Outlook: Clinical Trials

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

Elderly Reduce Risk of Falling with Ritalin

A recent study out of Tel-Aviv Sourasky Medical Center in Israel suggests that methylphenidate (Ritalin) can help elderly patients sharpen their mental acuity, thereby reducing their risk of falling. Researchers recruited 26 seniors considered healthy and able to live independently. The seniors performed fall risk tests before and after taking a dose of either methylphenidate or placebo. The results showed that the participants in the methylphenidate group were able to complete the test more quickly. Besides faster completion time, they exhibited less variability in stride and better results on executive function tests. While more studies are needed to better assess long-term efficacy and safety, the researchers were intrigued by the idea of treating fall risk with a pill. The full study appears in the Journal of the American Geriatrics Society (April 2008).

Fluoxetine May Reduce Inflammation in MS Patients

The results of a study of fluoxetine (Prozac) in the treatment of multiple sclerosis (MS) patients showed that the drug may reduce disease activity in patients with a relapsing remitting form of the disease. The researchers followed 38 randomly selected MS patients and administered 20 mg/day of fluoxetine or placebo for 24 weeks. Magnetic resonance imaging was completed every 4 weeks to monitor neurologic inflammation. The results showed that patients in the placebo group had more inflammation (an average of 5 new areas) than patients in the fluoxetine group (2 new areas). In fact, in the last 16 weeks of treatment, 63% of the patients in the fluoxetine group had no new areas of inflammation, compared with 26% in the placebo group.

Larger studies need to be conducted before anything conclusive can be determined. The results were recently published online in the Journal of Neurology, Neurosurgery, and Psychiatry.

Justifying Clinical Trials

A new report from the H. Lee Moffitt Cancer Center and Research Institute at the University of South Florida, Tampa, revealed that about one quarter to one half of the new cancer treatments that make it to phase 3 trials are eventually proven successful.

Data from this study came from all phase 3 randomized clinical trials completed by National Cancer Institute Cooperative groups since 1955?this equals 624 trials involving 216,451 patients. Of these trials, 30% had results considered statistically significant; in 80% of those cases, the new treatments proved superior to standard treatments.

The researchers note that the real benefit is measured in terms of patient outcomes. By that accounting, new treatments are slightly superior to standard treatments, with a 5% "relative reduction in the death rate." Study authors are careful to point out that the 5% rate should not be considered the average effect of new treatments. In 15% of clinical trials, breakthrough therapies were discovered. In 2% of those cases, the death rate was reduced by more than 50%. See the March 24, 2008, issue of Archives of Internal Medicine for more information on this study.

New Drug Approved For Opioid-induced Constipation

The FDA has approved methylnaltrexone for patients with opioid-induced bowel disorders as they receive palliative care for advanced illnesses. Patients in need of opiates for the relief of intense pain may decide not to pursue opioid treatment because of the side effects, such as severe constipation. Methylnaltrexone can block this side effect with no disruption to the opioid's effects. Elmer Abbo, MD, assistant professor of medicine at the University of Chicago, calls methylnaltrexone "a revolution, a godsend for palliative-care physicians." The injectable drug (brand name Relistor) can be administered as needed, but not more than one dose in a 24-hour period.

ASA 404 Begins Phase 3

Novartis' novel drug for lung cancer, known as ASA 404, has entered phase 3 trials. This is where investigators will further explore the drug's mechanism of action, which may represent a new approach to treating the most prevalent cause of death for cancer patients.

The drug is considered a "tumor-vascular disrupting agent (tumor-VDA)," which can deprive a tumor of its blood supply, thereby leading to tumor death. Other cancer drugs, known as angio-genesis inhibitors, work by preventing the tumor's ability to form new blood vessels. Non-small cell lung cancer, which is likely to be ASA 404's lead indicator, makes up 85% to 90% of all lung cancers.

In general, lung cancer is the number-1 cause of cancer deaths in both men and women.

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