The efficacy and safety of co-administration of fimasartan and rosuvastatin to patients with hypertension and dyslipidemia

Moo Yong Rhee; Taehoon Ahn; Kiyuk Chang; Shung Chull Chae; Tae Hyun Yang; Wan Joo Shim; Tae Soo Kang; Jae Kean Ryu; Deuk Young Nah; Tae Ho Park; In Ho Chae; Seung Woo Park; Hae Young Lee; Seung Jea Tahk; Young Won Yoon; Chi Young Shim; Dong Gu Shin; Hong Seog Seo; Sung Yun Lee; Doo Il Kim; Jun Kwan; Seung Jae Joo; Myung Ho Jeong; Jin Ok Jeong; Ki Chul Sung; Seok Yeon Kim; Sang Hyun Kim; Kook Jin Chun; Dong Joo Oh

doi:10.1186/s40360-016-0112-7

The efficacy and safety of co-administration of fimasartan and rosuvastatin to patients with hypertension and dyslipidemia

Moo Yong Rhee, Taehoon Ahn, Kiyuk Chang, Shung Chull Chae, Tae Hyun Yang, Wan Joo Shim, Tae Soo Kang, Jae Kean Ryu, Deuk Young Nah, Tae Ho Park, In Ho Chae, Seung Woo Park, Hae Young Lee, Seung Jea Tahk, Young Won Yoon, Chi Young Shim, Dong Gu Shin, Hong Seog Seo, Sung Yun Lee, Doo Il KimJun Kwan, Seung Jae Joo, Myung Ho Jeong, Jin Ok Jeong, Ki Chul Sung, Seok Yeon Kim, Sang Hyun Kim, Kook Jin Chun, Dong Joo Oh

Department of Internal Medicine

Research output: Contribution to journal › Article › peer-review

9 Citations (Scopus)

Abstract

Background: Hypertension and dyslipidemia are major risk factors of cardiovascular disease (CVD) events. The objective of this study was to evaluate the efficacy and safety of the co-administration of fimasartan and rosuvastatin in patients with hypertension and hypercholesterolemia. Methods: We conducted a randomized double-blind and parallel-group trial. Patients who met eligible criteria after 4 weeks of therapeutic life change were randomly assigned to the following groups. 1) co-administration of fimasartan 120 mg/rosuvastatin 20 mg (FMS/RSV), 2) fimasartan 120 mg (FMS) alone 3) rosuvastatin 20 mg (RSV) alone. Drugs were administered once daily for 8 weeks. Results: Of 140 randomized patients, 135 for whom efficacy data were available were analyzed. After 8 weeks of treatment, the FMS/RSV treatment group showed greater reductions in sitting systolic (siSBP) and diastolic (siDBP) blood pressures than those in the group receiving RSV alone (both p<0.001). Reductions in siSBP and siDBP were not significantly different between the FMS/RSV and FMS alone groups (p=0.500 and p=0.734, respectively). After 8 weeks of treatment, FMS/RSV treatment showed greater efficacy in percentage reduction of low-density lipoprotein cholesterol (LDL-C) level from baseline than that shown by FMS alone treatment (p<0.001). The response rates of siSBP with FMS/RSV, FMS alone, and RSV alone treatments were 65.22, 55.56, and 34.09%, respectively (FMS/RSV vs. RSV, p=0.006). The LDL-C goal attainment rates with FMS/RSV, RSV alone, and FMS alone treatments were 80.43%, 81.82%, and 15.56%, respectively (FMS/RSV vs. FMS, p<0.001). Incidence of adverse drug reactions with FMS/RSV treatment was 8.33%, which was similar to those associated with FMS and RSV alone treatments. Conclusion: This study demonstrated that the co-administration of fimasartan and rosuvastatin to patients with both hypertension and hypercholesterolemia was efficacious and safe. Trial registration: ClinicalTrials.gov Identifier: NCT02166814.

Original language	English
Article number	2
Journal	BMC Pharmacology and Toxicology
Volume	18
Issue number	1
DOIs	https://doi.org/10.1186/s40360-016-0112-7
Publication status	Published - 2017 Jan 5

Bibliographical note

Funding Information:
Dr. Rhee has received lecture honoraria from Pfizer Inc., LG Life Sciences Ltd, Bayer Korea Ltd., Hanmi Pharm. Co. Ltd., Yuhan Co. Ltd., Boryung Pharmaceutical Co. Ltd., and research grant from Boryung Pharmaceutical Co. Ltd. and Dong-A Pharmaceutical Co., Ltd. Dr. Oh has received research grant from Boryung Pharmaceutical Co. Ltd. The authors have indicated that they have no other conflicts of interest with regard to the content of this article. The study drugs were supplied by Boryung Pharmaceutical Co. Ltd. ClinicalTrials.gov Identifier: NCT02166814.

