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


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2017-12

AUTHORS

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

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 . 16 June 2014. More... »

PAGES

2

Identifiers

URI

http://scigraph.springernature.com/pub.10.1186/s40360-016-0112-7

DOI

http://dx.doi.org/10.1186/s40360-016-0112-7

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1047093108

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/28057081


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