Ximelagatran (Exanta): Alternative to Warfarin?

Vaughan, Christy

doi:10.1080/08998280.2005.11928037

Cited by 8 publications

(5 citation statements)

References 15 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…In fact, AstraZeneca had already applied at the EMEA for marketing approval when the company withdrew all applications due to concerns over the hepatotoxic potential of the drug [24]. Although this drug did reach the market in France, the U.S. FDA was not prepared to grant approval and the drug was never marketed in the U.S. [25]. Ximelagatran, which was the first orally available thrombin inhibitor that would have replaced the troublesome warfarin as an oral anticoagulant, serves as a good example where huge investments were made to get the drug to market, but a return on investment was never realised.…”

Section: Attrition Due To Hepatotoxicitymentioning

confidence: 99%

Pre-Clinical Assessment of the Potential Intrinsic Hepatotoxicity of Candidate Drugs

Tonder¹,

Steenkamp²,

Gulumian³

2013

New Insights Into Toxicity and Drug Testing

View full text Add to dashboard Cite

Section: Attrition Due To Hepatotoxicitymentioning

confidence: 99%

Pre-Clinical Assessment of the Potential Intrinsic Hepatotoxicity of Candidate Drugs

Tonder¹,

Steenkamp²,

Gulumian³

2013

New Insights Into Toxicity and Drug Testing

View full text Add to dashboard Cite

“…Ximelagatran, a direct thrombin inhibitor, was the fi rst oral drug developed in the new class of anticoagulants (Vaughn, 2005). It was trialed in comparison with warfarin and enoxaparin and was initially approved for use by the European Medicines Agency based on trial results in orthopaedic total joint arthroplasty (Hou, 2011a).…”

Section: Clinical Development and Clinical Trials Of The New Oral Antmentioning

confidence: 99%

Understanding the New Emerging Oral Anticoagulants for Venous Thromboembolism Prophylaxis

Welle

2012

Orthopaedic Nursing

View full text Add to dashboard Cite

Patients who have major orthopaedic surgery are at high risk for developing venous thromboembolism (VTE). Assessment of risk and treatment to prevent VTE are considered standard of care due to its significant morbidity, potential mortality, and clinical burden and cost. Guidelines are available aiding orthopaedic surgeons to choose the best methods of VTE prophylaxis. Optimal VTE prevention has not been achieved. Recent advances in the understanding of the coagulation cascade have evolved because of a novel understanding of the molecular influences on the coagulation pathway. Subsequently, new anticoagulants have been developed that target specific factors within the coagulation cascade that are contrasted to the currently used agents that have a broad effect on the coagulation pathway. Multiple clinical trials have tested the new anticoagulants within the orthopaedic total knee and total hip arthroplasty arena. In addition, research to find new ways to prevent VTE was driven by limitations of the currently available agents. The new oral anticoagulants extensively trialed in orthopaedics are dabigatran, rivaroxaban, and apixaban. Clinical trials indicate that the new oral agents have the potential to impact VTE prophylaxis in regard to efficacy, predictability and consistency, clinical monitoring, adherence as to use and duration, and convenience. Concerns persist regarding issues of bleeding complications, liver enzyme elevation, patients with renal disease, and drug-to-drug interactions. The new oral agents do not have an antidote to reverse bleeding effect and have no reliable assay to measure effect. Nurses need to be aware of these new VTE prophylactic choices and their implications in order to provide the best outcomes for their patients.

show abstract

“…However, extended treatment (greater than 35 fays) was found to be associated with an increased risk of liver toxicity in one study (Agnelli et al, 2009). The liver toxicity was unpredictable, and the product was later withdrawn from the market (Vaughan, 2005).…”

Section: Newer Agents Of Historic Importancementioning

confidence: 99%