Dabigatran for Anticoagulation in Atrial Fibrillation – Early Clinical Experience in a Hospital Population and Comparison to Trial Data

Michel, Jonathan; Mundell, D.; Boga, T.; Sasse, Alexander

doi:10.1016/j.hlc.2012.09.002

Cited by 17 publications

(14 citation statements)

References 16 publications

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“…Unfortunately, information from large randomised controlled studies (4,18) cannot provide a reliable indication of levels of persistence that might be anticipated in real world practice. Some studies, largely from pharmacy or health system administrative data and all limited to a single NOAC have attempted to estimate persistence and in some studies to determine whether that NOAC drug showed improved persistence compared with VKA (19)(20)(21)(22)(23)(24). To address this important question of OAC persistence in real-world practice following the approval of NOACs, we conducted a cohort study in the UK general practice of patients with a first diagnosis of AF, comparing VKA with NOAC persistence, i. e. the probability of continuing on OAC treatment at one year after the initiation of therapy.…”

Section: Discussionmentioning

confidence: 99%

Therapy persistence in newly diagnosed non-valvular atrial fibrillation treated with warfarin or NOAC

Martínez¹,

Katholing²,

Wallenhorst³

et al. 2016

Thromb Haemost

149

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SummaryEfforts to reduce stroke in atrial fibrillation (AF) have focused on increasing physician adherence to oral anticoagulant (OAC) guidelines, but high early vitamin K antagonist (VKA) discontinuation is a limitation. We compared persistence of non-VKA OAC (NOAC) with VKA treatment in the first year after OAC inception for incident AF in real-world practice. We studied 27,514 anticoagulant-naïve patients with incident non-valvular AF between January 2011 and May 2014 in the UK primary care Clinical Practice Research Datalink, with full medication use linkage: mean age 74.2 ± 12.4, 45.7 % female, mean follow-up 1.9 ± 1.1 years. After treatment initiation and follow-up until 1/2015, the proportion remaining on OAC at one year (persistence) was estimated using competing risk survival analyses. OAC was commenced ≤90 days after incident AF in 13,221 patients (48.1 %): 12,307 VKA and 914 NOAC (apixaban, dabigatran, rivaroxaban). Amongst those treated with OAC, the proportion commencing NOAC increased from zero in 1/2011 to 27.0 % in 5/2014, and OAC prescriptions for CHA2DS2VASc score ≥2 (guideline adherence) increased from 41.2 % to 65.5 %. Persistence with OAC declined over 12 months to 63.6 % for VKA and 79.2 % for NOAC (p< 0.0001). Persistence for those with CHA2DS2VASc ≥2 was significantly greater for NOAC (83.0 %) than VKA (65.3 %, p< 0.0001) at one year and all earlier time points. Comparison of VKA and NOAC cohorts matched on individual CHA2DS2VASc components showed consistent results. In conclusion, persistence was significantly higher with NOAC than VKA, and could alone lead to fewer cardioembolic strokes. Increased guideline adherence following NOAC introduction could further decrease AF stroke burden.Supplementary Material to this article is available online at www.thrombosis-online.com.

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Section: Discussionmentioning

confidence: 99%

Therapy persistence in newly diagnosed non-valvular atrial fibrillation treated with warfarin or NOAC

Martínez¹,

Katholing²,

Wallenhorst³

et al. 2016

Thromb Haemost

149

View full text Add to dashboard Cite

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“…Even more alarmingly, the rate of major gastrointestinal bleeding was 4.11%/year in our cohort, substantially higher than that of both the Asian (0.96%/year to 1.15%/year) and non-Asian population (1.14%/year to 1.69%/year) in the RE-LY study [21]. While some studies in the real world setting documented very few bleeding events, ranging from 3.3% to 5.2%,[16], [18], [22] Michel and colleagues revealed that 29% of patients receiving dabigatran had experienced bleeding events, predominantly minor ones [23]. In particular, Ho and colleagues reported the total bleeding and intracranial hemorrhagic risks of 22.95% and 1.64%, respectively, which were even higher than that in our cohort [17].…”

