American Academy of Pain Medicine

6 Apr
2010

Pain MedicineOnce-Daily Extended-Release Morphine Sulfate Beneficial for Low Back Pain

Speaker: Richard L. Rauck, MD, Medical Director, The Center for Clinical Research, LLC; Wake Forest University Baptist Medical Center, Winston-Salem, North Carolina

Once-daily extended-release (ER) morphine sulfate (Avinza, Ligand) proved superior to twice-a-day, controlled-release oxycodone HCl (OxyContin, Purdue Pharma) for chronic, moderate-to-severe low back pain in patients naive to sustained-release opioids.

Researchers enrolled 392 individuals into an open-label, randomized, parallel-group, multicenter study. The patients underwent titration of their opioid dose for three to six weeks; 132 patients were assigned to receive morphine, and 134 received oxycodone. Opioid dose stabilization, as established by a pain score of less than 4 millimeters (mm) for three consecutive days with two or fewer doses of ibuprofen pain rescue medication per day, was achieved in 266 patients. These subjects were then entered into the eight-week evaluation phase of the study.
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Patients taking morphine achieved significantly better around-the-clock pain control than those taking oxycodone, as demonstrated by a greater decrease in pain scores from baseline. The patients were at evaluated six, nine, and 12 hours after the morning doses of both opioids (P< .02).

Morphine once daily was also more effective than twice-daily oxycodone in terms of quality of sleep achieved, as measured by the Pittsburgh Sleep Quality Index (PSQI) for the entire evaluation period from weeks one to eight (P < .04).

The number of ibuprofen rescue medication doses required for breakthrough pain, adjusted for the number of patient days, was lower in the morphine group than in the oxycodone group. The total daily opioid dose was significantly higher with oxycodone than with morphine when oxycodone was converted to morphine equivalents (median, oxycodone 84 mg/day vs. morphone 58 mg/day; P = .0144). The two drugs were comparable in safety and tolerability. kamagra soft tabs

Extended-Release Oral Oxymorphone Relieves Low Back Pain in Opioid-Experienced Patients

Speaker: Harry Ahdieh, PhD, Director of Clinical Operations, Endo Pharmaceuticals, Inc., Chadds Ford, Pennsylvania

In an open-label titration study, most opioid-experienced patients with chronic, moderate-to-severe low back pain achieved a well-tolerated and effective dose of extended-release (ER) oxymorphone (Endo) following a program of dose conversion with additional gradual titration, as necessary. Oxy-morphone is an active metabolite of oxycodone and a semi-synthetic mu-opioid agonist.

Two hundred fifty patients who had previously received a fixed opioid regimen received oral oxymorphone ER every 12 hours at a daily dosage equivalent to their pre-study opioid requirement. Each dose was titrated in 10-mg increments every 12 hours for three to seven days until a stabilized dose of oxy-morphone ER was reached. Stabilization was defined as a dose that reduced average pain scores by 40 mm or lower on the 100-mm Visual Analogue Scale (VAS), with an acceptable toler-ability for three of five consecutive days and for which no more than two rescue doses of oxymorphone ER were needed per day.

Patients filled out daily diaries to record their pain intensity using the VAS. They also completed a Global Assessment of Pain Medication using a five-point categorical scale. An 11-point Pain Quality Assessment Scale (PQAS) was used to measure the type and quality of pain.

Of the 250 treated patients, 143 were successfully switched to oxymorphone ER and achieved titration to a stable dose. The average pain intensity of patients who successfully completed titration decreased from 69.5 mm on the VAS at screening to 23.6 mm at stabilization. After successful titration, PQAS scores also improved significantly; the composite mean ± the standard deviation (SD) PQAS score decreased by 60.3 ± 34.1 (P < .0001).

Only 14.5% of the patients who had achieved dose stabilization at screening rated their prestudy medication as “very good” to “excellent.” By contrast, 74.5% of these patients rated oxy-morphone ER as “very good” to “excellent” after stabilization.

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