Efficacy, safety, and tolerability of a ready-to-drink bowel preparation in overweight and obese adults: subanalysis by body mass index from a phase III, assessor-blinded study

Background: We performed a post hoc secondary analysis for the effect of body mass index (BMI) on the efficacy, tolerability, and safety of ready-to-drink sodium picosulfate, magnesium oxide, and citric acid (SPMC oral solution) bowel preparation. Methods: A phase III, randomized, assessor-blinded, multicenter, noninferiority study was conducted comparing split-dose, low-volume SPMC oral solution with a powder formulation for oral solution. A post hoc secondary analysis assessed efficacy, safety, and tolerability of SPMC oral solution stratified by BMI. BMI was classified by Centers for Disease Control and Prevention definitions (underweight and normal weight: BMI < 25 kg/m2; overweight: BMI 25–29.9 kg/m2; class I obesity: BMI 30–34.9 kg/m2; class II obesity: BMI 35–39.9 kg/m2; class III/severe obesity: BMI ⩾40 kg/m2). Prespecified primary efficacy endpoint (‘responders’) was the proportion of participants with ‘excellent’ or ‘good’ ratings on a modified Aronchick Scale (AS). Secondary efficacy outcomes were the quality of cleansing of the right colon as assessed by the Boston Bowel Preparation Scale (BBPS); as well as selected findings from the Mayo Clinic Bowel Prep Tolerability Questionnaire. Safety assessments included adverse events (AEs) and laboratory evaluations. Results: Between 82.8% and 92.5% of participants in any BMI group were responders by AS, and between 91.3% and 100% were responders by BBPS in the right colon. Efficacy was consistent across BMI groups, with no clear trends. Greater than 83% of participants in any BMI group found the preparation ‘easy’ or ‘acceptable’ to ingest, and the majority (>58%) rated SPMC oral solution as ‘better’ than a prior bowel preparation. In all BMI groups, safety data were similar to the overall cohort. Commonly reported, drug-related, treatment-emergent AEs were, by ascending BMI group, nausea (1.1%, 5.3%, 1.0%, 5.7%, and 0%) and headache (1.1%, 4.1%, 1.0%, 5.7%, and 0%). Conclusions: Ready-to-drink SPMC oral solution had consistent, good quality colon cleansing, and favorable tolerability among participants of all BMI groups. ClinicalTrials.gov Registration: NCT03017235

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Efficacy, safety, and tolerability of a ready-to-drink bowel preparation: subanalysis by age from a phase III, assessor-blinded study

Therapeutic Advances in Gastroenterology ◽

10.1177/1756284820902878 ◽

2020 ◽

Vol 13 ◽

pp. 175628482090287

Author(s):

Lawrence Hookey ◽

Gerald Bertiger ◽

Kenneth Lee Johnson ◽

Mena Boules ◽

Masakazu Ando ◽

...

Keyword(s):

Bowel Preparation ◽

Age Groups ◽

Secondary Analysis ◽

Oral Solution ◽

Phase Iii ◽

Age Group ◽

Split Dose ◽

Sodium Picosulfate ◽

The Right ◽

Post Hoc

Background: The incidence and mortality of colorectal cancer (CRC) increase with age and, therefore, it is recommended that adults undergo regular CRC screening, ideally by colonoscopy, with some new guidelines recommending screening begin at 45 years. Effective bowel preparation is a critical step to a successful colonoscopy. Of concern is that older adults may have poorer quality of bowel preparation or reduced tolerability for the bowel preparation. Here, we performed a post hoc secondary analysis for the effect of age on the efficacy, tolerability, and safety of ready-to-drink sodium picosulfate, magnesium oxide, and citric acid (SPMC oral solution) bowel preparation. Methods: A phase III, randomized, assessor-blinded, multicenter, non-inferiority study was conducted comparing split-dose, low-volume SPMC oral solution with split-dose, low-volume sodium picosulfate, magnesium oxide, and citric acid powder for oral solution. A post hoc secondary analysis was performed to assess efficacy, safety, and tolerability of SPMC oral solution by age group (<50 years, 50–64 years, ⩾65 years). The prespecified primary efficacy endpoint (‘responders’) was the proportion of participants with ‘excellent’ or ‘good’ ratings on a modified Aronchick Scale (AS). Secondary efficacy outcomes were the quality of cleansing of the right colon as assessed by the Boston Bowel Preparation Scale (BBPS); as well as selected findings from the Mayo Clinic Bowel Prep Tolerability Questionnaire. Safety assessments included adverse events (AEs) and laboratory evaluations. Results: Within age groups, at least 83.9% of participants were responders by the AS, and at least 91.1% of participants were responders by the BBPS in the right colon. On both scales, responder rates were highest in the youngest age group and decreased with increasing age. Greater than 88% of participants in any age group found the preparation ‘easy’ or ‘acceptable’ to ingest, with rates of ‘easy’ being highest in the oldest age group. No new safety signals were seen in any age group. The most commonly reported drug-related, treatment-emergent AEs were, by ascending age group, nausea (7.0%, 3.2%, 0.8%), headache (4.2%, 2.8%, 1.6%) and vomiting (2.8%, 1.2%, 0.8%). Conclusion: Ready-to-drink SPMC oral solution showed good efficacy of overall colon cleansing and tolerability in adults across different age groups, including those ⩾65 years. ClinicalTrials.gov identifier: NCT03017235.

