Double pooled analysis

A pooled analysis of 14 875 adults (Hispanic, n = 361 White, n = 10 108 African American, n = 547 Asian, n = 112) who participated in 104 double-blind, placebo-controlled paroxetine trials for mood and anxiety disorders was performed to ascertain minority group differences (Roy-Byrne et al., 2005). There were significant differences in rates of response by ethnicity (p = 0.014) with the odds of responding being lower for the Asian and Hispanic subjects compared to the African American and White subjects. There was also a higher placebo response rate in Hispanic subjects. Rapidity of response and emergence of adverse effects were similar across groups. 

In patients with mild to moderate Alzheimer s disease metrifonate significantly improved behavior as well as cognition, function in activities of daily living, and global functional status, as shown by a pooled analysis of four prospective, multicenter, randomized, double-bhnd, parallel-group, placebo-controlled trials, meeting FDA guidelines (8). 

Farlow MR, Cyrus PA. Metrifonate therapy in Alzheimer s disease a pooled analysis of four randomized, double-blind, placebo-controlled trials. Dement Geriatr Cogn Disord 2000 11(4) 202-11. 

In a pooled analysis of safety data from double-bUnd, placebo-controUed add-on trials of levetiracetam (1-3 g/ day) in adults with refractory partial seizures, adverse events occurring in at least 3% of patients and with at least 3% higher incidence in the active treatment group were tiredness (14 versus 10%), somnolence (15 versus 10%), dizziness (9 versus 4%), and common cold or upper respiratory tract infections (13 versus 7%) (11). The proportions of patients requiring withdrawal of treatment or dosage reduction owing to adverse events were 15% with levetiracetam and 12% with placebo. The efficacy and tolerability of levetiracetam monotherapy in refractory partial seizures have been studied in a double-blind, pla-cebo-controUed study in 286 patients (12). Adverse events that were more common with levetiracetam and that occurred in more than 5% of cases included weakness, infection, and somnolence. Of 181 patients who took levetiracetam, 36 completed the study compared with only 10 of 105 who took placebo. The tolerability and efficacy of levetiracetam, 2 or 4 g/day, as add-on therapy have been studied in 119 patients with refractory epilepsy (13). Somnolence was the most common reason for withdrawal and occurred more often with levetiracetam than placebo, as did weakness. Somnolence was more common with the higher dose, which was not more effective than... 

Kaplan SA, D Alisera PM. Tolerability of a-blockade with doxazosin as a therapeutic option for symptomatic benign prostatic hyperplasia in the elderly patient A pooled analysis of seven double-blind, placebo-controlled studies. J Gerontol 1998 53A M201-M206. 

The effect of race on olanzapine efficacy and safety has been studied in a pooled analysis of six randomized, double-blind trials in 605 white patients and 375 black patients taking olanzapine 5-20mg/day for 24-28 weeks for schizophrenia, schizophreniform disorder, or schizoaffective disorder... 

Ludwig H, Crawford J, Osterborg A, Vansteenkiste J, Henry DH, Fleishman A, Bridges K, Glaspy JA. Pooled analysis of individual patient-level data from all randomized, double-blind, placebo-controlled... 

Vanderburg DG, Batzar E, Fogel I, Kremer CM. A pooled analysis of suicidality in double-blind, placebo-con-trolled studies of sertraline in adults. J CUn Psychiatry 2009 70(5) 674—83. 

Tourian KA, Padmanabhan SK, Groark J, Brisard C, Farrington D. Desvenlafaxine 50 and 100 mg/d in the treatment of major depressive disorder an 8-week, phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial and a post hoc pooled analysis of three studies. Clin Ther 2009 31(Pt 1) 1405-23. 

Systematic reviews In a pooled analysis of data from five double-blind, randomized, placebo-controlled, multicenter trials of budesonide capsules 6 mg in Crohn s disease, the most common adverse reactions were gastrointestinal and endocrine (budesonide 6 mg/day, n = 208 placebo, n = 209)... 

An extensive analysis of the best IRP-1 binding sequences (from a pool of 16 384 different IRE variants) showed that the selected consensus corresponded exactly to the phylogenetically conserved IRE motif (Henderson et ah, 1994). A certain number of single or double mutations was tolerated at virtually every permuted position. 

Methodological controls. Some published studies on the effectiveness of hypericum have experimental design flaws, but there are several that are methodologically controlled, employing double-blind, randomization, and placebo controls. Randomized, placebo-controlled studies were summarized and evaluated in a meta-analysis by Linde and colleagues (1996). The combined subject pool was 1,757 outpatients with mild to... 

Feighner JP, Cohen JB Analysis of individual symptoms in generahzed anxiety disorder a pooled, multi-study, double evaluation of Buspirone. Neuropsychobiology 21 124-130, 1989... 

Kinetic gelation models [178] have been used to determine, within experimental error, the fraction of constrained and unconstrained double bonds over a wide range of conversions in the polymerization of ethylene glycol dimethacrylate. The amount of unconstrained and constrained functional groups was determined experimentally by solid state nuclear magnetic resonance spectroscopy. The rules for determining constraint in the model were that all pendant double bonds and all monomers in pools of six or less are constrained. Monomers in pools of seven or more are assumed to be unconstrained. Whether a site is constrained or not does not affect the reactivity only the analysis of the model is affected by the rules defining constraint. 

Based on an electrocardiographic analysis of pooled data from four 26-week, phase III, multicenter, double-blind, placebo-controlled trials of rivastigmine (n = 2791), there were no adverse effects on cardiac function (19). Rivastigmine can therefore be safely given to patients with Alzheimer s disease, without the need for cardiac monitoring. 

Analysis of the FFA extracted from pooled hair clippings of adult males has been carried out by Weitkamp et al. [140]. Their study did not contain data concerning the effect of lipolysis on the structures of FFA found in hair fat. Saturated and unsaturated fatty acids ranging in chain length from 5 to 22 carbon atoms have been found in human hair fat [140,141]. Location of the double bond in the unsaturated acids is suggested to occur at the 6,7 position, with some 8,9 and other isomers. Data from the study by... 

Gil-Nagel A, Eiger C, Ben-Menachem E, Halasz P, Lopes-lima J, Gabbai AA, et al. Efficacy and safety of esKcarbazepine acetate as add-on treatment in patients with focal-onset seizures integrated analysis of pooled data from double-blind phase HI clinical studies. Epilepsia January 2013 54(1) 98-107. 

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