Efficacy and safety of fenticonazole in the treatment of uncomplicated vulvovaginal candidiasis
Relevance: The recent statistical data have shown a steady increase in the incidence of Candida infection. About 75% of all women are estimated to experience vulvovaginal candidiasis (VVC) at least once in their lives, while 10% are subsequently going to have recurrent VVC (four or more episodes per year). Since the infection is so common, the problem of finding an effective treatment for VVC is particularly relevant nowadays.Bayramova G.R., Savicheva A.M., Tapilskaya N.I., Ivanets T.Yu., Donnikov A.E., Andreev A.O.
Objective: To evaluate the efficacy, tolerability and safety of fenticonazole (Lomexin 600 mg, vaginal capsules) in patients with uncomplicated VVC.
Materials and methods: The study included 125 women aged 19 to 45 years diagnosed with uncomplicated VVC which was confirmed by clinical and laboratory methods of examination. Body mass index of the patients ranged from 18.5 to 30 kg/m2. The patients were administered Lomexin 600 mg, vaginal capsules.
Results: Yeast-like fungi Candida spp. were not detected in 117/125 (93.6%) women 14 days after intravaginal administration of Lomexin, and yeast-like fungi were not detected in 113/121 (93.4%) patients 3 months after administration of the medication. Only 4/124 (3.2%) patients had discharge 14 days after intravaginal administration of the medication, and 3/119 (2.4%) patients had itching. None of the patients noted burning sensation or pain.
Conclusion: Lomexin 600 mg, vaginal capsules, has a high efficacy, tolerability and safety in the treatment of uncomplicated VVC.
Authors’ contributions: Bayramova G.R. – developing the study design, collecting the data for the study, analysis of the obtained data, writing the text of the manuscript; Savicheva A.M., Tapilskaya N.I. – collecting the data for the study, reviewing publications on the subject of the study, writing the text of the manuscript; Ivanets T.Yu. – review of publications on the subject of the study, analysis of the obtained data; Donnikov A.E. – review of publications on the subject of the study, writing the text of the manuscript, statistical data processing; Andreev A.O. – review of publications on subject of the study, writing the text of the manuscript.
Conflicts of interest: The authors declare that there are no conflicts of interest.
Funding: The study was conducted with the sponsorship of RUSFIC LLC.
Ethical Approval: The study was approved by the Ethical Review Board of Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia.
Patient Consent for Publication: The patients provided an informed consent for the publication of their data.
Authors' Data Sharing Statement: The data confirming the conclusions of this study are available upon request from the authors.
For citation: Bayramova G.R., Savicheva A.M., Tapilskaya N.I.,
Ivanets T.Yu., Donnikov A.E., Andreev A.O. Efficacy and safety of fenticonazole
in the treatment of uncomplicated vulvovaginal candidiasis.
Akusherstvo i Ginekologiya/Obstetrics and Gynecology. 2023; (5): 124-131 (in Russian)
https://dx.doi.org/10.18565/aig.2023.134
Keywords
uncomplicated vulvovaginal candidiasis
lower genital tract inflammation
treatment of vulvovaginal candidiasis
fenticonazole
References
- Spence D. Candidiasis (vulvovaginal). BMJ Clin. Evid. 2010; 2010: 0815.
- Будиловская О.В., Шипицына Е.В., Спасибова Е.В., Переверзева Н.А., Воробьева Н.Е., Цыпурдеева Н.Д., Григорьев А.Н., Савичева А.М. Дифференциальная экспрессия генов местного иммунного ответа во влагалище: значение для диагностики вагинальных инфекций. Бюллетень экспериментальной биологии и медицины. 2019; 168(11): 588-92. [Budilovskaya O.V., Shipitsina E.V., Spasibova E.V., Pereverzeva N.A., Vorobiova N.E., Tsypurdeeva N.D., Grigoryev A.N., Savicheva A.M. Differential expression of selected genes of local immune response in the vagina: implication for diagnosis of vaginal infections. Bulletin of Experimental Biology and Medicine. 2019; 168(11): 588-92. (in Russian)].
