A randomized controlled trial adding fluvastatin to peginterferon and ribavirin for naïve genotype 1 hepatitis C patients.

Fluvastatin or simvastatin has demonstrable antiviral activity against hepatitis C virus (HCV) as monotherapy. The safety and efficacy of adding fluvastatin or simvastatin to peginterferon/ribavirin for 48 weeks was tested in HCV genotype 1 naïve-to-treatment veterans. Thirty-seven naïve-to-treatment genotype 1 HCV patients were randomized to either a control group (n = 20) to receive peginterferon alfa plus ribavirin or an experimental group (n = 18) to similarly receive peginterferon alfa plus ribavirin as well as fluvastatin 20 mg/day. In addition, seven patients who presented for HCV treatment already were on simvastatin and could not be withdrawn. These simvastatin users were not randomized but were entered into a concurrent prospective pilot arm. There were no unique safety issues with fluvastatin or simvastatin when these drugs were given with peginterferon/ribavirin for 48 weeks. Thirteen of 25 statin patients achieved sustained viral response (SVR), while 5 of 20 control patients achieved SVR. Analysis of SVR by intention-to-treat showed P = 0.078. In this phase 2 study, there were no safety issues with the addition of fluvastatin or simvastatin to peginterferon and ribavirin for 48 weeks. There was a trend towards improvement in SVR when fluvastatin or simvastatin was administered with peginterferon/ribavirin. The size of the groups did not reach the prestudy size thought needed to show significant difference (type II error). These results support the significant results of two other larger randomized controlled trials reported using the same dose of fluvastatin in naïve-to-treatment genotype 1 HCV patients.

Optimizing chemotherapy: concomitant medication lists.

Identifying sources of variability in the response to cancer chemotherapy requires knowledge of all variables, including concomitant medications, that can alter the metabolism and pharmacokinetics of chemotherapy. This study investigated the accuracy of the lists of concomitant medications in the charts of cancer patients. Information collated from a questionnaire, patient interview, and the patient's medical chart was used to obtain validated medication lists. Patients took an average of 4.8 prescription drugs, 1.6 nonprescription drugs, and 1.6 other remedies within the 3 days prior to chemotherapy. Of the concomitant drugs actually taken, the medical records did not report 24% of prescription drugs, 84% of nonprescription drugs, and 83% of other remedies. Electronic medical records (EMRs) were more complete than paper charts, but even these omitted >75% of nonprescription drugs and other remedies. Potential drug interactions were noted in this study. This study documents the extent and complexity of the concomitant drugs taken by patients undergoing chemotherapy and the deficiencies in recording this information in medical charts.

How gastroenterologists inform patients of results after lower endoscopy.

OBJECTIVE: Little is known about how gastroenterologists communicate endoscopic findings and biopsy results to their patients. We sought to determine the factors that may influence this behavior. METHODS: A survey questionnaire was developed and mailed to the 80 members of the Delaware Valley Society for GI Endoscopy. Information was obtained on the demographic characteristics and responses to six case vignettes prepared to examine communication patterns. We determined possible influences of conscious sedation and the benignity or severity of findings on communication practices. RESULTS: Sixty-one surveys (76%) were completed and analyzed. Endoscopists immediately inform patients of normal results. For abnormal results, 92% would immediately inform nonsedated patients versus 79% that would inform sedated patients (p < 0.008). Analysis of responses to the case vignettes indicated that 82% of endoscopists would immediately reassure the patient about a benign appearing (< 1 cm) polyp, but only 70% would do so for a polyp > 2 cm (p < 0.01). In contrast, when presented with a frank malignancy, 94% would inform the patient. Eighty-four percent of endoscopists would telephone results of a benign pathology report, but only 34% would telephone report a dysplastic lesion (p < 0.001). There was no correlation between the response rate and various demographic parameters such as physician age, type of, or length of time in practice. CONCLUSIONS: Gastroenterologists usually report normal findings immediately, but are less likely to do so after use of sedation or encountering abnormal findings. Most of those surveyed would use the telephone to communicate abnormal findings.