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  1. Yap LB, Rusani BI, Umadevan D, Muhammad Z, Hussin A, Kaur S, et al.
    J Thromb Thrombolysis, 2014 Jul;38(1):39-44.
    PMID: 24197653 DOI: 10.1007/s11239-013-1020-y
    The use of novel anticoagulants such as dabigatran are increasing. Despite increased risks of intracerebral haemorrhage with warfarin among Asians, there is little published data on dabigatran to assess 'real world' efficacy and safety of dabigatran therapy in Asia. This was a retrospective observational study of patients prescribed dabigatran between 2010 and 2013. Data was available for 510 patients: median age 68 years (range 20-91), median CHA2DS2-VASc score was 2 and median HAS-BLED score was 2. The average follow-up duration of 315 days (range: 1-1,096). The overall discontinuation rate was 16% after a median 252 days of treatment with dabigatran. There were 17 (3.3%) patients with minor bleeding, 2 (0.4%) had major bleeding episodes. 20 patients (3.9%) developed dyspepsia which was the most common side effect. The rate of occurrences of adverse effects and bleeding were lower than those seen in the RE-LY trial. None of the patients had an ischaemic stroke, 1 (0.2%) patient had a haemorrhagic stroke. Out of 510 patients, 158 patients (31%) were switched to dabigatran from warfarin. This showed that patients frequently preferred the dabigatran due to convenience when given a choice to switch from warfarin. We report one of the largest registry of Asian patients. Reassuringly, we found that our cohort had a low rate of rate of ischaemic stroke, low rates of side effects and bleeding with the drug.
    Matched MeSH terms: Antithrombins/adverse effects
  2. Hasan SS, Kow CS, Curley LE, Baines DL, Babar ZU
    Expert Rev Pharmacoecon Outcomes Res, 2018 08;18(4):371-377.
    PMID: 29741099 DOI: 10.1080/14737167.2018.1474101
    INTRODUCTION: Anticoagulants refer to a variety of agents that inhibit one or more steps in the coagulation cascade. Generally, clinical conditions that require the prescribing of an oral anticoagulant increase in frequency with age. However, a major challenge of anticoagulation use among older patients is that this group of patients also experience the highest bleeding risk. To date, economic evaluation of prescribing of anticoagulants that includes the novel or newer oral anticoagulants (NOACs) in older adults has not been conducted and is warranted.

    AREAS COVERED: A review of articles that evaluated the cost of prescribing conventional (e.g. vitamin K antagonists) and NOACs (e.g. direct thrombin inhibitors and direct factor Xa inhibitors) in older adults.

    EXPERT COMMENTARY: While the use of NOACs significantly increases the cost of the initial treatment for thromboembolic disorders, they are still considered cost-effective relative to warfarin since they offer reduced risk of intracranial haemorrhagic events. The optimum anticoagulation with warfarin can be achieved by providing specialised care; clinics managed by pharmacists have been shown to be cost-effective relative to usual care. There are suggestions that genotyping the CYP2C9 and VKORC1 genes is useful for determining a more appropriate initial dose and thereby increasing the effectiveness and safety of warfarin.

    Matched MeSH terms: Antithrombins/adverse effects
  3. Choi EK, Lee YS, Chern AKC, Jiampo P, Chutinet A, Hanafy DA, et al.
    Open Heart, 2020 11;7(2).
    PMID: 33184127 DOI: 10.1136/openhrt-2020-001343
    BACKGROUND AND PURPOSE: Real-world data about treatment convenience and satisfaction in Asian non-valvular atrial fibrillation (NVAF) patients after switching from vitamin K antagonists (VKAs) to non-VKA oral anticoagulants were evaluated.

    METHODS: In this non-interventional study involving 49 sites across five countries in Southeast Asia and South Korea, 379 stable NVAF patients who switched from VKA therapy to dabigatran during routine clinical practice were recruited and followed up for 6 months. Treatment convenience and satisfaction were evaluated using Perception on Anticoagulant Treatment Questionnaire-2 (PACT-Q2). Through post hoc analysis, factors associated with improved treatment convenience scores at visit 2 were described.

    RESULTS: Treatment convenience and satisfaction significantly improved after switching from VKAs to dabigatran at visit 2 and visit 3 (convenience: p<0.001 each vs baseline; satisfaction: p=0.0174 (visit 2), p=0.0004 (visit 3) compared with baseline). Factors predictive of higher (>80th percentile) response on treatment convenience were female sex, younger age (<75 years), higher baseline stroke risk, higher creatinine clearance and absence of concomitant hypertension, stroke or gastrointestinal diseases.

    CONCLUSION: Dabigatran was associated with a significant improvement in treatment convenience and satisfaction after switching from VKAs when used for stroke prevention in NVAF patients from Southeast Asia and South Korea.

