Clinical therapeutics
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Clinical therapeutics · Jul 1996
Randomized Controlled Trial Multicenter Study Clinical TrialEfficacy, tolerability, and effects on quality of life of losartan, alone or with hydrochlorothiazide, versus amlodipine, alone or with hydrochlorothiazide, in patients with essential hypertension.
A randomized, double-masked, parallel-group, multicenter clinical trial was conducted to compare the efficacy, tolerability, and effects on quality of life associated with treatment regimens including the angiotensin II receptor antagonist losartan, with hydrochlorothiazide (HCTZ) added as needed, with regimens including the dihydropyridine calcium channel blocker amlodipine with HCTZ added as needed. The trial included patients whose sitting diastolic blood pressure (SiDBP) measurements were between 95 and 114 mm Hg, inclusive, at placebo baseline. Patients were randomized to receive either losartan or amlodipine in a double-masked, double-dummy fashion. ⋯ In particular, drug-related edema was more common in patients receiving the amlodipine regimen than in those receiving the losartan regimen (11% vs 1%). Patients in the amlodipine arm reported significantly more bother due to edema, regardless of whether edema was present at baseline, than did patients in the losartan arm (12% vs 2%), although overall quality of life was not different in the two treatment groups. This study demonstrates that a regimen of losartan with HCTZ added as needed, when compared with a regimen of amlodipine with HCTZ added as needed, provides comparable efficacy and superior tolerability and less bother to patients with respect to edema.
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Clinical therapeutics · Jul 1996
Review Comparative StudyComparative efficacy of oral and intravenous granisetron for the prevention of acute chemotherapy-induced emesis.
Intravenous 5-hydroxytryptamine3 (5-HT3) receptor antagonists are now established antiemetics in the treatment of chemotherapy-induced emesis. For optimal convenience and acceptability, oral therapy is desirable. Retrospective comparisons indicate that oral granisetron may have an efficacy comparable with that of intravenous granisetron. ⋯ Oral granisetron was well tolerated in all these trials. Headache and constipation were the most common adverse events, as has been reported for other 5-HT3 receptor antagonists. No randomized trials of oral-only tropisetron or dolasetron have yet been published.
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Clinical therapeutics · May 1996
Randomized Controlled Trial Comparative Study Clinical TrialEfficacy and tolerability of oral ondansetron versus prochlorperazine in the prevention of emesis associated with cyclophosphamide-based chemotherapy and maintenance of health-related quality of life.
This study compared the efficacy and tolerability of oral ondansetron (8 mg twice daily [BID] for up to 3 days) with those of phenothiazine prochlorperazine (10 mg BID for up to 3 days) in 133 cancer patients receiving cyclophosphamide-based chemotherapy. In addition, the study evaluated the impact of these treatments on patients' health-related quality of life, measured with both the Functional Living Index--Cancer and the Functional Living Index--Emesis questionnaires. The first dose of study drug was administered 30 minutes before initiation of chemotherapy. ⋯ Both treatments were well tolerated. The most common potentially drug-related adverse event was headache, which occurred in significantly more (16%) ondansetron-treated patients compared with prochlorperazine-treated patients (3%). The results of this study demonstrate that oral ondansetron 8 mg BID for up to 3 days is more effective than prochlorperazine 10 mg BID for up to 3 days in the prevention of emesis associated with moderately emetogenic chemotherapy.
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Clinical therapeutics · Jan 1996
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialThe efficacy, tolerability, and safety of 1200 mg/d of oxaprozin and 1500 mg/d of nabumetone in the treatment of patients with osteoarthritis of the knee.
This 6-week, multicenter, double-masked, placebo-controlled study compared the efficacy, tolerability, and safety of the recommended starting dose of oxaprozin (1200 mg/d) and a 1500-mg/d dose of nabumetone in the treatment of patients with moderate-to-severe osteoarthritis (OA) of the knee. A total of 347 patients with a mean age of 61.1 years were randomized to receive oxaprozin (116 patients), nabumetone (115 patients), or placebo (116 patients). Adults of either sex who were older than 18 years of age were eligible for entry into the study, if they had had OA of the knee for at least 6 months. ⋯ Combined with the results of an earlier study, the results of this study showed that a 1500-mg/d dose of nabumetone, which is higher than the recommended starting dose of 1000 mg/d, is required for efficacy equivalent to that of the recommended starting dose of oxaprozin, 1200 mg/d, in relieving the symptoms of OA. Thus nabumetone may require dosage titration from the recommended starting dose. Oxaprozin and nabumetone were found to have similar tolerability profiles, as shown by adverse-event monitoring and withdrawal rates, as well as clinically similar safety profiles, as demonstrated by physical examinations, hematologic and biochemical laboratory testing, hemoccult testing, and adverse-event monitoring and symptom assessment.
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Clinical therapeutics · Jan 1996
Comparative StudyEvaluation of the financial impact of ketorolac tromethamine therapy in hospitalized patients.
This retrospective cohort study aimed to determine the resource utilization and cost consequences of ketorolac tromethamine in postoperative pain management in a variety of clinical circumstances. All patients were treated at LDS Hospital, Salt Lake City, Utah, a 520-bed teaching hospital. A long-term archive of clinical and financial data from a computerized hospital information system was searched for patients with specified primary International Classification of Diseases, 9th Revision, Clinical Modification discharge diagnoses treated from June 1, 1990, to July 1, 1992, who received ketorolac (n = 229). ⋯ Linear regression modeling showed that ketorolac use was significantly related to reduced cost using inflation-adjusted dollars. We believe that ketorolac has significant cost advantages over opiate analgesics because of its narcotic-sparing effects. Advantages of ketorolac use include reduced rates of adverse drug events, reduced lengths of stay, especially for orthopedic surgery, and reduced overall hospital costs for diagnosis-related groups associated with cholecystectomy.