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Houston J.P.,Lilly United States LLC | Fijal B.,Lilly United States LLC | Heinloth A.N.,i3 Statprobe | Adams D.H.,Eli Lilly and Company
Psychiatry Research | Year: 2010

In patients from two clinical trials, we investigated the associations of single nucleotide polymorphisms (SNPs) in candidate genes with prolactin level changes during treatment with olanzapine/fluoxetine combination. In both cohorts, three dopamine receptor D2 (DRD2) SNPs were associated with prolactin changes. DRD2 may influence susceptibility to hyperprolactinemia associated with antipsychotic treatment. © 2009 Elsevier Ireland Ltd. All rights reserved. Source


Bonomi P.D.,Rush University Medical Center | MacE J.,Gulfcoast Oncology Associates | Mandanas R.A.,Integris Cancer Institute of Oklahoma | Min M.,Maryland Hematology Oncology Associates | And 5 more authors.
Journal of Thoracic Oncology | Year: 2013

INTRODUCTION: We conducted a phase II study of dual-agent monoclonal antibody therapy consisting of cetuximab and bevacizumab in combination with paclitaxel and carboplatin chemotherapy in non-small-cell lung cancer. METHODS: Patients with stage IIIB/IV nonsquamous non-small-cell lung cancer randomly received cetuximab (400 mg/m2 initially, 250 mg/m2 weekly thereafter) plus bevacizumab (15 mg/kg) for six cycles combined with paclitaxel (200 mg/m) and carboplatin (area under the curve 6) for either six cycles (six-cycle arm) or the first three cycles (three-cycle arm) (one cycle = 3 weeks). The primary objective was progression-free survival (PFS), estimated separately for each treatment arm. RESULTS: In 121 patients, the median PFS was 6.05 months (95% confidence interval [CI]: 5.65, 7.03) in the six-cycle arm and 4.50 months (95% CI: 4.01, 5.42) in the three-cycle arm. Respective median overall survival times were 12.06 months (95% CI: 9.40, 19.25) and 11.63 months (95% CI: 6.64, 17.61). The tumor response rate was 51.7% (95% CI: 39.0%, 64.3%) and 44.3% (95% CI: 31.8%, 56.7%) in the six-cycle and three-cycle arms, respectively, with corresponding median response durations of 4.86 months (95% CI: 4.30, 7.16) and 3.94 months (95% CI: 2.92, 4.47). Quality of life was consistent across arms. Cetuximab-related grade 3/4 events in greater than 5% of patients (six-cycle arm, three-cycle arm) were dermatitis acneiform (6.9%; 8.6%) and fatigue (13.8%; 5.2%). Three patients died during the study from drug-related adverse events (one in the six-cycle arm and two in the three-cycle arm). CONCLUSIONS: Both the regimens showed expected PFS and numerically comparable overall survival. Quality of life was similar in the two arms, and both the regimens were well tolerated. Copyright © 2013 by the International Association for the Study of Lung Cancer. Source


Pangallo B.,Eli Lilly and Company | Dellva M.A.,Eli Lilly and Company | D'Souza D.N.,i3 Statprobe | Essink B.,Oregon Center Clinical Investigation | And 2 more authors.
Journal of Psychiatric Research | Year: 2011

The efficacy, tolerability, and safety of LY2216684, a highly selective norepinephrine reuptake inhibitor, were studied in adult patients with major depressive disorder (MDD). This randomized, double-blind study compared flexible-dose LY2216684 6-18 mg once daily (N = 250) with placebo (N = 245) for 10 weeks acute therapy followed by 1 year LY2216684 treatment (results not reported here). Primary inclusion criteria consisted of GRID 17-item Hamilton Rating Scale for Depression total score ≥18 and Clinical Global Impressions-Severity score ≥4. The primary efficacy measure was the Montgomery-Asberg Depression Rating Scale (MADRS) total score. Response was defined as a ≥50% reduction in MADRS score and remission as MADRS total score ≤10. Global functioning was assessed using the Sheehan Disability Scale (SDS). LY2216684-treated patients showed significant improvement from baseline on the MADRS total score compared with placebo-treated patients (-13.3 vs. -9.8, p < .001), and they had a significantly higher probability of achieving response (49.5%) and remission (29.7%) compared with placebo-treated patients (29.3% and 18.8%, respectively). For the SDS global functional impairment score, LY2216684 treatment resulted in significantly greater improvement compared with placebo treatment (p < .001). More LY2216684-treated than placebo-treated patients discontinued from the study because of an adverse event or death (9.6% vs. 1.6%, p ≤ .001). LY2216684 was associated with significant increases (p < .01) from baseline in systolic (3 mm Hg) and diastolic (4 mm Hg) blood pressure and pulse (10 bpm) compared with placebo. LY2216684 6-18 mg demonstrated significant efficacy and was tolerated in the treatment of MDD. © 2011 Elsevier Ltd. Source


