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[Multicenter comparative study of felodipine-ER and nifedipine-OROS in the treatment of mild-to-moderate arterial
M Batlouni1, R Leite Luna, I Castro
1Instituto Dante Pazzanese de Cardiologia, São Paulo, SP.
Insights
Felodipine-ER and nifedipine OROS effectively lower blood pressure in patients with mild-to-moderate hypertension, showing similar efficacy and good tolerance. Both treatments are well-tolerated, with comparable side effect profiles in this hypertension study.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Medicine
Background:
- Arterial hypertension (AH) is a prevalent condition requiring effective management.
- Calcium channel blockers are a cornerstone in hypertension treatment.
- Comparing extended-release formulations ensures optimal patient outcomes.
Purpose of the Study:
- To evaluate and compare the efficacy of felodipine-ER and nifedipine OROS in treating mild-to-moderate uncomplicated arterial hypertension.
- To assess the tolerance and safety profiles of both felodipine-ER and nifedipine OROS.
- To determine if once-daily dosing of these antihypertensives provides comparable blood pressure control.
Main Methods:
- A multicenter, open-label, randomized, parallel trial involving 121 patients with mild-to-moderate essential hypertension.
- Patients received a two-week placebo period, followed by randomization to either felodipine-ER (5mg/day) or nifedipine OROS (30mg/day).
- Blood pressure, heart rate, laboratory tests, and ECGs were monitored at baseline and study completion, with blood pressure measured approximately 24 hours post-dose.
Main Results:
- Both felodipine-ER and nifedipine OROS significantly reduced systolic and diastolic blood pressure (p < 0.0001).
- Adequate blood pressure response was achieved in 78.3% of patients on felodipine-ER and 74.5% on nifedipine OROS (not statistically significant).
- Adverse events occurred in approximately 15% of patients in both groups, were generally mild and transient, and led to withdrawal in a small number of participants.
Conclusions:
- Felodipine-ER and nifedipine OROS demonstrate similar efficacy in managing mild-to-moderate essential hypertension.
- Both antihypertensive medications are generally well-tolerated, with comparable safety profiles.
- Once-daily felodipine-ER and nifedipine OROS are suitable treatment options for patients with uncomplicated mild-to-moderate hypertension.
Purpose:
To compare the efficacy and tolerance of felodipine-ER and nifedipine OROS, both once daily, in the treatment of mild-to-moderate uncomplicated arterial hypertension (AH).
Methods:
This was a multicentric, opened, randomized, paralled trial, that selected 121 patients with uncomplicated, mild to moderate essential AH (diastolic blood pressure (DBP) > or = 95 and < or = 110 mmHg; not under anti-hypertensive medication. All patients received placebo for two weeks. After that period, they would take either 5mg/day of felodipine, or 30mg/day of nifedipine OROS, both once daily, in a randomized fashion. Patients underwent laboratory tests and electrocardiogram (ECG) at the begining and at the end of the study, and heart rate and blood pressure (BP) measurements, nearly 24 hours after the last active drug dose.
Results:
Completed the study 111 patients, 60 in the felodipine group and 51 in the nifedipine group. Compared to baseline, the average of systolic BP and DBP decreased from 162.5 +/- 14.3mmHg and from 102.2 +/- 5.1mmHg to 143.3 +/- 14.6 and 87.9 +/- 7.2mmHg, respectively, at the end of the treatment in the felodipine group; and from 160.5 +/- 16.3mmHg and 102.5 +/- 6.2mmHg to 136.1 +/- 14.2 and 86.7 +/- 7.0mmHg, respectively in nifedipine group (p < 0.0001 for all diferences). Adequate BP response to the treatment (DBP normalization or reduction > 10mmHg from baseline) occured in 47/60 (78.3%) patients in the felodipine group and in 38/51 (74.5%) in the nifedipine group (NS). Side effects, occured in approximately 15% of the cases, and were similar in both groups. These were usually moderate and transient, but were responsible for the withdrawal from the study of two cases in the felodipine group and of three cases in the nifedipine group.
Conclusion:
Felodipine-ER and nifedipine OROS, are similarly effective and generally well tolerated in patients with mild-to-moderate essential hypertension.