Clinical Geriatrics

Safety and Efficacy of Topical Diclofenac Sodium 1% Gel in Seniors and Younger Patients with Hand Osteoarthritis

San Antonio, TX—Roy D. Altman, MD, University of California-Los Angeles, and colleagues examined the safety and efficacy of diclofenac sodium 1% gel (DSG) in patients age < 65 and ≥ 65 years with hand osteoarthritis (OA). Results, presented at the annual AAPM meeting, revealed that DSG was effective and generally well tolerated for hand OA, regardless of patient age.

Three hundred eighty-five adults with radiographically verified hand OA were randomized to double-blind treatment with DSG (n=198) or placebo (n=187), 2 g to each hand 4 times daily for 8 weeks. OA pain intensity (100-mm visual analog scale), Australian/Canadian Osteoarthritis Hand Index (AUSCAN) score, and global rating of disease (GRD) at 4 and 6 weeks were the primary outcomes. Efficacy outcomes were compared by patient age (< 65 yr vs ≥ 65 yr) using analysis of variance (ANOVA). Researchers recorded all adverse events (AEs).

Participants randomized to DSG experienced improvements relative to baseline at weeks 4 and 6, in OA pain intensity (42%, 46%), total AUSCAN score (35%, 38%), and GRD (36%, 40%). These improvements were significantly superior to those experienced by patients randomized to placebo for OA pain intensity and total AUSCAN score (P ≤ 0.02) at weeks 4 and 6, but for GRD only at week 6 (P = 0.02). Efficacy differences (DSG vs placebo) between patients age < 65 years (DSG, n=109; placebo n=100) versus ≥ 65 years (DSG, n=89; placebo n=87) were not statistically significant. Application-site reactions were more common with DSG versus placebo for patients age < 65 years (4% vs 1%) and ≥ 65 years (5% vs 3%). Researchers reported that no gastrointestinal bleeding or serious treatment-related AEs occurred.

Funding was provided by Endo Pharmaceuticals Inc.

Changes in Opioid Use and Economic Outcomes Among Diabetic Peripheral Neuropathic Pain Patients Treated with Duloxetine Versus Other Therapies

San Antonio, TX—Patients with continuous duloxetine-treated diabetic peripheral neuropathic pain (DPNP) appeared to have reduced opioid use and lower overall healthcare costs, as concluded in an abstract presented at the annual AAPM meeting. This exploratory analysis by Kimberly Fraser, BA, Abt Bio-Pharma Solutions, Inc, Lexington, MA, and colleagues examined changes in opioid use and healthcare costs among commercially-insured patients with DPNP who initiated duloxetine versus other standard of care (SOC) medications (tricyclic antidepressants, venlafaxine, gabapentin, pregabalin).

Administrative claims data were analyzed for patients with DPNP age 18-64 years who initiated duloxetine or SOC between 3/1/2005 and 12/31/2005. Initiation was defined as no pill coverage in the previous 90 days for the same medication. All patients had opioids dispensed in the prior 90 days. Medication possession ratio (MPR) measured medication compliance. Participants were classified as either “continuous” (MPR ≥ 80%) users or “non-continuous” (MPR < 80%) users. Over the 12 months pre- and post-index periods, total opioid days, number of opioid prescriptions dispensed, and cumulative morphine equivalents were examined. In order to assess the changes (pre-index minus post-index) in opioid use (total, short-acting vs long-acting) and healthcare costs, multivariate regressions were performed.

One thousand two hundred eighty-one patients were identified (98 duloxetine continuous users, 243 duloxetine non-continuous users, 195 SOC continuous users, and 745 SOC non-continuous users).