Efficacy and Tolerability of Telmisartan/Amlodipine and Rosuvastatin Coadministration in Hypertensive Patients with Hyperlipidemia: A Phase III, Multicenter, Randomized, Double-blind Study

Tae Seok Kim, Seung Woon Rha, Seok Yeon Kim, Dae Gyun Park, Ki Chul Sung, Myung Ho Yoon, Kye Hoon Kim, Han Cheol Lee, Woo Sik Kim, Yong Jin Kim, Jeong Cheon Ahn, Moo Yong Rhee, Dong Hun Cha, Byung Su Yoo, Sang Ho Park, Ki Dong Yoo, Dong Woon Jeon, Young Won Yoon, Sang Kyoon Cho, Yong Seog Oh

Research output: Contribution to journalArticle

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Abstract

Purpose: Dyslipidemia and hypertension increase the risk for cardiovascular disease. Combination therapy improves patient compliance. This study was conducted to compare the efficacy and tolerability of the combination therapies telmisartan/amlodipine + rosuvastatin, telmisartan/amlodipine, and telmisartan + rosuvastatin in patients with hypercholesterolemia and hypertension. Methods: In this Phase III, multicenter, 8-week randomized, double-blind study, participants with hypertension and dyslipidemia (defined as a sitting systolic blood pressure [sitSBP] of ≥140 mm Hg, a low-density lipoprotein-cholesterol [LDL-C] level of ≤250 mg/dL, and a triglyceride level of ≤400 mg/dL) were screened. After a 4-week washout/run-in period involving therapeutic lifestyle changes and telmisartan 80 mg once a day, eligible patients had a sitSBP of ≥140 mm Hg and met the LDL-C level criteria according to the National Cholesterol Education Program Adult Treatment Panel III cardiovascular disease risk category. Patients were randomly assigned to 1 of 3 groups: (1) telmisartan/amlodipine 80/10 mg + rosuvastatin 20 mg (TAR group); (2) telmisartan/amlodipine 80/10 mg (TA group); or (3) telmisartan 80 mg + rosuvastatin 20 mg (TR group). The primary efficacy end points were the percentage changes from baseline in LDL-C in the TAR and TA groups and the mean changes in sitSBP in the TAR and TR groups at week 8 compared to baseline. Continuous variables were compared using the unpaired t test or the Wilcoxon rank sum model, and categorical variables were compared using the χ 2 or Fisher exact test. Tolerability was assessed based on adverse events found on physical examination including vital sign measurements, laboratory evaluations, and 12-lead ECG. Findings: A total of 134 patients were enrolled. The least squares mean percentage changes in LDL-C at 8 weeks after administration of the drug compared to baseline were −51.9% (3.0%) in the TAR group and −3.2% (2.9%) in the TA group (P < 0.001). At 8 weeks after baseline, the least squares mean (SE) changes sitSBP were −28.3 (2.4) mm Hg in the TAR group and −10.7 (2.1) mm Hg in the TR group (P < 0.001). The prevalence rates of treatment-emergent adverse events were 15.0%, 25.0%, and 12.2% in the TAR, TA, and TR groups, respectively; those of adverse drug reactions were 15.0%, 22.7%, and 10.2%. None of the differences in rates were significant among 3 groups. Implications: Triple therapy with TAR can be an effective treatment in patients with dyslipidemia and hypertension. The TAR combination has value for hypertensive patients with hyperlipidemia in terms of convenience, tolerability, and efficacy. ClinicalTrials.gov identifier: NCT03566316.

Original languageEnglish
Pages (from-to)728-741
Number of pages14
JournalClinical Therapeutics
Volume41
Issue number4
DOIs
Publication statusPublished - 2019 Apr

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Hyperlipidemias
Double-Blind Method
Blood Pressure
LDL Cholesterol
Dyslipidemias
Hypertension
Least-Squares Analysis
Therapeutics
Cardiovascular Diseases
telmisartan amlodipine combination
Rosuvastatin Calcium
Vital Signs
Patient Compliance
Nonparametric Statistics
Hypercholesterolemia
Drug-Related Side Effects and Adverse Reactions
Physical Examination
Life Style
Electrocardiography
Triglycerides

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmacology (medical)

