Peripheral arterial disease has obvious benefits! Xarelto plus aspirin Phase 3 clinical results were produced.

Competitors are ramping up research and marketing, prescriptions are leveling off, and Johnson and Johnson and Bayer's Leva chabans have had a tough year of marketing in 2019.
but in a recent difficult artery disease, the positive results shown by Devalla Saban have rediscovered confidence and decided to pull back.
Johnson and Johnson's Jansen Pharmaceuticals recently announced that the EVALUATION of Xarelto ® (DevaSaban) joint aspirin in patients with peripheral artery disease (PAD) patients with symptoms after the reconstructive lower extremities of peripheral artery disease (PAD) achieved its main efficacy and main safety endpoint: combined therapy reduced the risk of major adverse limb and CV cardiovascular events by 15% compared to aspirin alone, while the incidence of TIMI1 haemorrhage was similar.
the results were presented at the 69th Annual Scientific Meeting of the American College of Cardiology and the World Society of Cardiology (ACC.20/ WCC), which was also published in the New England Journal of Medicine.
VOYAGER PAD is the only study in the patient population that has observed a double-pathway inhibitory effect (anticoagulants and aspirin) that has shown significant benefits.
the global, random, double-blind phase 3 study included 6,564 patients from 542 research sites in 34 countries.
eligible patients are at least 50 years old and have recorded symptomatic lower limb PAD.
patients have symptoms after successful blood reconstruction within the last 10 days.
65% of patients underwent intravascular surgery and 35% underwent surgery.
exclude patients if they are clinically unstable, have an increased risk of bleeding, or require prohibition of accompanying medications, including long-term use of clopidogrel.
patients were randomly assigned at a ratio of 1:1 and treated with devastachaban (2.5 mg at a time, twice a day) and aspirin (100 mg, once a day) or aspirin alone (100 mg, once a day) (n s 3,278). The median follow-up time in
patients was 28 months, with the main endpoint being a combination of major adverse limb and CV events, including acute limb ischemia, large amputationdue due to vascular causes, heart attack (myocardial infarction), ischemic stroke, or CV death.
according to the TIMI classification, the primary safety endpoint is hemorrhage.
results showed that delavsaban combined aspirin significantly reduced the risk of severe limb and cardiovascular events in terms of the primary end of the effects of the effects of aspirin alone.
the researchers observed that nearly one in five patients who took aspirin alone had severe physical or CV events, but the risk of such severe adverse events was reduced by 15 percent after the addition of delavitaban.
the three-year incidence of devastasaban/aspirin is estimated at 17.3% and 19.9% respectively compared to the use of aspirin alone (HR-0.85; p-0.009).
there was no significant increase in TIMI haemorrhage in patients with the devastsaban-aspirin group in the main safety endpoint compared to those who used aspirin alone, and the KM estimates for the three-year incidence of difasaban/aspirin were 2.65% and 1.87%, respectively (HR-1.43; p-0.07).
note, the number of intracranial haemorrhage events in the Devastasaban/Aspirin group was low (0.60% vs. 0.90%; HR was 0.78), and there was no increase in fatal bleeding (0.21% vs. 0.21%; HR.1.02).
the results of VOYAGER PAD complement the results of Phase 3 clinical studies COMPASS.
COMPASS is the largest clinical study to date for Levachaban, with 27,395 cases of chronic coronary heart disease (CAD) and/or PAD.
the study reached its primary end point and was discontinued about a year early due to its significant efficacy.
COMPASS study also suggests that combination therapy significantly reduces the risk of major cardiovascular and limb events in patients with chronic PAD and/or CAD compared to aspirin alone.
