Clinical therapeutics
-
Clinical therapeutics · Jan 2007
ReviewA review of the clinical efficacy and safety of 5alpha-reductase inhibitors for the enlarged prostate.
Enlargement of the prostate is common among aging men, with an incidence of 90% by the age of 85 years. It is a progressive condition, with growth in prostate size accompanied by lower urinary tract symptoms that can result in long-term complications (eg, acute urinary retention [AUR], need for enlarged prostate-related surgery). Current pharmacologic treatment options include alpha-blockers (alfuzosin, doxazosin, tamsulosin, and terazosin) and 5alpha-reductase inhibitors (5ARIs) (finasteride and dutasteride). ⋯ The use of 5ARI therapy is a rational approach to symptom management and prevention of long-term negative outcomes in men with enlarged prostates.V 3.
-
Clinical therapeutics · Jan 2007
Historical ArticleThe history and contemporary challenges of the US Food and Drug Administration.
The year 2006 marks the 100th anniversary of the regulatory agency now known as the US Food and Drug Administration (FDA), the first consumer protection agency of the federal government and arguably the most influential regulatory agency in the world. The FDA thus plays an integral role in the use of pharmaceuticals, not only in the United States but worldwide. ⋯ As shown in this review, the evolution of the FDA can be described as a series of "crisis-legislation-adaptation" cycles: a public health crisis promoted the passage of congressional legislation, which was then followed by implementation of the law by the FDA. However, the crises the FDA faces currently are likely to be overcome only under strong and permanent leadership willing to redefine the role and procedures of the FDA with an open mind.
-
Clinical therapeutics · Jan 2007
Diagnosis of menstrual headache and an open-label study among those with previously undiagnosed menstrually related migraine to evaluate the efficacy of sumatriptan 100 mg.
Headache associated with menses is often not formally diagnosed. ⋯ Seventy-five percent of women with previously undiagnosed menstrual headaches met diagnostic criteria for migraine in this small sample. Two hours after treatment with sumatriptan 100 rag, 70% of patients with headaches treated at moderate to severe pain had a pain relief response (reduction to mild or no pain).
-
Clinical therapeutics · Jan 2007
Randomized Controlled Trial Multicenter StudyPsychometric testing and validation of the Chronic Pain Sleep Inventory.
Patients with chronic pain often experience significant disruptions in sleep. A potential benefit of treatment aimed at pain relief is improved quality of sleep in patients with chronic pain. ⋯ CPSI items showed good construct validity, and the results support the scoring of a reliable single index from 3 of the 5 CPSI items that all attributed sleep problems to pain.
-
Clinical therapeutics · Jan 2007
Randomized Controlled Trial Multicenter StudyMetabolic effects of two years of exenatide treatment on diabetes, obesity, and hepatic biomarkers in patients with type 2 diabetes: an interim analysis of data from the open-label, uncontrolled extension of three double-blind, placebo-controlled trials.
Exenatide, an incretin mimetic for adjunctive treatment of type 2 diabetes mellitus (T2DM), reduced glycosylated hemoglobin (HbA(1c)) and weight in 30-week placebo-controlled trials. Some patients were followed up in open-label extensions to provide 'real-world' exenatide clinical experience. ⋯ In these patients with T2DM, adjunctive exenatide treatment for 2 years was generally well tolerated and resulted in a sustained reduction of HbA(1c), progressive reduction in weight, and improvements in HOMA-B, blood pressure, and the hepatic injury biomarkers, AST and ALT.