Clinical therapeutics
-
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.
-
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.
-
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.
-
Clinical therapeutics · Nov 2003
Bioequivalence and other unresolved issues in generic drug substitution.
Substitution of generic drugs for brand-name products is highly controversial and often is met with suspicion by health care providers and patients. Historically, the debate has focused on the issue of bioequivalence, and clinical practice has identified a number of drug classes for which generic substitution should be approached with caution. Current bioequivalence requirements are based on a measure of average bioequivalence; however, there are fears that use of this measure may be inappropriate in the case of a drug with a narrow or wide therapeutic range or high intrasubject or intersubject variability. Under these circumstances, measures of individual and population bioequivalence are proposed to be more accurate than measures of average bioequivalence. ⋯ I recommend that health care providers continue to exercise caution in the consideration of generic drug substitution under certain circumstances.
-
Clinical therapeutics · Oct 2003
Review Comparative StudyUse of gabapentin for postherpetic neuralgia: results of two randomized, placebo-controlled studies.
Postherpetic neuralgia (PHN), which affects up to 70% of elderly persons with herpes zoster, can have debilitating effects, including physical and social disability and significant psychological distress. A variety of agents have been used, either singly or in combination, to control PHN, including topical and oral analgesics, antidepressants, and antiepileptic drugs (AEDs). However, PHN often proves refractory to these therapies. ⋯ Gabapentin may provide benefits in terms of alleviation of pain and overall quality of life in patients with chronic PHN.