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Indianapolis, IN, United States

Clemow D.B.,Lilly United States LLC
Postgraduate Medicine

To raise awareness, this article provides a commentary on the frequent underdosing of atomoxetine for the treatment of adult attention-deficit/hyperactivity disorder (ADHD) that may be associated with poor patient outcomes. Data suggest an adequate atomoxetine dose for sufficient duration is important for ADHD symptom improvement. Despite the recommended 80 mg/day target dose, real-world data show that an approximately 60 mg/day average adult atomoxetine dose is utilized. This article discusses the factors that may contribute to this suboptimal dosing. Atomoxetine dose titration, setting patient expectations, and the importance of keeping the patient at target dose for an adequate length of time (about 4−6 weeks) prior to judging efficacy are also discussed. © Postgraduate Medicine. Source

To develop an adult self-report instrument for provisional diagnosis of four common mental disorders in primary care patients. Primary care patients were evaluated during routine clinic visits with a self-report screening tool comprised of 85 DSM-IV symptom-based candidate questions. Patients with a physician-assessed provisional diagnosis for generalized anxiety disorder (GAD), major depressive episode (MDE), past/present mania, and adult attention-deficit/hyperactivity disorder (ADHD), or none of these, completed additional self-report clinical questionnaires, and then were interviewed on the telephone by a trained rater for a SCID/ACDS diagnosis. Responses to the symptom-based candidate questions were used to calculate sensitivity and specificity for a SCID/ACDS diagnosis (GAD, N = 24; MDE, N = 89; Mania, N = 24; ADHD, N = 65) and to select the optimal four questions for each diagnosis to be included in the instrument. Analyses resulted in a 17-item instrument for provisional differential diagnosis of GAD, MDE, past/present mania, and ADHD. Comparison of limited symptom-based versus full DSM-IV criteria-based diagnosis showed minimal differences for relative diagnostic accuracy. Sensitivities and specificities, respectively, were 83% and 75% for GAD, 80% and 80% for MDE, 83% and 82% for mania, and 82%and 73% for ADHD. Based on this preliminary work, the Provisional Diagnostic Instrument-4 is a brief, easily scored, self-report instrument that may assist primary care physicians to identify potential cases of GAD, MDE, past/present mania, and ADHD. Copyright © 2011 The Academy of Psychosomatic Medicine. Published by Elsevier Inc. All rights reserved. Source

Rosen R.C.,New England Research Institutes, Inc. | Allen K.R.,New England Research Institutes, Inc. | Ni X.,Lilly United States LLC | Araujo A.B.,New England Research Institutes, Inc.
European Urology

Background: Despite widespread adoption of the six-item erectile function (EF) domain of the International Index of Erectile Function (IIEF) as a clinical trial end point, there are currently no objective data on what constitutes a minimal clinically important difference (MCID) in the EF domain. Objective: Estimate the MCID for the IIEF EF domain. Design, setting, and participants: Anchor-based MCIDs were estimated using data from 17 randomized, double-blind, placebo-controlled, parallel-group clinical trials of the phosphodiesterase type 5 inhibitor (PDE5-I) tadalafil for 3345 patients treated for 12 wk. Measurements: The anchor for the MCID is the minimal improvement measure calculated using change from baseline to 12 wk on IIEF question 7: "Over the past 4 weeks, when you attempted sexual intercourse how often was it satisfactory for you?" MCIDs were developed using analysis of variance (ANOVA)- and receiver operating characteristic (ROC)-based methods in a subset of studies (n = 11) by comparing patients with and without minimal improvement (n = 863). MCIDs were validated in the remaining six studies (n = 377). Results and limitations: The ROC-based MCID for the EF domain was 4, with estimated sensitivity and specificity of 0.74 and 0.73, respectively. MCIDs varied significantly (p < 0.0001) according to baseline ED severity (mild: 2; moderate: 5; severe: 7). MCIDs consistently distinguished between patients in the validation sample classified as no change or minimally improved overall and by geographic region, ED etiology, and age group. MCIDs did not differ by age group, geographic region, or ED etiology. Current analyses were based on 17 clinical trials of tadalafil. Results need to be replicated in studies using other PDE5-Is or in nonpharmacologic intervention studies. Conclusions: The contextualization of treatment-related changes in terms of clinically relevant improvement is essential to understanding treatment efficacy, to interpreting results across studies, and to managing patients effectively. This analysis provides, for the first time, anchor-based estimates of MCIDs in the EF domain score of the IIEF. © 2011 European Association of Urology. Source

Krege J.H.,Lilly United States LLC | Wan X.,Lilly United States LLC

Purpose: In the Fracture Prevention Trial, the risks of any nonvertebral fracture (relative risk [RR] 0.65, P= 0.04) and any fragility nonvertebral fracture (RR 0.47, P= 0.02) were significantly reduced in the teriparatide 20. μg/day (teriparatide) versus placebo group. The purpose of this analysis was to examine the efficacy of teriparatide versus placebo on a variety of other nonvertebral fracture outcomes. Materials and methods: The Fracture Prevention Trial was a double-blind trial of postmenopausal women with osteoporosis and vertebral fractures randomly assigned to teriparatide ( N= 541) or placebo ( N= 544) administered by daily self-injection for a median of 19. months and a median follow-up of 21. months. All patients received calcium and vitamin D supplementation. Reports of nonvertebral fractures were collected from patients at each visit and confirmed by review of a radiograph or written radiology report. Nonvertebral fractures were recorded for the following sites: distal radius/wrist, humerus, rib/clavicle, hip, ankle, distal foot, pelvis, or other. Pathological fractures and fractures of the face, skull, metacarpals, fingers and toes were excluded. Fractures were classified by investigators as fragility or traumatic fractures. The three endpoints considered were six nonvertebral sites (nonvert-6), a set of common nonvertebral fractures described in a Food and Drug Administration Guidance document for the treatment and prevention of postmenopausal osteoporosis (FDA), and a European Union major set (major) of nonvertebral fractures. Results: For teriparatide versus placebo, the point estimates for the RR of nonvert-6 (RR 0.54, P= 0.06; fragility RR 0.32, P= 0.014), FDA (RR 0.60, P= 0.15; fragility RR 0.38, P= 0.05), and major (RR 0.52, P= 0.02; fragility RR 0.38, P= 0.02) nonvertebral fracture endpoints were smaller than for the all nonvertebral fracture endpoint. Lower RRs were observed when the outcomes were limited to fragility fractures, and significant reductions in traumatic nonvertebral fractures were not observed. Conclusion: In the Fracture Prevention Trial, the risk reduction for nonvertebral fracture in patients treated with teriparatide versus placebo depended on the set of nonvertebral fractures included in the analysis; lower RRs were observed for nonvertebral fractures most likely to be of osteoporotic origin. No significant reductions in traumatic nonvertebral fractures were observed. © 2011 Elsevier Inc. Source

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

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. Source

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