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Comparison of the Efficacy and Safety of Fixed-Dose Amlodipine/Losartan and Losartan in Hypertensive Patients Inadequately Controlled with Losartan

A Randomized, Double-Blind, Multicenter Study

  • Original Research Article
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American Journal of Cardiovascular Drugs Aims and scope Submit manuscript

Abstract

Background

Fixed-dose combination drugs may enhance blood pressure (BP) goal attainment through complementary effects and reduced side effects, which leads to better compliance.

Objective

This study aimed to evaluate the efficacy and safety profiles of once-daily combination amlodipine/losartan versus losartan.

Methods

This was an 8-week, double-blind, multicenter, randomized phase III study conducted in outpatient hospital clinics. Korean patients with essential hypertension inadequately controlled on losartan 100 mg were administered amlodipine/losartan 5 mg/100 mg combination versus losartan 100 mg. The main outcome measures were changes in sitting diastolic blood pressure (DBP) and sitting systolic blood pressure (SBP) and BP response rate from baseline values, which were assessed after 4 and 8 weeks of treatment. Safety and tolerability were also assessed.

Results

At week 8, both groups achieved significant reductions from baseline in DBP (11.7 ± 7.0 and 3.2 ±7.9 mmHg), which was significantly greater in the amlodipine/losartan 5 mg/100 mg combination (n = 70) group (p < 0.0001). Additionally, the amlodipine/losartan 5 mg/100 mg combination group achieved significantly greater reductions in SBP at week 8 and in SBP and DBP at week 4 compared with the losartan 100 mg (n = 72) group (all p<0.0001). Response rates were significantly higher in the amlodipine/losartan 5 mg/100 mg group versus the losartan 100 mg group (81.4% vs 63.9% at week 4, p < 0.0192; 90.0% vs 66.7% at week 8, p<0.001). Both treatments were generally well tolerated.

Conclusion

Switching to a fixed-dose combination therapy of amlodipine/losartan 5 mg/100 mg was associated with significantly greater reductions in BP and superior achievement of BP goals compared with a maintenance dose of losartan 100 mg in Korean patients with essential hypertension inadequately controlled on losartan 100 mg.

Clinical Trial Registration

Registered at Clinicaltrials.gov as NCT00940680.

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Acknowledgments

This work was supported by Hanmi Pharmaceutical Ltd, Korea. The authors declare no conflicts of interest. The authors wish to thank Dr Mary E. Hanson of Merck Sharp and Dohme, Corp. for assistance in the preparation of the manuscript, although she did not fulfill all the criteria for authorship.

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Authors and Affiliations

  1. Heart Center, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, Korea

    Bum-Kee Hong

  2. Cardiology Division, Korea University Guro Hospital, Seoul, Korea

    Chang Gyu Park

  3. Cardiology Division, Daegu Catholic University Medical Center, Daegu, Korea

    Ki Sik Kim

  4. Cardiology Division, Anjou University Medical Center, Suwon, Korea

    Myeong Ho Yoon

  5. Cardiology Division, Seoul St Mary Hospital, Catholic University, Seoul, Korea

    Ho Joong Yoon

  6. Cardiology Division, CHA Bundang Medical Center, CHA University, 59 Yatap-Ro, Bundang-gu, Seongnam, Gyeonggi-do, Korea

    Jeong Han Yoon

  7. Department of Cardiology, National Health Insurance Corporation Ilsan Hospital, Ilsan, Korea

    Joo Young Yang

  8. Cardiology Division, Hanging Sacred Heart Hospital, Hallym University Medical Center, Seoul, Korea

    Young Jin Choi

  9. Cardiology Division, Cardiovascular Hospital, Yonsei University College of Medicine, 134 Sinchon-dong, Seodaemun-gu, Seoul, 120-752, Korea

    Seung Yun Cho MD, PhD

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  1. Bum-Kee Hong
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  2. Chang Gyu Park
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  9. Seung Yun Cho MD, PhD
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Corresponding author

Correspondence to Seung Yun Cho MD, PhD.

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Hong, BK., Park, C.G., Kim, K.S. et al. Comparison of the Efficacy and Safety of Fixed-Dose Amlodipine/Losartan and Losartan in Hypertensive Patients Inadequately Controlled with Losartan. Am J Cardiovasc Drugs 12, 189–195 (2012). https://doi.org/10.2165/11597410-000000000-00000

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  • DOI: https://doi.org/10.2165/11597410-000000000-00000

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