Pooled Post Hoc Analysis of Population Pharmacokinetics of Oxycodone and Acetaminophen Following Multiple Oral Doses of Biphasic Immediate-Release/Extended-Release Oxycodone/Acetaminophen Tablets

Pain Practice ◽  
2015 ◽  
Vol 16 (6) ◽  
pp. 730-736 ◽  
Author(s):  
Terri Morton ◽  
Ryan Franke ◽  
Krishna Devarakonda
Keyword(s):  
Population Pharmacokinetics ◽  
Extended Release ◽  
Immediate Release ◽  
Post Hoc Analysis ◽  
Post Hoc ◽  
Oral Doses

Extended‐release naltrexone/bupropion and liver health: pooled, post‐hoc analysis from 4 RCTs

2020 ◽  
Author(s):  
Harpreet S. Bajaj ◽  
Melonie Burrows ◽  
Jessica Blavignac ◽  
Emilia Paron ◽  
Fernando Camacho ◽  
...  
Keyword(s):  
Extended Release ◽  
Post Hoc Analysis ◽  
Liver Health ◽  
Post Hoc

Hydromorphone extended release for neuropathic and non-neuropathic/nociceptive chronic low back pain: A post hoc analysis of data from a randomized, multicenter, double-blind, placebo-controlled clinical trial

2014 ◽  
Vol 10 (5) ◽  
pp. 311 ◽  
Author(s):  
Srinivas Nalamachu, MD ◽  
Martin Hale, MD ◽  
Arif Khan, MD
Keyword(s):  
Clinical Trial ◽  
Low Back Pain ◽  
Extended Release ◽  
Controlled Clinical Trial ◽  
Low Back ◽  
Double Blind ◽  
Double Blind Placebo ◽  
Post Hoc Analysis ◽  
Titration Phase ◽  
Post Hoc

Objective: The aim of this study was to determine the efficacy and tolerability of hydromorphone extended release (ER) in patients with chronic low back pain (LBP) with or without a neuropathic component.Design: This was a post hoc analysis of data from a multicenter, double-blind, placebo-controlled clinical trial using a randomized withdrawal design, performed in patients with moderate to severe chronic LBP. Patients achieving stable doses of hydromorphone ER during a 2- to 4-week conversion and titration phase were randomized to continue treatment with hydromorphone ER or taper-down to placebo during a 12-week double-blind phase. The primary efficacy outcome was the mean change in 11-point Numeric Rating Scale (NRS) pain intensity score from randomization to the final visit of the double-blind phase. Tolerability was assessed by recording adverse events (AEs). Data were analyzed separately for patients with non-neuropathic and neuropathic LBP.Results: A total of 173 patients with non-neuropathic/nociceptive LBP and 94 with neuropathic LBP were randomized into the double-blind phase. During the conversion and titration phase, mean (SD) NRS scores decreased significantly from 6.5 (1.87) and 6.4 (1.99) at screening to 3.3 (0.98) and 3.2 (1.05), respectively. For both LBP subgroups, patients randomized to hydromorphone ER maintained this improvement over the double-blind treatment period, whereas those randomized to placebo reported significant increase in NRS scores. Across subgroups, the incidence of 1 or more AE was 54 percent to 57 percent in the conversion and titration phase and 47 percent to 55 percent in the double-blind phase.Conclusions: The results of this study indicate that hydromorphone ER is efficacious and generally well tolerated in the management of patients with non-neuropathic and neuropathic chronic LBP.

Efficacy and tolerability of quetiapine XR 400/600/800mg/day in acute schizophrenia: a post-hoc analysis of data from two pooled randomised studies

2011 ◽  
Vol 26 (S2) ◽  
pp. 1411-1411
Author(s):  
R. Kahn ◽  
A. Kalali ◽  
U. Gustafsson ◽  
S. Nyberg
Keyword(s):  
Dose Response ◽  
Extended Release ◽  
Efficacy And Safety ◽  
Double Blind ◽  
Once Daily ◽  
Quetiapine Fumarate ◽  
Post Hoc Analysis ◽  
Response Efficacy ◽  
Quetiapine Xr ◽  
Post Hoc

