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Efficacy of fimasartan/hydrochlorothiazide combination in hypertensive patients inadequately controlled by fimasartan monotherapy . BACKGROUND The study reported here compared the blood pressure ( BP ) -lowering efficacy of fimasartan alone with that of fimasartan/hydrochlorothiazide ( HCTZ ) combination in patients whose BP goal was not achieved after 4 weeks of treatment with once-daily fimasartan 60 mg. METHODS Patients with sitting diastolic blood pressure ( siDBP ) ≥90 mmHg with 4 weeks of once-daily fimasartan 60 mg were randomly assigned to receive either once-daily fimasartan 60 mg/HCTZ 12.5 mg or fimasartan 60 mg for 4 weeks . After 4 weeks , the dose was increased from fimasartan 60 mg/HCTZ 12.5 mg to fimasartan 120 mg/HCTZ 12.5 mg or from fimasartan 60 mg to fimasartan 120 mg if siDBP was ≥90 mmHg . RESULTS Of the 263 randomized patients , 256 patients who had available efficacy data were analyzed . The fimasartan/HCTZ treatment group showed a greater reduction of siDBP compared to the fimasartan treatment group at Week 4 ( 6.88±8.10 mmHg vs 3.38±7.33 , P=0.0008 ) , and the effect persisted at Week 8 ( 8.67±9.39 mmHg vs 5.02±8.27 mmHg , P=0.0023 ) . Reduction of sitting systolic BP in the fimasartan/HCTZ treatment group was also greater than that in the fimasartan treatment group ( at Week 4 , 10.50±13.76 mmHg vs 5.75±12.18 mmHg , P=0.0069 and , at Week 8 , 13.45±15.15 mmHg vs 6.84±13.57 mmHg , P=0.0007 ) . The proportion of patients who achieved a reduction of siDBP ≥10 mmHg from baseline and/or a mean siDBP < 90 mmHg after 4 weeks of treatment was higher in the fimasartan/HCTZ treatment group than in the fimasartan treatment group ( 53.6 % vs 39.8 % , P=0.0359 ) . The overall incidence of adverse drug reaction was 11.79 % with no significant difference between the treatment groups . CONCLUSION The combination treatment of fimasartan and HCTZ achieved better BP control than fimasartan monotherapy , and had comparable safety and tolerance to fimasartan monotherapy .
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Intervention_Pharmacological
fimasartan/hydrochlorothiazide combination
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Intervention_Physical
fimasartan monotherapy
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Intervention_Pharmacological
fimasartan alone
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Intervention_Pharmacological
fimasartan/hydrochlorothiazide ( HCTZ ) combination
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Intervention_Pharmacological
fimasartan
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Outcome_Other
Efficacy
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Outcome_Physical
blood pressure
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Outcome_Physical
sitting diastolic blood pressure ( siDBP )
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Participant_Condition
hypertensive patients
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Participant_Condition
diastolic blood pressure ( siDBP )
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Participant_Sample-size
263
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Participant_Sample-size
256