The Effect of a Single Dose of BI 1291583 on the Pharmacokinetics of a Single Dose of Dabigatran Following Oral Administration in Healthy Adult Male Subjects (an Open-label, 2- Period, Fixed-sequence Study)

The main objective of this trial is to investigate the effect of a single dose of BI 1291583 on the pharmacokinetics of a single dose of dabigatran, an efflux transporter P-glycoprotein (P-gp) substrate.

Start Date23 Jan 2025

Sponsor / Collaborator

Boehringer Ingelheim GmbH

NCT06650501

/ Not yet recruitingPhase 4IIT

Dabigatran for the Adjunctive Treatment of Staphylococcus Aureus Bacteremia: the DABI-SNAP Nested Randomized Controlled Trial

This is an open-label randomized controlled trial which will enroll patients with S. aureus bacteremia who are already taking oral anticoagulant medications (apixaban, edoxaban, or rivaroxaban) for an approved indication (stroke prevention in atrial fibrillation, prevention or treatment of venous thromboembolism). We will randomize patients to continue their existing medication or change to another medication (dabigatran) which is approved for the original indication.
Dabigatran is approved in many countries for the treatment or prevention of venous thromboembolism or preventing stroke in atrial fibrillation. Unlike the other medications listed above, dabigatran seems to have activity against S. aureus in the test tube, in animal models, and in a smaller randomized controlled trial. We wish to determine if changing to dabigratran will improve outcomes in S. aureus bacteremia in people who otherwise would have a reason to be taking it.
This study is an approved sub-study of The Staphylococcus aureus Network Adaptive Platform (SNAP) trial (NCT05137119).
If positive, this study will support a second RCT in people who do not currently have an indication for anticoagulation.

Start Date07 Jan 2025

Sponsor / Collaborator

Mcgill University Health Centre

[+1]

TCTR20240916009

/ Not yet recruitingPhase 1IIT

A Bioequivalence study of a randomized, open-label, single dose, fully replicated crossover design with four-period, two-treatment, and two-sequence of Dabigatran Etexilate capsules 150 mg relative to PRADAXA 150 MG in healthy Thai volunteers under fasting condition.

Start Date12 Dec 2024

Sponsor / Collaborator

Bio-innova Co., Ltd

100 Clinical Results associated with Dabigatran Etexilate Mesylate

100 Translational Medicine associated with Dabigatran Etexilate Mesylate

100 Patents (Medical) associated with Dabigatran Etexilate Mesylate

6,162

Literatures (Medical) associated with Dabigatran Etexilate Mesylate

01 Mar 2025·THROMBOSIS RESEARCH

Disparities in menstrual bleeding management during acute venous thromboembolism treatment: A review of UK practice and a call for clinical studies

Article

Author: Rose, Lucy ; Lowe, Gillian ; Buka, Richard J ; Jacob, Nkemdirim ; Nicolson, Phillip L R ; Nandra, Taran ; Alhamdi, Yasir ; Hassan, Eman ; Sutton, David

BACKGROUND:

Heavy menstrual bleeding (HMB) is a significant clinical burden for premenopausal individuals treated with anticoagulation for acute venous thromboembolism (VTE). Despite its prevalence, HMB management remains poorly studied, with wide variation in clinical practice.

OBJECTIVES:

The current study aimed to explore current UK practices in managing HMB in anticoagulated individuals and identify areas requiring clinical research to address disparities.

METHODS:

A national survey was conducted among haematology consultants and consultant clinical pharmacists managing anticoagulated patients. The survey focused on management strategies, including anticoagulant selection, use of tranexamic acid (TXA), contraceptive options, and anticoagulation interruption.

RESULTS AND CONCLUSION:

Responses were collected from 102 participants, across the UK. Apixaban was the preferred anticoagulant for patients with HMB, followed by LMWH then dabigatran. Timing of TXA initiation varied widely between respondents, with (35.3 %) prescribing it any time after anticoagulation initiation, (11.8 %) delaying TXA use for 3 months, and (7.8 %) would not give it at all. (47.1 %) of respondents advise to discontinue oestrogen containing contraceptives in patients with acute VTE. Almost all respondents never or rarely stop anticoagulation for a patient with HMB and recent VTE ≤4 weeks. (62.7 %) of respondents showed their willingness to participate in clinical studies to study TXA use in the setting of acute VTE ≤4 weeks in anticoagulated individuals. This study highlights significant variations in HMB management during anticoagulation for acute VTE. Disparities raise concerns about health inequities and underscore the urgent need for prospective clinical trials to improve patient outcomes.

01 Feb 2025·IJC Heart & Vasculature

Direct oral anticoagulants in deep vein thrombosis associated with inferior vena cava agenesis: A report of three cases and a systematic review

Review

Author: Osti, Nicola ; Martinelli, Nicola ; Susca, Nicola ; Racanelli, Vito ; Maino, Alberto

Background:

Inferior vena cava agenesis (IVCA) is a rare vascular abnormality characterised by the absence of one or more segments of the inferior vena cava and represents an underestimated cause of deep vein thrombosis (DVT). Given the very low prevalence of this condition and the lack of clinical trials, there is no consensus about the optimal anticoagulation strategy in IVCA-associated DVT.

Objectives:

To investigate efficacy and safety of direct oral anticoagulants (DOACs) in IVCA-associated DVT.

Methods:

We described three patients with IVCA-associated DVT followed at our Institution and treated with DOACs. Then, we performed a systematic review of the literature for ICVA-associated DVT treated with DOACs.

Results:

In addition to our 3 cases, we found data from 19 publications for a total of 30 patients with IVCA-associated DVT treated with DOACs (24 subjects treated with rivaroxaban, 8 with apixaban, and one with dabigatran). Most patients were males (72.7 %) with a median age at DVT onset of 26.0 years (min-max range 13-64 years). The majority of DVT events were unprovoked (76.0 %). The standard thrombophilia tests were mainly negative. The median follow-up period during DOAC therapy was 1.0 years (min-max range 0-10 years), with one recurrent splanchnic vein thrombosis reported and no haemorrhagic events.

Conclusions:

IVCA is a rare cause of DVT, which should be suspected in young adults with unprovoked DVT. Although future studies are needed, available data may support the use of DOACs in IVCA-associated DVT, with a reassuring profile of both efficacy and safety.

