HIGH-QUALITY COLON CLEANSING IMPROVES REAL-WORLD IDENTIFICATION OF HIGH-RISK PATIENTS: POST HOC ANALYSIS OF RANDOMISED CLINICAL TRIALS USING TWO VALIDATED CLEANSING SCALES

2019 ◽  
Author(s):  
J Manning ◽  
B Amlani ◽  
C Hassan ◽  
T Ponchon
Keyword(s):  
Clinical Trials ◽  
High Risk ◽  
Real World ◽  
Randomised Clinical Trials ◽  
High Quality ◽  
Post Hoc Analysis ◽  
High Risk Patients ◽  
Colon Cleansing ◽  
Risk Patients ◽  
Post Hoc

scholarly journals High-quality colon cleansing and multiple neoplasia detection with 1L NER1006 versus mid-volume options: Post hoc analysis of phase 3 clinical trials

2020 ◽  
Vol 08 (05) ◽  
pp. E628-E635
Author(s):  
Michael S. Epstein ◽  
Robert Benamouzig ◽  
Juha Halonen ◽  
Raf Bisschops
Keyword(s):  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Combined Treatment ◽  
Sulfate Solution ◽  
Lesion Detection ◽  
High Quality ◽  
Post Hoc Analysis ◽  
Colon Cleansing ◽  
Adenoma Detection ◽  
Post Hoc

Abstract Background and study aims Multiple neoplasia increase the risk of colorectal cancer. High-quality cleansing may improve adenoma detection. We assessed whether a new bowel preparation can improve colon cleansing and multiple lesion detection. Patients and methods This post hoc analysis of two randomized clinical trials in Europe and the US assessed the per study and combined cleansing efficacy of overnight split dosing with (preparation + clear fluids) 1 + 1 L polyethylene glycol (PEG) NER1006 versus 2 + 1 L PEG + ascorbate (2LPEG) or 1 + 2 L oral sulfate solution (OSS) combined. Treatment-blinded central readers assessed cleansing quality using the Harefield Cleansing Scale (HCS). Patients with full segmental scoring were included. HCS segmental scores 0–4 (high-quality = HCS 3–4) were analyzed for NER1006 versus 2LPEG/OSS. Mean number of polyps or adenomas per patient (MPP/MAP) was calculated for treatments in patients with at least one polyp or adenoma. Results In 1037 patients, NER1006 attained a greater rate of HCS 3 scores (29 % vs. 20 %; P < 0.001) and HCS 4 scores (20 % vs. 17 %; P = 0.007) versus 2LPEG/OSS. More polyps (678 versus 585) and adenomas (397 versus 331) were detected with NER1006 (N = 517) versus 2LPEG/OSS (N = 520). In all neoplasia-positive patients, with increasing minimal per-patient neoplasia multiplicity from 1 to 10, NER1006 numerically improved MPP (difference ± SE: 0.48 ± 0.24 to 3.89 ± 3.37) and MAP (0.47 ± 0.26 to 7.50 ± 9.00) versus 2LPEG/OSS. Conclusions Low-volume NER1006 enhances high-quality cleansing versus medium-volume 2LPEG or OSS, individually and when combined. NER1006 may consequently facilitate the detection of multiple neoplasia in patients.

scholarly journals Composite cardiovascular risk and BMI affected comparative profiles of BIAsp 30 + metformin vs BIAsp 30 monotherapy: a MERIT post-hoc analysis

2021 ◽  
Vol 11 (1) ◽  
Author(s):  
Lixin Guo ◽  
Baocheng Chang ◽  
Li Chen ◽  
Liyong Yang ◽  
Yu Liu ◽  
...  
Keyword(s):  
Cardiovascular Risk ◽  
High Risk ◽  
Safety Profile ◽  
Efficacy And Safety ◽  
Composite Target ◽  
Post Hoc Analysis ◽  
High Risk Patients ◽  
Risk Patients ◽  
Hba1c Target ◽  
Post Hoc

AbstractWe assessed whether comparative efficacy and safety of biphasic insulin aspart 30 (BIAsp 30) plus metformin versus BIAsp 30 monotherapy differed for patients with type 2 diabetes mellitus (T2DM) inadequately controlled with oral antidiabetic drugs with different cardiovascular risk scores and different body mass indexes (BMI) by performing a post hoc analysis of the randomized controlled MERIT study. In the MERIT study, eligible patients were randomized 1:1 to receive BIAsp 30 plus metformin or BIAsp 30 for 16 weeks. Patients in the 2 treatment groups were classified into “low” and “high” risk subgroups based on their GloboRisk scores and into “BMI ≤ 26 kg/m2”and “BMI > 26 kg/m2” subgroups. Primary efficacy endpoint was between-treatments comparison of HbA1c changes from baseline for these 2 sets of subgroups. Between-treatments comparisons of secondary efficacy and safety endpoints were also performed. We found that BIAsp 30 plus metformin led to significantly higher percentage of high-risk patients achieving HbA1c target < 7% than BIAsp 30 monotherapy, with an overall comparable safety profile for high-risk patients. Meanwhile, for patients with BMI ≤ 26 kg/m2, compared with BIAsp 30 monotherapy, BIAsp 30 plus metformin led to significantly higher percentages of patients achieving HbA1c target (47.83% vs 28.17%, P = 0.0165) and composite target of HbA1c < 7% without hypoglycemia or weight gain (20.29% vs 6.85%, P = 0.0187) and have a slightly better safety profile. In conclusion, for T2DM patients at high CV risk or with BMI ≤ 26 kg/m2, BIAsp 30 plus metformin was preferable to BIAsp 30 monotherapy.

Sign in / Sign up

Export Citation Format

Share Document