Funding Information:
This study was initiated and financially supported by Boryung Pharmaceutical Co. Ltd., Seoul, Republic of Korea (BR-FRC-CT-301). The sponsor supported the supply of study drug, laboratory test, data collection, and data analysis. The funding body had no role in data interpretation and the writing of the manuscript based on the data.

Publisher Copyright:
© 2017 The Author(s).

All Science Journal Classification (ASJC) codes

Pharmacology
Pharmacology (medical)

UN SDGs

This output contributes to the following UN Sustainable Development Goals (SDGs)

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10.1186/s40360-016-0112-7

Cite this

Rhee, M. Y., Ahn, T., Chang, K., Chae, S. C., Yang, T. H., Shim, W. J., Kang, T. S., Ryu, J. K., Nah, D. Y., Park, T. H., Chae, I. H., Park, S. W., Lee, H. Y., Tahk, S. J., Yoon, Y. W., Shim, C. Y., Shin, D. G., Seo, H. S., Lee, S. Y., ... Oh, D. J. (2017). The efficacy and safety of co-administration of fimasartan and rosuvastatin to patients with hypertension and dyslipidemia. BMC Pharmacology and Toxicology, 18(1), Article 2. https://doi.org/10.1186/s40360-016-0112-7

@article{b48831eec4224e52a27e6f0f99b90052,

title = "The efficacy and safety of co-administration of fimasartan and rosuvastatin to patients with hypertension and dyslipidemia",

abstract = "Background: Hypertension and dyslipidemia are major risk factors of cardiovascular disease (CVD) events. The objective of this study was to evaluate the efficacy and safety of the co-administration of fimasartan and rosuvastatin in patients with hypertension and hypercholesterolemia. Methods: We conducted a randomized double-blind and parallel-group trial. Patients who met eligible criteria after 4 weeks of therapeutic life change were randomly assigned to the following groups. 1) co-administration of fimasartan 120 mg/rosuvastatin 20 mg (FMS/RSV), 2) fimasartan 120 mg (FMS) alone 3) rosuvastatin 20 mg (RSV) alone. Drugs were administered once daily for 8 weeks. Results: Of 140 randomized patients, 135 for whom efficacy data were available were analyzed. After 8 weeks of treatment, the FMS/RSV treatment group showed greater reductions in sitting systolic (siSBP) and diastolic (siDBP) blood pressures than those in the group receiving RSV alone (both p<0.001). Reductions in siSBP and siDBP were not significantly different between the FMS/RSV and FMS alone groups (p=0.500 and p=0.734, respectively). After 8 weeks of treatment, FMS/RSV treatment showed greater efficacy in percentage reduction of low-density lipoprotein cholesterol (LDL-C) level from baseline than that shown by FMS alone treatment (p<0.001). The response rates of siSBP with FMS/RSV, FMS alone, and RSV alone treatments were 65.22, 55.56, and 34.09%, respectively (FMS/RSV vs. RSV, p=0.006). The LDL-C goal attainment rates with FMS/RSV, RSV alone, and FMS alone treatments were 80.43%, 81.82%, and 15.56%, respectively (FMS/RSV vs. FMS, p<0.001). Incidence of adverse drug reactions with FMS/RSV treatment was 8.33%, which was similar to those associated with FMS and RSV alone treatments. Conclusion: This study demonstrated that the co-administration of fimasartan and rosuvastatin to patients with both hypertension and hypercholesterolemia was efficacious and safe. Trial registration: ClinicalTrials.gov Identifier: NCT02166814.",

author = "Rhee, {Moo Yong} and Taehoon Ahn and Kiyuk Chang and Chae, {Shung Chull} and Yang, {Tae Hyun} and Shim, {Wan Joo} and Kang, {Tae Soo} and Ryu, {Jae Kean} and Nah, {Deuk Young} and Park, {Tae Ho} and Chae, {In Ho} and Park, {Seung Woo} and Lee, {Hae Young} and Tahk, {Seung Jea} and Yoon, {Young Won} and Shim, {Chi Young} and Shin, {Dong Gu} and Seo, {Hong Seog} and Lee, {Sung Yun} and Kim, {Doo Il} and Jun Kwan and Joo, {Seung Jae} and Jeong, {Myung Ho} and Jeong, {Jin Ok} and Sung, {Ki Chul} and Kim, {Seok Yeon} and Kim, {Sang Hyun} and Chun, {Kook Jin} and Oh, {Dong Joo}",

