Clinical trial: endoscopic evaluation of naproxen etemesil, a naproxen prodrug, vs. naproxen - a proof-of-concept, randomized, double-blind, active-comparator study.

BACKGROUND: Nonsteroidal anti-inflammatory drugs are associated with upper gastrointestinal mucosal injury. Naproxen etemesil is a lipophilic, non-acidic, inactive prodrug of naproxen that is hydrolysed to pharmacologically active naproxen once absorbed. We hypothesized that with lesser topical exposure to naproxen from the prodrug, there would be reduced gastroduodenal mucosal injury compared with naproxen. AIM: To compare the degree of endoscopic mucosal damage of naproxen etemesil vs. naproxen. METHODS: This multicentre, randomized, double-blind, double-dummy trial compared oral naproxen etemesil 1200 mg twice daily (n = 61) with naproxen 500 mg twice daily (n = 59) for 7.5 days in 120 healthy subjects (45-70 years; mean 51 years; 58% female) with baseline total modified gastroduodenal Lanza score ≤ 2 (no erosions/ulcers) on endoscopy. The primary endpoint was mean total modified gastroduodenal Lanza score on day 7. A secondary endpoint was incidence of gastric ulcers. RESULTS: The day 7 mean total modified gastroduodenal Lanza score was 2.8 ± 1.7 for naproxen etemesil vs. 3.5 ± 2.0 for naproxen (P = 0.03), and significantly fewer naproxen etemesil-treated subjects (3.3%) developed gastric ulcers compared with naproxen-treated subjects (15.8%) (P = 0.02). CONCLUSION: In this first proof-of-concept study, naproxen etemesil was associated with significantly lower gastroduodenal mucosal injury compared with naproxen after 7 days of exposure ( CLINICAL TRIAL NUMBER: NCT00750243).

Design and pilot evaluation of an Internet spit tobacco cessation program.

PURPOSE: To develop an interactive Web site to help smokeless tobacco (ST) users to reduce or stop their ST use and pilot test it for feasibility, acceptability, and short-term outcomes. METHODS: An interactive, multiple-contact Internet ST cessation program was developed, refined based on feedback from 17 ST users, and pilot-tested for feasibility, acceptability, and short-term effects on the ST-related behavior and attitudes among baseball athletes attending 3 colleges in California. Consenting ST users completed a baseline questionnaire and enrolled on the Web site for help with stopping ST use. One month later, outcomes were assessed. RESULTS: Although 18 ST-using baseball athletes enrolled on the Web site, follow-up data were obtained from 12 individuals. Loss to follow-up occurred when we were unable to contact participants by telephone or mailed surveys. At 1-month follow-up, over 80% (N=11) reported that the Web site was: "helpful in stopping or reducing my tobacco use"; easy to navigate; and "appealing." Moreover, 8% (n=1) self-reported abstinence from ST use. Among nonquitters, there was a 26% mean reduction in ST use per day compared to baseline values. In addition, among all enrollees, there was a 4-fold increase in motivation to quit (7% versus 31%) and a 21% increase in their confidence in being able to quit (67% versus. 85%) from baseline to follow-up. CONCLUSION: The interactive ST cessation Web site was feasible to implement, acceptable to ST users, and appeared to reduce ST use, enhance motivation to quit, and increase confidence about one's ability to quit. Further study with a larger sample size and a control group is needed to determine efficacy to promote cessation of ST use.