Efficacy and Tolerability of Telmisartan/Amlodipine + Hydrochlorothiazide Versus Telmisartan/Amlodipine Combination Therapy for Essential Hypertension Uncontrolled With Telmisartan/Amlodipine

The Phase III, Multicenter, Randomized, Double-blind TAHYTI Study

Ki Chul Sung, Yong Seog Oh, Dong Hun Cha, Soon Jun Hong, Kyung Heon Won, Ki Dong Yoo, Seung-Woon Rha, Young Keun Ahn, Jeong Cheon Ahn, Ji Yong Jang, Tack Jong Hong, Sang Kyoon Cho, Sang Ho Park, Min Su Hyon, Chang Wook Nam, In Ho Chae, Byung Su Yoo, Jong Min Song, Jin Ok Jeong, Young Won Yoon & 8 others Byung Soo Kim, Tae Hyun Yang, Deok Kyu Cho, Sang Hyun Kim, Yu Jeong Choi, Ji Hun Ahn, Dong Woon Jeon, Hyo Soo Kim

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Purpose This 8-week study in Korea aimed to evaluate the efficacy and tolerability of a telmisartan/amlodipine + hydrochlorothiazide (TAH) combination versus telmisartan/amlodipine (TA) combination in patients with essential hypertension that did not respond appropriately to 4-week treatment with TA. Methods All patients who met the inclusion criteria received TA (40/5 mg) during a 4-week run-in period (period 1). Patients who met the criteria for essential hypertension (mean sitting systolic blood pressure [MSSBP], ≥140 and <200 mm Hg, or ≥130 and<200 mm Hg in those with diabetes mellitus or chronic kidney disease) after period 1 were randomly assigned to receive TA 40/5 mg + hydrochlorothiazide 12.5 mg (test group) or TA only (control group). The test and control drugs were administered in each group for 2 weeks (period 2). Patients who completed period 2 underwent 6-week treatment (period 3) with a TAH and TA dose twice that in period 2. The primary end point was the change in MSSBP at week 8 of treatment. Secondary end points were the change in MSSBP at week 2 and MS diastolic BP, BP control rate, and BP response rate at weeks 2 and 8. Treatment tolerability was assessed based on adverse events (AEs), laboratory evaluations (chemistry, hematology, and urinalysis), 12-lead ECG, and physical examination including vital sign measurements. Findings We randomized 310 patients to the treatment groups. The mean (SD) ages of the TAH and TA groups were 62.0 (10.8) and 63.4 (10.4) years, respectively. The least squares mean change in MSSBP was significantly greater in the TAH group than in the TA group after 8 weeks (–18.7 vs –12.2 mm Hg; P < 0.001). Similar results were obtained on changes in MSSBP after 2 weeks and changes in sitting diastolic BP, BP control rate, and BP response rate at weeks 2 and 8 compared with the respective baseline values. The prevalences of treatment-emergent AEs (29.0% vs 16.3%; P = 0.008) and adverse drug reactions (20.0% vs 10.5%; P = 0.020) were significantly greater in the TAH group than in the TA group. Most treatment-emergent AEs were mild or moderate; none were severe. The most frequently reported AEs were dizziness and headache. Implication TAH triple therapy was more effective than was TA double therapy in reducing BP in these patients in Korea with essential hypertension that did not adequately respond to TA. ClinicalTrials.gov identifier: NCT02738632.

