Assessing the Impact of Losmapimod on Proteinuria in Idiopathic Focal Segmental Glomerulosclerosis.

Introduction: Idiopathic focal segmental glomerulosclerosis (FSGS) is a leading cause of nephrotic syndrome and end-stage renal disease. In preclinical models and biopsies of human FSGS kidneys, p38 mitogen-activated protein kinase (MAPK) has demonstrated enhanced activity; and p38 MAPK inhibition has improved disease markers. This proof-of-concept trial aimed to assess efficacy, safety, tolerability, and pharmacokinetics of losmapimod, an oral p38 MAPK inhibitor, in humans with FSGS.

Development and validation of a new instrument to evaluate the ease of use of patient-controlled analgesic modalities for postoperative patients.

Objective: To describe the development and psychometric evaluation of a questionnaire assessing the ease of use that patients associate with patient-controlled analgesia (PCA) modalities.

Methods: Qualitative interviews were conducted with patients who had experience with intravenous (IV) PCA for postoperative pain management to generate items relevant to the ease of using PCA modalities. The content validity of the resulting questionnaire was examined through follow-up patient interviews, and an expert panel reviewed the questionnaire.

Using the patient global assessment of the method of pain control to assess new analgesic modalities in clinical trials.

Objective: To assess the validity of the patient global assessment (PGA) of the method of pain control, a single-item patient-reported outcome measure of a method of pain control for patients experiencing postoperative pain.

Research Design And Methods: Content validity of the PGA of the method of pain control was assessed using cognitive debriefing interviews. Construct validity was evaluated using data from six clinical trials that compared the efficacy of the fentanyl HCl iontophoretic transdermal system (fentanyl ITS) with morphine intravenous patient-controlled analgesia or placebo fentanyl ITS for acute postoperative pain management.

Efficacy and safety of the fentanyl iontophoretic transdermal system (ITS) and intravenous patient-controlled analgesia (IV PCA) with morphine for pain management following abdominal or pelvic surgery.

Objective: The fentanyl HCl iontophoretic transdermal system (ITS) has effectively managed pain following several types of surgery. This study evaluated the efficacy, safety, and ease of care associated with fentanyl ITS and morphine intravenous patient-controlled analgesia (IV PCA) for pain management following abdominal or pelvic surgery.

Design: This open-label, multicenter, randomized, active-controlled, parallel-group, phase IIIb study enrolled 506 postoperative patients at 39 U.

Ease of care with patient controlled analgesia systems: questionnaire development and validation.

Aim: This paper is a report of the development and validation of two questionnaires assessing ease of caring for patients receiving patient controlled analgesia from the perspectives of nurses and physical therapists.

Background: While studies have assessed patient satisfaction with and preference for patient controlled analgesia modalities, no instruments have been developed to assess the ease of providing care (ease of care) for patients receiving patient controlled analgesia from nurses' and physical therapists' perspectives.

Method: Nurses and physical therapists participated in focus groups during 2003 to identify concepts associated with caring for patients receiving intravenous patient controlled analgesia.

Clinical staff resource use with intravenous patient-controlled analgesia in acute postoperative pain management: results from a multicenter, prospective, observational study.

The purpose of this study was to evaluate hospital resource utilization associated with intravenous patient-controlled analgesia (IV-PCA), with a focus on nursing, pharmacy, and central supply/engineering time spent from a hospital perspective. Data were collected during a multicenter (29 sites), prospective observational study in the United States of subjects who underwent total knee replacement (TKR), total hip replacement (THR), or abdominal hysterectomy (AH) and were administered analgesia through IV PCA for the management of acute postoperative pain. Nursing staff recorded the IV PCA-related tasks they performed for a subject and the duration of time required to perform each task from initial IV PCA set-up to discontinuation.

Fentanyl iontophoretic transdermal system for acute-pain management after orthopedic surgery: a comparative study with morphine intravenous patient-controlled analgesia.

Background And Objectives: The fentanyl HCl iontophoretic transdermal system (ITS) has been demonstrated in clinical trials to be safe and effective for acute-pain management after several types of major surgery. The current study compared the efficacy, safety, and convenience of fentanyl ITS with morphine intravenous patient-controlled analgesia (IV PCA) for acute-pain management after unilateral total-hip replacement (THR).

Methods: In this multicenter (52 sites), randomized, open-label, active-controlled, phase IIIb study, patients (n = 799) received fentanyl ITS (40 mug fentanyl [10-minute infusion/lockout], up to 6 doses/h) or morphine IV PCA (1-mg morphine bolus [5-minute lockout], up to 10 mg/h) after unilateral THR.

Estimated costs of prescription opioid analgesic abuse in the United States in 2001: a societal perspective.

Objectives: This study estimates the costs to society of prescription opioid analgesic (RxO) abuse in the United States.

Methods: Costs associated with RxO abuse were grouped into healthcare, criminal justice, and workplace categories. Costs were estimated by either (1) a quantity method that multiplies the number of RxO abusers derived from various national surveys by the estimated per abuser cost, or (2) an apportionment method that starts with overall (ie, prescription and nonprescription) drug abuse costs for a cost component (eg, police protection) and apportions the share of costs based on the prevalence of RxO abuse relative to overall drug abuse.

Long-term effects of analgesics in a population of elderly nursing home residents with persistent nonmalignant pain.

Background: Little is known about the long-term effects of analgesics on functional status and well-being of nursing home residents with chronic pain.

Methods: Using the Minimum Data Set, we performed a longitudinal study of nursing home residents (n = 10,372) with persistent pain. Using propensity score adjustment techniques, we compared the effect of different analgesics on changes in physical, cognitive, emotional, and social functioning, and examined rates of adverse events over a 6-month period.

An observational study of health-related quality of life and pain outcomes in chronic low back pain patients treated with fentanyl transdermal system.

Background: The analgesic effect of long-acting opioids, such as transdermal fentanyl, has been demonstrated in patients with cancer, neuropathic pain and chronic low back pain (CLBP). However, the broader effect of long-acting opioids on the patient's health-related quality of life (HRQoL) is less well known.

Objective: To evaluate HRQoL outcomes in CLBP patients treated with transdermal fentanyl.

Persistent nonmalignant pain and analgesic prescribing patterns in elderly nursing home residents.

Objectives: To determine the prevalence of analgesics used, their prescribing patterns, and associations with particular diagnoses and medications in patients with persistent pain.

Design: Cross-sectional study.

Setting: Nursing homes from 10 U.

Patient-reported utilization patterns of fentanyl transdermal system and oxycodone hydrochloride controlled-release among patients with chronic nonmalignant pain.

Background: Although use of long-acting opioid analgesics has increased for chronic nonmalignant pain management, little is known about patient-reported utilization patterns.

Objective: To assess patient-reported utilization patterns of fentanyl transdermal system and oxycodone hydrochloride (HCl) controlled-release among patients with chronic nonmalignant pain and to compare these patterns to standard dose administration guidelines recommended in the manufacturers. prescribing information (PI).