Wurdeman R L, Mooss A N, Mohiuddin S M, Lucas B D, Ryschon K L, Hilleman D E
Creighton University Cardiac Center, Omaha, Nebraska 68131, USA.
Pharmacotherapy. 1999 Jan;19(1):94-100. doi: 10.1592/phco.19.1.94.30512.
To evaluate 24-hour blood pressure control and frequency of adverse effects in patients with mild to moderate hypertension switched from nifedipine gastrointestinal therapeutic system (Nif-GITS) to nifedipine coat core (Nif-CC).
Open-label, prospective, switch study
University-affiliated outpatient cardiology clinic.
Twenty patients with mild to moderate essential hypertension, who were taking Nif-GITS 30, 60, or 90 mg/day for 8 weeks or longer.
Patients stabilized with Nif-GITS 30, 60, or 90 mg were monitored over 24 hours with an ambulatory blood pressure monitor and were then switched to an equivalent dosage of Nif-CC. After 8 weeks+/-1 week taking Nif-CC, they were again monitored with a 24-hour blood pressure monitor. The 24-hour blood pressure load (percentage of values > 135/85 mm Hg for 24 hrs), daytime blood pressure load (percentage of values > 140/90 mm Hg from 7:00 A.M.-10:00 P.M.), nighttime blood pressure load (percentage of values > 120/80 mm Hg from 10:00 P.M.-7:00 A.M.), diurnal blood pressure variation, average 24-hour blood pressure, daytime blood pressure, nighttime blood pressure, mean blood pressure for the first 4 hours, and last 8 hours of the dosing interval were measured. Adverse effects such as headache, dizziness, and edema were also reported.
No differences in average 24 hour-blood pressure readings were observed but significant differences in blood pressure control during the first 4 and last 8 hours of the dosing interval were seen. Systolic and diastolic blood pressures were higher after approximately 16 hours in patients switched from Nif-GITS to Nif-CC. Although Nif-CC caused a greater initial response, it was less effective than Nif-GITS after 16 hours. This could explain the lack of differences in average 24-hour blood pressure values between formulations. Of the 20 patients, 20% experienced increased headaches, 20% showed signs of increased peripheral edema, and 10% reported occasional dizziness after switching agents. Three patients discontinued Nif-CC, two as ordered by their primary care physician and one on his own due to headache.
This study suggests that patients switched from Nif-GITS to Nif-CC could experience increased blood pressure during the night or toward the end of the dosing interval. They could also experience adverse effects such as headache, edema, and dizziness, which could result in more physician visits and put patients with other disease states such as coronary heart disease at increased risk.
评估从硝苯地平胃肠道治疗系统（Nif - GITS）转换为硝苯地平包芯片（Nif - CC）的轻至中度高血压患者的24小时血压控制情况及不良反应发生频率。
开放标签、前瞻性、转换研究
大学附属医院门诊心脏病诊所
20例轻至中度原发性高血压患者，服用Nif - GITS 30、60或90毫克/天达8周或更长时间。
使用动态血压监测仪对服用30、60或90毫克Nif - GITS且病情稳定的患者进行24小时监测，然后转换为等效剂量的Nif - CC。服用Nif - CC 8周±1周后，再次使用24小时血压监测仪进行监测。测量24小时血压负荷（24小时内血压值>135/85毫米汞柱的百分比）、日间血压负荷（上午7:00至晚上10:00血压值>140/90毫米汞柱的百分比）、夜间血压负荷（晚上10:00至上午7:00血压值>120/80毫米汞柱的百分比）、昼夜血压变化、24小时平均血压、日间血压、夜间血压、给药间隔前4小时和后8小时的平均血压。还报告了头痛、头晕和水肿等不良反应。
未观察到24小时平均血压读数有差异，但在给药间隔的前4小时和后8小时的血压控制方面存在显著差异。从Nif - GITS转换为Nif - CC的患者在约16小时后收缩压和舒张压更高。虽然Nif - CC引起的初始反应更大，但16小时后其效果不如Nif - GITS。这可以解释两种制剂之间24小时平均血压值缺乏差异的原因。20例患者中，20%出现头痛加剧，20%有外周水肿加重迹象，10%在换药后报告偶尔头晕。3例患者停用Nif - CC，2例由初级保健医生医嘱停药，1例因头痛自行停药。
本研究表明，从Nif - GITS转换为Nif - CC的患者可能在夜间或给药间隔接近结束时血压升高。他们还可能出现头痛、水肿和头晕等不良反应，这可能导致更多次就医，并使患有其他疾病如冠心病的患者风险增加。
