Key result
Nifedipine GITS resulted in a more favorable quality-of-life profile compared with atenolol across multiple psychosocial, well-being, and vitality scales (p < 0.05).
Why the study?
Does nifedipine GITS improve quality of life compared to atenolol in male patients with mild-to-moderate hypertension?
RCT (n=394)
Single-blind
Yes
Does nifedipine GITS improve quality of life compared to atenolol in male patients with mild-to-moderate hypertension?
Answers are grounded in this paper and cite their sources.
Nifedipine GITS provides a better quality-of-life profile than atenolol in men with mild-to-moderate hypertension, and patient or spouse reporting is significantly more sensitive to side effects than physician assessment.
A multicenter clinical trial comparing nifedipine gastrointestinal therapeutic system (GITS) to atenolol was conducted to evaluate the effects of reporter (physician, patient, and spouse) and assessment of environment (clinic vs. take-home), and structure (long vs. short forms). After a 4-week single-blind, placebo washout, 394 male patients with mild-to-moderate hypertension were randomized to receive 20 weeks of either atenolol or nifedipine GITS, titrated to achieve goal blood pressure of < 90 mm hg for 8 weeks and maintained at the final dose for 12 weeks. Quality-of-life assessments included "long-form" clinical assessments by the patient, parallel "short-form," take-home, mail-back assessments by patient and spouse and a side effects and symptom distress evaluation by the physician. Patients completing 20 weeks of therapy indicated a more favorable quality-of-life profile (p < 0.05) for nifedipine GITS compared with atenolol for psychosocial, positive well-being, emotional ties, behavior/emotional control, vitality, and leisure scales using the long-form clinical assessment. The short-form, take-home, mail-back assessments were highly correlated with the clinic assessments, but their responsiveness to treatment differences was less owing to item structure and lower return rates. Spouse reports were more sensitive to treatment differences in sexual functioning with a more favorable response for patients taking nifedipine GITS (p < 0.02). Physicians were less sensitive to the overall impact of side effects, reporting only 14.9% of symptoms reported by the patient. Physician evaluation of symptoms and side effects does not provide the sensitivity required for detecting quality-of-life treatment differences.(ABSTRACT TRUNCATED AT 250 WORDS)
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Marcia A. Testa (1993) conducted an RCT in Mild-to-moderate hypertension (n=394). Nifedipine gastrointestinal therapeutic system (GITS) vs. Atenolol was evaluated on Quality-of-life profile using the long-form clinical assessment (p=< 0.05). Nifedipine GITS resulted in a more favorable quality-of-life profile compared with atenolol across multiple psychosocial, well-being, and vitality scales (p < 0.05).
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