note = "Funding Information: Dr. Rhee has received lecture honoraria from Pfizer Inc., LG Life Sciences Ltd, Bayer Korea Ltd., Hanmi Pharm. Co. Ltd., Yuhan Co. Ltd., Boryung Pharmaceutical Co. Ltd., and research grant from Boryung Pharmaceutical Co. Ltd. and Dong-A Pharmaceutical Co., Ltd. Dr. Oh has received research grant from Boryung Pharmaceutical Co. Ltd. The authors have indicated that they have no other conflicts of interest with regard to the content of this article. The study drugs were supplied by Boryung Pharmaceutical Co. Ltd. ClinicalTrials.gov Identifier: NCT02166814. Funding Information: This study was initiated and financially supported by Boryung Pharmaceutical Co. Ltd., Seoul, Republic of Korea (BR-FRC-CT-301). The sponsor supported the supply of study drug, laboratory test, data collection, and data analysis. The funding body had no role in data interpretation and the writing of the manuscript based on the data. Publisher Copyright: {\textcopyright} 2017 The Author(s).",

year = "2017",

month = jan,

day = "5",

doi = "10.1186/s40360-016-0112-7",

language = "English",

volume = "18",

journal = "BMC Pharmacology and Toxicology",

issn = "2050-6511",

publisher = "BioMed Central",

number = "1",

}

Rhee, MY, Ahn, T, Chang, K, Chae, SC, Yang, TH, Shim, WJ, Kang, TS, Ryu, JK, Nah, DY, Park, TH, Chae, IH, Park, SW, Lee, HY, Tahk, SJ, Yoon, YW, Shim, CY, Shin, DG, Seo, HS, Lee, SY, Kim, DI, Kwan, J, Joo, SJ, Jeong, MH, Jeong, JO, Sung, KC, Kim, SY, Kim, SH, Chun, KJ & Oh, DJ 2017, 'The efficacy and safety of co-administration of fimasartan and rosuvastatin to patients with hypertension and dyslipidemia', BMC Pharmacology and Toxicology, vol. 18, no. 1, 2. https://doi.org/10.1186/s40360-016-0112-7

TY - JOUR

T1 - The efficacy and safety of co-administration of fimasartan and rosuvastatin to patients with hypertension and dyslipidemia

AU - Rhee, Moo Yong

AU - Ahn, Taehoon

AU - Chang, Kiyuk

AU - Chae, Shung Chull

AU - Yang, Tae Hyun

AU - Shim, Wan Joo

AU - Kang, Tae Soo

AU - Ryu, Jae Kean

AU - Nah, Deuk Young

AU - Park, Tae Ho

AU - Chae, In Ho

AU - Park, Seung Woo

AU - Lee, Hae Young

AU - Tahk, Seung Jea

AU - Yoon, Young Won

AU - Shim, Chi Young

AU - Shin, Dong Gu

AU - Seo, Hong Seog

AU - Lee, Sung Yun

AU - Kim, Doo Il

AU - Kwan, Jun

AU - Joo, Seung Jae

AU - Jeong, Myung Ho

AU - Jeong, Jin Ok

AU - Sung, Ki Chul

AU - Kim, Seok Yeon

AU - Kim, Sang Hyun

AU - Chun, Kook Jin

AU - Oh, Dong Joo

N1 - Funding Information: Dr. Rhee has received lecture honoraria from Pfizer Inc., LG Life Sciences Ltd, Bayer Korea Ltd., Hanmi Pharm. Co. Ltd., Yuhan Co. Ltd., Boryung Pharmaceutical Co. Ltd., and research grant from Boryung Pharmaceutical Co. Ltd. and Dong-A Pharmaceutical Co., Ltd. Dr. Oh has received research grant from Boryung Pharmaceutical Co. Ltd. The authors have indicated that they have no other conflicts of interest with regard to the content of this article. The study drugs were supplied by Boryung Pharmaceutical Co. Ltd. ClinicalTrials.gov Identifier: NCT02166814. Funding Information: This study was initiated and financially supported by Boryung Pharmaceutical Co. Ltd., Seoul, Republic of Korea (BR-FRC-CT-301). The sponsor supported the supply of study drug, laboratory test, data collection, and data analysis. The funding body had no role in data interpretation and the writing of the manuscript based on the data. Publisher Copyright: © 2017 The Author(s).

