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Post hoc analysis of initial treatments and control status in the INITIAL study: an observational study of newly diagnosed patients with asthma.

ABSTRACT: BACKGROUND:The 12-week, multicentre, observational INITIAL study (NCT02143739) assessed asthma severity in newly diagnosed Chinese patients. METHODS:Post hoc analysis of medication combinations prescribed per routine clinical practice at baseline, and the impact on control levels evaluated using 2012 vs 2018 Global Initiative for Asthma (GINA) criteria. RESULTS:In total, 4491 patients were included in the analysis. At baseline, intermittent, mild, moderate and severe asthma was reported in 3.9, 12.0, 22.6 and 61.6% of patients, respectively. Most patients (90.2%) were prescribed inhaled corticosteroid/long-acting ?2 agonist (ICS/LABA). ICS/LABA plus ?1 additional medication(s) was prescribed to 66.7% of patients, with leukotriene receptor antagonist (LTRA, 54.7%) being the most common additional medication. Distribution of ICS/LABA vs ICS/LABA+LTRA was comparable in patients with intermittent (3.2% vs 3.0%), mild (11.5% vs 9.7%), moderate (21.2% vs 19.9%) and severe asthma (64.1% vs 67.4%). Control levels among patients using ICS/LABA+LTRA vs ICS/LABA were comparable using GINA 2012 and lower using GINA 2018 criteria. The proportion of patients using ICS/LABA+LTRA vs ICS/LABA with intermittent, mild, moderate and severe asthma controlled at Week 12 (using GINA 2012) were 78.1% vs 80.0, 86.5% vs 85.8, 78.5% vs 71.3, and 59.6% vs 61.8%, respectively. Using GINA 2018 criteria proportions were 86.8% vs 95.9, 86.1% vs 93.2, 82.1% vs 85.3, and 71.9% vs 77.6%, respectively. CONCLUSIONS:Asthma control was not improved by adding LTRA to ICS/LABA and may have been unnecessary for some newly diagnosed patients. These findings were irrespective of the GINA criteria (2012 vs 2018) used and baseline severity.

SUBMITTER: Lin J

PROVIDER: S-EPMC7147012 | biostudies-literature | 2020 Apr

REPOSITORIES: biostudies-literature

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Post hoc analysis of initial treatments and control status in the INITIAL study: an observational study of newly diagnosed patients with asthma.

Lin Jiangtao J Fu Xiuhua X Jiang Ping P Song Weidong W Hu Xiaoyun X Jie Zhijun Z Liu Chuntao C He Zhengguang Z Zhou Xiangdong X Tang Huaping H

BMC pulmonary medicine 20200409 1

<h4>Background</h4>The 12-week, multicentre, observational INITIAL study (NCT02143739) assessed asthma severity in newly diagnosed Chinese patients.<h4>Methods</h4>Post hoc analysis of medication combinations prescribed per routine clinical practice at baseline, and the impact on control levels evaluated using 2012 vs 2018 Global Initiative for Asthma (GINA) criteria.<h4>Results</h4>In total, 4491 patients were included in the analysis. At baseline, intermittent, mild, moderate and severe asthma ...[more]

PMID: 32272921

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Project description:BackgroundThere are no large sample, epidemiological data describing initial asthma severity and change. We used a large health care database to examine asthma severity at initial diagnosis, and the changes in severity over the first year of management.MethodsThe clinical data of patients diagnosed with asthma for the first time were collated from the SuValue electronic medical database. The following inclusion criteria were applied: (I) patients who were 14 years or older at the time of first diagnosis; (II) initial diagnosis occurred between Jan 2001 and Mar 2019; (III) patients were followed up for at least 12 months; (IV) patients had follow-up visits every 3 months. Disease severity at diagnosis and at each follow-up visit, medications prescribed were collated and analyzed.ResultsA total of 7,654 adult patients with newly diagnosed asthma from tertiary hospitals (26.38%) and secondary hospitals (73.62%), who were followed up for at least 12 months, were included in this retrospective analysis. Approximately 54% of patients were females and the largest age group was over 60 years old (37.66%). Nearly 16% of patients were moderate to severe asthma initially. The proportions of patients with moderate and severe asthma decreased during the first 6 months, and remained stable thereafter. At the end of the 1-year follow-up period, 2.7% of patients had severe asthma. Patients with mild asthma tended to continue to have mild asthma in the following 3 months (>76.19%). However, of the patients with mild or moderate asthma at 3 months, 92.85% and 75.1%, respectively, experienced maintenance and reduction in severity and had mild asthma by 12 months. 1.26% and 3.15% of patients with mild or moderate asthma, respectively, progressed to severe asthma by 12 months.ConclusionsPatients with mild asthma did not progress but rather, remained stable with mild asthma over the year. A proportion of patients diagnosed with moderate and severe asthma remained stable over a 1-year period. Further studies should be conducted to examine the clinical features of newly diagnosed patients with severe asthma without reduction in severity in order to facilitate intensive treatment and reduce the disease burden for these patients.