- Будиловская О.В., Крысанова А.А., Шипицына Е.В., Переверзева Н.А., Воробьева Н.Е., Герасимова Е.Н., Григорьев А.Н., Савичева А.М. Диагностика вагинальных инфекций с учетом профилей лактобациллярной микрофлоры и локального иммунного ответа слизистой влагалища. Молекулярная медицина. 2020; 18(3): 56-64. [Budilovskaya O.V., Krysanova A.A., Shipitsina E.V., Pereverzeva N.A., Vorobyeva N.E., Gerasimova E.N., Grigoryev A.N., Savicheva A.M. Diagnosis of vaginal infections with the profiles of lactobacillary microflora and the local immune response of the vaginal mucosa. Molecular Medicine. 2020; 18(3): 56-64. (in Russian)].https://dx.doi.org/10.29296/24999490-2020-03-07.
- Тапильская Н.И., Савичева А.М., Дьяконов С.А. Тихая охота. Особенности патогенеза и трудности терапии кандидозного вульвовагинита. StatusPraesens. Гинекология, акушерство, бесплодный брак. 2021; 6: 25-31. [Tapilskaya N.I., Savicheva A.M., Dyakonov S.A. Silent hunting. Peculiarities of pathogenesis and difficulties of therapy of candidiasis vulvovaginitis. StatusPraesens. Gynecology, Obstetrics, Infertile Marriage. 2021; (6): 25-31. (in Russian)].
- Савичева А.М. Современные представления о лабораторной диагностике репродуктивно значимых инфекций у женщин репродуктивного возраста. Мнение эксперта. Вопросы практической кольпоскопии. Генитальные инфекции. 2022; 3: 34-9. [Savicheva A.M. Modern ideas about the laboratory diagnosis of reproductively significant infections in women of reproductive age. Expert opinion. Issues of Practical Colposcopy & Genital Infections. 2022; (3): 34-9. (in Russian)]. https://dx.doi.org/10.46393/27826392_2022_3_34.
- Байрамова Г.Р., Амирханян А.С., Чернова В.Ф. Вульвовагинальный кандидоз: патогенез, диагностика и тактика лечения. Доктор.Ру. 2018; 10: 32-6. [Bairamova G.R., Amirkhanyan A.S., Chernova V.F. Vulvovaginal candidiasis: pathogenesis, diagnosis, and treatment strategy. Doctor.Ru. 2018; (10): 32-6. (in Russian)]. https://dx.doi.org/10.31550/1727-2378-2018-154-10-32-36.
- Хашукоева А.З., Сафонина М.С., Андреасян Г.О., Мясоутова А.И., Оверко А.В. Терапевтические подходы в лечении вульвовагинального кандидоза. Медицинский совет. 2020; 13: 138-46. [Khashukoeva A.Z., Safonina M.S., Andreasyan G.O., Myasoutova A.I., Overko A.V. Therapeutic approaches in the treatment of vulvovaginal candidiasis. Medical Council. 2020; (13): 138-46. (in Russian)]. https://dx.doi.org/10.21518/2079-701X-2020-13-128-146.
- Achkar J.M., Fries B.C. Candida infections of the genitourinary tract. Clin. Microbiol Rev. 2010; 23(2): 253-73. https://dx.doi.org/10.1128/CMR.00076-09.
- Ferrer J. Vaginal candidosis: epidemiological and etiological factors. Int. J. Gynaecol. Obstet. 2000; 71(Suppl. 1): S21-7. https://dx.doi.org/10.1016/s0020-7292(00)00350-7.
- Beigi R.H., Meyn L.A., Moore D.M., Krohn M.A., Hillier S.L. Vaginal yeast colonization in nonpregnant women: a longitudinal study. Obstet. Gynecol. 2004; 104(5, Pt 1): 926-30. https://dx.doi.org/10.1097/01.AOG.0000140687.51048.73.
- Dovnik A., Golle A., Novak D., Arko D., Takač I. Treatment of vulvovaginal candidiasis: a review of the literature. Acta Dermatovenerol. Alp. Pannonica Adriat. 2015; 24(1): 5-7. https://dx.doi.org/10.15570/actaapa.2015.2.
- Sekhavat L., Tabatabaii A., Tezerjani F.Z. Oral fluconazole 150 mg single dose versus intravaginal clotrimazole treatment of acute vulvovaginal candidiasis. J. Infect. Public Health. 2011; 4(4): 195-9. https://dx.doi.org/10.1016/j.jiph.2011.05.006.
- Sanguinetti M., Cantón E., Torelli R., Tumietto F., Espinel-Ingroff A., Posteraro B. In vitro activity of fenticonazole against candida and bacterial vaginitis isolates determined by mono- or dual-species testing assays. Antimicrob. Agents Chemother. 2019; 63(7): e02693-18. https://dx.doi.org/10.1128/AAC.02693-18.
