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A randomized, comparative, multicentric evaluation of atenolol/amlodipine combination with atenolol alone in
Anil Pareek1, Harsha Salkar, Pradeep Mulay
1Medical Affairs & Clinical Research, Ipca Laboratories Limited, Kandivli Industrial Estate, Kandivli, Mumbai, India. anilpareek@ipca.co.in
Insights
Atenolol/amlodipine combination therapy significantly lowers blood pressure more effectively than atenolol monotherapy for essential hypertension. This combination treatment leads to better blood pressure control and higher response rates in patients.
Area of Science:
- Cardiovascular Medicine
- Pharmacology
- Clinical Hypertension Research
Background:
- Elevated blood pressure (hypertension) is a major risk factor for cardiovascular diseases.
- Effective blood pressure control is crucial for reducing cardiovascular endpoints.
- Atenolol and amlodipine are common antihypertensive agents.
Purpose of the Study:
- To compare the efficacy of atenolol/amlodipine combination therapy versus atenolol monotherapy in reducing systolic and diastolic blood pressure.
- To assess the response rate and tolerability of both treatment regimens.
- To evaluate the achievement of normalized blood pressure levels.
Main Methods:
- A 12-week, randomized, comparative, multicentric study.
- Patients received either atenolol/amlodipine or atenolol monotherapy, with dose escalation for non-responders.
- Blood pressure measurements, response rates, and tolerability were assessed.
Main Results:
- Combination therapy demonstrated superior reductions in systolic blood pressure (SBP) and diastolic blood pressure (DBP) compared to monotherapy at both low and high doses.
- The combination group showed significantly higher response rates.
- More patients in the combination group achieved normalized blood pressure (SBP < 120 mmHg and DBP < 80 mmHg).
Conclusions:
- Once-daily atenolol/amlodipine fixed-dose combination therapy provides superior antihypertensive efficacy over atenolol monotherapy.
- This combination is effective in achieving blood pressure normalization in patients with mild-to-moderate essential hypertension.
- The findings support the use of atenolol/amlodipine combination for improved hypertension management.
Abstract:
As there is a strong, positive, and continuous correlation between blood pressure and risk of cardiovascular diseases; improved control of blood pressure is necessary to produce maximum reduction in clinical cardiovascular endpoints. The primary objective was to demonstrate that atenolol/amlodipine combination therapy is superior to atenolol monotherapy with respect to mean fall in systolic blood pressure and diastolic blood pressure. The secondary objective was to compare the response rate and to evaluate the tolerability of study medications. This randomized, comparative, multicentric, 12-week study consisted of screening visit followed by baseline visit 48-hours postscreening. All enrolled patients received 7-day placebo washout. Eligible patients were randomized to receive either atenolol 25 mg/amlodipine 2.5 mg or atenolol 25 mg alone. Nonresponders after 4 weeks of therapy were escalated to atenolol 50 mg/amlodipine 5 mg or atenolol 50 mg, respectively. Out of 190 enrolled patients (94: combination group; 96: monotherapy group), 174 patients (84: combination therapy, 90: monotherapy) completed the study. After 4 weeks of therapy, low-dose combination group was superior to low-dose monotherapy with respect to mean fall in SBP (P = 0.008) and DBP (P = 0.021) and response rate (P = 0.012). Also high-dose combination therapy was superior to high-dose monotherapy with respect to mean SBP (P = 0.001), DBP (P = 0.011), and response rate (P = 0.035) at the end of 12 weeks of therapy. At the end of therapy, significantly more number of patients from combination group achieved normalization of BP (SBP < 120 mmHg and DBP < 80 mmHg) (P = 0.009). Thus, once daily treatment with atenolol/amlodipine fixed-dose combination offers superior antihypertensive efficacy over atenolol monotherapy in patients with mild-to-moderate essential hypertension.
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