Clinical therapeutics
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Clinical therapeutics · Feb 2004
Randomized Controlled Trial Multicenter Study Clinical TrialEfficacy and tolerability of sumatriptan tablets in a fast-disintegrating, rapid-release formulation for the acute treatment of migraine: results of a multicenter, randomized, placebo-controlled study.
Sumatriptan tablets have been developed in a fast-disintegrating, rapid-release formulation designed to facilitate tablet disintegration and drug dispersion and to potentially mitigate the effects of gastric stasis that can accompany migraine. ⋯ In this study, sumatriptan tablets in a fast-disintegrating, rapid-release oral formulation provided pain-free efficacy in the acute treatment of migraine. Efficacy was maximized with the 100-mg dose compared with the 50-mg dose, and by treating early when pain was mild. In the intent-to-treat population, 51.1% of patients who received sumatriptan 50 mg and 66.2% of those who received sumatriptan 100 mg were pain free 2 hours after dosing. In the per-protocol population, 3 of 4 patients taking the 100-mg tablets for mild pain within 1 hour of its onset were pain free at 2 hours. Sumatriptan tablets were generally well tolerated.
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Clinical therapeutics · Feb 2004
ReviewStress-related mucosal disease: risk factors and prophylactic therapy.
The term stress-related mucosal disease (SRMD) represents a continuum of conditions ranging from stress-related injury (superficial mucosal damage) to stress ulcers (focal deep mucosal damage). Caused by mucosal ischemia, SRMD is most commonly seen in critically ill patients in the intensive care unit (ICU). Prophylaxis of stress ulcers may reduce major bleeding but has not yet been shown to improve survival. ⋯ Recent studies of PPIs have shown promising results in high-risk patients, making this class of drugs an option for the prophylaxis of SRMD.
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Clinical therapeutics · Feb 2004
Effects of blood loss and fluid volume replacement on serum and tissue gentamicin concentrations during colorectal surgery.
The prophylactic administration of antimicrobial agents to surgical patients has become standard practice to minimize the risk for postsurgical infection. During surgery, factors such as renal clearance, fluid administration, and blood loss contribute to drug concentrations achieved in the blood and tissues. The aminoglycoside gentamicin was chosen to investigate these factors because it is used for standard antimicrobial prophylaxis in colorectal surgery. ⋯ In this study, the administration of a 2-mg/kg dose of gentamicin as antimicrobial prophylaxis during colorectal surgery associated with significant intraoperative blood loss and therefore requiring significant fluid replacement did not achieve concentrations of the drug above MICs for gram-negative microorganisms throughout the procedures in either serum or tissue samples.