Pharmacy & Therapeutics - October 2008 - (Page PP18)

PRODUCT PROFILER: Granisetron Transdermal Delivery System Table 10 Inclusion and Exclusion Criteria for Study 392MD/8C Patients were enrolled in the study if they met the following inclusion criteria: • were 18 to 75 years of age (surgically sterilized, postmenopausal or premenopausal with a negative pregnancy test) • had histologically and/or cytologically confirmed solid tumors • had Eastern Cooperative Oncology Group (ECOG) status of 250 mg/m2), cyclophosphamide ( 25 mg/m2), or cisplatin ( 10 g/dL, leukocytes > 3 x 109/L, neutrophils > 1.5 x 109/L, platelets > 100 x 109/L, creatinine < 1.5 x upper limit of normal (ULN), liver enzymes < 2 x ULN, bilirubin < 2 x ULN • had a body mass index (BMI) of 18 to 30 kg/m2 • were able to read and write at a competent level for adequate completion of the patient diary • had given written informed consent to participate in the study From Study 392MD/8/C, pp 12–14.22 Patients with any of the following were excluded from the study: • tumors of the head, neck, or stomach • nausea or vomiting from other causes (i.e., gastric outlet obstruction, gastric ulcers, brain metastases) • retching, vomiting, or uncontrolled nausea within 24 hours prior to administration of the test medication • medications with known or potential antiemetic or serotonergic activity within the 24-hour period before administration of test medication • radiation therapy involving the abdomen or pelvis within the 48-hour period before the treatment period or patients scheduled to receive such radiation during the treatment period • any seizure disorder requiring anticonvulsants • a tendency to migrainous nausea • active infection • patients who received an investigational drug in the previous 30 days or who were scheduled to receive any investigational drug during the study period • a contraindication to receiving granisetron and/or dexamethasone • hypersensitivity to adhesive plaster (e.g., Elastoplast®) • alcohol, drug, or medication abuse within the previous year • severe psychiatric or neurological disorders • pregnant or nursing women • women of childbearing age who were not willing to use medically reliable methods of contraception for the entire study duration • incidence and severity of nausea (feeling of sickness with an inclination to vomit) using a 4-point scale • 1 = no nausea • 2 = mild nausea (no impairment of daily activities) • 3 = moderate nausea (daily activities impaired) • 4 = severe nausea (enforced bed rest because of nausea) • vomiting (expulsion of stomach contents through the mouth) and retching (an attempt to vomit that did not produce stomach contents), assessed by documenting the number of emetic episodes • emetic episodes (a single episode of vomiting or retching or any number of continuous vomits or retches, with continuous vomits or retches defined as two or more vomits or retches with an interval of less than one minute between the individual vomits or retches). 18 Patients also recorded their satisfaction with control over vomiting and nausea using a 100-mm Visual Analogue Scale (VAS) and documented any use of rescue medication.22 The primary efficacy endpoint was the proportion of patients achieving total control of CINV (no nausea, no vomiting, no use of rescue medication, or no withdrawal from the study) during the period 24 to 120 hours after chemotherapy (delayed phase of emesis). Secondary endpoints were the proportion of patients achieving total control of CINV during the 0- to 24-hour period (acute phase) and the 0- to 120-hour (overall) period after chemotherapy. There were no statistically significant differences between treatment groups in terms of demographic parameters. Most patients (99.4%) were Caucasian, and more women (63.2%) than men (36.8%) had been recruited. The mean age of these patients was 60.6 years (range, 33–83 years), and their mean body mass index (BMI) was 25.34 kg/m2. Approximately 50% of

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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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