PY - 2017/1/5

Y1 - 2017/1/5

N2 - Background: Hypertension and dyslipidemia are major risk factors of cardiovascular disease (CVD) events. The objective of this study was to evaluate the efficacy and safety of the co-administration of fimasartan and rosuvastatin in patients with hypertension and hypercholesterolemia. Methods: We conducted a randomized double-blind and parallel-group trial. Patients who met eligible criteria after 4 weeks of therapeutic life change were randomly assigned to the following groups. 1) co-administration of fimasartan 120 mg/rosuvastatin 20 mg (FMS/RSV), 2) fimasartan 120 mg (FMS) alone 3) rosuvastatin 20 mg (RSV) alone. Drugs were administered once daily for 8 weeks. Results: Of 140 randomized patients, 135 for whom efficacy data were available were analyzed. After 8 weeks of treatment, the FMS/RSV treatment group showed greater reductions in sitting systolic (siSBP) and diastolic (siDBP) blood pressures than those in the group receiving RSV alone (both p<0.001). Reductions in siSBP and siDBP were not significantly different between the FMS/RSV and FMS alone groups (p=0.500 and p=0.734, respectively). After 8 weeks of treatment, FMS/RSV treatment showed greater efficacy in percentage reduction of low-density lipoprotein cholesterol (LDL-C) level from baseline than that shown by FMS alone treatment (p<0.001). The response rates of siSBP with FMS/RSV, FMS alone, and RSV alone treatments were 65.22, 55.56, and 34.09%, respectively (FMS/RSV vs. RSV, p=0.006). The LDL-C goal attainment rates with FMS/RSV, RSV alone, and FMS alone treatments were 80.43%, 81.82%, and 15.56%, respectively (FMS/RSV vs. FMS, p<0.001). Incidence of adverse drug reactions with FMS/RSV treatment was 8.33%, which was similar to those associated with FMS and RSV alone treatments. Conclusion: This study demonstrated that the co-administration of fimasartan and rosuvastatin to patients with both hypertension and hypercholesterolemia was efficacious and safe. Trial registration: ClinicalTrials.gov Identifier: NCT02166814.

AB - Background: Hypertension and dyslipidemia are major risk factors of cardiovascular disease (CVD) events. The objective of this study was to evaluate the efficacy and safety of the co-administration of fimasartan and rosuvastatin in patients with hypertension and hypercholesterolemia. Methods: We conducted a randomized double-blind and parallel-group trial. Patients who met eligible criteria after 4 weeks of therapeutic life change were randomly assigned to the following groups. 1) co-administration of fimasartan 120 mg/rosuvastatin 20 mg (FMS/RSV), 2) fimasartan 120 mg (FMS) alone 3) rosuvastatin 20 mg (RSV) alone. Drugs were administered once daily for 8 weeks. Results: Of 140 randomized patients, 135 for whom efficacy data were available were analyzed. After 8 weeks of treatment, the FMS/RSV treatment group showed greater reductions in sitting systolic (siSBP) and diastolic (siDBP) blood pressures than those in the group receiving RSV alone (both p<0.001). Reductions in siSBP and siDBP were not significantly different between the FMS/RSV and FMS alone groups (p=0.500 and p=0.734, respectively). After 8 weeks of treatment, FMS/RSV treatment showed greater efficacy in percentage reduction of low-density lipoprotein cholesterol (LDL-C) level from baseline than that shown by FMS alone treatment (p<0.001). The response rates of siSBP with FMS/RSV, FMS alone, and RSV alone treatments were 65.22, 55.56, and 34.09%, respectively (FMS/RSV vs. RSV, p=0.006). The LDL-C goal attainment rates with FMS/RSV, RSV alone, and FMS alone treatments were 80.43%, 81.82%, and 15.56%, respectively (FMS/RSV vs. FMS, p<0.001). Incidence of adverse drug reactions with FMS/RSV treatment was 8.33%, which was similar to those associated with FMS and RSV alone treatments. Conclusion: This study demonstrated that the co-administration of fimasartan and rosuvastatin to patients with both hypertension and hypercholesterolemia was efficacious and safe. Trial registration: ClinicalTrials.gov Identifier: NCT02166814.

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ER -

The efficacy and safety of co-administration of fimasartan and rosuvastatin to patients with hypertension and dyslipidemia

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