Clinical Trials

Pharmacy Times
Volume 0

Azacitidine Doubles Survival Rates for Preleukemia Patients

A study found greatly improved survival rates for patients with high-risk forms of myelodysplastic syndromes (MDS) treated with azacitidine (Vidaza). The phase 3, randomized, multicenter, international trial examined 358 patients with high-risk MDS, dividing the group in half (n = 179). One group was treated with azacitidine injections for 7 days per month, for at least 6 months, with the other half of participants receiving one of the most commonly used conventional care treatments—best supportive care, low doses of cytarabine, or classical intensive chemotherapy with an anthracycline and cytarabine. The study results showed that overall survival for patients treated with azacitidine was 9 months longer than that of patients who underwent conventional care regimens. The researchers estimated that twice as many azacitidine patients would be alive 2 years after the start of treatment, compared with those who received conventional care. Azacitidine treatment also delayed the progression of MDS to acute myeloid leukemia by 6 months.

Menerba Effective for Menopausal Symptoms

The results of a phase 2 clinical trial showed that Menerba (formerly MF101) is an effective treatment for menopausal vasomotor symptoms (hot flushes and night sweats). The randomized, double-blind, placebo-controlled trial involved the administration of either 1 of 2 doses of Menerba, or an identical placebo to 217 healthy, postmenopausal women experiencing severe hot flushes. The study took place at 6 clinical sites nationwide and lasted for 12 weeks. At the end of the study period, the researchers found that those taking the higher dose of Menerba saw a statistically significant decrease in all hot flushes (P = .04). In addition, the higher dose participants were 2.3 times more likely to have a minimum of a 50% reduction in hot flushes after being treated for 12 weeks, compared with the placebo group (odds ratio 2.3, P = .03). Menerba also showed a reduction in awakenings during the night triggered by hot flushes or night sweats. The women receiving the higher dose of Menerba reported a 67% reduction in night sweats, a number significantly higher than that of the placebo group (P = .05).

New Drug Cuts Recurrence of GI Tumors

Imatinib mesylate (Gleevec) showed efficacy in reducing the rate of recurrence of Kit (CD117)-positive gastrointestinal stromal tumors (GIST), compared with placebo. A phase 3, double-blind, randomized, multicenter study included 713 GIST patients whose tumors had been surgically removed. Conducted throughout the United States and Canada, the trial compared the recurrence-free survival (RFS) of patients treated with either imatinib mesylate 400 mg daily or placebo immediately after surgery. The study results showed that 98% of those in the imatinib mesylate group maintained RFS 1 year following surgery, compared with approximately 83% of the placebo group (P <.0001). Although the researchers found imatinib mesylate to be well-tolerated by most participants, side effects experienced included nausea, diarrhea, and edema. The study is slated for publication in an upcoming issue of The Lancet.

PRO 2000 Shows Potential for Thwarting HIV Transmission

An investigational microbicide vaginal gel, known as PRO 2000, showed promise for the prevention of HIV infection in women, according to the results of a phase 2 clinical trial. Although not conclusive, the first human clinical study demonstrating efficacy for a microbicide in prevention of HIV and other sexually transmitted diseases saw PRO 2000 as 30% effective in blocking HIV transmission.

The study, conducted at 6 sites in Africa and 1 in the United States, enrolled 3099 women who were monitored for an average of 20 months. Study participants were randomly divided into 4 equal-sized groups:

• Women using PRO 2000 before engaging in sexual intercourse

• Women using another microbicide BufferGel (ReProtect Inc) before engaging in sexual intercourse

• Women using placebo gel before engaging in sexual intercourse

• Women not using gel before engaging in sexual intercourse

The study results, recently presented at the Conference on Retroviruses and Opportunistic Infections, revealed that a total of 194 participants became infected with HIV. Among PRO 2000 users, 36 became infected; among the BufferGel group, 54; among the placebo group, 51; and of those who did not use gel, 53 became infected. Although both PRO 2000 and BufferGel were found to be safe, BufferGel was determined not to have any detectable success in preventing HIV transmission.

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