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Combo of Fimasartan/Hydrochlorothiazide benefits Hypertensive Patients

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Combo of Fimasartan/Hydrochlorothiazide benefits Hypertensive Patients

Hypertension is a major independent risk factor for coronary artery disease, stroke, and renal failure. Reducing the blood pressure below the target goal is important to prevent cardiovascular and cerebrovascular events.

Fimasartan is one of the new antihypertensive drugs that lower the BP by blocking the angiotensin II type 1 receptor. Availability of various antihypertensive drugs, achieving target BP is difficult in the majority of the patients with hypertension. Most of them require a combination of two or more drugs are used to achieve their target BP as effective BP reduction is difficult with monotherapy. The most common drug used in the combination with angiotensin-receptor blockers (ARBs) is hydrochlorothiazide (HCTZ).

Objective of the Study

The main objective of the study was to compare the BP-lowering efficacy of fimasartan alone with that of fimasartan/HCTZ treatment in the patients with BP.

Study Criteria

Inclusion Criteria

Patients were included if they had:

  • Mean value of the two sitting diastolic blood pressure reading (siDBP) were
    <110 mmHg on screening visit who were on antihypertensive medication
  • Mean values of the two siDBP reading was ≥ 90 mmHg and
    <120 mmHg on screening visit who were on antihypertensive naïve

Exclusion Criteria

Patients were excluded if they had:

  • Mean sitting systolic blood pressure (siSBP) ≥ 200 mmHg at the screening visit
  • Difference of siSBP ≥ 20 mmHg or siDBP ≥ 10 mmHg between arms
  • Secondary hypertension
  • Renal Impairment
  • Active hepatitis B or C
  • Positive status for HIV
  • Electrolyte imbalance
  • Insulin-dependent or uncontrolled diabetes mellitus
  • Retinal hemorrhage
  • Drug or alcohol dependency

Materials and Methods

Sample Size

Patients of age 18 years and above were enrolled in the study. A total of 654 patients were selected for the study.

Study Design

The study was conducted at 18 institutions in as a multicenter, randomized, active-controlled, double-blind, parallel-group, and dose-titration trial. The study design was approved by the Korea Food Drug Administration and institutional review board of each site.

Study Procedure

A total of 654 patients were selected for the study. Among them, 263 were matched to eligible for the randomization criteria. Among the 263 patients, 175 were assigned to take four weeks of Fimasartan /HCTZ treatment, and 88 were assigned to take Fimasartan treatment. The patients were assigned to take the medication once daily between 6 am and 10 am and were instructed to fast for 12 hours. At each visit, after 5 minutes of the rest in a sitting position, siSBP, siDBP, and pulse rate were measured twice with a one-minute interval between measurements in the same arm. The average two sitting BP measurements were used, and all adverse events were evaluated and recorded at each visit.

Statistical Analyses

The change from the baseline in siDBP and siSBP of the two groups at the end of 4 and 8 weeks of the treatment were compared by two-sample t test. Descriptive statistics for the rates of the responders and control subjects at weeks 4 and 8 were calculated, and the differences between the two groups were analyzed by the Pearson’s chi-square. Demographic characteristics were compared by using the Wilcoxon rank-sum test or t test for continuous variables and the chi-square test or Fisher’s exact test for categorical variables. All the data were analyzed using SAS® software, and all the tests were done at a significant level of 5 % using a two-sided test.

Efficacy Evaluation

The study was designed to compare the antihypertensive efficacy of fimasartan 60 mg/HCTZ 12.5 mg treatment to that of the treatment with fimasartan 60 mg.

The primary efficacy of this study was to compare the changes in mean siDBP from the baseline to week 4 treatments with the study drug and the control drug in the patients who did not achieve the target of siDBP after 4 weeks of prior treatment once-daily fimasartan 60mg.

The secondary efficacy was to

  • Change the mean siSBP from baseline at 4 and 8 weeks
  • BP control rate and response rate at 4 and 8 weeks
  • Change of mean siDBP from baseline at 8 weeks

Safety Evaluation

Safety and tolerability were assessed at each visit by physical examination, direct questioning, and clinical laboratory test. Blood and urine samples were collected for laboratory tests at baseline, week 4, and week 8. Electrocardiography was performed at screening at the end of the study.

Results

Means of sitting diastolic blood pressure (siDBP) at baseline and weeks 4 and 8

The response rate of the fimasartan/HTCZ treatment was higher than that of the fimasartan treatment. The fimasartan/HCTZ group showed the greater reduction of siDBP compared to the fimasartan group.

Means of sitting systolic blood pressure (siSBP) at baseline and weeks 4 and 8

The fimasartan/HCTZ group showed the greater reduction of siSBP compared to the fimasartan group.

Conclusion

The results of the current study proved that the combination treatment with fimasartan and HCTZ was effective in the patients with hypertension. The safety and tolerability of the combination fimasartan and HCTZ treatment were comparable to those of fimasartan therapy.

Reference:

Moo-Yong.R, et al, Efficacy of fimasartan/hydrochlorothiazide combination in hypertensive patients inadequately controlled by fimasartan monotherapy. Drug Des Devel Ther. June 2015; 9: 2847–2854.

Available at: http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4459623/

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