A post-marketing survey evaluating the safety and efficacy of a fixed-dose single-pill combination of cilnidipine and valsartan in patients with hypertension: Real-world JSH 2014 and 2019 implementations

ABSTRACT

Methods

: The home blood pressure control by a single-pill combination of cilnidipine and valsartan (HOPE-Combi) survey sought to evaluate the safety and efficacy of cilnidipine 10 mg/valsartan 80 mg single-pill combination (SPC of Cil/Val) treatment in patients with hypertension for over 12 months. Of 2622 subjects’ data; we analyzed 2572 cases for safety and 2372 cases for efficacy.

Results

Adverse drug reaction (ADR) incidence rate was 3.77% (97 of 2572 patients). The frequency of ADRs did not differ between patients aged <75 years and those aged ≥75 years (3.70% vs. 3.93%, respectively); between patients with and without chronic liver disease (CLD; 6.44% vs. 3.54%, respectively); and between patients with and without chronic kidney disease (CKD; 5.26% vs. 3.59%, respectively). Office systolic blood pressure (BP) was reduced from 149.5 ± 19.6 mmHg to 133.5 ± 14.8 mmHg (−15.8 mmHg, P < .01); pulse rate was also reduced 75.5 ± 12.2 bpm to 73.5 ± 11.3 bpm (−1.8 bpm, P < .01) after 12 months.

Conclusions

: The SPC of Cil/Val was safe and effective in treating BP of hypertensive patients in real-world settings.

KEYWORDS:

• HOPE-Combi survey
• single-pill combination
• post-marketing survey
• cilnidipine
• valsartan
• JSH 2019

Acknowledgments

We would like to express our deepest gratitude to the physicians who provided valuable data and for their cooperation in conducting the HOPE-Combi survey. We would also like to thank Junko Yamashita, an employee of EA Pharma Co., Ltd., for planning the survey and progress management.

Declaration of interest

Kazuomi Kario received scholarship donations from MOCHIDA PHARMACEUTICAL CO., LTD and an honorarium as a medical professional from EA Pharma Co., Ltd. for this survey. Saori Matsuda, Shinobu Nagahama, Yoshiki Kurose and Maki Wakabayashi are employees of EA Pharma Co., Ltd. Hitoshi Sugii, Tsukasa Teshima, and Noriyuki Suzuki are employees of MOCHIDA PHARMACEUTICAL CO., LTD.

Supplementary material

Supplemental data for this article can be accessed here.

Additional information

Funding

This work was supported by EA Pharma Co., Ltd. and MOCHIDA PHARMACEUTICAL CO., LTD.