Original languageEnglish
Pages (from-to)50-63.e3
JournalClinical Therapeutics
Volume40
Issue number1
DOIs
Publication statusPublished - 2018 Jan 1

Fingerprint

Double-Blind Method
Blood Pressure
Therapeutics
hydrochlorothiazide drug combination telmisartan
Essential Hypertension
telmisartan amlodipine combination
Korea
Hydrochlorothiazide
Urinalysis
Vital Signs
Drug and Narcotic Control
Dizziness
Hematology
Drug-Related Side Effects and Adverse Reactions
Least-Squares Analysis
Chronic Renal Insufficiency
Physical Examination
Headache

Keywords

  • amlodipine
  • blood pressure control
  • hydrochlorothiazide
  • hypertension
  • telmisartan
  • triple combination

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

Efficacy and Tolerability of Telmisartan/Amlodipine + Hydrochlorothiazide Versus Telmisartan/Amlodipine Combination Therapy for Essential Hypertension Uncontrolled With Telmisartan/Amlodipine : The Phase III, Multicenter, Randomized, Double-blind TAHYTI Study. / Sung, Ki Chul; Oh, Yong Seog; Cha, Dong Hun; Hong, Soon Jun; Won, Kyung Heon; Yoo, Ki Dong; Rha, Seung-Woon; Ahn, Young Keun; Ahn, Jeong Cheon; Jang, Ji Yong; Hong, Tack Jong; Cho, Sang Kyoon; Park, Sang Ho; Hyon, Min Su; Nam, Chang Wook; Chae, In Ho; Yoo, Byung Su; Song, Jong Min; Jeong, Jin Ok; Yoon, Young Won; Kim, Byung Soo; Yang, Tae Hyun; Cho, Deok Kyu; Kim, Sang Hyun; Choi, Yu Jeong; Ahn, Ji Hun; Jeon, Dong Woon; Kim, Hyo Soo.

In: Clinical Therapeutics, Vol. 40, No. 1, 01.01.2018, p. 50-63.e3.