Project description:ObjectiveThis post hoc analysis evaluated whether continued treatment with perampanel monotherapy beyond initial titration may be appropriate for patients with focal-onset seizures (FOS) with currently untreated epilepsy to achieve seizure freedom with an effective dose.MethodsStudy 342 (NCT03201900; FREEDOM) is a single-arm, open-label, Phase III study of perampanel monotherapy. Patients aged ≥12 years with untreated FOS received perampanel 4 mg/d in a 32-week Treatment Phase (6-week Titration and 26-week Maintenance Periods); in case of seizure(s) during Maintenance Period, patients could enter a 30-week Treatment Phase (4-week Titration and 26-week Maintenance Periods) to be up-titrated to perampanel 8 mg/d. The primary endpoint was seizure-freedom rate during Maintenance Period in the modified Intent-to-Treat (mITT) Analysis Set (patients who had ≥1 post-dose efficacy measurement during Maintenance Period); safety was monitored. This analysis of 4-mg/d efficacy data assessed the proportion of patients achieving seizure freedom during the Maintenance Period (responders) relative to patients with an early/later response (depending on seizure status during the Titration Period).ResultsIn the mITT population (n = 73), 46 patients were 4-mg/d responders; of whom, 37 (80.4%) were early responders and nine (19.6%) were later responders. The mean (standard deviation) percent reductions in FOS frequency from baseline at the end of the 4-mg/d Titration Period were 100.0% (0.0%; early responders) and 46.3% (97.3%; later responders). Among the 27 4-mg/d nonresponders, nine (33.3%) patients who had an early response experienced seizure(s) during the subsequent 4-mg/d Maintenance Period. Safety outcomes were similar, regardless of responder status, without new safety concerns.SignificanceSome patients with untreated FOS may benefit from continued treatment beyond initial titration of perampanel monotherapy to achieve seizure freedom, suggesting that it may not be appropriate to make treatment decisions to discontinue or switch from perampanel monotherapy solely based on seizure response before an effective dose has been reached.

Project description:Abstract Objective To investigate the clinical outcomes of patients who underwent cardioversion compared with those who did not have cardioverson in a large dataset of patients with recent onset non-valvular atrial fibrillation. Design Observational study using prospectively collected registry data (Global Anticoagulant Registry in the FIELD-AF—GARFIELD-AF). Setting 1317 participating sites in 35 countries. Participants 52 057 patients aged 18 years and older with newly diagnosed atrial fibrillation (up to six weeks’ duration) and at least one investigator determined stroke risk factor. Main outcome measures Comparisons were made between patients who received cardioversion and those who had no cardioversion at baseline, and between patients who received direct current cardioversion and those who had pharmacological cardioversion. Overlap propensity weighting with Cox proportional hazards models was used to evaluate the effect of cardioversion on clinical endpoints (all cause mortality, non-haemorrhagic stroke or systemic embolism, and major bleeding), adjusting for baseline risk and patient selection. Results 44 201 patients were included in the analysis comparing cardioversion and no cardioversion, and of these, 6595 (14.9%) underwent cardioversion at baseline. The propensity score weighted hazard ratio for all cause mortality in the cardioversion group was 0.74 (95% confidence interval 0.63 to 0.86) from baseline to one year follow-up and 0.77 (0.64 to 0.93) from one year to two year follow-up. Of the 6595 patients who had cardioversion at baseline, 299 had a follow-up cardioversion more than 48 days after enrolment. 7175 patients were assessed in the analysis comparing type of cardioversion: 2427 (33.8%) received pharmacological cardioversion and 4748 (66.2%) had direct current cardioversion. During one year follow-up, event rates (per 100 patient years) for all cause mortality in patients who received direct current and pharmacological cardioversion were 1.36 (1.13 to 1.64) and 1.70 (1.35 to 2.14), respectively. Conclusion In this large dataset of patients with recent onset non-valvular atrial fibrillation, a small proportion were treated with cardioversion. Direct current cardioversion was performed twice as often as pharmacological cardioversion, and there appeared to be no major difference in outcome events for these two cardioversion modalities. For the overall cardioversion group, after adjustments for confounders, a significantly lower risk of mortality was found in patients who received early cardioversion compared with those who did not receive early cardioversion. Study registration ClinicalTrials.gov NCT01090362.

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Post hoc analysis of initial treatments and control status in the INITIAL study: an observational study of newly diagnosed patients with asthma.

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Post hoc analysis of initial treatments and control status in the INITIAL study: an observational study of newly diagnosed patients with asthma.

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