This open label, randomized, multicentric, post-marketing study was conducted in India. Adult patients with hypertension and renal impairment, receiving a stable dose of telmisartan and not on calcium channel blockers, were enrolled. Participants were randomized (1:1) to receive the TA or TC FDC for 12 months. The primary endpoint was change in the urine albumin-creatinine ratio (UACR) from baseline to 12 months. Secondary endpoints included changes in estimated glomerular filtration rate (eGFR), serum creatinine, and serum uric acid at 6 and 12 months, and office systolic blood pressure (SBP) and diastolic blood pressure (DBP) at 3, 6, 9, and 12 months. Similar parameters were assessed in the diabetic subpopulation. Adverse events were recorded and classified using system organ classification.
RESULTS: At 12 months, the TA and TC groups showed significant reductions in UACR by 119±157.7 mg/g and 97.5±128.6 mg/g, respectively (p<0.0001 for both). Improvements in eGFR and serum creatinine were comparable between groups (p>0.05). SBP reduction was significantly greater with TA at both 9 months (20.74±12.75 vs. 16.9±13.66) mmHg, (p=0.0430)] and 12 months (25.4±14.25 vs. 20.6±10.94) mmHg, (p=0.0397)], while DBP reductions were similar. The diabetic subgroup showed a superior SBP reduction favoring the TA group -24.5 (±13.75) mmHg (p≤.0001) Vs -18.9 (±10.68) mmHg (p≤.0001) while the renal parameters were similar between the two groups. A total of 17 mild drug-related adverse events were reported (TA: 8; TC: 9), with no serious events.
CONCLUSION: Both the TA and TC FDCs were effective and well tolerated when treating hypertension with renal impairment. The TA FDC may provide better BP reduction with similar reno-protective benefits than the TC FDC.