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Efficacy and safety of a ready-to-drink bowel preparation for colonoscopy: a randomized, controlled, non-inferiority trial

Therapeutic Advances in Gastroenterology ◽

10.1177/1756284819851510 ◽

2019 ◽

Vol 12 ◽

pp. 175628481985151 ◽

Cited By ~ 5

Author(s):

Lawrence Hookey ◽

Gerald Bertiger ◽

Kenneth Lee Johnson ◽

Julia Ayala ◽

Yodit Seifu ◽

...

Keyword(s):

Adverse Events ◽

Bowel Preparation ◽

Oral Solution ◽

Right Colon ◽

Split Dose ◽

Colon Cleansing ◽

Randomized Controlled ◽

Secondary Efficacy Endpoint ◽

Sodium Picosulfate ◽

The Right

Background: We performed a randomized, controlled, assessor-blinded, multicenter, non-inferiority (NI) study to compare the safety and efficacy of a ready-to-drink formulation of sodium picosulfate, magnesium oxide, and citric acid (SPMC oral solution) with a powder formulation (P/MC powder) for oral solution. Methods: Eligible participants (adults undergoing elective colonoscopy) were randomized 1:1 to split-dose SPMC oral solution or P/MC powder. The primary efficacy endpoint assessed overall colon-cleansing quality with the Aronchick Scale (AS), and the key secondary efficacy endpoint rated quality of right colon cleansing with the Boston Bowel Preparation Scale (BBPS). Assessments were performed by a treatment-blinded endoscopist. Tolerability was assessed using the Mayo Clinic Bowel Prep Tolerability Questionnaire. Safety assessments included adverse events and laboratory evaluations. Results: The study included 901 participants: 448 for SPMC oral solution; 453 for P/MC powder. SPMC oral solution demonstrated non-inferiority to P/MC powder {87.7% (393/448) responders versus 81.5% (369/453) responders [difference (95% confidence interval): 6.3% (1.8, 10.9)]}. The key secondary efficacy objective assessing the right colon was also met. According to the prespecified hierarchical testing, after meeting the primary and key secondary objectives, SPMC oral solution was tested for superiority to P/MC powder for the primary endpoint ( p = 0.0067). SPMC oral solution was well tolerated. Most common adverse events were nausea (3.1% versus 2.9%), headache (2.7% versus 3.1%), hypermagnesemia (2.0% versus 5.1%), and vomiting (1.3% versus 0.7%) for SPMC oral solution and P/MC powder, respectively. Conclusions: Ready-to-drink SPMC oral solution showed superior efficacy of overall colon cleansing compared with P/MC powder, with similar safety and tolerability. [ClinicalTrials.gov identifier: NCT03017235.]

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Body mass index and treatment response to subcutaneous abatacept in patients with psoriatic arthritis: a post hoc analysis of a phase III trial

RMD Open ◽

10.1136/rmdopen-2019-000934 ◽

2019 ◽

Vol 5 (1) ◽

pp. e000934 ◽

Cited By ~ 4

Author(s):

Iain B McInnes ◽

Gianfranco Ferraccioli ◽

Maria-Antonietta D'Agostino ◽

Manuela Le Bars ◽

Subhashis Banerjee ◽

...