01 Feb 2025·CURRENT OPINION IN NEUROLOGY

Update on management of cerebral venous thrombosis

Article

Author: Rosa, Sara ; Aguiar de Sousa, Diana ; Fragata, Isabel

Purpose of review:

This review intends to systematize the diagnostic and treatment approach to cerebral venous thrombosis (CVT), highlighting key studies that have been recently published.

Recent findings:

In light of the recent pandemic, new risk factors for CVT have emerged. Contrast-enhanced MRI and susceptibility-weighted imaging have been shown to offer increased sensitivity for detecting cortical vein thrombosis.Dabigatran seems to be as effective and well tolerated as warfarin for long-term anticoagulation. Partial venous recanalization often occurs in patients treated with anticoagulation only, as early as 8 days after treatment onset. For patients with CVT and impending brain herniation, two-thirds of those who undergo decompressive craniectomy survive, with one-third being functionally independent 6 months after diagnosis.

Summary:

CVT is an unusual type of cerebrovascular disease that mostly affects women of fertile age. Risk factors should be identified and addressed. Diagnosis relies on confirmation of venous sinus and/or vein thrombosis, usually by CT venography or MRI. Anticoagulation is the cornerstone of treatment. Despite the lack of high-quality evidence, endovascular treatment is often considered in severe cases. Special populations require tailored approaches. About 80% achieve mRS 0-1, but residual symptoms often affect quality of life and the ability to return to work.

News (Medical) associated with Dabigatran Etexilate Mesylate

13 Dec 2024

·www.globenewswire.com

HUTCHMED to Receive Milestone Payment from Takeda following First European Reimbursement for FRUZAQLA® (fruquintinib)

