New Drug Update 2009-2010 - LAFP
New Drug Update 2009-2010 - LAFP
New Drug Update 2009-2010 - LAFP
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with placebo. Results are summarized in Table 3. A prespecified noninferiority comparison of tapentadol<br />
75 mg with oxycodone 15 mg was also conducted; however, the 75 mg dose was not found to be<br />
noninferior to oxycodone 15 mg as the lower boundary of the 2-sided 95% confidence interval exceeded<br />
the prespecified noninferiority margin. A post hoc demonstrated noninferiority of tapentadol 100 mg with<br />
oxycodone 15 mg (Curr Med Res Opin. <strong>2009</strong>;25(3):765-776).<br />
Table 3. Tapentadol vs Oxycodone in the Treatment of Postsurgical Bunionectomy Pain<br />
Tapentadol<br />
50 mg<br />
(n = 119)<br />
Tapentadol<br />
75 mg<br />
(n = 120)<br />
Tapentadol<br />
100 mg<br />
(n = 118)<br />
Oxycodone<br />
15 mg<br />
(n = 125)<br />
Placebo<br />
(n = 121)<br />
Mean SPID12 23.2 a 30 a 35.5 a 35.6 a 4.7<br />
Mean SPID24 46.6 a 60.5 a 73.3 a 73. 3a 5.2<br />
Mean SPID48 119.1 a 139.1 a 167.2 a 172.3 a 24.5<br />
Mean SPID72 207.9 a 230.5 a 271.1 a 288.3 a 55.7<br />
Median time to perceptible<br />
pain relief<br />
Median time to meaningful<br />
pain relief<br />
≥ 50% reduction in<br />
pain intensity at 48 h<br />
Percentage rating overall<br />
status “much improved” or<br />
“very much improved”<br />
Percentage receiving<br />
rescue medication<br />
Percentage reporting<br />
adverse reactions<br />
a P < 0.001.<br />
46 min 31 min 36 min 30 min 34 min<br />
2 h 1.75 h 1.5 h 1.3 h 4 h<br />
58% 56.7% 70.3% 72.8% 30%<br />
67% 77% 89% 88% 41%<br />
19% 14% 10% 9% 49%<br />
70% 75% 85% 87% 41%<br />
Single-dose tapentadol immediate-release was also evaluated in a randomized, double-blind, placebocontrolled<br />
study in patients with moderate to severe pain following mandibular third molar extraction. The<br />
study enrolled 400 patients who were randomized to treatment with tapentadol 25, 50, 75, 100, or 200<br />
mg, morphine sulfate 60 mg, ibuprofen 400 mg, or placebo. TOTPAR-8 was the primary end point.<br />
TOTPAR-8 scores were greater for tapentadol 50, 75, 100, and 200 mg; morphine; and ibuprofen<br />
compared with placebo; the greater effect with ibuprofen established the sensitivity of the model. The<br />
study was not powered to detect differences between tapentadol and morphine. Results from this study<br />
are summarized in Table 4 (Anesth Analg. 2008;107(6):2048-2055.)<br />
Table 4. Single-Dose Study Using Tapentadol Immediate-Release to Treat Molar Extraction Pain<br />
Tapentadol<br />
25 mg<br />
Tapentadol<br />
50 mg<br />
Tapentadol<br />
75 mg<br />
Tapentadol<br />
100 mg<br />
Tapentadol<br />
200 mg<br />
Morphine<br />
60 mg<br />
Ibuprofen<br />
400 mg<br />
Placebo<br />
TOTPAR-8 6.3 7.9a 9.7a 11.6a 15.3a 13.8a 17.9a 4.7<br />
Median time to<br />
meaningful pain relief<br />
8 h 8 h 8 h 3.9 ha 1.5 ha 2.6 ha 1.5 ha 8 h<br />
≥ 50% pain relief 32.7% 46% 46% 64.6% a 87.8% a 64.7% a 76.5% a 25.5%<br />
72