Pharmacy & Therapeutics - March 2008 - (Page 171) CONTINUING EDUCATION CREDIT patients were not supposed to adjust medications, patients in both groups decreased or discontinued oral analgesics. Temporary burning was the most frequently reported side effect. The authors concluded that capsaicin, a nonprescription product, was effective in decreasing pain, improving daily activities, and enhancing quality of life in patients with DPN. supporting the use of oxycodone for pain associated with DPN are limited (Table 9).46,47 Two studies compared the effect of placebo and oxycodone 10 mg (up to 60 to 80 mg) every 12 hours. In both trials, oxycodone was more effective than placebo in reducing pain scores in patients with DPN. An average dose of 37 mg/day was reported in one study as the dose required for significant pain relief. In addition to pain relief, one study looked at the effect of oxycodone on health-related quality of life. Mean daily pain, steady pain, brief pain, skin pain, and total pain and disability were significantly lower in the oxycodone group. Tramadol Opioids Oxycodone Oxycodone (e.g., Percocet, Endo) is a narcotic analgesic that binds to opiate receptors in the central nervous system (CNS), producing alterations in the perception of and response to pain. The most commonly associated side effects include fatigue, drowsiness, dizziness, somnolence, pruritus, nausea, vomiting, constipation, and weakness.21 Much evidence exists to support the use of oxycodone for treating moderate-to-severe pain; however, clinical trial data Tramadol (Ultram, Ortho-McNeil) is a “non-narcotic” analgesic that binds to mu-receptors in the CNS, causing a change in the perception of and response to pain. Tramadol also inhibits the reuptake of NE and 5-HT, thereby further Table 8 Clinical Trials of Topical Agents Reference Meier40 Barbano41 Argoff42 Donofrio44 Donofrio45 No. Design Treatment LID 5% q 12 hr or PBO LID 5% q 18 hr LID 5% q 24 hr CAP 0.075% q.i.d. or PBO CAP 0.075% q.i.d. or PBO Study Conclusions Significant improvement in pain in LID arm on day 4; no difference in adverse events LID 5% allowed improved pain; tapering of concomitant analgesics noted Significant improvement in pain from PHN, DN, or LBP; no serious adverse events CAP was significantly more effective in pain relief, well tolerated; burning was noted more in CAP group Improved quality of life, including improvement in recreational activities 58 R, DB, PC, CO 56 OL 77 OL 277 R, DB, PC 277 R, DB, PC CAP = capsaicin; CO = crossover; DB = double-blind; DN = diabetic neuropathy; LBP = lower back pain; LID = lidocaine; OL = open-label; PBO = placebo; PC = placebo-controlled; PHN = postherpetic neuralgia; q.i.d. = four times daily; q 12 hr = every 12 hours; q 18 hr = every 18 hours; q 24 hr = every 24 hours; R = randomized. Table 9 Clinical Trials of Oxycodone and Tramadol Reference Gimbel46 Watson47 Harati48 No. Design Treatment OXY 10 mg (up to 60 mg) q 12 hr or PBO OXY 10 mg (up to 80 mg) q 12 hr or PBO Study Conclusions OXY at average dose of 37 mg/day provided significantly better pain relief than PBO Mean daily pain, total pain, and disability scores significantly lower in the OXY-treated group Original PBO group had higher pain scores on day 1 of open period, but by day 30, pain relief scores were similar in all patients despite initial therapy during six-week DB, PC portion of trial 159 R, DB, PC, PG 45 R, DB, CO 120 After six-week TRAM (up to a maximum dose of DB, PC portion 400 mg/day) patients could enroll in a sixmonth openextension period 313 R, DB, PC, PG TRAM 37.5 mg/APAP 325 mg (up to eight tablets daily) or PBO Freeman49 TRAM/APAP produced significant reduction in mean daily pain scores from baseline to study’s end compared with PBO APAP = acetaminophen; CO = crossover; DB = double-blind; OXY = oxycodone; PBO = placebo; PC = placebo-controlled; PG = parallel-group; q 12 hr = every 12 hours; R = randomized; TRAM = tramadol. Vol. 33 No. 3 • March 2008 • P&T® 171
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