Dataset Information

Efficacy and safety of PICOPREP tailored dosing compared with PICOPREP day-before dosing for colon cleansing: a multi-centric randomised study.

ABSTRACT: Background and study aims?The success of any colonoscopy procedure depends upon the quality of bowel preparation. We evaluated the efficacy and safety of a new tailored dosing (TD) regimen compared with the approved PICOPREP day-before dosing regimen (DBD) in the European Union. Patient and methods?Patients (??18 years) undergoing colonoscopy were randomised (2:1) to TD (Dose 1, 10?-?18 hours; Dose 2, 4?-?6 hours before colonoscopy) or DBD (Dose 1 before 8:00AM on the day before colonoscopy; Dose 2, 6?-?8 hours after Dose 1). The primary endpoint of overall colon cleansing efficacy was based on total Ottawa Scale (OS) scores (0?-?14, excellent-worst). The key secondary endpoint was a binary endpoint based on the ascending colon OS (success 0 or 1, failure [??2]). Convenience and satisfaction were evaluated similar to the primary and key secondary endpoints. Safety and tolerability were also evaluated. Results?Use of the PICOPREP TD regimen resulted in a statistically significant reduction in the mean total Ottawa Scale score compared to the PICOPREP DBD regimen (-3.93, 95?% confidence intervals [CI]:?-?4.99,?-?2.97; P?

SUBMITTER: Kiesslich R

PROVIDER: S-EPMC5382934 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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Efficacy and safety of PICOPREP tailored dosing compared with PICOPREP day-before dosing for colon cleansing: a multi-centric randomised study.

Kiesslich Ralf R Schubert Stefan S Mross Michael M Klugmann Tobias T Klemt-Kropp Michael M Behnken Imke I Bonnaud Gillaume G Keulen Eric E Groenen Marcel M Blaker Michael M Ponchon Thierry T Landry Wilfred W Stoltenberg Meredin M

Endoscopy international open 20170401 4

<b>Background and study aims</b> The success of any colonoscopy procedure depends upon the quality of bowel preparation. We evaluated the efficacy and safety of a new tailored dosing (TD) regimen compared with the approved PICOPREP day-before dosing regimen (DBD) in the European Union. <b>Patient and methods</b> Patients (≥ 18 years) undergoing colonoscopy were randomised (2:1) to TD (Dose 1, 10 - 18 hours; Dose 2, 4 - 6 hours before colonoscopy) or DBD (Dose 1 before 8:00AM on the day before co ...[more]

PMID: 28393103

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Project description:ObjectiveChronic obstructive pulmonary disease (COPD) is mainly treated pharmaceutically with bronchodilators. The purpose of this study was to evaluate the clinical benefits of two-times-per-day aclidinium bromide (Acli-BID) compared with once-a-day tiotropium bromide hydrate (Tio-QD) in patients with COPD.DesignThis study was a multicentre, open-label, randomised study.SettingFourcentres in Kagawa prefecture, Japan.ParticipantPatients who were diagnosed to have COPD Grade 2-3 according to the Global Initiative for Chronic Obstructive Lung Disease 2015 criteria were enrolled.InterventionsPatients were randomly assigned to receive Acli-BID or Tio-QD at a 1:1 ratio, and followed for 8 weeks. Acli-BID was administered in the morning and night, and Tio-QD was administered in the night.Primary and secondary outcome measuresPrimary outcome was forced expiratory volume in one second area under the curve (FEV1AUC0-3), and secondary outcomes were pulmonary function, physical activity, St George's Respiratory Questionnaire (SGRQ), modified Medical Research Council (mMRC), the 8-item Short-Form Health Survey (SF-8) and COPD exacerbations. Adverse events were evaluated during the study.Results44 patients were included in this study. FEV1AUC0-3 at week 8 was 4.62±1.43 L·hour in Acli-BID and 4.73±1.60 L·hour in Tio-QD (mean difference (MD) -0.11 L·hour; 95% CI), -1.04 to 0.83). Significant improvement was observed in activity-related subscales of SGRQ (MD -7.78; 95% CI -14.61 to -0.94) and SF-8 (MD 4.01; 95% CI 0.37 to 7.65), mMRC (MD -0.66; 95% CI -1.19 to -0.13) and rate ratio (0.52, 95% CI 0.27 to 0.99) of exacerbations in the Acli-BID compared with the Tio-QD. Acli-BID and Tio-QD significantly improved sedentary behaviour (MD -35.20 min; 95% CI -67.41 to -2.94 and MD -55.40 min; 95% CI -98.15 to -12.77) within each group, but there was no significant difference between the two groups.ConclusionAcli-BID as with Tio-QD could be one of the therapeutic options for patients with COPD to improve pulmonary function. Also, our results suggest that intervention with bronchodilators enhanced physical activity in patients with COPD.Trial registration numberUMIN 000020020.

Project description:BackgroundInterleukin-6 inhibitors reduce mortality in severe COVID-19. British Columbia began using tocilizumab 8 mg/kg (maximum 800 mg) in January 2021 in critically ill patients with COVID-19, but due to drug shortages, decreased dosing to 400 mg IV fixed dose in April 2021. The aims of this study were twofold: to compare physiological responses and clinical outcomes of these two strategies, and examine the cost-effectiveness of treating all patients with 400 mg versus half the patients with 8 mg/kg and the other half without tocilizumab.MethodsThis was a single-centre, before-after cohort study of critically ill COVID-19 patients treated with tocilizumab, and a control cohort treated with dexamethasone only. Physiological responses and clinical outcomes were compared between patients receiving both doses of tocilizumab and those receiving dexamethasone only. We built a decision tree model to examine cost-effectiveness.Findings152 patients were included; 40 received tocilizumab 8 mg/kg, 59 received 400 mg and 53 received dexamethasone only. Median CRP fell from 103 mg/L to 5.2 mg/L, 96 mg/L to 6.8 mg/L and from 81.3 mg/L to 48 mg/L in the 8 mg/kg, 400 mg tocilizumab, and dexamethasone only groups, respectively. 28-day mortality was 5% (n=2) vs 8% (n=5) vs 13% (n=7), with no significant difference in all pair-wise comparison. At an assumed willingness-to-pay threshold of $50,000 Canadian per life-year, utilizing 400 mg for all patients rather than 8 mg/kg for half the patients is cost-effective in 51.6% of 10,000 Monte Carlo simulations.InterpretationBoth doses of tocilizumab demonstrated comparable reduction of inflammation with similar 28-day mortality. Without consideration of equity, the net monetary benefits of providing 400 mg tocilizumab to all patients are comparable to 8 mg/kg to half the patients. In the context of ongoing drug shortages, fixed-dose 400 mg tocilizumab may be a practical, feasible and economical option.FundingThis work was supported by a gift donation from Hsu & Taylor Family to the VGH Foundation, and the Yale Bernard G. Forget Scholarship.

Dataset Information

Efficacy and safety of PICOPREP tailored dosing compared with PICOPREP day-before dosing for colon cleansing: a multi-centric randomised study.

Publications

Efficacy and safety of PICOPREP tailored dosing compared with PICOPREP day-before dosing for colon cleansing: a multi-centric randomised study.

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