LAS VEGAS, April 28, 1997 -- New understandings about the behavior of bacteria in the reproductive tract may encourage physicians to switch from topical to oral antibiotics in the treatment of many gynecologic infections, said women's health experts at the American College of Obstetricians and Gynecologists (ACOG) annual meeting today. Specifically, pathogens responsible for bacterial vaginosis (BV), a common infection associated with pelvic inflammatory disease, endometritis, and premature birth, have been found to migrate up into the uterus (womb), fallopian tubes and other tissues that have hot been shown to be effectively treated with topical medications.

"Until recently, the medical community considered BV to be a local condition that was treatable with topicals," said James McGregor, MD, professor, Department of Obstetrics and Gynecology, University of Colorado School of Medicine. "Current data now suggest that BV-related organisms travel from the lower genital tract to the upper reproductive tract and out of the path of topical agents, leading to potentially serious complications and necessitating use of systemic therapies, especially during later stages of pregnancy."

Cure Rates Examined in New Study

McGregor co-authored a study presented this past Saturday, April 26, at the International Infectious Disease Society for Obstetrics and Gynecology (I-IDSOG) - in conjunction with ACOG - that illustrates important differences between oral and topical medications in BV treatment. The study explored the effectiveness of Flagyl MR, a once-daily, 750 mg modified-release formulation of oral metronidazole, and 2% clindamycin vaginal cream in the treatment of non-pregnant, symptomatic women with BV. At this time, Flagyl MR is under FDA review only for the treatment of trichomoniasis, a sexually transmitted disease (STD) caused by Trichomonas vaginalis. Results of the BV studies will be submitted to the FDA shortly in support of an indication for BV.

Results of the 709-patient study showed that both five- and seven-day courses of Flagyl MR had one-week rapid clinical cure rates of approximately 60 percent - nearly twice that of the clindamycin group (32 percent) within the same time frame. At 28 days, the difference in cure rates narrowed: 56 percent for seven-day Flagyl MR, 51 percent for five-day Flagyl MR, and 47 percent for clindamycin.

In addition to its faster cure rate, the Flagyl MR group experienced much faster normalization of vaginal flora than the clindamycin group. Seven days after initiating therapy, 76 percent of patients in the five-day-treatment Flagyl MR group and 81 percent of subjects in the seven-day-treatment Flagyl MR group had normalized flora compared to 51 percent in the clindamycin arm.

"Although further study is necessary, these preliminary data suggest oral treatment may offer some benefits over topical treatment," said McGregor.

Bacteria Out of Balance

Bacterial vaginosis affects one out of six women and is the most common reproductive tract infection in women of child-bearing age. It is also prevalent in pregnant women, with 12 to 22 percent infected. The disease occurs when Lactobacilli, protective bacteria in the vagina, are outnumbered by other microorganisms, such as Garderella vaginalis, Escherichia coli or Mycoplasma hominis. The exact cause of this bacterial imbalance is unknown, although research indicated that risk increases for a woman who has multiple sex partners.

According to McGregor, bacteria introduced into the vagina are transported into the upper birth canal via uterine contractions that are also responsible for carrying sperm to the uterus. "Evidently, Mother Nature wants us to get pregnant and created the uterine contraction to help sperm to do their job. Bacteria capitalize on this same mechanism to enter the upper reproductive tract," said McGregor.

BV Goes Mainstream

In December of 1995, BV became a national health issue when a University of Pittsburgh study, sponsored by the National Institutes of Health, was published in The New England Journal of Medicine. The study indicated that pregnant women diagnosed with BV were 40 percent more likely to deliver a pre-term, low-birth-weight infant. A University of Alabama study published in the same issue showed that pregnant patients with BV treated with oral metronidazole and erythromycin had 40 percent fewer premature births than untreated women.

"Data from a broad range of studies over the past few years build a convincing argument for more aggressive screening and treatment of BV systemically, particularly in later stages of pregnancy," said McGregor. "Our presentation at I-IDSOG strengthens and sheds new light on this view."

Searle, a wholly owned subsidiary of Monsanto Company, is a research-based corporation that develops, manufactures and markets pharmaceutical products and other healthcare solutions worldwide. For more information about Searle and its line of women's healthcare products, consult Searle's Internet web site: www.searlehealthnet.com.

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