Tolerability of diclofenac sodium 1% gel with concomitant medications known to interact with diclofenac.

Background: Topical diclofenac sodium 1% gel (DSG) has demonstrated efficacy and tolerability in patients with osteoarthritis (OA) of the knees or hands, including elderly patients and those with an increased risk of gastrointestinal, cardiovascular, and renal adverse events (AEs). Medications known to interact with diclofenac were disallowed in a clinical trial of DSG for knee OA; however, patients were not to be discontinued for intake of disallowed treatment, unless there was a safety issue. This post hoc analysis examined the frequency and type of AEs in patients who received DSG concomitantly with drugs known to have potential interactions with diclofenac.

A review of pharmacotherapy for chronic low back pain with considerations for sports medicine.

Up to 30% of athletes experience low back pain (LBP) depending on sport type, sex, training intensity and frequency, and technique. United States clinical guidelines define back pain as chronic if it persists for ≥ 12 weeks, and subacute if it persists 4 to < 12 weeks. Certain sports injuries are likely to lead to chronic pain.

Long-term tolerability of topical diclofenac sodium 1% gel for osteoarthritis in seniors and patients with comorbidities.

Background: Adverse events associated with nonsteroidal anti-inflammatory drugs (NSAIDs) used to treat knee and hand osteoarthritis may be more frequent in certain patient populations. Topical NSAIDs, such as diclofenac sodium 1% gel (DSG), have equivalent efficacy and fewer adverse events compared with oral NSAIDs. This post hoc analysis assessed the long-term tolerability of DSG in elderly patients and patients with an elevated risk of gastrointestinal, cardiovascular, and renal adverse events.

Tolerability of concomitant use of selective serotonin reuptake inhibitors or serotonin-norepinephrine reuptake inhibitors and oxymorphone extended release.

Background: Opioids and antidepressants are frequently prescribed for chronic low back pain (cLBP). This post hoc analysis was conducted to assess the tolerability of oxymorphone extended release (ER) for cLBP in patients taking selective serotonin reuptake inhibitors (SSRIs) or serotonin-norepinephrine reuptake inhibitors (SNRIs) compared with patients not taking SSRIs/SNRIs.

Methods: Patients in 2 clinical trials (NCT00225797, November 22, 2004 to July 18, 2005; NCT00226421, October 13, 2004 to August 19, 2005) aged ≥ 18 years with moderate to severe cLBP were titrated to a stabilized dose of oxymorphone ER during an open-label titration phase and then randomized to treatment with this dose or placebo every 12 hours for 12 weeks.

An open-label, long-term safety and tolerability trial of diclofenac sodium 1% gel in patients with knee osteoarthritis.

Objective: To evaluate the long-term safety and tolerability of topical diclofenac sodium 1% gel (DSG) in the treatment of knee osteoarthritis (OA) for up to 12 months.

Methods: This was a multicenter open-label, extension of two 3-month, randomized, double-blind studies of DSG in patients with knee OA (NCT ID: NCT00171691, "Safety of Diclofenac Sodium Gel in Knee Osteoarthritis"). To ensure adequate enrollment, some DSG-naïve patients with OA who had not participated in the double-blind studies were also enrolled.

Factors affecting acceptability of titrated oxymorphone extended release in chronic low back pain - an individual patient analysis.

Objective: To evaluate the influence of age, sex, and previous opioid experience on the likelihood of successfully titrating opioid-naive and experienced patients with chronic low back pain (CLBP) to an effective and well-tolerated dose of oxymorphone extended release (ER).

Methods: Post hoc analysis of open-label titration phases of two enriched-enrollment randomized-withdrawal phase III trials in 575 adults with moderate-to-severe CLBP. Opioid-naive patients (n = 325) initiated oxymorphone ER at 10 mg/day (5 mg q12 h).

Correlation of pain relief with physical function in hand osteoarthritis: randomized controlled trial post hoc analysis.

Introduction: Nonsteroidal anti-inflammatory drugs are recommended for the relief of pain associated with hand osteoarthritis (OA) but do not alter the underlying structural changes that contribute to impaired physical function. The current analysis examined the relationship of pain relief with measures of function and global rating of disease in patients with hand OA.

Methods: This was a combined analysis of 2 prospective, randomized, double-blind, 8-week, multicenter, parallel-group studies comparing diclofenac sodium 1% gel with placebo gel (vehicle) in patients with radiographically confirmed mild to moderate hand OA.

Oxymorphone extended release for the treatment of chronic low back pain: a retrospective pooled analysis of enriched-enrollment clinical trial data stratified according to age, sex, and prior opioid use.

Objective: This study assessed the potential effects of age, sex, and prior opioid use on the response to oxymorphone extended release (ER) in patients with moderate to severe chronic low back pain.

Methods: Combined data from 2 placebo-controlled clinical trials with an enriched-enrollment, randomized-withdrawal design were analyzed. In patients aged > or =18 years with chronic low back pain, the dose of oxymorphone ER was titrated to a stable, tolerable, effective dose.