Nintedanib (OFEV®) May Offer Survival Advantage for IPF Patients

MedicalResearch.com Interview with:

Christopher J. Ryerson, M.D. Assistant Professor Centre for Heart Lung Innovation University of British Columbia Vancouver, Canada

Dr. Ryerson

Christopher J. Ryerson, M.D.
Assistant Professor
Centre for Heart Lung Innovation
University of British Columbia
Vancouver, Canada

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: A new Idiopathic pulmonary fibrosis (IPF) mortality analysis presented at the American Thoracic Society’s 2018 annual conference suggests that treatment with nintedanib may be associated with reduced risk of death in patients with the rare lung disease idiopathic pulmonary fibrosis (IPF).

Pooled data from the two Phase II INPULSIS trials and the Phase II TOMORROW study compared the number of deaths observed versus the number predicted based on GAP stage over one year. GAP stage is used to predict IPF prognosis and is based on gender, age and lung function (as measured by forced vital capacity [FVC] decline predicted and DLco % predicted). Higher stages of GAP are associated with an increased risk of death.

Across the population in the analysis (n=1,228), there were fewer deaths observed in each treatment group than predicted based on GAP stage at baseline (nintedanib: 42 vs. 89.9; placebo: 41 vs. 64.2). In the treated group, the number of observed deaths was 46.7% of the number predicted based on GAP stage, while in the placebo group the number of observed deaths was 63.9% of the number predicted. Based on these observations, the analysis suggests that nintedanib may be associated with a 26.8% relative reduction in the risk of death compared with placebo over one year.  Continue reading

FDA Grants Fast Track Designation to Nintedanib for Scleroderma with Lung Disease

MedicalResearch.com Interview with:

Dr. Thomas Leonard, Ph.D. Executive director, Clinical Development and Medical Affairs, Specialty Care Boehringer Ingelheim Pharmaceuticals, Inc.

Dr. Thomas Leonard

Dr. Thomas Leonard, Ph.D.
Executive director, Clinical Development and Medical Affairs, Specialty Care
Boehringer Ingelheim

MedicalResearch.com: What is the background for this announcement? Would you briefly explain what is meant by systemic sclerosis? What are the disease symptoms and manifestations?

Response: The FDA recently granted Fast Track designation to nintedanib for the treatment of systemic sclerosis with interstitial lung disease (SSc-ILD) – paving the way for Boehringer Ingelheim to take an important step in advancing this potential therapy for those affected by this disease. The designation was based on Boehringer Ingelheim’s Investigational New Drug application (IND) and the anticipated efficacy and safety data from SENSCIS™ (Safety and Efficacy of Nintedanib in Systemic SClerosIS), a double-blind, randomized, placebo-controlled global Phase III trial which is fully enrolled and includes more than 520 patients from 32 countries.

The FDA’s Fast Track designation facilitates the development of new therapies that treat serious conditions and fulfill an unmet medical need in an effort to get treatments to those in need sooner, like those living with systemic sclerosis.

Systemic sclerosis, also known as scleroderma, is a rare disease characterized by thickening and scarring of connective tissue of multiple organs in the body, typically affecting women between ages 25 and 55. Most people with the disease will develop some degree of lung scarring, or interstitial lung disease (ILD), which is the leading cause of death among people with systemic sclerosis.

Nintedanib, currently marketed as Ofev®, is approved for treatment of a rare lung disease called idiopathic pulmonary fibrosis, or IPF, and has been shown to slow disease progression as measured by annual rate of decline in lung function. Because SSc-ILD and IPF share similarities in how the underlying lung scarring, or fibrosis, forms in people with the disease, Boehringer Ingelheim is evaluating the impact of nintedanib on SSc-ILD.

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Global Initiative Highlights Inspirational Stories of People Living With Scleroderma

MedicalResearch.com Interview with:

Donald Zoz, MD Senior Associate Director Clinical Development & Medical Affairs IPF/ILD Boehringer Ingelheim Pharmaceuticals, Inc.

Dr. Zoz

Donald Zoz, MD
Senior Associate Director
Clinical Development & Medical Affairs IPF/ILD
Boehringer Ingelheim Pharmaceuticals, Inc.

