REPORTS FROM THE FIELD
Oral drug fights cancer; Kiss infusion good-bye
Capecitabine, an orally administered anti-cancer drug that mimics 5-fluorouracil (which requires infusion), offers great promise for treating women with breast cancer that fails to respond to chemotherapy agents, according to a new study released in The Oncologist. The author looked at the results of two large, multicenter phase II studies with more than 230 patients. In these studies, capecitabine showed a response rate of 20% to 25% in patients who had failed treatment with other chemotherapy agents.
As an oral agent, capecitabine is more convenient for patients and clinicians and permits more home-based therapy. In addition to added convenience, capecitabine has another advantage over the drug 5-fluorouracil: It is activated by an enzyme that is more active in tumors than in normal tissue, meaning it can generate more of the cancer-killing 5-fluorouracil directly into the tumor, reducing certain side effects such as hair loss and bone-marrow suppression.
[See: Blum JL. The role of capecitabine, an oral enzymatically activated fluoropyrimidine, in the treatment of metastatic breast cancer. Oncologist 2001; 6:56-64.]
Pravastatin reduces diabetes onset
Cholesterol drug prevents type 2 diabetes
Scottish researchers at the University of Glasgow have discovered that pravastatin, a drug widely prescribed to lower cholesterol and reduce the risk of heart attack and stroke, may also prevent the onset of diabetes in patients at risk for developing type 2 diabetes, according to a study in the journal Circulation.
The study of 5,974 men with elevated cholesterol levels and no history of heart disease showed that men randomly assigned to pravastatin therapy experienced a 30% reduction in diabetes risk. Researchers took the following baseline predictors of the transition from normal glucose control to diabetes:
- body mass index;
- log triglyceride;
- glucose;
- log white blood cell count;
- systolic blood pressure;
- total and HDL cholesterol.
Researchers found that men receiving placebo had about a 3% chance of developing diabetes over the five-year study — a normal maturity for onset of type 2 diabetes. Men receiving pravastatin experienced a 30% reduction in their risk of developing diabetes.
[See: Freeman DJ, Norrie J, Sattar N, et al. Pravastatin and the development of diabetes mellitus. Circulation 2001; 103:357-362.]
Drug option dissolves clots in catheters
May eliminate need for surgery
Surgery remains one of the few options for restoring blood flow to a long-term, indwelling catheter blocked by blood clots. Now, a researcher at the University of Nebraska Medical Center in Omaha reports that recombinant tissue plasminogen activator (t-PA) effectively dissolves blood clots and restores function without surgery.
William Haire, MD, presented results of the six-month, randomized, double-blind study of 150 patients with blocked catheters at the recent International Symposium on Endovascular Therapy in Miami. Patients in the study were randomized into two groups. In one group, patients were first given a dose of placebo in their catheter. If catheter function was not restored, patients received one 2-mg dose of t-PA. In this group, researchers found that 17.1% of patients had full function of their catheter after receiving placebo. In patients who received the placebo followed by t-PA, 90% regained full function of their catheter.
In the second group, each patient first received a 2-mg dose of t-PA, followed by another dose if the catheter remained blocked. Researchers found that 73.9% of patients had full function of their catheters after one dose of t-PA. Of patients whose catheters remained clogged, 90% regained full function after a second dose of t-PA.
No serious drug-related adverse effects were experienced by either group as a result of treatment, and there were no cases of intracranial hemorrhage or embolism.
Delivery time shorter with vaginal inserts
Drug also results in more vaginal births
Oxytocin administered concurrently with sustained-release dinoprostone vaginal insert significantly shortens delivery time and results in a higher proportion of vaginal deliveries within 24 hours with no apparent increase in maternal/fetal risk, according to a study presented at the recent Society of Maternal-Fetal Medicine 2001 Annual Meeting in Reno, NV.
Researchers from the University of New Mexico Health Sciences Center in Albuquerque randomly assigned 71 women with singleton pregnancies greater than 36 weeks and with no prior difficulties to one of two groups. One group received a low-dose of oxytocin infusion started 10 minutes after placement of a dinoprostone vaginal insert (the immediate group). The second group received a low-dose oxytocin infusion started 30 minutes after removal of the dinoprostone insert (the delayed group). In both groups, the vaginal insert was left in place for up to 12 hours. During this time, fetal heart rate and uterine activity were continuously monitored.
Findings include:
• Average induction to delivery time was 582 minutes shorter in the immediate group than in the delayed group.
• The proportion of vaginal deliveries within 24 hours was 93% in the immediate group compared to 55% in the delayed group.
• No uterine hyperstimulation or increased risk of fetal heart rate or other negative outcomes were observed.
Drug expands options for schizophrenia treatment
Pfizer in New York City recently received FDA approval for ziprasidone HCl capsules, an antipsychotic medicine for the treatment of schizophrenia. Ziprasidone is a serotonin and dopamine antagonist that is effective across its dose range in treating both positive and negative symptoms associated with schizophrenia, including visual and auditory hallucinations, delusions, lack of motivation, and social withdrawal.
In placebo-controlled, short-term clinical trials, ziprasidone (20 to 100 mg twice daily) was statistically superior to placebo for treatment of positive and negative symptoms in patients with acute exacerbation of schizophrenia and schizoaffective disorder.
In a one-year placebo-controlled study in chronic, stable inpatients, ziprasidone was shown effective in delaying time to and rate of relapse. In addition, ziprasidone does not appear to cause the weight gain associated with other antipsychotic medicines.
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