Comparison of the Efficacy and Safety of Fixed-dose S-Amlodipine/Telmisartan and Telmisartan in Hypertensive Patients Inadequately Controlled with Telmisartan

A Randomized, Double-blind, Multicenter Study

Chang Gyu Park, Tae Hun Ahn, Eun Ju Cho, Won Kim, Hyung Seob Kim, Ju Yeong Yang, Jae Geun Ryu, Cheol Ho Kim, Min Soo Hyeon, Seung Je Tak, Se Jung Im, Jong Won Ha, Wook Beom Pyeon, Je Geon Jae, Gyu Rok Han, Jun Hyung Doh, Sang Wook Im, Myeong Muk Lee

Research output: Contribution to journalArticle

4 Citations (Scopus)

Abstract

Purpose The objective of this study was to evaluate the efficacy and safety of the fixed-dose combination S-amlodipine plus telmisartan (S-AM/TEL) compared with TEL monotherapy in patients with hypertension inadequately controlled by TEL monotherapy. Methods this study was a randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare the superiority of the S-AM/TEL 2.5/40-mg and S-AM/TEL 5/40-mg combinations with TEL 80-mg mono-therapy. The primary end point was the change in the mean sitting diastolic blood pressure from baseline (week 0) after 8 weeks of therapy between treatment groups. Findings Of 325 patients screened, 183 were randomly assigned to 3 groups (61 in the S-AM/TEL 2.5/40-mg group, 60 in the S-AM/TEL 5/40-mg group, and 62 in the TEL 80-mg group). Mean (SD) age was 53.9 (7.5) years, and male patients comprised 87%. No significant differences were found among the 3 groups in baseline characteristics. The primary end points, the changes of mean (SD) diastolic blood pressure at week 8 from the baseline were −10.56 (7.23) mm Hg in the S-AM/TEL 2.5/40-mg group, −12.32 (9.23) mm Hg in the S-AM/TEL 5/40-mg group, and −2.44 (7.92) mm Hg in the TEL 80-mg group. Both the S-AM/TEL 2.5/40-mg group and the S-AM/TEL 5/40-mg group had a statistically superior hypotensive effect compared with the TEL 80-mg group (P < 0.0001 for both). For evaluation of the safety profile, the frequencies of adverse events (AEs) among the groups were also not significantly different (S-AM/TEL 2.5/40-mg group, 18.6%; S-AM/TEL 5/40-mg group, 20%; and TEL 80-mg group, 22.6%), and the incidences of AEs were not different among the groups. The most common AEs were respiratory disorders, followed by headache, dizziness, and peripheral edema. Implications Treatment with S-AM/TEL 2.5/40 mg and S-AM/TEL 5/40 mg was superior to increasing the TEL dose in terms of hypotensive effect in patients with hypertension inadequately controlled by TEL monotherapy. S-AM/TEL fixed-dose combinations are an effective and tolerable option for patients inadequately responding to TEL monotherapy and also a good option for improving patients’ medication adherence. ClinicalTrials.gov identifier: NCT011426100.

Original languageEnglish
Pages (from-to)2185-2194
Number of pages10
JournalClinical Therapeutics
Volume38
Issue number10
DOIs
Publication statusPublished - 2016 Oct 1

Fingerprint

Double-Blind Method
Multicenter Studies
Safety
Blood Pressure
telmisartan
telmisartan amlodipine combination
Hypertension
Headache Disorders
Medication Adherence
Dizziness
Therapeutics
Patient Compliance
Edema
Clinical Trials

Keywords

  • blood pressure
  • fixed-dose combinations
  • hypertension
  • S-amlodipine
  • single-pill combination
  • telmisartan

ASJC Scopus subject areas

  • Pharmacology
  • Pharmacology (medical)

Cite this

Comparison of the Efficacy and Safety of Fixed-dose S-Amlodipine/Telmisartan and Telmisartan in Hypertensive Patients Inadequately Controlled with Telmisartan : A Randomized, Double-blind, Multicenter Study. / Park, Chang Gyu; Ahn, Tae Hun; Cho, Eun Ju; Kim, Won; Kim, Hyung Seob; Yang, Ju Yeong; Ryu, Jae Geun; Kim, Cheol Ho; Hyeon, Min Soo; Tak, Seung Je; Im, Se Jung; Ha, Jong Won; Pyeon, Wook Beom; Jae, Je Geon; Han, Gyu Rok; Doh, Jun Hyung; Im, Sang Wook; Lee, Myeong Muk.

In: Clinical Therapeutics, Vol. 38, No. 10, 01.10.2016, p. 2185-2194.

