The efficacy and safety of acenocoumarol and warfarin therapy in patients with lower limb deep vein thrombosis

Bernát, Sándor Iván; Rókusz, László

doi:10.1556/oh.2012.29350

Cited by 1 publication

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“…VKA‐related ADRs also involved haemolymphopoietic and vascular disorders, specifically related to the PT hypocoagulable state reported only for acenocoumarol 63 . This could be explained by a more unstable INR with acenocoumarol 68 . Anaemia, instead, was reported in both cases with similar seriousness, probably due to the high INR value and to the hypocoagulable state 69,70 .…”

Section: Resultsmentioning

confidence: 96%

Adverse drug reactions with oral anticoagulants: data from sicilian spontaneous reporting system database

Cutroneo¹,

Baratelli

Cicala

et al. 2021

J Clin Pharm Ther

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Objective Direct oral anticoagulants (DOACs) were developed to avoid the limitations of vitamin K antagonists (VKAs). DOACs are associated with a greater incidence of gastrointestinal bleeding and a smaller number of intracranial haemorrhages than VKAs. Therefore, it is important to deepen our knowledge of their safety profiles. The aim of this study was thus to analyse adverse drug reaction (ADR) reports on DOACs and VKAs using the Sicilian Spontaneous Reporting System (SRS) database. Methods All ADR reports with DOACs and VKAs as suspected drugs that were entered into the Sicilian SRS database during the period 2001–2019 were selected. In detail, all reports with the following single active substances were included: dabigatran etexilate, rivaroxaban, apixaban and edoxaban; acenocoumarol and warfarin were included as a comparator group. Descriptive statistical methodology was used to evaluate characteristics of the reported cases with a case‐by‐case assessment. Results and Discussion Out of 521 reports related to anticoagulants, 444 (85.2%) and 77 (14.8%) involved DOACs and VKAs, respectively. DOAC‐related reports were mainly of gastrointestinal disorders. In contrast, VKAs were mostly associated with blood and lymphatic system disorders, injury, investigations and vascular disorders. Many more cases of ADRs in the form of gastrointestinal disorders concerned dabigatran etexilate (n = 179, 73.7%) than the other DOACs, while ADRs in the form of blood disorders were mainly associated with acenocoumarol (n = 27, 57.4%). The most commonly reported Preferred Terms for DOACs were dyspepsia (n = 89, 17.1%), upper abdominal pain (n = 41, 9.2%) and pruritus (n = 26, 5.8%), whereas for VKAs, they were anaemia (n = 21, 27.3%) and hypocoagulable state (n = 18, 3.5%). Potentially interacting concomitant medications particularly included antithrombotic agents (n = 19, 4.3%) for DOACs and proton‐pump inhibitors (PPIs) (n = 37, 48.1%) and antithrombotic agents (n = 13, 16.9%) for VKAs. Conclusion The ADRs most commonly associated with DOACs, especially dabigatran, were gastrointestinal disorders, particularly gastrointestinal bleeding. Our study also highlights the potential role of drug‐drug interactions in the ADRs. The cases of gastrointestinal bleeding highlight the need for careful prescribing of DOACs and use of potentially interacting concomitant drugs.

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Section: Resultsmentioning

confidence: 96%

Adverse drug reactions with oral anticoagulants: data from sicilian spontaneous reporting system database

Cutroneo¹,

Baratelli

Cicala

et al. 2021

J Clin Pharm Ther

View full text Add to dashboard Cite

show abstract

The efficacy and safety of acenocoumarol and warfarin therapy in patients with lower limb deep vein thrombosis

Abstract: The INR values were more stable in the warfarin group than in the acenocumarole group. In both groups the rate of complete vein recanalization was related to the rate of optimally stable INR values within the therapeutic range.

Cited by 1 publication

References 4 publications

Adverse drug reactions with oral anticoagulants: data from sicilian spontaneous reporting system database

Adverse drug reactions with oral anticoagulants: data from sicilian spontaneous reporting system database

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