Clinical therapeutics
-
Clinical therapeutics · Nov 2009
Changes in physicians' practice of prescribing cyclooxygenase-2 inhibitor after market withdrawal of rofecoxib: a retrospective study of physician-patient pairs in Taiwan.
Safety concerns regarding severe cardiovascular events associated with the use of selective cyclooxygenase-2 (COX-2) inhibitors resulted in the market withdrawal of rofecoxib in September 2004. ⋯ The volume of celecoxib prescribing was greatly reduced after rofecoxib was withdrawn from the market. Physicians' prescribing practice for COX-2 inhibitors significantly changed after the withdrawal, and it had a significant impact on the postwithdrawal volume of celecoxib prescribing.
-
Clinical therapeutics · Nov 2009
Probability of pharmacodynamic target attainment with standard and prolonged-infusion antibiotic regimens for empiric therapy in adults with hospital-acquired pneumonia.
The pharmacodynamic characteristics of antibiotics should be considered when choosing empiric dosage regimens for the treatment of pneumonia. ⋯ Results of this model suggest that standard doses of most antipseudomonal beta-lactams (cefepime, ceftazidime, and meropenem) had high probabilities of achieving optimal pharmacodynamic exposure as empiric therapy for HAP, whereas the low probabilities predicted from ceftriaxone, ertapenem, and the fluoroquinolones suggest that these agents would be inappropriate as monotherapy. For late-onset HAP, prolonged infusions of cefepime, ceftazidime, and meropenem offered the highest probabilities of achieving bactericidal exposure.
-
Clinical therapeutics · Oct 2009
Randomized Controlled Trial Multicenter StudyDiclofenac potassium liquid-filled soft gelatin capsules in the management of patients with postbunionectomy pain: a Phase III, multicenter, randomized, double-blind, placebo-controlled study conducted over 5 days.
Diclofenac potassium liquid-filled soft gelatin capsule (DPSGC) is a rapidly absorbed formulation of diclofenac potassium developed for the treatment of mild to moderate acute pain. ⋯ DPSGC 25 mg taken every 6 hours was effective in reducing postbunionectomy pain in the patients studied. DPSGC was well tolerated, suggesting that it may be a practicable option for the treatment of mild to moderate acute pain. ClinicalTrials. gov identifier: NCT00366444.
-
Clinical therapeutics · Oct 2009
Randomized Controlled Trial Comparative StudyA comparison of pretreatment with fentanyl and lidocaine preceded by venous occlusion for reducing pain on injection of propofol: a prospective, randomized, double-blind, placebo-controlled study in adult Japanese surgical patients.
Pain on injection is a recognized adverse effect of propofol, an agent used to induce general anesthesia in surgical patients. Pretreatment with fentanyl has been reported to be effective in reducing propofol-induced pain. ⋯ Preceded by venous occlusion for 1 minute, fentanyl 100 microg was not significantly different from lidocaine 40 mg in reducing pain during injection of propofol in these adult Japanese surgical patients. Fentanyl 50 microg was ineffective in reducing such pain compared with placebo.
-
Clinical therapeutics · Oct 2009
Randomized Controlled Trial Comparative StudyBioequivalence of a single 10-mg dose of finasteride 5-mg oral disintegrating tablets and standard tablets in healthy adult male Han Chinese volunteers: a randomized sequence, open-label, two-way crossover study.
Finasteride, an inhibitor of the steroid 5alpha-reductase, has been approved for the treatment of benign prostatic hyperplasia and androgenetic alopecia. An orally disintegrating tablet (ODT) 5-mg formulation of finasteride was recently developed. Information regarding its pharmacokinetics and bioequivalence was required to assess the efficacy and safety of this formulation before marketing it in China. ⋯ In this single-dose study, based on the rate and extent of absorption, the ODT (ie, test) and standard tablet (ie, reference) formulations of finasteride met the regulatory criteria for bioequivalence in these fasting healthy adult male Han Chinese volunteers. However, a significant difference was found for T(max) between the test and reference formulations. Both formulations were well tolerated. ClinicalTrials. gov identifier: 2005L02216.