Display options
Cite
Martsevich SY, Lukina YV, Kutishenko NP, et al. Comparison of the outcomes of the prolonged antianginal therapy use in stable coronary artery disease patients according to the data of randomized and observational studies. Contemp Clin Trials Commun. 2021;21:100743doi: 10.1016/j.conctc.2021.100743.
Martsevich, S. Y., Lukina, Y. V., Kutishenko, N. P., & Semenova, Y. V. (2021). Comparison of the outcomes of the prolonged antianginal therapy use in stable coronary artery disease patients according to the data of randomized and observational studies. Contemporary clinical trials communications, 21100743. https://doi.org/10.1016/j.conctc.2021.100743
Martsevich, S Yu, et al. "Comparison of the outcomes of the prolonged antianginal therapy use in stable coronary artery disease patients according to the data of randomized and observational studies." Contemporary clinical trials communications vol. 21 (2021): 100743. doi: https://doi.org/10.1016/j.conctc.2021.100743
Martsevich SY, Lukina YV, Kutishenko NP, Semenova YV. Comparison of the outcomes of the prolonged antianginal therapy use in stable coronary artery disease patients according to the data of randomized and observational studies. Contemp Clin Trials Commun. 2021 Feb 17;21:100743. doi: 10.1016/j.conctc.2021.100743. eCollection 2021 Mar. PMID: 33665472; PMCID: PMC7905070.
Copy Download .nbib Format: NLM
Share it on

Contemp Clin Trials Commun. 2021 Feb 17;21:100743. doi: 10.1016/j.conctc.2021.100743. eCollection 2021 Mar.

Comparison of the outcomes of the prolonged antianginal therapy use in stable coronary artery disease patients according to the data of randomized and observational studies.

Contemporary clinical trials communications

S Yu Martsevich, Yu V Lukina, N P Kutishenko, Yu V Semenova

Affiliations

  1. Federal State Institution "National Medical Research Center for Therapy and Preventive Medicine" of the Ministry of Healthcare of the Russian Federation, Bld. 10, Petroverigskiy Lane, Moscow, 101990, Russia.
  2. MEDSI Clinic, Solyanka St., 12 Bld. 1, Moscow, 109028, Russia.

PMID: 33665472 PMCID: PMC7905070 DOI: 10.1016/j.conctc.2021.100743

Abstract

OBJECTIVE: To compare the results of treatment with antianginal drug nicorandil in patients with stable coronary artery disease according to the results of the observational study (OS) «NIKEA» and randomized controlled trial (RCT) «IONA».

METHODS: «NIKEA » observational program included 590 patients with stable angina pectoris. Subgroups in the OS were formed based on the adherence to nicorandil use. Adherence was assessed during follow-up direct questioning. «IONA » RCT included 5126 patients with stable angina pectoris.

RESULTS: Follow-up period and mean age of patients were equal in OS and RCT. In OS the group of adherent to nicorandil use patients had fewer males, life-saving drugs were administered significantly more often than in RCT, comorbidities (arterial hypertension, peripheral atherosclerosis and diabetes mellitus) were more pronounced. Angina pectoris class III was diagnosed in 32% of the OS patients vs 11% of the RCT patients, and class I - in 4.4% and 26%, respectively (р<0.001). Both in RCT and OS, there were significantly fewer cases of all cardiovascular events in the groups of nicorandil and adherent to nicorandil use patients in comparison with the groups of placebo and nonadherent patients. Both in RCT and OS the use of nicorandil led to significant decrease in the risk of all cardiovascular events.

CONCLUSION: Results of the efficacy and effectiveness studies complement each other and give the opportunity to assess the realisation of the RCT results in real clinical practice.

© 2021 Published by Elsevier Inc.

Keywords: ACS, acute coronary syndrome; Antianginal therapy; CABG, coronary arterial bypass grafting; DOAC, direct oral anticoagulants; Effectiveness study; Efficacy study; HR, hazard ratio; MI, myocardial infarction; NHS, Nurses' Health Study; Nicorandil; OS, observational studies; Outcomes; PCEP, primary combined endpoint; PCI, percutaneous coronary intervention; RCP, real clinical practice; RCT, randomized controlled trial; SCAD, stable coronary artery disease; Stable coronary artery disease

Conflict of interest statement

Observational study « NIKEA» was conducted with the support from the Russian pharmaceutical company « PIС-PHARMA » which affected neither the results of the study, nor their interpretation and the fin

References

  1. Diabetologia. 2014 Jul;57(7):1273-5 - PubMed
  2. Lancet. 2002 Apr 13;359(9314):1269-75 - PubMed
  3. Thorax. 2007 Mar;62(3):219-23 - PubMed
  4. Drugs Real World Outcomes. 2019 Sep;6(3):93-104 - PubMed
  5. Pulm Pharmacol Ther. 2014 Apr;27(2):129-38 - PubMed
  6. Trials. 2015 Nov 03;16:495 - PubMed
  7. N Engl J Med. 2007 Apr 12;356(15):1503-16 - PubMed
  8. Ann Pharmacother. 2004 Feb;38(2):303-12 - PubMed
  9. Korean J Fam Med. 2013 Jul;34(4):227 - PubMed
  10. Heart. 2001 Jun;85(6):E9 - PubMed
  11. JAMA. 1993 Jun 2;269(21):2779-81 - PubMed
  12. Eur Heart J. 2013 Oct;34(38):2949-3003 - PubMed
  13. JAMA Intern Med. 2019 Jul 8;: - PubMed
  14. PLoS One. 2014 Oct 17;9(10):e110403 - PubMed
  15. J Cardiol. 2017 Jun;69(6):868-876 - PubMed

Publication Types