— US$10 million milestone payment to HUTCHMED follows first national reimbursement in Europe — — Follows June 2024 European approval of FRUZAQLA® (fruquintinib), the first novel oral targeted therapy in the EU for metastatic colorectal cancer regardless of biomarker status in over a decade — HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Dec. 12, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it will receive a US$10 million milestone payment by its partner Takeda (TSE:4502/NYSE:TAK). Takeda received a national reimbursement recommendation for FRUZAQLA® (fruquintinib) for patients with previously treated metastatic colorectal cancer (“CRC”) in Spain in December 2024, the first national reimbursement recommendation in Europe. CRC is the second most common cause of cancer-related deaths in Europe. FRUZAQLA® was approved by the European Commission (“EC”) of the European Union (“EU”) in June 2024. Takeda has the exclusive worldwide license to further develop, commercialize and manufacture fruquintinib outside of mainland China, Hong Kong and Macau. “We are delighted for both our partner, Takeda, and patients in Spain who will now be able to receive reimbursement for this innovative treatment. This is an important step forward in improving patient access across Europe more broadly,” said Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED. “It also underscores our ongoing collaboration with Takeda and reinforces our shared commitment to addressing the needs of patients with metastatic colorectal cancer.” The approvals by the EC were primarily based on results from the Phase III multiregional FRESCO-2 trial. Data from FRESCO-2 were published in The Lancet in June 2023. FRUZAQLA® was approved in the US in November 2023, in the EU in June 2024, in Switzerland in August 2024, in Canada, Japan and the United Kingdom in September 2024 and in Argentina, Australia and Singapore in October 2024. Regulatory applications are progressing in many other jurisdictions. About CRC CRC is a cancer that starts in either the colon or rectum. According to the International Agency for Research on Cancer/World Health Organization, CRC is the third most prevalent cancer worldwide, associated with more than 1.9 million new cases and 900,000 deaths in 2022. In Europe, CRC was the second most common cancer in 2022, with approximately 538,000 new cases and 248,000 deaths.1,2 In the US, it is estimated that 153,000 patients will be diagnosed with CRC and 53,000 deaths from the disease will occur in 2024.3 In Japan, CRC was the most common cancer, with an estimated 146,000 new cases and 60,000 deaths, in 2022.2 Although early-stage CRC can be surgically resected, metastatic CRC remains an area of high unmet need with poor outcomes and limited treatment options. Some patients with metastatic CRC may benefit from personalized therapeutic strategies based on molecular characteristics; however, most patients have tumors that do not harbor actionable mutations.4,5,6,7,8 About Fruquintinib Fruquintinib is a selective oral inhibitor of all three VEGF receptors (VEGFR-1, -2 and -3). VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for drug exposure that achieves sustained target inhibition and flexibility for potential use as part of a combination therapy. About Fruquintinib Approvals Global regulatory submissions are based on data from two large, randomized, controlled Phase III trials, the global, multi-regional FRESCO-2 trial and the FRESCO trial conducted in China, showing consistent benefit among a total of 734 patients treated with fruquintinib. Safety profiles were consistent across trials. Results from the FRESCO-2 trial were published in The Lancet in June 2023,9 while results from the FRESCO trial were published in The Journal of the American Medical Association, JAMA.10 In mainland China, Hong Kong and Macau, fruquintinib is co-marketed by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE®. It was included in the China National Reimbursement Drug List (NRDL) in January 2020. Since its launch in China, over 100,000 patients with colorectal cancer have been treated with fruquintinib. About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved in the US, Europe and Japan. For more information, please visit: www.hutch-med.com or follow us on LinkedIn. E.U. IMPORTANT SAFETY INFORMATION Please consult the FRUZAQLA (fruquintinib) Summary of Product Characteristics (SmPC) before prescribing. Guidance for use: FRUZAQLA should be initiated by a physician experienced in the administration of anticancer therapy. Patients should be given the package leaflet. CONTRAINDICATIONS: Hypersensitivity to the active substance or to any of the excipients. SPECIAL POPULATIONS: Renal impairment: No dose adjustment is required for patients with mild, moderate, or severe renal impairment; Hepatic impairment: No dose adjustment is required for patients with mild or moderate hepatic impairment. FRUZAQLA is not recommended for use in patients with severe hepatic impairment as FRUZAQLA has not been studied in this population; Elderly: No dose adjustment is required in patients aged 65 years or above; Pediatric population: There is no relevant use of FRUZAQLA in the pediatric population for the indication of metastatic colorectal cancer; Women of childbearing potential / Contraception in females: Women of childbearing potential should be advised to use highly effective contraception during treatment and for at least 2 weeks following the last dose of FRUZAQLA; Pregnancy: There are no clinical data available on the use of FRUZAQLA in pregnant women. Based on its mechanism of action, FRUZAQLA has the potential to cause fetal harm. Animal studies have shown reproductive toxicity, including fetal malformations. FRUZAQLA should not be used during pregnancy unless the clinical condition of the woman requires treatment with FRUZAQLA. If FRUZAQLA is used during pregnancy or if the patient becomes pregnant while on treatment, the patient must be informed of the potential hazard to the fetus; Breast-feeding: The safe use of FRUZAQLA during breast-feeding has not been established. It is not known whether FRUZAQLA or its metabolites are excreted in human milk. There are no animal data on the excretion of FRUZAQLA in animal milk. A risk to the breastfeeding newborns/infants cannot be excluded. Breastfeeding should be discontinued during treatment and for 2 weeks after the last dose; Fertility: There are no data on the effects of FRUZAQLA on human fertility. Results from animal studies indicate that FRUZAQLA may impair male and female fertility. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Hypertension: Hypertension, including hypertensive crisis, has been reported in patients treated with FRUZAQLA. Pre-existing hypertension should be monitored and adequately controlled in accordance with standard medical practices before starting FRUZAQLA treatment. Hypertension should be medically managed with antihypertensive medicinal products and adjustment of the FRUZAQLA dose, if necessary. FRUZAQLA should be permanently discontinued for hypertension that cannot be controlled with antihypertensive therapy or in patients with hypertensive crisis. Hemorrhagic events: Hemorrhagic events have been reported in patients treated with FRUZAQLA, including gastrointestinal (GI) tract events. Serious and sometimes fatal bleeding events have been reported in patients after treatment with FRUZAQLA. Hematologic and coagulation profiles should be monitored in accordance with standard medical practices in patients at risk for bleeding, including those treated with anticoagulants or other concomitant medicinal products that increase the risk of bleeding. In the event of severe bleeding requiring immediate medical intervention, FRUZAQLA should be permanently discontinued. Gastrointestinal perforation: GI perforation events, including fatal events, have been reported in patients treated with FRUZAQLA. Symptoms of GI perforation should be periodically monitored during treatment with FRUZAQLA. FRUZAQLA should be permanently discontinued in patients developing GI perforation. Proteinuria: Proteinuria events have occurred in patients treated with FRUZAQLA. Proteinuria should be monitored before initiation and during treatment with FRUZAQLA in accordance with standard medical practices. If urine dipstick proteinuria ≥ 2 g / 24 hours is detected, dose interruptions, adjustments, or discontinuation may be necessary. FRUZAQLA should be permanently discontinued in patients developing nephrotic syndrome. Palmar-plantar erythrodysesthesia syndrome (PPES): PPES is the most frequently reported dermatological adverse reaction. If Grade ≥2 skin reactions are detected, dose interruptions, adjustments, or discontinuation may be necessary. Posterior reversible encephalopathy syndrome (PRES): PRES has been reported in 1 patient (0.1%) treated with FRUZAQLA in clinical studies. PRES is a rare neurologic disorder that can present with headache, seizure, lethargy, confusion, altered mental function, blindness, and other visual or neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI). In patients developing PRES, discontinuation of FRUZAQLA, along with control of hypertension and supportive medical management of other symptoms, are recommended.Impaired wound healing: Impaired wound healing has been reported in 1 patient (0.1%) treated with FRUZAQLA in clinical studies. Patients are recommended to withhold FRUZAQLA for at least 2 weeks prior to surgery. FRUZAQLA should not be resumed for at least 2 weeks after surgery, as clinically indicated when there is evidence of adequate wound healing. Arterial and venous thromboembolic events: It is recommended to avoid starting treatment with FRUZAQLA in patients with a history of thromboembolic events (including deep vein thrombosis and pulmonary embolism) within the past 6 months or if they have a history of stroke and/or transient ischemic attack within the last 12 months. If arterial thrombosis is suspected, FRUZAQLA should be discontinued immediately. INTERACTIONS Effects of other medicinal products on the pharmacokinetics of FRUZAQLA CYP3A inducers Co-administration of FRUZAQLA with rifampicin (a strong CYP3A inducer) 600 mg once daily decreased FRUZAQLA AUCinf by 65% and decreased Cmax by 12%. The concomitant use of FRUZAQLA with strong and moderate CYP3A inducers should be avoided. CYP3A inhibitors Co-administration of FRUZAQLA with itraconazole (a strong CYP3A inhibitor) 200 mg twice daily did not result in clinically meaningful changes in the area under the concentration-time curve (AUC) and Cmax of FRUZAQLA. No dose adjustment of FRUZAQLA is needed during concomitant use with CYP3A inhibitors. Gastric acid lowering agents Co-administration of FRUZAQLA with rabeprazole (a proton pump inhibitor) 40 mg once daily did not result in clinically meaningful changes in the AUC of FRUZAQLA. No dose adjustment of FRUZAQLA is needed during concomitant use with gastric acid lowering agents. Effect of FRUZAQLA on the pharmacokinetics of other medicinal products Medicinal products that are substrates of P-glycoprotein (P-gp) Co-administration of a single dose of dabigatran etexilate 150 mg (a P-gp substrate) with a single dose of FRUZAQLA 5 mg decreased AUC of dabigatran by 9%. No dose adjustment is recommended for P-gp substrates during concomitant use with FRUZAQLA. Medicinal products that are substrates of breast cancer resistance protein (BCRP) Co-administration of a single 10 mg dose of rosuvastatin (a BCRP substrate) with a single 5 mg dose of FRUZAQLA decreased AUC of rosuvastatin by 19%. No dose adjustment is recommended for BCRP substrates during concomitant use with FRUZAQLA. UNDESIRABLE EFFECTS: The most commonly reported adverse reactions with FRUZAQLA are: Very common(frequency ≥1/10)Thrombocytopenia, hypothyroidism, anorexia, hypertension, dysphonia, diarrhea, stomatitis, aspartate aminotransferase increased, total bilirubin increased, alanine aminotransferase increased, palmar-plantar erythrodysesthesia syndrome, musculoskeletal discomfort, arthralgia, proteinuria, asthenia, and fatigueCommon(≥1/100 to <1/10)Pneumonia, upper respiratory tract infection, bacterial infections, leukopenia, neutropenia, hypokalemia, epistaxis, throat pain, gastrointestinal hemorrhage, gastrointestinal perforation, pancreatic enzymes increased, oral pain, rash, and mucosal inflammation For US Prescribing Information: https://www.fruzaqla.com/sites/default/files/resources/fruzaqla-prescribing-information.pdf For Japan Prescribing Information: https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/400256_42910H0M1028_1_01 For EU Prescribing Information: https://www.ema.europa.eu/en/documents/product-information/fruzaqla-epar-product-information_en.pdf Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including its expectations regarding the therapeutic potential of fruquintinib for the treatment of such patients with CRC and the further clinical development of fruquintinib in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of clinical data to support approval of fruquintinib for the treatment of patients with CRC or other indications in jurisdictions such as Europe, its potential to gain approvals from regulatory authorities, the safety profile of fruquintinib, HUTCHMED and/or Takeda’s ability to fund, implement and complete its further clinical development and commercialization plans for fruquintinib, the timing of these events, each party’s ability to satisfy the terms and conditions under the license agreement; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials or the regulatory pathway for fruquintinib; and Takeda’s ability to successfully develop and commercialize fruquintinib. In addition, as certain studies rely on the use of other drug products as combination therapeutics with fruquintinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, The Stock Exchange of Hong Kong Limited and on AIM. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries+852 2121 8200 /ir@hutch-med.com Media Enquiries Ben Atwell / Alex Shaw, FTI Consulting+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) /HUTCHMED@fticonsulting.comZhou Yi, Brunswick+852 9783 6894 (Mobile) /HUTCHMED@brunswickgroup.com Nominated Advisor Atholl Tweedie / Freddy Crossley / Rupert Dearden, Panmure Liberum+44 (20) 7886 2500 ___________________________ 1Bray F,et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 Countries.CA Cancer J Clin.2024;74(3):229-263. doi:10.3322/caac.21834.2Ferlay J,et al. Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from:https://gco.iarc.who.int/today, accessed 12 June 2024.3American Cancer Society. Cancer Facts & Figures 2024. Atlanta,American Cancer Society; 2024.4Bando H, et al. Therapeutic landscape and future direction of metastatic colorectal cancer.Nat Rev Gastroenterol Hepatol2023; 20(5)306-322. doi:10.1038/s41575-022-00736-1.5D'Haene N, et al. Clinical application of targeted next-generation sequencing for colorectal cancer patients: a multicentric Belgian experience.Oncotarget.2018;9(29):20761-20768. Published 2018 Apr 17. doi:10.18632/oncotarget.25099.6Venderbosch S, et al. Mismatch repair status and BRAF mutation status in metastatic colorectal cancer patients: A pooled analysis of the CAIRO, CAIRO2, COIN, and FOCUS Studies.Clinical Cancer Res.2014; 20(20):5322–5330. doi:10.1158/1078-0432.ccr-14-0332.7Koopman M, et al. Deficient mismatch repair system in patients with sporadic advanced colorectal cancer.Br J Cancer.2009;100(2), 266–273. doi:10.1038/sj.bjc.6604867.8Ahcene Djaballah S, et al. HER2 in Colorectal Cancer: The Long and Winding Road From Negative Predictive Factor to Positive Actionable Target.Am Soc Clin Oncol Educ Book.2022;42:1-14. doi:10.1200/EDBK_351354.9Dasari NA, et al. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, Phase III study.Lancet.2023;402(10395):41-53. doi:10.1016/S0140-6736(23)00772-9.10Li J,et al. Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial.JAMA. 2018;319(24):2486-2496. DOI:10.1001/jama.2018.7855.

