Respiratory Conditions

FDA drug approvals, breakthrough designations, fast-track designations, priority review

In an attempt to determine which patients with acute exacerbation of chronic obstructive pulmonary disease (COPD) are at high risk for serious adverse events upon presentation to the emergency department, Canadian researchers identified 10 clinical characteristics and developed a preliminary risk scale to help standardize the admission practices of these patients.

FDA approvals, complete response, fast-track designations, priority review, first-time generic approval

FDA approved umeclidinium and vilanterol inhalation powder (Anoro Ellipta, GlaxoSmithKline and Theravance) for the once-daily, long-term maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Fluticasone furoate and vilanterol inhalation powder (Breo Ellipta, GlaxoSmithKline and Theravance) once-daily for chronic obstructive pulmonary disease (COPD), is now available to pharmacies throughout the United States.

A new retrospective case-control study among patients with chronic obstructive pulmonary disease (COPD) found a 30% decreased risk of COPD exacerbation with any statin use.

Older patients with chronic obstructive pulmonary disease (COPD) may be at increased risk for cardiovascular events with newly prescribed long-acting beta-agonists (LABAs) and long-acting anticholinergics (LAAs) and need to be followed closely by their healthcare providers, according to a study published online May 20 for JAMA Internal Medicine.

FDA has approved fluticasone furoate and vilanterol inhalation powder (Breo Ellipta, GlaxoSmithKline and Theravance), an inhaled long-term, once-daily maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema. It is also indicated to reduce exacerbations of COPD in patients with a history of exacerbations.

Humana and Boehringer Ingelheim Pharmaceuticals have announced a multi-year collaboration to address key questions regarding treatment and healthcare costs for patients with chronic obstructive pulmonary disease (COPD), cardiovascular disease, and other disease states.

Long-term treatment with fixed-combination budesonide/formoterol (Symbicort Turbuhaler, AstraZeneca) was associated with fewer healthcare utilization-defined exacerbations and hospitalizations than fluticasone/salmeterol in patients with moderate and severe chronic obstructive pulmonary disease (COPD), according to a study published online in the Journal of Internal Medicine.

Budesonide/Formoterol maintenance and reliever therapy is an effective option for patients requiring treatment adjustments across Steps 2 to 4 of the Global Initiative for Asthma guidelines, according to the results of a study published online, June 2 in Respiratory Research.

Use of short- and long-acting inhaled anticholinergic medications in men with chronic obstructive pulmonary disease is associated with an increased risk of acute urinary retention, according to the results of a study published in the May 23 issue of Archives of Internal Medicine.

Pirfenidone, an investigational drug (InterMune) that inhibits the synthesis of TGF-beta and TNF-alpha, was associated with positive effects on lung function, 6-minute walk test distance, and progression-free survival in patients with mild-to-moderate idiopathic pulmonary fibrosis, according to a study published in The Lancet.

For the fourth consecutive year, diabetes therapy topped the list of contributors to drug use trends in therapeutic categories, contributing 16.1% to overall growth in drug spending in 2010 due to an increasing number of patients, according to the recently released 2011 Medco Drug Trend Report, which tracks utilization and spending.

New molecular entity: Roflumilast oral treatment was approved by FDA as treatment to reduce risk of COPD exacerbations.

The anticholinergic drug tiotropium is more effective than the ?2-agonist salmeterol in preventing exacerbations in patients with moderate-to-very-severe chronic obstructive pulmonary disease, according to a multicenter European study published in the New England Journal of Medicine.

New indication: Tigecycline (Tygacil), a tetracycline-class antibiotic, was approved on March 20, 2009, for the treatment of community-acquired bacterial pneumonia

Agents in late-stage development for the treatment of cystic fibrosis.

This article reviews the similarities and differences between albuterol (ALB) and levalbuterol (LEV) to provide P&T committees a concise summary of the available literature regarding efficacy, side effects, and cost of these agents.

New indication: Budesonide/formoterol (Symbicort), a corticosteroid/LABA combination, was approved on February 27, 2009, for the maintenance treatment of COPD

Agents in late-stage development for the treatment of asthma, COPD, and PAH

An observational retrospective study published in the American Journal of Respiratory and Critical Care Medicine demonstrated that mortality is reduced when patients with chronic obstructive pulmonary disease (COPD) are treated with cardioselective beta-blockers before major vascular surgery.

In the Understanding Potential Long-Term Impacts on Function with Tiotropium (UPLIFT) trial, tiotropium therapy for patients with chronic obstructive pulmonary disease (COPD) was associated with long-term improvements in lung function, quality of life, and COPD exacerbations. The therapy did not, however, significantly reduce the rate of decline in forced expiratory volume in 1 second (FEV1) compared with placebo.

A nested case-control analysis published in the Annals of Internal Medicine demonstrated an increased risk of all-cause and cardiovascular mortality among patients with recently diagnosed chronic obstructive pulmonary disease (COPD) treated with ipratropium.

Hospital-acquired pneumonia (HAP) is a frequently occurring complication of endotracheal intubation and hospitalization that is associated with a significant increase in morbidity, mortality, and cost of care.

In a retrospective cohort study of 162 primary care practices in the United Kingdom, the use of antibiotics was demonstrated to be effective in preventing serious complications following upper respiratory tract infection (URTI), sore throat, or otitis media; however, the authors stated that the number needed to treat (NNT) to prevent 1 such complication is too high to justify prescription of the drugs for this purpose.

A review of agents in late-stage development for the treatment of asthma (July 2007).

In a large, nested cohort study, use of inhaled corticosteroids at doses greater than 1,200 mcg/d was associated with a 61% reduction in the risk of developing lung cancer in patients with chronic obstructive pulmonary disease.

In a meta-analysis, inhaled corticosteroids were associated with a risk of oropharyngeal adverse events.