MedicalResearch.com: What is the background for this platform? Would you briefly explain what is meant by scleroderma? How does it affect a person’s skin and ability to function? Whom does this disease primarily affect? 

Response: “More Than Scleroderma™: The Inside Story” is Boehringer Ingelheim’s new global initiative highlighting real-life, inspirational stories of people living with the rare disease scleroderma. The new effort, created with support from the Scleroderma Foundation in the U.S., aims to raise awareness of the disease, dispel misperceptions and provide important resources to support and guide those on their journey with scleroderma. The initiative’s website http://www.morethanscleroderma.com/us/ features a powerful and inspiring collection of diverse photographs and video profiles of 10 people across the U.S. living with scleroderma and sharing their ‘inside story.’ Each tells their unique and moving experience with scleroderma through diagnosis to learning to live with the disease and manage it.

Scleroderma, also known as systemic sclerosis, is a rare disease characterized by thickening and scarring of the skin, lungs and other organs. Scleroderma affects fewer than 200,000 people in the U.S. and typically affects women in the prime of their lives, between the ages of 25 and 55 taking a marked toll just as they are building their careers and bearing the responsibility of caring for their family. Nearly all people with scleroderma (more than 90%) will develop some skin symptoms including skin thickening, tightened skin around the joints, small red spots on the face and hands and hard lumps on pressure points and joints. Most people with the disease will also develop some degree of lung scarring, or interstitial lung disease (ILD). When the disease’s signature thickening and scarring develops in vital organs, such as the lungs, there are potentially debilitating and life-threatening consequences.  Continue reading

Idarucizumab – Praxbind – Reverses Anticoagulant Effect of Pradaxa Prior To Emergency Surgery

MedicalResearch.com Interview with:

Thomas Seck, M.D., vice president Clinical Development and Medical Affairs, Primary Care Boehringer Ingelheim Pharmaceuticals, Inc.

Dr. Thomas Seck

Thomas Seck, M.D., vice president
Clinical Development and Medical Affairs
Primary Care
Boehringer Ingelheim Pharmaceuticals, Inc.

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This is a new subanalysis of the phase III RE-VERSE AD™ study, which evaluated the safety and efficacy of idarucizumab, marketed in the U.S. as Praxbind®, in reversing the anticoagulant effect of Pradaxa® (dabigatran etexilate mesylate). This data assessed idarucizumab in a subset of patients requiring an urgent procedure or emergency surgery.

The analysis found that idarucizumab rapidly and completely reversed the anticoagulant effect of dabigatran in approximately 98 percent of patients based on dTT. The median time between administration of idarucizumab and start of surgery was 1.7 hours for patients requiring abdominal procedures, 1.9 hours for orthopedic procedures, 1.4 hours for vascular procedures, 1.3 hours for drainage procedures and 1.2 hours for catheter procedures. Among these patients, periprocedural homeostasis was assessed as normal in more than 92 percent of patients, across all surgery types.

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Oral Semaglutide As Effective As Injectable In Reducing A1C and Weight Loss

MedicalResearch.com Interview with:

Melanie J Davies CBE MB ChB MD FRCP FRCGP Professor of Diabetes Medicine  NIHR Senior Investigator Emeritus Diabetes Research Centre Leicester Diabetes Centre – Bloom University of Leicester

Prof. Davies

Melanie J Davies CBE MB ChB MD FRCP FRCGP
Professor of Diabetes Medicine
NIHR Senior Investigator Emeritus
Diabetes Research Centre
Leicester Diabetes Centre – Bloom
University of Leicester

MedicalResearch.com: What is the background for this study? What are the main findings?

Response:  This was the first study to test the effectiveness of an oral GLP-1 in patients with type 2 diabetes.

The main findings were that compared to both placebo and a GLP-1, Semaglutide, delivered by sub-cutaneous injection weekly, the oral therapy delivered once a day produced better results than placebo and similar results to injectable GLP-1 with regard to reductions in HbA1c and weight loss.

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Standard or Low Dose Alteplase in Acute Ischemic Stroke–Does It Matter?