Drug ApprovalPhase 3ImmunotherapyClinical ResultLicense out/in

18 Nov 2024

·www.drugs.com

Certain Painkillers Can Raise Bleeding Risks for People on Blood Thinners

MONDAY, Nov. 18, 2024 -- People on blood thinners have a doubled risk of dangerous internal bleeding if they also take a non-steroidal anti-inflammatory drug (NSAID) like ibuprofen or naproxen, a new study warns. People typically are prescribed blood thinners to treat or prevent strokes , heart attacks, or blood clots in the legs or lungs, researchers said. NSAIDs also are known to thin the blood, and the new study shows that they can increase risk of uncontrolled bleeding in the gut, brain, lungs and bladder if taken alongside a blood thinner. “We found that for patients taking blood thinners for blood clots in the legs or lungs, using NSAIDs doubled the risk of bleeding compared with not using NSAIDs,” said researcher Soren Riis Peterson , a medical student with Aarhus University Hospital in Denmark. “The increased bleeding risk associated with NSAID use was not limited to the digestive tract but also seemed to affect other organ systems.” For the study, researchers analyzed data on nearly 52,000 Danish patients prescribed a blood thinner to treat a blood clot between 2012 and 2022. In Denmark, the NSAIDs diclofenac and naproxen can only be obtained through a prescription. This allowed researchers to track the health of patients who had been prescribed both a blood thinner and an NSAID. Overall, the risk of a bleed was two times higher when people took a blood thinner and an NSAID, compared to just taking a blood thinner, researchers found. The specific risk was four times higher for naproxen, three times higher for diclofenac and nearly twice as high for ibuprofen. Specific bleed risks included: Using NSAIDs with a blood thinner also tripled a person’s risk of anemia, researchers found. The pattern of risk remained similar across a wide variety of blood thinners, including rivaroxaban , apixaban , dabigatran , edoxaban and warfarin , results show. The new study was published Nov. 17 in the European Heart Journal . “For people taking blood thinners for blood clots in their legs or lungs, our research highlights the importance of being cautious when considering NSAIDs for pain or inflammation,” Petersen concluded in a journal news release. “We recommend that patients consult their doctor before taking NSAIDs along with a blood thinner.” In an accompanying editorial, Dr. Robert Storey , a professor of clinical cardiology with the University of Sheffield in the U.K., noted that NSAIDs are widely used, making up about 8% of prescriptions worldwide and often available over-the-counter. “It seems clear that avoiding NSAIDs in combination with [blood thinners] is the safest strategy to avoid excess bleeding risk,” Storey wrote. “However, if this is not possible, what mitigation can be put in place? NSAID prescription should obviously be at the lowest dose and for the shortest time possible, but choice of agent and route may also be important.” Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.

