117,783 research outputs found
Expression of concern regarding the article titled “Variability in the serum and tissue concentrations of pre-incisional ceftriaxone for surgery in paediatric population and outcome of surgical-site infections; An open labelled, prospective, non-randomized, analytical study”
No full textI am writing to formally express my concern regarding the article titled “Variability in the serum and tissue concentrations of pre-incisional ceftriaxone for surgery in the paediatric population and outcome of surgical-site infections; An open-labelled, prospective, non-randomized, analytical study” published in Current Research in Pharmacology and Drug Discovery (Sheikh et al., 2022). The primary issue pertains to the absence of a clinical trial registration number, which raises significant ethical considerations about the study's oversight and transparency. Clinical trial registration is crucial for ensuring ethical and scientific integrity in research involving human participants. This note will remain appended to the article to inform readers of these concerns until the authors provide the necessary registration details to the Editors of Current Research in Pharmacology and Drug Discovery. I appreciate the understanding and patience of all stakeholders as we seek to resolve this matter
Bayesian or frequentist: there is no question when comparing single-inhaler triple therapies via network meta-analysis. Focus on fluticasone furoate/umeclidinium/vilanterol fixed-dose combination in chronic obstructive pulmonary disease
No full textobjectives: Single-inhaler triple therapies (SITTs) have never been directly compared in randomized controlled trials (RCTs) in chronic obstructive pulmonary disease (COPD). cochrane recommends the bayesian approach for indirect comparisons but a frequentist network meta-analysis (NMA) reported superiority of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) over other SITT. We assessed the most appropriate inference method for NMA characterized by between-study heterogeneity on SITT in COPD. methods: bayesian and frequentist NMA were performed on RCTs investigating the effect of SITT on exacerbations and trough forced expiratory volume in the 1st second (FEV1) in COPD. results: the included RCTs (ETHOS, FULFIL, IMPACT, KRONOS 200812) reported significant between-study heterogeneity (I-2 > 99%, p < 0.001). the Bayesian random-effect NMA provided unbiased evidence that FF/UMEC/VI was not superior to other SITT on exacerbations and trough FEV1. the frequentist fixed-effect NMA indicated that FF/UMEC/VI was significantly (p < 0.05) more effective than other SITT, although results were affected by dispersion, asymmetry, and significant risk of bias. frequentist random-effect NMA provided effect estimates rather similar but not equal to those of bayesian approach. conclusion: Indirect comparison should be performed via bayesian approach instead of frequentist inference with a fixed-effect model. claiming the superiority of a specific medication over other therapies should be confirmed by findings originating from well-designed RCTs
Response to letter to the editor. Again on IMPACT: exacerbation after abrupt discontinuation of ICS and pneumonia in fluticasone furoate-containing FDCs
No full textLong-Acting Muscarinic Antagonists Under Investigational to Treat Chronic Obstructive Pulmonary Disease
No full textJosuel Ora,1 Angelo Coppola,2 Mario Cazzola,3 Luigino Calzetta,4 Paola Rogliani1,3 1Division of Respiratory Medicine, University Hospital Tor Vergata, Rome, Italy; 2Division of Respiratory Medicine, San Filippo Neri Hospital, Rome, Italy; 3Department of Experimental Medicine, University of Rome Tor Vergata, Rome, Italy; 4Department of Medicine and Surgery, Respiratory Disease and Lung Function Unit, University of Parma, Parma, ItalyCorrespondence: Josuel OraDivision of Respiratory Medicine, University Hospital Tor Vergata, Viale Oxford 81, Rome 00133, ItalyEmail [email protected]: Bronchodilators are the cornerstone of chronic obstructive pulmonary disease (COPD) therapy and long-acting muscarinic antagonists (LAMAs) as a mono or combination treatment play a pivotal role. Several LAMAs are already available on the market in different formulations, but developing a new compound with a higher M3 receptor selectivity and a lower affinity to M2 receptors to increase the therapeutic effect and minimize the adverse effects is still a goal. Moreover, new formulations could improve adherence to therapy.Areas Covered: This systematic review assesses investigational long-acting muscarinic antagonist in Phase I and II clinical trials over the last decade. It offers insights on whether LAMAs and/or their new formulations in clinical development can become effective treatments for COPD in the future.Expert Opinion: Research on LAMA seems to have come to a standstill, the few new molecules under study do not show distinctive characteristics compared to the previous ones. Muscarinic antagonist/β 2-agonist (MABAs) appear to be the major innovation currently under investigation, and they could theoretically open new research frontiers on the effect between adrenergic and muscarinic interaction in the same cell.Keywords: long-acting muscarinic antagonist, MABA, LAMA, Phase I, Phase II, efficacy, safety, COPD treatment, investigational drugs, chronic obstructive pulmonary diseas
Dose of Inhaled Corticosteroids and Cardiovascular Disease in Asthma: An Unexpected Misstep?
No full textImpact of Airway-Occluding Mucus Plugs on Mortality in Patients with COPD According to Disease Severity: A Subset Analysis of Data From COPDGene
No full textBackground: Chronic mucus hypersecretion (CMH) in chronic obstructive pulmonary disease (COPD) is associated with severe outcomes, but its impact on mortality across COPD stages is not well understood. This study evaluated the risk of mortality according to mucus plugs and COPD severity. Methods: A subset analysis was performed using secondary unadjusted data from published figures of a study on the COPDGene cohort. Data on mortality rates and mucus plug scores were extracted and classified by the GOLD stages. The mortality risk was calculated based on the number of mucus plugs occluding lung segments and GOLD stage, using calibration curves and best-fitting non-linear regression curve analysis. Results: The risk of all-cause mortality was significantly increased for GOLD stage 1 patients with ≥1 occluded lung segments (1.48, 95% CI 1.10–1.86; P<0.01) compared to those with no occlusions. Patients with GOLD stage 1 and ≥3 occluded lung segments had a significantly higher mortality risk (1.89, 95% CI 1.43–2.36; P<0.001). No increased mortality risk resulted for patients with 1–2 occluded lung segments and those at GOLD stage 2–4. The number needed to harm analysis indicated that 6 patients with ≥3 occluded segments at GOLD stage 1 were required to observe one death, compared to 26 patients at GOLD stage 4. Conclusion: The significant mortality risk associated with multiple mucus-plugged segments at GOLD stage 1 supports the potential benefit of thiol-based mucolytic therapy. Targeted interventions to reduce mucus plugs could be crucial in improving survival outcomes for early-stage COPD patients
Cardiovascular Events in Chronic Obstructive Pulmonary Disease: Squeezing ETHOS Dry for Clinical Evidence at Risk of Type I Error
No full textCardiovascular disease in COPD
No full textCOPD is a serious public health concern and is frequently associated with CVD. When COPD is associated with CVD, there is reduced health status and increased hospitalisation rate and mortality. CVD and COPD share a common background chronic low-grade systemic inflammation, triggered by several stimuli including air pollutants and cigarette smoke. The teleological activities and paradoxical effects of polypeptide cardiac hormones further support the intimate relationship between CVD and COPD. COPD exacerbations play a pivotal role in COPD progression, and early identification of cardiac problems could help to better phenotype COPD exacerbators and ameliorate disease prognosis. In this scenario, novel predictive tools and biomarkers of cardiovascular risk specifically validated in COPD populations may help to identify pre-symptomatic subjects. Current recommendations for the management of CVD in COPD patients are limited and therefore pulmonologists and cardiologists should work together in order to reach a correct and complementary diagnosis and identify tailored therapy
- …
