THE DYNAMICS OF LIFE QUALITY PARAMETERS WITH NICORANDIL USAGE IN STABLE CORONARY HEART DISEASE PATIENTS (RESULTS OF THE OBSERVATION STUDY “NIKEA”)

Aim. In the circumstances of real clinical practice, to evaluate the changes in life quality (LQ) parameters of the patients with coronary heart disease and stable angina with addition of nicorandil to standard treatment.

Material and methods. Study design — prospective, observational, multicenter. In the trial, the physicians participated, from 14 institutions in a range ofRussia regions. Totally, 590 included: 261 (44,2%) females, 329 (55,8%) males. All patients, in addition to the standard antianginal treatment, were prescribed with nicorandil. At the visits V0 (baseline) and V3 (3 months of therapy) they completedSeattle questionnaire (SAQ) of LQ assessment. Five parameters were assessed: exercise intolerance, attacks frequency, stability, attitudes toward disease, treatment satisfaction. At the visit V0 417 questionnaires were completed (response 71%), at V3 — 454 (response 82%).

Results. The significant increase was demonstrated, for parameters by SAQ in 3 months of observation, the highest parameters, except the scale exercise intolerance, were found in the group taking nicorandil during 3 months of follow-up (p<0,05 for all scale SAQ comparing to the group refused taking nicorandil at baseline or stopped at various stages of the study). By 3 months of follow-up, 3 times increase was noted of the patients with minimal number of angina attacks or absence, and the part of patients found that their life quality is “excellent”. Almost 4 times the part of patients raised by the stability parameter, and the amount by the score “treatment satisfaction” increased to 50,2%. Comparison of ranged SAQ parameters at V0 and V3 visits with Wilcoxon criteria, showed significant differences by all the scales of SAQ (р<0,0001).

Conclusion. Under the real practice circumstances there was significant increase of all LQ parameters by SAQ in 3 months of observation. Most prominent positive changes were noted in patients taking nicorandil during whole follow-up period, comparing to those not taking nicorandil or discontinued at various stages of the study.

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