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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.

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.

Detke H.C.,Lilly Research Laboratories | Weiden P.J.,University of Illinois at Chicago | Llorca P.-M.,Center Hospitalier University | Choukour M.,I3 Statprobe | And 3 more authors.
Journal of Clinical Psychopharmacology | Year: 2014

We compared long-term treatment effectiveness of monthly olanzapine long-acting injection (LAI) with that of oral olanzapine. Outpatients with 2 or more episodes of psychotic worsening in the past 24 months with Positive and Negative Syndrome Scale total score of lower than 70 were randomized to 405 mg/4 weeks of olanzapine LAI (n = 264) or 10 mg/d of oral olanzapine (n = 260) for 2 years of open-label treatment. Dosing thereafter was flexible (150-405 mg/4 weeks of LAI vs 5-20 mg/d of oral). Primary outcome was time to all-cause discontinuation. At baseline, patients were clinically stable (mean Positive and Negative Syndrome Scale total score of 57). Seventeen percent of patients had been psychiatrically hospitalized in the previous 6 months, and 4.6% were rated nonadherent in the month before study entry. The groups did not differ significantly in median time to all-cause discontinuation (645 days for LAI, 678 days for oral; P = 0.61), discontinuation rate (53.8% for LAI, 51.2% for oral; P = 0.60), or relapse rate (20.1% for LAI, 18.5% for oral; P = 0.66). Postbaseline psychiatric hospitalization rate was low for both groups (7.6% for LAI, 9.2% for oral), but mean hospitalization duration was significantly longer for oral patients (1.80 days [20 for those hospitalized] vs 0.43 days [6 for those hospitalized], P = 0.02). There were no clinically significant group differences in adverse events or safety measures. No post-injection delirium/sedation syndrome events occurred. In conclusion, olanzapine LAI and oral olanzapine were similarly effective and well tolerated for up to 2 years of treatment in patients with schizophrenia. Treatment discontinuation for olanzapine LAI was similar to that of oral olanzapine, despite the 3-hour post-injection observation period and other precautionary procedures related to risk of post-injection delirium/sedation syndrome. Copyright © 2014 by Lippincott Williams & Wilkins.

Mease P.J.,Swedish Medical Center | Hanna S.,I3 Statprobe | Frakes E.P.,Lilly United States LLC | Altman R.D.,University of California at Los Angeles
Journal of Rheumatology | Year: 2011

In this literature review, the mechanisms underlying pain associated with osteoarthritis (OA) are discussed, along with evidence for the efficacy of medications thought to act centrally to relieve OA pain. We survey the cascade of events from inflammation to activation of nociceptive and neuropathic pathways, to the development and maintenance of central and peripheral sensitization. Preclinical and clinical evidence for the sensitization hypothesis is discussed, along with recently identified genetic variations that may increase sensitivity to pain in patients with OA. Evidence is presented for the efficacy of centrally acting analgesics for OA pain (opioids, antiepileptics, tricyclic antidepressants, and serotonin/norepinephrine receptor inhibitors). The Journal of Rheumatology Copyright © 2011. All rights reserved.

Goldfischer E.,Premier Medical Group of the Hudson Valley | Kowalczyk J.J.,Urology Group of Southern California | Clark W.R.,Alaska Clinical Research Center | Brady E.,Eli Lilly and Company | And 3 more authors.
Urology | Year: 2012

Objective: To investigate the safety of daily coadministration of α-blockers with tadalafil 5 mg in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia. The standard-of-care medical therapy for moderate to severe symptoms of benign prostatic hyperplasia is α 1-adrenergic antagonist (α-blocker) therapy. Methods: Men aged ≥ 45 years receiving stable α-blocker therapy were evaluated for eligibility before a 2-week single-blind, placebo lead-in period. Subsequently, 318 men were randomized to tadalafil 5 mg or placebo once daily for 12 weeks. Enrollment was monitored to ensure inclusion of men ≥75 years old and men taking nonuroselective α-blockers. The primary objective was to compare the proportion of men reporting treatment-emergent dizziness between the 2 treatment groups. Orthostatic vital signs, general safety, and the International Prostate Symptom Score were also assessed. Results: The proportion of patients who reported treatment-emergent dizziness was not significantly different between the 2 treatment groups (tadalafil 7.0%; placebo 5.7%; P =.403). No difference between treatment groups was observed with respect to patients meeting the criteria for a positive orthostatic test (30 per treatment group, P = 1.00). The incidence of discontinuations was low among both treatment groups. Conclusion: Recognizing the limitations of the present study, the changes in the hemodynamic signs and symptoms were similar for the tadalafil and placebo groups in men with benign prostatic hyperplasia receiving concomitant α-blocker therapy. However, consistent with the results of previous clinical pharmacology studies of healthy subjects, a trend was seen for increased hemodynamic signs and symptoms in men taking nonuroselective α-blockers, most notably those taking doxazosin. © 2012 Elsevier Inc. All Rights Reserved.

