Studies find promising uses for three drugs
Two of the country’s largest drug manufacturers, SmithKline Beecham in Philadelphia and Eli Lilly in Indianapolis, recently released results of clinical trials that offer promising results for chronic illness.
• Osteoporosis prevention.
Lilly recently announced it has received clearance to market Evista 60 mg tablets for the prevention of osteoporosis in postmenopausal women. Evista is the first in a new class of drugs called selective estrogen receptor modulators (SERMs) to be approved for the prevention of osteoporosis, a condition that affects more than 28 million Americans, most of them women.
The U.S. Food and Drug Administration in Rockville, MD, reviewed data from 50 studies conducted in 28 countries to establish the safety and efficacy of Evista. A total of 1,764 postmenopausal women participated in pivotal Phase III osteoporosis prevention studies. In two studies, women were randomly assigned to take Evista or placebo. In the third study, women took Evista, placebo, or estrogen replacement therapy. All the women took calcium supplements. In each study, Evista was superior when compared with placebo in preventing bone loss in the lumbar spine and hip. However, Evista was less effective in building bone than estrogen replacement. Side effects included a rare but serious increase in venous thromboembolic events, hot flashes, and leg cramps. For full prescribing information, call (888) 286-8107 and request document #4410.
• Leukemia drug.
The drug Hycamtin manufactured by SmithKline Beecham in combination with cytosine arabinoside (ara-C) offers a promising new treatment for patients suffering from the severe blood disorders myelodysplastic syndrome (MDS) and chronic myelomonocyctic leukemia (CMML), according to results of a study presented at the recent annual meeting of the American Society of Hematology in San Diego.
In the study, patients treated with Hycamtin and ara-C achieved a complete response rate of 63%. This is especially encouraging because there currently is no standard treatment for MDS or CMML, which are difficult to treat, says lead investigator Miloslav Beran, MD, PhD, professor of medicine in the department of leukemia at the University of Texas, M.D. Anderson Cancer Center in Houston.
"The potential use of Hycamtin as combination therapy looks promising for MDS and CMML patients as well as for other leukemia patients," he says.
In Beran’s Phase II study, 35 patients with either MDS or CMML received Hycamtin 1.25 mg/m2 intravenously over 24 hours daily for five days and high-dose ara-C 1g/m2 over two hours daily for five days. More than 60% of patients achieved a complete response, 80% after only one course of therapy. A complete response was defined as bone marrow with 5% fewer immature marrow cells and normalization of the hemoglobin, platelets, and white blood cells. In addition, patients who achieved a complete response no longer required blood transfusions, and patients with pre-existing chromosomal abnormalities showed disappearance of these abnormalities.
Side effects of Hycamtin use included fever and low white blood cell count with or without infection. (For a discussion of other uses of Hycamtin, see Case Management Advisor, Jan. 1998, pp. 14-16.)
• Herpes simplex therapy.
Intravenous Penciclovir is a safe and effec- tive treatment for herpes simplex virus (HSV) in immunocompromised patients, according to a study presented at the recent Interscience Conference on Antimicrobial Agents and Chemotherapy in Toronto, Canada. Penciclovir is the active agent in SmithKline Beecham’s Famvir, an oral medication used to treat or suppress recurrent genital herpes and to treat herpes zoster in immunocompetent individuals.
"This drug is an important development in the treatment of herpes infections in people with severely weakened immune systems, such as transplant recipients and patients with cancer, particularly because many of these individuals cannot tolerate oral medications and treatment options are limited," says Hillard M. Lazarus, MD, lead investigator and professor of medicine and medical sciences at the University Hospitals of Cleveland and Case Western Reserve University.
In a randomized, double-blind multicenter trial, penciclovir was administered intravenously to 342 immunocompromised patients. Patients received penciclovir 5mg/kg either two or three times daily for seven days, or acyclovir 5 mg/kg three times daily for seven days. Penciclovir twice daily was comparable to acyclovir three times daily in preventing new lesions and time to cessation of viral shedding. In addition, there was no significant difference between the two treatment groups in time to loss of pain.
Penciclovir offers a potential treatment advantage over acyclovir because it requires less frequent dosing, Lazarus says. The drug may provide a significant treatment benefit because it means less administration time for both patients and caregivers and offers potential cost savings, he adds.
[Editor’s note: For more information about Hycamtin or Famvir, contact SmithKline Beecham’s Prescription Drug Patient Assistance Program at (800) 546-0420, or visit the company’s Web site at www.sb.com.]
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