American journal of therapeutics
-
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.
-
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.
-
It is widely accepted that randomized controlled trials (RCTs) are the gold standard for demonstrating the efficacy of a given therapy (results under ideal conditions). Observational studies, on the other hand, can complement this by demonstrating effectiveness (results under real-world conditions). ⋯ Observational studies of statin use in 'real-world' populations have served to augment the evidence base generated from statin RCTs in preselected populations of patients who are often at high CV risk and have led to similar safety and efficacy findings. They have also raised questions about factors affecting medication adherence, under-treatment, switching between statins, and failure to reach low-density lipoprotein cholesterol target levels, questions for which the answers could lead to improved patient care.
-
Although depression has been reported to be associated with various cardiovascular risk factors, whether an association exists between depression and prevalence of cardiovascular events is not well known. In particular, the effect of symptom frequency and cardiovascular events has not been described. Data were collected for patients older than 45 years from the 2007-2008 National Health and Nutrition Examination Survey (NHANES) data to study whether an association exists between depression and prevalence of coronary artery disease (CAD), myocardial infarction (MI), congestive heart failure (CHF), and stroke. ⋯ Significant associations were noted between depressive symptoms and prevalence of CAD, MI, CHF, and stroke. Those who reported being depressed more than half of the days of the week had 1.95 times greater odds of CAD [95% confidence interval (CI), 1.2473-3.0523], 2.54 times greater odds of CHF (95% CI, 1.6114-4.0126), 2.65 times greater odds of MI (95% CI, 1.7789-3.9521), and 1.91 greater odds of stroke (95% CI, 1.2002-3.0356) when compared with those who reported being depressed less than half of the days of the week. The results of this study suggest that the prevalence of CAD, MI, CHF, and stroke are significantly increased in individuals who report feeling down/depressed/hopeless for more than half the days of the week.
-
Observational Study
Role of Anemia in Home Oxygen Therapy in Chronic Obstructive Pulmonary Disease Patients.
Anemia is a known comorbidity found in chronic obstructive pulmonary disease (COPD) patients. Hypoxemia is common and basically due to ventilation/perfusion (V/Q) mismatch in COPD. Anemia, by decreasing arterial oxygen content, may be a contributing factor for decreased delivery of oxygen to tissues. ⋯ Multivariate logistic regression showed that anemia remained a strong predictor for long-term oxygen therapy use in COPD patients after adjusting for other significant parameters. Anemic COPD patients are more hypoxic especially during exercise than those who are not anemic. We conclude that anemia is a contributing factor in qualifying COPD patients for home oxygen therapy.