Inhibitory Effects of Azelnidipine Tablets on Morning Hypertension

Abstract

BackgroundMorning 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.ObjectiveThe 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.MethodsWe 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.ResultsAt 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.ConclusionThese data suggest that azelnidipine controlled morning hypertension well. Furthermore, azelnidipine reduced pulse rates significantly.Electronic supplementary materialThe online version of this article (doi:10.1007/s40268-013-0006-8) contains supplementary material, which is avail...

Study of Sustained Blood Pressure-Lowering Effect of Azelnidipine Guided by Self-Measured Morning and Evening Home Blood Pressure: Subgroup Analysis of the At-HOME Study

“…The At-HOME study [12] was conducted according to Article 14-4 (re-examination) of the Pharmaceutical Affairs Act, Japan, and in compliance with Good Post-marketing Study Practice (GPSP). For a list of participating medical centers [in Japanese], see the electronic supplementary material.…”

“…From among the patients who were included in the primary analysis of the At-HOME Study [12], cases with evening home BP measurements within 28 days prior to the baseline date are described in this article.…”

“…It was confirmed that there were no major differences in the results of the primary analysis when only those patients with two measurements of BP (protocol-compliant cases) were included. From among the safety and efficacy populations included in the primary analysis of the At-HOME Study [12], patients with no evening home BP measured within 28 days prior to the baseline date were excluded from the present study.

Fig. 1Patient classification according to morning and evening systolic blood pressure (ME average) and morning systolic blood pressure minus evening systolic blood pressure (ME difference) [5].

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“…In this study using the results from our previously reported special survey of azelnidipine (the Azelnidipine Treatment for Hypertension Open-label Monitoring in the Early morning [At-HOME] Study [12]), we performed subgroup analyses in cases with measurements of BP at home in the evening (evening home BP), to evaluate the effects of the agent on morning and evening home BP, using mainly ME average and ME difference as measures.…”

Clinical use of azelnidipine in the treatment of hypertension in Chinese patients

“…In this study, azelnidipine also significantly decreased plasma Hs-CRP ( P <0.05) concentration and increased 6-keto-PGF1α level to inhibit the formation and development of atherosclerosis. In addition, some previous literature has reported that azelnidipine featured reno-protective, improving insulin resistance, and cerebro-protective effects 16. However there is no relevant research in Chinese.…”