The option of taking a single drug for deep vein thrombosis (DVT), or to protect against recurrent DVT, is now available in Malaysia.
This new indication was approved in Malaysia based on evidence from the EINSTEIN global clinical trial involving 3,449 patients,which demonstrated rivaroxaban's effectiveness in treating patients diagnosed with DVT, as well as reducing a patient's risk of recurrent DVT by 82%.
DVT, a type of venous thromboembolism (VTE), is the formation of a blood clot (thrombus) in a vein that is deep inside a part of the body, usually the large veins in the lower leg and thigh. This clot can block blood flow and cause swelling and pain.
In addition, if a clot breaks off and moves through the bloodstream, there may be severe consequences, especially when it lodges in areas such as the lungs, causing pulmonary embolism, which can lead to sudden death if not treated in time.
"Blood clots are dangerous and the consequences potentially devastating," said consultant haematologist Dr Ng Soo Chin. "VTE is a leading cause of death worldwide, and has been estimated to be the third most common vascular disease after ischaemic heart disease and stroke.
"In Malaysia, the actual incidence of DVT is still unknown. There is growing evidence that VTE is not uncommon in Asians, and the incidence is increasing based on autopsy studies, hospital audits of admissions to major hospitals, and also subclinical DVT in high risk situations, such as after major joint surgeries."
Blood clots can be caused by anything that causes a person's blood not to circulate normally or clot properly, such as sitting still for long periods when travelling, or certain medical conditions.
A person's risk of DVT also increases with prolonged bed rest, such as a long hospital stay or paralysis, injury or surgery, pregnancy, some cancers, and heart failure. A personal or family history of DVT is also a risk factor.
Symptoms of DVT include leg pain or tenderness, cramping that intensifies over several days, redness of the skin or rash (erythema), warmth at the DVT site, or swelling caused by fluid retention (oedema).
However, it is also possible for patients not to display any symptoms of DVT.
Elaborating on the three-fold approach to treating DVT, Dr Ng said: "We first need to stop the blood clot from getting any bigger, then we prevent the clot from breaking loose and travelling to the lungs to cause a pulmonary embolism, after which we aim to reduce the chances of recurring DVT."
Current DVT treatment options include the use of blood thinners (anticoagulants) to decrease the blood's ability to clot, prevent clots from getting bigger, and reduce the patient's risk of developing additional clots; and thrombolytics or clotbusters to break up blood clots.
Although effective, there are many limitations to existing anticoagulation treatment options. "Currently, patients need injections or infusions of the blood thinner heparin, after which they are prescribed warfarin, which is another blood thinner in oral form, for at least three months.
"Patients on warfarin must adhere to a strict treatment schedule, a strict diet, and return for frequent blood monitoring. It can take at least five days for a stable antithrombotic effect to be achieved. This can pose a challenge for both patients and physicians.
"An effective single-drug option, such as rivaroxaban, that does not require injections, frequent monitoring or adherence to a strict diet, offers an attractive option for both physicians and patients," Dr Ng added.
Thrombosis is a key cause of morbidity and mortality across a broad range of acute and chronic blood-clotting disorders, and remains a massive burden on patients and healthcare systems around the world.
Although VTE treatment guidelines exist, they vary from country to country, and there are gaps in actual clinical practice.
"There is a grave misconception that DVT is rare in Asians. This is not true. Increasingly, we find that that Asians too are at risk of DVT," stated Prof Hatem Salem, head of department, Australian Centre for Blood Diseases.
"Many people who are at risk of DVT are either not getting the treatment they need, or are not effectively protected for the sufficient duration, simply because of the challenges posed by current treatment options. Rivaroxaban is a much needed evolution in thrombosis management. Its proven effectiveness and ease-of-use can help turn the tide towards ensuring that more patients around the world are protected from the devastating consequences of blood clots."
Commenting on this latest innovation from pharmaceutical company Bayer, Dr Axel Bouchon, general manager for Bayer HealthCare in Malaysia, Singapore and Brunei, said, "The drug is the culmination of years of intensive research, and a testament to Bayer's innovative strength. We are delighted to be able to offer rivaroxaban as a solution for the current unmet needs in thrombosis management."
The drug is also approved in Malaysia for the prevention of VTE in adult patients, and for stroke prevention in atrial fibrillation.