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The First Results of the Evaluation of Long-Term Nicorandil Treatment Effect on the Probability of Cardiovascular Complications in Patients with Stable Coronary Artery Disease (Data of Observational NIKEA Study)

https://doi.org/10.20996/1819-6446-2019-15-3-335-342

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Abstract

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. 

About the Authors

S. Yu. Martsevich
National Medical Research Center for Preventive Medicine
Russian Federation

MD, PhD, Professor, Head of Department of Preventive Pharmacotherapy

Petroverigsky per. 10, Moscow, 101990 Russia


Yu. V. Lukina
National Medical Research Center for Preventive Medicine
Russian Federation

MD, PhD, Leading Researcher, Department of Preventive Pharmacotherapy

Petroverigsky per. 10, Moscow, 101990 Russia


N. P. Kutishenko
National Medical Research Center for Preventive Medicine
Russian Federation

MD, PhD, Head of Laboratory of Pharmacoepidemiological Research, Department of Preventive Pharmacotherapy

Petroverigsky per. 10, Moscow, 101990 Russia


V. P. Voronina
National Medical Research Center for Preventive Medicine
Russian Federation

MD, PhD, Senior Researcher, Department of Preventive Pharmacotherapy

Petroverigsky per. 10, Moscow, 101990 Russia


N. A. Dmitrieva
National Medical Research Center for Preventive Medicine
Russian Federation

MD, PhD, Senior Researcher, Laboratory of Pharmacoepidemiological Research, Department of Preventive Pharmacotherapy

Petroverigsky per. 10, Moscow, 101990 Russia



A. V. Zagrebelnyy
National Medical Research Center for Preventive Medicine
Russian Federation

MD, PhD, Senior Researcher, Department of Preventive Pharmacotherapy

Petroverigsky per. 10, Moscow, 101990 Russia



O. V. Lerman
National Medical Research Center for Preventive Medicine
Russian Federation

MD, PhD, Senior Researcher, Department of Preventive Pharmacotherapy

Petroverigsky per. 10, Moscow, 101990 Russia



O. V. Gaisenok
Joint Hospital and Polyclinic, Administrative Department of the President of the Russian Federation
Russian Federation

MD, PhD, Head of General Cardiology Department

Michurinskiy prosp. 6, Moscow, 119285 Russia



T. A. Gomova
Tula Regional Clinical Hospital
Russian Federation

MD, PhD, Deputy Chief Physician on General Issues 

 Yablochkova ul. 1а, Tula, 300053 Russia



A. V. Ezhov
Izhevsk State Medical Academy
Russian Federation

MD, PhD, Professor, Chair of General Practitioner and Internal Medicine with the Course of Emergency Medical Care

Kommunarov ul. 281, Izhevsk, Republic of Udmurtia, 426034 Russia



A. D. Kuimov
Novosibirsk State Medical University
Russian Federation

MD, PhD, Professor, Head of Chair of Faculty Therapy

Krasnii pr. 52, Novosibirsk, 630091 Russia



R. A. Libis
Orenburg State Medical University
Russian Federation

MD, PhD, Professor, Head of Chair of Hospital Therapy

Sovetskaya ul. 6, Orenburg, 460000 Russia



G. V. Matyushin
Krasnoyarsk State Medical University named after Prof. V.F. Voino-Yasenetsky
Russian Federation

MD, PhD, Professor, Head of Chair of Cardiology and Functional Diagnostics

Partizana Zheleznyaka ul. 1, Krasnoyarsk, 660022 Russia



T. N. Mitroshina
Out-patient Clinic №3
Russian Federation

MD, Cardiologist

Komsomolskaya ul. 32, Orel, 302001 Russia



G. I. Nechaeva
Omsk State Medical University
Russian Federation

MD, PhD, Professor, Head of Chair of Internal Medicine and Family Medicine

Lenina ul. 12, Omsk, 644099 Russia



I. I. Reznik
Ural State Medical University
Russian Federation

MD, PhD, Professor, Chair of Therapy

 Repina ul. 3, Ekaterinburg, 620014 Russia



V. V. Skibitsky
Kuban State Medical University
Russian Federation

MD, PhD, Professor, Head of Chair of Hospital Therapy

 Mitrofana Sedina ul. 4, Krasnodar, 350063 Russia



A. I. Chesnikova
Rostov State Medical University
Russian Federation

MD, PhD, Professor, Chair of Internal Medicine №1

Suvorova ul. 119, Rostov-on-Don, 344022 Russia



N. V. Dobrynina
Ryazan State Medical University named after Academician I.P. Pavlov
Russian Federation

MD, PhD, Assistant, Chair of Hospital Therapy

Visokovoltnaya ul. 9, Ryazan, 390026 Russia



S. S. Yakushin
Ryazan State Medical University named after Academician I.P. Pavlov
Russian Federation

MD, PhD, Professor, Head of Chair of Hospital Therapy

Visokovoltnaya ul. 9, Ryazan, 390026 Russia



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For citation:


Martsevich S.Y., Lukina Y.V., Kutishenko N.P., Voronina V.P., Dmitrieva N.A., Zagrebelnyy A.V., Lerman O.V., Gaisenok O.V., Gomova T.A., Ezhov A.V., Kuimov A.D., Libis R.A., Matyushin G.V., Mitroshina T.N., Nechaeva G.I., Reznik I.I., Skibitsky V.V., Chesnikova A.I., Dobrynina N.V., Yakushin S.S. The First Results of the Evaluation of Long-Term Nicorandil Treatment Effect on the Probability of Cardiovascular Complications in Patients with Stable Coronary Artery Disease (Data of Observational NIKEA Study). Rational Pharmacotherapy in Cardiology. 2019;15(3):335-342. (In Russ.) https://doi.org/10.20996/1819-6446-2019-15-3-335-342

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