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The exact etiology of BV is not fully understood
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| BV is a complex, polymicrobial infection |
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Bacterial vaginosis (BV) is the most common vaginal infection, affecting one-third of US women at some point
in their lifetime.1 The condition occurs when there is a reduction of lactobacilli and concomitant overgrowth
of anaerobic bacteria in the vagina. However, the etiology is still unknown.2
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In the past, BV was referred to as Gardnerella vaginitis, after the bacteria
Gardnerella vaginalis, because
it was thought to be the only species associated with BV. Today we know that the infection is complex and
polymicrobial. Multiple species of bacteria that naturally live in the vagina can grow to excess and cause
BV. For example, in one clinical study in women with BV, an average of 13 different bacterial species were
identified.2
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In addition, there is evidence of new emerging pathogens that are associated with BV. They are being called
BVAB1, BVAB2, and BVAB3. They are so new that a species or genus has not been assigned yet. Researchers are
still studying and compiling information on these new pathogens, but two things they do know are that not
all BV infections are the same and they still don’t know everything there is to know about them.2
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| An antimicrobial agent is needed to effectively treat BV |
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It is important to take into consideration that multiple species of bacteria
are implicated in BV. For this reason, it is crucial to treat patients with
an antimicrobial agent, like clindamycin, that is effective against a range
of known BV pathogens.3-5,7-9,11,12
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Watch Jeanne Marrazzo, MD, MPH, Associate Professor of the Division of Infectious
Diseases at University of Washington, as she discusses
new information about the
pathology and epidemiology of BV.
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» Footnote References
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Clindesse® (clindamycin phosphate) Vaginal Cream, 2%, is indicated for the treatment of bacterial
vaginosis in non-pregnant women. Clindesse is Pregnancy Category B, which means there are no
adequate and well-controlled studies in pregnant women. Therefore, Clindesse should be used
during pregnancy only if clearly needed.
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Note: For purposes of this indication, a clinical diagnosis of bacterial vaginosis is usually defined
by the presence of a homogeneous vaginal discharge that (a) has a pH of greater than 4.5, (b) emits a “fishy” amine odor when mixed with a 10% KOH solution, and (c) contains clue cells on microscopic examination. Gram’s stain results consistent with a diagnosis of bacterial vaginosis include (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells.
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Other pathogens commonly associated with vulvovaginitis, e.g., Trichomonas vaginalis, Chlamydia trachomatis, N. gonorrhoeae, Candida albicans, and Herpes simplex virus, should be ruled out.
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| Important Safety Information |
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Clindesse is contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or any of the components of this vaginal cream, and in individuals with a history of regional enteritis, ulcerative colitis, or a history of “antibiotic-associated” colitis.
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This cream contains mineral oil that may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms. Therefore, the use of such barrier contraceptives is not recommended concurrently or for 5 days following treatment with Clindesse. During this time period, condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases.
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Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin. Orally and parenterally administered clindamycin has been associated with severe colitis. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of Clindesse, even though there is minimal systemic absorption of clindamycin from the vagina with administration of Clindesse Vaginal Cream.
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In clinical trials (n=368), 1.6% of patients discontinued therapy due to adverse events. The most frequently reported adverse events were vaginosis fungal (14.1%), vulvovaginal pruritus (3.3%), and headache (2.7%).
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