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Efficacy and safety of valsartan compared to enalapril in hypertensive children: a 12-week, randomized,
Franz Schaefer1, Mieczyslaw Litwin, Jacek Zachwieja
1Division of Paediatric Nephrology, Centre for Paediatric and Adolescent Medicine, University Hospital of Heidelberg, ImNeuenheimer Feld, Germany. franz.schaefer@med.uni-heidelberg.de
Insights
Valsartan and enalapril are equally effective and safe for treating high blood pressure (hypertension) in children aged 6-17. Both medications demonstrated comparable blood pressure reductions and were well-tolerated, offering effective hypertension management in pediatric patients.
Area of Science:
- Pediatric Cardiology
- Pharmacology
- Hypertension Management
Background:
- Pediatric hypertension is a growing concern with significant long-term cardiovascular implications.
- Limited data exists comparing the efficacy and safety of different antihypertensive agents in children.
- Valsartan and enalapril are commonly prescribed, but direct comparative studies in pediatric populations are needed.
Purpose of the Study:
- To compare the efficacy and safety of valsartan versus enalapril in hypertensive children aged 6-17 years.
- To assess noninferiority of valsartan to enalapril based on mean sitting systolic blood pressure (MSSBP) reduction.
- To evaluate other efficacy parameters including diastolic blood pressure, blood pressure control rates, and 24-hour ambulatory blood pressure monitoring.
Main Methods:
- A 12-week, randomized, double-blind, parallel-group, active-controlled study design.
- Inclusion of children aged 6-17 years with MSSBP at or above the 95th percentile for age, gender, and height.
- Force-titration of valsartan and enalapril to full doses over 11 weeks following a placebo run-in period.
Main Results:
- Valsartan demonstrated noninferiority to enalapril in reducing MSSBP (P < 0.0001).
- Both drugs achieved similar reductions in MSSBP (-15.4/-9.4 mmHg for valsartan vs. -14.1/-8.5 mmHg for enalapril) and blood pressure control rates (67% vs. 70%).
- Valsartan showed a statistically significant greater reduction in mean 24-hour systolic blood pressure compared to enalapril (P = 0.03).
Conclusions:
- Valsartan and enalapril are comparable in efficacy and safety for treating hypertension in children aged 6-17.
- Both antihypertensive agents provide effective blood pressure control and are well-tolerated in the pediatric population.
- The findings support the use of both valsartan and enalapril as therapeutic options for pediatric hypertension.
Objective:
This study compares efficacy and safety of valsartan with enalapril in hypertensive children aged 6-17 years.
Method:
This was a 12-week, randomized, double-blind, parallel-group, active-controlled study. After a single-blind placebo run-in period (4-28 days), patients with mean sitting systolic blood pressure (BP) (MSSBP) at least 95th percentile for age, gender, and height were randomized to receive half the assigned dose for first week, and force-titrated to full dose for 11 weeks (≥18 to <35 kg - valsartan: 80 mg, enalapril: 10 mg; ≥35 to <80 kg - valsartan: 160 mg, enalapril: 20 mg; ≥80 to ≤160 kg - valsartan: 320 mg, enalapril: 40 mg). The primary efficacy variable was changed from baseline in MSSBP to show noninferiority of valsartan to enalapril. Other efficacy variables were changed from baseline in MSDBP, SBP control rate, and 24-h ambulatory BP parameters.
Results:
Of 300 randomized patients, 281 (94%) completed the study. At week 12, MSSBP reductions were similar for valsartan and enalapril (primary endpoint of noninferiority, P < 0.0001). Least square mean BP reductions from baseline of -15.4/-9.4 mmHg were observed for valsartan compared with -14.1/-8.5 mmHg for enalapril. A similar proportion of patients achieved SBP control (valsartan: 67%; enalapril: 70%). In the subset of patients who underwent ambulatory BP assessments, valsartan provided greater reductions than enalapril in mean 24-h SBP (valsartan: -9.8 mmHg, enalapril: -7.2 mmHg: P = 0.03). The overall incidence of AEs was similar (valsartan 60%, enalapril 58%) with headache, cough, and nasopharyngitis reported most frequently.
Conclusions:
Valsartan and enalapril provided comparable BP reductions and effective BP control and were well tolerated in hypertensive children aged 6-17 years.
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