scholarly journals Efficacy of Dulaglutide Expanded Doses by Baseline A1C Categories: Post Hoc Analysis of AWARD-11

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A332-A333
Author(s):  
Juan Pablo Frias ◽  
Enzo Bonora ◽  
David A Cox ◽  
Anita Kwan ◽  
Sohini Raha ◽  
...  
Keyword(s):  
Glycemic Control ◽  
Adverse Events ◽  
Dose Escalation ◽  
Repeated Measures ◽  
Post Hoc Analysis ◽  
Metformin Monotherapy ◽  
Lower Baseline ◽  
The Difference ◽  
Glycemic Target ◽  
Post Hoc

Abstract The AWARD-11 trial demonstrated the safety and efficacy of dulaglutide (DU) once weekly doses of 3 mg and 4.5 mg compared to DU 1.5 mg in patients with type 2 diabetes (T2D) inadequately controlled with metformin monotherapy. This exploratory post hoc analysis of AWARD-11 assessed the effect of dulaglutide on A1C reduction by clinically-relevant baseline A1C subgroups (<8%; 8%-<9%; 9%-<10%; ≥10%) and the proportion of patients achieving A1C <7% in these subgroups through 36 and 52 weeks. Patients were randomized to once weekly DU 1.5 mg (n=612), 3 mg (n=616), or 4.5 mg (n=614). All patients initiated once weekly DU 0.75 mg for 4 weeks, followed by stepwise dose escalation every 4 weeks to the randomized dose. A mixed effects model for repeated measures was used within the A1C subgroups to assess the change in A1C from baseline at 36 and 52 weeks. A longitudinal logistic regression model was used within subgroups to analyze the proportion of patients achieving A1C <7% at 36 and 52 weeks. Efficacy analyses used data collected up to initiation of rescue medication or premature treatment discontinuation, if either occurred. DU 1.5 mg reduced A1C across all baseline A1C categories at 36 weeks (range, -1.0 to -2.2%) and effects were sustained through 52 weeks (range, -1.0 to -2.1%). A1C reductions were greater in patients randomized to DU 3 mg or 4.5 mg versus 1.5 mg in each A1C subgroup, with greater dose-related improvements in patients with higher baseline A1C through 36 weeks (A1C subgroup, least-squares mean change in A1C [%] with 1.5 mg, 3 mg, and 4.5 mg, respectively: A1C<8%, -1.0, -1.2, -1.2; A1C 8-<9%, -1.4, -1.6, -1.8; A1C 9-<10%, -2.1, -2.2, -2.3; A1C ≥10%, -2.2, -2.5, -3.2; interaction p<0.001). More patients randomized to 3 mg or 4.5 mg achieved A1C <7% versus those on 1.5 mg at 36 weeks regardless of baseline A1C, but the difference across dose groups was greater at higher baseline A1Cs. Over half of patients randomized to DU 4.5 mg achieved A1C <7% in every baseline A1C category (A1C<8%, 75%, 87%, 83%; A1C 8-<9%, 61%, 64%, 73%; A1C 9-<10%, 46%, 51%, 64%; A1C ≥10%, 19%, 33%, 55% for DU 1.5 mg, 3 mg, and 4.5 mg, respectively; interaction p=0.096). Similar patterns of dose-related improvement in A1C and proportions of patients achieving A1C <7% across baseline A1C categories were observed at 52 weeks. Gastrointestinal adverse events were similar between A1C subgroups. Glycemic control as measured by A1C and proportion of patients achieving A1C <7% was improved with DU dose escalation from 1.5 mg to 3 mg or 4.5 mg across a spectrum of clinically relevant baseline A1C categories without increasing incidence of GI adverse events. Patients at higher baseline A1Cs (9%-<10% and ≥10%) had larger dose-related improvements in glycemic control than those at lower baseline A1Cs (<8% and 8%-<9%). The majority of patients randomized to DU 4.5 mg achieved glycemic target across all categories of baseline A1C.

scholarly journals Comparison of Placido, Scheimpflug and Combined Dual Scheimpflug-Placido Technologies in Evaluating Anterior and Posterior CLMI, SimK's as well as Kmax, in Keratoconic and Postrefractive Surgery Ectasia

2012 ◽  
Vol 1 (1) ◽  
pp. 44-52 ◽  
Author(s):  
Thomas F Mauger ◽  
Ashraf M Mahmoud ◽  
Cynthia J Roberts ◽  
Lena V Chheda ◽  
Rebecca A Kuennen ◽  
...  
Keyword(s):  
Repeated Measures ◽  
Ohio State University ◽  
State University ◽  
Post Hoc Analysis ◽  
Repeated Measures Analysis ◽  
Financial Interests ◽  
The Difference ◽  
The Ohio State University ◽  
Map Data ◽  
Post Hoc

