Clinical therapeutics
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Clinical therapeutics · May 2008
Review Case ReportsAcute generalized exanthematous pustulosis induced by hydroxychloroquine: three cases and a review of the literature.
Acute generalized exanthematous pustulosis (AGEP) is a clinical reaction pattern that is principally drug induced and is characterized by acute, extensive formation of nonfollicular sterile pustules on an erythematous and edematous substrate. Hydroxychloroquine (HHCQ), an antimalarial drug widely used to treat rheumatic and dermatologic diseases, has been described as an uncommon cause of AGEP. ⋯ This article reports 3 cases of AGEP related to administration of HCQ. HCQ-induced AGEP is a rare but severe, extensive, and acute reaction. No specific therapy is available, and correct diagnosis generally leads to spontaneous resolution once the causative drug has been withdrawn.
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Clinical therapeutics · May 2008
Randomized Controlled Trial Comparative StudyEffect of exenatide on 24-hour blood glucose profile compared with placebo in patients with type 2 diabetes: a randomized, double-blind, two-arm, parallel-group, placebo-controlled, 2-week study.
The aim of this study was to examine the glucose-lowering effect of exenatide over 24 hours in patients with type 2 diabetes with inadequate glycemic control using metformin, with or without a thiazolidinedione (TZD). ⋯ In these patients with type 2 diabetes, exenatide was associated with significantly reduced glucose concentrations at multiple time points during 24 hours, with the greatest effect seen on postprandial glucose concentrations. In addition, exenatide was associated with decreased overall hyperglycemic exposure and significantly decreased postprandial triglyceride excursions. These results are consistent with those seen in other studies that reported the effectiveness of exenatide in controlling hyperglycemia in patients with type 2 diabetes.
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Clinical therapeutics · May 2008
ReviewRotigotine transdermal system for the treatment of Parkinson's disease.
Levodopa has been the cornerstone of the treatment of Parkinson's disease (PD) for >30 years, but long-term levodopa therapy is associated with development of such motor complications as motor fluctuations, dyskinesias, and drug-induced involuntary movements. Rotigotine is a dopamine agonist with high affinity for the D(2) receptor. Rotigotine transdermal system, the first such system approved by the US Food and Drug Administration for the management of PD, has been formulated to deliver a consistent concentration of drug to the bloodstream with the goal of minimizing the complications associated with pulsatile dosing. ⋯ The available evidence suggests that rotigotine transdermal system was effective compared with placebo in decreasing morbidity in patients with early and advanced PD. The most commonly reported adverse events associated with rotigotine transdermal system were application-site reaction, nausea, and somnolence. Additional clinical trials are needed to determine the long-term tolerability profile of rotigotine transdermal system and its clinical efficacy and tolerability compared with oral dopamine agonists.
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Clinical therapeutics · May 2008
Validity, reliability, and clinical importance of change in a 0-10 numeric rating scale measure of spasticity: a post hoc analysis of a randomized, double-blind, placebo-controlled trial.
The measurement of spasticity as a symptom of neurologic disease is an area of growing interest. Clinician-rated measures of spasticity purport to be objective but do not measure the patient's experience and may not be sensitive to changes that are meaningful to the patient. In a patient with clinical spasticity, the best judge of the perceived severity of the symptom is the patient. ⋯ The measurement of the symptom of spasticity using a patient-rated 0-10 NRS was found to be both reliable and valid. The definitions of CID and MCID will facilitate the use of appropriate responder analyses and help clinicians interpret the significance of future results.
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Clinical therapeutics · May 2008
In vitro stability of two formulations of recombinant activated factor VIIa reconstituted in inappropriate solvents or at inappropriate volumes.
Recombinant activated factor VIIa (rFVIIa) is indicated for on-demand treatment of bleeding and the prevention and treatment of surgical bleeding in patients with hemophilia A or B who have antibodies to coagulation factors VIII or IX. The currently approved single-use formulation of rFVIIa is freeze dried and is stable for up to 3 years when stored at 2 degrees C to 8 degrees C (36 degrees F-46 degrees F). A new formulation has been developed that is stable for up to 2 years when stored at temperatures up to 25 degrees C (77 degrees F). This formulation does not require refrigerated storage and does not have to be brought to room temperature before use. Both formulations must be reconstituted before use. The original formulation is reconstituted with sterile water for injection (SWFI), whereas the new formulation is reconstituted with a solvent containing histidine. ⋯ Based on the results of these experiments, the 2 rFVIIa products should be reconstituted using the appropriate solvent at the correct volume.