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Effects of Long-Acting ACE Inhibitor (Temocapril) and Long-Acting Ca Channel Blocker (Amlodipine) on 24-H Ambulatory BP in Elderly Hypertensive Patients

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Effects of Long-Acting ACE Inhibitor (Temocapril) and Long-Acting Ca Channel Blocker (Amlodipine) on 24-H Ambulatory BP in Elderly Hypertensive Patients Journal of Human Hypertension (2001) 15, 643–648 2001 Nature Publishing Group All rights reserved 0950-9240/01 $15.00 www.nature.com/jhh ORIGINAL ARTICLE Effects of long-acting ACE inhibitor (temocapril) and long-acting Ca channel blocker (amlodipine) on 24-h ambulatory BP in elderly hypertensive patients K Eguchi1,2, K Kario2 and K Shimada2 1Department of Internal Medicine, Nishiarita Kyoritu Hospital, Saga, Japan; 2Department of Cardiology, Jichi Medical School, Tochigi, Japan In a prospective randomised cross-over study, we com- ferences in the office, 24-h or daytime BPs between the pared the effects of ACE inhibitor temocapril and cal- two groups (dippers and non-dippers). Though the cium channel blocker (CCB) amlodipine on ambulatory office BPs and daytime BPs were successfully con- blood pressure in 59 asymptomatic elderly hypertensive trolled to the same levels with both treatments and in patients (mean age 69 years). This study was performed both dipping groups, the antihypertensive effects were in a cross-over fashion after a 2-week placebo period stronger with the CCB than with the ACE inhibitor in the and 4 to 8 weeks each of treatment with temocapril and night time and morning, especially in non-dippers. We amlodipine. Of those 59 hypertensive patients, three conclude that even though office BPs were controlled patients with side effects and 10 patients whose office successfully to almost the same levels, there is a possi- BPs did not achieve the target BPs were excluded, and bility that these long-acting drugs have differential anti- the remaining 46 were analysed in this study: they con- hypertensive effects on night time and morning BPs sisted of 30 dippers, with a night time reduction in sys- among hypertensive patients with different night time tolic BP (SBP) у10% and 16 non-dippers, with reduction BP dipping statuses. by Ͻ10%. At the baseline, there were no significant dif- Journal of Human Hypertension (2001) 15, 643–648 Keywords: long-acting ACE inhibitor; calcium channel blocker; non-dipper; night time BP Introduction well controlled by a calcium channel blocker (CCB) or ACE inhibitor, and we assessed diurnal BP vari- In recent years, the usefulness of non-invasive ation. ambulatory blood pressure monitoring (ABPM) as a Long-acting CCBs and long-acting ACE inhibitors method for evaluating diurnal blood pressure (BP) are most popular antihypertensive drugs in Japan, variations in addition to the BP level per se has been 1 and are recommended for use once daily. However, reported. Non-dippers (blunted night time BP fall), there are few reports assessing the efficacy of these in particular, have been reported to have greater drugs throughout 24 h, and we do not know how hypertensive target organ damage1–5 and poorer car- 4 long the drugs remain at a therapeutic level after diovascular prognosis. This indicates that con- administration or how potent these drugs are. And trolling night time and morning BPs may be essen- there are few reports comparing these drugs in terms 6 tial for antihypertensive treatment. Even when of diurnal BP variations.7 We conducted this study office BPs are well controlled, it is uncertain to evaluate the effects of temocapril (a long-acting whether the BPs are controlled all day in clinical ACE inhibitor), and amlodipine (a long-acting CCB) practice. Using ABPM, we noted that office BPs were on 24-h ambulatory BP under successful office BP control. Correspondence: Kazuo Eguchi, MD, Department of Internal Medicine, Nishiarita Kyoritu Hospital, 2485–3, Ogiotsu, Nishiar- Patients and methods ita, Nishimatsuura, Saga, 849–4193, Japan. Fax: +81 955 41 2036 or Kazuomi Kario, MD, PhD, Jichi Medical School, Department Study design of Cardiology, 3311–1, Yakushiji, Minamikawachi, Kawachi, Tochigi, 329–0498, Japan. Fax: +81 285 44 5317 The study was a randomised prospective cross-over Received 12 January 2001; revised 29 March 2001; accepted 1 study. After a 2-week washout and run-in period, May 2001 baseline ABPM was performed. The patients were Effects of temocapril and amlodipine on 24-h ABP K Eguchi et al 644 then randomised to temocapril (2–8 mg) or amlodip- variation). Written, informed consent was obtained ine (2.5–10 mg) for 4 to 8 weeks, and a second from all subjects. This study was approved by the ABPM was performed. Then the drug used for treat- Research Ethics Committee, Department of Cardi- ment was changed from temocapril to amlodipine or ology, Jichi Medical School, Japan. from amlodipine to temocapril, and 4 to 8 weeks later a third ABPM was performed. The dose was Measurement of blood pressure and heart rate adjusted according to