Because the pharmacokinetics of Tiprogyn in patients with severe renal impairment (CrCL
Clinical Studies Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Among 3669 patients treated with a single 2 g dose of Tiprogyn, in both controlled and uncontrolled trichomoniasis and giardiasis clinical studies, adverse reactions were reported by 11.0% of patients. For multi-day dosing in controlled and uncontrolled amebiasis studies, adverse reactions were reported by 13.8% of 1765 patients. Common ( ≥ 1% incidence) adverse reactions reported by body system are as follows. (Note: Data described in Table 1 below are pooled from studies with variable designs and safety evaluations.)
A randomized, double-blind, placebo-controlled clinical trial in 235 non-pregnant women was conducted to evaluate the efficacy of Tiprogyn for the treatment of bacterial vaginosis. A clinical diagnosis of bacterial vaginosis was based on Amsel's criteria and defined by the presence of an abnormal 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 ≥ 20% clue cells on microscopic examination. Clinical cure required a return to normal vaginal discharge and resolution of all Amsel's criteria. A microbiologic diagnosis of bacterial vaginosis was based on Gram stain of the vaginal smear demonstrating (a) markedly reduced or absent Lactobacillus morphology, (b) predominance of Gardnerella morphotype, and (c) absent or few white blood cells, with quantification of these bacterial morphotypes to determine the Nugent score, where a score ≥ 4 was required for study inclusion and a score of 0-3 considered a microbiologic cure. Therapeutic cure was a composite endpoint, consisting of both a clinical cure and microbiologic cure. In patients with all four Amsel's criteria and with a baseline Nugent score ≥ 4, Tiprogyn oral tablets given as either 2 g once daily for 2 days or 1 g once daily for 5 days demonstrated superior efficacy over placebo tablets as measured by therapeutic cure, clinical cure, and a microbiologic cure.
Table 2: Efficacy of Tindamax in the Treatment of Bacterial Vaginos is in a Randomized, Double-Blind, Double-Dummy, Placebo-Controlled Trial: Modified Intent-to-Treat Population 1 (n=227) Outcome Tindamax 1 g x 5 days (n=76) Tindamax 2 g x 2 days (n=73) Placebo (n=78) % Cure % Cure % Cure Therapeutic Cure 36.8 27.4 5.1 Difference 2 97.5% CI 3 31.7 (16.8, 46.6) 22.3 (8.0, 36.6) Clinical Cure 51.3 35.6 11.5 Difference 2 97.5% CI 3 39.8 (23.3, 56.3) 24.1 (7.8, 40.3) Nugent Score Cure Difference 2 97.5% CI 3 38.2 33.1 (18.1, 48.0) 27.4 22.3 (8.0, 36.6) 5.1 1 Modified Intent-to-Treat defined as all patients randomized with a baseline Nugent score of at least 4 2 Difference in cure rates (Tindamax-placebo) 3 CI: confidence interval p-values for both Tindamax regimens vs. placebo for therapeutic, clinical and Nugent score cure rates for both 2 and 5 days
The therapeutic cure rates reported in this clinical study conducted with Tindamax were based on resolution of 4 out of 4 Amsel's criteria and a Nugent score of
Metron >Tiprogyn is given orally and distributes into tissues including the brain. Metronidazole and Tiprogyn are eliminated mainly by metabolism in the liver and have half-lives of 6–9 hours and 12–14 hours, respectively.