Jie Zhang

Tobramycin inhalation powder for P. aeruginosa infection in cystic fibrosis: the EVOLVE trial.

Tobramycin inhalation solution is used to treat chronic Pseudomonas aeruginosa lung infection in cystic fibrosis (CF) patients. We evaluated the efficacy and safety of a novel, light‐porous particle, dry‐powder formulation of tobramycin, which was developed to improve delivery efficiency to the airways and substantially reduce the delivery time. In this randomized, double‐blind study, patients with CF (age 6–21 years) received tobramycin inhalation powder (112 mg tobramycin) twice daily (n = 46) or placebo (n = 49) via the T‐326 Inhaler for one cycle, followed by two open‐label cycles (all patients). Cycles were 28 days on, 28 days off treatment. The primary endpoint was change in forced expiratory volume in 1 sec (FEV1) % predicted from baseline to Day 28 of Cycle 1. The study was terminated early based on positive results in the interim analysis. Tobramycin inhalation powder significantly improved FEV1 % predicted versus placebo at Day 28 (difference 13.3, 95% CI: 5.31–21.28; P = 0.0016). Similar changes in FEV1 were seen in patients switching from placebo to tobramycin inhalation powder in Cycle 2; improvements were maintained over time. Tobramycin inhalation powder also reduced sputum P. aeruginosa density, respiratory‐related hospitalization and antipseudomonal antibiotic use versus placebo. The most common adverse event was cough; the frequency of cough was higher in patients receiving placebo (26.5%) versus tobramycin inhalation powder (13.0%) in Cycle 1. Tobramycin inhalation powder was not associated with ototoxicity or nephrotoxicity. Administration time was between 4 and 6 min. In conclusion, tobramycin inhalation powder was effective and well tolerated in CF patients, and may offer an important treatment option to decrease the treatment burden of CF pseudomonas lung infections. Pediatr Pulmonol. 2011; 46:230–238.

Pulmonary Medication Adherence and Health-care Use in Cystic Fibrosis

BACKGROUND Poor treatment adherence is common in cystic fibrosis (CF) and may lead to worse health outcomes and greater health-care use. This study evaluated associations of adherence to pulmonary medications, age, health-care use, and cost among patients with CF. METHODS Patients with CF aged ≥ 6 years were identified in a national commercial claims database. A 12-month medication possession ratio (MPR) was computed for each pulmonary medication and then averaged for a composite MPR (CMPR) for each patient. The CMPR was categorized as low (< 0.50), moderate (0.50-0.80), or high (≥ 0.80). Annual health-care use and costs were measured during the first and second year and compared across adherence categories by multivariable modeling. RESULTS Mean CMPR for the sample (N = 3,287) was 48% ± 31%. Age was inversely related to CMPR. In the concurrent year, more CF-related hospitalizations were observed among patients with low (event rate ratio [ERR], 1.35; 95% CI, 1.15-1.57) and moderate (ERR, 1.25; 95% CI, 1.05-1.48) vs high adherence; similar associations were observed for all-cause hospitalizations and CF-related and all-cause acute care use (hospitalizations + ED) in the concurrent and subsequent year. Rates of CF-related and all-cause outpatient visits did not differ by adherence. Low and moderate adherence predicted higher concurrent health-care costs by

Reduced mortality in cystic fibrosis patients treated with tobramycin inhalation solution.

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Inhaled corticosteroid use in patients with chronic obstructive pulmonary disease and the risk of pneumonia: a retrospective claims data analysis.

5,557-

Nationwide trends in the medical care costs of privately insured patients with cystic fibrosis (CF), 2001-2007

24,371) and

Real-world patterns of endocrine therapy for metastatic hormone-receptor-positive (HR+)/human epidermal growth factor receptor-2-negative (HER2−) breast cancer patients in the United States: 2002–2012

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Impact of omalizumab on emergency-department visits, hospitalizations, and corticosteroid use among patients with uncontrolled asthma

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Brain metastases in patients with ALK+ non-small cell lung cancer: clinical symptoms, treatment patterns and economic burden

19,709), respectively, compared with high adherence. CONCLUSIONS Worse adherence to pulmonary medications was associated with higher acute health-care use in a national, privately insured cohort of patients with CF. Addressing adherence may reduce avoidable health-care use.

Disease management patterns for postmenopausal women in Europe with hormone-receptor-positive, human epidermal growth factor receptor-2 negative advanced breast cancer

Though tobramycin inhalation solution has been used for over a decade to improve lung function and reduce exacerbations in patients with cystic fibrosis (CF), its effects on mortality have not been well‐described. This study aimed to assess the association between use of tobramycin inhaled solution and mortality in patients with CF and chronic Pseudomonas aeruginosa (PA) infection.

Comparative Efficacy of Ceritinib and Crizotinib as Initial ALK–Targeted Therapies in Previously Treated Advanced NSCLC: An Adjusted Comparison with External Controls

Background The use of inhaled corticosteroids in patients with chronic obstructive pulmonary disease (COPD) has been associated with an increased risk of pneumonia in controlled clinical trials and case-control analyses. Objective Using claims databases as a research model of real-world diagnosis and treatment, to determine if the use and dose of inhaled corticosteroids (ICS) among patients with newly diagnosed COPD are associated with increased risk of pneumonia. Patients and methods This was a retrospective cohort analysis of patients diagnosed with COPD between January 01, 2006 and September 30, 2010, drawn from databases (years 2006–2010). Patients (aged ≥45 years) were followed until first pneumonia diagnosis, end of benefit enrollment, or December 31, 2010, whichever was earliest. A Cox proportional hazard model was used to assess the association of ICS use and risk of pneumonia, controlling for baseline characteristics. Daily ICS use was classified into low, medium, and high doses (1 μg–499 μg, 500 μg–999 μg, and ≥1000 μg fluticasone equivalents daily) and was modeled as a time-dependent variable. Results Among 135,445 qualifying patients with a total of 243,097 person-years, there were 1020 pneumonia incidences out of 5677 person-years on ICS (crude incidence rate, 0.180 per person-year), and 27,730 pneumonia incidences out of 237,420 person-years not on ICS (crude incidence rate, 0.117 per person-year). ICS use was associated with a dose-related increase in risk of pneumonia, with adjusted hazard ratios (versus no use; (95% confidence interval) of 1.38 (1.27–1.49) for low-dose users, 1.69 (1.52–1.88) for medium-dose users, and 2.57 (1.98–3.33) for high-dose users (P < 0.01 versus no use and between doses). Conclusion The use of ICS in newly diagnosed patients with COPD is potentially associated with a dose-related increase in the risk of pneumonia.