ASSESSMENT OF QUALITY-OF-LIFE BY PATIENT AND SPOUSE DURING ANTIHYPERTENSIVE THERAPY WITH ATENOLOL AND NIFEDIPINE GASTROINTESTINAL THERAPEUTIC SYSTEM

被引:76
作者
TESTA, MA
HOLLENBERG, NK
ANDERSON, RB
WILLIAMS, GH
机构
[1] Department of Biostatistics, Harvard School of Public Health, Boston
[2] Departments of Radiology and Medicine, Brigham and Womens Hospital and Harvard Medical School, Boston
[3] Phase V Technologies, Inc, Wellesley Hills
[4] Depart­ment of Medicine, Brigham and Womens Hospital, Harvard Medi­cal School, Boston, MA
关键词
ANTIHYPERTENSIVE THERAPY; QUALITY OF LIFE; RANDOMIZED CLINICAL TRIAL;
D O I
10.1093/ajh/4.4.363
中图分类号
R6 [外科学];
学科分类号
1002 ; 100210 ;
摘要
To evaluate differences in efficacy, safety, and quality of life, 394 male patients with mild-to-moderate hypertension were randomized to receive 20 weeks of either atenolol or nifedipine gastrointestinal therapeutic system (GITS) in a multicenter double-blind trail. A four-week placebo washout was followed by 8 weeks of titration and 12 weeks of maintenance therapy. Quality-of-life evaluation included clinical assessments by the patient and parallel take-home assessments by patient and spouse. Blood pressure was controlled equally in both groups. The total incidence of adverse reactions was similar in both groups, but a greater percentage of nifedipine GITS patients withdrew due to peripheral edema. Patients completing 20 weeks of therapy demonstrated a more favorable quality-of-life profile (P < .05) for nifedipine GITS over atenolol in psychosocial (P < .01), well-being (P < .05), general affect (P < .05), emotional ties (P < .01), emotional control (P < .05), vitality (P < .05), and leisure (P < .05) scores. Treatment differences were particularly pronounced for patients over 50 years of age and were not fully detectable until after 14 weeks of therapy. Deterioration in quality of life was associated with withdrawl. Spouses of younger patients receiving atenolol reported deterioration in sexual satisfaction as compared to spouses of patients taking nifedipine GITS (P < .02). Thus age, length of trial, and third-party observation are important factors in quality-of-life assessment. Comparison of adverse reactions provides an incomplete measure of how well a drug is tolerated. In contrast, findings indicate that even subtle CNS-mediated effects on mood and well-being can be detected by quality-of-life evaluation.
引用
收藏
页码:363 / 373
页数:11
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