Lixiana® was as effective as Fragmin® at preventing new blood clots in people with DVT or PE due to cancer.
3 more people out of 100 taking Lixiana® had major bleeding compared with people who took Fragmin®. Most of the serious bleeds occurred in people with cancer of the stomach or esophagus.
Understanding the problem
Cancer is a powerful risk factor for forming DVTor PE. We know that cancer triggers the clotting process, but we don’t fully understand how. We also don’t know why only some people with cancer develop a DVT or PE while others do not (about 15 out of every 100 people with cancer will develop a DVT or PE).
Most people with DVT or PE due to cancer are given anticoagulants by needle to protect them from forming new blood clots. The needles contain a medication called low-molecular-weight heparin (LMWH) that is available under different brand names (e.g. Fragmin®). Older studies showed that the needles are better than an older anticoagulant pill, warfarin (Coumadin®) at protecting people with cancer from forming new blood clots. Researchers wondered whether a new anticoagulant pill (Lixiana®) is just as effective and safe at preventing new blood clots as LMWH needles in people with cancer.
Who? The study included 1046 people with cancer (average age 64; 52% male) and DVT or PE.
What? The study compared 5 days of LMWH followed by Lixiana® with Fragmin® alone for 6 to 12 months.
LMWH once a day for 5 days* followed by Lixiana® 60 mg once a day for 6 to 12 months
*needles must be given for the first 5 days
Fragmin® 200 IU/kg once a day for 30 days followed by 150 IU/kg once a day for 6 to 12 months
Lixiana® vs Fragmin® for DVT or PE in people with cancer
Outcomes at 12 months
Rate of events with Lixiana®
Rate of events with Fragmin®
New DVT or PE
8 out of 100 people
11 out of 100 people
7 out of 100 people
4 out of 100 people
3 more people out of 100 had a major bleed while taking Lixiana®
*Although the rates for the 2 groups look different, the differences were not statistically significant—this means that the difference could simply be due to chance rather than due to the different treatments.
This Evidence Summary is based on the following article:
Raskob GE, van Es N, Verhamme P, et al. Edoxaban for the Treatment of Cancer-Associated Venous Thromboembolism. N Engl J Med. 2018 Feb 15;378(7):615-624. doi: 10.1056/NEJMoa1711948. Epub 2017 Dec 12. PubMed
Lori-Ann Linkins, MD, MSc (Clin Epi), FRCPC
Dr. Linkins is an Associate Professor of Medicine (thrombosis) at McMaster University in Hamilton, Canada. She holds a Masters Degree in Health Research Methodology and is a Deputy Editor with the Health Information Research Unit, McMaster. She is Co-Editor of the ACP Journal Club and Co-lead on the CanVECTOR Knowledge Translation Platform.
Published: Friday, June 22, 2018
Last Updated: Thursday, July 30, 2020