Breaking News
March 23, 2018 - AMD Treat-and-Extend Regimens OK: Ophthalmology Times
March 23, 2018 - Safe-sleep recommendations for infants have not reduced sudden deaths in newborns
March 23, 2018 - Survey finds inappropriate prescribing of antibiotics for hospitalized children
March 23, 2018 - Researchers propose alternative treatment to target lymphoma signaling at its root
March 22, 2018 - Compound found in beet extract could help slow progression of Alzheimer’s disease
March 22, 2018 - Lower temperatures can trigger the body’s ‘good’ fat formation at cellular level
March 22, 2018 - Sentinel lymph node biopsies could be safely avoided for some breast cancer patients
March 22, 2018 - Combined Preeclampsia Test Superior to U.K. Standards
March 22, 2018 - Exclusive breastfeeding in hospital associated with longer breastfeeding duration
March 22, 2018 - Researchers prove link between common childhood cancer and inflammation
March 22, 2018 - Targeting aberrantly active telomerase to treat therapy-resistant melanoma
March 22, 2018 - California’s tax on millionaires yields big benefits for people with mental illness, study finds
March 22, 2018 - Weight-loss surgery reduces risk for severe chronic kidney disease and kidney failure
March 22, 2018 - Study identifies two genes associated with extreme nausea and vomiting during pregnancy
March 22, 2018 - Biohaven Enrolls First Patient In Phase 3 Clinical Trial To Evaluate Rimegepant Zydis® ODT In The Acute Treatment Of Migraine
March 22, 2018 - ‘Bionic Pancreas’ OK for Very Young T1D Patients
March 22, 2018 - Parkinson’s gene initiates disease outside of the brain
March 22, 2018 - NMSU researchers publish findings on effective measures to remedy stress among adolescents
March 22, 2018 - Immunotherapy combination increases overall survival in people with kidney cancer, study shows
March 22, 2018 - Gut microbiome may promote pancreatic cancer by inducing immune suppression
March 22, 2018 - New ocular inserts allow patient’s cornea to absorb more antibiotics
March 22, 2018 - FDA Alert: NeuroBlate Probe by Monteris Medical: Letter to Health Care Providers, Class I Recall
March 22, 2018 - Cessation of exercise can result in increased depressive symptoms
March 22, 2018 - Morning Break: Booze Study Brouhaha; Stem Cells for MS; Big Debt Problem
March 22, 2018 - New wearable tech from Western may hold big benefits for people with Parkinson’s
March 22, 2018 - Immune cells can repopulate in the retina after elimination, mice study shows
March 22, 2018 - States extend Medicaid for birth control, cutting costs — and future enrollment
March 22, 2018 - Research provides better understanding of how cancerous cells behave in low oxygen
March 22, 2018 - Menopausal hormone therapy taken soon after menopause may benefit the brain
March 22, 2018 - Booze Boosts Your Heart Rate
March 22, 2018 - Skeptical Cardiologist: Classifying Heart Failure
March 22, 2018 - Instead of nagging your spouse to lose weight, try going on a diet yourself
March 22, 2018 - Neem Biotech to share findings on cystic fibrosis biofilm disruption at ECFS Basic Science Conference
March 22, 2018 - Study uncovers new genetic cause of posterior polymorphous corneal dystrophy
March 22, 2018 - ENDO: Big Breakfast May Help in Diabetics
March 22, 2018 - I’m not overweight, so why do I need to eat healthy foods?
March 22, 2018 - UCLA-led study suggests unexpected reason for reduction in cardiovascular health disparities
March 22, 2018 - Study suggests detailed neuropsychological assessment for brief cardiac arrest survivors
March 22, 2018 - Anticoagulant drugs found safe to use in patients undergoing surgery for irregular heartbeat
