PMID- 36297321
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20230308
IS  - 1424-8247 (Print)
IS  - 1424-8247 (Electronic)
IS  - 1424-8247 (Linking)
VI  - 15
IP  - 10
DP  - 2022 Sep 29
TI  - Analysis of Adverse Events in the Treatment of Patients with Non-Valvular Atrial 
      Fibrillation with Oral Anticoagulants: Data from the "ANTEY" Observational Study.
LID - 10.3390/ph15101209 [doi]
LID - 1209
AB  - Rationale. Therapy with oral anticoagulants (OACs) in patients with atrial 
      fibrillation (AF) is based on finding the optimal balance of efficacy and safety 
      of these drugs. Data from observational studies are an additional source of 
      information for the adverse events (AEs) of pharmacotherapy. Objective: To 
      investigate pharmacotherapy AEs with OACs in the "ANTEY" prospective 
      observational study in patients with non-valvular atrial fibrillation (AF). 
      Material and Methods: A total of 201 people were enrolled (83 (41.3%) were 
      women). The age of subjects was 71.1 +/- 8.7 years (data presented as mean with 
      standard deviation). The study protocol included two face-to-face visits 
      (contacts V0 and V1) and one follow-up (FU) phone contact which were made with 
      the patient at an interval of 6 months. At V0, all patients were recommended to 
      take one of the non-vitamin K antagonist oral anticoagulants (NOACs); starting 
      from V1, warfarin could have been prescribed or NOAC could have been changed. 
      Information about AEs and OACsadministration was collected at V0, V1, and FU. 
      Results. During 1 year of observation, 15 out of 201 patients refused to take 
      OACs, and 186 initiated the recommended drug. Rivaroxaban was initiated in 93 
      patients, dabigatran in 46, apixaban in 40, and warfarin in 7 patients. There 
      were 55 AEs, 25 of which were serious (SAEs), including 4 deaths. Of the 30 AEs, 
      there were 18 bleedings: eight (8.6%) occurred with the administration of 
      rivaroxaban; four (8.5%) with dabigatran, three (7.5%) with apixaban, and three 
      (42.9%) with warfarin. Differences in the incidence of bleeding events between 
      NOACs and warfarin are statistically significant (p = 0.025). Any AEs increased 
      the chance of nonadherence to treatment nine-fold: OR = 9.2 (CI95%: 3.6-23.5), p 
      < 0.0001. Conclusions. The most typical and common AEs in real-world clinical 
      practice settings treatment with OACs were bleedings, the incidence of which was 
      approximately 8% to 9% in the treatment with NOACs and was much higher with 
      warfarin, bleedings in the treatment with OACs are statistically significantly 
      associated with nonadherence to the use of these drugs in the future.
FAU - Martsevich, Sergey Yu
AU  - Martsevich SY
AD  - Department of Preventive Pharmacotherapy, National Medical Research Center for 
      Therapy and Preventive Medicine, 101990 Moscow, Russia.
FAU - Lukina, Yulia V
AU  - Lukina YV
AD  - Department of Preventive Pharmacotherapy, National Medical Research Center for 
      Therapy and Preventive Medicine, 101990 Moscow, Russia.
FAU - Kutishenko, Natalia P
AU  - Kutishenko NP
AD  - Department of Preventive Pharmacotherapy, National Medical Research Center for 
      Therapy and Preventive Medicine, 101990 Moscow, Russia.
FAU - Kiselev, Anton R
AU  - Kiselev AR
AUID- ORCID: 0000-0003-3967-3950
AD  - Coordinating Center for Fundamental Research, National Medical Research Center 
      for Therapy and Preventive Medicine, 101990 Moscow, Russia.
FAU - Drapkina, Oxana M
AU  - Drapkina OM
AUID- ORCID: 0000-0003-0323-2635
AD  - National Medical Research Center for Therapy and Preventive Medicine, 101990 
      Moscow, Russia.
LA  - eng
GR  - 122013100210-1/Russian Ministry of Health/
PT  - Journal Article
DEP - 20220929
PL  - Switzerland
TA  - Pharmaceuticals (Basel)
JT  - Pharmaceuticals (Basel, Switzerland)
JID - 101238453
PMC - PMC9610593
OTO - NOTNLM
OT  - adverse events
OT  - atrial fibrillation
OT  - oral anticoagulants
COIS- The authors declare no conflict of interest.
EDAT- 2022/10/28 06:00
MHDA- 2022/10/28 06:01
PMCR- 2022/09/29
CRDT- 2022/10/27 01:49
PHST- 2022/08/25 00:00 [received]
PHST- 2022/09/26 00:00 [revised]
PHST- 2022/09/27 00:00 [accepted]
PHST- 2022/10/27 01:49 [entrez]
PHST- 2022/10/28 06:00 [pubmed]
PHST- 2022/10/28 06:01 [medline]
PHST- 2022/09/29 00:00 [pmc-release]
AID - ph15101209 [pii]
AID - pharmaceuticals-15-01209 [pii]
AID - 10.3390/ph15101209 [doi]
PST - epublish
SO  - Pharmaceuticals (Basel). 2022 Sep 29;15(10):1209. doi: 10.3390/ph15101209.