Comparison of High Dose Mono-Therapy of Amlodipine or Telmisartan and Their Low Dose Combination in Mild to Moderate Hypertension
Hypertension is one of the leading public health challenges worldwide. It is common in both developed and developing countries.
Essential hypertension is believed to be a result of complex interaction of genetic and environmental factors. Increased peripheral resistance is responsible for most of the cases of essential hypertension.
Angiotensin Receptor Blockers (ARB) is first line therapy of Hypertension. Telmisartan is a potent, long-lasting, nonpeptide angiotensin II antagonist that acts on the Angiotensin 1 (AT 1) receptor subtype. The effective dose of Telmisartan is 40–80 mg once daily.
Calcium channel blockers (CCBs) are another class of first line anti-hypertensive drugs. Amlodipine, a third generation dihydropyridine calcium antagonist, is illustrated by a lesser negative inotropic effect and higher vascular selectivity compared to other CCBs. The recommended anti-hypertensive dose of Amlodipine in adults is 2.5 to 10 mg.
In cases of mild to moderate hypertension, the initiation of drug treatment with a low dose of either CCBs or ARBs is an established therapy.
However, optimal treatment strategies in mild to moderate hypertensive patients who fail to achieve blood pressure (BP) control with high-dose mono-therapy are not well established.
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This study was planned to compare efficacy and safety of low dose combination of Amlodipine (CCB) and Telmisartan (ARB) vs. high dose mono-therapy of each in mild to moderate hypertensives, who failed to achieve blood pressure control with low dose mono-therapy of either drug.
In the present study, low dose combination of Amlodipine 5 mg and Telmisartan 40 mg showed maximum reduction in mean SBP as compared to Telmisartan 80 mg mono-therapy and in mean DBP as compared to Amlodipine 10 mg mono-therapy after two, four & eight weeks treatment.
Adverse Drug Reactions (ADRs) were also lowest in combination group. Achievement of target SBP and target DBP was also seen in low dose combination group as compared to Amlodipine or Telmisartan alone.
In this study, a low dose Telmisartan–Amlodipine combination has demonstrated significantly greater BP reductions for both SBP and DBP compared to high dose mono-therapy of Telmisartan and Amlodipine in the overall study population. This combination is well tolerated with a safety profile consistent with its mono-therapy components.
So, in terms of BP control, low-dose combination therapy appears a better therapeutic approach than high-dose mono-therapy for mild to moderate hypertensive patients who failed to achieve BP target on low-dose mono-therapy.
This study indicates that clinicians can be assured of efficacy and safety of low dose combination than monotherapy.
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Introduction: Hypertension is one of the major public health challenges worldwide. Angiotensin receptor blockers (ARBs) and Calcium channel blockers (CCBs) are among the first line antihypertensive drugs. However, optimal treatment strategies in mild to moderate hypertensives who failed to achieve blood pressure (BP) control with low-dose mono-therapy are not well established. This study was done to compare efficacy and safety of high dose mono-therapy of Amlodipine, Telmisartan and their low dose combination in mild to moderate hypertensives who failed to achieve BP control with low dose mono-therapy of either drug.
Materials and Methods: A total of 96 patients, fulfilling inclusion and exclusion criteria were enrolled in the study after obtaining informed consent. Patients were randomized into three treatment groups i.e. Telmisartan 80 mg, Amlodipine 10 mg and low dose combination of Telmisartan 40 mg +Amlodipine 5 mg once daily for two months. The systolic BP, Diastolic BP, and ADRs were recorded at 0, 2, 4, 8 weeks.
Results: In the present study, significant reduction of mean systolic blood pressure (SBP) and mean diastolic blood pressure (DBP) was seen in all the three treatment groups. Low dose combination of Amlodipine 5 mg and Telmisartan 40 mg showed statistically significant reduction in SBP as compared to Telmisartan 80 mg mono-therapy and in DBP as compared to Amlodipine 10 mg mono-therapy. Maximum adverse drug reactions (ADRs) were reported in Amlodipine mono-therapy group, like ankle oedema, constipation, headache and fatigue.
Discussion and Conclusion: In term of BP control, low-dose combination therapy appears a better therapeutic approach than high-dose mono-therapy.
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