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 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.
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Clinical therapeutics · Feb 2003
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialA multicenter, randomized, double-blind, double-dummy, placebo- and active-controlled, parallel-group comparison of diclofenac-K and ibuprofen for the treatment of adults with influenza-like symptoms.
The alleviation of influenza-like symptoms, such as fever, headache, and muscle/joint aches and pains, is important so that sufferers can return to their normal daily activities. A flexible dosing regimen is proposed, starting with an initial dose of 2 tablets (2 x 12.5 mg), followed by 1 to 2 tablets every 4 to 6 hours as needed, to a maximum daily dose of 75 mg for up to 3 days for fever and 5 days for pain. This flexible dosing regimen matches the existing over-the-counter dosing regimen of ibuprofen, which allows the patient to adjust the treatment according to the type, duration, and severity of symptoms. ⋯ In this 3-day study, diclofenac-K 12.5 mg taken in a flexible dosing regimen was more effective than placebo in relieving influenza-like symptoms, with comparable tolerability Efficacy and tolerability of diclofenac-K were similar to those of ibuprofen 200 mg.
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Clinical therapeutics · Feb 2003
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialA comparison of 5-day courses of dirithromycin and azithromycin in the treatment of acute exacerbations of chronic obstructive pulmonary disease.
Short-term use of antibiotics has become a common component of the management of acute exacerbations of chronic bronchitis (AECB), particularly in complex cases with productive cough or purulent phlegm. The macrolide antibiotics, particularly second-generation agents such as dirithromycin and azithromycin, are among the antibiotic classes frequently recommended and used to treat upper and lower respiratory infections, including AECB. ⋯ The results of this study suggest comparable clinical efficacy between 5-day courses of once-daily dirithromycin and azithromycin in acute exacerbations of COPD. There were insufficient data to permit meaningful comparison of the bacteriologic efficacy of these macrolide antibiotics.
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Clinical therapeutics · Jan 2003
Randomized Controlled Trial Multicenter Study Clinical TrialEfficacy and safety profile of glimepiride in Mexican American Patients with type 2 diabetes mellitus: a randomized, placebo-controlled study.
Mexican Americans, the fastest growing ethnic group in the United States, have a 2- to 3-fold higher prevalence of type 2 diabetes mellitus relative to the non-Hispanic white population. It is estimated that 10% of Mexican Americans >or=20 years of age have diabetes. ⋯ These results indicate that once-daily glimepiride plus diet/exercise was effective in Mexican Americans with type 2 diabetes whose disease was inadequately controlled with diet/exercise alone. It appeared to be well tolerated in the population studied. More weight gain was seen with glimepiride compared with placebo. Given the high prevalence of type 2 diabetes among Mexican Americans, further clinical studies of glimepiride and other glucose-lowering therapies are needed in this ethnic subset.