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Inhibitory effects of azelnidipine tablets on morning hypertension
Kazuomi Kario1, Yuki Sato, Masayuki Shirayama
1Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, 3311-1 Yakushiji, Shimotsuke, Tochigi, 329-0498, Japan. kkario@jichi.ac.jp
Insights
Azelnidipine effectively controlled morning hypertension, significantly lowering blood pressure and pulse rates in patients. This long-acting calcium antagonist improved hypertension management and patient compliance.
Area of Science:
- Cardiology
- Pharmacology
- Hypertension Research
Background:
- Morning hypertension is a significant risk factor for cardiovascular and cerebrovascular events.
- Self-monitoring of blood pressure (BP) in the morning improves patient adherence to antihypertensive medication.
Purpose of the Study:
- To evaluate the blood pressure (BP) and pulse rate-lowering effects of azelnidipine, a once-daily, long-acting dihydropyridine calcium antagonist.
- To assess azelnidipine's efficacy in managing morning hypertension.
Main Methods:
- The Azelnidipine Treatment for Hypertension Open-label Monitoring in the Early morning (At-HOME) Study enrolled 5,433 hypertensive patients in Japan.
- Efficacy analysis included data from 4,852 patients, defining high systolic BP (SBP) as ≥135 mmHg at home (morning) and ≥140 mmHg at the clinic (day).
Main Results:
- Azelnidipine significantly reduced BP and pulse rates across home (morning/evening) and clinic measurements after 16 weeks (p < 0.0001).
- Home morning SBP <135 mmHg was achieved by 43.3% of patients (vs. 6.6% at baseline), and clinic SBP <140 mmHg by 56.1% (vs. 12.9% at baseline).
- 32.2% of patients achieved well-controlled hypertension in both home and clinic settings, with a 2.92% incidence of expected adverse drug reactions.
Conclusions:
- Azelnidipine demonstrates significant efficacy in controlling morning hypertension.
- The drug effectively reduces blood pressure and pulse rate, contributing to better overall hypertension management.
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.
Conclusion:
These data suggest that azelnidipine controlled morning hypertension well. Furthermore, azelnidipine reduced pulse rates significantly.
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