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New Data Suggests Improved Tolerability Associated with VIDEX EC(R) (didanosine) Capsules.

/EMBARGOED FOR RELEASE AT 2:30 PM EST, TODAY/

- Patients report fewer GI side effects -

/ADVANCE/ SAN FRANCISCO, March 23 /PRNewswire/ --

Results from a study demonstrate that switching from Videx(R) (didanosine) chewable tablets to Videx EC(R) capsules, (enteric coated beadlets of didanosine) may significantly reduce common gastrointestinal (GI) side effects associated with the earlier buffered formulations of Videx. These data were presented today at The American Foundation for AIDS Research's (amfAR) 13th National HIV/AIDS Update Conference.

"Our study showed striking tolerability advantages with Videx EC capsules that supports routine switching to EC when patients experience side effects from the conventional buffered tablet formulation of Videx," said Nancy Reinhalter, R.N., Research Coordinator, JSI Clinical Research, Inc., who conducted this study. "Including Videx EC as part of a patient's HIV treatment regimen will reduce the undesirable GI side effects and likely promote good adherence, which is one of the major obstacles to treating HIV."

The six week pilot, open label crossover study (Abstract No. 264) evaluated the tolerability of Videx tablets compared to Videx EC capsules in 42 patients. The trial evaluated frequency and magnitude of GI symptoms in patients experiencing one or more of the following symptoms of at least moderate severity while on a treatment regimen which included Videx tablets: nausea, bloating, GI upset, diarrhea, abdominal cramping and gas. Data were recorded before and after patients switched from the tablets to Videx EC capsules. Quality of life, lifestyle changes, and use of antidiarrheals or other medications for symptom relief were also assessed.

The severity of all GI symptoms was significantly reduced after four weeks on Videx EC, as was the negative impact of side effects on patient activities (41% on tablets vs. 7% on EC, p<0.01). Over the week preceding their visits, study participants rated daily GI symptoms on a seven point scale (0 = absent, 6=severe). Using the weekly averages, diarrhea was reduced from 2.11 on the chewable Videx to 0.99 and 0.79 on Videx EC at 2 and 4 weeks after switching. Reductions were also seen in reports of bloating (1.23 to 0.49 and 0.32), gas (2.00 to 0.95 and 0.79), cramps (0.74 to 0.21 and 0.05), GI upset (0.69 to 0.16 and 0.14) and nausea (0.66 to 0.32 and 0.22). All reductions were statistically significant (p<0.05).

"We were impressed that all participants elected to switch to Videx EC capsules at the end of the study," said Reinhalter. "This clear preference is strong evidence that the well-tolerated Videx EC formulation offers a major new improvement in HIV treatment options."

JSI Clinical Research, Inc. is a Boston-based clinical investigative site and specialty clinical trials organization, affiliated with John Snow, Inc., an international public health consulting firm. The study was designed and conducted by JSI Clinical Research, Inc., under the direction of John Mazzullo, MD (principal investigator). Co-investigators affiliated with the Community Research Initiative of New England also participated in the study.
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Publication:PR Newswire
Date:Mar 23, 2001
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