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.

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.

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.

Stauffer V.,Eli Lilly and Company | Case M.,Eli Lilly and Company | Kollack-Walker S.,Eli Lilly and Company | Ascher-Svanum H.,Eli Lilly and Company | And 3 more authors.
Schizophrenia Research | Year: 2011

Research has identified distinct trajectories of antipsychotic response in patients with chronic schizophrenia in short-duration trials (~. 12. weeks). This post-hoc analysis identified trajectories in patients with chronic schizophrenia treated for ?. 24. weeks. We pooled data from 1990 patients with chronic schizophrenia from 6 randomized, double-blind, olanzapine-comparator trials of atypical antipsychotics. Trajectory analysis identified homogeneous subpopulations within the larger heterogeneous population. Baseline demographics were compared between the identified latent classes. Five distinct response trajectories based on Positive and Negative Syndrome Scale (PANSS) Total score were identified: Dramatic Responders (n = 47/1990, 2.4%), severely-ill patients (PANSS = 124) with rapid and sustained improvement (51%) by Week 3; Partial Responders (n = 1802/1990, 90.6%), moderately-ill (PANSS = 90) with minimal improvement (21%) by Week 4, and little further improvement; Partial Responders-Unsustained (Late) (n = 32/1990, 1.6%), markedly-ill (PANSS = 95) with minimal initial improvement followed by worsening after Week 12; Partial Responders-Unsustained (Early) (n = 28/1990, 1.4%), markedly-ill (PANSS = 102) with minimal initial improvement followed by worsening after Week 8; and Delayed Responders (n = 81/1990, 4.1%), markedly-to-severely-ill (PANSS = 113) with minimal (11%) improvement at Week 8, but noticeable improvement thereafter (49%). Significant differences were noted for several baseline characteristics (p < .05) and discontinuation rates (46%-72%). Dramatic Responders were younger and more likely to be female and Hispanic with higher baseline illness severity. Analysis of antipsychotic response over 24. weeks in a large, pooled, heterogeneous population treated for schizophrenia revealed 5 distinct trajectories. Most patients had modest and sustained improvements during atypical antipsychotic treatment, regardless of their baseline illness severity, representing a partial response to currently available treatments. © 2011 Elsevier B.V.

Sheetz M.J.,Eli Lilly and Company | Aiello L.P.,Harvard University | Shahri N.,I3 Statprobe | Davis M.D.,University of Wisconsin - Madison | And 2 more authors.
Retina | Year: 2011

Purpose: The PKC-DRS2 was a Phase 3, randomized, double-masked, placebo (PBO)-controlled, 3-year study of the effect of 32 mg/day of ruboxistaurin (RBX), an orally administered protein kinase C inhibitor, on vision loss in patients with moderate to severe nonproliferative diabetic retinopathy. Ruboxistaurin reduced the occurrence of sustained moderate visual loss (SMVL; ≥15-letter decline in visual acuity sustained for the last 6 months of study participation) from 9.1% in the PBO group (N = 340) to 5.5% in the RBX group (N = 345, P = 0.034). This study evaluates the primary end point of SMVL in a 2-year open-label extension (OLE) of the PKC-DRS2, which began a median of 466 days (range, 263-1,296 days) after the conclusion of PKC-DRS2. Methods: Visual acuity was measured by certified examiners using the Early Treatment Diabetic Retinopathy Study chart. Results: Of the 514 patients who completed PKC-DRS2, 366 did so in the 32 study centers participating in the OLE, and of these, 203 (55%) enrolled in the OLE for treatment with 32 mg/day of RBX for 2 years. Of the 203 enrolled in the OLE, 100 had previously been treated with PBO (prior PBO subgroup) and 103 had been treated with RBX (prior RBX subgroup). PKC-DRS2 baseline patient and ocular characteristics were well matched between these two subgroups and were similar to the PKC-DRS2 patient population as a whole. Using the PKC-DRS2 baseline as the starting point, SMVL occurred in 6% of the prior PBO subgroup during the PKC-DRS2, increasing to 26% by the end of the OLE. However, in the prior RBX subgroup, SMVL occurred in only 4% and 8% during the PKC-DRS2 and by the end of the OLE, respectively (P < 0.001 for difference at the end of the OLE). In the prior PBO subgroup, mean visual acuity declined from 79.6 letters at PKC-DRS2 baseline to 73.1 letters at OLE end point (-6.5 letters). In the prior RBX subgroup, this loss was 2.7 letters (79.8 to 77.1) over the same period (P = 0.02). Conclusion: Over a 6-year study period incorporating 3 years of a rigorously placebo-controlled trial, approximately 1 year off treatment and 2-year OLE where all groups received therapy, those patients with greatest RBX exposure (∼5 years) experienced less SMVL compared with those in the original PBO group (∼2-year RBX exposure). Copyright © 2011 Lippincott Williams &Wilkins.

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