    Matched MeSH terms: Antithrombins/adverse effects
  4. Beshir SA, Chee KH, Lo YL
    Int J Clin Pharm, 2016 Oct;38(5):1182-90.
    PMID: 27450507 DOI: 10.1007/s11096-016-0350-1
    Background Oral anticoagulant therapy is indicated for the prevention of stroke or other thromboembolic events. Premature discontinuation of oral anticoagulants may increase the risk of thromboembolism resulting in adverse sequelae. There are sparse data on the prevalence and the predictors of dabigatran discontinuation in Malaysian patients with atrial fibrillation. Objectives Determine the reasons and identify associated factors for abrupt discontinuation of dabigatran, assess the switching pattern and the occurrence of thromboembolic events after dabigatran discontinuation. Setting A university-affiliated tertiary hospital in Kuala Lumpur, Malaysia. Methods The clinical and demographic data of a cohort who were initiated with dabigatran between 2010 and 2012 at the University of Malaya Medical Centre were reviewed until the date of death or on 31st December 2013. Those patients who discontinued dabigatran were further followed up until 31st December 2015 to determine the occurrence of any thromboembolic event. Main outcome measure Permanent discontinuation of dabigatran for more than 8 weeks. Results 26 (14 %) of a cohort of 192 patients discontinued dabigatran therapy during a median follow-up period of 20 (range 3-45) months. About one-half of the discontinuation occurred within the first 6 months of dabigatran use. The three most cited reasons for discontinuation are bleeding events (19 %), high out-of-pocket drug payment (19 %) and cardioversion (19 %). Heart failure [adjusted odds ratio 3.699 (95 % confidence interval 1.393-9.574)] or chronic kidney disease [adjusted odds ratio 5.211 (95 % confidence interval 1.068-23.475)] were found to be independent risk factors for abrupt dabigatran discontinuation. Patients who discontinued dabigatran received warfarin (38 %), antiplatelet agents (16 %) or no alternative antithrombotic therapy (46 %). Five of the 26 patients who discontinued dabigatran developed an ischaemic stroke within 3-34 months after discontinuation. Conclusion Abrupt dabigatran discontinuation without an alternative oral anticoagulant increases the risk of thromboembolic events. As adverse drug events and renal impairment contribute substantially to the premature discontinuation of dabigatran, it is important to identify and monitor patients at risk to reduce dabigatran discontinuation rate especially during the first six months of dabigatran therapy.
    Matched MeSH terms: Antithrombins/adverse effects
  5. Beshir SA, Yap LB, Sim S, Chee KH, Lo YL
    J Pharm Pharm Sci, 2017;20(1):365-377.
    PMID: 29145930 DOI: 10.18433/J3TP9Q
    PURPOSE: To assess the predicted rate and the factors associated with bleeding events among patients with non-valvular atrial fibrillation (NVAF) receiving dabigatran therapy.

    METHODS: This retrospective cohort study includes adult patients of two tertiary hospitals in Malaysia. Potential study subjects were identified using pharmacy supply database or novel oral anticoagulant (NOAC) registry. Demographics, clinical data and laboratory test results were extracted from the medical records of the patients or electronic databases. The main outcome measure is the occurrence of a bleeding event. Bleeding events were classified into major bleeding, clinically relevant non-major bleeding, or minor bleeding, according to the International Society on Thrombosis and Haemostasis criteria. We consider clinically relevant non-major bleeding events or major bleeding events as clinically relevant bleeding events. An occurrence of any bleeding event was recorded from the initiation of NOAC therapy until the death of a patient, or the date of permanent discontinuation of NOAC use, or the last day of data collection. The predicted rate of dabigatran-induced bleeding events per 100 patient-years was estimated.

    RESULTS: During a median follow-up period of 18 months, 73 patients experienced 90 bleeding events. Among these patients, 25 including 4 fatal cases, experienced major bleeding events. The predicted rate per 100 patient-years of follow-up of any bleeding events was 9.0 [95% CI 6.9 to 11.1]; clinically relevant bleeding events 6.0 [95% CI 4.8 to 8.3], and major bleeding events 3.0 [95% CI 1.9 to 4.2]. The independent risk factor for clinically relevant bleeding events is prior bleeding. While prior bleeding or congestive heart failure is linked with major bleeding events.

    CONCLUSIONS: The predicted rate for dabigatran-induced major bleeding episodes is low but these adverse events carry a high fatality risk. Preventive measures should target older patients who have prior bleeding or congestive heart failure. This article is open to POST-PUBLICATION REVIEW. Registered readers (see "For Readers") may comment by clicking on ABSTRACT on the issue's contents page.

    Matched MeSH terms: Antithrombins/adverse effects*
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