- Tumietto F., Posteraro B., Sanguinetti M. Looking for appropriateness in the cure of mixed vaginitis: the role of fenticonazole as an empiric treatment. Future Microbiol. 2019; 14: 1349-55. https://dx.doi.org/10.2217/fmb-2019-0189.
- Veraldi S., Milani R. Topical fenticonazole in dermatology and gynaecology: current role in therapy. Drugs. 2008; 68(15): 2183-94.https://dx.doi.org/10.2165/00003495-200868150-00007.
- Studd J.W., Dooley M.M., Welch C.C., Vijayakanthan K., Mowat J.M., Wade A., Newell M. Comparative clinical trial of fenticonazole ovule (600 mg) versus clotrimazole vaginal tablet (500 mg) in the treatment of symptomatic vaginal candidiasis. Curr. Med. Res. Opin. 1989; 11(8): 477-84.https://dx.doi.org/10.1185/03007998909110458.
- Wiest W., Azzollini E., Ruffmann R. Comparison of single administration with an ovule of 600 mg fenticonazole versus a 500 mg clotrimazole vaginal pessary in the treatment of vaginal candidiasis. J. Int. Med. Res. 1989; 17(4): 369-72.https://dx.doi.org/10.1177/030006058901700410.
- Lawrence A.G., Houang E.T., Hiscock E., Wells M.B., Colli E., Scatigna M. Single dose therapy of vaginal candidiasis: a comparative trial of fenticonazole vaginal ovules versus clotrimazole vaginal tablets. Curr. Med. Res. Opin. 1990; 12(2): 114-20. https://dx.doi.org/10.1185/03007999009110479.
- Efficiency of fenticonazole for the treatment of vaginal candidiasis. Srp. Arh. Celok. Lek. 2012; 140(7-8): 469-74. (in Serbian). https://dx.doi.org/10.2298/sarh1208469z.
Received 22.05.2023
Accepted 28.05.2023
About the Authors
Gyuldana R. Bayramova, Dr. Med. Sci., Honored Doctor of the Russian Federation, Professor at the Department of Obstetrics and Gynecology of the Department of Vocational Education, Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia; Head of Clinical Work at the Outpatient Department, Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia, bayramova@mail.ru, https://orcid.org/0000-0003-4826-661X, 117997, Russia, Moscow, Academician Oparin str., 4.Alevtina M. Savicheva, Dr. Med. Sci., Professor, Merited Scholar of the Russian Federation, Head of the Department of Medical Microbiology, Head of the Laboratory of Clinical Microbiology, D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology; Head of the Department of Clinical Laboratory Diagnostics of AF and FVE, St. Petersburg State Pediatric Medical University, Ministry of Health of Russia, savicheva@mail.ru, https://orcid.org/0000-0003-3870-5930,
199034, Russia, St. Petersburg, Mendeleevskaya line, 3.
Natalya I. Tapilskaya, Dr. Med. Sci., Professor, Leading Researcher at the Department of Reproduction, D.O. Ott Research Institute of Obstetrics, Gynecology and Reproductology; Professor at the Department of Obstetrics and Gynecology, St. Petersburg State Pediatric Medical University, Ministry of Health of the Russia,
tapnatalia@yandex.ru, https://orcid.org/0000-0001-5309-0087, 199034, Russia, St. Petersburg, Mendeleevskaya line, 3.
Tatyana Yu. Ivanets, Dr. Med. Sci., Head of the Clinical Diagnostic Laboratory, Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia, t_ivanets@mail.ru, 117997, Russia, Moscow, Academician Oparin str., 4.
Andrey E. Donnikov, PhD, Head of the Laboratory of Molecular Genetic Methods, Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia, donnikov@dna-technology.ru, https://orcid.org/0000-0003-3504-2406, 117997, Russia, Moscow, Academician Oparin str., 4.
Alexander O. Andreev, obstetrician-gynecologist at the Outpatient Department, Academician V.I. Kulakov National Medical Research Center for Obstetrics, Gynecology and Perinatology, Ministry of Health of Russia, sasha.grash2010@yandex.ru, https://orcid.org/0000-0002-9835-440X, 117997, Russia, Moscow, Academician Oparin str., 4.
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