Effect of the Thrombin Inhibitor Argatroban in Acute Cerebral Thrombosis

Kobayashi, Shotai; Tazaki, Yuichi

doi:10.1055/s-2007-996131

Cited by 90 publications

(42 citation statements)

References 7 publications

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“…Briefly, the characteristics of the Japanese Guidelines for the Management of Stroke 2004 can be summarized as follows: (1) it is the first evidence-based guideline for stroke treatment in Japan and the East; (2) it was produced by the Joint Committee on Guidelines for the Management of Stroke with the cooperation of 5 stroke-related societies in Japan; (3) it was developed jointly by neurologists, stroke internists, neurosurgeons, rehabilitation specialists, and clinical epidemiologists; (4) no financial support was accepted from any company; (5) it provides comprehensive coverage of all types of stroke in the acute and chronic stages, including prevention; (6) it is not a translation of stroke guidelines from the West, but rather a new guideline for the treatment of Japanese people, developed by Japanese doctors, and taking into consideration the evidence from the Japanese language literature, as well as the local situation in Japan; (7) novel pharmaceutical treatments so far approved only in Japan, but for which only one randomized controlled trial dealing with a rather small number of subjects [7][8][9] was available, were tentatively assigned recommendation grade B; (8) original classifications based on global standards were used for evidence levels and recommendation grades; (9) an evidence level was assigned to all the cited literature; and (10) an attempt was made to clarify what evidence is lacking in each field of stroke.…”

Section: Representative Characteristics Of the Japanese Guidelinesmentioning

confidence: 99%

Postpublication External Review of the Japanese Guidelines for the Management of Stroke 2004

Shinohara

Nagayama²,

Origasa³

2009

Stroke

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Background and Purpose-Many guidelines for management of stroke have been published throughout the world, but no postpublication external review of any set of stroke guidelines by users, using standard checklists, has been reported. The purpose of this article is to present the results of an external review of the Japanese Guidelines for the Management of Stroke 2004, conducted several months postpublication. Methods-Forty-one evaluators, who had not been involved in developing the guidelines, were selected from representative stroke centers and institutions in Japan. They consisted of 30 physicians including 22 stroke specialists, and 11 nurse practitioners. Three standard checklists, ie, Appraisal of Guidelines for Research and Evaluation (AGREE) instrument, checklist by Shaneyfelt et al, and the Conference on Guideline Standardization (COGS) checklist, were used. Results-Confidence ratios according to the AGREE checklist were 75%, 77%, and 86% for stroke specialists, physicians other than stroke specialists, and nurse practitioners, respectively. The average scores were 2.98, 3.13, and 3.29, respectively. The confidence ratios according to the checklist by Shaneyfelt et al were 72%, 73% and 86% respectively, and those for the COGS checklist were 66%, 74%, and 91%, respectively. Conclusions-Although it is impossible to compare our results with those for other stroke guidelines, because none of them has been externally reviewed by users postpublication, our results seem better than those for published guidelines for treatment of other diseases in Japan. These results should be helpful in the process of updating stroke guidelines in Japan and elsewhere.

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Section: Representative Characteristics Of the Japanese Guidelinesmentioning

confidence: 99%

Postpublication External Review of the Japanese Guidelines for the Management of Stroke 2004

Shinohara

Nagayama²,

Origasa³

2009

Stroke

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“…The Ministry of Health Labour, and Welfare of Japan approved argatroban in patients with stroke according to the following schedule: argatroban infused continuously at a dose of 60 mg/d for the first 2 days, followed by twice daily infusion, at a dose of 10 mg over 3 hours, for 5 days. 4,5,11 …”

Section: Use Of Argatroban For Acute Ischemic Stroke In Japanmentioning

confidence: 99%

“…2 To the best of our knowledge, there are only 3 randomized controlled trials on argatroban use in patients with acute ischemic stroke: 1 from North America 3 and 2 from Japan. 4,5 These studies suggested that argatroban was effective and safe for the use as early anticoagulant therapy in acute ischemic stroke. However, the sample sizes of these studies were small.…”

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confidence: 99%

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Outcomes of Argatroban Treatment in Patients With Atherothrombotic Stroke

