scholarly journals Efficacy, safety, and tolerability of brivaracetam with concomitant lamotrigine or concomitant topiramate in pooled Phase III randomized, double-blind trials: A post-hoc analysis

2018 ◽  
Vol 80 ◽  
pp. 129-134 ◽  
Author(s):  
Selim Benbadis ◽  
Pavel Klein ◽  
Jimmy Schiemann ◽  
Anyzeila Diaz ◽  
Sami Elmoufti ◽  
...  
Keyword(s):  
Phase Iii ◽  
Double Blind ◽  
Post Hoc Analysis ◽  
Post Hoc ◽  
Blind Trials

scholarly journals 935. Effect of Tesamorelin in People with HIV with and without Dorsocervical Fat: Post Hoc Analysis of Phase III Double Blind Placebo Control Trial

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S500-S501
Author(s):  
Farah Rahman ◽  
Marilyn de Chantal ◽  
Pedro Mesquita ◽  
Judith A Aberg
Keyword(s):  
Growth Hormone ◽  
Abdominal Fat ◽  
Fat Deposition ◽  
Phase Iii ◽  
Placebo Control ◽  
People Living With Hiv ◽  
Anthropometric Parameters ◽  
Double Blind ◽  
Post Hoc Analysis ◽  
Post Hoc

Abstract Background Lipohypertrophy is defined as excess fat deposition in abdominal defined as visceral adipose tissue (VAT) as well as in the dorsocervical region, breasts, trunk, and along with possible fat deposition in liver, muscle, myocardium and epicardium. Multiple factors have been described as contributing to lipohypertrophy in people living with HIV (PLWH), including patient characteristics, antiretroviral therapy (ART) and also impaired growth hormone (GH) secretion. Tesamorelin, a synthetic form of growth-hormone-releasing hormone (GHRH), is indicated for reduction of excess abdominal fat in PLWH with lipodystrophy Methods Post-hoc analysis was done on phase 3 randomized, double-blind, multicenter trials. Patients were eligible if between 18 and 65 years of age, had confirmed HIV infection, had evidence of excess abdominal fat accumulation and on stable ART regimen for 8 weeks or more. Participants were randomized to receive tesamorelin 2 mg daily or placebo daily for 26 weeks. Only tesamorelin responders, defined as patients with at least 8% decrease in VAT and who were adherent to the medication, were used for this analysis. Results are reported for patients with and without dorsocervical (DC) fat deposition. Results Demographic characteristics of responders at week 26 are shown according to presence or absence of DC fat (Table 1). At week 26, on average, the patients with DC fat deposition had higher BMI and waist circumference (WC) than the group without DC fat. Most patients in both groups had lipoatrophy. Metabolic and anthropometric parameters were measured at week 26 in patients with and without DC fat (Table 2). There was a decrease in VAT and also an improvement in their WC at week 26 in both groups. Table 1: Baseline Characteristics of Tesamorelin Responder Subjects at Week 26, by Dorsocervical Status Table 2: Change in Abdominal Adiposity, Insulin-Like Growth Factor-1 Levels, and Metabolic Parameters Between Baseline and Week 26 Among Tesamorelin Responders Conclusion This data demonstrates that tesamorelin is effective at reducing VAT in both patients with and without DC fat. The medication was well tolerated without significant changes to metabolic based measurements. Treatment of excessive VAT with tesamorelin has seemingly positive results in fat reduction in patients with or without DC fat deposition and our study contributes to the growing literature. Disclosures Marilyn de Chantal, PhD, Theratechnologies Inc (Employee) Pedro Mesquita, PhD, Theratechnologies, Inc. (Employee) Judith A. Aberg, MD, Theratechnology (Consultant)

scholarly journals Triamcinolone Acetonide in the Treatment of Perennial Allergic Rhinitis: A post hoc Efficacy Analysis of a Phase III Study Performed in Russia

