Arch Intern Med
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Randomized Controlled Trial Clinical Trial
Effect of tamoxifen on lumbar spine bone mineral density in postmenopausal women after 5 years.
Because adjuvant tamoxifen citrate is given to women with early-stage breast cancer for long periods, it is important to know how it affects risk factors for osteoporotic bone fractures, particularly since rates of bone fracture increase rapidly with age in postmenopausal women. In a 2-year randomized placebo-controlled toxicity study in 140 subjects, we demonstrated that tamoxifen was associated with preservation of bone mineral density (BMD), a major risk factor for fractures, in the lumbar spine. ⋯ While remodeling of bone may be lower, resorption of lumbar spine bone mineral is also lower, and tamoxifen preserves BMD in the lumbar spine over 5 years of treatment in postmenopausal women. Over longer periods, this preservation of BMD might be expected to be associated with lower fracture rates.
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The purpose of this study was to investigate the association of glycemia with cause-specific mortality in a diabetic population. ⋯ These results suggest possible benefit to the control of glycemia with respect to death due to vascular disease and diabetes.
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Antiendotoxin monoclonal antibodies are under investigation as adjunctive therapy for severe sepsis. One of these antibodies (the human IgM monoclonal antibody HA-1A) was marketed in Europe during 1992 for treatment of patients with severe sepsis, especially those with shock, and probable gram-negative bacilli (GNB) bacteremia, after a placebo-controlled trial showed improved outcome in such patients. This cohort study was designed to assess characteristics and determinants of outcome of patients through a nationwide registry of all adult patients hospitalized in intensive care units of French hospitals and treated with HA-1A. ⋯ This cohort study did not confirm decreased mortality in patients with GNB bacteremia, as reported in the first placebo-controlled HA-1A trial, and it further suggests excess mortality in the subgroup of patients with non-GNB infection. In clinical trials of patients with severe sepsis, controlling for both the severity of acute illness score and the number of organ system failures, as well as for the severity of underlying disease and the source of infection, should be considered, especially when subgroups are analyzed.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Efficacy and safety of once-daily vs twice-daily dosing with fluvastatin, a synthetic reductase inhibitor, in primary hypercholesterolemia.
Fluvastatin sodium is a new, entirely synthetic 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor that may be an effective lipid-lowering agent in patients whose hyperlipidemia does not respond to dietary therapy. We conducted a study to evaluate the effects of fluvastatin on lipoprotein levels in subjects with primary hypercholesterolemia and to compare the efficacy and safety of two fluvastatin sodium dosing regimens: 20 mg once daily vs 10 mg twice daily. ⋯ Fluvastatin therapy demonstrated excellent short-term safety and efficacy in reducing total and low-density lipoprotein cholesterol levels in patients with primary hypercholesterolemia. Fluvastatin sodium, the first totally synthetic 3-hydroxy-3-methylglutaryl coenzyme A reductase inhibitor to be used in clinical trials, appears to be both effective and well tolerated at 20 mg/d, given in either a single or divided dose.
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Because of extremely poor outcomes, the practice of continuing cardiopulmonary resuscitation in hospital emergency departments after unsuccessful out-of-hospital cardiopulmonary resuscitation has been strongly questioned. Before revising our institutional guidelines according to previous pessimistic reports we wished to review our own experience with this practice. ⋯ Institutional guidelines for the decision whether to continue resuscitation after failed out-of-hospital efforts should be based on an analysis of the characteristics and results of the local emergency medical system. Continuing efforts in the hospital may not be inevitably futile.