Research output: Contribution to journalArticle

Sung, KC, Oh, YS, Cha, DH, Hong, SJ, Won, KH, Yoo, KD, Rha, S-W, Ahn, YK, Ahn, JC, Jang, JY, Hong, TJ, Cho, SK, Park, SH, Hyon, MS, Nam, CW, Chae, IH, Yoo, BS, Song, JM, Jeong, JO, Yoon, YW, Kim, BS, Yang, TH, Cho, DK, Kim, SH, Choi, YJ, Ahn, JH, Jeon, DW & Kim, HS 2018, 'Efficacy and Tolerability of Telmisartan/Amlodipine + Hydrochlorothiazide Versus Telmisartan/Amlodipine Combination Therapy for Essential Hypertension Uncontrolled With Telmisartan/Amlodipine: The Phase III, Multicenter, Randomized, Double-blind TAHYTI Study', Clinical Therapeutics, vol. 40, no. 1, pp. 50-63.e3. https://doi.org/10.1016/j.clinthera.2017.11.006
Sung, Ki Chul ; Oh, Yong Seog ; Cha, Dong Hun ; Hong, Soon Jun ; Won, Kyung Heon ; Yoo, Ki Dong ; Rha, Seung-Woon ; Ahn, Young Keun ; Ahn, Jeong Cheon ; Jang, Ji Yong ; Hong, Tack Jong ; Cho, Sang Kyoon ; Park, Sang Ho ; Hyon, Min Su ; Nam, Chang Wook ; Chae, In Ho ; Yoo, Byung Su ; Song, Jong Min ; Jeong, Jin Ok ; Yoon, Young Won ; Kim, Byung Soo ; Yang, Tae Hyun ; Cho, Deok Kyu ; Kim, Sang Hyun ; Choi, Yu Jeong ; Ahn, Ji Hun ; Jeon, Dong Woon ; Kim, Hyo Soo. / Efficacy and Tolerability of Telmisartan/Amlodipine + Hydrochlorothiazide Versus Telmisartan/Amlodipine Combination Therapy for Essential Hypertension Uncontrolled With Telmisartan/Amlodipine : The Phase III, Multicenter, Randomized, Double-blind TAHYTI Study. In: Clinical Therapeutics. 2018 ; Vol. 40, No. 1. pp. 50-63.e3.
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abstract = "Purpose This 8-week study in Korea aimed to evaluate the efficacy and tolerability of a telmisartan/amlodipine + hydrochlorothiazide (TAH) combination versus telmisartan/amlodipine (TA) combination in patients with essential hypertension that did not respond appropriately to 4-week treatment with TA. Methods All patients who met the inclusion criteria received TA (40/5 mg) during a 4-week run-in period (period 1). Patients who met the criteria for essential hypertension (mean sitting systolic blood pressure [MSSBP], ≥140 and <200 mm Hg, or ≥130 and<200 mm Hg in those with diabetes mellitus or chronic kidney disease) after period 1 were randomly assigned to receive TA 40/5 mg + hydrochlorothiazide 12.5 mg (test group) or TA only (control group). The test and control drugs were administered in each group for 2 weeks (period 2). Patients who completed period 2 underwent 6-week treatment (period 3) with a TAH and TA dose twice that in period 2. The primary end point was the change in MSSBP at week 8 of treatment. Secondary end points were the change in MSSBP at week 2 and MS diastolic BP, BP control rate, and BP response rate at weeks 2 and 8. Treatment tolerability was assessed based on adverse events (AEs), laboratory evaluations (chemistry, hematology, and urinalysis), 12-lead ECG, and physical examination including vital sign measurements. Findings We randomized 310 patients to the treatment groups. The mean (SD) ages of the TAH and TA groups were 62.0 (10.8) and 63.4 (10.4) years, respectively. The least squares mean change in MSSBP was significantly greater in the TAH group than in the TA group after 8 weeks (–18.7 vs –12.2 mm Hg; P < 0.001). Similar results were obtained on changes in MSSBP after 2 weeks and changes in sitting diastolic BP, BP control rate, and BP response rate at weeks 2 and 8 compared with the respective baseline values. The prevalences of treatment-emergent AEs (29.0{\%} vs 16.3{\%}; P = 0.008) and adverse drug reactions (20.0{\%} vs 10.5{\%}; P = 0.020) were significantly greater in the TAH group than in the TA group. Most treatment-emergent AEs were mild or moderate; none were severe. The most frequently reported AEs were dizziness and headache. Implication TAH triple therapy was more effective than was TA double therapy in reducing BP in these patients in Korea with essential hypertension that did not adequately respond to TA. ClinicalTrials.gov identifier: NCT02738632.",
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T1 - Efficacy and Tolerability of Telmisartan/Amlodipine + Hydrochlorothiazide Versus Telmisartan/Amlodipine Combination Therapy for Essential Hypertension Uncontrolled With Telmisartan/Amlodipine