Wada

Yasunaga

Horiguchi

et al. 2016

Stroke

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Background and Purpose-Argatroban, a selective thrombin inhibitor, is recommended for the use in patients with atherothrombotic stroke by the Japanese Guidelines for the Management of Patients with Acute Ischemic Stroke. We performed a nationwide Japanese study to investigate whether argatroban improved early stroke outcomes in patients with acute atherothrombotic stroke. Methods-This retrospective observational study, using the Diagnosis Procedure Combination database in Japan, included patients who were hospitalized from July 1, 2010, to March 31, 2012, with a diagnosis of atherothrombotic stroke within 1 day of stroke onset. Patients were divided into 2 groups: those receiving argatroban on admission (argatroban group), and those who did not receive argatroban during hospitalization (control group). To balance the baseline characteristics and concomitant treatments during hospitalization between the 2 groups, one-to-one propensity-score matching analyses were performed. The main outcomes were the modified Rankin Scale score at discharge and the occurrence of hemorrhagic complications during hospitalization. An ordinal logistic regression analysis evaluated the association between argatroban use and modified Rankin Scale at discharge. Results-After propensity-score matching, 2289 pairs of patients were analyzed. There were no significant differences in modified Rankin Scale at discharge between the argatroban and the control groups (adjusted odds ratio, 1.01; 95% confidence interval, 0.88-1.16). The occurrence of hemorrhagic complications did not differ significantly between the argatroban and the control groups (3.5% versus 3.8%; P=0.58). Conclusions-The present study suggested that argatroban was safe, but had no added benefit in early outcomes after acute atherothrombotic stroke. The aim of the present study was to investigate whether argatroban was effective and safe in patients with acute ischemic stroke, using a database of Japanese inpatients. Methods Study Design and SettingThis was a retrospective observational cohort study using data from a nationwide administrative claims and discharge abstract database in Japan, the Diagnosis Procedure Combination database. The Diagnosis Procedure Combination database has been described in detail previously. 9 In brief, >1000 hospitals, including all 82 academic hospitals in Japan, contribute to the Diagnosis Procedure Combination database. The annual number of cases added to the database is ≈7 000 000 and encompasses ≈50% of all hospital admissions in Japan.The Diagnosis Procedure Combination database contains the following information for each patient: patient demographics, a unique hospital identifier, diagnoses, outcomes, drugs used, procedures performed, healthcare costs, and several disease-specific data. Diagnoses include the main diagnosis on admission, preexisting comorbidities, and postadmission complications, which are recorded separately with International Classification of Diseases-10th revision codes and text data in Japanese. Drugs and procedures ar...

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“…51,52 In Japan only, argatroban is also licensed for treatment of ischemic complications in patients with chronic peripheral arterial occlusions and for treatment of patients with ischemic stroke. 53,54 Argatroban has also been evaluated in several small, randomized, controlled trials in patients with acute coronary syndromes, but results were inconclusive. [55][56][57] …”

Section: Clinical Trials With Argatrobanmentioning

confidence: 99%

Translational Success Stories

Coppens

Eikelboom

Gustafsson

et al. 2012

Circulation Research

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ReviewTranslational Success Stories highlight how basic discoveries have led to clinical advances (such as the use of new drugs or diagnostic modalities in patients). This initiative reflects the renewed emphasis of our journal on translational research. It is hoped that these articles will stimulate efforts to translate basic insights into clinical practice. Translational Success Stories Development of Direct Thrombin InhibitorsMichiel Coppens, John W. Eikelboom, David Gustafsson, Jeffrey I. Weitz, Jack Hirsh Abstract: Anticoagulants are the cornerstone of therapy for conditions associated with arterial and venous thrombosis.Direct thrombin inhibitors (DTIs) are anticoagulants that bind to thrombin and block its enzymatic activity. The bivalent parenteral DTIs hirudin and bivalirudin were based on the observation that the salivary extracts of medicinal leeches prevented blood from clotting. Key events that facilitated the subsequent development of small molecule active site inhibitors, such as argatroban, were the observation that fibrinopeptide A had antithrombotic properties and determination of the crystal structure of thrombin. Hirudin and argatroban have found their niche for the treatment of patients with heparin-induced thrombocytopenia, whereas bivalirudin is approved as an alternative to heparin for patients undergoing percutaneous coronary intervention. The development of orally active direct thrombin inhibitors was challenging because of the need to convert water-soluble, poorly absorbable, active site inhibitors into fat-soluble prodrugs that were then transformed back to the active drug after intestinal absorption. Dabigatran etexilate was the first new oral anticoagulant to be approved for long-term anticoagulant treatment in 6 decades. This Review highlights the development of DTIs as a translational success story; an example in which the combination of scientific ingenuity, structure-based design, and rigorous clinical trials has created a new class of anticoagulants that has improved patient care. (Circ Res. 2012;111:920-929.) Key Words: thrombin Ⅲ anticoagulant Ⅲ drug development D irect thrombin inhibitors (DTIs) are anticoagulants that bind directly to thrombin and block its activity. Prior to their development, the injectable anticoagulants in clinical use were heparin and low-molecular-weight heparins (LMWHs). Both are classified as indirect inhibitors because they have no intrinsic activity; instead, they produce their anticoagulant effect by activating antithrombin. The only class of oral anticoagulants that was available at that time was the vitamin K antagonists (VKAs), such as warfarin.Several key events led to the development of DTIs. The first was the observation in 1884 that salivary secretions of the medicinal leech, Hirudo medicinalis, prevented blood from clotting. 1 This finding subsequently led to the development of hirudin, which was initially extracted from leeches and later obtained via rDNA technology. [2][3][4][5] The second observation, made in 1956 by Bettelheim, was th...

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Effect of the Thrombin Inhibitor Argatroban in Acute Cerebral Thrombosis

Cited by 90 publications

References 7 publications

Postpublication External Review of the Japanese Guidelines for the Management of Stroke 2004

Postpublication External Review of the Japanese Guidelines for the Management of Stroke 2004

Outcomes of Argatroban Treatment in Patients With Atherothrombotic Stroke

Translational Success Stories

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