MedicalResearch.com Interview with:

Craig Anderson | MD PhD FRACP Executive Director  Professor of Neurology and Epidemiology, Faculty of Medicine, UNSW Sydney Neurologist, Neurology Department, Royal Prince Alfred Hospital The George Institute for Global Health at Peking University Health Science Center Haidian District | Beijing, 100088 P.R. China

Prof. Anderson

Craig Anderson | MD PhD FRACP
Executive Director
Professor of Neurology and Epidemiology, Faculty of Medicine, UNSW Sydney
Neurologist, Neurology Department, Royal Prince Alfred Hospital
The George Institute for Global Health at Peking University Health Science Center
Haidian District | Beijing, 100088 P.R. China

MedicalResearch.com: What is the background for this study? What are the main findings?

Response:  There is much controversy over the benefits of a lower dose of intravenous alteplase, particularly in Asia, after the Japanese regulatory authorities approved a dose of 0.6 mg/kg 10 years ago compared to the US FDA and other regulatory authorities approving 0.9 mg/kg 20 years ago.  The investigator inititiated and conducted ENCHANTED trial aimed to determine the effectiveness and safety of these two doses in an international multicentre pragmatic open design.

The main results did not confirm the low-dose to be statistically ‘non-inferior’ partly due to the primary outcome measure chosen and partly due to the statistical approach, but it did confirm that the lower dose was safer with less risk of the major complication of this treatment, that of major bleeding in the brain.  However, it would appear that this safety effect was offset by some reduce efficacy in terms of functional recovery.

The aim of this secondary analysis of the trial data was to examine in more detail the differences between low and standard dose alteplase according to the participants’ age, ethnicity (Asian vs non-Asian) and severity of neurological deficit at the time of treatment.  We did this because the popular belief is that a lower dose might be preferred in older people, and Asians, because of the potential for more likelihood of bleeding, and preferentially to use the standard dose in those with more severe strokes potentially due to greater ‘clot burden’ from a blocked artery to the brain.

The results showed that the main findings on the outcome of surviving free of disability were the same according to age, ethnicity and stroke severity – that is, there was no preferential dose in any of these groups.  Similarly, the safety benefit of low dose alteplase on brain haemorrhage, did not clearly translate into clinical disability outcomes in any of the patient groups studied.

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IPF: Combination of Nintedanib and Pirfenidone May Have Added Benefit With Manageable Side Effects

MedicalResearch.com Interview with:

Professor Carlo Vancheri Professor of Respiratory Medicine, University of Catania, Italy and Director of the Regional Referral Centre for Rare Lung Diseases and the Laboratory of Experimental Respiratory Medicine.

Prof. Vancheri

Professor Carlo Vancheri
Professor of Respiratory Medicine,
University of Catania, Italy and Director of the Regional Referral Centre for Rare Lung Diseases and the Laboratory of Experimental Respiratory Medicine.

MedicalResearch.com: What is the background for this study? What are the main findings? 

Response: The aim of Boehringer Ingelheim’s INJOURNEY trial was to investigate the safety profile of Ofev (nintedanib) in combination with pirfenidone in treating patients with idiopathic pulmonary fibrosis (IPF). Nintedanib and pirfenidone, the only two FDA-approved drugs for the treatment of IPF, are able to slow down the progression of the disease, reducing the forced vital capacity (FVC) decline of about 50%, but this is not a cure. The target for the future is to have even more effective treatments. In the meanwhile, it is necessary to optimize the use of the available drugs. The medical treatment of other pulmonary diseases such as COPD, asthma or pulmonary hypertension is already based on different combinations of drugs.

This 12-week, open-label, randomized study was designed to evaluate the safety, tolerability and pharmacokinetics of nintedanib with add-on pirfenidone, compared with nintedanib alone in patients with IPF. Change in FVC, the established efficacy endpoint in IPF trials, was evaluated as an exploratory endpoint.

The primary endpoint of the INJOURNEY trial was the percentage of patients with on-treatment gastrointestinal adverse events from baseline to week 12 of randomized treatment, and the results showed that the combination of nintedanib and add-on pirfenidone resulted in a manageable safety and tolerability profile, similar to the profile of each drug individually in the majority of patients. Results also indicated there may be a slower decline in FVC in patients treated with pirfenidone along with nintedanib compared with nintedanib alone, suggesting a potential benefit of the combination. However, further research will be necessary to fully evaluate the efficacy of the combination.

