Postmarketing Surveillance Study on Amlopres-L (Amlodipine/Lisinopril combination)

19 Apr, 14

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Aim

To assess the antihypertensive efficacy and safety of a fixed-dose combination of amlodipine and lisinopril (Amlopres-L) in Indian patients.

Study Patients

Patients with moderate hypertension or hypertension not controlled by amlodipine and atenolol alone (N=340).

Study Medication

Amlodipine 5 mg and lisinopril 5 mg once daily (Amlopres L)

Efficacy Parameters

Responder rate defined as patients who achieved DBP ≤90 mmHg at the end of the study.

Results

Treatment with Amlopres-L showed significant reduction in blood pressure at end of 4 weeks

* p<0.05

At the end of therapy 78% of patients were classified as 'responders' to Amlopres-L therapy
According to the study investigators Amlopres-L was 'very effective' in 69.7% patients, 'moderately effective' in 27.58% and poorly effective' in 2.7% patients

Safety

Amlopres-L was safe in Indian patients with hypertension
Treatment with Amlopres-L exhibited an excellent tolerability profile
Commonly seen side effects were oedema, fatigue and headache

The once daily regimen of the fixed dose combination of amlodipine and lisinopril is safe in Indian patients with hypertension and results in clinically valuable additive antihypertensive effects.

The Indian Practitioner 1998: 51; 441-447

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