2021 ◽  
pp. 1-8
Author(s):  
Alexander V. Karaulov ◽  
Natalia I. Ilina ◽  
Natalia Shartanova ◽  
Aleksandr Maslakov ◽  
Luiz Lucio
Keyword(s):  
Allergic Rhinitis ◽  
Triamcinolone Acetonide ◽  
Mixed Model ◽  
Linear Mixed Model ◽  
Nasal Symptom ◽  
Phase Iii ◽  
Double Blind ◽  
Post Hoc Analysis ◽  
Post Hoc ◽  
To Receive

<b><i>Introduction:</i></b> Allergic rhinitis (AR) is a disease which affects &#x3e;24% of the population in Russia. Triamcinolone acetonide (TAA) is a corticosteroid used for treating AR. This post hoc analysis assesses the efficacy of intranasal TAA in improving perennial AR (PAR) symptom scores over 4 weeks. <b><i>Methods:</i></b> NASANIF (NCT03317015) was a double-blind, parallel-group, multicenter, prospective, non-inferiority, phase III clinical trial in which patients with PAR were randomized (1:1) to receive TAA or fluticasone propionate (FP) over 4 weeks. Our post hoc analysis evaluates weekly change in PAR symptoms using the reflective Total Nasal Symptom Score (rTNSS), overall and for individual symptoms (sneezing, nasal itching, rhinorrhoea, and nasal obstruction). Proportion of patients and time to achieve a ≥50 or ≥75% reduction in rTNSS were assessed. For rTNSS endpoints, a linear mixed-model methodology was used; for time-to-event endpoints, cumulative incidence functions were estimated using the Kaplan-Meier method, in the per-protocol population. <b><i>Results:</i></b> Of 260 patients, 128 each completed the study and were randomized to receive TAA or FP. From baseline to week 4, the changes in total rTNSS were −7.78 (95% CI: −8.1701 to −7.3967; <i>p</i> &#x3c; 0.001) and −7.52 (−7.9053 to −7.1320; <i>p</i> &#x3c; 0.001) for TAA and FP, respectively. Individual symptoms improved significantly from baseline. The proportion of patients achieving ≥50 and ≥75% reductions in total rTNSS was 88.0 and 67.2%, respectively in the TAA group. No significant differences were observed between the TAA and FP in any analyses. <b><i>Conclusions:</i></b> TAA produced effective and prolonged improvement of PAR symptoms over a 4-week treatment period.

scholarly journals Subcutaneous methylnaltrexone for opioid-induced constipation in advanced-illness patients with or without active cancer

2020 ◽  
Vol 10 (2) ◽  
pp. 73-84 ◽  
Author(s):  
Bruce H Chamberlain ◽  
Michelle Rhiner ◽  
Neal E Slatkin ◽  
Nancy Stambler ◽  
Robert J Israel
Keyword(s):  
Clinical Trial ◽  
Phase Iii ◽  
Opioid Analgesia ◽  
Advanced Illness ◽  
Two Phase ◽  
Double Blind ◽  
Clinical Trial Registration ◽  
Post Hoc Analysis ◽  
Post Hoc ◽  
Active Cancer

Aim: To evaluate methylnaltrexone for opioid-induced constipation in patients with and without cancer. Methods: This post hoc analysis comprises two Phase III, multicenter, double-blind, randomized studies of advanced-illness patients who received methylnaltrexone subcutaneous injection or placebo. Results: Significantly more patients treated with methylnaltrexone than placebo experienced laxation within 4 (cancer = 55.5 vs 15.5%; noncancer = 55.6 vs 12.8%) and 24 (cancer = 64.7 vs 29.8%; noncancer = 64.4 vs 30.8%) h after the first dose (p < 0.01 vs placebo). Regardless of cancer status, methylnaltrexone reduced median time to laxation and improved constipation relief without impacting opioid analgesia or withdrawal symptoms. Conclusion: Methylnaltrexone provided significant improvements in opioid-induced constipation over placebo in advanced-illness patients with and without cancer. Clinical trial registration numbers: study 301: NCT00401362; study 302: NCT00402038.

