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EMPA-REG and Other Cardiovascular Outcome Trials of Glucose-lowering Agents: Implications for Future Treatment Strategies in Type 2 Diabetes Mellitus.
Abstract During the last decade, the armamentarium for glucose-lowering drugs has increased enormously by the development of DPP-4 inhibitors, GLP-1 receptor agonists and SGLT2 inhibitors, allowing individualization of antidiabetic therapy for patients with type 2 diabetes (T2DM). Some combinations can now be used without an increased risk for severe hypoglycemia and weight gain. Following a request of the US Food and Drug Administration, many large cardiovascular (CV) outcome studies have been performed in patients with longstanding disease and established CV disease. In the majority of CV outcome studies, CV ris...
Source: Clinical Therapeutics - May 18, 2016 Category: Drugs & Pharmacology Authors: Schernthaner G, Schernthaner-Reiter MH, Schernthaner GH Tags: Clin Ther Source Type: research

Number needed to harm in the post‐marketing safety evaluation: results for rosiglitazone and pioglitazone
ConclusionThe NNH values suggested an increased CV risk with rosiglitazone versus pioglitazone across several sources of information. The inclusion of objective metrics in post‐marketing drug's benefit–risk assessments could be of increased value and help RAs to make consistent decisions on drug safety. Copyright © 2015 John Wiley & Sons, Ltd.
Source: Pharmacoepidemiology and Drug Safety - September 1, 2015 Category: Drugs & Pharmacology Authors: Diogo Mendes, Carlos Alves, Francisco Batel‐Marques Tags: Original Report Source Type: research

FDA approves alogliptin for type 2 diabetes as three separate preparations
Source: FDA Area: News The FDA has approved alogliptin for the treatment of type 2 diabetes as three separate preparations: alogliptin monotherapy; alogliptin in combination with metformin; and alogliptin in combination with pioglitazone.   Alogliptin stimulates insulin release following meals and was shown to be safe and effective as monotherapy in 14 clinical trials involving approximately 8,500 patients with type 2 diabetes.  Alogliptin monotherapy reduced glycosylated haemoglobin (HBA1c) by 0.4 to 0.6% compared to placebo following 26 weeks of treatment.   The FDA has requested additional data ...
Source: NeLM - News - January 28, 2013 Category: Drugs & Pharmacology Source Type: news