Clinical therapeutics
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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.
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Clinical therapeutics · Jan 2007
Comparative StudyUse of rapid-acting insulin analogues in the treatment of patients with type 1 and type 2 diabetes mellitus: insulin pump therapy versus multiple daily injections.
Replicating endogenous insulin production is the goal of treatment for diabetes mellitus (DM) and is necessary to minimize the risk of vascular complications. The 2 main methods of achieving this goal are continuous subcutaneous insulin infusion (CSII) and multiple daily injections (MDIs) comprising basal and prandial injections. ⋯ CSII with the rapid-acting insulin analogue insulin aspart is a viable choice for patients with type 1 or type 2 DM who want close-to-physiologic insulin treatment.
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Clinical therapeutics · Jan 2007
Health care costs and mortality for Canadian urban and rural patients with diabetes: population-based trends from 1993-2001.
Recent reports suggest that the health status of individuals residing in rural areas (as much as one third of the Canadian population) may be inferior to those who live in urban areas. ⋯ From 1993 to 2001, we observed systematic differences in costs of individual resource categories according to urban/rural residence in Saskatchewan, with urban dwellers with diabetes incurring greater costs in most categories. Age-adjusted total costs and mortality rates were similar, however, suggesting that rural populations with diabetes may not be as disadvantaged as commonly believed. Investing in better primary care access for all patients with diabetes may reduce downstream costs in Saskatchewan's provincial health care system.
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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).