"While the COMPASS study has determined the efficacy of delavasabanda aspirin for stable PAD and CAD patients, there are important unresolved issues with the best strategies for patients with symptomatic PAD after lower limb blood transport reconstruction, including those without CAD." "THE VOYAGER PAD STUDY SHOWS THAT DEVALSABANGA ASPIRIN HAS POTENTIAL CLINICAL USEFULNESS IN PREVENTING THE MOST CRITICAL THROMBOSIS COMPLICATIONS, ADVERSE LIMBS, AND CARDIOVASCULAR OUTCOMES DURING THE BLOOD TRANSPORT RECONSTRUCTION THAT IS MOST LIKELY TO OCCUR IN PAD PATIENTS," SAID DR. MARK BONAKA, HEAD OF THE DEPARTMENT OF CARDIOVASCULAR MEDICINE AT THE UNIVERSITY OF COLORADO AT THE UNIVERSITY OF COLORADO AT OSHURA,
. "The EXPLORER research program continues to provide evidence of xarelto's key role in helping to change clinical practices and cardiovascular care," said James List, head of cardiovascular and metabolic treatment at Janssen Pharmaceuticals at
.
based on the findings of the COMPASS and VOYAGER PAD studies, we believe that the two-way treatment of Xarelto in combination with aspirin may change the way PAD is managed.
look forward to discussing the data with the FDA and applying for new clinical indications. Dr. Mathai Mammen, global head of
" Jansen Pharmaceuticals, believes That Xarelto is expected to be the first anticoagulant in 20 years to benefit PAD patients after blood transport reconstruction in the lower extremities.
PAD is a common circulatory disease that occurs when vascular stenosis reduces blood flow to the limbs ( usually the legs ).
PAD affects more than 200 million people worldwide and about 8 million in the United States.
the disease is the leading cause of amputation, leading to a high rate of fatal and non-fatal CV events.
PAD is usually asymptomatic at first and develops into a symptomatic form of chronic disease that requires blood reconstruction when symptoms are severe.
current PAD guidelines recommend using antiplatelet therapy alone, such as aspirin or clopidogrel, to help prevent CV events after vascular reconstruction.
However, in these patients, there are no specific drugs to prevent amputation or acute amchemia.
delavsaban is an inhibitor of a highly selective direct action factor Xa that acts quickly and can simultaneously inhibit the free Xa and Xa factors bound in the clotting enzyme protoenzyme complex.
inhibitor Xa interrupts the internal and exoskeleton pathways of the clotting cascade, thereby inhibiting the formation of clotting enzymes and thrombosis.
but delavsaban did not inhibit clotting enzymes, nor was it shown to have an effect on platelets.
, developed by Bayer, was approved for listing in the United States in 2011 and has sales rights in the United States.
October 2018, Levasaban received FDA approval to reduce the risk of CV events in PAD patients, and Xarelto has now been approved by the FDA for eight indications, six of which are specifically designed to prevent blood clots, including venous thrombosis in adult patients with elective hip or knee replacement surgery;
2019, Xarelto's total U.S. sales were $2.3 billion, down 6.6 percent from the previous year.
Johnson and Johnson said the continued decline in sales of the drug was due to stagnant prescription drug sales in the U.S., increased competition and Medicare's Medicare Section D.
another Xa factor inhibitor, Pfizer and Baccarat's Eliquis, which has taken a lead in the blood thinner market, leading the U.S. market share first in the U.S. market share, then surpassing wal-aflin itself, with global sales of $6.2 billion in 2019.
Xarelto is struggling with competition for high-performance blood thinners such as Eliquis, and hopes that the positive evidence from the new study will give Xarelto some momentum to expand its market share.
Source: 1, Landmark Phase 3 VOYAGER PAD Study of XareLTO ® (Rivaroxaban) Plus Aspirin Shows The Rt StyrtS In Patients with The Sonofatic Peripheral Seido (PAD) After Lower-Extrationcity Reization Vascular 2, Landmark Phase 3 PE®D Lower-Extremity Revascular3, ACC: J.J.J., Bayer's Blood Thyllo Xarelto sylls in disease post-surgery.