scholarly journals Effects of Cariprazine on Cognition in Patients With Bipolar Mania or Mixed States: Post Hoc Analysis From 3 Randomized, Controlled Phase III Studies

CNS Spectrums ◽  
2021 ◽  
Vol 26 (2) ◽  
pp. 182-182
Author(s):  
Roger S. Mcintyre ◽  
Eduard Vieta ◽  
Willie Earley ◽  
Mehul Patel
Keyword(s):  
Repeated Measures ◽  
Missing Values ◽  
Rating Scale ◽  
Phase Iii ◽  
Cognitive Symptoms ◽  
Double Blind ◽  
Bipolar I Disorder ◽  
Post Hoc Analysis ◽  
Cognitive Subscale ◽  
Post Hoc

AbstractIntroductionCariprazine, a dopamine D3-preferring D3/D2 and serotonin 5-HT1A receptor partial agonist, is approved for the treatment of schizophrenia and for depressive, manic, or mixed episodes associated with bipolar I disorder. Previous post hoc analyses have demonstrated that cariprazine was effective versus placebo for improving cognitive symptoms in patients with schizophrenia or bipolar depression. This post hoc analysis evaluated the effects of cariprazine on cognitive symptoms in patients with acute manic or mixed bipolar episodes.MethodsData from 3 phase II/III, randomized, double-blind, placebo-controlled studies in patients with manic or mixed episodes associated with bipolar I disorder (NCT00488618, NCT01058096, NCT01058668) were pooled and analyzed. Patients were randomized to placebo or flexibly dosed cariprazine (3-12 mg/d, 3-6 mg/d, or 6-12 mg/d [1 study only]) for 3 weeks of double-blind treatment; all dose groups were combined for the pooled analysis. Cognitive symptoms were assessed using the Positive and Negative Syndrome Scale (PANSS) Cognitive subscale (sum of PANSS items P2, N5, N7, G10, G11); a score of 15 or greater at baseline indicated the presence of cognitive symptoms. Mean changes from baseline to week 3 in PANSS cognitive subscale/item scores and Young Mania Rating Scale (YMRS) total score were evaluated in the overall intent-to-treat (ITT) population and in the subgroup of patients with baseline cognitive symptoms. A mixed-effects model for repeated measures (MMRM) was used to impute missing values.ResultsOf the 1012 patients in the ITT population, 174 (placebo=71; cariprazine=103) had a PANSS Cognitive subscale score of 15 or greater at baseline. At week 3, the cariprazine group demonstrated significantly greater mean improvement than the placebo group on PANSS cognitive subscale scores in both the ITT population (−2.2 vs −1.3; P<.0001) and the subgroup with baseline cognitive symptoms (−4.0 vs −1.9; P=.0002). In patients with baseline cognitive symptoms, improvement was significantly greater for cariprazine- versus placebo-treated patients on YMRS total score (−16.7 vs −8.2; P<.0001) and the individual PANSS cognitive subscale items of conceptual disorganization (−1.1 vs −0.5; P=.0004), difficulty in abstract thinking (−0.8 vs −0.3; P=.0044), stereotyped thinking (−0.3 vs −0.1; P=.0350), and poor attention (−1.1 vs −0.6; P=.0043).ConclusionIn patients with manic or mixed episodes associated with bipolar I disorder, cariprazine versus placebo was effective in improving cognitive symptoms in the overall patient population as well as in patients with baseline cognitive symptoms. In addition, cariprazine versus placebo also demonstrated efficacy in improving manic symptoms in patients with baseline cognitive symptoms. These results suggest that cariprazine may provide benefits for the treatment of cognitive symptoms in patients with bipolar I mania.FundingAbbVie Inc.

scholarly journals Efficacy and safety of filgotinib in methotrexate-naive patients with rheumatoid arthritis with poor prognostic factors: post hoc analysis of FINCH 3

