Current medical research and opinion
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Randomized Controlled Trial Multicenter Study Comparative Study
Gabapentin enacarbil in Japanese patients with restless legs syndrome: a 12-week, randomized, double-blind, placebo-controlled, parallel-group study.
Gabapentin enacarbil (GEn) was effective and well-tolerated for the treatment of restless legs syndrome (RLS) in North American studies. However, no placebo-controlled studies of GEn have been performed in Asian patients with RLS. Therefore, we investigated the efficacy and safety of GEn in Japanese patients with RLS to determine the optimal dosage. ⋯ GEn is effective and well-tolerated for the treatment of RLS in Japanese patients. All three doses produced improvements in IRLS compared with placebo; 600 mg GEn is a suitable target dose. However, our analysis possibly introduced positive bias by assuming that symptoms improve after discontinuation.
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Multicenter Study Clinical Trial
THAOS - The Transthyretin Amyloidosis Outcomes Survey: initial report on clinical manifestations in patients with hereditary and wild-type transthyretin amyloidosis.
Transthyretin (TTR) amyloidosis is a rare, life-threatening, systemic, autosomal dominant condition occurring in adults, with two main forms: hereditary (associated with TTR gene mutations) and wild-type. Studies indicate considerable heterogeneity in disease presentation, with predominantly polyneuropathic, predominantly cardiac, or mixed phenotypes. ⋯ This preliminary analysis highlights the considerable phenotypic heterogeneity for neurological and cardiac manifestations in patients with hereditary and wild-type TTR amyloidosis and the necessity of providing multidisciplinary care. THAOS registry data will help better characterize the diverse presentation and course of TTR amyloidosis worldwide and aid in improving and standardizing diagnosis and treatment.
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Clinical Trial
Meaningful cut-off pain intensity for breakthrough pain changes in advanced cancer patients.
To assess the level of pain intensity at which patients feel the impetus to ask for a breakthrough cancer pain (BTcP) medication, and level of pain intensity at which patients consider they have achieved acceptable pain control after receiving a BTcP medication. ⋯ The meaningful BTcP intensity and pain intensity expected after BTcP medication can be useful in selecting patients in studies of BTcP. The principal limitation of this study was the specific setting of an acute unit with specific features and the relatively low number of patients. This observation should be followed up by further surveys with a larger number of patients and different settings.
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Randomized Controlled Trial Multicenter Study Comparative Study
Efficacy and safety of ceftazidime-avibactam versus imipenem-cilastatin in the treatment of complicated urinary tract infections, including acute pyelonephritis, in hospitalized adults: results of a prospective, investigator-blinded, randomized study.
The aim of this prospective phase II, randomized, investigator-blinded study (NCT00690378) was to compare the efficacy and safety of ceftazidime-avibactam and imipenem-cilastatin in hospitalized adults with serious complicated urinary tract infection (cUTI) due to Gram-negative pathogens. ⋯ The results suggest that the efficacy and safety of ceftazidime-avibactam may be similar to that of imipenem-cilastatin.
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An intranasal (IN) formulation of ketorolac was recently FDA approved in adult patients for the short-term management of moderate to moderately severe pain that requires analgesia at the opioid level. ⋯ Based on the clinical trials reviewed, IN ketorolac was associated with significant pain reduction in patients with various post-operative procedures, with good tolerability.