Outcomes Better for PAH Patients Treated at Specialty Centers... - Pulmonary Hypertension News

Posted: 27 Jul 2020 08:00 AM PDT

People with pulmonary arterial hypertension (PAH) who are treated at specialty care centers have better survival chances and a lower likelihood of hospitalization, a study reports.

These findings support referring PAH patients to specialty care centers for treatment, where factors like more careful disease monitoring might be decisive.

The study, "Outcomes of Pulmonary Arterial Hypertension Are Improved in a Specialty Care Center," was published in the journal CHEST.

Current guidelines suggest that PAH care be administered at care centers specialized in treating the disease. However, published data concerning whether a specialty care center improves treatment outcomes are limited.

A team of researchers analyzed data collected from the University of Pittsburgh Medical Center (UPMC) medical system, which includes both specialty and non-specialty care centers. This allowed researchers to compare outcomes for patients treated at either type of center in the same geographic area.

In total, researchers analyzed data from 580 PAH patients, of whom 455 (78%) were managed at a specialty center.

Patients seen at specialty centers were younger — a median age 58.8 vs. 64.8 years in the group treated at non-specialty care centers — and more likely to be female — 68.4% vs. 51.2% among non-specialty treated patients. They also had more comorbidities, including hypertension and obesity.

No significant racial or economic differences were evident between the groups, and no significant differences in how far away patients lived from the respective center.

By some indices, but not others, patients seen at a specialty center had more severe PAH. For instance, those seen at the specialty center had significantly higher mean pulmonary arterial pressure (45 vs. 40.5 mm Hg), whereas the two groups had similar pulmonary vascular resistance.

After adjusting data for factors like age, sex, lung transplant status, and comorbidities, results showed that patients who went to a specialty center were 32% less likely to die relative to those treated at a non-specialty care center. Significant increases in survival were seen in both sexes.

Specialty care centers also had fewer hospital admissions. This difference was statistically significant for the overall group and for females, but it was not significant for males.

Of note, 58 patients (12.7%) were seen only once at a specialty center. The above differences remained significant when these patients were re-classified as non-specialty center patients.

PAH is typically managed with vasodilators, medicines that cause blood vessels to widen, decreasing blood pressure. Patients managed at a specialty center were significantly more likely to be prescribed a vasodilator (80.7%) than those at non-specialty centers (34.7%).

While vasodilator use was associated with significant improvements in survival, in statistical models the use of vasodilators did not fully account for the differences in outcomes between the two types of care.

"These data emphasize the importance of vasodilator use in improving outcomes across both cohorts. However, vasodilator use alone did not explain the entirety of benefits observed in SCC [specialty care center] patients," the researchers wrote.

Lung transplants were performed at similar rates in patients seen at specialty and non-specialty care centers, so this form of treatment also did not explain the differences in clinical outcomes.

"This supports the importance of other factors, such as more frequent disease monitoring, to drive additional outcome improvements in SCC patients," the team wrote. In keeping with this idea, testing of lung function, as well as functional tests like the six minute walk test, were performed significantly more frequently in specialty centers.

"Our data indicate that PAH care at an SCC was associated with improvements in all-cause mortality and hospitalization. Although some of SCC benefits are likely derived from increased vasodilator use, differences in management strategies with increased guideline compliance may also contribute," the researchers concluded.

"These findings provide crucial support for more robust referral to SCCs and collaboration with the community," the team added.

Author Details

Marisa holds an MS in Cellular and Molecular Pathology from the University of Pittsburgh, where she studied novel genetic drivers of ovarian cancer. She specializes in cancer biology, immunology, and genetics. Marisa began working with BioNews in 2018, and has written about science and health for SelfHacked and the Genetics Society of America. She also writes/composes musicals and coaches the University of Pittsburgh fencing club.

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Patrícia holds her PhD in Medical Microbiology and Infectious Diseases from the Leiden University Medical Center in Leiden, The Netherlands. She has studied Applied Biology at Universidade do Minho and was a postdoctoral research fellow at Instituto de Medicina Molecular in Lisbon, Portugal. Her work has been focused on molecular genetic traits of infectious agents such as viruses and parasites.

