Aim. To assess the influence of addition of nicorandil on long-term cardiovascular complications in patients with chronic coronary artery disease (CAD) in the framework of a prospective observational study.Material and methods. Prospective observational multicenter NIKEA study included 590 patients with stable CAD. All patients were recommended to add nicorandil to their baseline therapy. After 21 months, 547 telephone contacts were made, the life status of 524 people was specified, 23 patients were lost to follow-up. The following complications were registered: death from any cause; non-fatal myocardial infarction (MI); non-fatal stroke; urgent myocardial revascularization; hospitalization due to deterioration of CAD, chronic heart failure (CHF) or atrial fibrillation (AF). In 479 patients, a telephone survey was performed to identify adherence (persistence) to nicorandil– i.e. to verify the continuing the treatment for the prescribed duration.Results. During the follow-up period, 15 deaths were recorded, the causes of which were as follows: 3 CAD (2 MI, 1 left ventricular aneurysm), 1 pulmonary embolism, 2 CHF; 1 stroke, 1 oncology, 1 bilateral pneumonia. In the remaining 6 cases, the causes of death were not known. Cardiovascular (CV) complications were MI (8 cases in 7 patients, 1 patient had 2 MI in the follow-up period, 3 patients from this group died), stroke in 6 patients (7 cases, 1 patient had 2 strokes, 1 patient died). Urgent percutaneous coronary intervention was performed in 3 patients (in 2 patients due to acute MI, in 1 patient due to unstable angina). During the observation period, 21 people were urgently hospitalized due to deterioration of clinical condition. According to the results of a medical survey, by the end of the follow-up period, 237 people were not adherent to prescribed nicorandil, and 242 patients took the recommended medication (adherent patients). The main cardiovascular complications and death from any cause (р<0.001) as well as the number of urgent hospitalizations (р=0.017) were significantly more common in non-adherent to nicorandil patients in comparison with adherent patients.Conclusion. The overall rate of CAD complications in NIKEA study was typical for patients with stable CAD receiving contemporary medical therapy. Addition of nicorandil significantly reduced the rate of CV complications in adherent patients in comparison with non-adherent patients.

Aim. To assess quality of life (QoL) and its dynamics during nicorandil treatment in patients with stable ischemic heart disease, to study the relationship of treatment adherence and QoL indicators when treated with nicorandil. Material and methods. Observational program NIKEA included 590 patients with angina pectoris. Seattle Angina Questionnaire (SAQ) was used to assess QoL. Patients completed SAQ at the visit of inclusion (V0) and at the visit after 3 months of observation (V3). Potential and actual adherence to therapy was assessed by medical interviews at visits V0, V1 (1 month of observation) and V3. During the visit V0 417 people (from 590 ones enrolled into the study) completed SAQ (71% response); after 3 months (V3) SAQ was filled in by 454 of 552 people who came to this visit (82% response). According to the results of medical interviews, potential adherence (visit V0) was determined in all 590 patients, actual adherence to nicorandil (visits V1 and V3) was assessed in 552 patients who came to these visits. In accordance with the degree of adherence, all patients were divided into 3 groups: (1) adherent to treatment (taking nicorandil for the first three months), (2) non-adherent (who refused to take nicorandil), and (3) partially non-adherent (who started nicorandil, but for various reasons stopped taking the drug). Results. In all patients, regardless of their adherence to the recommended drug, there was an increase in QoL according to all five scales of the SAQ after 3 months of follow-up. Statistically significant positive dynamics of all SAQ indicators was found only in adherent patients (p< 0.0001 for all aspects). Patients, who showed good adherence to nicorandil at V1, had more severe angina at the beginning of treatment (according to " Angina Stability" and "Angina Frequency" indicators). These patients also had lower QoL "Disease Perception" score and more confidence in the doctor ("Treatment Satisfaction" score) than non-adherent patients (p< 0.05). In non-adherent patients a mild degree of angina was determined 2 times more often according to "Angina Frequency" indicator (p= 0.03). Conclusion. The results of the study confirm the interrelation and mutual influence of the QoL indicators and treatment adherence to nicorandil. Effective treatment with nicorandil in patients with lower health-related QoL indicators could increase treatment adherence. On the other hand, the mild degree of angina, the low level of confidence in the treating doctor, the side effects of the new drug reduce medication adherence of patients, which, as a result, negatively affects the QoL of these patients.

