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

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.

scholarly journals 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

2020 ◽  
Vol 13 ◽  
pp. 175628482091005
Author(s):  
Lawrence Hookey ◽  
Gerald Bertiger ◽  
Kenneth Lee Johnson ◽  
Mena Boules ◽  
Masakazu Ando ◽  
...  
Keyword(s):  
Body Mass Index ◽  
Body Mass ◽  
Bowel Preparation ◽  
Safety Data ◽  
Secondary Analysis ◽  
Oral Solution ◽  
Phase Iii ◽  
Right Colon ◽  
The Right ◽  
Post Hoc

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

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

2019 ◽  
Vol 12 ◽  
pp. 175628481985151 ◽  
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.]

scholarly journals Efficacy and Patient Tolerability of Split-Dose Sodium Picosulfate/Magnesium Citrate (SPMC) Oral Solution Compared to the Polyethylene Glycol (PEG) Solution for Bowel Preparation in Outpatient Colonoscopy: An Evidence-Based Review

2020 ◽  
Vol Volume 13 ◽  
pp. 449-457
Author(s):  
Antonio Afonso de Miranda Neto ◽  
Diogo Turiani Hourneaux de Moura ◽  
Kelly E Hathorn ◽  
Francisco Tustumi ◽  
Eduardo Guimarães Hourneaux de Moura ◽  
...  
Keyword(s):  
Polyethylene Glycol ◽  
Bowel Preparation ◽  
Oral Solution ◽  
Evidence Based ◽  
Magnesium Citrate ◽  
Split Dose ◽  
Sodium Picosulfate

scholarly journals Efficacy and Safety of Teriflunomide in Multiple Sclerosis across Age Groups: Analysis from Pooled Pivotal and Real-world Studies

2021 ◽  
Vol 13 ◽  
pp. 117957352110287
Author(s):  
Jiwon Oh ◽  
Sandra Vukusic ◽  
Klaus Tiel-Wilck ◽  
Jihad Said Inshasi ◽  
David Rog ◽  
...  
Keyword(s):  
Multiple Sclerosis ◽  
Real World ◽  
Age Groups ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Additional Group ◽  
Disability Status ◽  
Scale Scores ◽  
Post Hoc ◽  
Phase Ii And Iii

Background: Evidence suggests that efficacy and safety of disease-modifying treatments for multiple sclerosis may differ with age. We evaluate efficacy and safety of teriflunomide across age subgroups of patients from pooled clinical trials and real-world studies. Methods: Post hoc analyses of patients who received teriflunomide 14 mg in the pooled phase II and III TEMSO, TOWER, TENERE, and TOPIC core and extension studies (n = 1978), and the real-world Teri-PRO (n = 928) and TAURUS-MS I (n = 1126) studies were conducted. Data were stratified by age at study entry: ⩽25, >25 to ⩽35, >35 to ⩽45, and >45 years. In Teri-PRO and TAURUS-MS I, an additional group, >55 years, was assessed. Results: In the pooled core studies, teriflunomide reduced annualized relapse rate (ARR) versus placebo across all ages. Unadjusted ARRs remained low across age groups in pooled extensions (0.18-0.30), Teri-PRO (0.10-0.35), and TAURUS-MS I (0.14-0.35). Baseline Expanded Disability Status Scale scores were higher with age, but stable through core and extension studies (mean increases over 7 years: ⩽25 years, +0.59; >25 to ⩽35 years, +0.46; >35 to ⩽45 years, +0.35; >45 years, +0.81). Across age groups, adverse event (AE) incidences were 78.4% to 90.7% in pooled core and extension studies and Teri-PRO, and 29.2% to 37.7% in TAURUS-MS I; serious AE incidences were ⩽21.3% in all studies. In pooled phase III and Teri-PRO studies, lymphocyte count decreases over 1 year after initiating teriflunomide, and proportions of patients developing lymphopenia, were small across age groups. Conclusions: Teriflunomide efficacy was demonstrated regardless of age. Safety was generally consistent across age groups.