RMD Open ◽  
2021 ◽  
Vol 7 (2) ◽  
pp. e001621
Author(s):  
Daniel Aletaha ◽  
René Westhovens ◽  
Cecile Gaujoux-Viala ◽  
Giovanni Adami ◽  
Alan Matsumoto ◽  
...  
Keyword(s):  
Rheumatoid Arthritis ◽  
Prognostic Factors ◽  
Structural Damage ◽  
High Sensitivity ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Post Hoc Analysis ◽  
American College Of Rheumatology ◽  
Post Hoc

ObjectiveThis analysis evaluated efficacy and safety of filgotinib, a Janus-associated kinase 1-preferential inhibitor, in methotrexate (MTX)-naive patients with rheumatoid arthritis (RA) with multiple poor prognostic factors (PPFs).MethodsThis was a post hoc analysis of the phase III, randomised, double-blind, active-controlled, FINCH 3 study (clinicaltrials.gov NCT02886728). Patients received once-daily oral filgotinib 200 or 100 mg plus once-weekly oral MTX ≤20 mg (FIL200 + MTX and FIL100 + MTX), filgotinib 200 mg monotherapy (FIL200), or oral MTX monotherapy (MTX-mono) for up to 52 weeks. PPFs investigated were seropositivity for rheumatoid factor or anticyclic citrullinated peptide antibodies, high-sensitivity C reactive protein (CRP) ≥4 mg/L, Disease Activity Score in 28 joints with CRP (DAS28(CRP)) >5.1, and presence of erosions. Filgotinib efficacy and safety in patients with all four PPFs at baseline were explored versus MTX-mono within this subgroup and compared informally with the overall population.ResultsOf 1249 patients in FINCH 3, 510 (40.8%) had all PPFs. Efficacy of FIL200 + MTX among these patients was comparable to the overall population, with higher rates of 20%/50%/70% improvement from baseline by American College of Rheumatology criteria, DAS28(CRP) <2.6, and remission; greater improvement in physical function and pain; and better inhibition of structural damage relative to MTX-mono. FIL100 + MTX and FIL200 were not consistently more efficacious versus MTX-mono. Safety of filgotinib in patients with PPFs was comparable to the overall population; no new safety signals were observed.ConclusionFIL200 + MTX efficacy and safety in patients with multiple PPFs were similar to the overall population.

scholarly journals Efficacy and safety of ceftobiprole in patients aged 65 years or older: a post hoc analysis of three Phase III studies

2021 ◽  
Author(s):  
Tobias Welte ◽  
Thomas WL Scheeren ◽  
J Scott Overcash ◽  
Mikael Saulay ◽  
Marc Engelhardt ◽  
...  
Keyword(s):  
Community Acquired Pneumonia ◽  
Phase Iii ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Skin Structure ◽  
Treatment Groups ◽  
Post Hoc Analysis ◽  
Post Hoc ◽  
Hospital Acquired ◽  
Phase Iii Studies

Aim: To evaluate the efficacy and safety of ceftobiprole in patients aged ≥65 years. Materials & methods: We conducted a post hoc analysis of three randomized, double-blind, Phase III studies in patients with acute bacterial skin and skin structure infections, community-acquired pneumonia and hospital-acquired pneumonia. Results: Findings for patients aged ≥65 years (n = 633) were consistent with those for the overall study populations, although a trend toward improved outcomes was reported in some subgroups, for example, patients aged ≥75 years with community-acquired pneumonia were more likely to achieve an early clinical response with ceftobiprole than comparator (treatment difference 16.3% [95% CI:1.8–30.8]). The safety profile was similar between treatment groups in all studies. Conclusion: This analysis further supports the efficacy and safety of ceftobiprole in older patients with acute bacterial skin and skin structure infections or pneumonia. Clinicaltrials.gov trial identifiers: NCT03137173 , NCT00326287 , NCT00210964 , NCT00229008

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