The challenges of new drugs benefits and risks analysis: Lessons from the ximelagatran FDA Cardiovascular Advisory Committee.
 |
Related Articles |
The challenges of new drugs benefits and risks analysis: Lessons from the ximelagatran FDA Cardiovascular Advisory Committee.
Contemp Clin Trials. 2006 May 6;
Authors: Boudes PF
Ximelagatran is a new oral anticoagulant that acts by direct and reversible inhibition of thrombin and has the potential to replace warfarin. In 2004, the FDA Cardiovascular and Renal drug Advisory Committee (CRAC) reviewed the ximelagatran clinical program. Three indications were proposed: the prevention of venous thromboembolism (VTE) in patients undergoing total knee replacement surgery (TKR), the prevention of stroke and other thromboembolic complications associated with atrial fibrillation (AF), and the long-term secondary prevention of VTE after standard treatment of an episode of acute VTE. The database consisted of a total of 30,698 subjects and included five phase III pivotal studies. During the advisory panel debate, widely divergent analyses of the benefits and risks of ximelagatran were presented. Ximelagatran hepatic toxicity was a key feature leading the CRAC to conclude that the benefit risk ratio of ximelagtran was unfavorable for the three proposed indications. Some design issues also undermined the strength of efficacy data. This paper reviews the benefits and risks of ximelagatran and analyzes the reasons leading to conflicting conclusions among various experts. The aim of this review is to facilitate the interpretation of benefits and risks associated with a new drug product and to improve future clinical drug developments.
PMID: 16769255 [PubMed - as supplied by publisher]
Related posts:
- Low density lipoprotein cholesterol, statins and cardiovascular events: a meta-analysis.
- Obesity and Cardiovascular Risk Factors in Korean Children and Adolescents Aged 10-18 Years from the Korean National Health and Nutrition Examination Survey, 1998 and 2001.
- Use of alternative pharmacotherapy in management of cardiovascular diseases.
- n-3 Fatty acids from fish or fish-oil supplements, but not {alpha}-linolenic acid, benefit cardiovascular disease outcomes in primary- and secondary-prevention studies: a systematic review.
- Interim analysis of the effects of exenatide treatment on A1C, weight and cardiovascular risk factors over 82 weeks in 314 overweight patients with type 2 diabetes.