Clinical therapeutics
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The safety of naproxen sodium for over-the-counter use was evaluated based on 48 randomized, double-blind, placebo-controlled clinical trials that evaluated naproxen/naproxen sodium (NAP) for indications appropriate to, and under, conditions common to, nonprescription analgesics. Of the 48 studies, 27 were single-dose studies and 21 were multiple-dose studies of 1 to 10 days' duration; 19 studies included ibuprofen and 9 included acetaminophen. A total of 4138 patients received naproxen or naproxen sodium (3589 patients received naproxen 187.5 to 400 mg and 549 received naproxen sodium 220 to 440 mg), 2423 received placebo, 1574 received ibuprofen (200 or 400 mg), and 671 received acetaminophen (500 to 1000 mg). ⋯ Across all 48 studies, 83% of both the NAP- and placebo-treated patients reported no adverse events. The incidence rates were similar between NAP and placebo, with headache (4.8% NAP, 6.4% placebo), nausea (3.4% NAP, 3.1% placebo), and somnolence (2.7% NAP, 1.9% placebo) the most commonly reported events. Rates of adverse events with NAP, ibuprofen, and acetaminophen were similar.
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Clinical therapeutics · May 1995
Randomized Controlled Trial Multicenter Study Clinical TrialUse of anesthesia selection in controlling surgery costs in an HMO hospital.
The cost of induction and maintenance of anesthesia is analyzed in this article from the perspective of a health maintenance organization's (HMO) chief financial officer. While earlier economic studies tended to focus on the raw cost of anesthesia drugs, our model also includes the cost of the clinical labor involved in administering the drug as well as the fixed costs associated with the facility. Such a model is consistent with the goal of an HMO, which is to provide high-quality health care services to its membership while containing costs. ⋯ Because institutional pricing policies differ greatly, only the findings at the HMO hospital are presented in this report. Our results suggest that intra-abdominal surgical procedures with a duration of less than 4 hours that use propofol for induction and maintenance of anesthesia reduce the total cost of surgery by $202.71, compared with the costs of using thiopental/isoflurane. Sensitivity analysis maintains the robustness of the conclusions with regard to all major parameters.
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Clinical therapeutics · May 1995
Multicenter Study Clinical TrialMulticenter, phase IV evaluation of intravenous ciprofloxacin as initial therapy in patients with lower respiratory tract, urinary tract, and skin/skin structure infections.
A prospective, open-label, multicenter, Phase IV study of the efficacy and safety of intravenous (IV) ciprofloxacin (400 mg by 60-minute infusion every 12 hours) in the treatment of lower respiratory tract infections (LRTIs), urinary tract infections (UTIs), and skin/skin structure infections (SSSIs) in hospitalized patients was conducted in 1991. After a minimum of 3 days of IV therapy, patients could be switched to oral therapy with any antimicrobial. ⋯ Adverse events were noted in 72 (9%) of 782 patients and led to premature discontinuation of IV therapy in 23 (3%) patients. IV ciprofloxacin appears to be effective and safe in the management of mild-to-moderate LRTI and SSSI and mild, moderate, or severe UTI in hospitalized patients.
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Clinical therapeutics · Jan 1995
Randomized Controlled Trial Multicenter Study Clinical TrialAntiemetic treatment with oral granisetron in patients receiving moderately emetogenic chemotherapy: a dose-ranging study.
The antiemetic efficacy and tolerability of four different oral doses of granisetron (0.25, 0.5, 1, and 2 mg twice daily [BID]) were compared in a randomized, double-blind, parallel-group, multicenter study involving 930 patients with malignant disease receiving moderately emetogenic chemotherapy over a 7- or 14-day period. On the first day of granisetron treatment, a statistically significant association between complete response and dose was seen (P = 0.001), with the maximum response (81.1%) achieved at a dose of 1 mg BID. ⋯ No advantage in terms of complete response rate was shown for 2 mg BID over 1 mg BID. Granisetron was well tolerated, and few patients required additional treatment with other antiemetics.
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Clinical therapeutics · Sep 1994
Clinical TrialPrevalence of migraine headache and association with sex, age, race, and rural/urban residence: a population-based study of Georgia Medicaid recipients.
The estimates of migraine headache prevalence vary widely and fluctuate with the population examined and the methodologic factors used in studies examining this condition. As an alternative to survey techniques, a retrospective review of Medicaid claims data from 22 continuous months (January 1, 1989, to October 31, 1990) was used to detect medical episodes and physician-initiated pharmacologic therapy indicative of migraine headache. Specifically, the objectives of this study were to measure the prevalence of migraine headache in Georgia Medicaid recipients, estimate the prevalence in the US population, and describe the relationships between migraine and sociodemographic variables including sex, age, race, and rural versus urban residence. ⋯ Migraine headache in the United States is estimated to afflict 4.5 million females and 1.4 million males. This prevalence is lower than previously reported and indicates that migraine headache may not be as common as previously believed. An alternative explanation is that many Medicaid recipients self-treat the condition, thus circumventing physician care and subsequent diagnosis and treatment.