Kupsch A.R.,University Medicine Berlin | Bajaj N.,Royal Infirmary | Weiland F.,Sutter Health | Tartaglione A.,S. Andrea Hospital and Ass. Sistema Nervoso | And 5 more authors.
Journal of Neurology, Neurosurgery and Psychiatry | Year: 2012

Background: This study assessed the impact of DaTscan on clinical management, diagnosis, confidence of diagnosis (CoD), quality of life (QoL), health resource use (HRU) and safety during a 1-year follow-up in patients with clinically uncertain parkinsonian syndromes (CUPS). Methods: A total of 19 university hospital centres in Europe and the USA participated in this open-label, single-dose, prospective, clinical trial in patients with CUPS who were randomised to a DaTscan imaging group or to a no-imaging (control) group. The proportion of patients with changes in clinical management, diagnosis, CoD, QoL and HRU from baseline through 1 year post-DaTscan was compared between groups. Results: There were 273 patients randomised (135 DaTscan, 138 control). Significantly more patients in the DaTscan imaging group had at least one change in their actual clinical management after 12 weeks (p=0.002) and after 1 year (p<0.001) compared with patients in the control group. In addition, significantly more DaTscan patients had changes in diagnosis and an increased CoD at 4 weeks, 12 weeks and 1 year (all p<0.001) compared with control patients. No significant differences in total score for QoL or HRU were observed between groups during the 1-year follow-up period. DaTscan was safe and well tolerated. One patient in the imaging group had an adverse event (headache) with suspected relationship to DaTscan post-administration. Conclusions: DaTscan had a significant impact on clinical management, diagnosis and CoD in patients with CUPS. DaTscan is safe and well tolerated, and is a useful adjunct to differentiate a diagnosis of CUPS. Trial registration number http://ClinicalTrials.gov Identifier: NCT00382967. Source


Clark P.E.,Eli Lilly and Company | Valentine V.,Diabetes Network Inc. | Bodie J.N.,i3 Statprobe | Sarwat S.,Eli Lilly and Company
Current Medical Research and Opinion | Year: 2010

Objectives: To determine patient ease of use and preference for the Humalog KwikPen* (prefilled insulin lispro [Humalog†] pen, Eli Lilly and Company, Indianapolis, IN, USA) (insulin lispro pen) versus the Next Generation FlexPen‡ (prefilled insulin aspart [NovoRapid§] pen, Novo Nordisk A/S, Bagsværd, Denmark) (insulin aspart pen). Research design and methods: This was a randomized, open-label, 2-period, 8-sequence crossover study in insulin pen-nave patients with diabetes. Randomized patients (N367) received device training, then simulated low-(15U) and high-(60U) dose insulin injections with an appliance. Patients rated pens using an ease of use questionnaire and were asked separately for final pen preferences. Main outcome measures: The Insulin Device Ease of Use Battery is a 10-item questionnaire with a 7-point scale (higher scores reflect greater ease of use). The primary objective was to determine pen preference for easy to press to inject my dose (by comparing composite scores [low-plus high-dose]). Secondary objectives were to determine pen preference on select questionnaire items (from composite scores), final pen preference, and summary responses for all questionnaire items. Results: On the primary endpoint, easy to press to inject my dose, a statistically significant majority of patients with a preference chose the insulin lispro pen over the insulin aspart pen (68.4, 95 CI62.773.6). Statistically significant majorities of patients with a preference also favored the insulin lispro pen on secondary items: easy to hold in my hand when I inject (64.9, 95 CI58.870.7), easy to use when I am in a public place (67.5, 95 CI61.073.6), and overall easy to use (69.9, 95 CI63.975.4). A statistically significant majority of patients had a final preference for the insulin lispro pen (67.3, 95 CI62.272.1). Conclusions: Among pen-nave patients with diabetes who had a preference, the majority preferred the insulin lispro pen over the insulin aspart pen with regard to ease of use. Study limitations included open-label design and injection simulation, use of an unvalidated questionnaire, and enrollment of mostly insulin-nave patients. © 2010 Informa UK Ltd. Source

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