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Clindesse

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Clindesse

Clindesse

CLINICAL PHARMACOLOGY

Mechanism of Action

Clindamycin is an antibacterial drug [see Microbiology]

Pharmacokinetics

Following a single intravaginal application of Clindesse (clindamycin phosphate) cream to 20 healthy women, the mean (range) AUC0-inf and Cmax estimates were 175 (38.6 to 541) ng/mL·hr and 6.6 (0.8 to 39) ng/mL, respectively. The mean Cmax of clindamycin for Clindesse (clindamycin phosphate) was approximately 0.3%, 0.1%, and 7.6% of that observed after the administration of a 150 mg Cleocin oral capsule (2.5 mcg/mL), a 600 mg Cleocin intravenous injection (10.9 mcg/mL), and a single dose of 100 mg of Cleocin Vaginal Cream (86.5 ng/mL), respectively. The peak serum concentration of clindamycin was attained approximately 20 hours post dosing for Clindesse (clindamycin phosphate) .

Microbiology

Mechanism of Action

Clindamycin inhibits bacterial protein synthesis at the level of the bacterial ribosome. The antibiotic binds preferentially to the 50S ribosomal subunit and affects the process of peptide chain initiation. Although clindamycin phosphate is inactive in vitro , in vivo hydrolysis converts this compound to the antibacterially active clindamycin.

Activity In Vitro

Clindamycin is an antibacterial agent active in vitro against most strains of the following organisms that have been reported to be associated with bacterial vaginosis:

Bacteroides spp.
Gardnerella vaginalis

Mobiluncus
spp.
Mycoplasma hominis

Peptostreptococcus
spp.

Standard methodology for the susceptibility testing of the potential bacterial vaginosis pathogens has not been defined. Culture and sensitivity testing of bacteria are not routinely performed to establish the diagnosis of bacterial vaginosis [see Clinical Studies].

Clinical Studies

Two clinical studies were conducted to evaluate the efficacy of Clindesse (clindamycin phosphate) for the treatment of bacterial vaginosis. A clinical diagnosis of bacterial vaginosis was 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.

In a randomized, double-blind, placebo-controlled, clinical study involving 144 non-pregnant female patients aged 18 to 64 with a baseline Nugent score ≥ 4, Clindesse (clindamycin phosphate) demonstrated statistically significantly higher cure rates over placebo as measured by therapeutic cure, clinical cure, and Nugent score cure (Table 2) assessed at 21-30 days after administration of the drug. Therapeutic cure was a composite endpoint which required both clinical cure and Nugent score cure. Clinical cure required normal vaginal discharge, vaginal pH < 4.7, < 20% clue cells on wet mount preparation, and negative “whiff” test (detection of amine odor on addition of 10% KOH solution to sample of the vaginal discharge). A Nugent score of 0-3 was considered a Nugent score cure. The Nugent scoring is based on microscopic examination of the Gram's stained vaginal smears for quantification of specific bacterial morphotypes. Cure rates were consistently higher for Clindesse (clindamycin phosphate) compared to placebo for the following demographic subsets: age, race, height, weight, sexual behavior, and recalcitrant infection status.

Table 2: Efficacy of Clindesse (clindamycin phosphate) for Treatment of Bacterial Vaginosis in a Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study

Outcome Clindesse
N=78
Placebo
N=66
Treatment Difference† (%) [97.5% Confidence Interval]
  % Cure % Cure  
Therapeutic Cure 29.5 3.0 26.5 [14.0, 39.0]
Clinical Cure 41.0 19.7 21.3 [4.7, 38.0]
Nugent Score Cure 44.9 6.1 38.8 [24.6, 53.1]
N = number of patients in treatment group (modified intent-to-treat population defined as all subjects randomized who received at least one dose of study medication, and who had a baseline Nugent score of at least 4)
†Treatment difference = Clindesse (clindamycin phosphate) minus placebo cure rates

In a second controlled clinical study involving 432 patients aged 18 to 78 with a baseline Nugent score of ≥ 4, 221 women self-administered a single dose of Clindesse (clindamycin phosphate) , and 211 women self-administered a single daily dose of a formulation of clindamycin vaginal cream for 7 days. A single dose of Clindesse (clindamycin phosphate) was shown to be similar to 7 daily doses of the clindamycin vaginal cream for treatment of bacterial vaginosis as measured by therapeutic cure, clinical cure or Nugent score cure assessed at 21-30 days after administration of the drug in the modified intent-to-treat population (Table 3) and for the per protocol population (Table 4). The study endpoints were identical to those described above for the placebo-controlled study. Statistical analyses did not reveal any significant differences when controlling for the following demographic variables: age, race, height, weight, sexual behavior, and recalcitrant infection status.

The cure rates reported in the clinical studies with Clindesse (clindamycin phosphate) were based on resolution of 4 out of 4 Amsel criteria and a Nugent score of < 4, while the criteria for cure in previous clinical studies with the clindamycin vaginal cream were based solely on resolution of 2 out of 4 Amsel criteria, resulting in higher reported rates of cure for bacterial vaginosis.

Table 3: Efficacy of Clindesse (clindamycin phosphate) in Treatment of Bacterial Vaginosis in a Randomized, Investigator-Blind, Active-Controlled Comparative Study – Modified-Intent-to-Treat

Outcome Clindesse Single Dose
N=221
Clindamycin Vaginal Cream (7 doses)
N=211
Treatment Difference† (%) [95% Confidence Interval]
  % Cure % Cure  
Therapeutic Cure 33.0 37.0 -3.9 [-12.9, 5.1]
Clinical Cure 53.4 54.0 -0.6 [-10.0, 8.8]
Nugent Score Cure 45.7 49.3 -3.6 [-13.1, 5.8]
†Treatment difference = Clindesse (clindamycin phosphate) minus clindamycin vaginal cream cure rates
N = number of patients in treatment group (modified intent-to-treat population defined as all subjects randomized who received at least one dose of study medication, and who had a baseline Nugent score of at least 4)

Table 4: Efficacy of Clindesse (clindamycin phosphate) in Treatment of Bacterial Vaginosis in a Randomized, Investigator-Blind, Active-Controlled Comparative Study – Per Protocol

Outcome Clindesse Single Dose
N=126
Clindamycin Vaginal Cream (7 doses)
N=125
Treatment Difference† (%) [95% Confidence Interval]
  % Cure % Cure  
Therapeutic Cure 42.1 45.6 -3.5 [-15.8, 8.7]
Clinical Cure 64.3 63.2 1.1 [-10.8, 13.0]
Nugent Score Cure 56.5‡ 57.7‡ -1.3 [-13.6, 11.1]
† Treatment difference = Clindesse (clindamycin phosphate) minus clindamycin vaginal cream cure rates
N = number of patients in treatment group (per protocol population defined as all subjects included in the modified intent-to-treat population who completed the study without significant protocol violation)
‡ Four subjects (2 from each treatment group) did not have complete Nugent scores and were not included in the Nugent Score cure analysis

Last reviewed on RxList: 2/3/2011
This monograph has been modified to include the generic and brand name in many instances.

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