Inhaled nitric oxide at higher dose shows benefit in pulmonary hypertension, fibrotic ILD - Healio

Posted: 06 Aug 2020 04:09 PM PDT

August 06, 2020

2 min read

Source/Disclosures

Source:

Nathan SD, et al. B16 – ILD Therapy II. Presented at: American Thoracic Society Virtual; Aug. 5-10, 2020 (virtual meeting).

Disclosures: The study was funded by Bellerophon Therapeutics. Healio could not confirm relevant financial disclosures at time of publication.

Pulsed, inhaled nitric oxide at a higher dose was safe and well tolerated, and resulted in improvements in physical activity and other outcomes in patients at risk for pulmonary hypertension-associated fibrotic interstitial lung disease.

A new study evaluated safety and efficacy of pulsed, inhaled nitric oxide (Bellerophon Therapeutics) at a dose of 45 µg/kg of ideal body weight per hour.

"Inhaled nitric oxide is a proven vasodilator and has recently been shown to benefit physical activity in a placebo-controlled trial of patients with fibrotic ILD when used at a dose of 30 µg/kg ideal body weight per hour for 2 months. The objective of this current trial was to explore the safety and efficacy of a higher dose — 45 µg/kg ideal body weight per hour — for a longer period of 4 months," Steven D. Nathan, MD, director of the Advanced Lung Disease Program and Lung Transplant Program at Inova Fairfax Hospital in Virginia, said during a prerecorded presentation during the American Thoracic Society Virtual meeting.

The randomized, double-blind, placebo-controlled study enrolled patients at risk for pulmonary hypertension associated with pulmonary fibrosis on background oxygen therapy. Patients were randomly assigned to inhaled nitric oxide 45 µg/kg of ideal body weight per hour (n = 30) or placebo (n = 14) for 4 months. The researchers monitored changes in activity levels via a wrist-worn medical grade activity monitor.

The primary endpoint was placebo-corrected change from baseline to 4 months in moderate to vigorous physical activity, which represents activities of daily living, such as walking, climbing stairs and yardwork, Nathan said. Additional outcomes included patient-reported outcomes of the St. George's Respiratory Questionnaire and the University of California San Diego Shortness of Breath Questionnaire.

Researchers reported a statistically significant placebo-corrected benefit of 14 minutes per day in moderate to vigorous physical activity among the patients assigned inhaled nitric (P = .02). Results also showed a 7% benefit in overall activity with inhaled nitric oxide compared with placebo. Moreover, for both activity parameters, Nathan noted that while the inhaled nitric oxide treatment group remained stable, the placebo group deteriorated.

Nathan also reported clinically significant changes in the University of San Diego Shortness of Breath Questionnaire (4.8 points) and the St. George's Respiratory Questionnaire Total (3.3), Activity (4.8) and Impact (5.7) domain scores. Again, over the study period, patients assigned inhaled nitric oxide remained stable, while the placebo group deteriorated.

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The researchers also conducted an anchoring analysis between moderate to vigorous physical activity and the Activity domain in the St. George's Respiratory Questionnaire, which established an estimated minimally important difference of approximately 5 minutes per day for moderate to vigorous physical activity, Nathan said.

Pulsed, inhaled nitric oxide at the higher dose was well tolerated, with fewer severe adverse events observed compared with the placebo group (10% vs. 21.4%). The overall incidence of adverse events was low and balanced between the two groups. No deaths were reported during the treatment period, according to the results.

The new data confirm the previously reported results with inhaled nitric oxide at a lower concentration, according to the researchers.

"The inhaled nitric oxide 45 µg/kg ideal body weight per hour dose was safe and well tolerated and is currently being studied in a large registrational, phase 3, placebo-controlled clinical trial in patients with fibrosing ILD," Nathan said.

Reference:

Nathan SD, et al. Am J Respir Crit Care Med. 2020;201;A2757.

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