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Persistence of the antihypertensive efficacy of amlodipine and nifedipine GITS after two ‘missed doses’: a randomised, double-blind comparative trial in Asian patients

Journal of Human Hypertension volume 16, pages 805–813 (2002)Cite this article

Abstract

Suboptimal management of hypertension is often a result of poor patient compliance in the form of missed doses of their antihypertensive medication. This multicentre, randomised, double-blind, parallel-group trial was designed to compare the persistence of the antihypertensive efficacy of the amlodipine and nifedipine gastrointestinal therapeutic system (GITS) after two ‘missed doses’, and also to compare the drugs' overall efficacy and safety in Asian patients with mild-to-moderate essential hypertension. Following a 2-week placebo run-in period, 222 patients were randomised to receive either amlodipine (5 mg daily, increased after 6 weeks if necessary to 10 mg daily, n=109) or nifedipine GITS (30 mg daily, increased after 6 weeks if necessary to 60 mg daily; n=113) for 12 weeks. A placebo was then substituted for further 2 days with continuous ambulatory blood pressure (BP) monitoring. The increases in the last 9 h of mean ambulatory BP on day 2 after treatment withdrawal were significantly less with amlodipine than with nifedipine GITS: 4.4±7.0 vs 11.2±11.3 mmHg for systolic BP (P⩽0.0001) and 2.4±6.3 vs 6.0±6.0 mmHg for diastolic BP (P⩽0.0002). Significant differences between the two drugs in mean 24-h ambulatory BP levels were already evident on day 1 after withdrawal, even though there were no significant differences on the final day of treatment. No differences in safety parameters were observed, and neither drug caused any serious or severe treatment-related adverse events. In conclusion, amlodipine provides greater protection than nifedipine GITS against loss of BP control following missed doses.

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Acknowledgements

This study was supported by Pfizer, Inc.

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Authors and Affiliations

  1. St Luke's Medical Center, Quezon City, Philippines

    I Ongtengco

  2. Manila Doctors Hospital, Manila, Philippines

    D Morales

  3. The Chinese University of Hong Kong, Hong Kong

    J Sanderson

  4. Xian Medical University, First Affiliated Hospital, Xian, China

    Z-R Lu

  5. University Department of Medicine, University of Western Australia, Perth, Australia

    L J Beilin, V Burke & I B Puddey

  6. Ramathibodi Hospital, Mahidol University, Bangkok, Thailand

    S Tanomsup

  7. Beijing Chaoyang Hospital, Beijing, China

    H Dayi

  8. Rumah Sakit Cipto Mangunkusumo, Jakarta, Indonesia

    P Rahardjo

  9. Institute Jantung Negara, Kuala Lumpur, Malaysia

    Dato R Zambahari

  10. Kuang Tien General Hospital, Taichung, Taiwan

    C-Y Chen

  11. Rumah Sakit Harapan Kita, Jakarta, Indonesia

    A A Soenarta

  12. Siriraj Hospital, Mahidol University, Bangkok, Thailand

    P Buranakitjaroen

  13. University Hospital, Kuala Lumpur, Malaysia

    C Tan

  14. Changi General Hospital, Singapore

    T K Soon

  15. Chung-Shan Medical and Dental College, Taichung, Taiwan

    D-J Wu

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  1. I Ongtengco
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Appendix

Appendix

Members of the study group who conducted this trial were:

China: Principal investigators: Hu Dayi, Beijing Chaoyang Hospital, Beijing; Zhuo-Ren Lu, Xian Medical University First Affiliated Hospital, Xian. Co-investigators: Zhao Xiuli, Xu Zhimin, Liu Xiaohui, Cui Liang, Beijing Chaoyang Hospital, Beijing; Xue Xiaolin, Yuan Zuyi, Wang Dongqi, Qu Yi, Xian Medical University First Affiliated Hospital, Xian. Study coordinators: Yin Rongxiu, Beijing Chaoyang Hospital, Beijing; Guo Ning, Min Hui-e, Xian Medical University First Affiliated Hospital, Xian.

