scholarly journals High-dose versus low-dose prednisolone in symptomatic patients with post-COVID-19 diffuse parenchymal lung abnormalities: an open-label, randomised trial (Acronym: COLDSTER)

2021 ◽  
pp. 2102930
Author(s):  
Sahajal Dhooria ◽  
Shivani Chaudhary ◽  
Inderpaul Singh Sehgal ◽  
Ritesh Agarwal ◽  
Siddhant Arora ◽  
...  
Keyword(s):  
Low Dose ◽  
Randomised Trial ◽  
High Dose ◽  
Open Label ◽  
Lung Abnormalities ◽  
Parenchymal Lung

scholarly journals Open-label randomised pragmatic trial (CONTACT) comparing naproxen and low-dose colchicine for the treatment of gout flares in primary care

2019 ◽  
Vol 79 (2) ◽  
pp. 276-284 ◽  
Author(s):  
Edward Roddy ◽  
Kris Clarkson ◽  
Milica Blagojevic-Bucknall ◽  
Rajnikant Mehta ◽  
Raymond Oppong ◽  
...  
Keyword(s):  
Primary Care ◽  
Pain Intensity ◽  
Primary Outcome ◽  
Low Dose ◽  
Rating Scale ◽  
Randomised Trial ◽  
Pragmatic Trial ◽  
Open Label ◽  
Gout Flare ◽  
Gout Flares

ObjectivesTo compare the effectiveness and safety of naproxen and low-dose colchicine for treating gout flares in primary care.MethodsThis was a multicentre open-label randomised trial. Adults with a gout flare recruited from 100 general practices were randomised equally to naproxen 750 mg immediately then 250 mg every 8 hours for 7 days or low-dose colchicine 500 mcg three times per day for 4 days. The primary outcome was change in worst pain intensity in the last 24 hours (0–10 Numeric Rating Scale) from baseline measured daily over the first 7 days: mean change from baseline was compared between groups over days 1–7 by intention to treat.ResultsBetween 29 January 2014 and 31 December 2015, we recruited 399 participants (naproxen n=200, colchicine n=199), of whom 349 (87.5%) completed primary outcome data at day 7. There was no significant between-group difference in average pain-change scores over days 1–7 (colchicine vs naproxen: mean difference −0.18; 95% CI −0.53 to 0.17; p=0.32). During days 1–7, diarrhoea (45.9% vs 20.0%; OR 3.31; 2.01 to 5.44) and headache (20.5% vs 10.7%; 1.92; 1.03 to 3.55) were more common in the colchicine group than the naproxen group but constipation was less common (4.8% vs 19.3%; 0.24; 0.11 to 0.54).ConclusionWe found no difference in pain intensity over 7 days between people with a gout flare randomised to either naproxen or low-dose colchicine. Naproxen caused fewer side effects supporting naproxen as first-line treatment for gout flares in primary care in the absence of contraindications.Trial registration numberISRCTN (69836939), clinicaltrials.gov (NCT01994226), EudraCT (2013-001354-95).

scholarly journals Effect of high versus low dose of dexamethasone on clinical worsening in patients hospitalised with moderate or severe COVID-19 Pneumonia: an open-label, randomised clinical trial

2021 ◽  
pp. 2102518
Author(s):  
Manuel Taboada ◽  
Nuria Rodríguez ◽  
Pablo Manuel Varela ◽  
María Teresa Rodríguez ◽  
Romina Abelleira ◽  
...  
Keyword(s):  
Dose Group ◽  
Oxygen Therapy ◽  
Low Dose ◽  
Ordinal Scale ◽  
High Dose Group ◽  
High Dose ◽  
Open Label ◽  
Once Daily ◽  
Significant Difference ◽  
Clinical Worsening

BackgroundLow dose dexamethasone demonstrated clinical improvement in patients with coronavirus disease 2019 (COVID-19) needing oxygen therapy; however, evidence on the efficacy of high dose of dexamethasone is limited.MethodsWe performed a randomised, open-label, controlled trial involving hospitalised patients with confirmed COVID-19 pneumonia needing oxygen therapy. Patients were randomly assigned in a 1:1 ratio to receive low dose dexamethasone (6 mg once daily for 10 days) or high dose dexamethasone (20 mg once daily for 5 days, followed by 10 mg once daily for additional 5 days). The primary outcome was clinical worsening within 11 days since randomisation. Secondary outcomes included 28-day mortality, time to recovery, and clinical status at day 5, 11, 14 and 28 on an ordinal scale ranging from 1 (discharged) to 7 (death).ResultsA total of 200 patients (mean (sd) age, 64 (14) years; 62% male) were enrolled. Thirty-two patients of 102 (31.4%) enrolled in the low dose group and 16 of 98 (16.3%) in the high dose group showed clinical worsening within 11 days since randomisation (rate ratio, 0.427; 95% CI, 0.216–0.842; p=0.014). The 28-day mortality was 5.9% in the low dose group and 6.1% in the high dose group (p=0.844). There was no significant difference in time to recovery, and in the 7-point ordinal scale at day 5, 11, 14 and 28.ConclusionsAmong hospitalised COVID-19 patients needing oxygen therapy, high dose of dexamethasone reduced clinical worsening within 11 days after randomisation as compared with low dose.

scholarly journals P1371HEART FAILURE HOSPITALISATIONS IN THE PIVOTAL TRIAL OF IV IRON IN HAEMODIALYSIS PATIENTS: A PRE-SPECIFIED SECONDARY ANALYSIS

