Clinical therapeutics
-
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.
-
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.
-
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.
-
Clinical therapeutics · May 1994
Randomized Controlled Trial Comparative Study Clinical TrialA single-dose, double-blind comparison of naproxen sodium, acetaminophen, and placebo in postoperative dental pain.
The analgesic efficacy and duration of action of naproxen sodium 440 mg (n = 92), acetaminophen 1000 mg (n = 89), and placebo (n = 45) were compared in a single-dose, randomized, double-blind, 12-hour study of patients with at least moderate pain secondary to extraction of three or four third molars. Time to remedication, a measure of duration of analgesic effect, was significantly longer (P < 0.001) with naproxen sodium (median, 9.9 hours) than with either acetaminophen (median, 3.1 hours) or placebo (median, 2.0 hours). ⋯ The overall percentages of patients reporting adverse events, and the types of events reported, were comparable with the three treatments. Thus naproxen sodium demonstrated superior efficacy and similar tolerability to acetaminophen in this postoperative dental pain model.
-
Clinical therapeutics · May 1994
Randomized Controlled Trial Comparative Study Clinical TrialComparison of single-dose ibuprofen lysine, acetylsalicylic acid, and placebo for moderate-to-severe postoperative dental pain.
In a single-dose, double-blind, parallel-group, single-site study, ibuprofen lysine 200 mg (IBL 200) was compared with acetylsalicylic acid 500 mg (ASA 500) and placebo in 183 patients with moderate-to-severe postoperative dental pain. The relative onset of analgesic response, duration and degree of analgesia, and safety were assessed over a 6-hour postdose period. ⋯ IBL 200 also had a significantly faster onset of action, greater peak and overall analgesic effect, and longer duration of analgesia than ASA 500. All treatments were generally well tolerated.