Keyword(s):

Body Mass Index ◽

Psoriatic Arthritis ◽

Normal Subgroup ◽

Treatment Response ◽

Body Mass ◽

Health Assessment ◽

Phase Iii ◽

Baseline Body Mass Index ◽

Post Hoc ◽

Baseline Bmi

ObjectiveThis post hoc analysis of the phase III Active PSoriaTic Arthritis RAndomizEd TriAl (ASTRAEA) evaluated the effect of baseline body mass index (BMI) on subsequent response to subcutaneous (SC) abatacept in patients with psoriatic arthritis (PsA).MethodsIn ASTRAEA, patients with active PsA were randomised (1:1) to receive blinded weekly SC abatacept 125 mg or placebo for 24 weeks. Treatment response at week 24 was assessed by the proportions of patients achieving American College of Rheumatology 20% improvement response, Disease Activity Score in 28 joints (DAS28 (C reactive protein (CRP))) ≤3.6 and <2.6, Health Assessment Questionnaire-Disability Index reduction from baseline ≥0.35 and radiographic non-progression (defined as change from baseline ≤0 in PsA-modified total Sharp/van der Heijde score). Responses were stratified by baseline BMI (underweight/normal, <25 kg/m2; overweight, 25–30 kg/m2; obese, >30 kg/m2) and compared in univariate and multivariate models.ResultsOf 212/213 and 210/211 patients with baseline BMI data in the abatacept and placebo groups, respectively, 15% and 19% were underweight/normal, 36% and 27% were overweight, and 49% and 54% were obese. After adjusting for baseline characteristics, there were no significant differences for any outcome measure at week 24 with abatacept in the overweight or obese versus underweight/normal subgroup. In the placebo group, patients in the obese versus underweight/normal subgroup were significantly less likely to achieve DAS28 (CRP) <2.6 at week 24 (OR 0.26; 95% CI 0.08 to 0.87; p=0.03).ConclusionBMI does not impact clinical or radiographic response to SC abatacept in patients with PsA.Trial registration numberNCT01860976.

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Índice de longitud digital 2D:4D en deportes de pelota (2D:4D Digital Length Index in Ball Sports)

Retos ◽

10.47197/retos.v0i39.78257 ◽

2020 ◽

pp. 284-288

Author(s):

Santiago Ramos Bermúdez ◽

Angélica M. García ◽

Carlos Federico Ayala ◽

Héctor Haney Aguirre Loaiza

Keyword(s):

Body Mass Index ◽

Body Mass ◽

Ring Finger ◽

Sports Performance ◽

Left Hand ◽

Competence Level ◽

Manual Pressure ◽

The Mean ◽

The Right ◽

Post Hoc

El índice de longitud digital (2D:4D) es un biomarcador del equilibrio entre testosterona T y los estrógenos fetales, por tanto, predictor del desarrollo de masa muscular y hemoglobina, relacionadas con el rendimiento deportivo. Aunque el 2D:4D se ha asociado con el deporte, se requiere comparar el 2D:4D entre deportes. Con el objetivo de establecer diferencias del 2D:4D entre deportistas de deportes de pelota, fueron estudiados 204 deportistas (Medad= 25.9, DE= 10.0), competidores a nivel nacional colombiano e internacional. Se autorreportó talla y masa corporal para calcular Índice de Masa Corporal IMC. También se midió fuerza de prensión manual, longitud de los dedos índice y anular de ambas manos. El estudio fue avalado por comité de bioética. Los resultados del Anova señalaron que el 2D:4D fue similar en ambas. El promedio 2D:4D en ambas manos mostró diferencias [F(9, 194)=2.06, p= 0.34, η2=.29, 1-β=.82]. El análisis de longitud por cada dedo mostró diferencias: En la mano derecha 2Dd [F(9, 194)= 14.8, p= .00, η2=.63, 1-β=.95], 4Dd [F(9, 194)= 12.6, p= .000, η2=.60, 1-β=.99]. En la mano izquierda, 2Di [F(9, 194)= 18.5, p= .000, η2= .68, 1-β=1.0], 4Di [F(9, 194)= 13.2, p= .000, η2=.61, 1-β=.1.0]. El análisis post-hoc de Tukey-B del 4Dd, 2Di, y 4Di mostró cuatro subconjuntos homogéneos, mientras, el 2Dd cinco subconjuntos. En conclusión, se observaron diferencias en el 2D:4D del promedio de ambas manos. La longitud de los dedos 2Dd-i y 4Dd-i muestra diferencias en los deportes de pelota, principalmente, bádminton, softbol, y squash. Abstract. The digital ratio length (2D:4D) is a biomarker of the balance between testosterone (T) and fetal estrogens, therefore, it is a predictor of muscular mass and hemoglobin development, associated with sports performance. Although the 2D:4D has been associated with sports, it is required to compare 2D:4D among sports. With the aim of establishing differences of the 2D:4D between athletes of ball sports, 204 Colombian athletes (Mage= 25.9, SD= 10.0) with national and international competence level were observed. Height and body mass were self-reported in order to calculate Body Mass Index (BMI). Also, strength manual pressure and length of index and ring finger of both hands were measured. This study was approved by the bioethics committee. The Anova results indicated that 2D:4D was similar in both hands. The mean 2D:4D of both hands showed differences [F(9, 194)= 2.06, p= .034, η2=.29, 1-β=.82]. The analysis of each finger showed differences: In the right-hand (r), 2Dr [F(9, 194)= 14.8, p= .000, η2=.63, 1-β=.95], 4Dr [F(9, 194)= 12.6, p= .000, η2=.60, 1-β=.99]. In the left-hand (l), 2Dl [F(9, 194)= 18.5, p= .000, η2=.68, 1-β=1.0], 4Di [F(9, 194)= 13.2, p= .000, η2=.61, 1-β=.1.0]. The post-hoc Tukey-B analysis of the 4Dr and 2Dr-4Dl fingers showed four homogenous subsets, while the 2Dr five subsets. In conclusion, differences of the 2D:4D mean of both hands were observed. The fingers length 2D-4Dr-l showed differences among ball sports, mostly, badminton, softball, and squash.

