American journal of therapeutics
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Noninvasive ventilation (NIV) has been found to be beneficial for respiratory failure in many disease states; however, limited data are available supporting its use in acute asthma exacerbation. A retrospective chart analysis of adult patients admitted for acute asthma exacerbation and treated with NIV between January 2007 and December 2009 at a tertiary care community hospital was done. Ninety-eight patient encounters were identified. ⋯ Use of inhalers and other medications was not found to significantly influence the rate of failure of NIV. NIV can be used initially in patients with acute asthma exacerbation, as it is associated with shorter duration of hospital stay and can prevent the morbidity of mechanical intubation. Patients with initial requirement of higher FiO2 were more likely to fail NIV and should be carefully monitored.
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To fully assess the safety and efficacy of therapeutics before approval, the US Food and Drug Administration (FDA) has encouraged adequate representation and assessment of demographic subgroups in clinical trials through guidance documents and regulations. This study aimed to survey the demographics of participants in pivotal clinical trials, as well as the presence of analyses by sex on efficacy and safety for FDA-approved new drug applications (NDAs) and biologics license applications (BLAs) from 2010 to 2012. Medical and statistical reviews for new molecular entity drugs and biological products approved during this period were obtained from Drugs@FDA. ⋯ Overall, women constituted 45% of trial participants for NDAs and 65% for BLAs. Sex analysis related to safety and efficacy was reported in 92% of the surveyed FDA medical and statistical reviews. Most NDAs and BLAs (82%) had a study population that was representative of the sex distribution for the intended patient population; however, most study participants were whites (77%), and minority racial/ethnic groups had lower participation rates in the study population than would be representative of the US racial group populations.