Clinical therapeutics
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Clinical therapeutics · Nov 1992
Randomized Controlled Trial Multicenter Study Clinical TrialEffect of intravenous flumazenil on reversal of the central effects of midazolam used with short-acting opioids for general anesthesia in hospitalized patients: report of a multicenter, double-blind clinical study. The Flumazenil in General Anesthesia in Hospitalized Patients Study Group I.
Midazolam, a short-acting benzodiazepine central nervous system (CNS) depressant widely used for the induction and maintenance of general anesthesia, is often supplemented with short-acting opioids for general anesthesia. Administered postoperatively, flumazenil, a specific benzodiazepine antagonist, reverses the CNS sedative effects of midazolam. In a double-blind clinical trial in hospitalized patients, flumazenil, administered postoperatively at an average intravenous dose of 0.89 mg (range: 0.4 mg to 1 mg), was more effective than placebo in reversing sedation and other residual effects of benzodiazepines in patients recovering from general anesthesia induced by midazolam (mean dose 29 mg) in conjunction with fentanyl (mean dose 0.4 mg) or sufentanil (mean dose 0.056 mg). ⋯ Measurements of psychomotor function and memory also showed significant between-group differences. Flumazenil, compared with placebo, was not associated with a substantially greater frequency of operative-site pain. These results demonstrate that the efficacy and safety of flumazenil were not compromised by the addition of a short-acting opioid to the anesthetic regimen.
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Clinical therapeutics · Nov 1992
Randomized Controlled Trial Multicenter Study Clinical TrialReversal of the central effects of midazolam by intravenous flumazenil after general anesthesia and use of a long-acting opioid in hospitalized patients: report of a multicenter double-blind clinical study. The Flumazenil in General Anesthesia in Hospitalized Patients Study Group II.
A double-blind clinical trial was conducted to evaluate the efficacy and safety of flumazenil, a benzodiazepine antagonist, in 146 hospitalized patients, who had had general anesthesia induced by midazolam and a long-acting opioid. Ninety-eight patients received flumazenil and 48 received placebo. Administered postoperatively at a mean intravenous dose of 0.84 mg (range: 0.2 mg to 1 mg), flumazenil reversed benzodiazepine-induced sedation to a greater extent than did placebo. ⋯ Flumazenil, compared with placebo, was not associated with an increased frequency of operative-site pain, and no serious adverse effects of this benzodiazepine antagonist were reported. The most frequent adverse experiences in both treatment groups were nausea, shivering, and operative-site pain. Vomiting, dizziness, and injection-site reactions were also reported in > or = 5% of patients treated with flumazenil.
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Clinical therapeutics · Sep 1992
Randomized Controlled Trial Comparative Study Clinical TrialComparison of the efficacy and tolerability of Prinivil and Procardia XL in black and white hypertensive patients.
The efficacy and tolerability of Prinivil and Procardia XL were compared in 135 (67 black, 68 white) patients with mild to moderate uncomplicated essential hypertension. The goal of therapy was to achieve and maintain a supine diastolic blood pressure (SDBP) of > 90 mmHg or a decrease in SDBP > or = 10 mmHg. Patients received Prinivil 10 to 40 mg once daily or Procardia XL 30 to 120 mg once daily during a titration period of 2 to 8 weeks to achieve the goal blood pressure before a 4-week maintenance period. ⋯ There were no differences in treatment responses in either the black or white hypertensive subgroups. Thus both drugs were equally effective in black and white patients with mild to moderate essential hypertension. Both drugs were generally well tolerated, but the number of adverse experiences requiring discontinuation of therapy was significantly higher (P = 0.03) in patients receiving Procardia XL.
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Clinical therapeutics · Jul 1992
Comparative StudyThe pricing of pharmaceuticals: an international comparison.
Four types of pricing policies and regulations are recognized: product price control, as practiced in France, Italy, Portugal, and Spain; reference pricing, as in Germany and the Netherlands; profit control, as in the United Kingdom; and no control, as in the United States. The system in Canada is a hybrid of product price control and reference pricing; a producer may set any price for a new product as long as it is within guidelines established by a federal government review board. ⋯ Various prescription reimbursement policies are used to control consumer and government expenditures for drugs. Expenditure is a function of many factors, including price, consumption patterns, reimbursement policies, and social, economic, and political values.
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Clinical therapeutics · Jan 1992
Multicenter Study Clinical TrialEfficacy of leuprorelin acetate depot in symptomatic fibromatous uteri: the Italian Multicentre Trial.
A total of 110 nonmenopausal women (mean age 42.1 years) presenting with symptomatic uterine leiomyomata and/or fibromatous uteri have been enrolled in this trial to evaluate the efficacy of the depot formulation of leuprorelin acetate in decreasing uterine volume and minimizing menorrhagia, dysmenorrhoea and pressure over the bladder. All patients were treated with an intramuscular injection of leuprorelin acetate depot 3.75 mg every 4 weeks for 16 weeks. Clinical examinations and hormonal and ultrasound determinations were performed before, during and at the end of treatment. ⋯ In most patients the achievement of amenorrhoea minimized the fear of surgical emergency, facilitating an increased awareness of their clinical condition. With the exception of the three patients who dropped out, side effects were mild in all patients, consisting mainly of hot flushes, which were easily tolerated. In the following 8-12 months, the regrowth of uterine volume to original size has been usual in most of the 82 patients now in follow-up.(ABSTRACT TRUNCATED AT 400 WORDS)