Pilocarpine hydrochloride for the treatment of xerostomia in patients with Sjögren's syndrome in Taiwan--a double-blind, placebo-controlled trial

Cheng-Han Wu, Song-Chou Hsieh, Kuang-Lun Lee, Ko-Jen Li, Ming-Chi Lu, Chia-Li Yu, Cheng-Han Wu, Song-Chou Hsieh, Kuang-Lun Lee, Ko-Jen Li, Ming-Chi Lu, Chia-Li Yu

Abstract

Background/purpose: Sjögren's syndrome (SS) is characterized by diminished exocrine secretions with the resultant symptoms of dry mouth and dry eye. As genetic predisposition and ethnicity may alter the effectiveness of drug treatment, evaluation of the efficacy and safety of the secretagogue pilocarpine hydrochloride in the treatment of xerostomia in patients with SS in different populations is needed.

Methods: Forty-four patients with SS were enrolled in this double-blind, placebo-controlled trial. Patients were randomized to receive 5 mg pilocarpine (Salagen) or placebo tablet four times daily for 12 weeks. Global evaluation and subjective responses of patients were assessed by questionnaires with visual analog scales and categorical checkboxes. Saliva production was also measured by modified Saxon's test.

Results: Pilocarpine treatment significantly improved global assessment of dry mouth, symptoms associated with dry mouth (mouth comfort, ability to sleep and ability to speak), and saliva production compared to placebo. The drug was well tolerated and the most common adverse effect was sweating (5/23, 21.7%) resulting from the muscarinic agonist action of the drug. No serious drug-related adverse effect was found in this study.

Conclusion: The results of this study suggest that therapy with 5 mg pilocarpine four times daily is effective, safe and well tolerated for the relief of oral symptoms in patients with SS in Taiwan.

References

    1. Vitali C, Bombardieri S, Moutsopoulos HM. Preliminary criteria for the classification of Sjögren's syndrome. Results of a prospective concerted action supported by the European Community. Arthritis Rheum. 1993;36:340–347.
    1. Venables PJ. Sjögren's syndrome. Best Pract Res Clin Rheumatol. 2004;18:313–329.
    1. Derk CT, Vivino FB. A primary care approach to Sjögren's syndrome. Helping patients cope with sicca symptoms, extraglandular manifestations. Postgrad Med. 2004;116:49–54. 59, 65.
    1. Pillemer SR, Matteson EL, Jacobsson LT. Incidence of physician-diagnosed primary Sjögren's syndrome in residents of Olmsted County, Minnesota. Mayo Clin Proc. 2001;76:593–599.
    1. Manoussakis MN, Moutsopoulos HM. Sjögren's syndrome: current concepts. Adv Intern Med. 2001;47:191–217.
    1. Andonopoulos AP, Drosos AA, Skopouli FN. Secondary Sjögren's syndrome in rheumatoid arthritis. J Rheumatol. 1987;14:1098–1103.
    1. Andonopoulos AP, Skopouli FN, Dimou GS. Sjögren's syndrome in systemic lupus erythematosus. J Rheumatol. 1990;17:201–204.
    1. Fox RI. Sjögren's syndrome. Lancet. 2005;366:321–331.
    1. Price EJ, Rigby SP, Clancy U. A double blind placebo-controlled trial of azathioprine in the treatment of primary Sjögren's syndrome. J Rheumatol. 1998;25:896–899.
    1. Vivino FB. The treatment of Sjögren's syndrome patients with pilocarpine-tablets. Scand J Rheumatol. 2001;(Suppl 115):1–13.
    1. Daniels TE. Evaluation, differential diagnosis, and treatment of xerostomia. J Rheumatol. 2000;27(Suppl 61):6–10.
    1. Vivino FB, Al-Hashimi I, Khan Z. Pilocarpine tablets for the treatment of dry mouth and dry eye symptoms in patients with Sjögren's syndrome: a randomized, placebo-controlled, fixed-dose, multicenter trial. P92–01 Study Group. Arch Intern Med. 1999;159:174–181.
    1. Fox RI, Konttinen Y, Fisher A. Use of muscarinic agonists in the treatment of Sjögren's syndrome. Clin Immunol. 2001;101:249–263.
    1. LeVeque FG, Montgomery M, Potter D. 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. J Clin Oncol. 1993;11:1124–1131.
    1. Rieke JW, Hafermann MD, Johnson JT. Oral pilo-carpine for radiation-induced xerostomia: integrated efficacy and safety results from two prospective randomized clinical trials. Int J Radiat Oncol Biol Phys. 1995;31:661–669.
    1. Bell M, Askari A, Bookman A. Sjögren's syndrome: a critical review of clinical management. J Rheumatol. 1999;26:2051–2061.
    1. Bolstad AI, Jonsson R. Genetic aspects of Sjögren's syndrome. Arthritis Res. 2002;4:353–359.
    1. Kang HI, Fei HM, Saito I. Comparison of HLA class II genes in Caucasoid, Chinese, and Japanese patients with primary Sjögren's syndrome. J Immunol. 1993;150:3615–3623.
    1. Nishikawa T, Provost TT. Differences in clinical, serologic, and immunogenetic features of white versus oriental anti-SS-A/ Ro-positive patients. J Am Acad Dermatol. 1991;25:563–564.
    1. Kohler PF, Winter ME. A quantitative test for xerostomia. The Saxon test, an oral equivalent of the Schirmer test. Arthritis Rheum. 1985;28:1128–1132.
    1. Ho C, Murray N, Laskin J. Asian ethnicity and adeno-carcinoma histology continues to predict response to gefitinib in patients treated for advanced non-small cell carcinoma of the lung in North America. Lung Cancer. 2005;49:225–231.
    1. PaPas A, Charney M, Goden H. The effectiveness of oral pilocarpine-HCL tablets for the treatment of dry mouth symptoms associated with Sjögren's syndrome-a dose-titration study. Arthritis Rheum. 1997;40(Suppl 9):S202.
    1. Tsifetaki N, Kitsos G, Paschides CA. Oral pilocarpine for the treatment of ocular symptoms in patients with Sjögren's syndrome: a randomised 12 week controlled study. Ann Rheum Dis. 2003;62:1204–1207.
    1. Solans R, Bosch JA, Selva A. Usefulness of oral pilocarpine therapy in the treatment of xerostomia and xerophthalmia in patients with primary Sjögren's syndrome. Med Clin (Barc) 2004;122:253–255.
    1. Fox RI, Tornwall J, Michelson P. Current issues in the diagnosis and treatment of Sjögren's syndrome. Curr Opin Rheumatol. 1999;11:364–371.
    1. Konttinen YT, Hukkanen M, Kemppinen P. Peptide-containing nerves in labial salivary glands in Sjögren's syndrome. Arthritis Rheum. 1992;35:815–820.
    1. Beroukas D, Goodfellow R, Hiscock J. Up-regulation of M3-muscarinic receptors in labial salivary gland acini in primary Sjögren's syndrome. Lab Invest. 2002;82:203–210.
    1. Soto-Rojas AE, Kraus A. The oral side of Sjögren's syndrome. Diagnosis and treatment. A review. Arch Med Res. 2002;33:95–106.
    1. Salagen tablets . Physician's Desk Reference. 51st edition. Medical Economics Books; Montvale, NJ: 1997. pp. 1546–1547.

Source: PubMed

Sponsorer och medarbetare

Medicinska tillstånd

Läkemedelsinterventioner

3
Prenumerera