Hong Kong: Principal investigator: John Sanderson, The Chinese University of Hong Kong, Hong Kong. Co-investigator: Brian Tomlinson, The Chinese University of Hong Kong, Hong Kong. Study Coordinator: Wong Sau Ying, The Chinese University of Hong Kong, Hong Kong.

Indonesia: Principal investigators: Pudji Rahardjo, Rumah Sakit Cipto Mangunkusumo, Jakarta; Arieska Ann Soenarta, Rumah Sakit Harapan Kita, Jakarta. Co-investigators: Lucky Azizah Bawazier, Rumah Sakit Cipto Mangunkusomo, Jakarta; Santoso Karo-karo, Ismoyo Sunu, Rumah Sakit Harapan Kita, Jakarta. Study coordinators: Nanit Rahardjo, Rumah Sakit Cipto Mangunkusomo, Jakarta; Lasmaria Sitorus, Rumah Sakit Harapan Kita, Jakarta.

Malaysia: Principal investigators: Dato Robaayah Zambahari, Institute Jantung Negara, Kuala Lumpur; Christina Tan, University Hospital, Kuala Lumpur. Co-investigators: Na Boon Seng, Lam Kai Huat, Institute Jantung Negara, Kuala Lumpur; Chia Yook Chin, Chua Chin Teong, Lang Chim Choy, University Hospital, Kuala Lumpur. Study coordinators: Chia See Moi, Fong Chew Khew, Institute Jantung Negara, Kuala Lumpur; Tan Chan Soo Looi, University Hospital, Kuala Lumpur.

Philippines: Principal investigators: Dante Morales, Manila Doctors Hospital, Manila; Isabelo Ongtengco, St Luke's Medical Center, Quezon City. Co-investigators: Rody Sy, Rafael Castillo, Dennis Donor, Philip Chua, Manila Doctor's Hospital, Manila; Abondino Yunque, Michael Mercier Enriquez, St Luke's Medical Center, Quezon City. Study coordinators: Dannette Marbella, Manila Doctor's Hospital, Manila; Beverly Anne Callejo, St. Luke's Medical Center, Quezon City.

Singapore: Principal investigator: Tan Kok Soon, Changi General Hospital. Co-investigator: Woon Voon Ching, Changi General Hospital. Study Coordinator: Yew Lay Hwa, Changi General Hospital, Singapore.

Taiwan: Principal investigators: Chung-Yin Chen, Kuang-Tien General Hospital, Taichung; Der-Jinn Wu, Chung-Shan Medical and Dental College, Taichung. Co-investigators: Shih-Chung Huang, Mau-Rem Lin, Kuang Tien General Hospital, Taichung; Kwo-Chang Ueng, Chung-Shan Medical and Dental College, Taichung. Study coordinators: Chiao-Ling Chang, Kuang-Tien General Hospital, Taichung; Miao-Chi Chiu, Chung-Shan Medical and Dental College, Taichung.

Thailand: Principal investigators: Supachai Tanomsup, Ramathibodi Hospital, Mahidol University, Bangkok; Peera Buranakitjaroen, Siriraj Hospital, Mahidol University, Bangkok. Co-investigators: Suchet Takdhada, Ramathibodi Hospital, Mahidol University, Bangkok; Meta Phoojaroenchanachai, Siriraj Hospital, Mahidol University, Bangkok. Study coordinators: Nongluck Intarayota, Ramathibodi Hospital, Mahidol University, Bangkok; Surachai Saravich, Siriraj Hospital, Mahidol University, Bangkok.

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Ongtengco, I., Morales, D., Sanderson, J. et al. Persistence of the antihypertensive efficacy of amlodipine and nifedipine GITS after two ‘missed doses’: a randomised, double-blind comparative trial in Asian patients. J Hum Hypertens 16, 805–813 (2002). https://doi.org/10.1038/sj.jhh.1001485

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