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FDA guidance on diabetes safety clinical trials

In 2008, the Food and Drug Administration mandated the pharmaceutical industry to prove cardiovascular safety for all new anti-diabetes medications. As a consequence, we presently have critically useful safety data from clinical trials like LEADER, SUSTAIN, CANVAS, PIONEER 6, DECLARE-TIMI 58, and REWIND.

The FDA has now issued a new draft recommendation to broaden the above requirement by including safety clinical trials for nephropathy, neuropathy, retinopathy, and sleep apnea, in addition to ischemic atherosclerosis. The rationale is that the above non-ASCVD complications can also increase the mortality risk in patients with type 2 diabetes.

Although recommendations have not been specified or finalized, they will change the landscape of anti-diabetes clinical research for the next 15 years. Stay tuned.

I am the decisive element

I have come to the frightening conclusion that I am the decisive element. It is my personal approach that creates the climate. It is my daily mood that makes the weather… In all situations, it is my response that decides whether a crisis is escalated or de-escalated, and a person is humanized or is dehumanized.

Goethe

2020 ADA guidelines: Key Revisions

Here you can find the critical modifications in 2020 ADA guidelines. Particular emphasis is placed on pharmacological therapy with GLP-1 agonists or SGLT-2 inhibitors for patients with established cardiovascular disease, heart failure, or chronic kidney disease. Guidelines are published yearly in the month of January.

History in Brief: Age of Reason

Here is a good summary of the enlightenment period lasting approximately from 1685 to 1815. Enlightenment was founded on Italian and Northern Renaissance Humanism, which in turn gave way to Romanticism, Liberalism, Classicism, and Modernism.

“If I have seen further than others, it is by standing upon the shoulders of giants.”

“It is dangerous to be right in matters on which the established authorities are wrong.”

“Dare to know! Have the courage to use your own reason!”

The above three quotes of legendaries, Isaac Newton, Voltaire, and Immanuel Kant, capture the spirit of the age:

Harmony of the whole

Beauty: the adjustment of all parts proportionately so that one cannot add or subtract or change without impairing the harmony of the whole.

Leon Battista Alberti

New FDA approval: oral medication for Cushing’s disease

Cushing’s syndrome (CS) is a rare condition. It’s health consequences can be severe, leading to visceral adiposity, muscle weakness, depression, insulin resistance, diabetes, blood clots, reduced immune system, and cardiovascular disease.

A portion of patients diagnosed with CS has Cushing’s disease (CD). In Cushing’s disease, the root cause of hypercortisolism is a pituitary tumor producing excessive ACTH hormone. The preferred treatment is pituitary surgery. Unfortunately, in a small subset of patients, the operation is not successful or indicated.

To address the health concerns for individuals who are not responsive or candidates for pituitary tumor resection, the FDA has now approved a backup treatment via the oral drug Isturisa.

Isturisa, taken twice daily, is a potent inhibitor of 11-β-hydroxylase, a key enzyme in cortisol production. Side effects can include relative adrenal insufficiency, swelling, nausea, vomiting, and headaches. Clinical studies have shown that about 50% of patients respond to therapy.

Isturisa is an excellent addition to the arsenal of combating refractory Cushing’s disease.

Dr. Tashko

Testosterone for Women

Women who are diagnosed accurately with hypoactive sexual desire dysfunction (HSDD) and female sexual arousal disorder (FSAD), could benefit from testosterone supplementation. Testosterone therapy appears to be helpful and safe when the dose does not exceed premenopausal physiological levels. For more details, refer to the Global Position Statement published in JCEM in October 2019.

Motivic Unity

His remarkable flair for text illustration is evident even in the early cantatas, particularly the two finest of them, the Actus tragicus, BWV 106, and Christ lag in Todes Banden, BWV 4. We already sense a powerful mind behind the notes in the motivic unity of the early cantatas, in the use of reprise to bind their mosaic forms together.

Richard D. P. Jones

New FDA approval: fish oil (vascepa) for cardiovascular risk reduction

Vascepa is a form of omega-3 fish oil named icosapent ethyl. It was first approved by the FDA in 2012 for the treatment of severe hypertriglyceridemia, as defined by blood triglyceride levels >500 mg/dL.

The FDA has now added a second indication for Vascepa. It can be utilized in patients with established cardiovascular disease or in those who have diabetes plus two or more other risk factors (e.g., hypertension, hypercholesterolemia, smoking, kidney dysfunction) for cardiovascular disorder. Before treatment, patients must also have baseline triglyceride measures >150 mg/dL.

This significant approval comes after reviewing the results of REDUCE-IT, a landmark randomized clinical trial published in NEJM, January 2019. REDUCE-IT confirmed significant cardiovascular outcome reduction of 25% in patients receiving icosapent ethyl when added to statin therapy.

I anticipate widespread use of the fish oil, icosapent ethyl, especially in patients with diabetes, who, by its nature of insulin resistance, frequently have both the increased risk of ASCVD and high triglycerides. Clinicians should be aware of possible induction or worsening of atrial fibrillation, atrial flutter, and bleeding with Vascepa, particularly in the predisposed individuals.

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