AHA

31 Oct 2024

·www.globenewswire.com

HUTCHMED to Receive First Commercial Milestone Payment Following Over US$200 Million in FRUZAQLA® (fruquintinib) Sales by Takeda

— US$20 million payment based on sales of FRUZAQLA® in metastatic colorectal cancer —HONG KONG and SHANGHAI and FLORHAM PARK, N.J., Oct. 31, 2024 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM; HKEX:13) today announces that it will receive a US$20 million milestone payment from its partner Takeda (TSE:4502/NYSE:TAK), triggered by reaching over US$200 million in sales of FRUZAQLA® (fruquintinib) for metastatic colorectal cancer (“CRC”). CRC is the second most common cause of cancer-related deaths in the US. There are approximately 840,000 new cases of CRC each year across the US, Europe and Japan. Takeda delivered US$203 million in net sales of FRUZAQLA® in the nine months ended September 2024. This US$20 million payment will be the first ever commercial milestone payment received by HUTCHMED. Takeda has the exclusive worldwide license to further develop, commercialize, and manufacture fruquintinib outside of mainland China, Hong Kong and Macau, and markets under the FRUZAQLA® brand name. It received approval in the US in November 2023, in the EU in June 2024, in Switzerland in August 2024, in Canada, Japan and the United Kingdom in September 2024 and in Argentina, Australia and Singapore in October 2024. Regulatory applications are progressing in many other jurisdictions. “The achievement of US$200 million in sales is a testament to Takeda’s commercial strength in launching global brands, the clinical benefit of fruquintinib and the success of our partnership strategy for commercializing our medicines outside of China,” said Dr Weiguo Su, Chief Executive Officer and Chief Scientific Officer of HUTCHMED. “Receiving the US$20 million milestone payment will strengthen our balance sheet as we look to expand the use of fruquintinib into new indications, and highlights our strategy of global partnerships across our broad pipeline.” About CRC CRC is a cancer that starts in either the colon or rectum. According to the International Agency for Research on Cancer/World Health Organization, CRC is the third most prevalent cancer worldwide, associated with more than 1.9 million new cases and 900,000 deaths in 2022. In the US, it is estimated that 153,000 patients will be diagnosed with CRC and 53,000 deaths from the disease will occur in 2024.1 In Europe, CRC was the second most common cancer in 2022, with approximately 538,000 new cases and 248,000 deaths. In Japan, CRC was the most common cancer, with an estimated 146,000 new cases and 60,000 deaths, in 2022.2,3 Although early-stage CRC can be surgically resected, metastatic CRC remains an area of high unmet need with poor outcomes and limited treatment options. Some patients with metastatic CRC may benefit from personalized therapeutic strategies based on molecular characteristics; however, most patients have tumors that do not harbor actionable mutations.4,5,6,7,8 About Fruquintinib Approvals Global regulatory submissions are based on data from two large, randomized, controlled Phase III trials, the global, multi-regional FRESCO-2 trial and the FRESCO trial conducted in China, showing consistent benefit among a total of 734 patients treated with fruquintinib. Safety profiles were consistent across trials. Results from the FRESCO-2 trial were published in The Lancet in June 2023,9 while results from the FRESCO trial were published in The Journal of the American Medical Association, JAMA.10 In mainland China, Hong Kong and Macau, fruquintinib is co-marketed by HUTCHMED and Eli Lilly and Company under the brand name ELUNATE®. It was included in the China National Reimbursement Drug List (NRDL) in January 2020. Since its launch in China, over 100,000 patients with colorectal cancer have been treated with fruquintinib. About Fruquintinib Fruquintinib is a selective oral inhibitor of all three VEGF receptors (VEGFR-1, -2 and -3). VEGFR inhibitors play a pivotal role in inhibiting tumor angiogenesis. Fruquintinib was designed to have enhanced selectivity that limits off-target kinase activity, allowing for drug exposure that achieves sustained target inhibition and flexibility for potential use as part of a combination therapy. About HUTCHMED HUTCHMED (Nasdaq/AIM:HCM; HKEX:13) is an innovative, commercial-stage, biopharmaceutical company. It is committed to the discovery and global development and commercialization of targeted therapies and immunotherapies for the treatment of cancer and immunological diseases. It has approximately 5,000 personnel across all its companies, at the center of which is a team of about 1,800 in oncology/immunology. Since inception it has focused on bringing cancer drug candidates from in-house discovery to patients around the world, with its first three medicines marketed in China, the first of which is also approved in the US, Europe and Japan. For more information, please visit www.hutch-med.com or follow us on LinkedIn. E.U. IMPORTANT SAFETY INFORMATION Please consult the FRUZAQLA (fruquintinib) Summary of Product Characteristics (SmPC) before prescribing. Guidance for use: FRUZAQLA should be initiated by a physician experienced in the administration of anticancer therapy. Patients should be given the package leaflet. CONTRAINDICATIONS: Hypersensitivity to the active substance or to any of the excipients. SPECIAL POPULATIONS: Renal impairment: No dose adjustment is required for patients with mild, moderate, or severe renal impairment; Hepatic impairment: No dose adjustment is required for patients with mild or moderate hepatic impairment. FRUZAQLA is not recommended for use in patients with severe hepatic impairment as FRUZAQLA has not been studied in this population; Elderly: No dose adjustment is required in patients aged 65 years or above; Pediatric population: There is no relevant use of FRUZAQLA in the pediatric population for the indication of metastatic colorectal cancer; Women of childbearing potential / Contraception in females: Women of childbearing potential should be advised to use highly effective contraception during treatment and for at least 2 weeks following the last dose of FRUZAQLA; Pregnancy: There are no clinical data available on the use of FRUZAQLA in pregnant women. Based on its mechanism of action, FRUZAQLA has the potential to cause fetal harm. Animal studies have shown reproductive toxicity, including fetal malformations. FRUZAQLA should not be used during pregnancy unless the clinical condition of the woman requires treatment with FRUZAQLA. If FRUZAQLA is used during pregnancy or if the patient becomes pregnant while on treatment, the patient must be informed of the potential hazard to the fetus; Breast-feeding: The safe use of FRUZAQLA during breast-feeding has not been established. It is not known whether FRUZAQLA or its metabolites are excreted in human milk. There are no animal data on the excretion of FRUZAQLA in animal milk. A risk to the breastfeeding newborns/infants cannot be excluded. Breastfeeding should be discontinued during treatment and for 2 weeks after the last dose; Fertility: There are no data on the effects of FRUZAQLA on human fertility. Results from animal studies indicate that FRUZAQLA may impair male and female fertility. SPECIAL WARNINGS AND PRECAUTIONS FOR USE Hypertension: Hypertension, including hypertensive crisis, has been reported in patients treated with FRUZAQLA. Pre-existing hypertension should be monitored and adequately controlled in accordance with standard medical practices before starting FRUZAQLA treatment. Hypertension should be medically managed with antihypertensive medicinal products and adjustment of the FRUZAQLA dose, if necessary. FRUZAQLA should be permanently discontinued for hypertension that cannot be controlled with antihypertensive therapy or in patients with hypertensive crisis. Hemorrhagic events: Hemorrhagic events have been reported in patients treated with FRUZAQLA, including gastrointestinal (GI) tract events. Serious and sometimes fatal bleeding events have been reported in patients after treatment with FRUZAQLA. Hematologic and coagulation profiles should be monitored in accordance with standard medical practices in patients at risk for bleeding, including those treated with anticoagulants or other concomitant medicinal products that increase the risk of bleeding. In the event of severe bleeding requiring immediate medical intervention, FRUZAQLA should be permanently discontinued. Gastrointestinal perforation: GI perforation events, including fatal events, have been reported in patients treated with FRUZAQLA. Symptoms of GI perforation should be periodically monitored during treatment with FRUZAQLA. FRUZAQLA should be permanently discontinued in patients developing GI perforation. Proteinuria: Proteinuria events have occurred in patients treated with FRUZAQLA. Proteinuria should be monitored before initiation and during