Most patients report improvement in nasal and sleep symptoms after correction of nasal airway obstruction. However, nasal surgery alone does not consistently improve OSA when measured objectively. Depending on the severity of OSA, nasal airway reconstruction may contribute to a decrease in CPAP level and improvement in oxygen saturation. Correction of the obstructed nasal airway should certainly be included in the overall treatment plan for OSA.

The results show that submucous resection of inferior turbinates with a microdebrider is a safe method of achieving turbinate size reduction with minimal morbidity.

Epidemiological studies suggest diabetes mellitus (DM) may be an extrahepatic manifestation of chronic hepatitis C virus (HCV) infection. Since diabetes and HCV are common in liver transplant recipients, we sought to examine the unique contribution of HCV infection to risk of de novo diabetes posttransplantation. Using a cohort of 555 liver transplant recipients (median age 49 years, 54% males, 82% Caucasian) without preexisting diabetes from 3 U.S. centers enrolled between 1990 and 1994 and followed for a median duration of 5 years, we determined the incidence of de novo diabetes and the independent predictors of the development of diabetes. De novo diabetes was defined by the use of antidiabetic medications. De novo diabetes developed in 209/555 (37.7%) patients of whom 157 (28.3%) had transient-DM (T-DM) and 52 (9.4%) had persistent-DM (P-DM). Among HCV-infected transplant recipients, de novo T-DM and P-DM developed in 26% and 14%, respectively. HCV was predictive of P-DM (P ‫؍‬ .02) but not T-DM. Older age (P ‫؍‬ .03) and tacrolimus use (P ‫؍‬ .02) were also independent predictors of P-DM. In conclusion, de novo diabetes is common in transplant recipients, but is typically transient in nature. Epidemiological studies have shown an association between HCV and diabetes. Among persons 40 years of age or older in the United States, those with HCV infection are nearly 4 times more likely to have DM than those without HCV infection; 3 additionally, the prevalence of HCV infection is about 2.5 times higher in patients with diabetes than in those without diabetes. 4 Moreover, the association between HCV and diabetes seems specific, as the odds of developing diabetes are 2 to 16 times higher in individuals with chronic HCV than those with chronic hepatitis B or other types of chronic liver disease. [3][4][5][6][7] Preliminary data suggest DM is more frequent among patients undergoing liver transplantation for HCV than for other indications and that posttransplant diabetes is more common in HCVinfected transplant recipients than in those without HCV. 8,9 However, limitations of prior studies include small sample size, 9 -11 failure to control for potential confounders such as amount of immunosuppression and comorbidities such as obesity, 9,11 or failure to clearly differentiate transient from persistent diabetes posttransplantation. 8,9 Using a large cohort of liver transplant recipients from 3 U.S. transplant centers, we evaluated the relationship between HCV and new onset diabetes after liver transplantation.

The goal of clinical trial research is to deliver safe and efficacious new treatments to patients in need in a timely and cost-effective manner. There is precedent in using historical control data to reduce the number of concurrent control subjects required in developing medicines for rare diseases and other areas of unmet need. The purpose of this paper is to provide a review for a regulatory and industry audience of the current state of relevant statistical methods, and of the uptake of these approaches and the opportunities for broader use of historical data in confirmatory clinical trials. General principles to consider when incorporating historical control data in a new trial are presented. Bayesian and frequentist approaches are outlined including how the operating characteristics for such a trial can be obtained. Finally, examples of approved new treatments that incorporated historical controls in their confirmatory trials are presented.

BackgroundCombination therapy with an inhaled corticosteroid (ICS) and long-acting β2 agonist (LABA) is recommended for patients with asthma symptomatic on ICS alone. However, there is ongoing debate regarding the risk-benefit ratio of using LABA in asthma.ObjectiveTo evaluate the effect of the addition of a novel LABA, vilanterol (VI), to a once-daily ICS, fluticasone furoate (FF), on the risk of severe asthma exacerbations in patients with uncontrolled asthma.MethodsThis randomised double-blind comparative study of variable duration (≥24–78 weeks) was designed to finish after 330 events (each patient's first on-treatment severe asthma exacerbation). 2019 patients with asthma aged ≥12 years with ≥1 recorded exacerbation within 1 year were randomised and received FF/VI 100/25 μg or FF 100 μg, administered once daily in the evening. The primary endpoint was time to first severe exacerbation; secondary endpoints were rate of severe asthma exacerbations per patient per year and change in trough evening forced expiratory volume in 1 s (FEV1) from baseline.ResultsCompared with FF, FF/VI delayed the time to first severe exacerbation (HR 0.795, 95% CI 0.642 to 0.985) and reduced the annualised rate of severe exacerbations (rate reduction 25%, 95% CI 5% to 40%). Significantly greater improvements in trough FEV1 (p<0.001) were observed with FF/VI than with FF at weeks 12, 36, 52 and at endpoint. Both treatments were well tolerated with similar rates of treatment-related adverse events and on-treatment serious adverse events.ConclusionsOnce-daily FF/VI reduced the risk of severe asthma exacerbations and improved lung function compared with FF alone, with good tolerability and safety profile in adolescents and adults with asthma currently receiving ICS.ClinicalTrials.gov NoNCT01086384