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Dual Antithrombotic Therapy with Dabigatran after PCI in Atrial Fibrillation 

MedicalResearch.com Interview with:

Professor Christopher P. Cannon MD Executive Director, Cardiometabolic Trials, Baim Institute Cardiologist Brigham and Women's Hospital Baim Institute for Clinical Research Columbia University College of Physicians and Surgeons

Dr. Cannon

Professor Christopher P. Cannon MD
Executive Director, Cardiometabolic Trials, Baim Institute
Cardiologist Brigham and Women’s Hospital
Baim Institute for Clinical Research
Columbia University College of Physicians and Surgeons

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The trial explored whether a dual therapy approach of anticoagulation and P2Y12 antagonist – without aspirin – in non-valvular atrial fibrillation (AF) patients following percutaneous coronary intervention (PCI) and stent placement would be as safe, and still efficacious, as the current standard treatment – triple therapy. For more detailed background on the study, readers may want to review the first paragraph of the article in the New England Journal of Medicine.

Results showed significantly lower rates of major or clinically relevant non-major bleeding events for dual therapy with dabigatran, when compared to triple therapy with warfarin.

In the study, the risk for the primary safety endpoint (time to major or clinically relevant non-major bleeding event) was 48 percent lower for dabigatran 110 mg dual therapy and 28 percent lower for dabigatran 150 mg dual therapy (relative difference), with similar rates of overall thromboembolic events.

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COMPASS Study Finds Rivaroxaban -XARELTO® – Plus Aspirin Reduces Adverse Events in Patients With Heart Disease or PAD

MedicalResearch.com Interview with:

John Eikelboom MBBS Associate Professor, Division of Hematology & Thromboembolism Department of Medicine Canada Research Chair in Cardiovascular Medicine Canadian Institutes for Health Research McMaster University

Dr. Eikelboom

John Eikelboom MBBS
Associate Professor, Division of Hematology & Thromboembolism
Department of Medicine
Canada Research Chair in Cardiovascular Medicine
Canadian Institutes for Health Research
McMaster University

MedicalResearch.com: What is the background for this study?

Response: Cardiovascular disease affects 1 in 25 persons around the world and a total of more than 300 million individuals. Thrombus formation at the site of a ruptured atherosclerotic plaque is the commonest mechanism of myocardial infarction and ischemic stroke in patients with cardiovascular disease. Aspirin is effective for the prevention of these complications but reduces the risk by only 19% during long term therapy.

Rivaroxaban has previously been tested in the ATLAS ACS-2 TIMI 51 trial at doses of 2.5 mg twice daily or 5 mg twice daily on top of background antiplatelet therapy and has been shown to reduce major adverse cardiovascular events as well as mortality. We tested these same doses of rivaroxaban for the prevention of cardiovascular death, stroke or myocardial infarction in patients with stable cardiovascular disease.

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Does Spironolactone Work In Acute Heart Failure?

MedicalResearch.com Interview with:

Javed Butler, MD, PhD Chief of the Cardiology Division Dr. Vincent Yang, Simons Chair in Internal Medicine Stony Brook University

Dr. Butler

Javed Butler, MD, PhD
Chief of the Cardiology Division
Dr. Vincent Yang, Simons Chair in Internal Medicine
Stony Brook University

 MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Persistent congestion is associated with worse outcomes in acute heart failure (AHF). Mineralocorticoid receptor antagonists at high doses may relieve congestion, overcome diuretic resistance, and mitigate the effects of adverse neurohormonal activation in AHF. We therefore studies high dose spironolactone in patients with AHF. Unfortunately all of our primary and secondary endpoints were not different between spironolactone and placebo arms.