Working Group of the NIKEA Program. Ekaterinburg: Akulina E.N.; Izhevsk: Shinkareva S. E., Grebnev S.A.; Krasnodar: Kudryashov E.A., Fendrikova A.V.; Krasnoyarsk: Nemik D.B., Pitaev R.R., Altaev V.D., Samokhvalov E.V., Stolbikov Y.Y.; Moscow: Dmitrieva N.A., Zagrebelnyy A.D., Zakharova A.V., Balashov I.S., Leonov A.S., Sladkova T.A., Zelenova T.I., Shestakova G.N., Kolganova E.V., Maksimova M.A.; Novosibirsk: Moskalenko I.V., Shurkevich A.A.; Omsk: Loginova E.N., Gudilin V.A.; Orel: Zhuravleva L.L., Lobanova G.N., Luneva M.M.; Orenburg: Kondratenko V.Y.; Rostov-on-Don: Kalacheva N.M., Kolomatskaia O.E., Dubishcheva N.F., Romadina G.V., Chugunova I.B., Skarzhinskaia N.S.; Ryazan: Bulanov A.V., Trofimova Y.M., Nikolaeva A.S.; St. Petersburg: Savinova E.B., Ievskaia E.V., Vasileva L.B.; Tula: Zubareva L.A., Berberfish L.D., Gorina G.I., Nadezhkina K.N., Iunusova K.N., Nikitina V.F., Dabizha V.G., Renko I.E., Soin I.A.Aim. To study the adherence to treatment and the factors that affect it in patients with stable coronary heart disease during the treatment with nicorandil. Material and methods. The use of nicorandil in addition to standard antianginal therapy was recommended to patients (n=590) in a prospective, observational, multicenter NIKEA study. Patients completed original questionnaires on adherence, including a Morisky-Green test at the enroll visit. The questionnaires were filled by 423 patients (73% response). The factors that influence adherence were studied.Results. All patients were divided into 3 groups, depending on the adherence to the use of nicorandil: immediately refused to take the drug (n=150; group 1); started, but stopped taking nicorandil in the first 3 months of observation (n=75; group 2); who took nicorandil for 3 months (n=327; group 3). Potentially adherents (intention to treat) were 582 out of 590 (98.6%) patients, and actually adherents – only 327 of 552 (59.2%) patients. The main reason for non-adherence to the beginning of therapy is polypharmacy; to the continuation of the treatment that had just started – adverse events; for termination of long-term therapy – polypharmacy, adverse events and insufficient effectiveness of treatment. Group 3 had initially more severe angina pectoris: more number of angina attacks (p=0.014) and the need of short-acting nitrates (p<0.0001). Patients of the group 1 compared to the patients of group 3 did not visit the doctors more often or attended them only when necessary, violated the medical prescriptions for taking medications (p<0.05). According to the results of the Morisky-Green test, 150 patients (36.2%) were not are committed to medical recommendations, 264 (63.8%) – are committed. Women were more adherent than men (p=0.47); patients with class I angina were more adherent than patients with class III angina (p=0.027), and patients who regularly attended the treating physician (more often than once a month) were more committed to medical recommendations than patients, not visiting the treating physician (p=0.004).Сonclusion. The levels of overall adherence according to Morisky-Green test, the potential adherence according to the survey and the actual adherence of patients to treatment vary considerably. The leading cause of non-adherence at the beginning of therapy is polypharmacy, for the continuation of the recently started treatment – the adverse events; for long-term sustained treatment – equally polypharmacy, drug adverse events and the lack of treatment efficacy.

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.

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.

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