title: Inhibitory effects of azelnidipine tablets on morning hypertension.
abstract: BACKGROUND
  Morning hypertension is a risk factor for cardiovascular and cerebrovascular events. Furthermore, it is a useful measure for definitive diagnosis of hypertension, and patients who self-assess their own blood pressure (BP) in the morning tend to exhibit better compliance with antihypertensive medication than those who do not.
  
  
  OBJECTIVE
  The objective of this analysis was to determine the BP- and pulse rate-lowering effects of azelnidipine, a long-acting dihydropyridine calcium antagonist administered once daily in the morning.
  
  
  METHODS
  We conducted the Azelnidipine Treatment for Hypertension Open-label Monitoring in the Early morning (At-HOME) Study by surveying patients who were taking azelnidipine. According to the study protocol, high systolic BP (SBP) was defined as ≥135 mmHg when measured at home in the morning and ≥140 mmHg when measured at the clinic during the day. A total of 5,433 hypertensive patients, who were registered at 1,011 medical institutions across Japan, were enrolled in the study. Data obtained from 4,852 of these patients (mean age, 64.8 years; female, 52.9 %; previous medication with other antihypertensive agents used concomitantly with the present study agent, 45.5 %) were used for efficacy analysis.
  
  
  RESULTS
  At baseline, the subjects' mean [± standard deviation] SBP/diastolic BP values at home in the morning, at the clinic during the day, and at home in the evening were 156.9 ± 16.4/89.7 ± 12.0, 157.5 ± 18.7/89.1 ± 13.3, and 150.2 ± 17.6/85.6 ± 12.2 mmHg, respectively. The mean pulse rates were 72.7 ± 10.7, 74.9 ± 11.2, and 72.5 ± 9.6 beats/min, respectively. Patients whose BP was defined as high accounted for 83.4 % of the study population, whereas 9.9 % had 'masked' hypertension, defined as SBP of ≥135 mmHg at home in the morning and <140 mmHg at the clinic. However, from 4 weeks after initiation of azelnidipine treatment till the end of the study at week 16, all three daily BP determinations were significantly (p < 0.0001) lowered, and pulse rates at home in the morning, at the clinic, and at home in the evening were similarly and significantly reduced (by -3.7 ± 8.0, -3.5 ± 9.5, and -3.5 ± 7.3 beats/min, respectively). Whereas achievement of home SBP of <135 mmHg in the morning was noted in only 6.6 % of patients before the start of azelnidipine treatment, this was noted in 43.3 % after 16 weeks. Meanwhile, achievement of clinic SBP of <140 mmHg was increased from 12.9 % of patients to 56.1 % of patients at the same timepoints. After azelnidipine treatment, 32.2 % of patients had well-controlled hypertension in both the home and clinic settings. Adverse drug reactions occurred in 2.92 % of patients (154/5,265). All adverse drug reactions were as expected for the calcium antagonist class of agents.
  
  
  CONCLUSIONS
  These data suggest that azelnidipine controlled morning hypertension well. Furthermore, azelnidipine reduced pulse rates significantly.
authors.affiliation: Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, 3311-1 Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan. kkario@jichi.ac.jp
authors.forename: Kazuomi
authors.initials: K
authors.lastname: Kario
authors.forename: Yuki
authors.initials: Y
authors.lastname: Sato
authors.forename: Masayuki
authors.initials: M
authors.lastname: Shirayama
authors.forename: Megumi
authors.initials: M
authors.lastname: Takahashi
authors.forename: Kazuhito
authors.initials: K
authors.lastname: Shiosakai
authors.forename: Katsutoshi
authors.initials: K
authors.lastname: Hiramatsu
authors.forename: Masahiro
authors.initials: M
authors.lastname: Komiya
authors.forename: Kazuyuki
authors.initials: K
authors.lastname: Shimada
mesh_terms: D000368:Aged; D001383:Azetidinecarboxylic Acid / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use; D001794:Blood Pressure / Q000187:drug effects / Q000502:physiology; D002121:Calcium Channel Blockers / Q000494:pharmacology / Q000627:therapeutic use*; D002940:Circadian Rhythm / Q000187:drug effects* / Q000502:physiology; D004095:Dihydropyridines / Q000494:pharmacology / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D012042:Registries; D013607:Tablets; D016896:Treatment Outcome
chemical_list: D002121:Calcium Channel Blockers; D004095:Dihydropyridines; D013607:Tablets; D001383:Azetidinecarboxylic Acid; C061679:azelnidipine