06 May 2022

This week in PVD

Inhaled ventavis of benefit as add-on PAH therapy over longer term

Longer-term use of Ventavis (iloprost) as an add-on therapy significantly improved blood flow and lowered blood pressure in people with pulmonary arterial hypertension (PAH), a small study in Japan reported.

Findings support this inhaled therapy’s established benefits as a pulmonary vasodilator — a medicine that  widens, or dilate, blood vessels to lower pressure — and provide evidence for its “long-term hemodynamic [blood flow] benefits in PAH patients receiving combination therapy,” its researchers wrote.

The study, “Inhaled Iloprost Induces Long-term Beneficial Hemodynamic Changes in Patients with Pulmonary Arterial Hypertension Receiving Combination Therapy,” was published in the journal Pulmonary Circulation

PAH is characterized by a narrowing of the arteries supplying blood to the lungs, leading to increased arterial blood pressure, reduced blood flow, and poor oxygen transport through the body.

Assessment of inhaler technique in asthma and COPD clinical trials

The use of correct inhaler technique is rarely checked, optimized, or reported among patients with asthma or COPD who take part in randomized controlled trials (RCTs) involving the use of inhalers at baseline and some form of escalation treatment, according to a systematic review that was recently in The Journal of Allergy and Clinical Immunology: In Practice.  The article also included a Best-Practice Inhaler Technique Assessment & Reporting Checklist.

Correct use of inhalers is fundamental to controlling airway disease, yet past research has indicated that inhaler technique errors are made by 90% of patients, noted review authors. Such technique errors can affect the accuracy of results of RCTs for asthma and COPD that involve inhaler use, potentially offering a false indication for the need for escalating biological therapies. Moreover, the extent to which inhaler technique is checked and optimized in RCTs is unclear due to a lack of reporting or guidelines on this subject.

Researchers noted that “if assessment and optimization of inhaler technique are not being carried out as part of the study protocol in the majority of relevant RCTs of asthma and COPD therapy, this detracts from the credibility of the data and the robustness of the conclusions.”

Low pulmonary artery pulsatility index may identify high risk for cardiovascular disease

Patients with low pulmonary artery pulsatility index (PAPi) have a greater risk of all-cause mortality, major adverse cardiac events, and heart failure (HF) hospitalizations, with the highest risk in the lowest quartile. These finding were published in Circulation: Heart Failure.

Researchers evaluated consecutive ambulatory and hospitalized patients receiving right heart catheterization (RHC) from 2005 to 2016 and obtained clinical characteristics from participants’ medical records.

The primary outcomes were all-cause mortality and HF hospitalization, and the secondary outcome was major adverse cardiac events (MACE). All-cause mortality was based on National Social Security Death Master Index and hospital records and abstracted on June 10, 2020.

Smart sensor platform for respiratory health receives FDA clearance for home use

Strados Labs announced it received FDA clearance for home use of its smart sensor platform for respiratory health, according to a press release.

The RESP Smart Sensor Platform provides early, remote detection of key changes in lung acoustics and ventilation patterns to enable prediction of worsening respiratory diseases, according to the company. The platform detects lung sounds associated with asthma, COPD, heart failure and infectious diseases including COVID-19, according to the release.

The FDA clearance will allow users to track objective symptoms associated with pulmonary disease from home and connect with doctors remotely to track improvement or decline.

“This 510(k) clearance expands the use of RESP to include home care of more than 5 million patients who are discharged from the hospital or ED each year with a primary diagnosis of asthma, COPD or heart failure,” Mitchell Glass, MD, chief medical officer at Strados Labs, said in the release. “More than 30 million patient visits each year can be improved, or avoided entirely, by adding real-time remote auscultation to the tools of the caregiver who has ready access to the patient’s RESP archive for comparison.”

Functional exercise capacity in COPD: Are field tests reliable measures?

Among patients with chronic obstructive pulmonary disease (COPD), peak oxygen uptake was correlated significantly with the incremental shuttle walk test (ISWT) and almost as significantly with the 6-minute walk test (6MWT), according to study findings published recently in BMC Pulmonary Medicine.

