Pharmacy & Therapeutics - October 2008 - (Page PP20)

PRODUCT PROFILER: Granisetron Transdermal Delivery System cation period. All but five patches (one in the GTDS group and four in the comparator group) stayed attached until the scheduled removal time.22 On the day of chemotherapy, plasma granisetron concentrations were generally higher after oral granisetron administration than after GTDS application (median 7.0 ng/mL and 1.1 mg/mL, respectively). As expected, concentrations of granisetron reported on Day 1 and thereafter were consistently higher in the GTDS group than in the comparator group.22 The apparent dose, determined from the amount of granisetron in the used patches, was, on average, 16.3 mg over the five-day application period, which corresponds to an in vivo flux of 3.26 mg every 24 hours.22 Of the 183 patients enrolled in the study, 175 received either GTDS or a placebo patch. Two patients withdrew from the study before their first follow-up observation and were therefore excluded from the safety population. In both the GTDS and comparator groups, most patients in the safety population wore their patches for the planned five days (94.3% and 97.6%, respectively).22 Forty-three patients experienced a total of 65 treatment-emergent AEs (Table 12). A higher proportion of patients receiving GTDS experienced any AE (30.7%), compared with 18.8% in the comparator group. However, the proportion of patients who experienced treatment-related AEs was higher in the comparator group than in the GTDS group (9.4% vs. 4.5%, respectively), although the number of AEs experienced was similar.22 No treatment-related deaths or serious AEs were reported in the study.22 A higher proportion of patients in the GTDS group experienced severe AEs, serious AEs, and AEs that led to withdrawal. Most AEs reported were mild or moderate in severity (69.8% of events in the GTDS group and 95.5% of events in the comparator group).22 The most commonly reported AE in both groups was headache (in 3.4% and 4.7% of patients in the GTDS and comparator groups, respectively).22 Overall, there were no clinically relevant differences in the incidence or nature of AEs experienced in the two treatment groups.22 Most AEs that occurred were considered unrelated or unlikely to be related to the study medication in both the GTDS group (36 of 43 events, 83.7%) and the comparator group (14 of 22 events, 63.6%).22 All severe AEs reported were considered unrelated or unlikely to be related to the study medication.22 Overall, the patches were well tolerated. At all time points, most of the patients who recorded an assessment experienced no irritation, with only a small proportion experiencing minimal irritation. In general, the incidence of irritation was similar for the treatment groups, with only a slightly higher incidence in the GTDS group. Four patients (three in the GTDS group and one in the comparator group) experienced moderate irritation. None of the patients reported severe irritation. 22 Local tolerance was similar between groups. There were no clinically significant effects on hematology, biochemistry, urinalysis, vital signs, ECG, or Eastern Cooperative Oncology Group (ECOG) status during the study.22 Taking into account efficacy results reported with moderately emetogenic chemotherapy in a similar patient population, the response rates observed for acute and delayed CINV in both groups were lower than expected. These lower-than-expected response rates might be attributable to the exclusion of dexamethasone from the antiemetic therapy, which (as discussed earlier) is a mainstay of CINV prevention, along with NK1 receptor antagonists. Some literature has suggested that achieving control of CINV in the acute phase is a probable predictor of achieving control in the delayed phase; therefore, if poor control is achieved Table 12 Summary of Treatment-Emergent Adverse Events in the Safety in the acute phase, similar Population results should occur in the delayed phase. In this study, the Granisetron TDS (N = 88) Comparator (N = 85) poor response observed in the No. of Events No. of Events acute phase might have subse(No. of Patients,%) (No. of Patients, %) quently led to the low response Any adverse event 43 (27, 30.7%) 22 (16, 18.8%) rates in the delayed phase.22 An exploratory analysis was Treatment-related 7 (4, 4.5%) 8 (8, 9.4%) adverse events conducted to investigate this possible association. In the Severe adverse events 13 (8, 9.1%) 1 (1, 1.2%) GTDS group, 22 of 38 patients Serious adverse events 10 (6, 6.8%) 1 (1, 1.2%) (58%) who had achieved total control in the acute phase also Adverse events leading 5 (4, 4.5%) 2 (1, 1.2%) reported total control in the to withdrawal delayed phase, compared with From Study 392MD/8/C, p 66.22 six of 49 patients (12%) who did not record total control in the 20

Table of Contents Feed for the Digital Edition of Pharmacy & Therapeutics - October 2008

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

For optimal viewing of this digital publication, please enable JavaScript and then refresh the page. If you would like to try to load the digital publication without using Flash Player detection, please click here.