scholarly journals Qualified health claim for whole-grain intake and risk of type 2 diabetes: an evidence-based review by the US Food and Drug Administration

2016 ◽  
Vol 74 (10) ◽  
pp. 601-611 ◽  
Author(s):  
Sedigheh Yamini ◽  
Paula R. Trumbo
Keyword(s):  
Type 2 Diabetes ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Evidence Based ◽  
Whole Grain ◽  
Health Claim ◽  
The Us

Psyllium husk intake and risk of type 2 diabetes: an evidence-based scientific and regulatory review of a qualified health claim conducted by the US Food and Drug Administration

2020 ◽  
Vol 78 (10) ◽  
pp. 787-797
Author(s):  
Crystal R Rivers ◽  
Mark A Kantor
Keyword(s):  
Type 2 Diabetes ◽  
Drug Administration ◽  
Scientific Evidence ◽  
Food And Drug Administration ◽  
Evidence Based ◽  
Health Claim ◽  
Regulatory Review ◽  
Psyllium Husk ◽  
The Us

Abstract The US Food and Drug Administration (FDA) received a petition from a company requesting that FDA issue an authorized health claim for the relationship between psyllium husk and a reduced risk of type 2 diabetes. After an initial assessment of the available scientific evidence, FDA determined that significant scientific agreement was lacking for this substance-disease relationship, whereupon the company agreed to have its petition reviewed as a qualified health claim. This article describes the process FDA used in conducting an evidence-based review of the science underpinning the proposed claim and addresses certain safety issues associated with psyllium husk that FDA considered in its review of the petition. Of the 6 studies from which scientific conclusions could be drawn, as identified through FDA’s review, psyllium husk significantly improved plasma glucose levels and insulin sensitivity in only 1 study. Therefore, FDA’s enforcement discretion letter for this qualified health claim stated: “Psyllium husk may reduce the risk of type 2 diabetes, although the FDA has concluded that there is very little scientific evidence for this claim.”

scholarly journals Heart Failure End Points in Cardiovascular Outcome Trials of Sodium Glucose Cotransporter 2 Inhibitors in Patients With Type 2 Diabetes Mellitus

Circulation ◽  
2019 ◽  
Vol 140 (25) ◽  
pp. 2108-2118 ◽  
Author(s):  
Javed Butler ◽  
Milton Packer ◽  
Stephen J. Greene ◽  
Mona Fiuzat ◽  
Stefan D. Anker ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Heart Failure ◽  
Type 2 Diabetes ◽  
Type 2 Diabetes Mellitus ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
End Points ◽  
Sodium Glucose Cotransporter ◽  
The Us

Following regulatory guidance set forth in 2008 by the US Food and Drug Administration for new drugs for type 2 diabetes mellitus, many large randomized, controlled trials have been conducted with the primary goal of assessing the safety of antihyperglycemic medications on the primary end point of major adverse cardiovascular events, defined as cardiovascular death, nonfatal myocardial infarction, or nonfatal stroke. Heart failure (HF) was not specifically mentioned in the US Food and Drug Administration guidance and therefore it was not a focus of these studies when planned. Several trials subsequently showed the impact of antihyperglycemic drugs on HF outcomes, which were not originally specified as the primary end point of the trials. The most impressive finding has been the substantial and consistent risk reduction in HF hospitalization seen across 4 trials of sodium glucose cotransporter 2 inhibitors. However, to date, these results have not led to regulatory approval of any of these drugs for a HF indication or a recommendation for use by US HF guidelines. It is therefore important to explore to what extent persuasive treatment effects on nonprimary end points can be used to support regulatory claims and guideline recommendations. This topic was discussed by researchers, clinicians, industry sponsors, regulators, and representatives from professional societies, who convened on the US Food and Drug Administration campus on March 6, 2019. This report summarizes these discussions and the key takeaway messages from this meeting.

Primer on Depression

Depression ◽  
2019 ◽  
pp. 197-217
Author(s):  
Naji C. Salloum ◽  
George I. Papakostas
Keyword(s):  
Major Depressive Disorder ◽  
Depressive Disorder ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Mechanisms Of Action ◽  
Evidence Based ◽  
Augmentation Strategies ◽  
Investigational Drugs ◽  
The Us ◽  
Initial Medication

Several first-line antidepressant therapies are currently available for the treatment of major depressive disorder (MDD), but in most patients depression fail to remits after an initial medication trial. In this chapter, we explore the evidence for different augmentation strategies used to enhance the response from an initial antidepressant monotherapy. Atypical antipsychotics, several of which are now approved by the US Food and Drug Administration as adjunctive agents for the treatment of MDD, and lithium are among the most evidence-based augmentation pharmacotherapies. Other therapies, such as bupropion, mirtazapine, triiodothyronine, nutraceuticals, and psychotherapy, are also commonly used. Additionally, several investigational drugs, including ketamine, esketamine, and ALKS 5461, with novel mechanisms of action, show promise.

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