ABSTRACT Purpose To calculate and compare cone location and magnitude index (CLMI), Kmax and other corneal measures derived from three different technologies, Placido, Scheimpflug, and a combination dual Scheimpflug-Placido device, from the same group of eyes with keratoconus and postrefractive surgery corneal ectasia. Methods Keratoconus (n = 26) eyes of (n = 19) subjects and postrefractive surgery ectasia (n = 5) eyes of (n = 5) subjects were selected to have measurements performed using the Keratron Scout, Pentacam HR and Galilei Dual Scheimpflug Analyzer. Device-generated SimK's and device-specific CLMI and Kmax indices as well as map data, were exported from each device. Index values for multiple exams were averaged. The map data were processed using The Ohio State University Corneal Topography Tool (OSUCTT) to calculate CLMI parameters, Kmax and SimK values using consistent algorithms on all three devices. Maps were averaged before calculation for multiple examinations. Repeated measures analysis of variance and post- hoc analysis were used to identify differences between devices. Results The anterior axial CLMI calculated from the Keratron data was significantly higher than CLMI for the Galilei (p = 0.0443) or Pentacam (p < 0.0004) with keratoconus, 12.23 compared with 11.20 and 11.00 diopters, respectively. Kmax was also significantly higher in the Keratron than the Galilei (p = 0.0063) or the Pentacam (p < 0.0002). Galilei and Pentacam were not significantly different from each other in either CLMI (p = 0.6287) or Kmax (p = 0.2115). The anterior CLMI values for the postrefractive surgery ectasia eyes were not significantly different between devices. Posterior CLMI values were calculated from the Galilei and Pentacam data and were −2.60 and −2.46 diopters (p = 0.1173) for keratoconus and −2.66 and −3.04 diopters (p = 0.2242) for postrefractive surgery ectasia. Conclusion The small cone Placido measured dioptric values that were greater than the pure Scheimpflug system, but the difference was only about 1 diopter, which is not relevant clinically in evaluating and managing ectasia. The combined dual Scheimpflug-Placido system produced measured dioptric values between the other two technologies. The anterior CLMI calculations accurately predicted keratoconus with all three devices. The posterior CLMI in ectasia may be a potentially valuable calculation in demonstrating asymmetric steepening. How to cite this article Mauger TF, Mahmoud AM, Roberts CJ, Chheda LV, Kuennen RA, Hendershot AJ, Lembach RG. Comparison of Placido, Scheimpflug and Combined Dual Scheimpflug-Placido Technologies in Evaluating Anterior and Posterior CLMI, SimK's as well as Kmax, in Keratoconic and Postrefractive Surgery Ectasia. Int J Keratoco Ectatic Corneal Dis 2012;1(1):44-52. • C Roberts is a Consultant for Oculus Optikgerate GmbH and Ziemer Ophthalmic Systems AG, and has an interest in the GALILEI. • A Mahmoud has an interest in the GALILEI. • T Mauger, L Chheda, R Kuennen, A Hendershot, and R Lembach have no financial interests.

725-P: Effect of a Continuous Remote Care Intervention on Glycemic Target Achievement and Medication Use among Adults with T2D: A Post Hoc Analysis

Diabetes ◽  
2020 ◽  
Vol 69 (Supplement 1) ◽  
pp. 725-P
Author(s):  
SHAMINIE J. ATHINARAYANAN ◽  
REBECCA N. ADAMS ◽  
SARAH HALLBERG ◽  
STEPHEN PHINNEY ◽  
AMY MCKENZIE
Keyword(s):  
Medication Use ◽  
Post Hoc Analysis ◽  
Care Intervention ◽  
Remote Care ◽  
Glycemic Target ◽  
Post Hoc

scholarly journals Perampanel with concomitant levetiracetam and topiramate: Post hoc analysis of adverse events related to hostility and aggression

2017 ◽  
Vol 75 ◽  
pp. 79-85 ◽  
Author(s):  
Steve Chung ◽  
Betsy Williams ◽  
Cindy Dobrinsky ◽  
Anna Patten ◽  
Haichen Yang ◽  
...  
Keyword(s):  
Adverse Events ◽  
Post Hoc Analysis ◽  
Post Hoc

Post hoc analysis of a randomised, placebo-controlled, active-reference 6-week study of brexpiprazole in acute schizophrenia

2020 ◽  
Vol 32 (3) ◽  
pp. 153-158 ◽  
Author(s):  
Stephen R. Marder ◽  
Hans Eriksson ◽  
Yudong Zhao ◽  
Mary Hobart
Keyword(s):  
Adverse Events ◽  
Repeated Measures ◽  
Mixed Model ◽  
Least Square ◽  
Analysis Of Covariance ◽  
Sensitivity Analyses ◽  
Symptom Improvement ◽  
Syndrome Scale ◽  
Quetiapine Xr ◽  
Post Hoc

