Efficacy and safety of fixed-dose combination therapy with olmesartan medoxomil and rosuvastatin in korean patients with mild to moderate hypertension and dyslipidemia

An 8-week, multicenter, randomized, double-blind, factorial-design study (OLSTA-D RCT: OLmesartan rosuvaSTAtin from daewoong)

Jin Sun Park, Joon Han Shin, Taek Jong Hong, Hong Seog Seo, Wan Joo Shim, Sang Hong Baek, Jin Ok Jeong, Youngkeun Ahn, Woong Chol Kang, Young Hak Kim, Sang Hyun Kim, Min Su Hyon, Donghoon Choi, Chang Wook Nam, Tae Ho Park, Sang Chol Lee, Hyo Soo Kim

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

The pill burden of patients with hypertension and dyslipidemia can result in poor medication compliance. This study aimed to evaluate the efficacy and safety of fixed-dose combination (FDC) therapy with olmesartan medoxomil (40 mg) and rosuvastatin (20 mg) in Korean patients with mild to moderate hypertension and dyslipidemia. This multicenter, randomized, double-blind, factorial-design study included patients aged $20 years with mild to moderate essential hypertension and dyslipidemia. Patients were randomly assigned to receive FDC therapy (40 mg olmesartan medoxomil, 20 mg rosuvastatin), 40 mg olmesartan medoxomil, 20 mg rosuvastatin, or a placebo. The percentage change from baseline in low-density lipoprotein cholesterol levels was compared between FDC therapy and olmesartan medoxomil, and the change from baseline in diastolic blood pressure was compared between FDC therapy and rosuvastatin 8 weeks after treatment. A total of 162 patients were included. The least square mean percentage change (standard error) from baseline in low-density lipoprotein cholesterol levels 8 weeks after treatment was significantly greater in the FDC than in the olmesartan medoxomil group (−52.3% [2.8%] vs −0.6% [3.5%], P, 0.0001), and the difference was −51.7% (4.1%) (95% confidence interval: −59.8% to −43.6%). The least square mean change (standard error) from baseline in diastolic blood pressure 8 weeks after treatment was significantly greater in the FDC group than in the rosuvastatin group (−10.4 [1.2] mmHg vs 0.1 [1.6] mmHg, P, 0.0001), and the difference was −10.5 (1.8) mmHg (95% confidence interval: −14.1 to −6.9 mmHg). There were 50 adverse events in 41 patients (22.7%) and eight adverse drug reactions in five patients (2.8%). The study found that FDC therapy with olmesartan medoxomil and rosuvastatin is an effective, safe treatment for patients with hypertension and dyslipidemia. This combination may improve medication compliance in patients with a large pill burden.

Original languageEnglish
Pages (from-to)2599-2609
Number of pages11
JournalDrug Design, Development and Therapy
Volume10
DOIs
Publication statusPublished - 2016 Aug 16

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Dyslipidemias
Hypertension
Safety
Blood Pressure
Therapeutics
Medication Adherence
Least-Squares Analysis
LDL Cholesterol
Confidence Intervals
olmesartan
Olmesartan Medoxomil
Rosuvastatin Calcium
Drug-Related Side Effects and Adverse Reactions
Placebos