treatment with FRUZAQLA in accordance with standard medical practices. If urine dipstick proteinuria ≥ 2 g / 24 hours is detected, dose interruptions, adjustments, or discontinuation may be necessary. FRUZAQLA should be permanently discontinued in patients developing nephrotic syndrome. Palmar-plantar erythrodysesthesia syndrome (PPES): PPES is the most frequently reported dermatological adverse reaction. If Grade ≥2 skin reactions are detected, dose interruptions, adjustments, or discontinuation may be necessary. Posterior reversible encephalopathy syndrome (PRES): PRES has been reported in 1 patient (0.1%) treated with FRUZAQLA in clinical studies. PRES is a rare neurologic disorder that can present with headache, seizure, lethargy, confusion, altered mental function, blindness, and other visual or neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI). In patients developing PRES, discontinuation of FRUZAQLA, along with control of hypertension and supportive medical management of other symptoms, are recommended.Impaired wound healing: Impaired wound healing has been reported in 1 patient (0.1%) treated with FRUZAQLA in clinical studies. Patients are recommended to withhold FRUZAQLA for at least 2 weeks prior to surgery. FRUZAQLA should not be resumed for at least 2 weeks after surgery, as clinically indicated when there is evidence of adequate wound healing. Arterial and venous thromboembolic events: It is recommended to avoid starting treatment with FRUZAQLA in patients with a history of thromboembolic events (including deep vein thrombosis and pulmonary embolism) within the past 6 months or if they have a history of stroke and/or transient ischemic attack within the last 12 months. If arterial thrombosis is suspected, FRUZAQLA should be discontinued immediately. INTERACTIONS Effects of other medicinal products on the pharmacokinetics of FRUZAQLA CYP3A inducers Co-administration of FRUZAQLA with rifampicin (a strong CYP3A inducer) 600 mg once daily decreased FRUZAQLA AUCinf by 65% and decreased Cmax by 12%. The concomitant use of FRUZAQLA with strong and moderate CYP3A inducers should be avoided. CYP3A inhibitors Co-administration of FRUZAQLA with itraconazole (a strong CYP3A inhibitor) 200 mg twice daily did not result in clinically meaningful changes in the area under the concentration-time curve (AUC) and Cmax of FRUZAQLA. No dose adjustment of FRUZAQLA is needed during concomitant use with CYP3A inhibitors. Gastric acid lowering agents Co-administration of FRUZAQLA with rabeprazole (a proton pump inhibitor) 40 mg once daily did not result in clinically meaningful changes in the AUC of FRUZAQLA. No dose adjustment of FRUZAQLA is needed during concomitant use with gastric acid lowering agents. Effect of FRUZAQLA on the pharmacokinetics of other medicinal products Medicinal products that are substrates of P-glycoprotein (P-gp) Co-administration of a single dose of dabigatran etexilate 150 mg (a P-gp substrate) with a single dose of FRUZAQLA 5 mg decreased AUC of dabigatran by 9%. No dose adjustment is recommended for P-gp substrates during concomitant use with FRUZAQLA. Medicinal products that are substrates of breast cancer resistance protein (BCRP) Co-administration of a single 10 mg dose of rosuvastatin (a BCRP substrate) with a single 5 mg dose of FRUZAQLA decreased AUC of rosuvastatin by 19%. No dose adjustment is recommended for BCRP substrates during concomitant use with FRUZAQLA. UNDESIRABLE EFFECTS: The most commonly reported adverse reactions with FRUZAQLA are: Very common(frequency ≥1/10)Thrombocytopenia, hypothyroidism, anorexia, hypertension, dysphonia, diarrhoea, stomatitis, aspartate aminotransferase increased, total bilirubin increased, alanine aminotransferase increased, palmar-plantar erythrodysesthesia syndrome, musculoskeletal discomfort, arthralgia, proteinuria, asthenia, and fatigueCommon(≥1/100 to <1/10)Pneumonia, upper respiratory tract infection, bacterial infections, leukopenia, neutropenia, hypokalemia, epistaxis, throat pain, gastrointestinal hemorrhage, gastrointestinal perforation, pancreatic enzymes increased, oral pain, rash, and mucosal inflammation For US Prescribing Information: https://www.fruzaqla.com/sites/default/files/resources/fruzaqla-prescribing-information.pdf For Japan Prescribing Information: https://www.pmda.go.jp/PmdaSearch/iyakuDetail/ResultDataSetPDF/400256_42910H0M1028_1_01 Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the US Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect HUTCHMED’s current expectations regarding future events, including but not limited to, its expectations regarding the receipt of the milestone payment, the therapeutic potential of fruquintinib for the treatment of such patients with CRC and the further clinical development of fruquintinib in this and other indications. Forward-looking statements involve risks and uncertainties. Such risks and uncertainties include, among other things, assumptions regarding the sufficiency of clinical data to support approval of fruquintinib for the treatment of patients with CRC or other indications in other jurisdictions such as Japan, its potential to gain approvals from regulatory authorities, the safety profile of fruquintinib, HUTCHMED and/or Takeda’s ability to fund, implement and complete its further clinical development and commercialization plans for fruquintinib, the timing of these events, each party’s ability to satisfy the terms and conditions under the license agreement; actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials or the regulatory pathway for fruquintinib; and Takeda’s ability to successfully develop and commercialize fruquintinib. In addition, as certain studies rely on the use of other drug products as combination therapeutics with fruquintinib, such risks and uncertainties include assumptions regarding the safety, efficacy, supply and continued regulatory approval of these therapeutics. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. For further discussion of these and other risks, see HUTCHMED’s filings with the US Securities and Exchange Commission, on AIM and on The Stock Exchange of Hong Kong Limited. HUTCHMED undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise. Medical Information This press release contains information about products that may not be available in all countries, or may be available under different trademarks, for different indications, in different dosages, or in different strengths. Nothing contained herein should be considered a solicitation, promotion or advertisement for any prescription drugs including the ones under development. CONTACTS Investor Enquiries+852 2121 8200 / ir@hutch-med.com Media Enquiries Ben Atwell / Alex Shaw, FTI Consulting+44 20 3727 1030 / +44 7771 913 902 (Mobile) / +44 7779 545 055 (Mobile) / HUTCHMED@fticonsulting.comZhou Yi, Brunswick+852 9783 6894 (Mobile) / HUTCHMED@brunswickgroup.com Nominated Advisor Atholl Tweedie / Freddy Crossley / Rupert Dearden, Panmure Liberum+44 (20) 7886 2500 __________________________ REFERENCES 1American Cancer Society. Cancer Facts & Figures 2024. Atlanta, American Cancer Society; 2024.2Bray F, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 Countries. CA Cancer J Clin. 2024;74(3):229-263. doi:10.3322/caac.21834.3Ferlay J, et al. Global Cancer Observatory: Cancer Today. Lyon, France: International Agency for Research on Cancer. Available from: https://gco.iarc.who.int/today, accessed 12 June 2024.4Bando H, et al. Therapeutic landscape and future direction of metastatic colorectal cancer. Nat Rev Gastroenterol Hepatol 2023; 20(5)306-322. doi:10.1038/s41575-022-00736-1.5D'Haene N, et al. Clinical application of targeted next-generation sequencing for colorectal cancer patients: a multicentric Belgian experience. Oncotarget. 2018;9(29):20761-20768. Published 2018 Apr 17. doi:10.18632/oncotarget.25099.6Venderbosch S, et al. Mismatch repair status and BRAF mutation status in metastatic colorectal cancer patients: A pooled analysis of the CAIRO, CAIRO2, COIN, and FOCUS Studies. Clinical Cancer Res. 2014; 20(20):5322–5330. doi:10.1158/1078-0432.ccr-14-0332.7Koopman M, et al. Deficient mismatch repair system in patients with sporadic advanced colorectal cancer. Br J Cancer. 2009;100(2), 266–273. doi:10.1038/sj.bjc.6604867.8Ahcene Djaballah S, et al. HER2 in Colorectal Cancer: The Long and Winding Road From Negative Predictive Factor to Positive Actionable Target. Am Soc Clin Oncol Educ Book. 2022;42:1-14. doi:10.1200/EDBK_351354.9Dasari NA, et al. Fruquintinib versus placebo in patients with refractory metastatic colorectal cancer (FRESCO-2): an international, multicentre, randomised, double-blind, Phase III study. Lancet. 2023;402(10395):41-53. doi:10.1016/S0140-6736(23)00772-9.10Li J, et al. Effect of Fruquintinib vs Placebo on Overall Survival in Patients With Previously Treated Metastatic Colorectal Cancer: The FRESCO Randomized Clinical Trial. JAMA. 2018;319(24):2486-2496. DOI:10.1001/jama.2018.7855.