Research output: Contribution to journalArticle

Park, CG, Ahn, TH, Cho, EJ, Kim, W, Kim, HS, Yang, JY, Ryu, JG, Kim, CH, Hyeon, MS, Tak, SJ, Im, SJ, Ha, JW, Pyeon, WB, Jae, JG, Han, GR, Doh, JH, Im, SW & Lee, MM 2016, 'Comparison of the Efficacy and Safety of Fixed-dose S-Amlodipine/Telmisartan and Telmisartan in Hypertensive Patients Inadequately Controlled with Telmisartan: A Randomized, Double-blind, Multicenter Study', Clinical Therapeutics, vol. 38, no. 10, pp. 2185-2194. https://doi.org/10.1016/j.clinthera.2016.09.006
Park, Chang Gyu ; Ahn, Tae Hun ; Cho, Eun Ju ; Kim, Won ; Kim, Hyung Seob ; Yang, Ju Yeong ; Ryu, Jae Geun ; Kim, Cheol Ho ; Hyeon, Min Soo ; Tak, Seung Je ; Im, Se Jung ; Ha, Jong Won ; Pyeon, Wook Beom ; Jae, Je Geon ; Han, Gyu Rok ; Doh, Jun Hyung ; Im, Sang Wook ; Lee, Myeong Muk. / Comparison of the Efficacy and Safety of Fixed-dose S-Amlodipine/Telmisartan and Telmisartan in Hypertensive Patients Inadequately Controlled with Telmisartan : A Randomized, Double-blind, Multicenter Study. In: Clinical Therapeutics. 2016 ; Vol. 38, No. 10. pp. 2185-2194.
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abstract = "Purpose The objective of this study was to evaluate the efficacy and safety of the fixed-dose combination S-amlodipine plus telmisartan (S-AM/TEL) compared with TEL monotherapy in patients with hypertension inadequately controlled by TEL monotherapy. Methods this study was a randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare the superiority of the S-AM/TEL 2.5/40-mg and S-AM/TEL 5/40-mg combinations with TEL 80-mg mono-therapy. The primary end point was the change in the mean sitting diastolic blood pressure from baseline (week 0) after 8 weeks of therapy between treatment groups. Findings Of 325 patients screened, 183 were randomly assigned to 3 groups (61 in the S-AM/TEL 2.5/40-mg group, 60 in the S-AM/TEL 5/40-mg group, and 62 in the TEL 80-mg group). Mean (SD) age was 53.9 (7.5) years, and male patients comprised 87{\%}. No significant differences were found among the 3 groups in baseline characteristics. The primary end points, the changes of mean (SD) diastolic blood pressure at week 8 from the baseline were −10.56 (7.23) mm Hg in the S-AM/TEL 2.5/40-mg group, −12.32 (9.23) mm Hg in the S-AM/TEL 5/40-mg group, and −2.44 (7.92) mm Hg in the TEL 80-mg group. Both the S-AM/TEL 2.5/40-mg group and the S-AM/TEL 5/40-mg group had a statistically superior hypotensive effect compared with the TEL 80-mg group (P < 0.0001 for both). For evaluation of the safety profile, the frequencies of adverse events (AEs) among the groups were also not significantly different (S-AM/TEL 2.5/40-mg group, 18.6{\%}; S-AM/TEL 5/40-mg group, 20{\%}; and TEL 80-mg group, 22.6{\%}), and the incidences of AEs were not different among the groups. The most common AEs were respiratory disorders, followed by headache, dizziness, and peripheral edema. Implications Treatment with S-AM/TEL 2.5/40 mg and S-AM/TEL 5/40 mg was superior to increasing the TEL dose in terms of hypotensive effect in patients with hypertension inadequately controlled by TEL monotherapy. S-AM/TEL fixed-dose combinations are an effective and tolerable option for patients inadequately responding to TEL monotherapy and also a good option for improving patients’ medication adherence. ClinicalTrials.gov identifier: NCT011426100.",
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TY - JOUR

T1 - Comparison of the Efficacy and Safety of Fixed-dose S-Amlodipine/Telmisartan and Telmisartan in Hypertensive Patients Inadequately Controlled with Telmisartan

