Clinical therapeutics
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Clinical therapeutics · Apr 2003
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialEfficacy of a low-dose regimen of cyclobenzaprine hydrochloride in acute skeletal muscle spasm: results of two placebo-controlled trials.
Cyclobenzaprine hydrochloride is a muscle relaxant that is effective in improving muscle spasm, reducing local pain and tenderness, and increasing range of motion in acute, painful musculoskeletal conditions. Sedation is the most common adverse event associated with its use at the usual dosage of 10 mg TID. Studies in healthy adults suggest that a lower dose may produce less sedation. Because cyclobenzaprine's duration of action is 4 to 6 hours, reducing the dosing frequency to 10 mg BID would create a potentially painful untreated interval between doses. The alternative is administration of a lower dose (eg, 5 or 2.5 mg) TID. ⋯ Cyclobenzaprine 2.5 mg TID was not significantly more effective than placebo. The cyclobenzaprine 5- and 10-mg TID regimens were associated with significantly higher mean efficacy scores compared with placebo. Cyclobenzaprine 5 mg TID was as effective as 10 mg TID, and was associated with a lower incidence of sedation.
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Clinical therapeutics · Apr 2003
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialTramadol/acetaminophen combination tablets for the treatment of chronic lower back pain: a multicenter, randomized, double-blind, placebo-controlled outpatient study.
Tramadol and acetaminophen (APAP) have both shown efficacy in the treatment of lower back pain. The combination of these 2 agents has demonstrated synergistic analgesic action in animal models at specific ratios. ⋯ In this study, tramadol 37.5 mg/APAP 325 mg combination tablets were effective and had a favorable safety profile in the treatment of chronic lower back pain.
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Clinical therapeutics · Apr 2003
Randomized Controlled Trial Comparative Study Clinical TrialA comparison of granisetron, droperidol, and metoclopramide in the treatment of established nausea and vomiting after breast surgery: a double-blind, randomized, controlled trial.
Women undergoing breast surgery are at particular risk for post-operative nausea and vomiting (PONV), with an incidence of emesis as high as 50% when no prophylactic antiemetic is used. ⋯ Granisetron was significantly more effective than the traditional antiemetics droperidol and metoclopramide for the treatment of PONV in this population of patients undergoing breast surgery.
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Clinical therapeutics · Apr 2003
Comparative StudyTimeliness of review and approval of new drugs in Canada from 1999 through 2001: is progress being made?
The median time to approval of new drugs in Canada decreased considerably in the mid-1990s, although it continued to be longer than in such countries as Australia, Sweden, the United Kingdom, and the United States. Ongoing concern about approval times pointed to a need for a further international comparison. ⋯ Overall approval times of new drugs in Canada were longer than those in Australia, Sweden, the United Kingdom, and the United States in the period studied. The findings warrant ongoing monitoring of Canadian drug approval times.
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Clinical therapeutics · Apr 2003
Randomized Controlled Trial Multicenter Study Clinical TrialAn analysis of cholesterol control and statin use in the Losartan Intervention for Endpoint Reduction in Hypertension Study.
There is general agreement that patients who have elevated lipid levels and/or risk factors for or existing cardiovascular disease should receive aggressive cholesterol-lowering therapy. However, it is not clear whether patients are receiving the recommended treatment. ⋯ In this long-term cardiovascular end point study in patients with moderate to severe hypertension and left ventricular hypertrophy, statins were not optimally administered and cholesterol levels were poorly controlled.