Everyone has probably seen this abstract, and it's relevant only to the indication that is already FDA approved. However, it reminded me of a story that I haven't told here, relating to one reason that I like MOGN. In the dark ages, at a Bayer subsidiary, I made some monolconals against Gram-negative flagellar antigens. We were trying to write patents that would give us broad-spectrum protection covering a variety of "pathogenesis factors" in bacteria. Chuck Muscoplat, now at MGI, had already published concerning antibodies to E. coli adhesins. As a result, my patents issued with largely useless claims.
;-)
J Clin Oncol 1993 Jun;11(6):1124-1131
A multicenter, randomized, double-blind,
placebo-controlled, dose-titration study of oral
pilocarpine for treatment of radiation-induced
xerostomia in head and neck cancer patients.
LeVeque FG, Montgomery M, Potter D, Zimmer MB, Rieke JW, Steiger BW,
Gallagher SC, Muscoplat CC
Harper Hospital, Detroit, MI 48201.
PURPOSE: To determine the efficacy and safety of pilocarpine hydrochloride for symptomatic
relief of postradiation xerostomia symptoms and for saliva production in patients with head and
neck cancer. PATIENTS AND METHODS: One hundred sixty-two head and neck cancer
patients who had received at least 40 Gy of radiation (117 patients had received > 60 Gy) with
clinically significant xerostomia were enrolled onto a randomized, double-blind,
placebo-controlled, multi-center clinical investigation. Patients received 2.5-mg tablets for the first
4 weeks, 5.0-mg tablets for the second 4 weeks, and 10.0-mg tablets for the last 4 weeks of the
12-week study. Patients were allowed to titrate pilocarpine or placebo for improvement in
symptoms or to reduce side effects. Patients were evaluated for symptomatic relief by
questionnaires and visual analog scales (VAS), and for saliva production by sialometry.
RESULTS: Pilocarpine produced a significant improvement (P = .035) in overall global
assessments compared with placebo. There was a statistically significant (P = .020) decreased use
of oral comfort agents such as artificial saliva, hard candy, and water. Values for symptomatic
improvement in dryness approached significance (P = .057). There were statistically significant
postdose improvements in whole and parotid salivary flow in pilocarpine treatment groups versus
placebo. All pilocarpine dosages tested were judged to be safe. Adverse experiences were
primarily sweating, rhinitis, headache, nausea, and urinary frequency, with the most common side
effect being mild to moderate sweating. There were no serious drug-related adverse experiences in
any of the pilocarpine treatment groups. CONCLUSION: It is concluded that pilocarpine
produces clinically significant benefits for the symptomatic treatment of postradiation xerostomia.
Best results were obtained with continuous treatment for 8 to 12 weeks with doses greater than
2.5 mg three times per day. |