Section: Discussionmentioning

confidence: 99%

Continuation of Dabigatran Therapy in “Real-World” Practice in Hong Kong

Cheung

et al. 2014

PLoS ONE

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BackgroundDabigatran, an oral direct thrombin inhibitor, possesses several advantages over warfarin that can in principle simplify the management of stroke prevention in atrial fibrillation (AF). Nonetheless it remains unclear whether these advantages can translate to clinical practice and encourage long-term therapy. The objective was to describe long-term dabigatran therapy for stroke prevention in AF and to identify risk factors for discontinuation of therapy.Methods and ResultsWe studied 467 consecutive Chinese patients (72±11 years, male: 53.8%) with a mean CHA2DS2-VASc score of 3.6 prescribed dabigatran for stroke prevention in AF from March 2010 to September 2013. Over a mean follow-up of 16 months, 101 patients (21.6%) permanently discontinued dabigatran. The mean time-to-discontinuation was 8 months. The most common reason for discontinuation was dyspepsia (30.7%), followed by other adverse events (17.8%) such as minor bleeding (8.9%), major gastrointestinal bleeding (7.9%), and intracranial hemorrhage (1%). Other reasons included dosing frequency (5.9%), fear of side effects (4.0%), lack of laboratory monitoring (1.0%), and cost (1.0%). Multivariable analysis revealed that low baseline estimated glomerular filtration rate (p = 0.02), absence of hypertension (p = 0.01), and prior use of a proton-pump inhibitor (p = 0.02) and H2-receptor blocker (p = 0.01) were independent predictors of drug discontinuation. In addition, there were altogether 9 ischemic strokes (1.5%/years), 3 intracranial hemorrhages (0.5%/year), and 24 major gastrointestinal bleedings (4.1%/year).ConclusionDabigatran discontinuation is very common amongst Chinese AF patients. This reveals a management gap in the prevention of stroke in AF.

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“…33 In a prospective observational study from New Zealand 24% of the 70 patients discontinued dabigatran; 4 due to gastrointestinal side effects, 3 due to bleeding, and 19 reported difficulty with the twice daily dosing regimen, whereas 13 of 70 reported missed doses. 34 Few studies have been recently reported which specifically looked into adherence with NOACs. A retrospective preimplementation-postimplementation study conducted at a Veterans Affairs hospital which utilized medication possession ratio (MPR) with acceptable adherence, defined as an MPR of !…”

Section: Current Available Real-world Data On Dabigatranmentioning

confidence: 99%

When the Rubber Meets the Road: Adherence and Persistence with Non–Vitamin K Antagonist Oral Anticoagulants and Old Oral Anticoagulants in the Real World—A Problem or A Myth ?

Suryanarayan

Schulman

2014

Semin Thromb Hemost

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For patients taking vitamin K antagonist (VKA) anticoagulants, poor adherence to the drug regimen is associated with a lower percent time in therapeutic range and also with an increased risk of thromboembolic complications. The non-vitamin K antagonist oral anticoagulants (NOACs) do not require routine laboratory monitoring and therefore the risk of nonadherence remaining undetected and without any corrective attempts must be recognized. Persistence with the NOACs and VKA was quite comparable in the phase III trials, whereas a postmarketing study demonstrated better persistence with dabigatran than with warfarin. Preliminary studies on adherence to the dabigatran regimen have shown poor adherence in 12 to 27%, and also for this drug such behavior seems associated with an unfavorable outcome. There is uncertainty about the best methods to evaluate adherence. Studies on the adherence are needed for all the NOACs, for different clinical settings and patient populations. A combination of strategies should probably be used to achieve the best possible adherence, including patient education and some form of automatic reminders.

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Dabigatran for Anticoagulation in Atrial Fibrillation – Early Clinical Experience in a Hospital Population and Comparison to Trial Data

Cited by 17 publications

References 16 publications

Therapy persistence in newly diagnosed non-valvular atrial fibrillation treated with warfarin or NOAC

Therapy persistence in newly diagnosed non-valvular atrial fibrillation treated with warfarin or NOAC

Continuation of Dabigatran Therapy in “Real-World” Practice in Hong Kong

When the Rubber Meets the Road: Adherence and Persistence with Non–Vitamin K Antagonist Oral Anticoagulants and Old Oral Anticoagulants in the Real World—A Problem or A Myth ?

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