Comparison of Safety Profiles of New Oral Anticoagulants with Warfarin Using the Japanese Spontaneous Reporting Database

Hosohata, Keiko; Oyama, Saki; Niinomi, Iku; Wakabayashi, Tomohito; Inada, Ayaka; Iwanaga, Kazunori

doi:10.1007/s40261-019-00788-3

Cited by 7 publications

(6 citation statements)

References 34 publications

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“…The most frequent ADRs related to DOACs were mainly of gastrointestinal disorders, as observed in some previous studies 1,61‐63 . For dabigatran and rivaroxaban, the main reported ADRs were the onset of upper and lower‐gastrointestinal bleeding, particularly melena and rectal haemorrhage 1,21,33 .…”

Section: Resultsmentioning

confidence: 57%

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: 57%

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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“…Jia et al's (2014) meta-analysis also found reduced hemorrhagic stroke risk with NOACs. However, the analysis of the Japanese ADE reporting system by Hosohata et al (2019) found that rivaroxaban, NOACs, and warfarin all significantly increased relative odds for hemorrhagic stroke. Lack of consistent results across three major ADE databases regarding rivaroxaban's association with hemorrhagic stroke suggests cautious use of rivaroxaban.…”

Section: Discussionmentioning

confidence: 98%

Predictors of hemorrhagic stroke in older persons taking nonsteroidal anti-inflammatory drugs: Results from the Food and Drug Administration Adverse Event Reporting System

McDonald

Srisopa

2020

J Am Assoc Nurse Pract

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Background: Hemorrhagic strokes have not declined in the United States despite a decline worldwide. Purpose: To identify hemorrhagic stroke risk associated with nonsteroidal anti-inflammatory drugs (NSAIDs), other medications associated with increased risk for hemorrhagic stroke, and diabetes, cardiovascular disease, gender, and age. Methods: A post hoc design was used to examine predictors of hemorrhagic stroke for adults of age 65 years and older from the Food and Drug Administration Adverse Events Reporting System database. The initial sample consisted of all cases reported during the third quarter of 2016 and the second quarter of 2018 with an NSAID as the primary suspect for the adverse drug event (ADE). An additional 397 cases with warfarin as the primary suspect were included in the final sample (N = 3,784) to test for bias from including only NSAID as the primary ADE suspect cases. Extracted data included the primary ADE (hemorrhagic stroke or other ADE), age, gender, primary suspect drug (NSAID or warfarin), and presence of a second NSAID, rivaroxaban, warfarin, clopidogrel, antidepressants (selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, and tricyclic antidepressants), inhaled corticosteroids, diabetes, or cardiovascular medications. Logistic regression was used to predict hemorrhagic stroke. Results: Aspirin and warfarin increased the risk for hemorrhagic stroke by 3.458 and 3.059, respectively. Presence of an additional NSAIDs reduced the risk by 48%. Implications for practice: Hemorrhagic stroke risk specific to older adults may provide helpful estimates for practitioners as they weigh the risk benefit of prescribing aspirin as an antiplatelet therapy for older adults.

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“…In fact, the lack of credibility in the risk assessment of the case/non‐case method originates from the challenge of choosing suitable non‐cases, which is similar to the controls in the case/control method. As far as we know, the output of traditional case/non‐case method was the increased signal (via ROR) of the risk related to drug X compared with the risk related to no use of drug X 14,16,20 . And due to their nature, these ROR values did not allow for a comparison between drugs.…”

Section: Discussionmentioning

confidence: 99%

Risk comparison of beta‐lactam‐induced anaphylaxis: Therapeutic stratification analysis in a Vietnamese pharmacovigilance database

Nguyen

et al. 2021

J Clin Pharm Ther

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What is known and objective There is limited data on the specific risks of anaphylaxis induced by beta‐lactam drugs. The aim of this study was to compare the risks of reporting beta‐lactam‐induced anaphylaxis using the national pharmacovigilance database of Vietnam (NPDV). Methods The multivariate generalised linear regression model was applied for signal generation and comparison of beta‐lactams. Results Between 2010 and 2016, there were 2,921 reports of anaphylaxis (19.93%) from 14,655 spontaneous reports of beta‐lactam use in the NDPV. Anaphylaxis signal generation was also found for the subgroup J01D (cephalosporins and carbapenems) (ROR = 1.27 [1.16‐1.39]) and beta‐lactamase‐sensitive penicillins (ROR = 1.74 [1.27‐2.35]). In the third generation cephalosporin subgroup, different risks were identified for the following combinations of beta‐lactams: 1) cefotaxime with cefoperazone+sulbactam; 2) cefixime/cefpodoxime/cefdinir with cefoperazone+sulbactam or ceftizoxime/cefoperazone/ceftazidime/ceftriaxone/cefotaxime. For the second generation cephalosporin subgroup, different risks were found for cefotiam compared to cefmetazole, cefaclor, cefamandole and cefuroxime. What is new and conclusion These findings identified and highlighted the different anaphylactic risks caused by various beta‐lactams in the main subgroups.

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Comparison of Safety Profiles of New Oral Anticoagulants with Warfarin Using the Japanese Spontaneous Reporting Database

Cited by 7 publications

References 34 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

Predictors of hemorrhagic stroke in older persons taking nonsteroidal anti-inflammatory drugs: Results from the Food and Drug Administration Adverse Event Reporting System

Risk comparison of beta‐lactam‐induced anaphylaxis: Therapeutic stratification analysis in a Vietnamese pharmacovigilance database

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