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Phase III Study of Stivarga (Regorafenib) For Progressed Hepatocellular Carcinoma

MedicalResearch.com Interview with:

Dr. Jordi Bruix, MD Professor of Medicine University of Barcelona Director of the Barcelona Clinic Liver Cancer (BCLC) Group Liver Unit Hospital Clinic of Barcelona

Dr. Bruix

Dr. Jordi Bruix, MD
Professor of Medicine
University of Barcelona
Director of the Barcelona Clinic Liver Cancer (BCLC) Group Liver Unit
Hospital Clinic of Barcelona

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The RESORCE Phase III pivotal trial is an international, multicenter, placebo-controlled trial which investigated the efficacy of Stivarga (regorafenib) in adults with Child-Pugh A and Barcelona Clinic Liver Cancer Stage Category B or C hepatocellular carcinoma (HCC) who had documented disease progression following first-line treatment with Nexavar (sorafenib).

Trial participants were administered a daily oral 160mg dose (three weeks on/ one week off) of regorafenib plus best supportive care (BSC), or placebo plus BSC.

Results from the trial demonstrated that participants treated with regorafenib experienced a statistically significant and clinically meaningful improvement in the study’s primary endpoint—overall survival (OS). Participants treated with regorafenib demonstrated a median overall survival of 10.6 months vs. 7.8 months with placebo.

At ASCO 2017, an exploratory analysis evaluated the impact of baseline alpha-fetoprotein (AFP) and c-Met as predictors of poor prognosis in patients enrolled in the RESORCE trial (Abstract #4078).

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PCSK9 Inhibitor Praluent Added to Statins Improved Lipid Profile in Diabetes

MedicalResearch.com Interview with:

Dr-Robert-R-Henry.jpg

Dr. Henry

Robert R. Henry, M.D.
Professor of Medicine
Member of the ODYSSEY DM Steering Committee and
Director of the Center for Metabolic Research
VA San Diego Healthcare System

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The ODYSSEY DM-DYSLIPIDEMIA trial was a randomized, open-label, parallel-group study designed to evaluate the superiority of Praluent versus usual care in 413 patients with type 2 diabetes with mixed dyslipidemia at high cardiovascular (CV) risk, not adequately controlled with maximally tolerated dose (MTD) statins. The primary endpoint was percent change in non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to week 24.

In ODYSSEY DM-DYSLIPIDEMIA, Praluent 75 mg was added to MTD statins, with dose adjusted at week 12 to 150 mg every two weeks if their non-HDL-C was greater than or equal to 100 mg/dL at week 8. Approximately 64 percent of patients reached their lipid goals with the Praluent 75 mg dose.

Results from the ODYSSEY DM-DYSLIPIDEMIA study found that Praluent added to MTD statins showed significant reduction in non-HDL-C and other lipid parameters compared to those on usual care.

Praluent was superior to usual care in lowering non-HDL-C (37.3 percent and 4.7 percent, for the usual care arm). The mean difference between the two treatment arms was -32.5 percent (p<0.0001).

Praluent in combination with MTD statins reduced LDL-C by 43 percent from baseline compared to a 0.3 percent increase for usual care (p<0.0001). Treatment with Praluent also improved the overall lipid profile.

There is a large unmet need for improving cholesterol lowering in patients with diabetes. Despite current standard of care, nearly 70 percent of people age 65 or older with diabetes die from some form of heart disease; and 16 percent die of stroke. Furthermore, in spite of current standard of care, many people with diabetes continue to have persistent lipid abnormalities resulting in high residual CV risk.

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Adding Praluent (Alirocumab) To Statins Reduces LDL in High Cardiovascular Risk Diabetics

MedicalResearch.com Interview with:

Lawrence Leiter, M.D. MDCM, FRCPC, FACP, FACE, FAHA Chair of the ODYSSEY DM Steering Committee and Director of the Lipid Clinic at the Li Ka Shing Knowledge Institute St. Michael’s Hospital University of Toronto, Canada

Dr. Lawrence Leiter

Lawrence Leiter, M.D. MDCM, FRCPC, FACP FACE, FAHA
Chair of the ODYSSEY DM Steering Committee and
Director of the Lipid Clinic at the Li Ka Shing Knowledge Institute
St. Michael’s Hospital
University of Toronto, Canada

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The ODYSSEY DM-INSULIN trial was a randomized, double-blind, placebo-controlled, multicenter study that evaluated alirocumab (Praluent) in 517 patients with insulin treated type 1 and type 2 diabetes with high cardiovascular (CV) risk and hypercholesterolemia despite maximally tolerated dose (MTD) statins. The primary endpoint was percent change in calculated LDL-C from baseline to week 24.

