Bayer introduces new innovation to lessen risk of major adverse limb events in patients with PAD

A significant medicinal development has led to the innovation of Bayer’s anti-thrombotic medication called Xarelto (rivaroxaban). Approved by the Ministry of Health, with the intake of rivaroxaban 2.5mg twice daily, plus aspirin low dose once daily helps in lessening the risk of major adverse limb events (MALE) in patients with PAD.

Xarelto is the only non-vitamin K antagonist oral anticoagulant (NOAC), in combination with aspirin, indicated for this patient group.

Peripheral Artery Disease (PAD) is on constant rise, especially  for Asia, where it is seen rising faster than other regions. While those who are affected and people close to them may be well aware of the disease, PAD is growing at a rate of four times faster because the awareness surrounding the disease is relatively low. Globally, it increased by 17.02 percent between 2010 and 2015.

In Asia, it rose by nearly 20 percent and it is reported that more than 70 percent of the world’s new PAD cases over that period, and the years since, have occurred in the Asia-Pacific region.

While non-communicable diseases may be perceived as the world’s biggest cause of death, there are more than double the numbers highlighting artery-related deaths worldwide every year. PAD typically affects the arteries in the legs, resulting in reduced blood flow to your limbs, which may lead to amputation.

Despite other factors that contribute to PAD, the most common cause is the build-up of fatty deposits that cause the narrowing of arteries and estimated to affect over 200 million people worldwide in 2010. PAD may lead to disability, loss of limb, or death, which also have been identified as the number one cause of death worldwide, which accounts to 31 percent of deaths.

Sedentary lifestyle adoptation has been categorised as one of the key factors associated with the risk of increasing artery diseases.

According to Dr Hanafiah  Harunarashid, Managing Director, Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia (UKM) and Consultant Vascular Surgeon, Hospital Canselor Tuanku Muhriz, Universiti Kebangsaan Malaysia, the increased prevalence of unhealthy lifestyle such as smoking, lack of exercises, high saturated fat food intake as well as ageing are among the risk factors that highly contributed as the key risk factors of PAD in a patient.

“PAD not only disrupts patients’ quality of life, but it also impose greater consequences such as limb amputation caused by PAD. It is not uncommon that patients with PAD need to undergo a lower limb amputation, with or without previous revascularization attempts. Despite that, the patient’s experience of amputation differs from one another. The impact of the amputation and disease goes beyond physical disability and financial burden for treatment,” Hanafiah said.

“The disease remains a major public health concern and can have devastating effects on patients physically, emotionally and economically. At Bayer, our goal is to consistently leverage on the latest in medicinal technology for a solution that caters to the current unmet needs in PAD management. This serves as a testament in Bayer’s commitment to bring new innovative treatment options to patients so that they can have hundreds and thousands of special extra moments with their loved ones,” said Dr. Vincent Ruland, Country Division Head of Bayer’s Pharmaceuticals Division for Malaysia, Singapore and Brunei.

Besides, Global Burden of Disease (GBD) estimated 131 million (1.8% of the global population) had diabetes related lower-extremity complications DRLECs in 2016[5]. There are more than 1 million annual limb amputations globally7, being a large and growing contributor to the disability burden worldwide and disproportionately affect middle- to older-aged populations.

It progresses more rapidly and is more diffuse in patients with diabetes mellitus (DM). The risk of lower extremity amputation and mortality are also higher in diabetics compared to non-diabetics. The American Diabetic Association has estimated that 40 to 50 percent of the diabetic related amputations are preventable.

In Malaysia, the overall prevalence of PAD was 16 percent in the diabetic population.

He stressed, “Clinical reports have indicated that a significant number of lower limb amputees are experiencing psychological adjustment problems. The quality of life of a person is likely to be adversely affected following an amputation of his/her body parts. It is reported that 47.4% of amputees have depressive symptoms, while 24.5% of these patients were diagnosed to have major depression. He/she may find it challenging to adjust to new limitations as the normal physical activities that this individual used to perform is now curtailed.”

As part of the panelists, Dr Zanariah Hussein, Consultant Endocrinologist, Hospital Putrajaya and President of Malaysian Endocrine and Metabolic Society (MEMS) highlighted on the importance of early prevention for PAD to ensure that it doesn’t lead up to major amputations.

She stressed, “There is an urgent need to address the unmet needs and disease burden for patients suffering from PAD. Few of us from the many were not aware that the leading factor is PAD, whereby narrowing or blockage of the arterial supply to the foot. However, it is preventable, and globally, the success of amputation reduction have reached 50% to 75%. Early diagnosis is advisable and this can be easily done using basic clinical examination and administered by general practitioners or nurses.”

“The good news is, breakthrough in medication have resulted in viable treatment that can help lessen the burdens brought by PAD. The end-goal in treating patients with PAD is to maintain healthy blood flow in the peripheral arteries. This subsequently will help to prevent serious events such as losses of the limb that may lead to disability, which in turn decreases a person’s quality of life,” said Dr Hanafiah.

Antiplatelet therapy has been considered as the recommended treatment for PAD whereby it aims to prevent blood platelets from agrgregating, however antiplatelet therapy alone in treating PAD has presenting clinical limitation and provide the opportunity in designing a new approach.

Rivaroxaban, an oral anticoagulation medicine has been shown to foster benefits for patients against blood clots by inhibiting Factor Xa, an enzyme which acts at a key point in the blood-clotting process.

“New research has indicated that a new standard of care by combining the antiplatelet ASA with an oral anticoagulation medicine brings a dual targeted approach that helps in reducing the risk of disease burdens such as acute limb ischaemia in patients with chronic PAD,”

The VOYAGER PAD and COMPASS study have also shown that Rivaroxaban 2.5mg twice daily with added aspirin does benefit patients who have undergone lower limb intervention and continuing through long-term prevention.

Thus making it as the  regimen to achieve this outcome. On top of the available treatment, patients are also advised to adopt a healthy lifestyle, maintain medication treatment schedule following their recovery to prevent other complications.

This is a medicine product advertisement approved by the Medicine Advertisement Board.


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