the BP response to achieve successful BP control. Successful BP control was Measurement of office SBPs and DBPs were made defined as a reduction to Ͻ150/90 mm Hg by a single physician with a standard mercury systolic/diastolic BP (SBP/DBP) and if the BP was sphygmomanometer at each clinical visit, 24 ± 4h higher than 150/90 mm Hg after treatment, a after the previous intake of medication (ie, at reduction of у20/10 mm Hg was considered suc- trough). Pulse rate (PR) was measured by pulse pal- cessful. Initially, all patients were treated with tem- pation for 30 seconds immediately after the BP ocapril (2 to 4 mg) or amlodipine (2.5 to 5 mg) once measurement. These measurement were made in the daily. Then, the temocapril dose was increased by seated position after patients had rested in the 2 mg or amlodipine by 2.5 mg or by 4 mg or 5 mg, seated position for 5 min. We used the left arm for respectively for 2 weeks up to twice the maximum measurements with an appropriate-sized cuff reference dose recommended in Japan (ie, to 8 mg because the left arm is ordinarily used for ABPM for temocapril and 10 mg for amlodipine). For measurements. Automatic ABPM with electric-pow- patients in whom BP was not controlled success- ered cuff inflation (TM2421, A&D, Tokyo, Japan), fully within 8 weeks, ABPM was carried out after 8 which recorded BP and PR every 30 min for 24 h, weeks of each therapy. was performed. The ABPM device was attached in the morning. The accuracy of this device was pre- viously validated.8 The ambulatory data used in the Patients present study were obtained using the oscillometric We studied 59 consecutive asymptomatic (never method. Each subject recorded his or her own daily treated) elderly hypertensive outpatients, each of activities. Patients with documented disturbed sleep whom had visited our office more than three times (frequent waking during sleep) were not included in during 14 to 28 days and showed a mean office SBP the present study. The night time BP was defined as Ͼ150 mm Hg or mean office DBP Ͼ90 mm Hg on the mean BP for the interval from the time the two or more occasions during this run-in period. We patient went to bed until he or she awoke. The did not use a placebo. All patients were uncompli- morning BP was defined as the mean BP during the cated and ambulant. Exclusion criteria included first 2 h after waking (5 points), and daytime BP as possible diabetes mellitus (fasting glucose the mean BP from waking until he or she went to Ͼ100 mg/dl and/or haemoglobin A1c Ͼ6.2%), sec- bed. The night lowest BP was the mean BP of three ondary or malignant hypertension, history of myo- consecutive measurements, including as the middle cardial infarction, angina pectoris, stroke, transient value the lowest BP recorded during the night. The ischaemic attack or other severe concomitant dis- night–day ratio of BP was calculated as the ratio of ease before the study. Secondary hypertension was night time BP to daytime BP. The night time SBP ruled out based on history of hypertension, physical fall was calculated using the formula (daytime SBP examination, blood and urine tests. When secondary − night time SBP)/daytime SBP and was also hypertension was suspected, we performed expressed as a percentage. additional tests, including hormonal profile. Of the 59 consecutive hypertensive patients enrolled in Other measurements this study, three cases did not complete the protocol because of side effects (one case had general fatigue, The body mass index was calculated as weight one case had facial oedema due to temocapril, and (kg)/height (m)2. The left ventricular (LV) wall thick- one case developed weakness due to excessive low- ness and LV end diastolic and systolic diameters ering of BP during amlodipine therapy; the patient were measured with an ultrasonic echocardiograph who developed general fatigue was a 58-year-old (ALOKA, SSD500CV, Tokyo, Japan). LV mass index man receiving amlodipine (10 mg) therapy. His (LVMI) was calculated using the formula introduced clinic BP was 124/66 mm Hg, and his baseline BP by Devereux et al.9 was 176/88 mm Hg. Because he wanted to quit the study, we excluded him. Ten patients did not achi- Statistical considerations eve successful BP control with only temocapril, and were excluded. Finally, the data from 46 patients The SAS statistical program (SAS Institute, Cary, who achieved successful BP control were analysed. NC, USA) was used to perform all statistical analy- Thirty were classified as dippers (night time SBP fall ses. Student’s t-test was used to compare the mean у10%, considered normal diurnal BP variation) and values between dippers and non-dippers. A two- 16 were classified as non-dippers (night time SBP tailed paired t-test was used to compare the mean fall Ͻ10%, considered abnormal diurnal BP values before and after each drug therapy within the Journal of Human Hypertension Effects of temocapril and amlodipine on 24-h ABP K Eguchi et al 645 same subgroup (dippers or non-dippers).
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