Effects of Linaclotide on Bowel Movements (BMs) and Straining in Patients with Chronic Constipation (CC): A Post Hoc Analysis of Pooled Data from Two Phase Three Trials

2012 ◽  
Vol 107 ◽  
pp. S709
Author(s):  
Satish Rao ◽  
Anthony Lembo ◽  
Bernard Lavins ◽  
Brenda Jeglinski ◽  
Donald Fitch ◽  
...  
Keyword(s):  
Chronic Constipation ◽  
Two Phase ◽  
Post Hoc Analysis ◽  
Pooled Data ◽  
Bowel Movements ◽  
Post Hoc

scholarly journals Utility of the Mini-Cog for Detection of Cognitive Impairment in Primary Care: Data from Two Spanish Studies

2013 ◽  
Vol 2013 ◽  
pp. 1-7 ◽  
Author(s):  
Cristóbal Carnero-Pardo ◽  
Isabel Cruz-Orduña ◽  
Beatriz Espejo-Martínez ◽  
Carolina Martos-Aparicio ◽  
Samuel López-Alcalde ◽  
...  
Keyword(s):  
Primary Care ◽  
Cognitive Impairment ◽  
Characteristic Curve ◽  
Total Sample ◽  
Phase Iii ◽  
Kappa Index ◽  
Two Phase ◽  
Clock Drawing Test ◽  
Pooled Data ◽  
Post Hoc

Objectives. To study the utility of the Mini-Cog test for detection of patients with cognitive impairment (CI) in primary care (PC).Methods. We pooled data from two phase III studies conducted in Spain. Patients with complaints or suspicion of CI were consecutively recruited by PC physicians. The cognitive diagnosis was performed by an expert neurologist, after formal neuropsychological evaluation. The Mini-Cog score was calculatedpost hoc, and its diagnostic utility was evaluated and compared with the utility of the Mini-Mental State (MMS), the Clock Drawing Test (CDT), and the sum of the MMS and the CDT (MMS+CDT) using the area under the receiver operating characteristic curve (AUC). The best cut points were obtained on the basis of diagnostic accuracy (DA) and kappa index.Results. A total sample of 307 subjects (176 CI) was analyzed. The Mini-Cog displayed an AUC (±SE) of0.78±0.02, which was significantly inferior to the AUC of the CDT (0.84±0.02), the MMS (0.84±0.02), and theMMS+CDT(0.86±0.02). The best cut point of the Mini-Cog was 1/2 (sensitivity 0.60, specificity 0.90, DA 0.73, and kappa index0.48±0.05).Conclusions. The utility of the Mini-Cog for detection of CI in PC was very modest, clearly inferior to the MMS or the CDT. These results do not permit recommendation of the Mini-Cog in PC.

scholarly journals Secukinumab efficacy on resolution of enthesitis in psoriatic arthritis: pooled analysis of two phase 3 studies

2019 ◽  
Vol 21 (1) ◽  
Author(s):  
Laura C. Coates ◽  
Johan K. Wallman ◽  
Dennis McGonagle ◽  
Georg A. Schett ◽  
Iain B. McInnes ◽  
...  
Keyword(s):  
Psoriatic Arthritis ◽  
Pooled Analysis ◽  
Search Query ◽  
Two Phase ◽  
Pooled Data ◽  
Link Type ◽  
Full Resolution ◽  
Shift Analysis ◽  
Post Hoc ◽  
Future 2

