08 March 2018

This week in PVD

A sample of the latest PH news output from around the web for your reference.

 

 

 

Tenax Therapeutics announces new scientific publication of preclinical data which provides additional evidence of Levosimendan treatment effects in Pulmonary Hypertension

MORRISVILLE, N.C.-Tenax Therapeutics, Inc. has announced the publication of a positive preclinical study of levosimendan conducted by Hansen et al in the March 1, 2018, issue of Pulmonary Circulation. The study was titled “Levosimendan improves cardiac function and myocardial efficiency in rats with right ventricular failure” and found that chronic administration of levosimendan improved right heart function. Dr. Hansen and colleagues assessed the effects of levosimendan in an experimental model of right heart failure. The authors conclude the study results support the “potential therapeutic value of chronic levosimendan in treatment RV failure.”

NIH Awards $2.8M Grant to PhaseBio Supporting Clinical Development of PB1046 in PAH

The National Institutes of Health (NIH) awarded a $2.8 million Fast Track Small Business Innovation Research (SBIR) grant to PhaseBio Pharmaceuticals to advance the clinical development of PB1046, the first sustained-release analogue of the natural vasoactive intestinal peptide (VIP), in patients with pulmonary arterial hypertension (PAH).

In the first stage, the grant will support an ongoing exploratory Phase 1 clinical trial investigating the safety, tolerability, and hemodynamic effects of PB1046 in adults with PAH using a permanently implanted hemodynamic monitor. The open-label study (NCT03315507) is currently recruiting participants.

In the second stage, the grant will support a larger Phase 2 clinical trial in PAH. PhaseBio Pharmaceuticals plans to begin enrollment in mid-2018.

Week 1 of the PLOS Medicine Special Issue on Cardiovascular Disease and Multimorbidity

This week, publication of a Special Issue on Cardiovascular Disease (CVD) and Multimorbidity begins in PLOS Medicine, advised by Guest Editors Carolyn S. P. Lam, Duke-NUS Medical School, Singapore, Kazem Rahimi, The George Institute for Global Health, University of Oxford, UK, and Steven Steinhubl, Scripps Translational Science Institute, USA. The issue will feature research and discussion content related to multimorbidity in patients with CVD, the number one cause of death and disability globally.  In week 1, three research articles and one Health in Action article are publishing.

Using data from the UK Clinical Practice Research Datalink, a population-based dataset including routinely collected data from 674 UK general practices, Kazem Rahimi of the George Institute for Global Health, Oxford, UK, and colleagues describe the prevalence of 56 clinically important and common comorbidities in 229,205 patients with newly diagnosed non-fatal CVD between 2000 and 2014. Using age- and sex-standardized estimates, the researchers found that while the incidence of CVD decreased by 34% between 2000 to 2014, the prevalence of having 5 or more comorbidities increased from 6.3% (95% CI 5.6%±17.0%) in 2000 to 24.3% (22.1%±34.8%) in 2014. The most common comorbidities were hypertension (28.9%), depression (23.0%), arthritis, (20.9%), asthma (17.7%), and anxiety (15.0%). The researchers emphasize the need to broaden the current single-disease paradigm in CVD management to account for the increasing burden of comorbidities.

Pulmonary Arterial Hypertension Specific Therapy in Patients with Combined Post- and Precapillary Pulmonary Hypertension

BackgroundSpecific therapy for patients with PAH is associated with good outcomes. Little is known about the effect of this treatment in patients with Cpc-PH (PAPm ≥ 25 mmHg, PAWP > 15 mmHg, DPG ≥ 7 mmHg, and/or PVR > 3 WU). This study evaluates the outcome of treating patients with Cpc-PH using PAH specific therapy.

Methods. The primary outcome was survival. Secondary outcomes were WHO functional class and 6-minute walk distance (6-MWD).

Results. Twenty-six patients with Cpc-PH (half with VHD and half with HF) received PAHST. Six patients did not tolerate treatment due to pulmonary edema. No predictors for treatment intolerance were identified. In twenty patients who tolerated the treatment, the mean WHO functional class improved from at initial assessment to () and () at 6 and 9 months, respectively. Mean 6-MWD improved from meters at initial assessment to meters () and meters () at 6 and 9 months, respectively. Twelve patients died during the follow-up period. Mean survival for all patients was days.

Conclusion. PAHST may be beneficial in the treatment of Cpc-PH (both short and long term). Prospective randomized controlled trials of PAHST in this population are needed to assess its potential efficacy.

Co-existence of COPD and bronchiectasis: a risk factor for a high ratio of main pulmonary artery to aorta diameter (PA:A) from computed tomography in COPD patients

Background: Pulmonary vascular disease, especially pulmonary hypertension, is an important complication of COPD. Bronchiectasis is considered not only a comorbidity of COPD, but also a risk factor for vascular diseases. The main pulmonary artery to aorta diameter ratio (PA:A ratio) has been found to be a reliable indicator of pulmonary vascular disease. It is hypothesized that the co-existence of COPD and bronchiectasis may be associated with relative pulmonary artery enlargement (PA:A ratio >1).

Methods: This retrospective study enrolled COPD patients from 2012 through 2016. Demographic and clinical data were collected. Bhalla score was used to determine the severity of bronchiectasis. Patient characteristics were analyzed in two ways: the high (PA:A >1) and low (PA:A ≤1) ratio groups; and COPD with and without bronchiectasis groups. Logistic regression analysis was used to assess risk factors for high PA:A ratios.

Results: In this study, 480 COPD patients were included, of whom 168 had radiographic bronchiectasis. Patients with pulmonary artery enlargement presented with poorer nutrition (albumin, 35.6±5.1 vs 38.3±4.9, P<0.001), lower oxygen partial pressure (74.4±34.5 vs 81.3±25.4, P<0.001), more severe airflow obstruction (FEV1.0, 0.9±0.5 vs 1.1±0.6, P=0.004), and a higher frequency of bronchiectasis (60% vs 28.8%, P<0.001) than patients in the low ratio group. Patients with both COPD and bronchiectasis had higher levels of systemic inflammation (erythrocyte sedimentation rate, P<0.001 and fibrinogen, P=0.006) and PA:A ratios (P<0.001). A higher PA:A ratio was significantly closely correlated with a higher Bhalla score (r=0.412, P<0.001). Patients with both COPD and bronchiectasis with high ratios presented higher levels of NT-proBNP (P<0.001) and systolic pulmonary artery pressure (P<0.001). Multiple logistic analyses have indicated that bronchiectasis is an independent risk factor for high PA:A ratios in COPD patients (OR =3.707; 95% CI =1.888–7.278; P<0.001).

Conclusion: Bronchiectasis in COPD has been demonstrated to be independently associated with relative pulmonary artery enlargement.

Predictors of Mortality After Hospitalization for COPD Exacerbation

In patients hospitalized for a severe exacerbation of chronic obstructive pulmonary disease (COPD), predictors of 1-year mortality after index hospitalization included patient age, prior hospitalization for COPD exacerbation, aspects of the COPD index event, and features of the hospital in which the patient was treated, according to the results of a recent prospective, observational, multicenter Spanish cohort study published in BMC Pulmonary Medicine.


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