2020 ◽  
Vol 35 (Supplement_3) ◽  
Author(s):  
Pardeep Jhund ◽  
Mark Petrie ◽  
Michele Robertson ◽  
Patrick Mark ◽  
Michael Macdonald ◽  
...  
Keyword(s):  
Heart Failure ◽  
Low Dose ◽  
Randomised Trial ◽  
Recurrent Event ◽  
High Dose ◽  
Iron Group ◽  
Dose Strategy ◽  
Iv Iron ◽  
Cardiovascular Endpoint ◽  
The Impact

Abstract Background and Aims Heart failure (HF) is a common and potentially deadly complication in patients receiving haemodialysis which is difficult to diagnose and treat. The impact of a proactive high-dose strategy compared to a reactive low-dose strategy of IV iron administration was investigated in the PIVOTAL randomised trial in incident haemodialysis patients, with fatal HF and HF hospitalisation being components of the composite primary cardiovascular endpoint as well as a pre-specified key secondary event. The aim of this analysis was to examine the effect of a proactive high-dose strategy compared to a reactive lower dose strategy on HF events in patients recruited to PIVOTAL. Method As with the primary composite cardiovascular endpoint, HF hospitalisations in PIVOTAL were recorded prospectively via an electronic database, and events were then adjudicated by a blinded Endpoint Adjudication Committee. The time-to-event analyses of the primary, secondary and post hoc outcomes were performed in the intention-to-treat population using Cox proportional hazards regression, with treatment group as the only explanatory variable. The Kaplan–Meier method was used to estimate event rates. Both fatal and non-fatal HF events were analysed as time to first event, and a recurrent event analysis was also performed for non-fatal events. Results Overall, 2141 participants were followed for a median of 2.1 years. A first fatal or non-fatal HF event occurred in 51 of 1093 patients (4.7%) in the high-dose iron group and in 70 of 1048 patients (6.7%) in the low-dose iron group (hazard ratio 0.66, 95% confidence interval 0.46 to 0.94; P<0.001) (Figure). There was a total of 63 HF events (including first and recurrent events) in the high-dose iron group and 98 in the low-dose iron group, giving a rate ratio of 0.59 (0.40-0.87); p=0.0084. A history of HF and diabetes were independent predictors of a heart failure event. Conclusion Compared with a low-dose regimen, high-dose intravenous iron decreased the occurrence of first and recurrent heart failure events in incident patients undergoing haemodialysis, with large relative and absolute risk reductions.

Randomised trial of high-dose isosorbide dinitrate plus low-dose furosemide versus high-dose furosemide plus low-dose isosorbide dinitrate in severe pulmonary oedema

The Lancet ◽  
1998 ◽  
Vol 351 (9100) ◽  
pp. 389-393 ◽  
Author(s):  
Gad Cotter ◽  
Einat Metzkor ◽  
Edo Kaluski ◽  
Zwi Faigenberg ◽  
Rami Miller ◽  
...  
Keyword(s):  
Pulmonary Oedema ◽  
Isosorbide Dinitrate ◽  
Low Dose ◽  
Randomised Trial ◽  
High Dose

scholarly journals A randomised controlled trial evaluating IGF1 titration in contrast to current GH dosing strategies in children born small for gestational age: the North European Small-for-Gestational-Age Study

2014 ◽  
Vol 171 (4) ◽  
pp. 509-518 ◽  
Author(s):  
Rikke Beck Jensen ◽  
Ajay Thankamony ◽  
Susan M O'Connell ◽  
Jeremy Kirk ◽  
Malcolm Donaldson ◽  
...  
Keyword(s):  
Gestational Age ◽  
Small For Gestational Age ◽  
Dose Group ◽  
Low Dose ◽  
Randomised Trial ◽  
High Dose ◽  
Average Dose ◽  
The North ◽  
Dosing Strategies ◽  
Second Year

BackgroundShort children born small for gestational age (SGA) are treated with a GH dose based on body size, but treatment may lead to high levels of IGF1. The objective was to evaluate IGF1 titration of GH dose in contrast to current dosing strategies.MethodsIn the North European Small-for-Gestational-Age Study (NESGAS), 92 short pre-pubertal children born SGA were randomised after 1 year of high-dose GH treatment (67 μg/kg per day) to three different regimens: high dose (67 μg/kg per day), low dose (35 μg/kg per day) or IGF1 titration.ResultsThe average dose during the second year of the randomised trial did not differ between the IGF1 titration group (38 μg/kg per day,s.d.0.019) and the low-dose group (35 μg/kg per day,s.d.0.002;P=0.46), but there was a wide variation in the IGF1 titration group (range 10–80 μg/kg per day). The IGF1 titration group had significantly lower height gain (0.17 SDS,s.d.0.18) during the second year of the randomised trial compared with the high-dose group (0.46 SDS,s.d.0.25), but not significantly lower than the low-dose group (0.23 SDS,s.d.0.15;P=0.17). The IGF1 titration group had lower IGF1 levels after 2 years of the trial (mean 1.16,s.d.1.24) compared with both the low-dose (mean 1.76,s.d.1.48) and the high-dose (mean 2.97,s.d.1.63) groups.ConclusionIGF1 titration of GH dose in SGA children proved less effective than current dosing strategies. IGF1 titration resulted in physiological IGF1 levels with a wide range of GH dose and a poorer growth response, which indicates the role of IGF1 resistance and highlights the heterogeneity of short SGA children.

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