Cite this

Kim, Tae Seok ; Rha, Seung Woon ; Kim, Seok Yeon ; Park, Dae Gyun ; Sung, Ki Chul ; Yoon, Myung Ho ; Kim, Kye Hoon ; Lee, Han Cheol ; Kim, Woo Sik ; Kim, Yong Jin ; Ahn, Jeong Cheon ; Rhee, Moo Yong ; Cha, Dong Hun ; Yoo, Byung Su ; Park, Sang Ho ; Yoo, Ki Dong ; Jeon, Dong Woon ; Yoon, Young Won ; Cho, Sang Kyoon ; Oh, Yong Seog. / Efficacy and Tolerability of Telmisartan/Amlodipine and Rosuvastatin Coadministration in Hypertensive Patients with Hyperlipidemia : A Phase III, Multicenter, Randomized, Double-blind Study. In: Clinical Therapeutics. 2019 ; Vol. 41, No. 4. pp. 728-741.
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title = "Efficacy and Tolerability of Telmisartan/Amlodipine and Rosuvastatin Coadministration in Hypertensive Patients with Hyperlipidemia: A Phase III, Multicenter, Randomized, Double-blind Study",
abstract = "Purpose: Dyslipidemia and hypertension increase the risk for cardiovascular disease. Combination therapy improves patient compliance. This study was conducted to compare the efficacy and tolerability of the combination therapies telmisartan/amlodipine + rosuvastatin, telmisartan/amlodipine, and telmisartan + rosuvastatin in patients with hypercholesterolemia and hypertension. Methods: In this Phase III, multicenter, 8-week randomized, double-blind study, participants with hypertension and dyslipidemia (defined as a sitting systolic blood pressure [sitSBP] of ≥140 mm Hg, a low-density lipoprotein-cholesterol [LDL-C] level of ≤250 mg/dL, and a triglyceride level of ≤400 mg/dL) were screened. After a 4-week washout/run-in period involving therapeutic lifestyle changes and telmisartan 80 mg once a day, eligible patients had a sitSBP of ≥140 mm Hg and met the LDL-C level criteria according to the National Cholesterol Education Program Adult Treatment Panel III cardiovascular disease risk category. Patients were randomly assigned to 1 of 3 groups: (1) telmisartan/amlodipine 80/10 mg + rosuvastatin 20 mg (TAR group); (2) telmisartan/amlodipine 80/10 mg (TA group); or (3) telmisartan 80 mg + rosuvastatin 20 mg (TR group). The primary efficacy end points were the percentage changes from baseline in LDL-C in the TAR and TA groups and the mean changes in sitSBP in the TAR and TR groups at week 8 compared to baseline. Continuous variables were compared using the unpaired t test or the Wilcoxon rank sum model, and categorical variables were compared using the χ 2 or Fisher exact test. Tolerability was assessed based on adverse events found on physical examination including vital sign measurements, laboratory evaluations, and 12-lead ECG. Findings: A total of 134 patients were enrolled. The least squares mean percentage changes in LDL-C at 8 weeks after administration of the drug compared to baseline were −51.9{\%} (3.0{\%}) in the TAR group and −3.2{\%} (2.9{\%}) in the TA group (P < 0.001). At 8 weeks after baseline, the least squares mean (SE) changes sitSBP were −28.3 (2.4) mm Hg in the TAR group and −10.7 (2.1) mm Hg in the TR group (P < 0.001). The prevalence rates of treatment-emergent adverse events were 15.0{\%}, 25.0{\%}, and 12.2{\%} in the TAR, TA, and TR groups, respectively; those of adverse drug reactions were 15.0{\%}, 22.7{\%}, and 10.2{\%}. None of the differences in rates were significant among 3 groups. Implications: Triple therapy with TAR can be an effective treatment in patients with dyslipidemia and hypertension. The TAR combination has value for hypertensive patients with hyperlipidemia in terms of convenience, tolerability, and efficacy. ClinicalTrials.gov identifier: NCT03566316.",
author = "Kim, {Tae Seok} and Rha, {Seung Woon} and Kim, {Seok Yeon} and Park, {Dae Gyun} and Sung, {Ki Chul} and Yoon, {Myung Ho} and Kim, {Kye Hoon} and Lee, {Han Cheol} and Kim, {Woo Sik} and Kim, {Yong Jin} and Ahn, {Jeong Cheon} and Rhee, {Moo Yong} and Cha, {Dong Hun} and Yoo, {Byung Su} and Park, {Sang Ho} and Yoo, {Ki Dong} and Jeon, {Dong Woon} and Yoon, {Young Won} and Cho, {Sang Kyoon} and Oh, {Yong Seog}",
year = "2019",
month = "4",
doi = "10.1016/j.clinthera.2019.02.013",
language = "English",
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pages = "728--741",
journal = "Clinical Therapeutics",
issn = "0149-2918",
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Kim, TS, Rha, SW, Kim, SY, Park, DG, Sung, KC, Yoon, MH, Kim, KH, Lee, HC, Kim, WS, Kim, YJ, Ahn, JC, Rhee, MY, Cha, DH, Yoo, BS, Park, SH, Yoo, KD, Jeon, DW, Yoon, YW, Cho, SK & Oh, YS 2019, 'Efficacy and Tolerability of Telmisartan/Amlodipine and Rosuvastatin Coadministration in Hypertensive Patients with Hyperlipidemia: A Phase III, Multicenter, Randomized, Double-blind Study', Clinical Therapeutics, vol. 41, no. 4, pp. 728-741. https://doi.org/10.1016/j.clinthera.2019.02.013

