Alan,
as you know, acyclivir is only 1/2 day better in US studies. Yet it is a successful drug, around 1 billion in the US.
I guess you saw the lidakol study numbers saying lidakol is 3/4 day better. These were out June 9. Only 3 patients from placebo and 3 from treated group were excluded.
Since the lidakol study was measured from point of drug administration, I assume the 40% of patients that had aborted episodes are included in the numbers (it certainly looks they are since the placebo numbers are low). This waters down the numbers for patients that actually had blisters and went on to the classic stages of a herpes outbreak.
Acyclivir et al, measured from the blister stage and their studies exclude the aborted episodes.
To truly compare lidakol and acyclivir, one can exclude the aborted episodes to measure only the cases that became active outbreaks. It looks to me that Lidakol is 1.2 days better than placebo when looked at in the same framework as acyclivir (only 1/2 day better).
I posted the news release below. You seem to be talking of statistics, but I assume you also looked at these numbers. Let me know if you did, and what you think of them. Thanks.
Also at the meeting, Dr. Yakatan presented the results of the LIDAKOL Phase 3 clinical trials which were successfully completed in August 1997. The clinic-initiated, double-blind studies involved 743 patients at 21 geographically diverse sites. LIDAKOL Cream or the placebo was applied five times a day until healing or for a maximum of 10 days. Treatment was initiated at the beginning of the recurrent episode before development of a blister. The studies were monitored and the data compiled and analyzed by PARAXEL International Corporation, a major contract research organization.
In the primary study endpoint, time-to-healing, a median difference of 18 hours favoring LIDAKOL-treated patients vs. placebo-treated patients was reported. The distribution of healing times favored LIDAKOL-treated patients and was highly significant (p=0.0076).
The secondary endpoint, time-to-cessation of pain and/or burning, itching and tingling, showed a median difference of 13.4 hours in favor of LIDAKOL- treated patients compared to placebo-treated patients (52.3 hours (2.18 days) vs. 65.7 hours (2.74 days)). The distribution of time-to-symptom relief favored LIDAKOL-treated patients and was highly significant (p=0.0015).
Dr. Yakatan concluded, ''Whether the study data are presented as a p-value or as a cumulative percent of healed patients by study day, LIDAKOL clearly demonstrated both clinical and statistical significance vs. placebo. In addition, 40 percent of LIDAKOL-treated patients experienced an aborted episode, meaning that after applying LIDAKOL Cream at the first symptoms of a recurrence, the blister did not form.'' |
