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Institution

Eli Lilly and Company

CompanyIndianapolis, Indiana, United States
About: Eli Lilly and Company is a company organization based out in Indianapolis, Indiana, United States. It is known for research contribution in the topics: Population & Agonist. The organization has 17826 authors who have published 22835 publications receiving 946714 citations. The organization is also known as: Eli Lily.
Topics: Population, Agonist, Insulin, Placebo, Olanzapine


Papers
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Journal ArticleDOI
TL;DR: Intramuscular olanzapine is a safe and effective treatment for reducing acute agitation in patients with bipolar mania and no significant differences among the three treatment groups were observed in safety measures.
Abstract: There are no rapid-acting intramuscular formulations of atypical antipsychotics available for quickly calming an agitated patient with bipolar disorder. In this study, 201 agitated patients with bipolar mania were randomly assigned to receive one to three injections of the atypical antipsychotic olanzapine (10 mg, first two injections; 5 mg, third injection), the benzodiazepine lorazepam (2 mg, first two injections; 1 mg, third injection), or placebo (placebo, first two injections; olanzapine, 10 mg, third injection) within a 24-hour period. Agitation was measured at baseline, every 30 minutes for the first 2 hours, and at 24 hours after the first injection using the Positive and Negative Syndrome Scale-Excited Component subscale and two additional agitation scales. At 2 hours after the first injection, patients treated with olanzapine showed a significantly greater reduction in scores on all agitation scales compared with patients treated with either placebo or lorazepam. At 24 hours after the first injection, olanzapine remained statistically superior to placebo in reducing agitation in patients with acute mania, whereas patients treated with lorazepam were not significantly different from those treated with placebo or olanzapine. Furthermore, no significant differences among the three treatment groups were observed in safety measures, including treatment-emergent extrapyramidal symptoms, the incidence of acute dystonia, or QTc interval changes. These findings suggest that intramuscular olanzapine is a safe and effective treatment for reducing acute agitation in patients with bipolar mania.

234 citations

Journal ArticleDOI
TL;DR: Both dulaglutide doses demonstrated superior glycemic control versus sitagliptin at 52 weeks with an acceptable tolerability and safety profile.
Abstract: OBJECTIVE To compare the efficacy and safety of two doses of once-weekly dulaglutide, a glucagon-like peptide 1 receptor agonist, to sitagliptin in uncontrolled, metformin-treated patients with type 2 diabetes. The primary objective was to compare (for noninferiority and then superiority) dulaglutide 1.5 mg versus sitagliptin in change from baseline in glycosylated hemoglobin A1c (HbA1c) at 52 weeks. RESEARCH DESIGN AND METHODS This multicenter, adaptive, double-blind, parallel-arm study randomized patients ( N = 1,098; mean baseline age 54 years; HbA1c 8.1% [65 mmol/mol]; weight 86.4 kg; diabetes duration 7 years) to dulaglutide 1.5 mg, dulaglutide 0.75 mg, sitagliptin 100 mg, or placebo (placebo-controlled period up to 26 weeks). The treatment period lasted 104 weeks, with 52-week primary end point data presented. RESULTS The mean HbA1c changes to 52 weeks were (least squares mean ± SE): −1.10 ± 0.06% (−12.0 ± 0.7 mmol/mol), −0.87 ± 0.06% (9.5 ± 0.7 mmol/mol), and −0.39 ± 0.06% (4.3 ± 0.7 mmol/mol) for dulaglutide 1.5 mg, dulaglutide 0.75 mg, and sitagliptin, respectively. Both dulaglutide doses were superior to sitagliptin ( P < 0.001, both comparisons). No events of severe hypoglycemia were reported. Mean weight changes to 52 weeks were greater with dulaglutide 1.5 mg (−3.03 ± 0.22 kg) and dulaglutide 0.75 mg (−2.60 ± 0.23 kg) compared with sitagliptin (−1.53 ± 0.22 kg) ( P < 0.001, both comparisons). The most common gastrointestinal treatment-emergent adverse events in dulaglutide 1.5- and 0.75-mg arms were nausea, diarrhea, and vomiting. CONCLUSIONS Both dulaglutide doses demonstrated superior glycemic control versus sitagliptin at 52 weeks with an acceptable tolerability and safety profile.

233 citations

Journal ArticleDOI
TL;DR: The main conclusion is that the mixed model approach is more efficient and reliable as a method of primary analysis, and should be preferred to the inherently biased and statistically invalid simple imputation approaches.
Abstract: This position paper summarizes relevant theory and current practice regarding the analysis of longitudinal clinical trials intended to support regulatory approval of medicinal products, and it reviews published research regarding methods for handling missing data. It is one strand of the PhRMA initiative to improve efficiency of late-stage clinical research and gives recommendations from a cross-industry team. We concentrate specifically on continuous response measures analyzed using a linear model, when the goal is to estimate and test treatment differences at a given time point. Traditionally, the primary analysis of such trials handled missing data by simple imputation using the last, or baseline, observation carried forward method (LOCF, BOCF) followed by analysis of (co)variance at the chosen time point. However, the general statistical and scientific community has moved away from these simple methods in favor of joint analysis of data from all time points based on a multivariate model (eg, of a mixed-effects type). One such newer method, a likelihood-based mixed-effects model repeated measures (MMRM) approach, has received considerable attention in the clinical trials literature. We discuss specific concerns raised by regulatory agencies with regard to MMRM and review published evidence comparing LOCF and MMRM in terms of validity, bias, power, and type I error. Our main conclusion is that the mixed model approach is more efficient and reliable as a method of primary analysis, and should be preferred to the inherently biased and statistically invalid simple imputation approaches. We also summarize other methods of handling missing data that are useful as sensitivity analyses for assessing the potential effect of data missing not at random.

233 citations

Journal ArticleDOI
TL;DR: The formamide acetals as mentioned in this paper have been used in two main categories of reactions, namely alkylation and formylation, and are used in the synthesis of esters from acids, ethers and thioethers from phenols and aromatic and heterocyclic thiols.

233 citations

Journal ArticleDOI
TL;DR: These analyses demonstrate a statistically significant interaction between treatment effect and NSCLC histology, indicating superior efficacy of pemetrexed in nonsquamous patients compared with other standard treatment options.

233 citations


Authors

Showing all 17866 results

NameH-indexPapersCitations
Mark J. Daly204763304452
Irving L. Weissman2011141172504
Eric J. Topol1931373151025
Tony Hunter175593124726
Xiang Zhang1541733117576
Jerrold M. Olefsky14359577356
Stephen F. Badylak13353057083
George A. Bray131896100975
Lloyd Paul Aiello13150685550
Levi A. Garraway12936699989
Mark Sullivan12680263916
James A. Russell124102487929
Tony L. Yaksh12380660898
Elisabetta Dejana12243048254
Hagop S. Akiskal11856550869
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Performance
Metrics
No. of papers from the Institution in previous years
YearPapers
20236
202287
2021815
2020868
2019732
2018742