Comparative safety of filgrastim versus sargramostim in patients receiving myelosuppressive chemotherapy.

STUDY OBJECTIVE: To compare rates of adverse events with filgrastim versus sargramostim when given prophylactically to patients receiving myelosuppressive chemotherapy. DESIGN: Retrospective review with center crossover. SETTING: Ten United States outpatient chemotherapy centers. PATIENTS: Four hundred ninety patients treated for lung, breast, lymphatic system, or ovarian tumors. INTERVENTION: Prophylactic use of filgrastim or sargramostim, with dosages at investigator discretion. MEASUREMENTS AND MAIN RESULTS: The frequency and severity of adverse events and the frequency of switching to the alternative CSF were assessed. There was no difference in infectious fever. Fever unexplained by infection was more common with sargramostim (7% vs 1%, p<0.001), as were fatigue, diarrhea, injection site reactions, other dermatologic disorders, and edema (all p<0.05). Skeletal pain was more frequent with filgrastim (p=0.06). Patients treated with sargramostim switched to the alternative agent more often (p<0.001). CONCLUSION: Adverse events were less frequent with filgrastim than with sargramostim, suggesting that quality of life and treatment costs also may differ.

Comparison of G-CSF and GM-CSF adverse event profiles in office-based practices: preliminary study results.

We investigated the adverse event profile of colony-stimulating factors (CSFs) used in office-based oncology practices in the United States. The impetus for the study was anecdotal reports from physicians and nurses working in community practice settings describing the differences in adverse drug events (ADEs) that their-patients experienced with the two CSFs currently available in the United States. The study was a retrospective review of office-based oncology practice records. The frequencies of drug-induced fever and other ADEs secondary to granulocyte (G)-CSF were compared with those of granulocyte-macrophage (GM)-CSF. Adverse drug events were those events that were documented by a clinician as being causally linked to CSF therapy and not obviously due to other causes. This preliminary report of the data indicated that there were some significant differences in the ADEs attributable to either G-CSF or GM-CSF. The appropriate use of CSFs in clinical practice also is discussed.

Effects of 4- and 8-h preexercise feedings on substrate use and performance.

Seven well-trained male cyclists were studied during 105 min of cycling (65% of maximal oxygen uptake) and a 15-min "performance ride" to compare the effects of 4- and 8-h preexercise carbohydrate (CHO) feedings on substrate use and performance. A high CHO meal was given 1) 4-h preexercise (M-4), 2) 8-h preexercise (M-8), 3) 4-h preexercise with CHO feedings during exercise (M-4CHO), and 4) 8-h preexercise with CHO feedings during exercise (M-8CHO). Blood samples were obtained at 0, 15, 60, 105, and 120 min and analyzed for lactate, glucose, insulin, and glycerol. Total work output during the performance ride was similar for the M-4 (217,893 +/- 13,348 N/m) and M-8 trials (216,542 +/- 13,905) and was somewhat higher for the M-4CHO (223,994 +/- 14,387) and M-8CHO (224,702 +/- 15,709) trials (P = 0.059, NS). Glucose was significantly elevated throughout exercise, and insulin levels were significantly elevated at 15 and 60 min during M-4CHO and M-8CHO compared with M-4 and M-8 trials. Glycerol levels were significantly lower during the CHO feeding trials compared with placebo and were not significantly different during exercise when the subject had fasted an additional 4 h. The results of this study suggest that when preexercise meals are ingested 4 or 8 h before submaximal cycling exercise, substrate use and performance are similar.

Role of the infectious disease specialist in containing costs of antibiotics in the hospital.

Antimicrobial agents account for a significant proportion of drug expenditures and are used inappropriately approximately half the time in hospital practice. This has led to substantial increases in medical costs for hospitalized patients. Methods have been proposed to reduce inappropriate use of antibiotics, particularly in hospitalized patients. Two of these methods, education and control, were employed effectively by infectious disease specialists at a university teaching hospital to reduce inappropriate use of second-generation cephalosporins. These efforts resulted in significant savings of approximately $130,00 per year. The infectious disease specialist may also make major contributions to cost containment of antibiotics in other equally important areas, including other classes of antibiotics, inappropriate daily frequency, excessive duration of administration, and prevention of adverse drug reactions. The infectious disease specialist is better trained in appropriate antimicrobial use and clinically more knowledgeable in treating infections than other medical specialists and is the best-equipped member of the medical staff to educate the medical community on antibiotic use and to control antibiotic costs.

Control and accountability of controlled substance administration in the operating room.

Personnel working in the operating room complex may be at increased risk for chemical impairment. It has been proposed that this predisposition may be related to the frequency of use of controlled substances and the inadequate control over distribution of these medications, which frequently exists in the operating room. A system utilizing a pharmacy satellite in the operating room has increased the control and accountability of drug administration practices. Several other alternative systems are also reviewed. Emphasis is placed on the establishment of a quality assurance program to monitor compliance routinely.