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Displaying 691 - 700 of 7510 in ACP Online
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Displaying 691 - 700 of 6736 in Annals of Internal Medicine
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Regulatory Review Duration and Differences in Submission Times of Drugs in the United States and Europe, 2011 to 2020
The speed of drug regulatory agencies in the United States and Europe is often a source of discussion. The objective of this research was to assess regulatory review duration of first and supplementary indications approved between 2011 and 2020 in the United States and Europe (European Union [EU] and Switzerland) and differences in submission times between the United States and Europe. Descriptive statistics were applied to review times between the jurisdictions and across the therapeutic areas. A regression analysis was done to estimate the association between approval agency and review times. The primary analysis cohort included 241 drugs approved in the United States, the EU, and Switzerland. Of these, 128 drugs had supplemental indications (331 in total) in the United States and 87 had supplemental indications (206 in total) in the EU. Overall median review duration from submission to approval subtracting the clock stop period was 39 weeks in the United States, 44 weeks in the EU, and 44 weeks in Switzerland. When review times within each drug were compared, the European Medicines Agency took a median of 3.7 weeks (IQR, −6.7 to 14.9 weeks) longer than the U.S. Food and Drug Administration and Swissmedic a median of 0.3 weeks (IQR, −10.6 to 15.3 weeks) longer. Median total review duration for supplemental indications was 26 weeks in the United States and 40 weeks in the EU. Applications were submitted a median of 1.3 and 17.9 weeks later in the EU and Switzerland, respectively, than in the United States. The regression analysis showed small differences in submission times between the United States and the EU (−2.1 weeks [95% CI, −11.7 to 7.6 weeks]) and larger differences between the United States and Switzerland (33.0 weeks [CI, 23.1 to 42.8 weeks]). It would be beneficial for patients if differences in submission times between the United States and Europe continue to be minimized.
Improving COVID-19 Disease Severity Surveillance Measures: Statewide Implementation Experience
Measurement of the burden of COVID-19 on U.S. hospitals has been an important element of the public health response to the pandemic. However, because of variation in testing density and policies, the metric is not standardized across facilities. Two types of burdens exist, one related to the infection control measures that patients who test positive for SARS-CoV-2 require and one from the care of severely ill patients receiving treatment of COVID-19. With rising population immunity from vaccination and infection, as well as the availability of therapeutics, severity of illness has declined. Prior research showed that dexamethasone administration was highly correlated with other disease severity metrics and sensitive to the changing epidemiology associated with the emergence of immune-evasive variants. On 10 January 2022, the Massachusetts Department of Public Health began requiring hospitals to expand surveillance to include reports of both the total number of “COVID-19 hospitalizations” daily and the number of inpatients who received dexamethasone at any point during their hospital stay. All 68 acute care hospitals in Massachusetts submitted COVID-19 hospitalization and dexamethasone data daily to the Massachusetts Department of Public Health over a 1-year period. A total of 44 196 COVID-19 hospitalizations were recorded during 10 January 2022 to 9 January 2023, of which 34% were associated with dexamethasone administration. The proportion of patients hospitalized with COVID-19 who had received dexamethasone was 49.6% during the first month of surveillance and decreased to a monthly average of approximately 33% by April 2022, where it has remained since (range, 28.7% to 33%). Adding a single data element to mandated reporting to estimate the frequency of severe COVID-19 in hospitalized patients was feasible and provided actionable information for health authorities and policy makers. Updates to surveillance methods are necessary to match data collection with public health response needs.
Comparative Effectiveness and Safety of Generic Versus Brand-Name Fluticasone–Salmeterol to Treat Chronic Obstructive Pulmonary Disease
Background: In 2019, the U.S. Food and Drug Administration (FDA) approved the first generic maintenance inhaler for asthma and chronic obstructive pulmonary disease (COPD). The inhaler, Wixela Inhub (fluticasone–salmeterol; Viatris), is a substitutable version of the dry powder inhaler Advair Diskus (fluticasone–salmeterol; GlaxoSmithKline). When approving complex generic products like inhalers, the FDA applies a special “weight-of-evidence” approach. In this case, manufacturers were required to perform a randomized controlled trial in patients with asthma but not COPD, although the product received approval for both indications. Objective: To compare the effectiveness and safety of generic (Wixela Inhub) and brand-name (Advair Diskus) fluticasone–salmeterol among patients with COPD treated in routine care. Design: A 1:1 propensity score–matched cohort study. Setting: A large, longitudinal health care database. Patients: Adults older than 40 years with a diagnosis of COPD. Measurements: Incidence of first moderate or severe COPD exacerbation (effectiveness outcome) and incidence of first pneumonia hospitalization (safety outcome) in the 365 days after cohort entry. Results: Among 45 369 patients (27 305 Advair Diskus users and 18 064 Wixela Inhub users), 10 012 matched pairs were identified for the primary analysis. Compared with Advair Diskus use, Wixela Inhub use was associated with a nearly identical incidence of first moderate or severe COPD exacerbation (hazard ratio [HR], 0.97 [95% CI, 0.90 to 1.04]) and first pneumonia hospitalization (HR, 0.99 [CI, 0.86 to 1.15]). Limitations: Follow-up times were short, reflecting real-world clinical practice. The possibility of residual confounding cannot be completely excluded. Conclusion: Use of generic and brand-name fluticasone–salmeterol was associated with similar outcomes among patients with COPD treated in routine practice. Primary Funding Source: National Heart, Lung, and Blood Institute.
Major Update: Masks for Prevention of SARS-CoV-2 in Health Care and Community Settings—Final Update of a Living, Rapid Review
Background: Optimal use of masks for preventing COVID-19 is unclear. Purpose: To update an evidence synthesis on N95, surgical, and cloth mask effectiveness in community and health care settings for preventing SARS-CoV-2 infection. Data Sources: MEDLINE, EMBASE, medRxiv (3 June 2022 to 2 January 2023), and reference lists. Study Selection: Randomized trials of interventions to increase mask use and risk for SARS-CoV-2 infection and observational studies of mask use that controlled for potential confounders. Data Extraction: Two investigators sequentially abstracted study data and rated quality. Data Synthesis: Three randomized trials and 21 observational studies were included. In community settings, mask use may be associated with a small reduced risk for SARS-CoV-2 infection versus no mask use, on the basis of 2 randomized trials and 7 observational studies. In routine patient care settings, surgical masks and N95 respirators may be associated with similar risk for SARS-CoV-2 infection, on the basis of 1 new randomized trial with some imprecision and 4 observational studies. Evidence from observational studies was insufficient to evaluate other mask comparisons due to methodological limitations and inconsistency. Limitation: Few randomized trials, studies had methodological limitations and some imprecision, suboptimal adherence and pragmatic aspects of randomized trials potentially attenuated benefits, very limited evidence on harms, uncertain applicability to Omicron variant predominant era, meta-analysis not done due to heterogeneity, unable to formally assess for publication bias, and restricted to English-language articles. Conclusion: Updated evidence suggests that masks may be associated with a small reduction in risk for SARS-CoV-2 infection in community settings. Surgical masks and N95 respirators may be associated with similar infection risk in routine patient care settings, but a beneficial effect of N95 respirators cannot be ruled out. Primary Funding Source: None.