Key result
Low-dose chlorthalidone (6.25 mg) plus atenolol (25 mg) was noninferior to high-dose atenolol alone and an atenolol-amlodipine combination for blood pressure response (p=0.799).
Why the study?
Does low-dose chlorthalidone plus atenolol combination improve blood pressure in stage I hypertensive patients uncontrolled on monotherapy compared to high-dose atenolol or atenolol plus amlodipine?
RCT (n=300)
randomized
Yes
Does low-dose chlorthalidone plus atenolol combination improve blood pressure in stage I hypertensive patients uncontrolled on monotherapy compared to high-dose atenolol or atenolol plus amlodipine?
p-value: p=0.799
Low-dose chlorthalidone (6.25 mg) combined with atenolol is noninferior to high-dose atenolol or atenolol plus amlodipine for blood pressure control in stage I hypertension, potentially reducing metabolic adverse effects.
May support low-dose combination to limit adverse effects in stage I hypertension; extends options for atenolol-based regimens.
OBJECTIVE: To compare the efficacy and safety of low-dose chlorthalidone + atenolol combination with atenolol and atenolol + amlodipine combination in stage I hypertensive patients uncontrolled on active run-in monotherapy. METHODS: Newly diagnosed stage I hypertensive patients were randomized to active run-in monotherapy either with atenolol 25 mg (98/300) or chlorthalidone 6.25 mg (100/300) or amlodipine 2.5 mg (102/300). A total of 282/300 patients (atenolol 92, chlorthalidone 91, amlodipine 99) completed the active run-in phase successfully. Patients uncontrolled on active run-in monotherapy (atenolol 33, chlorthalidone 45, amlodipine 47) received the study treatment, namely atenolol 50 mg alone, chlorthalidone 6.25 mg+atenolol 25 mg and atenolol 25 mg+amlodipine 2.5 mg, respectively. Efficacy of the therapy was evaluated by BP measurement at weeks 12 and 20 post-therapy. RESULTS: Post-active run-in monotherapies, the study treatment groups showed a significant fall in mean SBP and DBP from baseline (p<0.05). The mean fall in SBP and DBP was comparable for study treatments (atenolol 50 mg, atenolol 25 mg+chlorthalidone 6.25 mg and atenolol 25 mg+amlodipine 2.5 mg) (p=0.337 for SBP and p=0.054 for DBP) at week 12 and (p=0.744 for SBP and p=0.855 for DBP) at week 20; also, the percentage of responders was comparable for the three study treatment groups (p=0.799) indicating that the low-dose chlorthalidone+atenolol combination is noninferior to the high-dose atenolol alone and atenolol+amlodipine combination. No serious laboratory/clinical adverse events were reported in this study. CONCLUSION: Chlorthalidone 6.25 mg in combination with atenolol 25 mg is effective and safe in stage I (JNC 7) essential hypertensive patients. This low dose of chlorthalidone could reduce dose-related concerns over metabolic adverse effects and may lead to wider usage of this proven antihypertensive agent in combination therapy.
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Pareek et al. (2008) conducted an RCT in stage I hypertension (n=300). chlorthalidone + atenolol vs. atenolol 50 mg alone and atenolol 25 mg + amlodipine 2.5 mg was evaluated on fall in mean SBP and DBP from baseline and percentage of responders (p=0.799). Low-dose chlorthalidone (6.25 mg) plus atenolol (25 mg) was noninferior to high-dose atenolol alone and an atenolol-amlodipine combination for blood pressure response (p=0.799).
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