Clinical therapeutics
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Clinical therapeutics · Jul 1995
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialComparison of the efficacy and safety of oxaprozin and nabumetone in the treatment of patients with osteoarthritis of the knee.
This multicenter, 6-week, double-blind, placebo-controlled, parallel-group study compared the efficacy and safety of oxaprozin 1200 mg once daily with that of nabumetone 1000 mg once daily in patients with moderate-to-severe osteoarthritis (OA) of the knee. To be eligible, patients had to experience a flare of OA within 2 weeks of discontinuing their usual OA medication (nonsteroidal anti-inflammatory drug or analgesic). Eligible patients were assessed at baseline and then randomized to receive oxaprozin (n = 109), nabumetone (n = 110), or placebo (n = 109). ⋯ Four of these patients had reversible elevations of aspartate aminotransferase and alanine aminotransferase greater than three times the upper limit of normal range (P < 0.05); two of these patients were taking other medications known to induce liver enzyme abnormalities. The study showed that oxaprozin 1200 mg once daily was statistically significantly more efficacious than nabumetone 1000 mg once daily for the treatment of patients with moderate-to-severe OA of the knee. Both drugs were clinically well tolerated.
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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.