Clinical therapeutics
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Clinical therapeutics · Nov 2003
Randomized Controlled Trial Multicenter Study Comparative Study Clinical TrialA multicenter, randomized, open-label, comparative, two-period crossover trial of preference, efficacy, and safety profiles of a prefilled, disposable pen and conventional vial/syringe for insulin injection in patients with type 1 or 2 diabetes mellitus.
The accuracy and convenience of pen devices for insulin injection have improved quality of life for patients with insulin-treated diabetes mellitus (DM). Prefilled, disposable pens have the advantage of simplicity, with minimal training and attention required and no installation of new cartridges necessary. ⋯ In this trial, differences in efficacy and safety profiles between the vial/syringe and prefilled, disposable pen appeared negligible. However, more patients expressed a preference to continue use of the pen.
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Clinical therapeutics · Nov 2003
Multicenter Study Comparative StudyA multicenter retrospective cohort study of practice patterns and clinical outcomes of the use of darbepoetin alfa and epoetin alfa for chemotherapy-induced anemia.
Darbepoetin alfa is the second erythropoietic protein to be approved for the treatment of chemotherapy-induced anemia (CIA). In the clinical setting, darbepoetin alfa can be administered less frequently than epoetin alfa with similar efficacy. Practice patterns and outcomes associated with the use of darbepoetin alfa and epoetin alfa in the clinical setting have not been reported. ⋯ Darbepoetin alfa 200 microg q2wk was used as a standard regimen for CIA at the 16 US oncology practices participating in this study. It appeared to be as effective as epoetin alfa 40,000 U qwk, with a reduced frequency of dosing.
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Clinical therapeutics · Nov 2003
The effects of intramuscular interferon beta-Ia in patients at high risk for development of multiple sclerosis: a post hoc analysis of data from CHAMPS.
In the Controlled High Risk Subjects Avonex Multiple Sclerosis Prevention Study (CHAMPS), intramuscular (IM) interferon beta-1a (IFNbeta-1a) delayed the development of clinically definite multiple sclerosis (CDMS) in patients with a single demyelinating event who had magnetic resonance imaging (MRI) evidence of previous subclinical disease activity (defined as >or=2 T2-weighted hyperintense lesions, 1 of which was periventricular or ovoid, on unenhanced MRI scans). ⋯ The results of this subgroup analysis are compatible with IM IFNbeta-1a reducing the risk of a second demyelinating event in patients meeting the more stringent definition of high risk. Although the treatment effect of IFNbeta-1a was significant in both the overall CHAMPS population (44% risk reduction vs placebo; P = 0.002) and in this high-risk subgroup (66%), the results of the present analysis suggest that the magnitude of treatment benefit with IFNbeta-1a may be greater in patients with more disease activity, as measured by MRI parameters.
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Clinical therapeutics · Nov 2003
Measuring satisfaction with migraine treatment: expectations, importance, outcomes, and global ratings.
Patients tend to express high satisfaction with treatment using global rating scales. Previous work in health services, marketing, and operations research suggested that global ratings of satisfaction need to account for multiple influences and differing patient values. Prior qualitative work with patients and clinicians supported a 4-part model that incorporates the gap between expectations and outcomes of treatment and accounts for the relative importance of different treatment attributes. ⋯ The 4-part conceptual model reflecting multiple attributes of treatment and preliminary scoring system for the MTSM generated satisfaction scores that improved discrimination among patients. Further validation is warranted.
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Clinical therapeutics · Nov 2003
Change in opioid use after the initiation of gabapentin therapy in patients with postherpetic neuralgia.
Postherpetic neuralgia (PHN) is a chronic painful disorder that sometimes develops after an acute episode of herpes zoster infection (shingles) and can be difficult to treat. Although opioids are sometimes effective for chronic neuropathic pain, adverse effects are common, particularly among the elderly, and may cause many patients to discontinue therapy. ⋯ In this study, initiation of gabapentin therapy in patients with PHN was associated with a reduction in the use of opioid analgesics.