German Drug May Improve Pulmonary Hypertension Symptoms
On average, patients who received nebulized iloprost for 12 weeks were able to travel 36 meters farther than placebo users during a six-minute walk test. Both groups of patients continued to take their conventional therapies. Twenty-five percent of the 101 iloprost users improved at least one level in New York Heart Association (NYHA) functional class, which measures a person's ability to withstand physical activity. The NYHA functional class improved in 13 percent of the 102 patients who received a placebo for 12 weeks.
Seventeen percent of the iloprost users and 5 percent of patients in the placebo group reached the study's combined endpointa 10 percent increase in the patients' six-minute walking distance and an improvement in the NYHA functional class. The results of the study appear in the Aug. 1 New England Journal of Medicine.
Treatment with iloprost also appeared to improve pulmonary vascular resistance, cardiac output, pulmonary artery pressure, and other factors related to blood flow.
The study took place at 37 clinical centers in Europe. Patients who participated in the study had primary pulmonary hypertension, chronic thromboembolic pulmonary hypertension, or pulmonary hypertension associated with scleroderma or the use of appetite suppressants. All study participants were clinically stable and had an NYHA functional class of III or IV after receiving standard care for pulmonary hypertension.
The study medications, iloprost or placebo, were diluted in a sodium chloride solution to a concentration of 10 mcg/mL, and 2 mL of this dilution was added to a nebulizer. Patients received 2.5 or 5.0 mcg of iloprost or an equivalent amount of placebo through the nebulizer, a process that the research team reported often took 10 minutes. The treatment was repeated six to nine times a day for 12 weeks.
Patients who received iloprost were more likely than placebo users to faint or report an increased frequency of cough, flushing, or jaw pain during treatment. One patient in the iloprost group and four people in the placebo group died during the study. In addition to the patients who died, three people in the iloprost group and 10 in the placebo group either discontinued their study medication or withdrew their consent to continue the study.
The study was funded by Schering AG of Germany, and all of the study authors reported having a financial relationship with Schering. The company's 2001 annual report announced that Iloprost will be marketed in Europe next year under the name Ventavis. Fazwa Almamakly, a pharmacist for Schering's U.S. subsidiary, Berlex Laboratories Inc., said that there are no plans to develop the drug for use in the United States in the near future.