Abstract Background Enthesitis is one of the psoriatic arthritis (PsA) domains. Patients with enthesitis are associated with worse outcomes than those without enthesitis. The effect of secukinumab on the resolution of enthesitis in patients with PsA was explored using pooled data from the FUTURE 2 and 3 studies. Method Assessments of enthesitis through week 104 used the Leeds Enthesitis Index. These post hoc analyses included resolution of enthesitis count (EC = 0), median time to first resolution of enthesitis (Kaplan-Meϊer estimate), and shift analysis (as observed) of baseline EC (1, 2, or 3–6) to full resolution (FR), stable (similar or reduction of EC), or worse (EC > baseline). Efficacy outcomes (ACR, PASI, HAQ-DI, SF-36 PCS, and DAS28-CRP) were assessed in patients with or without baseline enthesitis. Results are reported for secukinumab 300 and 150 mg in the overall population and by prior TNFi treatment. Results A total of 65% (466/712) of patients had baseline enthesitis. In the overall population, FR was achieved as early as week 16 in 65% (300 mg) and 56% (150 mg) versus 44% (placebo) patients, with further improvements to 91% (300 mg) and 88% (150 mg) at week 104. The majority (89%) of patients without enthesitis at baseline maintained this status at week 104. Median days to resolution of EC were shorter with secukinumab 300 and 150 mg versus placebo (57 and 85 vs 167 days, respectively). In patients with EC of 1 or 2, shift analysis from baseline to week 24 showed that more patients achieved FR with secukinumab 300 mg and 150 mg versus placebo, whereas no difference between secukinumab and placebo was shown in the more severe patients with EC of 3–6. Increases in proportions of patients with FR were observed with secukinumab irrespective of the severity of EC from baseline to week 104. Improvements in efficacy outcomes were similar in patients with or without enthesitis treated with secukinumab 300 mg. Conclusion Secukinumab provided early and sustained resolution of enthesitis in patients with PsA over 2 years. Secukinumab 300 mg provided higher resolution than 150 mg in patients with more severe baseline EC and showed similar overall efficacy in patients with or without enthesitis. Trial registration FUTURE 2: ClinicalTrials.gov, NCT01752634 (date of study registration: December 19, 2012), and EudraCT, 2012-004439-22 (date of study registration: December 12, 2012) FUTURE 3: ClinicalTrials.gov, NCT01989468 (date of study registration: November 21, 2013), and EudraCT, 2013-004002-25 (date of study registration: December 17, 2013)

scholarly journals Pediatric subset of primary immunodeficiency patients treated with SCIG: post hoc analysis of SHIFT and IBIS pooled data

2020 ◽  
Vol 16 (1) ◽  
Author(s):  
Viviana Moschese ◽  
◽  
Clementina Canessa ◽  
Antonino Trizzino ◽  
Baldassarre Martire ◽  
...  
Keyword(s):  
Bacterial Infection ◽  
Immunoglobulin G ◽  
Rate Ratio ◽  
Incidence Rate Ratio ◽  
Treatment Options ◽  
Post Hoc Analysis ◽  
Pooled Data ◽  
Primary Endpoints ◽  
Post Hoc ◽  
Monthly Dose

Abstract Background Primary immunodeficiencies (PID) constitute a heterogeneous group of more than 350 monogenetic diseases. PID patients with antibody impairment require lifelong administration of immunoglobulin G replacement therapy, administered either intravenously (IVIG) or subcutaneously (SCIG). Although the effectiveness of weekly and biweekly (every other week) SCIG administration has been shown in several trials, data on the viability of these two regimens in pediatric PID patients are sparse. Methods Data on the pediatric subsets of PID patients enrolled in SHIFT (weekly) and IBIS (biweekly) studies were pooled and analyzed to indirectly compare two different 20%-concentrated SCIG (Hizentra®) regimens. The primary endpoints were to evaluate trough IgG levels and cumulative monthly doses; the secondary endpoint was to analyze incidence of infections. Results Fifteen and 13 children from the SHIFT and IBIS studies were included, respectively. Cumulative 20%-concentrated SCIG monthly dose was slight lower for the biweekly regimen (Δ = − 2.04, 90% CI − 8.3 to 4.23). However, the trough IgG levels were similar between the two groups (Δ = 0.28, 90% CI − 0.51 to 1.07) and constantly above the threshold of 5 g/L. After adjusting for potential confounders, the annualized rate of infections was similar between SHIFT and IBIS patients (incidence rate ratio = 1.09, 90% CI 0.72–1.67); only 1 serious bacterial infection was experienced by a patient in the IBIS group. Conclusion In pediatric PID patients, weekly and biweekly Hizentra® administrations appeared equally effective treatment options.

Sign in / Sign up

Export Citation Format

Share Document