License out/inPhase 3Drug ApprovalImmunotherapyClinical Result

100 Deals associated with Dabigatran Etexilate Mesylate

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KEGG	Wiki	ATC	Drug Bank
D07082	Dabigatran Etexilate Mesylate	B01AE07	DB06695

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Recurrent deep vein thrombosis	EU	Teva GmbH	19 Feb 2024
Recurrent deep vein thrombosis	IS	Teva GmbH	19 Feb 2024
Recurrent deep vein thrombosis	LI	Teva GmbH	19 Feb 2024
Recurrent deep vein thrombosis	NO	Teva GmbH	19 Feb 2024
Systemic embolism	AU	Boehringer Ingelheim Pty Ltd.	24 Nov 2008
Atrial Fibrillation	EU	Boehringer Ingelheim International GmbH	17 Mar 2008
Atrial Fibrillation	IS	Boehringer Ingelheim International GmbH	17 Mar 2008
Atrial Fibrillation	LI	Boehringer Ingelheim International GmbH	17 Mar 2008
Atrial Fibrillation	NO	Boehringer Ingelheim International GmbH	17 Mar 2008
Embolism	EU	Boehringer Ingelheim International GmbH	17 Mar 2008
Embolism	IS	Boehringer Ingelheim International GmbH	17 Mar 2008
Embolism	LI	Boehringer Ingelheim International GmbH	17 Mar 2008
Embolism	NO	Boehringer Ingelheim International GmbH	17 Mar 2008
Pulmonary Embolism	EU	Boehringer Ingelheim International GmbH	17 Mar 2008
Pulmonary Embolism	IS	Boehringer Ingelheim International GmbH	17 Mar 2008
Pulmonary Embolism	LI	Boehringer Ingelheim International GmbH	17 Mar 2008
Pulmonary Embolism	NO	Boehringer Ingelheim International GmbH	17 Mar 2008
Stroke	EU	Boehringer Ingelheim International GmbH	17 Mar 2008
Stroke	IS	Boehringer Ingelheim International GmbH	17 Mar 2008
Stroke	LI	Boehringer Ingelheim International GmbH	17 Mar 2008

