TY - JOUR
T1 - Study of sustained blood pressure-lowering effect of azelnidipine guided by self-measured morning and evening home blood pressure
T2 - Subgroup analysis of the at-home study
AU - Kario, Kazuomi
AU - Uehara, Yoko
AU - Shirayama, Masayuki
AU - Takahashi, Megumi
AU - Shiosakai, Kazuhito
AU - Hiramatsu, Katsutoshi
AU - Komiya, Masahiro
AU - Shimada, Kazuyuki
N1 - Funding Information:
Acknowledgments The authors would like to thank all of the investigators who cooperated with the At-HOME Study and provided valuable data. The authors would also like to thank Rod McNab and Nila Bhana from inScience Communications, Springer Healthcare (Auckland, New Zealand), who provided English-language editing. This assistance, as well as the translation from Japanese to English, was funded by Daiichi Sankyo Co., Ltd (Tokyo, Japan). Kazuyuki Shimada is now employed by Oyama Municipal Hospital (Tochigi, Japan). Masahiro Komiya is now employed by Daiichi Sankyo Healthcare Co., Ltd (Tokyo, Japan). The authors have no other conflicts of interest that are directly relevant to the content of this article. A version of this manuscript was previously published in Japanese in the Journal of Clinical Therapeutics & Medicine [2009;25(3): 281–96]. The publisher of the Journal of Clinical Therapeutics & Medicine has given permission for publication of this article in English.
PY - 2013/3
Y1 - 2013/3
N2 - Background: Morning hypertension is a risk factor for cardiovascular and cerebrovascular events, and consequently diagnosis and control of morning hypertension are considered very important. We previously reported the results of the Azelnidipine Treatment for Hypertension Open-label Monitoring in the Early morning (At-HOME) Study, which indicated that azelnidipine effectively controlled morning hypertension. Objectives: The objective of this At-HOME subgroup analysis was to evaluate the sustained blood pressure (BP)-lowering effect of azelnidipine, using mean morning and evening systolic BP [ME average] and morning systolic BP minus evening systolic BP (ME difference). Methods: We analyzed the self-measured home BP data (measured in the morning and at bedtime) from this 16-week prospective observational study to clarify the effect of morning dosing of azelnidipine (mean [± standard deviation] maximum dose 14.3 ± 3.6 mg/day). A subgroup of patients from the At-HOME Study who had an evening home BP measurement within 28 days prior to the baseline date were used for efficacy analysis (n = 2,546; mean age, 65.1 years; female, 53.6 %). Results: Home systolic BP/diastolic BP levels in the morning and evening were significantly lowered (p < 0.0001) by -19.4 ± 17.1/-10.3 ± 10.6 and -16.9 ± 17.0/-9.4 ± 10.6 mmHg, respectively. Home pulse rates in the morning and evening were also significantly lowered (p < 0.0001) by -3.5 ± 7.8 and -3.5 ± 7.3 beats/min, respectively. At baseline, patients whose ME average was ≥135 mmHg and whose ME difference was ≥15 mmHg (defined as morning-predominant hypertension) accounted for 20.4 % of the study population. However, at the end of the study, the number of such patients was significantly reduced to 7.9 % (p < 0.0001). Patients whose ME average was ≥135 mmHg and whose ME difference was <15 mmHg (defined as sustained hypertension) accounted for 71.1 % of the study population at baseline. This was reduced significantly to 42.8 % at the end of the study (p < 0.0001). ME average decreased significantly from 153.8 ± 15.5 mmHg to 135.6 ± 11.9 mmHg, and ME difference also decreased significantly from 6.7 ± 13.1 mmHg to 4.7 ± 10.8 mmHg (both p < 0.0001). Conclusion: These results suggest that azelnidipine improved morning hypertension with its sustained BP-lowering effect.
AB - Background: Morning hypertension is a risk factor for cardiovascular and cerebrovascular events, and consequently diagnosis and control of morning hypertension are considered very important. We previously reported the results of the Azelnidipine Treatment for Hypertension Open-label Monitoring in the Early morning (At-HOME) Study, which indicated that azelnidipine effectively controlled morning hypertension. Objectives: The objective of this At-HOME subgroup analysis was to evaluate the sustained blood pressure (BP)-lowering effect of azelnidipine, using mean morning and evening systolic BP [ME average] and morning systolic BP minus evening systolic BP (ME difference). Methods: We analyzed the self-measured home BP data (measured in the morning and at bedtime) from this 16-week prospective observational study to clarify the effect of morning dosing of azelnidipine (mean [± standard deviation] maximum dose 14.3 ± 3.6 mg/day). A subgroup of patients from the At-HOME Study who had an evening home BP measurement within 28 days prior to the baseline date were used for efficacy analysis (n = 2,546; mean age, 65.1 years; female, 53.6 %). Results: Home systolic BP/diastolic BP levels in the morning and evening were significantly lowered (p < 0.0001) by -19.4 ± 17.1/-10.3 ± 10.6 and -16.9 ± 17.0/-9.4 ± 10.6 mmHg, respectively. Home pulse rates in the morning and evening were also significantly lowered (p < 0.0001) by -3.5 ± 7.8 and -3.5 ± 7.3 beats/min, respectively. At baseline, patients whose ME average was ≥135 mmHg and whose ME difference was ≥15 mmHg (defined as morning-predominant hypertension) accounted for 20.4 % of the study population. However, at the end of the study, the number of such patients was significantly reduced to 7.9 % (p < 0.0001). Patients whose ME average was ≥135 mmHg and whose ME difference was <15 mmHg (defined as sustained hypertension) accounted for 71.1 % of the study population at baseline. This was reduced significantly to 42.8 % at the end of the study (p < 0.0001). ME average decreased significantly from 153.8 ± 15.5 mmHg to 135.6 ± 11.9 mmHg, and ME difference also decreased significantly from 6.7 ± 13.1 mmHg to 4.7 ± 10.8 mmHg (both p < 0.0001). Conclusion: These results suggest that azelnidipine improved morning hypertension with its sustained BP-lowering effect.
UR - http://www.scopus.com/inward/record.url?scp=84876222367&partnerID=8YFLogxK
U2 - 10.1007/s40268-013-0007-7
DO - 10.1007/s40268-013-0007-7
M3 - Article
C2 - 23519655
AN - SCOPUS:84876222367
SN - 1174-5886
VL - 13
SP - 75
EP - 85
JO - Drugs in R and D
JF - Drugs in R and D
IS - 1
ER -