Outlook: Clinical Trials

FEBRUARY 01, 2008
Susan Farley

Good News for INSPIRE Study

The INSPIRE trial compared 2 different treatments for severe and very severe chronic obstructive pulmonary disease (COPD): salmeterol/fluticasone propionate (SFC) and tiotropium bromide. Researchers found both treatments to be similar in their effect on symptom exacerbation, but they differed when it came to the nature of the exacerbations—which indicates that the treatments work in different ways. Further, the type of exacerbations will differ, depending on the therapy. The study also found that over 2 years, SFC had a sustained improvement in quality of life, compared with tiotropium; however, in adverse side effects, SFC fared worse than tiotropium—the most common adverse event being exacerbation of symptoms.

Warning for New Anticlotting Drug

While clinical trials have shown the new anticlotting drug idraparinix to be effective for the treatment of deep vein thrombosis (DVT) and for the longterm prevention of blood clots, new trials indicate that it is not as effective for treating potentially life-threatening pulmonary embolisms. In fact, long-term use indicates that, compared with standard treatment, idraparinix may have a higher rate of serious bleeding complications.

Three studies by the drug's manufacturer, sanofi-aventis, support these findings, and all appeared in the New England Journal of Medicine. Edward Amorosi, MD, of the New York University Medical Center noted, "The long duration of action for idraparinix is a benefit, but it is also a hazard because there is no antidote. It appears to be a more effective antithrombotic for DVT, but it is not safe enough to make it standard treatment."

Vitamin E Claims May Be False

A recent study in Free Radical Biology and Medicine suggests that years of data from clinical trials on vitamin E may be flawed. Researchers say that the levels of vitamin E being used in those studies were not high enough. The level of vitamin E needed to reduce oxidative stress is about 1600 to 3200 IU daily, 4 to 8 times higher than what was being studied. Scientists say that this fact could account for the inconsistency in vitamin E study results over the years, researched mostly for its use in preventing or treating cardiovascular disease.

Update on HIV Drug Trial

A new phase 3 trial comparing HIV drugs darunavir (Prezista) with ritonavir and lopinavir/ritonavir (Kaletra) in treatment-na?ve patients yielded the following conclusions:

  • 84% of darunavir/ritonavir patients reached an undetectable viral load vs 78% of patients in the lopinavir/ritonavir group
  • Both groups had a low incidence of discontinuation
  • Incidence of lipid-related adverse events were 1.7% in the darunavir/ritonavir group and 5.2% in the lopinavir/ritonavir group
  • The average change in CD4-1 cells from baseline was similar in both groups

It is important to note that the once-daily, 800-mg dose of Prezista is not yet FDA-approved.

Gardasil Even More Effective

A Merck-sponsored study on its human papillomavirus (HPV) drug Gardasil has determined the drug's efficacy in preventing strains that cause 90% of all cervical cancers. The study, which included 11,000 women aged 15 to 26, showed Gardasil to be 38% effective against 10 additional types of HPV that are believed to cause 20% of all cervical cancer.

Gardasil study results so far have shown:


% Effectiveness

HPV 16


HPV 18


HPV 45


HPV 31


HPV remains the most common sexually transmitted disease in America—6.2 million Americans are infected with genital HPV each year, and half of all sexually active women and men will get it at some point in their lives, according to the Centers for Disease Control and Prevention.

BLOOM Trial Continues as Planned

An independent Echocardiographic Data Safety Monitoring Board has reviewed the phase 3 Behavioral Modification and Lorcaserin for Overweight and Obesity Management (BLOOM) trial and declared no reason to discontinue the study. In an effort to ensure patient safety, the monitoring board reviewed the unblended echocardiograms of patients performed after 6 months of the trial. Rates of FDAdefined valvulopathy in the study group did not constitute stopping the trial. BLOOM is a double-blind, randomized, placebo-controlled trial of 3200 patients to evaluate 10-mg bid doses of lorcaserin versus placebo over a 2-year treatment period.

MS Drug Improves Quality of Life

According to a recent phase 3 clinical trial, natalizumab (Tysabri), by Biogen Idec and Elan Corp, offers significant improvements in healthrelated quality of life for patients with multiple sclerosis. When compared with placebo, results from the trial indicated that patients sustained their improved quality of life rather than just a slowing down of quality of life deterioration. Study details appeared in the August 20, 2007, issue of Annals of Neurology.