T2 - The Phase III, Multicenter, Randomized, Double-blind TAHYTI Study

AU - Sung, Ki Chul

AU - Oh, Yong Seog

AU - Cha, Dong Hun

AU - Hong, Soon Jun

AU - Won, Kyung Heon

AU - Yoo, Ki Dong

AU - Rha, Seung-Woon

AU - Ahn, Young Keun

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AU - Cho, Sang Kyoon

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AU - Nam, Chang Wook

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AU - Song, Jong Min

AU - Jeong, Jin Ok

AU - Yoon, Young Won

AU - Kim, Byung Soo

AU - Yang, Tae Hyun

AU - Cho, Deok Kyu

AU - Kim, Sang Hyun

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N2 - Purpose This 8-week study in Korea aimed to evaluate the efficacy and tolerability of a telmisartan/amlodipine + hydrochlorothiazide (TAH) combination versus telmisartan/amlodipine (TA) combination in patients with essential hypertension that did not respond appropriately to 4-week treatment with TA. Methods All patients who met the inclusion criteria received TA (40/5 mg) during a 4-week run-in period (period 1). Patients who met the criteria for essential hypertension (mean sitting systolic blood pressure [MSSBP], ≥140 and <200 mm Hg, or ≥130 and<200 mm Hg in those with diabetes mellitus or chronic kidney disease) after period 1 were randomly assigned to receive TA 40/5 mg + hydrochlorothiazide 12.5 mg (test group) or TA only (control group). The test and control drugs were administered in each group for 2 weeks (period 2). Patients who completed period 2 underwent 6-week treatment (period 3) with a TAH and TA dose twice that in period 2. The primary end point was the change in MSSBP at week 8 of treatment. Secondary end points were the change in MSSBP at week 2 and MS diastolic BP, BP control rate, and BP response rate at weeks 2 and 8. Treatment tolerability was assessed based on adverse events (AEs), laboratory evaluations (chemistry, hematology, and urinalysis), 12-lead ECG, and physical examination including vital sign measurements. Findings We randomized 310 patients to the treatment groups. The mean (SD) ages of the TAH and TA groups were 62.0 (10.8) and 63.4 (10.4) years, respectively. The least squares mean change in MSSBP was significantly greater in the TAH group than in the TA group after 8 weeks (–18.7 vs –12.2 mm Hg; P < 0.001). Similar results were obtained on changes in MSSBP after 2 weeks and changes in sitting diastolic BP, BP control rate, and BP response rate at weeks 2 and 8 compared with the respective baseline values. The prevalences of treatment-emergent AEs (29.0% vs 16.3%; P = 0.008) and adverse drug reactions (20.0% vs 10.5%; P = 0.020) were significantly greater in the TAH group than in the TA group. Most treatment-emergent AEs were mild or moderate; none were severe. The most frequently reported AEs were dizziness and headache. Implication TAH triple therapy was more effective than was TA double therapy in reducing BP in these patients in Korea with essential hypertension that did not adequately respond to TA. ClinicalTrials.gov identifier: NCT02738632.

AB - Purpose This 8-week study in Korea aimed to evaluate the efficacy and tolerability of a telmisartan/amlodipine + hydrochlorothiazide (TAH) combination versus telmisartan/amlodipine (TA) combination in patients with essential hypertension that did not respond appropriately to 4-week treatment with TA. Methods All patients who met the inclusion criteria received TA (40/5 mg) during a 4-week run-in period (period 1). Patients who met the criteria for essential hypertension (mean sitting systolic blood pressure [MSSBP], ≥140 and <200 mm Hg, or ≥130 and<200 mm Hg in those with diabetes mellitus or chronic kidney disease) after period 1 were randomly assigned to receive TA 40/5 mg + hydrochlorothiazide 12.5 mg (test group) or TA only (control group). The test and control drugs were administered in each group for 2 weeks (period 2). Patients who completed period 2 underwent 6-week treatment (period 3) with a TAH and TA dose twice that in period 2. The primary end point was the change in MSSBP at week 8 of treatment. Secondary end points were the change in MSSBP at week 2 and MS diastolic BP, BP control rate, and BP response rate at weeks 2 and 8. Treatment tolerability was assessed based on adverse events (AEs), laboratory evaluations (chemistry, hematology, and urinalysis), 12-lead ECG, and physical examination including vital sign measurements. Findings We randomized 310 patients to the treatment groups. The mean (SD) ages of the TAH and TA groups were 62.0 (10.8) and 63.4 (10.4) years, respectively. The least squares mean change in MSSBP was significantly greater in the TAH group than in the TA group after 8 weeks (–18.7 vs –12.2 mm Hg; P < 0.001). Similar results were obtained on changes in MSSBP after 2 weeks and changes in sitting diastolic BP, BP control rate, and BP response rate at weeks 2 and 8 compared with the respective baseline values. The prevalences of treatment-emergent AEs (29.0% vs 16.3%; P = 0.008) and adverse drug reactions (20.0% vs 10.5%; P = 0.020) were significantly greater in the TAH group than in the TA group. Most treatment-emergent AEs were mild or moderate; none were severe. The most frequently reported AEs were dizziness and headache. Implication TAH triple therapy was more effective than was TA double therapy in reducing BP in these patients in Korea with essential hypertension that did not adequately respond to TA. ClinicalTrials.gov identifier: NCT02738632.

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