Monthly ibandronate suppresses serum CTX-I within 3 days and maintains a monthly fluctuating pattern of suppression.

UNLABELLED: Bone turnover markers such as serum C-terminal cross-linking telopeptide of type I collagen (CTX-I) can be used to assess drug efficacy in osteoporosis. This study evaluated the pattern of CTX-I suppression in postmenopausal osteoporotic women receiving ibandronate. Ibandronate decreased serum CTX-I levels within 3 days of therapy initiation. Over 6 months, the levels remained suppressed below baseline. INTRODUCTION: This randomized, double-blind, placebo-controlled study evaluated the rapidity of onset and pattern of suppression of the bone resorption marker serum CTX-I in women with postmenopausal osteoporosis (PMO) who received once-monthly oral ibandronate. METHODS: Women diagnosed with PMO received once-monthly oral ibandronate (150 mg) or placebo for 6 months. Serum CTX-I was measured at baseline and after study dose administration on day 3 (month 1 only) and days 7, 14, 21, and 28 (months 1-6). Bone-specific alkaline phosphatase was measured on days 7 and 28 (months 1-6). RESULTS: This study enrolled 67 women: 49 received ibandronate, 17 received placebo, and one took no study drug. At day 3, median reduction in serum CTX-I from baseline was 70.2% with ibandronate and 6.0% with placebo (difference, -64.2%; 95% confidence interval, -80.3% to -46.2%; p < 0.0001). In women receiving ibandronate, serum CTX-I levels remained consistently below baseline, exhibiting a regular monthly fluctuating pattern of suppression over 6 months. Ibandronate was well-tolerated. CONCLUSIONS: Monthly ibandronate decreased serum CTX-I within 3 days. Over 6 months, in women receiving once-monthly ibandronate, serum CTX-I remained suppressed below baseline. A monthly fluctuation, related to time from last dose, was observed.

Impact of compliance and persistence with bisphosphonate therapy on health care costs and utilization.

UNLABELLED: The impact of persistence and compliance with bisphosphonate therapy on health care costs and utilization was examined in women newly prescribed bisphosphonates. At 3 years, women who were persistent and compliant with bisphosphonate therapy had lower total costs compared with non-persistent and non-compliant women, after controlling for relevant risk factors. INTRODUCTION: The impact of persistence and compliance with bisphosphonate therapy on health care costs and utilization was examined in bisphosphonate-naïve women. METHODS: Two claims databases were used to identify women > or = 45 years of age and who filled a new bisphosphonate prescription during 2000-2002. Persistence and compliance were evaluated over 3 years. Compliance was defined as a medication possession ratio (days of bisphosphonate supply/days of follow-up) > or = 0.80; persistence was defined as no refill gaps > or = 30 days. Multivariate models accounted for potential confounders. RESULTS: This analysis included 32,944 women (mean age, 64 years) who filled a new prescription for daily or weekly alendronate (n = 26,581) or risedronate (n = 6,363). At 3 years, 37% of women were compliant and 21% of women were persistent. Unadjusted total mean health care costs were lower for the compliant vs. non-compliant and persistent vs. non-persistent cohorts. After adjusting for potential confounders, total health care costs were reduced by 8.9% for persistent patients (p < 0.001) and 3.5% for compliant patients (p = 0.014). Persistence decreased the likelihood of inpatient admission by 47%. CONCLUSION: At 3 years, women who were persistent and compliant with bisphosphonate therapy had lower total costs compared with non-persistent and non-compliant women, after controlling for relevant risk factors.

The pharmacokinetics of once-daily dosing with gentamicin in women with postpartum endometritis.

OBJECTIVE: To evaluate the pharmacokinetics and cost of once-daily dosing with gentamicin in women with postpartum endometritis. METHODS: Gentamicin in a single daily dose of 4.5 mg/kg was administered intravenously to 10 women with postpartum endometritis. Peak and trough gentamicin levels were measured, and nephrotoxicity and clinical ototoxicity were monitored. Pharmacokinetic data were analyzed, and a cost analysis of once-daily gentamicin administration was performed. RESULTS: The mean elimination constant was 0.105 +/- 0.008 L/h, and the mean volume of distribution was 0.34 +/- 0.07 L/kg. Mean peak gentamicin levels exceeded 11 mg/L, and all trough levels were < 0.3 mg/L. Cost savings of 44% were achieved with once-daily dosing of gentamicin, compared with traditional thrice-daily dosing. CONCLUSIONS: Once-daily dosing with gentamicin in women with postpartum endometritis achieves therapeutic peak levels without drug accumulation. Substantial cost savings are realized with this dosing regimen.

Lymphoproliferative disorder involving the cervix in a patient being treated with FK-506.

FK-506 is an immunosuppressive agent used mainly to prevent allograft rejection in organ transplant patients. Recently, it has been applied as a treatment for patients with autoimmune disorders. An entity called posttransplant lymphoproliferative disorder (PTLD) is a well-recognized result of immunosuppression in transplant patients receiving long-term immunosuppression. This disorder is a complication of treatment with FK-506 in 0.7 to 1.6% of transplant patients and is usually of B-cell origin. A majority of patients have serologic evidence of EBV infection. We report a case of a patient receiving long-term FK-506 therapy for multiple sclerosis who developed lymphoproliferative disorder involving the cervix. We will discuss the possible role of FK-506 initiation of this tumor.