Medical therapy, symptoms, and the distress the cause: relation to quality of life in patients with angina pectoris and/or hypertension.
BACKGROUND
Adverse events during drug therapy can be assessed through measurement of 2 features: their frequency and their severity. Their severity, in turn, can be measured by assessing the distress that they cause. Our goal was to relate the magnitude of the distress induced by treatment with calcium-channel blocking agents to the change in quality of life assessed through psychosocial instruments in patients treated with calcium-channel blocking agents, either for hypertension or for angina pectoris.


METHODS
Four hundred seventy-five patients with angina pectoris were randomized to double-blind treatment with PPR (physiological pattern release) verapamil hydrochloride, amlodipine besylate, amlodipineatenolol combination, or placebo. In addition, 557 hypertensive patients were randomized either to PPR verapamil or nifedipine GITS (gastrointestinal system). Both studies were double-blind.


RESULTS
Significant differences in treatment of angina pectoris or hypertension, were not found between the regimens. Overall quality of life also failed to show a significant difference in either group. In both groups, however, remarkable concordance was found between the degree of distress associated with specific symptoms and a change in quality of life. An unchanged, stable symptom distress was associated with a significant improvement in the quality of life of about 0.1 SD. Improvement or erosion of symptom distress represented by 1 step was associated with a 0.1- to 0.2-SD change. The extreme change in symptom distress was associated with a substantially larger change in global quality of life.


CONCLUSIONS
The magnitude of symptom distress or relief associated with symptoms in 2 patient populations correlated strongly with a shift in quality of life. The assessment of distress associated with symptoms provides valuable additional information on drug therapy.
Hollenberg
N K
NK
Department of Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, Mass 02115, USA.
Williams
G H
GH
Anderson
R
R
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D017311:Amlodipine / Q000009:adverse effects / Q000627:therapeutic use; D000787:Angina Pectoris / Q000188:drug therapy* / Q000523:psychology; D000959:Antihypertensive Agents / Q000009:adverse effects* / Q000627:therapeutic use; D001262:Atenolol / Q000009:adverse effects / Q000627:therapeutic use; D002121:Calcium Channel Blockers / Q000009:adverse effects* / Q000627:therapeutic use; D003692:Delayed-Action Preparations; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D006973:Hypertension / Q000188:drug therapy* / Q000523:psychology; D008297:Male; D008875:Middle Aged; D009543:Nifedipine / Q000009:adverse effects / Q000627:therapeutic use; D011788:Quality of Life; D016896:Treatment Outcome; D014700:Verapamil / Q000009:adverse effects / Q000627:therapeutic use
D000959:Antihypertensive Agents; D002121:Calcium Channel Blockers; D003692:Delayed-Action Preparations; D017311:Amlodipine; D001262:Atenolol; D014700:Verapamil; D009543:Nifedipine