Brief Answer:
Yes it is recommended to take Ryzodeg

Detailed Answer:
Dear Mr. XXXXXXX

I am actually pleased to see this question. You are in my definition a 'good patient' because a) You consulted a well qualified 'genuine' specialist for your father's diabetes b) you have asked the right questions regarding his medications.

First, it is needless to say that your father's diabetes is poorly controlled. The HbA1c is high and the blood sugars are high. Your endocrinologist has prescribed you Ryzodeg for the control of blood sugars.

Now to answer your question, Ryzodeg and Tresiba have both been granted approval by US-FDA in September 2015. Initially the FDA approval was rejected because of concern of Cardiovascular safety based on a meta-analysis. However, when the company resubmitted the documents and pointed to a direct study and not a meta-analysis, the FDA granted the approval.

This is the statement from FDA regarding the same:
"The data in the resubmission is more reliable than the data in the original CV-risk meta-analysis in that it is derived from a single trial specifically designed to address CV-risk. The analysis in the resubmission is also based on ~1.7 times the number of major adverse cardiovascular events (non-fatal MI, non-fatal strokes and CV-death) than the number of events in the meta-analysis. The analysis in the resubmission has definitely excluded the possibility that insulin degludec is associated with an excess in CV-risk of 80% over a comparator with no known CV-risk"

Which means the FDA has agreed that the drug is safe from Cardiovascular point of view. However, in the mean time the company had already launched a dedicated clinical trial to study that CV safety. The results of the trial are expected in 2018. This was done because they did not expect the FDA would approve the drug on resubmission of the documents !

So in summary, the US-FDA agrees that the drug is CV safe based on an earlier trial. Besides this the drug is approved for use in Europe and XXXXXXX since many years and deemed to be safe.

So to summarize, the drug is safe and approved by all regulatory agencies including the FDA and I think you should continue the insulin as advised by your Endocrinologist.

Regards
Dr. Om J Lakhani, MD
Department of Endocrinology
Sir XXXXXXX XXXXXXX Hospital,
New XXXXXXX

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