Archive for November 2014

FDA approves Ofev to treat idiopathic pulmonary fibrosis

FDA approves Ofev to treat idiopathic pulmonary fibrosis

The U.S. Food and Drug Administration today approved Ofev (nintedanib) for the treatment of idiopathic pulmonary fibrosis (IPF).

Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and have difficulty participating in everyday physical activities. Current treatments for IPF include oxygen therapy, pulmonary rehabilitation, and lung transplant.

“Today’s Ofev approval expands the available treatment options for patients with idiopathic pulmonary fibrosis, a serious, chronic condition,” said Mary H. Parks, M.D., deputy director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “Providing health care professionals and patients with additional treatment options helps enable appropriate care decisions based on a patient’s need.”

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FDA approves Esbriet to treat idiopathic pulmonary fibrosis

FDA approves Esbriet to treat idiopathic pulmonary fibrosis

The U.S. Food and Drug Administration today approved Esbriet (pirfenidone) for the treatment of idiopathic pulmonary fibrosis (IPF).

Idiopathic pulmonary fibrosis is a condition in which the lungs become progressively scarred over time. As a result, patients with IPF experience shortness of breath, cough, and have difficulty participating in everyday physical activities. Current treatments for IPF include oxygen therapy, pulmonary rehabilitation, and lung transplant.

“Esbriet provides a new treatment option for patients with idiopathic pulmonary fibrosis, a serious, chronic lung disease,” said Curtis J. Rosebraugh, M.D., M.P.H., director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research. “We continue to help advance medication therapies by approving products that treat conditions that impact public health.”

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10 Commandments for Children Sleep

10 COMMANDMENTS FOR CHILDREN SLEEP

Sleep is one of the most important contributors to your child’s physical and mental health. Good sleep habits, sleep hygiene, or “sleep health” are alternative terms often used to describe sleep promoting practices. The explanation as to why healthy sleep practices promote sleep is likely to be, at least in part, that they work by improving the regulation of sleep

, either by reinforcing the body’s natural circadian rhythms (ie, timing of light and darkness), or by increasing the drive to sleep. Other sleep practices help us to associate certain activities (like a bedtime routine) and environments (ie, the bedroom) with sleep. Healthy sleep behaviors also promote sleep by reducing factors in the environment which are stimulating (like caffeine) and increasing relaxation, making it easier to fall and stay asleep.

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Is Stopping Inhaled Steroids in COPD Feasible?

AUSTIN, Texas — Withdrawing inhaled corticosteroids (ICS) from patients with severe chronic obstructive pulmonary disease (COPD) did not lead to an increased rate of exacerbations, investigators reported.

Steroid withdrawal was associated with 1,097 exacerbations of any severity among 1,242 patients, which met statistical criteria for noninferiority versus continuation of ICS (1,078 exacerbations in 1,243 patients). The frequency of severe or moderate/severe exacerbations did not differ between groups or within any subgroups. The time to first COPD exacerbation also was similar between groups.

Withdrawal of ICS was associated with a larger drop in FEV1 during the final step of withdrawal, Helgo Magnussen, MD, of the Pulmonary Research Institute in Grosshansdorf, Germany, said here atCHEST 2014.

“In patients with GOLD [Global Initiative for Chronic Obstructive Lung Disease] 3-4 COPD, receiving dual bronchodilators, the risk for moderate to severe exacerbations is statistically noninferior with ICS withdrawal compared with ICS therapy,” Magnussen said. “On the basis of these results we conclude that inhaled corticosteroids may be successfully withdrawn in patients receiving dual bronchodilator therapy with a long-acting muscarinic antagonist (LAMA) and a long-acting beta-agonist (LABA).

In contrast, hospitalized patients with severe COPD had an increased risk of subsequent hospitalization for pneumonia if they did not receive prophylactic antibiotic therapy, according to results of a separate study reported at the meeting.

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