March 22, 2018 - SP Industries appoints Brian Larkin as new President and CEO
March 22, 2018 - GTx Announced New Data Demonstrating Enobosarm’s Potential to Treat Stress Urinary Incontinence
March 22, 2018 - Higher Risk of Brain Deficits in Older Alcoholics
March 22, 2018 - Top US health official resigns in conflict of interest
March 22, 2018 - Study shows benefits of hair loss drug in improving cognitive function and vascular health
March 22, 2018 - Researchers explain link between 2 key Alzheimer’s proteins
March 22, 2018 - Patients on replacement therapy with thyroid hormone may have more comorbidities
March 22, 2018 - Higher online patient ratings linked to urologists who saw fewer Medicare patients
March 22, 2018 - FDA Approves Ilumya (tildrakizumab-asmn) for the Treatment of Moderate-to-Severe Plaque Psoriasis
March 22, 2018 - Beer Raises Heart Rate; KardiaBand Hyperkalemia Test; CHD Clinics
March 22, 2018 - A retinal implant that is more effective against blindness
March 22, 2018 - New system based on artificial intelligence provides reliable detection of breast cancer
March 22, 2018 - Research offers new understanding about cause of Parkinson’s disease
March 22, 2018 - HORIBA’s Microsemi CRP analyzer improves quality of care in emergency pediatric units, study shows
March 22, 2018 - Neuroscientists move closer to developing tools for deciphering brain function
March 22, 2018 - New test methods with less fear
March 22, 2018 - Range of Vaginal Dryness Products Can Help Postmenopausal Women: Study
March 22, 2018 - Higher Dose Tx Deemed Safe in Pulmonary TB
March 22, 2018 - Discovery of new ALS gene points to cytoskeleton as potential target for drug development
March 22, 2018 - Diet soda associated with higher odds of diabetic retinopathy
March 22, 2018 - LSD reduces ‘sense of self’
March 22, 2018 - Vitamin D deficiency linked to metabolic syndrome in postmenopausal women
March 22, 2018 - Changes in the intestines may be responsible for reversal of diabetes after bariatric surgery
March 22, 2018 - iPads and Cancer; Clot Retrieval and Stroke: It’s PodMed Double T!
March 22, 2018 - Premature births linked to changes in mother’s bacteria
March 22, 2018 - Brain SPECT scans predict treatment outcomes in patients with depression
March 21, 2018 - Researchers succeed in integrating artificial organelles into cells of living organism
March 21, 2018 - Researchers discover ‘missing mutation’ in severe infant epilepsy
March 21, 2018 - Researchers develop statistics-based computational scheme to zoom in on brain function
March 21, 2018 - Verge joins Genomics England’s Discovery Forum industry partnership
March 21, 2018 - Trovagene Announces First Patient Successfully Completes Cycle 1 of Treatment with PCM-075 in Combination with Low Dose Cytarabine (LDAC) in AML Trial
March 21, 2018 - Congenital Cardiac Cath Tx Often Strays from Guidelines
March 21, 2018 - Marked increase in cardiovascular risk factors in women after preeclampsia
March 21, 2018 - New app may help predict, track manic and depressive episodes in bipolar patients
March 21, 2018 - Discovery of genes could lead to development of novel therapies for EBV-related cancers
March 21, 2018 - High-fat, high-cholesterol diet depletes ranks of artery-protecting immune cells
March 21, 2018 - Research misconduct allegations shadow likely CDC appointee
March 21, 2018 - Most Breast Ca Patients Fail to Get Genetic Counseling
March 21, 2018 - Lopsided ear function can lead to lopsided brain development
March 21, 2018 - Acupuncture helps manage menopausal symptoms, review finds
March 21, 2018 - Motor skill training may contribute to reading skills in obese children
PCSK9 inhibitor offers clinical benefit to patients with peripheral artery disease

