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[Multicenter community-based trial of amlodipine in hypertension in Israel]
C Yosefy1, J R Viskoper, Y Leshem
1Ben-Gurion University of the Negev, Beer Sheba.
Insights
Amlodipine effectively lowers blood pressure in patients with mild to moderate hypertension. This real-world study shows Amlodipine is well-tolerated and suitable for widespread use.
Area of Science:
- Cardiology
- Pharmacology
- Clinical Medicine
Background:
- Hypertension is a prevalent cardiovascular risk factor.
- Effective and well-tolerated antihypertensive medications are crucial for patient management.
Purpose of the Study:
- To evaluate the safety and efficacy of Amlodipine (AML) in a real-world setting for mild to moderate hypertension.
- To assess Amlodipine's effectiveness and tolerability in a diverse patient population.
Main Methods:
- Open, non-comparative trial involving 266 patients with mild to moderate hypertension.
- Amlodipine initiated at 5 mg daily, with dose adjustment to 10 mg if needed.
- Patients were evaluated over 12 weeks, with blood pressure and adverse events monitored.
Main Results:
- Significant reduction in blood pressure (BP) from 165/101 mmHg to 139/83 mmHg (p < 0.05).
- Greater BP reduction observed in patients under 70 years and those with BMI > 30 kg/m2.
- Most common adverse event was pedal edema (2.6% requiring cessation); overall tolerability was good.
Conclusions:
- Amlodipine is an effective antihypertensive agent for mild to moderate hypertension in a real-world clinical setting.
- The drug demonstrates good tolerability, with manageable side effects.
- Amlodipine is a suitable treatment option for a broad range of hypertensive patients.
Abstract:
The safety and efficacy of Amlodipine (AML) for mild to moderate hypertension was evaluated in a "real life" setting. This open non-comparative trial included 123 men and 143 women (age 30-91 years, mean 59.4). All had sitting diastolic blood pressure (DBP) between 95 and 115 mmHg, confirmed in most by 2 baseline measurements, 2 weeks apart. Eligible patients were given AML 5 mg daily as add-on or monotherapy and were evaluated 4 weeks later. If DBP was then > 90 mmHg, the daily dose was raised to 10 mg; those with < 90 mmHg remained on 5 mg. AML was continued for 8 weeks. Other BP-lowering drugs were unchanged. Of the original 266 patients 22 (8.2%) withdrew due to adverse events (AE), and others were protocol violators, lost to follow-up or withdrew, leaving 211 available for efficacy analysis. In this major group BP was reduced from 165 +/- 15/101 +/- 4 to 139 +/- 11/83 +/- 5 after 12 weeks of AML (p < 0.05). The reduction was greater in those under 70 years, from 173 +/- 12/100 +/- 5 to 142 +/- 12/80 +/- 4 (p < 0.05). In those with BMI > 30 kg/m2, BP decreased from 165 +/- 15/101 +/- 5 to 140 +/- 12/83 +/- 5 (p < 0.05). Mean change in heart rate was -1.5 bpm (p < 0.05). Mean final AML dose was 5.5 mg/day. The most common AML-related AE requiring cessation of the drug was pedal edema in 2.6% of the 266 patients; in 3.7% it persisted during therapy. Other AE occurring in > 1% were dizziness in 1.8%, headache 1.5%, flushing 1.1% and fatigue 1.1%. We conclude that AML is an effective and well-tolerated antihypertensive suitable for most hypertensive patients.