T2 - A Randomized, Double-blind, Multicenter Study

AU - Park, Chang Gyu

AU - Ahn, Tae Hun

AU - Cho, Eun Ju

AU - Kim, Won

AU - Kim, Hyung Seob

AU - Yang, Ju Yeong

AU - Ryu, Jae Geun

AU - Kim, Cheol Ho

AU - Hyeon, Min Soo

AU - Tak, Seung Je

AU - Im, Se Jung

AU - Ha, Jong Won

AU - Pyeon, Wook Beom

AU - Jae, Je Geon

AU - Han, Gyu Rok

AU - Doh, Jun Hyung

AU - Im, Sang Wook

AU - Lee, Myeong Muk

PY - 2016/10/1

Y1 - 2016/10/1

N2 - Purpose The objective of this study was to evaluate the efficacy and safety of the fixed-dose combination S-amlodipine plus telmisartan (S-AM/TEL) compared with TEL monotherapy in patients with hypertension inadequately controlled by TEL monotherapy. Methods this study was a randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare the superiority of the S-AM/TEL 2.5/40-mg and S-AM/TEL 5/40-mg combinations with TEL 80-mg mono-therapy. The primary end point was the change in the mean sitting diastolic blood pressure from baseline (week 0) after 8 weeks of therapy between treatment groups. Findings Of 325 patients screened, 183 were randomly assigned to 3 groups (61 in the S-AM/TEL 2.5/40-mg group, 60 in the S-AM/TEL 5/40-mg group, and 62 in the TEL 80-mg group). Mean (SD) age was 53.9 (7.5) years, and male patients comprised 87%. No significant differences were found among the 3 groups in baseline characteristics. The primary end points, the changes of mean (SD) diastolic blood pressure at week 8 from the baseline were −10.56 (7.23) mm Hg in the S-AM/TEL 2.5/40-mg group, −12.32 (9.23) mm Hg in the S-AM/TEL 5/40-mg group, and −2.44 (7.92) mm Hg in the TEL 80-mg group. Both the S-AM/TEL 2.5/40-mg group and the S-AM/TEL 5/40-mg group had a statistically superior hypotensive effect compared with the TEL 80-mg group (P < 0.0001 for both). For evaluation of the safety profile, the frequencies of adverse events (AEs) among the groups were also not significantly different (S-AM/TEL 2.5/40-mg group, 18.6%; S-AM/TEL 5/40-mg group, 20%; and TEL 80-mg group, 22.6%), and the incidences of AEs were not different among the groups. The most common AEs were respiratory disorders, followed by headache, dizziness, and peripheral edema. Implications Treatment with S-AM/TEL 2.5/40 mg and S-AM/TEL 5/40 mg was superior to increasing the TEL dose in terms of hypotensive effect in patients with hypertension inadequately controlled by TEL monotherapy. S-AM/TEL fixed-dose combinations are an effective and tolerable option for patients inadequately responding to TEL monotherapy and also a good option for improving patients’ medication adherence. ClinicalTrials.gov identifier: NCT011426100.

AB - Purpose The objective of this study was to evaluate the efficacy and safety of the fixed-dose combination S-amlodipine plus telmisartan (S-AM/TEL) compared with TEL monotherapy in patients with hypertension inadequately controlled by TEL monotherapy. Methods this study was a randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare the superiority of the S-AM/TEL 2.5/40-mg and S-AM/TEL 5/40-mg combinations with TEL 80-mg mono-therapy. The primary end point was the change in the mean sitting diastolic blood pressure from baseline (week 0) after 8 weeks of therapy between treatment groups. Findings Of 325 patients screened, 183 were randomly assigned to 3 groups (61 in the S-AM/TEL 2.5/40-mg group, 60 in the S-AM/TEL 5/40-mg group, and 62 in the TEL 80-mg group). Mean (SD) age was 53.9 (7.5) years, and male patients comprised 87%. No significant differences were found among the 3 groups in baseline characteristics. The primary end points, the changes of mean (SD) diastolic blood pressure at week 8 from the baseline were −10.56 (7.23) mm Hg in the S-AM/TEL 2.5/40-mg group, −12.32 (9.23) mm Hg in the S-AM/TEL 5/40-mg group, and −2.44 (7.92) mm Hg in the TEL 80-mg group. Both the S-AM/TEL 2.5/40-mg group and the S-AM/TEL 5/40-mg group had a statistically superior hypotensive effect compared with the TEL 80-mg group (P < 0.0001 for both). For evaluation of the safety profile, the frequencies of adverse events (AEs) among the groups were also not significantly different (S-AM/TEL 2.5/40-mg group, 18.6%; S-AM/TEL 5/40-mg group, 20%; and TEL 80-mg group, 22.6%), and the incidences of AEs were not different among the groups. The most common AEs were respiratory disorders, followed by headache, dizziness, and peripheral edema. Implications Treatment with S-AM/TEL 2.5/40 mg and S-AM/TEL 5/40 mg was superior to increasing the TEL dose in terms of hypotensive effect in patients with hypertension inadequately controlled by TEL monotherapy. S-AM/TEL fixed-dose combinations are an effective and tolerable option for patients inadequately responding to TEL monotherapy and also a good option for improving patients’ medication adherence. ClinicalTrials.gov identifier: NCT011426100.

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KW - single-pill combination

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