Sleep Disturbances Associated with Age and HIV

2005 ◽  
Vol 96 (2) ◽  
pp. 433-434 ◽  
Author(s):  
David E. Vance ◽  
Joe W. Burrage
Keyword(s):  
Sleep Disturbances ◽  
Age Groups ◽  
Secondary Analysis ◽  
Hiv Positive ◽  
Age Group ◽  
Hiv Disease ◽  
Hiv Status ◽  
Normal People ◽  
Immunodeficiency Virus ◽  
Hiv Negative

Sleep disturbances are common in normal people of several age groups and those with Human Immunodeficiency Virus (HIV) disease. In a secondary analysis of data, 50 HIV-positive and 50 HIV-negative adults between 30 and 65 years old responded to 5 items about sleep. No statistically significant differences by HIV status or age group were found.

scholarly journals Topography of lymph nodes around the right main bronchus

2020 ◽  
pp. 5-9
Author(s):  
O. I. Fedulov ◽  
V. V. Maslyakov
Keyword(s):  
Lymph Nodes ◽  
Main Bronchus ◽  
Age Groups ◽  
Practical Interest ◽  
Forensic Autopsy ◽  
Lung Pathology ◽  
Age Group ◽  
Thoracic Cavity ◽  
Topographic Features ◽  
The Right

The study is based on the study of 30 organ complexes from the human thoracic cavity, distributed into 5 age groups with 10-year interval, 6 observations in each group: 1st age group – 20–30 years, 2nd age group – 31–40 years, 3rd age group – 41–50 years, 4th age group – 51–60 years, 5th age group – 61–70 years. All medications were taken from people without heart and lung pathology at forensic autopsy according to the generally accepted method. Based on the results obtained, topographic features of lymph nodes location around the right main bronchus are given, which is of practical interest.

scholarly journals Profile of Suspected Cholera Patients during May – November 2017 in Sanaa City Secondary Analysis

2020 ◽  
pp. 40-48
Author(s):  
Mohammed Qassime ◽  
Ryad Al- Nemri ◽  
Mutahar Al- Qassimi
Keyword(s):  
Age Groups ◽  
Secondary Analysis ◽  
Case Fatality ◽  
Health Care Facilities ◽  
Epidemiological Surveillance ◽  
Age Group ◽  
Under Five ◽  
Management Interventions ◽  
Care Facilities ◽  
Control And Management

Introduction: From 27 April to 3 August 2017, 453,175 suspected cholera cases and 1,930 deaths (CFR: 0.4%) have been reported in 95.6% (22/23) of Yemen governorates, and 89.2% (297/333) of the districts. The five most affected governorates were Amanat Al-Asima, Al Hudaydah, Hajjah, Amran and Dhamar with 53% (239,877/453,175) of the cases reported since 27 April 2017. In amanat al Asimah (Sana'a city) 55563 cases 61 deaths are registered in that period with case fatality rate 0.1% and attack rate 1.68% Objectives: To study Profile of suspected cholera patients in Sanaa city. Materials and Methods: A retrospective descriptive study was carried out by using secondary analysis of available data collected from (DTCs), (ORCs) and other health facilities by department of epidemiological surveillance – Sanaa city health office. Results: A total of 92995 suspected cholera patients were included in the study whereas the average age of study subjects was 22.7 years where standard deviation (SD) 18.8 most affected age groups were (15-29),(5-14),(<5) the predominant of the study subjects from Sanaa city (96%) from Ma'ain, Bani-Alhareth, AND Al-Sabain districts Most cases are reported from DTCs (59300), ORCs (29547) Cases starts to appear in week 17 reaches a peak in weeks 24,25  and then slowly decreases. 155 suspected cholera cases were culture positives Conclusion: 1. Cholera is one of the urgent health problems in Sana’a city Cholera distribution is not gender sensitive, the most affected age group is (15-29) years, followed by (5-14) then under five Cases are mainly distributed in Ma'ain, Bani-Alhareth, & Al-Sabain within Sana’a city (50% of the total cases). The main cholera health care facilities are mainly DTCs and ORCs supported by WHO & UNICEF Most of the subjects seek medical care within the first 2 days after onset of symptoms The peak of cholera suspected cases is registered in weeks 24 & 24. Confirmed cholera cases by culture are 155 from 655 specimen tested whereas 1984 are positive by cholera RDT Recommendations:1. More cholera control interventions are necessary and urgent to eradicate it. More field related research must be carried out to guide control and management interventions. Some interventions must be concentrated on the age groups 5-14 & under five and at the most affected areas.

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