Pharmacy & Therapeutics - October 2008 - (Page PP19)

PRODUCT PROFILER: Granisetron Transdermal Delivery System fidence interval [CI]: 0.422, 1.685). The patient’s sex was shown to have a staGranisetron TDS Comparator Total tistically significant impact, with (N = 87 (N = 84 (N = 171 women at an increased risk of therapy Patients) Patients) Patients) Endpoint failure during this time period (odds Total control ratio, 2.921; P = 0.0077). The impact of Delayed phase 28 (32.2%) 25 (29.8%) 53 (31.0%) nicotine use was also close to statistiP = 0.6288 cal significance (P = 0.0523), with a decreased risk of therapy failure in Total control smokers (odds ratio: 0.461).22 Acute phase 38 (43.7%) 44 (52.4%) 82 (48.0%) There were no statistically signifiP = 0.2445 cant differences between the groups Overall period 22 (25.3%) 21 (25.0%) 43 (25.1%) in achieving total control of CINV in P = 0.9111 the acute phase (P = 0.2445) or in the overall period (0.9111). In both groups, Complete response* total control was achieved more in the Delayed phase 40 (46.0%) 39 (46.4%) 79 (46.2%) acute phase alone than during the P = 0.9164 delayed phase or during the entire Acute phase 43 (49.4%) 52 (61.9%) 95 (55.6%) study period.22 No statistically signifiP = 0.0912 cant differences for complete response (no emetic episode or use of rescue Overall 27 (31.0%) 32 (38.1%) 59 (34.5%) medication) or for complete control P = 0.2802 (no more than mild nausea, no vomitComplete control† ing, no use of rescue medication, or Delayed phase 37 (42.5%) 34 (40.5%) 71 (41.5%) withdrawal from the study) between P = 0.7696 the groups were observed during the acute phase, delayed phase, or overall Acute phase 42 (48.3%) 50 (59.5%) 92 (53.8%) period. P = 0.1358 The severity of nausea experienced during the study was generally similar Overall 26 (29.9%) 28 (33.3%) 54 (31.6%) for the treatment groups, both overall P = 0.6151 and for the different time periods * A complete response is defined as no emetic episode and no use of rescue med(0–24 hours, 24–48 hours, 48–72 hours, ication. 72–96 hours, and 96–120 hours).22 No † Complete control is defined as no emetic episode, no use of rescue medication, statistically significant differences beand no more than mild nausea. tween the GTDS group (mean, 2.8 22 From Study 392MD/8/C, pp 50–53. episodes) and the comparator group (mean, 2.5 episodes) were observed for the number of the patients were current smokers (23.4%) or former emetic or vomiting episodes.22 22 smokers (33.9%). In both groups, the most common There was also no statistically significant difference tumor types were breast cancer (in 46.2%) and lung between the groups in terms of satisfaction with concancer (in 33.9%).22 trol over CINV. The mean maximum value for GTDS The proportions of patients achieving total control was 47.5; for the comparator groups, it was 40.5 of CINV in the delayed phase (primary endpoint) and (P = 0.3401).22 Similar proportions of patients experienced treatin the acute phase and overall period (secondary endment failure (66.7% in the GTDS group, 61.9% in the points) are summarized in Table 11. comparator group) or received rescue medication There was no statistically significant difference (56.3% and 48.8%, respectively). The median time to between the treatment groups in the proportion of treatment failure was shorter with GTDS (9 hours) patients who achieved total control of CINV in the than with the comparator regimen (17.3 hours), but delayed phase of emesis (P = 0.6288). In both treatthe median time to administration of rescue medicament groups, approximately one-third of patients tion was similar (10.8 hours and 12.3 hours, respecachieved total control.22 Logistic regression analysis revealed a higher risk of tively). No statistically significant differences were therapy failure during the delayed phase in the comidentified for either endpoint.22 parator group, with an odds ratio of 0.843 (95.01% conPatch adhesion was very good over the entire appli19 Table 11 Total Control of Emesis in the Intent-to-Treat Population

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Pharmacy & Therapeutics - October 2008 Contents Editorial Medication Errors Prescription: Washington New Drugs/Drug News/ New Medical Devices Drug Forecast Medical Management of Parkinson’s Disease Why Is Health Care Regulation So Complex? The Next President’s Prescription for Action on Drugs Trends in Managing Multiple Sclerosis Product Profiler: Sancuso®

Pharmacy & Therapeutics - October 2008

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