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Am J Cardiovasc Drugs. 2016;16(2):129-38.

Efficacy and Safety Study of Olmesartan Medoxomil, Amlodipine, and Hydrochlorothiazide Combination Therapy in Patients with Hypertension Not Controlled with Olmesartan Medoxomil and Hydrochlorothiazide Combination Therapy: Results of a Randomized, Double-Blind, Multicenter Trial.

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제1저자 손일석 · 교신저자 오병희

PMID 26691333 PMC4819539 DOI 10.1007/s40256-015-0156-x IF 3.2 순환기내과
소속 (6)
  1. Kyung Hee University Hospital at Gangdong, Seoul, Republic of Korea.
  2. Division of Cardiology, Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Hospital, 101 Daehak-ro(28 Yongon-dong), Jongno-gu, Seoul, 110-744, Republic of Korea. ohbhmed@snu.ac.kr.
  3. Pusan National University Hospital, Busan, Republic of Korea.
  4. Korea University Guro Hospital, Seoul, Republic of Korea.
  5. Daedong Hospital, Busan, Republic of Korea.
  6. Yeouido St. Mary's Hospital of the Catholic University of Korea, Seoul, Republic of Korea.

Abstract

BACKGROUND This study was to evaluate the efficacy and safety of triple fixed-dose combination (FDC) therapy with olmesartan medoxomil (OM) 20 mg, amlodipine (AML) 5 mg, and hydrochlorothiazide (HCTZ) 12.5 mg (OM/AML/HCTZ 20/5/12.5) in Korean patients with moderate hypertension not controlled with dual FDC therapy (OM/HCTZ 20/12.5).

METHODS In this multicenter, randomized, double-blind, parallel-group study, Korean patients aged 20 to 75 years with stage 2 hypertension who had a mean seated diastolic blood pressure (msDBP) ≥100 mmHg were enrolled when their BP was uncontrolled [mean seated systolic BP (msSBP)/msDBP >140/90 mmHg or msSBP/msDBP >130/80 mmHg with diabetes or chronic kidney disease] with 4-week dual FDC therapy (OM/HCTZ 20/12.5). The patients were randomized to receive either OM/AML/HCTZ 20/5/12.5 or OM/HCTZ 20/12.5 once daily for 8 weeks. At the end of 8 weeks, patients with uncontrolled BP were assigned to receive either OM/AML/HCTZ 40/5/12.5 or OM/AML/HCTZ 20/5/12.5 in an additional 8-week open-label extension period.

RESULTS A total of 623 patients received a 4-week run-in treatment with OM/HCTZ, 341 patients were randomized, and finally, 167 patients in the OM/AML/HCTZ group and 171 patients in the OM/HCTZ group were analyzed for the full analysis set. Non-responders after the 8 weeks of double-blind treatment continued the 8-week open-label treatment with OM/AML/HCTZ 40/5/12.5 mg (n = 32) or OM/AML/HCTZ 20/5/12.5 mg (n = 71). After 8 weeks of double-blind treatment, the changes in msDBP were -9.50 (8.46) mmHg in the OM/AML/HCTZ group and -4.23 (7.41) mmHg in the OM/HCTZ group (both p < 0.0001 vs. baseline; p < 0.0001 between groups). The response rates for both msSBP and msDBP at week 8 were 65.27 % in the OM/AML/HCTZ group and 37.43 % in the OM/HCTZ group (p < 0.0001 between groups). The response rates for both msSBP and msDBP at week 16 after open-label treatment were 18.75 % in the OM/AML/HCTZ 40/5/12.5 group and 46.48 % in the OM/AML/HCTZ 20/5/12.5 group (p = 0.0073 between groups). All medications were well tolerated.

CONCLUSION In Korean patients with moderate hypertension not controlled with dual FDC therapy (OM/HCTZ 20/12.5) as first-line therapy, switching to triple FDC therapy (OM/AML/HCTZ 20/5/12.5) was associated with significant BP reductions and greater achievement of BP goals, and was well tolerated (ClinicalTrials.gov Identifier: NCT01838850).

Figures

Fig. 1
Fig. 1 Study flow and patient disposition. AML amlodipine, BP blood pressure, HCTZ hydrochlorothiazide, OM olmesartan medoxomil. Non-responders were defined as patients who did not meet BP goals [msSBP/msDBP <140/90 mmHg (msSBP/msDBP <130/80 mmHg in patients with diabetes or chronic kidney disease)]
Fig. 2
Fig. 2 Changes in mean seated diastolic blood pressure (msDBP) (a) and mean seated systolic blood pressure (msSBP) (b) from randomization to weeks 4 and 8 of the double-blind treatment. AML amlodipine, HCTZ hydrochlorothiazide, OM olmesartan medoxomil. *p < 0.0001 vs. OM/HCTZ
Fig. 3
Fig. 3 Changes in mean seated diastolic blood pressure (msDBP) (a) and mean seated systolic blood pressure (msSBP) (b) from week 8 to week 16 during the open-label period. AML amlodipine, HCTZ hydrochlorothiazide, OM olmesartan medoxomil. *p = 0.0434, † p = 0.1650, ‡ p = 0.2012, § p = 0.1085 vs. OM/AML/HCTZ 20/5/12.5, respectively
Fig. 4
Fig. 4 Least-squares (LS) mean change in the mean seated diastolic blood pressure (msDBP) from randomization to 8 weeks of double-blind treatment according to sex, age, smoking status, and body mass index. *Adjusted for age, smoking, alcohol, and body mass index

그림 출처: PubMed Central 공개 논문 (PMC4819539)

Comment · 정정

그 밖의 정보
출판 형태
Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
저널
American journal of cardiovascular drugs : drugs, devices, and other interventions · eISSN 1179-187X
MeSH
Adult · Aged · Amlodipine / administration & dosage / adverse effects · Antihypertensive Agents / adverse effects / therapeutic use · Blood Pressure / drug effects · Double-Blind Method · Drug Therapy, Combination / adverse effects / methods · Female · Humans · Hydrochlorothiazide / administration & dosage / adverse effects · Hypertension / drug therapy · Male · Middle Aged · Olmesartan Medoxomil / administration & dosage / adverse effects · Young Adult
Substances
Antihypertensive Agents · Hydrochlorothiazide · Amlodipine · Olmesartan Medoxomil
데이터
ClinicalTrials.gov: NCT01838850
참고문헌
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