OBSERVATIONAL MULTICENTER TRIAL OF NICORANDIL USE IN STABLE CORONARY HEART DISEASE HIGH RISK PATIENTS (NIKEA): DESIGN AND FIRST RESULTS

Aim. To assess the results of addition of nicorandil to the treatment of ischemic heart disease: clinical course and long-term outcomes, and to evaluate life quality and treatment adherence in stable angina patients. The article provides data on the NIKEA study design and results of antianginal efficacy of the drug.

Material and methods. The design is prospective multicenter observational study. Totally, 14 institutions participated, from different Russia regions. Included 590 patients: 261 women (44,2%) and 329 men (55,8%). Mean age 65,1±9,6 y.o. All patients had inclusion criteria and no exclusion criteria. All participants, in addition to standard antianginal therapy, were recommended to take nicorandil dosage 20 mg daily with titration up to 40 mg daily in 1 month of the observation. By the protocol, three office visits were set (inclusion, in 1 month and in 3 months): V0, V1, V3. During the visits, physical examination was done, anthropometry, hemodynamics measurement. Antianginal efficacy was assessed with patients diaries on angina attacks and demand of short-acting nitrates (SAN). At the visits V0 and V3 patients completed Seattle life quality questionnaire in CHD, and at V0 also an original questionnaire was completed for adherence evaluation.

Results. Among 590 patients included in NIKEA, 582 (98,6%) confirmed their intention to take nicorandil and 6 refused to buy additional medication. On the planned visits V1 and V3552 patients came: of them 402 started taking nicorandil, and in 1 month 383 continued; in 3 months — 327 patients continued. During the visits V1 and V3 a statistically significant decrease in angina attacks frequency and in demand of SAN was noted  (p<0,05).  In comparison analysis of dynamics of these parameters with those refused or having stopped taking the medication (controls) it was found that these parameters declined in both groups, and in nicorandil group — more seriously; in 3 months the difference between groups became significant (p<0,05).  During the first 3 months of the observation there was almost triple increase of those having 1st functional class of angina: from 4% to 11,6%, and decrease of the 3rd class angina patients almost 1,5 times: from 32% to 20%.

Conclusion. The results of observational program demonstrated good antianginal efficacy of the added nicorandil — antianginal medication with proven positive prognostic influence: decrease of angina attacks, decrease of the demand in SAN, increase of the 1st functional class patients and decrease — of the 3rd, respectively

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