Therapeutic Advances in Respiratory Disease current issue

Adverse events associated with intranasal influenza vaccine in the United States

Vasu, N., Ghaffari, G., Craig, E. T., Craig, T. J. — 2008-07-22

Methods: The goal of this review was to analyze the post-vaccination adverse effects associated with Live Attenuated Influenza Vaccine (LAIV) compared to those of the Injectable Trivalent Inactivated Vaccine (TIV) in patients with egg allergy and asthma. PubMed, Ovid, and Google searches were conducted. Searched articles relating to allergic reactions, asthma or food allergy, and LAIV were reviewed.

Results: Similar or superior efficacy of LAIV compared to TIV was reported by various studies. Respiratory symptoms were the most common adverse events following both vaccinations. Although no evidence was found of a direct causal relationship between intranasal influenza vaccine and anaphylaxis due to egg allergy, a number of cases of anaphylaxis were reported. To date, there are no studies directly comparing the frequency of anaphylactic reactions between the two vaccines.

Conclusions: The safety of LAIV in individuals with unstable asthma and egg allergy has not been established and it should be avoided in these populations. For patients with unstable asthma, TIV should remain the therapy of choice.

Long-term safety of nebulized formoterol: Results of a twelve-month open-label clinical trial

2008-07-22

Formoterol fumarate is a long-acting β2-agonist that is an effective bronchodilator for the maintenance management of patients with chronic obstructive pulmonary disease. The safety profile of the newly developed nebulized formoterol was evaluated over a twelve-month period in an open-label, active-control study. After completing a twelve-week double-blind double-dummy period, 569 subjects with chronic obstructive pulmonary disease entered an open-label extension study and received twice-daily 20 µg formoterol fumarate inhalation solution for nebulization (FFIS) or 12 µg formoterol fumarate dry powder inhalation (FA) for 52 weeks. Most of the FFIS-treated subjects (86%) completed at least six months of open-label treatment with over 90% compliance, comparable to the FA group (88%). Results of safety monitoring for adverse events, laboratory values, and cardiac changes were similar between treatment groups. Three hundred forty (73%) of FFIS-treated subjects and 83 (78%) of FA-treated subjects experienced an adverse event over the course of the study, the majority of which were mild to moderate and considered unrelated to treatment. COPD exacerbation occurred in 15.8% of FFIS-treated and 17.9% of FA-treated subjects. Deaths, serious adverse events, and discontinuations for adverse events occurred in 1.3, 16.2, and 5.4% of the nebulized group versus 1.9, 17.9, and 7.5% of the inhaled group, respectively. There were no clinically important changes from baseline in laboratory tests, including serum potassium and glucose, or vital signs and no treatment-related increases in cardiac arrhythmias, heart rate, or QTc prolongation. We conclude that nebulized formoterol fumarate twice daily is well tolerated over long-term treatment in moderate-to-severe COPD subjects and has a similar safety profile to the DPI formulation.

Prulifloxacin in the treatment of acute exacerbations of COPD in cigarette smokers

Pasqua, F., Biscione, G., Crigna, G., Cazzola, M. — 2008-07-22

Smoking is associated with an increased risk of respiratory tract infection in adults likely because components in the smoke might alter properties of the epithelial cell surface. In studies with smokers suffering from acute exacerbations of COPD (AECOPD), the most common bacterial pathogens found were mainly Haemophilus influenzae, but also Streptococcus pneumoniae, Staphylococcus aureus, and Moraxella catarrhalis. Therefore, antibiotics should be effective against such possible pathogens. Prulifloxacin has demonstrated in vitro activity against all these pathogens. We designed the present study to evaluate the efficacy of prulifloxacin in the treatment of AECOPD in cigarette smokers. We enrolled 61 consecutive smokers hospitalized or out-patients of either sex with symptoms and signs compatible with the usual diagnosis criteria for AECOPD. Haemophilus influenzae was the most common bacterial species isolated in the sputum (in 42.6% of the total sample), followed by S. pneumoniae (16.5%), S. aureus (14.7%), M. catarrhalis (11.5%), and others (14.7%). Prulifloxacin 600 mg was given orally once daily for 10 days. Clinical success was observed in 91.8% of patients (67.2% cured and 24.6% improved). Bacteriological eradication rate of H. influenzae was 100%. Persistent pathogens were S. pneumoniae (2 out of 10), S. aureus (1 out of 8), M. catarrhalis (1 out of 7), and P. aeruginosa (1 out of 3). This study seems to indicate that prulifloxacin is of particular value in the treatment of AECOPD in cigarette smokers.

Review: Oxidant--antioxidant imbalance in asthma: scientific evidence, epidemiological data and possible therapeutic options

Nadeem, A., Masood, A., Siddiqui, N. — 2008-07-22

Prevalence of asthma has increased considerably in recent decades throughout the world especially in developed countries. Airway inflammation is thought to be prime cause for repeated episodes of airway obstruction in asthmatics. Several studies have shown that reactive oxygen species (ROS) play a key role in initiation as well as amplification of inflammation in asthmatic airways. Excessive ROS production in asthma leads to alteration in key enzymatic as well as nonenzymatic antioxidants such as glutathione, vitamins C and E, beta-carotene, uric acid, thioredoxin, superoxide dismutases, catalase, and glutathione peroxidases leading to oxidant—antioxidant imbalance in airways. Oxidant—antioxidant imbalance leads to pathophysiological effects associated with asthma such as vascular permeability, mucus hypersecretion, smooth muscle contraction, and epithelial shedding. Epidemiological data also support the scientific evidence of oxidant—antioxidant imbalance in asthmatics. Therefore, the supplementation of antioxidants to boost the endogenous antioxidants or scavenge excessive ROS production could be utilized to dampen/prevent the inflammatory response in asthma by restoring oxidant—antioxidant balance. This review summarizes the scientific and epidemiological evidence linking asthma with oxidant—antioxidant imbalance and possible antioxidant strategies that can be used therapeutically for better management of asthma.

Review: Update on lung transplantation

Gottlieb, J. — 2008-07-22

Lung transplantation is a suitable treatment to improve the quality of life and the prognosis of patients with various end-stage pulmonary diseases. There is a shortage of organs and the number of patients on waiting list is exceeding the number of transplants per year approximately two-fold in most countries. Strategies to increase the donor pool are therefore crucial. The long-term prognosis after lung transplantation is not yet as good as for other transplantation procedures and special complications should be taken into account. Aside from infections chronic organ dysfunction is the main cause of death and the most important prognosis limiting factor. Other typical problems are rejection, bronchus complications, and primary transplant dysfunction. However, the results of large centers show promising improvements in recent years.

Review: Therapeutic advances in pulmonary arterial hypertension

2008-07-22

Pulmonary arterial hypertension (PAH) is characterized by vasoconstriction, in situ thrombosis, and vascular remodeling of small pulmonary arteries inducing increased pulmonary arterial resistance. Conventional treatment is based on life style modification and nonspecific treatment (warfarine, diuretics, oxygen). Calcium channel blockers are vasodilatators that have been shown to be of great efficacy in a very specific subpopulation of patients with PAH. For the majority of patients, specific PAH therapies are still lacking. Numerous studies evaluating prostacyclin agonists, endothelin-receptor antagonists, and phosphodiesterase type 5 inhibitors are now available to guide therapeutic choices. Despite those important advances there is still no cure for PAH. Fortunately, research is ongoing and many drugs show promises.