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DOI: 10.2337/dc06-1469
© 2007 by the American Diabetes Association
Pathophysiology/Complications |
Prevalence of Candida glabrata and Its Response to Boric Acid Vaginal Suppositories in Comparison With Oral Fluconazole in Patients With Diabetes and Vulvovaginal Candidiasis
1 Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New Delhi, India
2 Department of Microbiology, All India Institute of Medical Sciences, New Delhi, India
3 Department of Obstetrics and Gynecology, All India Institute of Medical Sciences, New Delhi, India
4 Department of Obstetrics and Gynecology, Maulana Azad Medical College, New Delhi, India
5 Department of Biostatistics, All India Institute of Medical Sciences, New Delhi, India
Address correspondence and reprint requests to Dr. Ravinder Goswami, MD, DM, Associate Professor, Department of Endocrinology and Metabolism, All India Institute of Medical Sciences, New Delhi 110029, India. E-mail: Ravinder Goswami at gosravinder{at}hotmail.com or Uma Banerjee at uma_banerjee{at}hotmail.com
OBJECTIVE—A large proportion of vulvovaginal candidiasis (VVC) in diabetes is due to non–albicans Candida species such as C. glabrata and C. tropicalis. Observational studies indicate that diabetic patients with C. glabrata VVC respond poorly to azole drugs. We evaluated the response to oral fluconazole and boric acid vaginal suppositories in diabetic patients with VVC.
RESEARCH DESIGN AND METHODS—A total of 112 consecutive diabetic patients with VVC were block randomized to receive either single-dose oral 150-mg fluconazole or boric acid vaginal suppositories (600 mg/day for 14 days). The primary efficacy outcome was the mycological cure in patients with C. glabrata VVC in the two treatment arms. The secondary outcomes were the mycological cure in C. albicans VVC, overall mycological cure irrespective of the type of Candida species, frequencies of yeast on direct microscopy, and clinical symptoms and signs of VVC on the 15th day of treatment. Intention-to-treat (ITT; n = 111) and per-protocol (PP; n = 99) analyses were performed.
RESULTS—C. glabrata was isolated in 68 (61.3%) and C. albicans in 32 (28.8%) of 111 subjects. Patients with C. glabrata VVC showed higher mycological cure with boric acid compared with fluconazole in the ITT (21 of 33, 63.6% vs. 10 of 35, 28.6%; P = 0.01) and PP analyses (21 of 29, 72.4% vs. 10 of 30, 33.3%; P = 0.01). The secondary efficacy outcomes were not significantly different in the two treatment arms in the ITT and PP analyses.
CONCLUSIONS—Diabetic women with C. glabrata VVC show higher mycological cure with boric acid vaginal suppositories given for 14 days in comparison with single-dose oral 150-mg fluconazole.
Abbreviations: HVS, high vaginal swab • ITT, intention to treat • PP, per-protocol • VVC, vulvovaginal candidiasis
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