Issues in emerging health technologies
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Issues Emerg Health Technol · Oct 2005
Roflumilast for asthma and chronic obstructive pulmonary disease.
Roflumilast is an inhibitor of phosphodiesterase- IV (PDE4), a cellular enzyme that is linked to airway inflammation in asthma and chronic obstructive pulmonary disease (COPD). In clinical trials, roflumilast produced significant improvements in FEV1 (forced expiratory volume in one second) and PEF (peak expiratory flow) compared with low-dose inhaled beclomethasone in asthma patients, and compared with placebo in COPD patients. Roflumilast reduced the use of rescue medication in both populations. ⋯ Evidence is only available in non-peer-reviewed format abstracts. Most of the measures used are markers of clinical effects as opposed to clinical outcomes. More studies are needed to determine the role of roflumilast in the treatment of asthma and COPD.
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Sativex (R) is a cannabis-based pharmaceutical product containing delta 9-tetrahydrocannabinol (THC) and cannabidiol (CBD) in a 1:1 ratio, delivered in an oromucosal (mouth) spray. It has been approved as adjunctive treatment for neuropathic pain in patients with multiple sclerosis (MS). It is being investigated for the management of other MS symptoms, such as spasticity. ⋯ In some trials, THC:CBD spray significantly reduced neuropathic pain, spasticity, muscle spasms and sleep disturbances. The most common adverse events (AEs) reported in trials were dizziness, sleepiness, fatigue, feeling of intoxication and a bad taste. Long-term safety and the potential for dependence, abuse, misuse and diversion are unknown.
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The Philips HeartStart Home Defibrillator is an automated external defibrillator (AED) that is approved for home use by untrained users. Most cardiac arrests occur in the home, so a rapid response with cardiopulmonary resuscitation (CPR) and defibrillation is critical for survival. No prospective studies demonstrate that the use of AEDs in the home by untrained persons improves health outcomes. Further investigation is needed to determine the benefit and harm of AEDs in the home.
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Pregabalin is an anticonvulsant drug that is under review for use in Canada. It was recently approved in the US and Europe for the treatment of adults with peripheral neuropathic pain (NeP). In most short-term randomized controlled trials (RCTs) of pregabalin in patients with diabetic peripheral neuropathy (DPN) and or post-herpetic neuralgia (PHN), there were early and significant decreases in mean pain scores. ⋯ The most common adverse effects were dizziness and sleepiness. Withdrawal due to adverse events was also more frequent with pregabalin than with placebo. While pregabalin appears to be an effective treatment for NeP, there is no evidence that it offers advantages over treatments being used in Canada.
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Issues Emerg Health Technol · Mar 2005
Memantine for treatment of moderate to severe Alzheimer's disease.
Health Canada has issued a Notice of Compliance with conditions (NOC/c) for memantine in the treatment of moderate to severe Alzheimer's disease (AD). The evidence of relative benefit and harm from memantine in this population derives from two randomized controlled trials (RCT) of 24 to 28 weeks duration, in a total of 656 patients; and a post hoc subgroup analysis of 79 patients with severe AD from a third trial of 12 weeks. Memantine alone or in combination with donepezil demonstrates improvements in primary outcome scores of activities of daily living and cognition, but not of global performance. Memantine's rate of diffusion may be rapid, as it is the only drug available for severe AD and it has a potential for use in unapproved indications.