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A randomized, double-blind study to evaluate the efficacy and safety of a single-pill combination of telmisartan 80 mg/amlodipine 5 mg versus amlodipine 5 mg in hypertensive Asian patients.
J Int Med Res. 2014 Feb; 42(1):52-66.JI

Abstract

OBJECTIVE

To investigate the efficacy and safety of telmisartan 80 mg/amlodipine 5 mg (T80/A5) single-pill combination versus A5 in patients with essential hypertension not adequately controlled on A5 monotherapy.

METHODS

Asian patients ≥18 years old, with inadequately controlled blood pressure (BP) at enrolment, who failed to achieve a seated diastolic BP (DBP) goal (≥90 mmHg) following 6-weeks' open-label A5 treatment, were randomly allocated 1 : 1 to 8 weeks' double-blind treatment with T80/A5 single-pill combination or A5.

RESULTS

A total of 324 patients entered the double-blind treatment phase. The adjusted mean ± SE reduction in seated trough DBP from baseline to week 8 was significantly greater with T80/A5 (12.4 ± 1.0 mmHg) than A5 (10.2 ± 0.9 mmHg [primary endpoint, n = 314]). Results were similar in the subset of 262 Chinese patients. Treatment-related adverse events were 1.9% with T80/A5 and 2.4% with A5.

CONCLUSIONS

In Asian patients with hypertension, T80/A5 single-pill combination provided improved BP reduction after 8 weeks' treatment compared with A5 monotherapy. Both treatments were well tolerated.

Authors+Show Affiliations

Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.No affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

24391142

Citation

Zhu, Dingliang, et al. "A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of a Single-pill Combination of Telmisartan 80 Mg/amlodipine 5 Mg Versus Amlodipine 5 Mg in Hypertensive Asian Patients." The Journal of International Medical Research, vol. 42, no. 1, 2014, pp. 52-66.
Zhu D, Gao P, Holtbruegge W, et al. A randomized, double-blind study to evaluate the efficacy and safety of a single-pill combination of telmisartan 80 mg/amlodipine 5 mg versus amlodipine 5 mg in hypertensive Asian patients. J Int Med Res. 2014;42(1):52-66.
Zhu, D., Gao, P., Holtbruegge, W., & Huang, C. (2014). A randomized, double-blind study to evaluate the efficacy and safety of a single-pill combination of telmisartan 80 mg/amlodipine 5 mg versus amlodipine 5 mg in hypertensive Asian patients. The Journal of International Medical Research, 42(1), 52-66. https://doi.org/10.1177/0300060513503756
Zhu D, et al. A Randomized, Double-blind Study to Evaluate the Efficacy and Safety of a Single-pill Combination of Telmisartan 80 Mg/amlodipine 5 Mg Versus Amlodipine 5 Mg in Hypertensive Asian Patients. J Int Med Res. 2014;42(1):52-66. PubMed PMID: 24391142.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, double-blind study to evaluate the efficacy and safety of a single-pill combination of telmisartan 80 mg/amlodipine 5 mg versus amlodipine 5 mg in hypertensive Asian patients. AU - Zhu,Dingliang, AU - Gao,Pingjin, AU - Holtbruegge,Werner, AU - Huang,Chenglei, Y1 - 2014/01/03/ PY - 2014/1/7/entrez PY - 2014/1/7/pubmed PY - 2014/8/26/medline KW - Amlodipine KW - Asian KW - Chinese KW - essential hypertension KW - randomized controlled trial KW - renin–angiotensin system inhibitor KW - single-pill combination KW - telmisartan SP - 52 EP - 66 JF - The Journal of international medical research JO - J Int Med Res VL - 42 IS - 1 N2 - OBJECTIVE: To investigate the efficacy and safety of telmisartan 80 mg/amlodipine 5 mg (T80/A5) single-pill combination versus A5 in patients with essential hypertension not adequately controlled on A5 monotherapy. METHODS: Asian patients ≥18 years old, with inadequately controlled blood pressure (BP) at enrolment, who failed to achieve a seated diastolic BP (DBP) goal (≥90 mmHg) following 6-weeks' open-label A5 treatment, were randomly allocated 1 : 1 to 8 weeks' double-blind treatment with T80/A5 single-pill combination or A5. RESULTS: A total of 324 patients entered the double-blind treatment phase. The adjusted mean ± SE reduction in seated trough DBP from baseline to week 8 was significantly greater with T80/A5 (12.4 ± 1.0 mmHg) than A5 (10.2 ± 0.9 mmHg [primary endpoint, n = 314]). Results were similar in the subset of 262 Chinese patients. Treatment-related adverse events were 1.9% with T80/A5 and 2.4% with A5. CONCLUSIONS: In Asian patients with hypertension, T80/A5 single-pill combination provided improved BP reduction after 8 weeks' treatment compared with A5 monotherapy. Both treatments were well tolerated. SN - 1473-2300 UR - https://www.unboundmedicine.com/medline/citation/24391142/A_randomized_double_blind_study_to_evaluate_the_efficacy_and_safety_of_a_single_pill_combination_of_telmisartan_80_mg/amlodipine_5_mg_versus_amlodipine_5_mg_in_hypertensive_Asian_patients_ L2 - https://journals.sagepub.com/doi/10.1177/0300060513503756?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -