Reports From The Field-Research roundup
News from the American Academy of Neurology
Multiple sclerosis (MS) patients benefit significantly from higher doses of beta interferon after four years of treatment, according to a study presented in San Diego at the recent 52nd annual Meeting of the American Academy of Neurology. The new long-term study provides additional hope for more than a million patients worldwide living with the continuing threat of disability due to relapsing-remitting MS.
The study began in 1994 and involved 560 patients at 22 centers in nine countries. Two-year data from the trial were published in 1998 in the British medical journal The Lancet. The data from that study demonstrated that both Rebif 3 × 22 mcg and Rebif 3 × 44 mcg per week significantly reduced the number and severity of relapses, delayed disability progression, and reduced disease activity and burden of disease as measured by magnetic resonance imaging. The new four-year data demonstrate that the higher dose of Rebif is statistically superior to the lower dose.
In evaluating patients at the four-year interval, researchers found that disease progression was most delayed in patients who started treatment two years earlier in the disease with the higher dose of Rebif, or 3 × 44 mcg per week, as compared with postponing treatment at the lower dose, or 3 × 22 mcg per week.
Rebif is not currently on the market in the United States due to Orphan Drug Law exclusivity for two other products. However, researchers are currently enrolling patients in a clinical study to directly compare interferon beta-1a doses across different product formulations.
The head-to-head trial will compare a 132 mcg weekly subcutaneous dose of Rebif to 30 mcg per week intramuscular doses of two other interferon beta products.
Rebif is manufactured by Ares-Serono in Geneva, Switzerland. Patients with MS interested in enrolling in the continued study of Rebif may call (888) 797-4477 or visit the World Wide Web at www.mspatient.com.
According to another study presented at the annual meeting, a drug used to treat some of the symptoms of the sleeping disorder narcolepsy also appears to help control fatigue in patients with MS. Researchers found that a 200 mg/day dose of the drug modafinil, manufactured under the name Provigil by Cephalon in West Chester, PA, successfully controlled fatigue in patients with MS. "About 70% of MS patients suffer from fatigue," says Kottil Rammohan, MD, associate professor of neurology at Ohio State University. "It's one of the most disabling symptoms of MS."
During a nine-week trial, the researchers studied 72 patients with severe fatigue and MS. The patients received a placebo during the first two weeks and again during the final three weeks of the study. During weeks three and four, each patient received 200 mg of modafinil. During weeks five and six, the dosage was increased to 400 mg daily.
Evaluating side effects
After each phase of treatment, the researchers asked each patient to evaluate his or her level of fatigue and sleepiness. Overall, patients said they experienced significantly less fatigue when they took the 200 mg dose, compared with the placebo. However, when patients took the 400 mg dose, some of them experienced side effects that overshadowed the favorable effects of decreased fatigue.
In this study, the most common side effects were headaches, nervousness, and loss of physical strength.
In another study presented at the meeting, diabetic patients felt significant reduction in nighttime neuropathic pain after treatment with Memantine, a drug being developed in the United States by Neurobiological Technologies in Richmond, CA. The trial compared two dosage levels of Memantine, 20 mg and 40 mg, with placebo. In the 40 mg group, 44% of the patients experienced a 50% reduction in pain, compared with 29% of the placebo group patients. There was no significant difference between the 20 mg group and placebo, the study showed.
No drug has been approved by the Food and Drug Administration specifically for treatment of neuropathic pain. In addition to offering pain relief, note researchers, Memantine appears to have a more favorable safety profile than existing off-label treatments, which are primarily antidepressants.
News from the American Urological Association
The largest controlled study of overactive bladder suggests patients taking an investigational once-daily capsule of the currently marketed Detrol (tolterodine tartrate tablets) produced by Pharmacia & Upjohn in Peapack, NJ, experienced significant improvement of all symptoms of the condition.
