CLINICAL TRIAL NEWS

Advances in Skin & Wound Care, Jul/Aug 2004 by Hess, Cathy Thomas

Diabetic Foot

The investigational drug Cymbalta (duloxetine hydrochloride), a selective serotonin norepinephrine reuptake inhibitor manufactured by EIi Lilly, Indianapolis, IN, significantly reduced diabetic neuropathic pain and was safe and well tolerated according to long-term study results presented at the American Psychiatric Association meeting, New York, NY. In the 52-week study, patients treated with Cymbalta reported significantly fewer serious adverse events than those given routine care for diabetic neuropathy.

* Information: http://www.lilly.com

Preliminary results of a pilot study to determine the efficacy of GraftJacket tissue matrix in wound closure were published in a recent issue of Orthopedics.1 A prospective, randomized study compares the success of the novel acellular regenerative tissue matrix, from Wright Medical Technology lnc, Arlington, TN, as an aid in wound healing with conventional treatment. Researchers used diabetic foot ulcers to evaluate the outcome of the tissue matrix in wound repair. Only a single administration of the GraftJacket Tissue was required. After a month of treatment, preliminary results demonstrate that the product promotes faster healing at a statistically significant rate over conventional treatment.

* Information: http://www.wmt.com

Urinary Incontinence

Results of trials with solifenacin succinate, presented at the American College of Obstetrics and Gynecology (ACOG) annual meeting, Philadelphia, PA, included significant reduction in urgency, frequency, and incontinence. Solifenacin succinate, a once-daily oral antimuscarinic agent in development by Yamanouchi Pharmaceuticals Co, Ltd, Tokyo, Japan, significantly reduced these key symptoms of overactive bladder in 4 pooled trials involving 2466 women. The drug appears to be the first antimuscarinic agent to report consistent and statistically significant reductions in the 3 main symptoms of overactive bladder across multiple trials.

The data showed that 63% of women receiving the recommended dose of solifenacin, 5 mg once daily, and 68% of women receiving 10 mg once daily reported reductions of 50% or more in urgency episodes, compared with only 44% of women receiving placebo. Those participants who received tolterodine twice daily reported a 53% reduction in urgency episodes compared with placebo.

* Information: http://www.yamanouchi.com

Results of 2 separate Phase III studies involving Enablex (darifenacin hydrobromide), an M3 selective receptor antagonist being developed for the treatment of overactive bladder (OAB), demonstrated a statistically significant reduction in the frequency of weekly incontinence episodes (up to 77%) with Enablex treatment versus placebo. Results from 1 of the studies indicate that Enablex reduces the number of weekly nocturnal awakenings due to OAB by 23%, versus 3.6% with placebo. Results of both studies were presented recently at the annual meeting of the American Urological Association, San Francisco, CA.

Acquired by Novartis in 2003, Enablex is currently under review by the US Food and Drug (FDA) Administration for the treatment of OAB. The company received an approvable letter from the FDA in October 2003, and expects to launch the drug this year.

* Information: http://www.novartis.com

Reference

1. Brigido SA, Boc SF, Lopez RC. Effective management of major lower extremity wounds using an acellular regenerative tissue matrix: a pilot study. Orthopedics 2004;27 (1 Suppl):s145-9.

Department Editor: Cathy Thomas Hess, BSN, RN, CWOCN