IntroductionData from two, identically designed, placebo-controlled, randomised, double-blind clinical trials (D1444C00132+D1444C00133) for once-daily extended-release quetiapine fumarate (QTP-XR) were pooled and analysed.ObjectiveEvaluate dose response, efficacy and safety for QTP-XR in schizophrenia.MethodsPost-hoc analysis of data from patients receiving QTP-XR 400, 600, 800 mg/day or placebo. Endpoints: least squares means (LSM) change from baseline to Day 42 in PANSS total and positive and negative subscale scores. No corrections for multiplicity were performed. Adverse events (AEs) were recorded.Results914 patients were included; PANSS scores were assessed in the MITT population (n = 889). LSM change from baseline in PANSS total score diverged significantly from placebo at: Day 14 for QTP-XR 800 mg/day (-15.3 vs -12.1 for placebo; p = 0.018); Day 21 for 600 mg/day (-17.3 vs -14.2; p = 0.039); Day 42 for 400 mg/day (-19.2 vs -15.4; p = 0.033).Jonckheere-Terpstra analysis of change in PANSS total score at Day 42 showed a significant QTP-XR dose response (p = 0.0196; p < 0.001 with placebo). PANSS positive scores diverged by Day 21 for both QTP-XR 800 (-5.7 vs -4.8; p = 0.049) and 600 mg/day (-5.8 vs -4.8; p = 0.046). PANSS negative scores diverged by Day 21 (-4.0 vs -3.2; p = 0.040) and 42 (-4.8 vs -3.6; p = 0.009) for QTP-XR 800 and 600 mg/day, respectively. AEs occurred in 59.4%, 66.5%, 62.1% and 56.2% of patients in the QTP-XR 800, 600, 400 mg/day and placebo groups, respectively. Most common AEs were somnolence, dry mouth, sedation, insomnia, dizziness, headache, constipation and nausea.ConclusionsQTP-XR was generally well tolerated and demonstrated efficacy that increased with dose in schizophrenia.Financial support: AstraZeneca.

scholarly journals Dose-response relationship of extended-release methylphenidate for ADHD in adults: post-hoc analysis based on a systematic review

2021 ◽  
Author(s):  
Kim Boesen ◽  
Karsten Juhl Jørgensen ◽  
Peter C Gøtzsche
Keyword(s):  
Systematic Review ◽  
Dose Response ◽  
Extended Release ◽  
Fixed Dose ◽  
Adhd Symptoms ◽  
Post Hoc Analysis ◽  
Using Data ◽  
Meta Analyses ◽  
Post Hoc ◽  
Relationship Of

Objective: To assess potential dose-response relationships of extended-release methylphenidate for ADHD in adults on efficacy outcomes. Study design and setting: Post-hoc analysis based on a systematic review of extended-release methylphenidate (https://doi.org/10.1002/14651858.CD012857). Using data from clinical trials comparing multiple fixed-dose methylphenidate groups with placebo, we conducted subgroup meta-analyses for available efficacy outcomes. Results and conclusion: Five trials used a fixed-dose design with multiple methylphenidate groups receiving different doses. All trials were pivotal industry sponsored studies conducted to obtain marketing authorisation. We analysed four efficacy outcomes: Self-rated ADHD symptoms (5 trials, 1807 participants), investigator-rated ADHD symptoms (5 trials, 1904 participants), quality of life (4 trials, 1158 participants), and peer-rated ADHD symptoms (2 trials, 879 participants). There were no dose-response relationships for any outcome.

scholarly journals Efficacy of Triamcinolone Acetonide Extended-Release in Participants with Unilateral Knee Osteoarthritis: A Post Hoc Analysis

2019 ◽  
Vol 36 (6) ◽  
pp. 1398-1411 ◽  
Author(s):  
Michael J. Langworthy ◽  
Philip G. Conaghan ◽  
Joseph J. Ruane ◽  
Alan J. Kivitz ◽  
Joelle Lufkin ◽  
...  
Keyword(s):  
Knee Osteoarthritis ◽  
Triamcinolone Acetonide ◽  
Extended Release ◽  
Post Hoc Analysis ◽  
Post Hoc
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