Efficacy and Tolerability of Telmisartan/Amlodipine and Rosuvastatin Coadministration in Hypertensive Patients with Hyperlipidemia : A Phase III, Multicenter, Randomized, Double-blind Study. / Kim, Tae Seok; Rha, Seung Woon; Kim, Seok Yeon; Park, Dae Gyun; Sung, Ki Chul; Yoon, Myung Ho; Kim, Kye Hoon; Lee, Han Cheol; Kim, Woo Sik; Kim, Yong Jin; Ahn, Jeong Cheon; Rhee, Moo Yong; Cha, Dong Hun; Yoo, Byung Su; Park, Sang Ho; Yoo, Ki Dong; Jeon, Dong Woon; Yoon, Young Won; Cho, Sang Kyoon; Oh, Yong Seog.

In: Clinical Therapeutics, Vol. 41, No. 4, 04.2019, p. 728-741.

Research output: Contribution to journalArticle

TY - JOUR

T1 - Efficacy and Tolerability of Telmisartan/Amlodipine and Rosuvastatin Coadministration in Hypertensive Patients with Hyperlipidemia

T2 - A Phase III, Multicenter, Randomized, Double-blind Study

AU - Kim, Tae Seok

AU - Rha, Seung Woon

AU - Kim, Seok Yeon

AU - Park, Dae Gyun

AU - Sung, Ki Chul

AU - Yoon, Myung Ho

AU - Kim, Kye Hoon

AU - Lee, Han Cheol

AU - Kim, Woo Sik

AU - Kim, Yong Jin

AU - Ahn, Jeong Cheon

AU - Rhee, Moo Yong

AU - Cha, Dong Hun

AU - Yoo, Byung Su

AU - Park, Sang Ho

AU - Yoo, Ki Dong

AU - Jeon, Dong Woon

AU - Yoon, Young Won

AU - Cho, Sang Kyoon

AU - Oh, Yong Seog

PY - 2019/4

Y1 - 2019/4

N2 - Purpose: Dyslipidemia and hypertension increase the risk for cardiovascular disease. Combination therapy improves patient compliance. This study was conducted to compare the efficacy and tolerability of the combination therapies telmisartan/amlodipine + rosuvastatin, telmisartan/amlodipine, and telmisartan + rosuvastatin in patients with hypercholesterolemia and hypertension. Methods: In this Phase III, multicenter, 8-week randomized, double-blind study, participants with hypertension and dyslipidemia (defined as a sitting systolic blood pressure [sitSBP] of ≥140 mm Hg, a low-density lipoprotein-cholesterol [LDL-C] level of ≤250 mg/dL, and a triglyceride level of ≤400 mg/dL) were screened. After a 4-week washout/run-in period involving therapeutic lifestyle changes and telmisartan 80 mg once a day, eligible patients had a sitSBP of ≥140 mm Hg and met the LDL-C level criteria according to the National Cholesterol Education Program Adult Treatment Panel III cardiovascular disease risk category. Patients were randomly assigned to 1 of 3 groups: (1) telmisartan/amlodipine 80/10 mg + rosuvastatin 20 mg (TAR group); (2) telmisartan/amlodipine 80/10 mg (TA group); or (3) telmisartan 80 mg + rosuvastatin 20 mg (TR group). The primary efficacy end points were the percentage changes from baseline in LDL-C in the TAR and TA groups and the mean changes in sitSBP in the TAR and TR groups at week 8 compared to baseline. Continuous variables were compared using the unpaired t test or the Wilcoxon rank sum model, and categorical variables were compared using the χ 2 or Fisher exact test. Tolerability was assessed based on adverse events found on physical examination including vital sign measurements, laboratory evaluations, and 12-lead ECG. Findings: A total of 134 patients were enrolled. The least squares mean percentage changes in LDL-C at 8 weeks after administration of the drug compared to baseline were −51.9% (3.0%) in the TAR group and −3.2% (2.9%) in the TA group (P < 0.001). At 8 weeks after baseline, the least squares mean (SE) changes sitSBP were −28.3 (2.4) mm Hg in the