Outlook: Clinical Trials

Pharmacy Times
Volume 0

Ms. Farley is a freelance medical writer based in Wakefield, Rhode Island.

Cancer Drug Has Healing Properties for Injured Kidneys

With the use of rituximab (Rituxan), injured kidneys may be healed significantly in patients with membranous nephropathy, a condition that can lead to kidney failure in 30% to 40% of cases. Membranous nephropathy causes significant protein loss in urine, which impairs kidney function and can lead to dialysis or kidney transplant. Whereas other drugs have resulted in significant toxicity, rituximab selectively depletes the cells that make antibodies that cause membranous nephropathy. Originally targeted as a cancer drug for patients with B cell lymphoma, researchers recognized the drug's ability to safely reduce protein loss in urine, as well as reduce the extent of kidney injury in this population. Of the 50 study participants treated with rituximab, 10 achieved complete remission of the disease. Researchers note that "whether this may apply to other [similar kidney conditions] and may translate into longterm protection from renal function loss and the potentially life-threatening complications...remains to be established.

Experimental CF Drug Targets Genetic Flaw

A small clinical trial may offer good news for cystic fibrosis (CF) patients. The drug, currently known as PCT124, blocks the genetic flaw that prevents salt from breaking down mucus, which is what causes CF patients to produce the thick, sticky mucus that affects their lungs and digestive systems. In the Israeli study, 23 CF patients received the drug-3 doses/day for 14 days, followed by a break for 14 days, then 3 higher daily doses. The goal of normal salt flow was achieved in 13 patients during the first treatment cycle and in 9 more patients during the second treatment cycle. Although results were encouraging, researchers acknowledge that a larger scale, placebo- controlled study is necessary, and they plan to start one next year. The complete study appears online in the August 21, 2008, issue of The Lancet.

Trial Yields Positive Results for Treating Kids with JRA

Phase 3 trials of adalimumab (Humira) for the treatment of juvenile rheumatoid arthritis (JRA) resulted in "significantly fewer" JRA patients reporting a worsening of their disease, when compared with placebo. The study focused on patients with active polyarticular JRA, a type of arthritis that affects at least 5 joints. "Flares" refer to a patientrated worsening of disease symptoms. Results showed that adding adalimumab to treatment may alleviate symptoms for kids with JRA. Further study information can be found in the August 21, 2008, issue of the New England Journal of Medicine.

Depression Drug Eases Stress of PMDD

Women who suffer from premenstrual dysphoric disorder (PMDD), a severe form of premenstrual syndrome, can find relief by taking the antidepressant paroxetine (Paxil), according to a Canadian study. If taken when symptoms are at their peak, Paxil can improve irritability and social functioning. Study participants rated their premenstrual symptoms every day for 2 menstrual cycles. Those whose symptoms appeared in the luteal phase of the menstrual cycle (time between ovulation and beginning of next period) randomly received 10 or 20 mg of paroxetine or placebo during their luteal phase for the next 4 periods. Women in the paroxetine group, when compared with those in the placebo group, had "significant improvements in the psychological symptoms associated with PMDD, such as irritability, depressed mood, and tension," according to researchers.

Women in the 20-mg paroxetine group reported improvements in their social and family life functioning. More information can be found in the June 2008 issue of the Journal of Clinical Psychiatry.

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