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Impact of body-mass index on treatment and outcome in locally advanced rectal cancer: A secondary, post-hoc analysis of the CAO/ARO/AIO-04 randomized phase III trial

Radiotherapy and Oncology ◽

10.1016/j.radonc.2021.09.028 ◽

2021 ◽

Author(s):

Markus Diefenhardt ◽

Ethan B. Ludmir ◽

Ralf-Dieter Hofheinz ◽

Michael Ghadimi ◽

Bruce D. Minsky ◽

...

Keyword(s):

Body Mass Index ◽

Rectal Cancer ◽

Body Mass ◽

Locally Advanced ◽

Advanced Rectal Cancer ◽

Locally Advanced Rectal Cancer ◽

Phase Iii ◽

Phase Iii Trial ◽

Post Hoc Analysis ◽

Post Hoc

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Normal values of coronary arteries branching height in women

Reports of Morphology ◽

10.31393/morphology-journal-2021-27(4)-06 ◽

2021 ◽

Vol 27 (4) ◽

pp. 41-46

Author(s):

U.Ye. Pidvalna ◽

D.M. Beshley ◽

M.Z. Mirchuk ◽

L.R. Mateshuk-Vatseba

Keyword(s):

Body Mass Index ◽

Coronary Artery ◽

Body Mass ◽

Coronary Arteries ◽

Body Surface ◽

Left Coronary Artery ◽

Statistical Significance ◽

Lower Edge ◽

The Mean ◽

The Right

Morphometric analysis of the structures of the aortic bulb and coronary arteries is necessary for the planning of cardiac surgery and endovascular interventions. The aim of the study was to determine the height of the coronary arteries branching in healthy women of Lviv city and Lviv region and to determine the relationship between the height of the location of the orifice of the coronary artery with anthropometric indicators. Fifteen computed tomography images with contrast of female thorax without heart and ascending aortic lesions (normal) were selected for the study. The height of the upper and lower edges of the coronary arteries was measured; height of Valsalva sinuses. The comparison of the mean values was performed according to the Student’s t-test. The correlation between the observed variables (age, height, body weight, body mass index, body surface area, height of the sinuses of Valsalva) was calculated using the Pearson linear correlation method (r). According to the study, the population group consisted of persons of the second period of adulthood (46.67 %) and the elderly (53.33 %). According to the body mass index, 80 % were overweight or obese I-II degree. The mean height of the coronary artery orifice in women without structural changes of the heart and ascending aorta was: 11.19±1.96 mm for the left and 11.68±1.80 mm for the right. The height of the orifice of the right and left coronary arteries were almost the same, without statistical significance (p=0.26). Analysis of the correlation between the values of the height of the orifice of the coronary artery did not show a probable dependence on height, weight, age, body mass index and body surface area. There is a direct relationship between the parameters of the height of the lower edge of the right coronary artery and the height of the upper edge of the right coronary artery (r=+0.75, p=0.001) and between the value of the lower edge of the left coronary artery and the upper edge of the left coronary artery (r=+0.63, p=0.01). Thus, the analysis of the correlation between the values of the height of the orifice of the coronary artery in women in norm and anthropometric indicators did not show a significant relationship. There was no statistical significance between the indicators of the height of the orifice of the right and left coronary arteries in women.

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