Current medical research and opinion
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Administrative claims databases provide a wealth of data for assessing the effect of treatments in clinical practice. Our aim was to propose methodology for real-world studies in multiple sclerosis (MS) using these databases. ⋯ The methods suggested in this study offer a good foundation for performing real-world research in MS using administrative claims databases, potentially allowing evidence from different studies to be compared and combined more systematically than in current research practice.
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Primary care physicians face significant challenges when treating painful diabetic peripheral neuropathy (pDPN). The physician must determine the best dosing strategy, consider the use of combination therapy, and decide how best to treat patients who have responded poorly to other treatment options in the past. With a focus on these issues, this paper will review the use of pregabalin for the treatment of pDPN in order to provide physicians with clinical data needed to develop, in combination with real-world prescribing data, effective treatment strategies for this common but challenging type of pain. ⋯ There is some difference with respect to the maximum approved dose of pregabalin for the treatment of pDPN in the United States (300 mg/day) and European Union (600 mg/day), though clinical data demonstrate that pregabalin doses >300 mg/day may be beneficial in some patients. Pregabalin has shown efficacy (and is approved) as a monotherapy for pDPN, although several guidelines recommend combination therapy for challenging cases. However, evidence to support combination therapy is sparse and the decision of monotherapy vs. combination therapy should be at the physician's discretion. There are data demonstrating the efficacy of pregabalin in some patients with pDPN who have not responded to other pharmacological treatments, including those unresponsive to treatment with gabapentin. Clinical guidelines acknowledge the paucity of head-to-head data among treatment options, but consistently recommend pregabalin as a first-tier treatment for pDPN.
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Randomized Controlled Trial Multicenter Study Comparative Study
A randomized, double-blind, phase 2 study evaluating the safety and efficacy of AMG 416 for the treatment of secondary hyperparathyroidism in hemodialysis patients.
Secondary hyperparathyroidism (SHPT) is a frequent complication of chronic kidney disease. We evaluated AMG 416, a long-acting peptide agonist of the calcium-sensing receptor, to assess its safety, tolerability, and efficacy and to determine a safe and effective starting dose for subsequent phase 2 studies. The study was not designed to titrate AMG 416 dosing to achieve a specific PTH treatment goal. ⋯ The present clinical findings support the continued development of AMG 416 as a treatment for SHPT in hemodialysis patients.
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Multicenter Study Observational Study
Real-life safety and efficacy of vildagliptin as add-on to metformin in patients with type 2 diabetes in Turkey--GALATA study.
To evaluate tolerability/safety and the efficacy of the combination of vildagliptin plus metformin in a real-life population of patients with type 2 diabetes mellitus (T2DM). ⋯ In a 'real-life' setting, the vildagliptin and metformin combination was associated with significant improvements in reaching target HbA1c levels, even in elderly and obese patients with T2DM. Moreover, vildagliptin and metformin demonstrated a good overall tolerability/safety profile.