Drug Information
Gruer et al published their results of treating men with glucocorticoid-induced osteoporosis (n=92).5 In this 18-month, randomized, open-label, active comparator–controlled study, patients received either daily 20 micrograms subcutaneous teriparatide (n=45) or weekly 35 mg risedronate (n=47). Lumbar spine volumetric bone mineral density (BMD) measured by quantitative computed tomography (QCT) was the primary objective. QCT was measured at baseline and Months 6 and 18. The mean patient age was 56 years old. Patients also received one gram of elemental calcium and 800 to 1,200 international units of vitamin D daily. Trabecular BMD increased significantly greater for teriparatide (16.3%) versus risedronate (3.7%). Vertebral strength increases at 18 months were significantly greater for both agents, increasing from 4.2% to 6.7% for risedronate and 26% to 34% for teriparatide. Adverse events were similar between the two groups. New clinical fractures developed in five risedronate-treated patients compared to no teriparatide-treated patients.
Safety
Glucosamine supplements may be linked to ocular hypertension. Murphy et al conducted a small (n=17) retrospective study of patients who utilized oral glucosamine supplements, and also had ocular hypertension (e.g., an intraocular pressure (IOP) greater than 21 mm Hg) or a diagnosis of open-angle glaucoma.6 Eleven patients (Cohort A) had baseline IOPs measured one to three times prior to oral glucosamine supplementation, and six patients (Cohort B) had no prior measurements of IOP prior to starting oral glucosamine. Patients in cohort A had significant IOP increases from before glucosamine supplementation to during supplementation, which decreased following discontinuation of the supplement. For patients in Cohort B, IOP significantly decreased after the supplement was discontinued. The study had limitations; however, the authors believe that this IOP elevation with glucosamine supplementation requires further exploration and that patients who choose to utilize glucosamine supplements should have their IOP routinely measured.
The FDA has approved label changes for zolpidem (Ambien, Ambien CR, Edluar, Zolpimist) products.7 These new dosing recommendations are related to the known risk of next-morning impairment related to zolpidem use. The Warnings and Precautions section of product labeling was also updated for patients who take zolpidem extended-release in either the lower 6.25-mg dose or the higher 12.5-mg dose, warning them not drive or participate in activities that require complete mental alertness the day after taking zolpidem. This is because zolpidem is still at a high enough level the following day to significantly impair performance of these activities. Also included in the label updates are the dosing recommendations previously stated in the FDA’s January 2013 Drug Safety Communication, which were reported in the March 2013 issue’s “Drug Updates”.