Researchers presented the findings of the 1,500-patient study at the 95th annual meeting of the American Urological Association recently in Atlanta. Patients in the study were treated with the investigational once-daily Detrol capsule, the currently marketed twice-daily Detrol formulation, or placebo. Patients reported the number of times they urinated, the volume of urine voided per bathroom visit, and the number of urge incontinence episodes periodically throughout the 12-week treatment period. Findings include:
• Significantly more patients taking the once-daily formulation of Detrol reported improvements in overall bladder condition than patients treated with placebo.
• Patients taking the once-daily formulation of Detrol reported a 71% improvement over placebo in reducing incontinence episodes per week.
• A larger proportion of once-daily patients reported improvement in urinary urgency, compared with placebo-treated patients.
Also reported at the annual meeting, results of a study of patients with prostate cancer suggest that the oral hormonal medication Casodex (bicalutamide, 150 mg tablets) shows no statistically significant difference in overall survival or time to progression when compared with surgical or medical castration in patients with nonmetastatic, locally advanced prostate cancer.
Researchers reported results from combined analysis of two studies of nonmetastatic, locally advanced prostate cancer; 480 patients were randomized to receive Casodex 150 mg once daily or castration. After a median follow-up of 6.3 years, there was no statistically significant difference in survival between the Casodex and castration groups. The difference in time to progression of disease also was not statistically significant. Casodex provided significant quality-of-life benefits over castration, including improved sexual interest and physical capacity. Casodex is manufactured by AstraZeneca in Wilmington, DE.
News from the American College of Cardiology
Researchers have new evidence that a noninvasive test called Cardiolite can accurately predict the likelihood of a heart attack or cardiac death in patients with diabetes, according to a study presented at the recent American College of Cardiology meeting in Anaheim, CA.
In this multicenter study of 4,755 patients with known heart disease, researchers evaluated the role of Cardiolite in predicting heart attacks and cardiac death among 929 patients with diabetes. In addition, a subanalysis of 451 female patients with diabetes was conducted. Highlighting the findings, researchers concluded that the Cardiolite stress test successfully identified patients with diabetes at high or low risk for future heart attacks or cardiac deaths.
The researchers also found the test equally effective in predicting cardiac events in men and women. Notably, women with diabetes have considerably higher rates of heart attack and are more likely to suffer fatal heart attacks than are men with diabetes and nondiabetic women.
"What's particularly encouraging about the study results is that, by evaluating risk factors such as high blood pressure and high cholesterol, in combination with the information that Cardiolite imaging provides, we can identify the risk for heart attacks and cardiac death just as effectively in women as in men," explains Leslee Shaw, PhD, co-author of the study and associate professor of medicine at Emory University in Atlanta.
"Additionally, utilizing a test that performs equally well in women and men and in patients with and without diabetes makes it an extremely valuable tool in guiding cardiac treatment decisions," she says.
Cardiolite is the leading cardiac stress imaging agent in the Untied States. It is the only cardiac imaging agent approved by the Food and Drug Administration for the noninvasive evaluation of the heart's pumping ability and for gauging the amount of blood flow to the heart muscle itself. Cardiolite is manufactured by DuPont Pharmaceuticals in Wilmington, DE.
Another study at the annual meeting reported that chest pain patients can be assessed up to 75% faster with more frequent and rapid testing of cardiac markers. Investigators at the San Diego Veterans Administration Medical Center (SDVAMC) and the University of California at San Diego (UCSD) found that an accelerated chest management protocol using the Triage Cardiac System, a rapid diagnostic test manufactured by Biosite Diagnostics in San Diego, enabled patient assessment within 90 minutes and provided highly sensitive and specific means of managing chest pain patients. Additionally, 90% of low-risk patients were discharged before or at the 90-minute point with no adverse effects.
"Our study demonstrates that frequent, rapid testing of three key cardiac markers can enable physicians to make medical decisions regarding treatment, admission, and discharge earlier, which ultimately benefits the patient," says Alan Maisel, MD, professor of medicine at UCSD and director of the cardiac care unit at the SDVAMC. "This new capability may alleviate crowding in emergency rooms and critical care units, freeing up urgently needed medical resources for those patients who can best benefit from them."
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