Although cardiopulmonary exercise testing (CPET) is more precise than field testing for evaluating patients with COPD, CPET is cumbersome and expensive. In contrast, field tests — specifically, the 6MWT and the ISWT — evaluate functional exercise capacity, including prognosis and response to treatment, and are much simpler to administer. Peak oxygen uptake (peak VO2) measures cardiopulmonary capacity and has previously demonstrated a strong correlation with the distance of a field test. Researchers aimed to compare the correlations of the 2 walking test distances with peak VO2 in patients with COPD.

To accomplish this, they conducted a systematic review and meta-analysis of 12 studies found in MEDLINE, Scopus, Embase, and the Cochrane Library through June, 2020, comparing the correlation of peak VO2 with either the 6MWT or ISWT in COPD patients. These studies included 746 patients with sample sizes varying from 13 to 209 patients, with 10 studies reporting correlation between peak VO2 and 6MWT distance and 5 reporting correlation between peak VO2 and ISWT distance.

Chiesi buys monoclonal antibody portfolio with potential to treat PAH

Chiesi Farmaceutici has acquired the worldwide rights to a number of investigational antibodies that may be able to treat pulmonary arterial hypertension (PAH) from the developer, Allinaire Therapeutics. All of the antibodies act against the endothelial monocyte-activating polypeptide (EMAP II), a pro-inflammatory molecule that is thought to contribute to cell death and inflammation in PAH.

These antibodies are currently in the early phases of being evaluated as a potential PAH treatment, Chiesi reported.

“This agreement is further evidence of Chiesi’s commitment to seek out novel treatments for conditions with a high unmet medical need such as PAH,” Thomas Eichholtz, PhD, head of Global R&D at Chiesi, said in a press release.

“We believe that an anti-EMAP II [antibody] is a promising novel approach for the treatment and slowing of disease progression for patients with PAH,” Eichholtz added.

PAH is a rare type of pulmonary hypertension that arises when the blood vessels that transport blood to the lungs are narrowed. As a consequence, the blood pressure in these arteries is increased, making the heart work harder to pump blood.

Functional exercise capacity in COPD: Are field tests reliable measures?

Among patients with chronic obstructive pulmonary disease (COPD), peak oxygen uptake was correlated significantly with the incremental shuttle walk test (ISWT) and almost as significantly with the 6-minute walk test (6MWT), according to study findings published recently in BMC Pulmonary Medicine.

Although cardiopulmonary exercise testing (CPET) is more precise than field testing for evaluating patients with COPD, CPET is cumbersome and expensive. In contrast, field tests — specifically, the 6MWT and the ISWT — evaluate functional exercise capacity, including prognosis and response to treatment, and are much simpler to administer. Peak oxygen uptake (peak VO2) measures cardiopulmonary capacity and has previously demonstrated a strong correlation with the distance of a field test. Researchers aimed to compare the correlations of the 2 walking test distances with peak VO2 in patients with COPD.

To accomplish this, they conducted a systematic review and meta-analysis of 12 studies found in MEDLINE, Scopus, Embase, and the Cochrane Library through June, 2020, comparing the correlation of peak VO2 with either the 6MWT or ISWT in COPD patients. These studies included 746 patients with sample sizes varying from 13 to 209 patients, with 10 studies reporting correlation between peak VO2 and 6MWT distance and 5 reporting correlation between peak VO2 and ISWT distance.

Itraconazole for chronic pulmonary aspergillosis: Longer is better

A randomized controlled trial in India demonstrated that 12 months of oral itraconazole was superior to a 6-month regimen in reducing relapses of chronic pulmonary aspergillosis, researchers reported in The Lancet Infectious Diseases.

“We had observed chronic pulmonary aspergillosis relapses in about 50% of patients treated with 6 months of oral itraconazole after treatment discontinuation. Also, many patients required prolonged therapy with oral itraconazole,” Inderpaul S. Sehgal, MD, DM, an assistant professor in the department of pulmonary medicine at the Postgraduate Institute of Medical Education and Research in Chandigarh, told Healio.

Sehgal and colleagues conducted a single-center, open-label, randomized controlled trial at one chest clinic in Chandigarh. Between July 1, 2019, and Aug. 31, 2021, they randomly assigned 164 patients with chronic pulmonary aspergillosis who were naive to antifungal treatment to receive a starting dose of 400 mg per day of oral itraconazole for either 6 months or 12 months. The primary outcome of the study was the proportion of patients who relapsed 2 years after treatment initiation.


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