PCSK9 inhibitor offers clinical benefit to patients with peripheral artery disease

image_pdfDownload PDFimage_print

Patients with peripheral artery disease (PAD) are at high risk of heart attack, stroke and cardiovascular death. In addition, PAD patients can suffer major adverse limb events, such as acute limb ischemia – the equivalent of a heart attack in the leg – that can lead to limb loss. Managing PAD is challenging for patients and physicians alike – despite best available treatment including high-intensity statins, risk of cardiovascular and limb events remains high. With few clinical trials focused on patients with PAD, physicians must often extrapolate from studies in broader populations with atherosclerosis about the best treatment approach for these patients. Unfortunately, few of these studies have characterized limb risk and fewer have demonstrated benefits of preventive therapies in reducing this risk. A new sub-analysis of the FOURIER clinical trial, however, now offers information on the safety and effectiveness of giving the PCSK9 inhibitor evolocumab on top of statin therapy to this high-risk population. At the 2017 American Heart Association Scientific Sessions, Marc Bonaca, MD, MPH, investigator at the TIMI Study Group and director of the Aortic Disease Center at Brigham and Women’s Hospital, presented results from the sub-analysis, which are published simultaneously in Circulation.

“Whenever trials like FOURIER demonstrate benefit of a therapy in a broad population, we then want to understand the efficacy and safety in subpopulations to help clinicians understand which patients are going to derive the greatest absolute benefit. We’ve found that several sub-groups of patients respond well to evolocumab, but it’s especially encouraging to see these results for patients with PAD since this is a population at heightened cardiovascular risk and there are few therapies that modify limb risk,” said Bonaca. “We see that adding evolocumab can make a big difference for these patients.”

The team analyzed data from more than 3,600 trial participants, half of whom had no history of a heart attack or stroke. Evolocumab reduced risk of a future cardiovascular event for patients with or without PAD. Because patients with PAD are at especially high risk of a heart attack or stroke, these patients had a higher absolute risk reduction (3.5% PAD, 1.6% no PAD) of a cardiovascular event. In addition, evolocumab reduced their risk of a major adverse limb event by about half, compared to PAD patients who received the placebo. Among patients with PAD and no history of a heart attack or stroke, evolocumab reduced risk of a cardiovascular or adverse limb event by 6 percent over 2.5 years. Researchers report that the number needed to treat (NNT) – that is, how many patients would need to be prescribed the drug for 2.5 years to prevent an adverse event – is as low as 16 for this patient population. The team found no offsetting safety concerns.

Bonaca will present PAD findings as part of a Clinical Trials Update at the Scientific Sessions. Several other AHA Scientific Sessions related to FOURIER will be presented by BWH investigators. These include a second Clinical Trials Update presented by Marc Sabatine, MD, analyzing the clinical benefit of evolocumab in different subgroups of patients with a history of heart attacks, finding that those who are at higher risk – including those closer to their most recent heart attack, with multiple prior heart attacks or with multivessel disease – also reap greater relative and absolute risk reduction from the treatment. BWH investigators will also present oral presentations on the efficacy of evolocumab on different types of myocardial infractions, such as STEMI. In addition, investigators will present on the efficacy of evolocumab in reducing total cardiovascular events. Most cardiovascular trials only take into account the first cardiovascular event a patient goes on to experience, but many patients who experience a non-fatal heart attack will experience additional events. Taking these later events into account, evolocumab prevented double the number of events, compared with first events only. Finally, investigators will also present a poster on the application of the TIMI Risk Score for stable ischemic heart disease to FOURIER.

“As we continue to analyze the FOURIER data, we gain greater insight into the patients who enjoy the most substantial clinical benefits from intensive LDL-C lowering with the PCSK9 inhibitor evolocumab,” said Sabatine.

Evolocumab is a member of a new class of cholesterol lowering drugs known as PCSK9 inhibitors that have emerged as an effective treatment for drastically lowering LDL cholesterol beyond what is possible with statin therapy alone. Previous research demonstrated that evolocumab effectively reduces LDL cholesterol by approximately 60 percent. The FOURIER trial (Further Cardiovascular OUtcomes Research with PCSK9 Inhibition in subjects with Elevated Risk) was designed to determine whether evolocumab, when added to statin therapy, would reduce adverse cardiovascular events.

FOURIER was designed in a collaboration between the Executive Committee and the trial sponsor, Amgen, which manufactures evolocumab and provided a research grant to the TIMI Study Group at BWH. The TIMI Study Group conducted all data analyses presented in the paper. Sabatine and the TIMI Study Group receive research grants from various pharmaceutical companies that produce other lipid-lowering therapies and Sabatine reports receiving honoraria from Amgen and various pharmaceutical companies that produce other lipid-lowering therapies.


Tagged with:

About author

Related Articles