AbstractObjective:We provide a closer look at the result of a randomised, placebo-controlled, active-reference (quetiapine XR), flexible-dose, 6-week study of brexpiprazole in schizophrenia, which did not meet its primary endpoint – change from baseline in Positive and Negative Syndrome Scale (PANSS) total score. We also investigate potential expectancy bias from the well-known side-effect profile of the active reference that could have affected the study outcome.Methods:Pre-specified sensitivity analyses of the primary end point were performed using analysis of covariance (ANCOVA) last observation carried forward (LOCF) and observed cases (OC). Post hoc analyses of change from baseline in PANSS total score were performed using the mixed model for repeated measures approach with treatment groups split by having typical adverse events with potential for functional unblinding, for example, somnolence, increase in weight, dizziness, dry mouth and sedation.Results:Pre-specified sensitivity analyses showed separation from placebo for brexpiprazole at week 6: LOCF, ANCOVA: −4.3 [95% CI (−8.0, −0.5), p = 0.0254]. OC, ANCOVA: −3.9 [95% CI (−7.3, −0.5), p = 0.0260]. Patients treated with brexpiprazole experiencing typical adverse events with potential for functional unblinding before or at Week 2 had a least square (LS) mean PANSS change of −29.5 (improvement), with a difference in change from baseline to Week 6 in PANSS total score between brexpiprazole and placebo of −13.5 [95% CI (−23.1, −4.0), p = 0.0057], and those who did not had an LS mean change of −18.9 and a difference between brexpiprazole and placebo of −2.9 [95% CI (−7.2, 1.4), p = 0.1809].Conclusion:Pre-specified sensitivity analyses showed separation from placebo for brexpiprazole at Week 6. A post hoc analysis suggested a potential confounding of efficacy rating towards symptom improvement in patients who experience known side effects of quetiapine XR.

scholarly journals Influence of Foot Orthotics and Intrinsic Factors on Strain Measurements in the Fifth Metatarsal

2020 ◽  
Vol 5 (4) ◽  
pp. 2473011420S0025
Author(s):  
Jeffrey W. Hoffman ◽  
Rogerio C. Bitar ◽  
Daniel R. Sturnick ◽  
Glenn Garrison ◽  
Constantine A. Demetracopoulos ◽  
...  
Keyword(s):  
Risk Factors ◽  
Repeated Measures ◽  
Statistical Significance ◽  
Return To Play ◽  
Peak Strain ◽  
Lateral Plate ◽  
Intrinsic Factors ◽  
Post Hoc Analysis ◽  
Zone Ii ◽  
Post Hoc

Category: Midfoot/Forefoot; Sports Introduction/Purpose: Fractures of the fifth metatarsal occur in young, athletic populations and often result in sub-optimal clinical outcomes, even after surgical fixation. With such a high demand for decreased return to play in athletic populations, the development of intervention strategies which mitigate intrinsic and extrinsic risk factors of initial injury is important. Foot orthotics have been shown to decrease strain in the 2nd metatarsal. However, limited research has investigated the influence of intrinsic risk factors and the use of foot orthotics on fifth metatarsal strain. Therefore, the purpose of our study was to investigate the effect of foot orthotics and intrinsic risk factors on fifth metatarsal strain during cadaveric simulation. Methods: Ten specimens were loaded to simulate the stance phase of normal gait using a validated 6-degree of freedom robot with tendon actuators. Strain gauges were placed at the metaphyseal - diaphyseal junction (Zone II), and the proximal diaphysis (Zone III) to measure principal strain. Specimens were tested in a sneaker-only control condition and ten orthotic conditions, which include combinations of a commercial orthotic insole, three plates, and two foam wedges (Figure 1A). The average peak strain from three simulations were recorded for each orthotic condition. Relevant intrinsic factors were recorded from reconstructions of axially loaded computed tomography scans. A two-way repeated measures ANOVA was conducted to determine the effect of orthotic conditions on fifth metatarsal strains, with significantly correlated intrinsic factors included as covariates. Tukey-Kramer post-hoc analysis with a Bonferroni correction was used to analyze differences between individual orthotic conditions and main effects of components. Results: Metatarsus adductus angle, 4-5 intermetatarsal angle, and Meary’s angle (R2= 0.944; p<0.001) were included as covariates in analysis of Zone III strain. Significant (p<0.05) differences in Zone III strain were found for the both the main effect of a plate and individual orthotic cond itions with statistical adjustment for previously stated intrinsic measurements. However, post- hoc testing revealed no significant differences between non-plate conditions and full plate conditions(p=0.23), lateral plate conditions (p=0.025), or lateral cut plate conditions (p=0.026). Additionally, the Full Plate with Lateral Wedge condition reduced strains by 285 µΕ relative to the sneaker condition, no significant differences (p = 0.07) were found in post-hoc analysis. No significant differences were found in Zone II with the models considered. Conclusion: Zone III strains were shown to be significantly correlated with intrinsic factors in the current analysis. Plate conditions demonstrated a trend towards significant reduction of Zone III strain relative to the sneaker condition, despite failing to achieve statistical significance in conservative post-hoc analysis. However, these results may be clinically significant as the reduction of strain in plate conditions exceeded previously reported significant decreases in the 2nd metatarsal. Correlations found between intrinsic risk factors and strain in this study corroborate with previous studies. This indicates that the effectiveness of foot orthotics to reduce strain is strongly influenced by individual foot structure.

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