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Thrombosis of cerebral veins	Phase 3	FR	Boehringer Ingelheim GmbH	13 Dec 2016
Thrombosis of cerebral veins	Phase 3	DE	Boehringer Ingelheim GmbH	13 Dec 2016
Thrombosis of cerebral veins	Phase 3	IN	Boehringer Ingelheim GmbH	13 Dec 2016
Thrombosis of cerebral veins	Phase 3	IT	Boehringer Ingelheim GmbH	13 Dec 2016
Thrombosis of cerebral veins	Phase 3	NL	Boehringer Ingelheim GmbH	13 Dec 2016
Thrombosis of cerebral veins	Phase 3	PL	Boehringer Ingelheim GmbH	13 Dec 2016
Thrombosis of cerebral veins	Phase 3	PT	Boehringer Ingelheim GmbH	13 Dec 2016
Thrombosis of cerebral veins	Phase 3	RU	Boehringer Ingelheim GmbH	13 Dec 2016
Thrombosis of cerebral veins	Phase 3	ES	Boehringer Ingelheim GmbH	13 Dec 2016
Embolic Stroke	Phase 3	US	Boehringer Ingelheim GmbH	27 Nov 2014

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05788328 (CTgov)	Phase 1	Obesity	16	DE (Period 1: DE 150 mg)	paxczchxwr(dwrimstcew) = zsdktudlgo sleyrfkpkz (jchtmujugm, ncsbnyzyel - uuqlfbyjul) View more	-	15 Nov 2024
				DE+PF-07081532 (Period 4: DE 150 mg + PF-07081532 80 mg QD)	paxczchxwr(dwrimstcew) = qaxvqcdjen sleyrfkpkz (jchtmujugm, jbkslwrmru - hbhjoggwra) View more
NCT04257032 (CTgov)	Phase 1	-	28	Rosuvastatin (Rosuvastatin (Part 1, Reference 1))	dzqdtiwwea(pejkgssjxe) = uuqqlpcgtu knwgdbrora (ovwwpamdnx, ryjhrvcfxg - ciifjyxmog) View more	-	23 Feb 2024
				Rosuvastatin+BI 1323495 (Rosuvastatin + BI 1323495 (Part 1, Test 1))	dzqdtiwwea(pejkgssjxe) = jskdyvmvqw knwgdbrora (ovwwpamdnx, ooelsqdlnb - trjuooqsyi) View more
NCT01895777 \| NCT02197416 (Pubmed \| J Am Heart Assoc)	Phase 3	Venous Thromboembolism	-	Dabigatran	ehibukakvh(mfxekejopm) = yauasxwbwa kwbxuvgubl (jgihadkwhq, 0.08 - 1.23)	Positive	20 Feb 2024
				Dabigatran (Standard of care)	kikaiwsphz(icnkvnngzb) = srqbrnfdyh zjixnhcqax (fkobliqppd ) View more
ISC2024	Not Applicable	Cerebral Hemorrhage \| Ischemic Attack, Transient \| Acute Ischemic Stroke	-	Dabigatran 150/110 mg twice daily	lxwjhdcttt(qrmdvlnkok) = zmfjvhkgkf mprjpueecw (efjoqwaqic ) View more	-	01 Feb 2024
				Aspirin 81 mg daily	lxwjhdcttt(qrmdvlnkok) = bveiadunqe mprjpueecw (efjoqwaqic ) View more
NCT02744092 (CANVAS, CTgov)	Not Applicable	Pulmonary Embolism \| Neoplasms \| Venous Thrombosis ... View more	811	Rivaroxaban+Edoxaban+Apixaban+Dabigatran (Randomized Arm 1 (DOACs))	gjabstjqzh(iydatmdvuw) = cgofwpjaal beskinzunl (mvwpdjxwzx, qjljyfeize - tpzttvlyjg) View more	-	03 Oct 2023
				Warfarin+Fondaparinux+Enoxaparin+Dalteparin (Randomized Arm 2 (LMWH))	gjabstjqzh(iydatmdvuw) = uapiqtaevi beskinzunl (mvwpdjxwzx, qmaftxjqzw - eiiflkodkf) View more
ISTH2023	Not Applicable	-	-	Dabigatran	adzlpzhydp(oxdadwezqn) = dgrmimwkkw zajvxqklyf (givlowdlhm )	-	24 Jun 2023
ESMO_ASIA2022	Not Applicable	Venous Thromboembolism	30	Generic dabigatran	nzgfdwvind(oeywkqgfkf) = xknvluwmpx seunpxbmee (evzkrqyjum )	-	03 Dec 2022
NCT01895777 (DIVERSITY, Pubmed)	Phase 2/3	Venous Thromboembolism	267	Dabigatran	ukuogxhcgo(zkjupdrrzk): Mantel-Haenszel-weighted rate difference = -0.135 (95% CI, -0.36 to 0.08), P-Value = 0.0014	-	23 Sep 2022
				Dabigatran (Standard of care)
ISTH2022	Not Applicable	-	-	Thromboclotin on Sysmex CS25000 (R1)	pcabbfikfo(hwoqttacnw) = ejwjvqofyc wvhiosylay (qsljyegrvi )	-	09 Jul 2022
				dabigatran	pcabbfikfo(hwoqttacnw) = zfiybqhgyj wvhiosylay (qsljyegrvi )
NCT01661101 (MANAGE, Pubmed \| Am J Cardiovasc Drugs)	Phase 3	Myocardial injury	-	Dabigatran 110 mg twice daily	zhwmkmrafn(rejvofhbxv) = vugslgfuqh bqzjnzykhn (lzdbvmelcy )	-	01 Jan 2022

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