10 June 2021

This Week in PVD

How environmental noise harms the cardiovascular system

More than 100 years ago, the German physician and Nobel Prize winner Robert Koch predicted that “one day mankind will have to fight the burden of noise as fiercely as plague and cholera.” He was right. While many sounds in our environments are quite pleasant, noise, defined as unwanted sound, has the potential to cause real damage to our bodies and minds.

The principal sources of environmental noise are transportation and industrial operations. Since Koch’s time, researchers have come to recognize that such noise can cause sleep disturbances, elicit anger, and trigger conditions such as tinnitus and coronary heart disease caused by reduced blood flow to the organ. Noise can also lead to memory and learning impairments in children. In 2011, the World Health Organization (WHO) concluded that exposure to transportation-related noise—specifically from aircraft, vehicles, and trains—is responsible for the annual loss of up to 1.6 million cumulative years of healthy life among people in Western Europe. 

Hypertension during pregnancy is associated with increased risk of stroke in offspring

Previous research has suggested that children exposed to maternal hypertensive disorders during gestation have increased risks of preterm birth, foetal growth restriction and cardiovascular risk factors including high blood pressure, obesity, and diabetes later in life. But evidence for a direct link with severe cardiovascular disease is limited. This study explored this link focusing on ischaemic heart disease and stroke.

This population-based cohort study linked national registers from two countries. Live singleton births in Sweden (1973 to 2014) and Finland (1987 to 2014) were followed for ischaemic heart disease and stroke until 2014. Hypertensive pregnancy disorders were identified including high blood pressure (starting before or during pregnancy), and preeclampsia (high blood pressure and organ damage).

The researchers estimated the hazards of ischaemic heart disease and stroke related to high blood pressure conditions during pregnancy. The analyses were adjusted for factors that could influence the relationships such as the child's year of birth, sex, and congenital anomalies and the mother’s age, parity, marital status, education level, body mass index, smoking during early pregnancy, and family history of cardiovascular disease.

LIQ861 inhalation therapy for PAH again under FDA review

The U.S. Food and Drug Administration (FDA) has accepted an updated application asking that the dry-powder inhalation therapy LIQ861 (treprostinil) be approved to treat pulmonary arterial hypertension (PAH).

Liquidia Corporation, the therapy’s developer, first requested approval in April 2020, but the FDA asked for more data on LIQ861 in a complete response letter issued in November.

Specifically, the regulatory agency requested more information and clarification of the medicine’s chemistry, manufacturing, and controls. Additional data also had to include further evidence of the safety of the portable device used to deliver LIQ861. No further clinical trial data or information regarding the therapy’s pharmacology or toxicology were required.

In confirming its acceptance of the resubmitted application, the FDA set November 7 as the intended date for a decision on possible approval, according to a press release.

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