Clinical Trials

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Prostate Cancer Survival Rate Increased with Cabazitaxel
Recent data from a large international phase 3 study showed that patients with advanced hormone-refractory prostate cancer whose disease had progressed and were treated with cabazitaxel plus prednisone/prednisolone had an increased overall survival rate and progressionfree survival rate. No treatments have been approved by the FDA to treat these patients.

The results of the TROPIC trial showed that the combination of cabazitaxel and prednisone/prednisolone significantly reduced the risk of death by 30% (hazard ratio [HR], 0.70; 95% confidence interval (CI), 0.59-0.83; P <.0001) with a clinically meaningful improvement in the median overall survival of 15.1 months in the cabazitaxel combination arm, compared with 12.7 months in the mitoxantrone combination arm. Patients who received the combination treatment with cabazitaxel also experienced a significant increase in median progression-free survival (2.8 vs 1.4 months) (HR, 0.74; 95% CI, 0.64-0.86; P <.0001).


Acne Combination Therapy Safe and Effective
Positive results were recently obtained from a study looking at a combination therapy regimen for patients with significant acne. The results of the recent Acne Combination Evaluation Study in Severe Patients (ACCESS) found that the addition of adapalene and benzoyl peroxide (Epiduo Gel) 0.1%/2.5% to doxycycline 100 mg proved to be a powerful treatment regimen for patients who present with more severe acne. The results of ACCESS, a vehiclecontrolled, multicenter, double-blind study, were published in the February 2010 issue of Cutis. By week 12, the combination regimen of adapalene and benzoyl peroxide 0.1%/2.5% and oral doxycycline demonstrated a 72 median percent reduction in inflammatory lesion count; it was superior to gel vehicle/doxycycline in reducing total, inflammatory, and noninflammatory lesion counts.


Two Carisoprodol Trials Show Improvements in Patients with Low Back Pain
The results of 2 multicenter, double-blind, placebo-controlled clinical trials of more than 1300 subjects showed that patients with acute low back pain who were treated with carisoprodol (Soma) 250 mg showed significantly improved functionality and reduced disability after 3 days of treatment, as measured by the Roland-Morris Disability Questionnaire (RMDQ). The coprimary end points were met in both studies—patients receiving carisoprodol 250 mg reported a statistically significant improvement in global impression of change and relief from starting backache on day 3, the primary analysis, compared with placebo (P <.0001).

A secondary end point of the studies was also measured. Patients achieved significantly greater clinical improvement as measured by the RMDQ with carisoprodol 250 mg versus placebo on day 3. The improved functionality with carisoprodol 250 mg was demonstrated by lower RMDQ scores, compared with placebo (31% and 17%, respectively) after 3 days of treatment. A clinically meaningful improvement—as stated by Ostelo et al in recommendations published in Spine in 2008—is shown by a greater than 30% reduction in RMDQ score from baseline.


Pancrelipase Improves Fat Absorption in Children with CF
Children with cystic fibrosis (CF) who also experience exocrine pancreatic insufficiency (EPI) may have a new treatment option on the horizon. According to data from a short-term, double-blind, randomized, multicenter, placebo-controlled, cross-over study phase 3b trial, which was published in the January 2010 issue of Clinical Therapeutics, pancrelipase (CREON) delayed-release capsules significantly improve a key measure of fat absorption in children aged 7 to 11 years who have EPI due to CF. EPI is a condition resulting from a deficiency in the production and/or secretion of pancreatic enzymes that are necessary to digest nutrients in food.

The coefficient of fat absorption (CFA) is calculated based on measures of fat ingestion and fat excretion; assessing the CFA of a patient is another way to measure the absorption of fat as a percentage of fat intake in patients being tested for EPI. In this study, 16 patients aged 7 to 11 with EPI due to CF were given 12,000 lipase unit capsules at a dose of 4000 lipase units/g of dietary fat intake per day. The children enrolled in this clinical study experienced an improved CFA during treatment with pancrelipase, compared with placebo. The mean CFA was greater during treatment with pancrelipase (82.8%), compared with placebo (47.4%), which resulted in a significant difference of 35.4% (P <.001).

In addition, positive results were obtained for a secondary outcome measure—the coefficient of nitrogen absorption (CNA). CNA was used as a measure to evaluate the absorption of proteins. CNA is calculated based on the amount of nitrogen intake and nitrogen excretion. The mean CNA was greater during treatment with pancrelipase (80.3%), compared with placebo (45.0%) (P <.001).