Alirocumab 75 mg every two weeks was added to MTD statins, with the dose increased at week 12 to 150 mg every two weeks if the LDL-C at week 8 was greater than or equal to 70 mg/dL. In fact, only about 20% of the alirocumab treated participants required the higher dose.

Results of the type 2 diabetes study population (n=441) showed that the addition of alirocumab to MTD statin therapy, reduced LDL-C by 48.2 percent from baseline compared to a 0.8 percent increase for placebo. The mean difference between the two treatment arms was -49 percent (p<0.0001). Treatment with alirocumab also improved the overall lipid profile. Furthermore, no new safety issues were identified.

There is a large unmet need for improving cholesterol lowering in patients with diabetes. Despite current standard of care, nearly 70 percent of people age 65 or older with diabetes die from some form of heart disease; and 16 percent die of stroke. Additionally, in spite of current standard of care, many people with diabetes continue to have persistent lipid abnormalities resulting in high residual CV risk.

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Head-to-Head Study Compares All Costs Associated With New Anticoagulants in Non-Valvular AFib

MedicalResearch.com Interview with:

Sabine Luik, M.D.</strong> Senior vice president, Medicine & Regulatory Affairs Boehringer Ingelheim Pharmaceuticals, Inc.

Sabine Luik

Sabine Luik, M.D.
Senior vice president, Medicine & Regulatory Affairs
Boehringer Ingelheim Pharmaceuticals, Inc.

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This study is the first real-world, matched head-to-head study comparing all cause healthcare costs and healthcare resource utilization (HCRU) among novel oral anticoagulants (NOACs).

The study analyzed claims data from 70,898 newly-diagnosed NVAF patients who were newly treated with Pradaxa, rivaroxaban or apixaban.

The analysis found that Pradaxa was associated with lower all-cause costs and HCRU compared to rivaroxaban. Compared to apixaban, Pradaxa was associated with similar all-cause costs and hospitalizations, but higher all-cause outpatient and pharmacy HCRU.

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First Patients Enrolled in Study of Nintedanib For Progressive Fibrosing Lung Conditions

MedicalResearch.com Interview with:

Thomas Leonard, Ph.D. Executive director, Clinical Development and Medical Affairs, Specialty Care Boehringer Ingelheim Pharmaceuticals, Inc.

Dr. Thomas Leonard

Thomas Leonard, Ph.D.
Executive director, Clinical Development and Medical Affairs, Specialty Care
Boehringer Ingelheim Pharmaceuticals, Inc.

MedicalResearch.com: What is the background for this study? Would you tell us a little more about IPF?

Response: Boehringer Ingelheim’s Phase III PF-ILD (progressive fibrosing interstitial lung disease) trial will investigate the safety and efficacy of nintedanib, in a range of progressive fibrosing lung conditions other than idiopathic pulmonary fibrosis, or IPF. The PF-ILD trial is the first time that patients with different fibrosing lung diseases will be included in one single clinical trial assessing the efficacy of nintedanib as a potential treatment, and the trial is the first in the field of fibrosing lung diseases to group patients based on the clinical characteristics of their disease, rather than the diagnosis.

There are more than 200 conditions that affect the tissue and space around the air sacs of the lungs, or interstitium, and, collectively, these conditions are called interstitial lung diseases — or ILDs. Based on clinical observations, there is a group of patients with ILD who, independent from the classification of the ILD, exhibit progressive fibrosis. The proposed terminology for describing this group of patients is PF-ILD. In these patients, the disease appears to follow a course similar to IPF with worsening of respiratory symptoms, lung function, quality of life and ability to perform daily activities, as well as early mortality despite treatment.

There is currently no efficacious treatment available for PF-ILD. This trial is exploring how fibrosis in the lungs is treated and whether nintedanib is a potential treatment, based on the efficacy and safety of nintedanib in IPF, a rare and serious lung disease that causes permanent scarring of the lungs, making it difficult to breathe. IPF affects as many as 132,000 Americans, typically men over the age of 65. On average, people with IPF live only three to five years after diagnosis, and approximately 40,000 people die from this disease every year.

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