TAR group and −10.7 (2.1) mm Hg in the TR group (P < 0.001). The prevalence rates of treatment-emergent adverse events were 15.0%, 25.0%, and 12.2% in the TAR, TA, and TR groups, respectively; those of adverse drug reactions were 15.0%, 22.7%, and 10.2%. None of the differences in rates were significant among 3 groups. Implications: Triple therapy with TAR can be an effective treatment in patients with dyslipidemia and hypertension. The TAR combination has value for hypertensive patients with hyperlipidemia in terms of convenience, tolerability, and efficacy. ClinicalTrials.gov identifier: NCT03566316.

AB - Purpose: Dyslipidemia and hypertension increase the risk for cardiovascular disease. Combination therapy improves patient compliance. This study was conducted to compare the efficacy and tolerability of the combination therapies telmisartan/amlodipine + rosuvastatin, telmisartan/amlodipine, and telmisartan + rosuvastatin in patients with hypercholesterolemia and hypertension. Methods: In this Phase III, multicenter, 8-week randomized, double-blind study, participants with hypertension and dyslipidemia (defined as a sitting systolic blood pressure [sitSBP] of ≥140 mm Hg, a low-density lipoprotein-cholesterol [LDL-C] level of ≤250 mg/dL, and a triglyceride level of ≤400 mg/dL) were screened. After a 4-week washout/run-in period involving therapeutic lifestyle changes and telmisartan 80 mg once a day, eligible patients had a sitSBP of ≥140 mm Hg and met the LDL-C level criteria according to the National Cholesterol Education Program Adult Treatment Panel III cardiovascular disease risk category. Patients were randomly assigned to 1 of 3 groups: (1) telmisartan/amlodipine 80/10 mg + rosuvastatin 20 mg (TAR group); (2) telmisartan/amlodipine 80/10 mg (TA group); or (3) telmisartan 80 mg + rosuvastatin 20 mg (TR group). The primary efficacy end points were the percentage changes from baseline in LDL-C in the TAR and TA groups and the mean changes in sitSBP in the TAR and TR groups at week 8 compared to baseline. Continuous variables were compared using the unpaired t test or the Wilcoxon rank sum model, and categorical variables were compared using the χ 2 or Fisher exact test. Tolerability was assessed based on adverse events found on physical examination including vital sign measurements, laboratory evaluations, and 12-lead ECG. Findings: A total of 134 patients were enrolled. The least squares mean percentage changes in LDL-C at 8 weeks after administration of the drug compared to baseline were −51.9% (3.0%) in the TAR group and −3.2% (2.9%) in the TA group (P < 0.001). At 8 weeks after baseline, the least squares mean (SE) changes sitSBP were −28.3 (2.4) mm Hg in the TAR group and −10.7 (2.1) mm Hg in the TR group (P < 0.001). The prevalence rates of treatment-emergent adverse events were 15.0%, 25.0%, and 12.2% in the TAR, TA, and TR groups, respectively; those of adverse drug reactions were 15.0%, 22.7%, and 10.2%. None of the differences in rates were significant among 3 groups. Implications: Triple therapy with TAR can be an effective treatment in patients with dyslipidemia and hypertension. The TAR combination has value for hypertensive patients with hyperlipidemia in terms of convenience, tolerability, and efficacy. ClinicalTrials.gov identifier: NCT03566316.

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