Bayer HealthCare Release: New Data Show Need For Improved Monitoring For Pulmonary Hypertension Following Pulmonary Embolism

WHIPPANY, N.J., May 19, 2015 /PRNewswire/ -- Results from a retrospective cohort study presented today at the American Thoracic Society (ATS) 2015 International Conference in Denver found that the incidence of pulmonary hypertension (PH) among patients who experienced pulmonary embolism (PE) was twice as high as expected based on previous studies, and that many patients do not receive necessary follow-up tests.^{[1],[2] [3]} 

"These data indicate that, despite the risk of pulmonary hypertension among pulmonary embolism  patients, the use of tests necessary to identify PH and that determine the specific type of PH   is lacking," said Dario Mirski, M.D., vice president and head, U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.

The study, which investigated the incidence of PH diagnoses following acute PE in the U.S., concluded that the two-year cumulative incidence of PH is 7.6 percent.  The study also evaluated routine disease monitoring practice in PE patients and found nearly half (45 percent) did not undergo imaging tests that could identify PH within 24 months of their PE diagnosis even though 87 percent of these patients showed signs and symptoms suggestive of the disease.^[4]

"The need for improved monitoring of these patients is especially important, as the various types of PH are more prevalent than previously thought," said Richard Channick, M.D., director of Massachusetts General Hospital's Pulmonary Hypertension and Thromboendarterectomy Program.

One such diagnostic test is the lung ventilation/perfusion, or VQ scan, an imaging test that measures air and blood flow in the lungs.^[5] The VQ scan is recommended as the preferred screening diagnostic for a rare, life-threatening form of PH, called chronic thromboembolic pulmonary hypertension (CTEPH).^[6] CTEPH has symptoms similar to those of other more common conditions, such as asthma and chronic obstructive pulmonary disease, as well as other types of PH. However, unlike other types of PH, CTEPH is potentially curable with pulmonary endarterectomy surgery^[7]. In part because of the nonspecific symptoms, CTEPH is underdiagnosed and often misdiagnosed as another disease.^[8]

"These findings are important because the progression of PH can be slowed with effective treatment," said Victor Tapson, M.D., director of the Venous Thromboembolism and Pulmonary Vascular Disease Research Program at Cedars-Sinai Medical Center in Los Angeles.  "Consistent use of accurate PH imaging diagnostics is critical to effective treatment." 

About Pulmonary Hypertension

PH is a severe, progressive, life-changing and life-threatening disorder of the heart and lungs in which the blood pressure in the pulmonary arteries is above normal, and which can lead to heart failure and death.^{[9],[10],[11]} The most common symptoms of PH include shortness of breath, fatigue, dizziness and fainting, all of which are worsened by exertion.^[12],[13] As the symptoms of PH are non-specific, diagnosis can be delayed by as much as two years.^[14],[15]

About Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
CTEPH is a progressive and life-threatening disease and a type of PH, in which it is believed that thromboembolic occlusion (organized blood clots) of pulmonary vessels gradually lead to an increased blood pressure in the pulmonary arteries, resulting in an overload of the right heart. CTEPH is a rare disease and is comparable in terms of population size to PAH, though there are fewer diagnoses made so far. CTEPH may evolve after prior episodes of acute pulmonary embolism, but the pathogenesis is not yet completely understood. The standard and potentially curative treatment for CTEPH is pulmonary endarterectomy (PEA), a surgical procedure in which the blood vessels of the lungs are cleared of clot and scar material. However, a considerable number of patients with CTEPH (20%-40%) are not operable and in up to 35% of patients, the disease persists or reoccurs after PEA.

About Bayer HealthCare Pharmaceuticals Inc.

Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions. As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women's Healthcare. The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

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Forward Looking Statement

This news release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer Web site at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

[1] Channick R, Joish V, Platt D, et al. Estimating the Incidence of Pulmonary Hypertension in Newly Diagnosed Pulmonary Embolism Patients in the United States. Presented at American Thoracic Society 2015 International Conference; May 2015; Denver, Colorado.

[2] Tapson V, Joish V, Platt D, et al. Evaluating Routine Disease Monitoring Practice in Incident Pulmonary Embolism Patients in the United States. Presented at American Thoracic Society 2015 International Conference; May 2015; Denver, Colorado.

[3] Channick R, Joish V, Platt D, et al. Estimating the Incidence of Pulmonary Hypertension in Newly Diagnosed Pulmonary Embolism Patients in the United States. Presented at American Thoracic Society 2015 International Conference; May 2015; Denver, Colorado.

[4] Tapson V, Joish V, Platt D, et al. Evaluating Routine Disease Monitoring Practice in Incident Pulmonary Embolism Patients in the United States. Presented at American Thoracic Society 2015 International Conference; May 2015; Denver, Colorado.

[5] NHLBI. What is a Lung Ventilation/Perfusion Scan? Available at: https://www.nhlbi.nih.gov/health/health-topics/topics/lvq. Accessed March 26, 2015.

[6] Piazza G and Goldhaber SZ. Chronic thromboembolic pulmonary hypertension. N Engl J Med. 2011;364:351-360.

[7] Kim et al. J Am Coll Cardiol 2013; 62: D92-9

[8] Tapson V et al. Incidence and prevalence of chronic thromboembolic pulmonary hypertension: from acute to chronic pulmonary embolism. Proc Am Thorac Soc. 2006;3:564-7.

[9] Rosenkranz, S. Pulmonary hypertension: current diagnosis and treatment. Clin Res Cardiol 2007;96:527541.

[10] Macchia, A et al. A meta-analysis of trials of pulmonary hypertension: A clinical condition looking for drugs and research methodology. Am Heart J 2007;153:10371047

[11] PHA website. Available from: http://www.phassociation.org/AboutPH Last accessed: July 2013

[12] McKenna, S et al. The Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR): A measure of health-related quality of life and quality of life for patients with pulmonary hypertension. Qual Life Res 2006;15:103115.

[13] PHA website. Available from: http://www.phassociation.org/AboutPH Last accessed: July 2013

[14] Armstrong, I et al. The trajectory to diagnosis with pulmonary arterial hypertension: a qualitative study. BMJ Open 2012; 2:e000806.

[15] Peacock, JA. Treatment of pulmonary hypertension. BMJ 2003; 326:835-836.

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