All Science Journal Classification (ASJC) codes

  • Pharmacology
  • Pharmaceutical Science
  • Drug Discovery

Cite this

Park, Jin Sun ; Shin, Joon Han ; Hong, Taek Jong ; Seo, Hong Seog ; Shim, Wan Joo ; Baek, Sang Hong ; Jeong, Jin Ok ; Ahn, Youngkeun ; Kang, Woong Chol ; Kim, Young Hak ; Kim, Sang Hyun ; Hyon, Min Su ; Choi, Donghoon ; Nam, Chang Wook ; Park, Tae Ho ; Lee, Sang Chol ; Kim, Hyo Soo. / Efficacy and safety of fixed-dose combination therapy with olmesartan medoxomil and rosuvastatin in korean patients with mild to moderate hypertension and dyslipidemia : An 8-week, multicenter, randomized, double-blind, factorial-design study (OLSTA-D RCT: OLmesartan rosuvaSTAtin from daewoong). In: Drug Design, Development and Therapy. 2016 ; Vol. 10. pp. 2599-2609.
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title = "Efficacy and safety of fixed-dose combination therapy with olmesartan medoxomil and rosuvastatin in korean patients with mild to moderate hypertension and dyslipidemia: An 8-week, multicenter, randomized, double-blind, factorial-design study (OLSTA-D RCT: OLmesartan rosuvaSTAtin from daewoong)",
abstract = "The pill burden of patients with hypertension and dyslipidemia can result in poor medication compliance. This study aimed to evaluate the efficacy and safety of fixed-dose combination (FDC) therapy with olmesartan medoxomil (40 mg) and rosuvastatin (20 mg) in Korean patients with mild to moderate hypertension and dyslipidemia. This multicenter, randomized, double-blind, factorial-design study included patients aged $20 years with mild to moderate essential hypertension and dyslipidemia. Patients were randomly assigned to receive FDC therapy (40 mg olmesartan medoxomil, 20 mg rosuvastatin), 40 mg olmesartan medoxomil, 20 mg rosuvastatin, or a placebo. The percentage change from baseline in low-density lipoprotein cholesterol levels was compared between FDC therapy and olmesartan medoxomil, and the change from baseline in diastolic blood pressure was compared between FDC therapy and rosuvastatin 8 weeks after treatment. A total of 162 patients were included. The least square mean percentage change (standard error) from baseline in low-density lipoprotein cholesterol levels 8 weeks after treatment was significantly greater in the FDC than in the olmesartan medoxomil group (−52.3{\%} [2.8{\%}] vs −0.6{\%} [3.5{\%}], P, 0.0001), and the difference was −51.7{\%} (4.1{\%}) (95{\%} confidence interval: −59.8{\%} to −43.6{\%}). The least square mean change (standard error) from baseline in diastolic blood pressure 8 weeks after treatment was significantly greater in the FDC group than in the rosuvastatin group (−10.4 [1.2] mmHg vs 0.1 [1.6] mmHg, P, 0.0001), and the difference was −10.5 (1.8) mmHg (95{\%} confidence interval: −14.1 to −6.9 mmHg). There were 50 adverse events in 41 patients (22.7{\%}) and eight adverse drug reactions in five patients (2.8{\%}). The study found that FDC therapy with olmesartan medoxomil and rosuvastatin is an effective, safe treatment for patients with hypertension and dyslipidemia. This combination may improve medication compliance in patients with a large pill burden.",
author = "Park, {Jin Sun} and Shin, {Joon Han} and Hong, {Taek Jong} and Seo, {Hong Seog} and Shim, {Wan Joo} and Baek, {Sang Hong} and Jeong, {Jin Ok} and Youngkeun Ahn and Kang, {Woong Chol} and Kim, {Young Hak} and Kim, {Sang Hyun} and Hyon, {Min Su} and Donghoon Choi and Nam, {Chang Wook} and Park, {Tae Ho} and Lee, {Sang Chol} and Kim, {Hyo Soo}",
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Efficacy and safety of fixed-dose combination therapy with olmesartan medoxomil and rosuvastatin in korean patients with mild to moderate hypertension and dyslipidemia : An 8-week, multicenter, randomized, double-blind, factorial-design study (OLSTA-D RCT: OLmesartan rosuvaSTAtin from daewoong). / Park, Jin Sun; Shin, Joon Han; Hong, Taek Jong; Seo, Hong Seog; Shim, Wan Joo; Baek, Sang Hong; Jeong, Jin Ok; Ahn, Youngkeun; Kang, Woong Chol; Kim, Young Hak; Kim, Sang Hyun; Hyon, Min Su; Choi, Donghoon; Nam, Chang Wook; Park, Tae Ho; Lee, Sang Chol; Kim, Hyo Soo.

In: Drug Design, Development and Therapy, Vol. 10, 16.08.2016, p. 2599-2609.

Research output: Contribution to journalArticle

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T1 - Efficacy and safety of fixed-dose combination therapy with olmesartan medoxomil and rosuvastatin in korean patients with mild to moderate hypertension and dyslipidemia

T2 - An 8-week, multicenter, randomized, double-blind, factorial-design study (OLSTA-D RCT: OLmesartan rosuvaSTAtin from daewoong)

AU - Park, Jin Sun

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AU - Hong, Taek Jong

AU - Seo, Hong Seog

AU - Shim, Wan Joo

AU - Baek, Sang Hong

AU - Jeong, Jin Ok

AU - Ahn, Youngkeun

AU - Kang, Woong Chol

AU - Kim, Young Hak

AU - Kim, Sang Hyun

AU - Hyon, Min Su

AU - Choi, Donghoon

AU - Nam, Chang Wook

AU - Park, Tae Ho

AU - Lee, Sang Chol

AU - Kim, Hyo Soo

PY - 2016/8/16

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N2 - The pill burden of patients with hypertension and dyslipidemia can result in poor medication compliance. This study aimed to evaluate the efficacy and safety of fixed-dose combination (FDC) therapy with olmesartan medoxomil (40 mg) and rosuvastatin (20 mg) in Korean patients with mild to moderate hypertension and dyslipidemia. This multicenter, randomized, double-blind, factorial-design study included patients aged $20 years with mild to moderate essential hypertension and dyslipidemia. Patients were randomly assigned to receive FDC therapy (40 mg olmesartan medoxomil, 20 mg rosuvastatin), 40 mg olmesartan medoxomil, 20 mg rosuvastatin, or a placebo. The percentage change from baseline in low-density lipoprotein cholesterol levels was compared between FDC therapy and olmesartan medoxomil, and the change from baseline in diastolic blood pressure was compared between FDC therapy and rosuvastatin 8 weeks after treatment. A total of 162 patients were included. The least square mean percentage change (standard error) from baseline in low-density lipoprotein cholesterol levels 8 weeks after treatment was significantly greater in the FDC than in the olmesartan medoxomil group (−52.3% [2.8%] vs −0.6% [3.5%], P, 0.0001), and the difference was −51.7% (4.1%) (95% confidence interval: −59.8% to −43.6%). The least square mean change (standard error) from baseline in diastolic blood pressure 8 weeks after treatment was significantly greater in the FDC group than in the rosuvastatin group (−10.4 [1.2] mmHg vs 0.1 [1.6] mmHg, P, 0.0001), and the difference was −10.5 (1.8) mmHg (95% confidence interval: −14.1 to −6.9 mmHg). There were 50 adverse events in 41 patients (22.7%) and eight adverse drug reactions in five patients (2.8%). The study found that FDC therapy with olmesartan medoxomil and rosuvastatin is an effective, safe treatment for patients with hypertension and dyslipidemia. This combination may improve medication compliance in patients with a large pill burden.

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