Home » Diabetes, Aifa approves a new therapy

Diabetes, Aifa approves a new therapy

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When a single therapy is no longer enough to keep blood sugar under control, we must look further: the Italian Medicines Agency (Aifa) has just approved the combination of dulaglutide, latest generation active ingredient, with oral hypoglycemic Sglt-2 inhibitors, when these are no longer effective enough. The new indication comes from the evaluation of the data of an important international study (Award-10) which demonstrated how dulaglutide, a glp1 receptor agonist (glucagon like peptide-1), allows to improve glycemic control compared to Sglt inhibitors alone. 2. Dulaglutide (by Eli Lilly) is a very simple therapy, which involves only one injection per week and which protects against the possibility of hypo and hyperglycemia, also helping to reduce weight and significantly reducing the risk of cardiovascular events even in those who does not have established cardiovascular disease.

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“Type 2 diabetes progresses over time, so patients are often forced to change their lifestyle and therapies to maintain the same blood glucose goals,” he notes. Angelo Avogaro, director of the complex operating unit of Metabolic Diseases of the University Hospital of Padua and elected president of the Italian Diabetes Society – Aifa’s approval of the association of dulaglutide with sglt-2 inhibitors is a great help in this sense: when these oral hypoglycemic agents, which increase the urinary excretion of glucose by inhibiting the sodium-glucose co-transporter, are no longer sufficient to achieve a good glycemic compensation, the association with the Glp1 receptor agonist allows a better glycemic control with simple and well tolerated treatment. In fact, only one subcutaneous administration per week is enough for therapy with dulaglutide: although it is an injection therapy, patients accept it willingly and this translates into greater adherence to treatment and better results. Furthermore – concludes Avogaro – the injection with the ‘pen’ is very simple and this helps patients to approach injection therapy with greater confidence and ease “.

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The data from the award-10 study showed that the combination of Dulaglutide 0.75 or 1.5 milligrams with Sglt-2 inhibitors improves metabolic control already after six months; moreover, Dulaglutide allows a significant decrease in body weight and is above all the only drug for which an effect of reducing the risk of cardiovascular events has been demonstrated even in patients without established cardiovascular disease. The weight reduction and glycemic control possible with dulaglutide are dose-dependent, i.e. they increase as the dosage of the drug increases: for this reason the Aifa approved dulaglutide with two further dosages, 3 and 4.5 milligrams, following the evaluation of data from the award-11 study.

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“This study included over 1,800 people with type 2 diabetes randomized to receive dulaglutide 1, 5, 3, or 4.5 milligrams in a weekly injection: the results show that higher doses allow for better and better glycemic control. a significantly increasing weight loss – explains Enzo Bonora, full professor of Endocrinology at the University of Verona and director of the UOC of Endocrinology, Diabetology and Metabolic Diseases of the Integrated University Hospital of Verona – with the standard dosage of 1.5 milligrams glycated hemoglobin decreases by 1.5% and approximately 3 kg are lost, with dulaglutide 3 milligrams the glycate is lowered by 1.7% and weight decreases by approximately 4 kg, with maximum dosage the glycated hemoglobin decreases 1.9% and almost 5 kg are lost on average, very significant data in absolute terms; all this without affecting tolerability “.

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The availability of a wider range of drug dosages means having greater flexibility of use and being able to meet needs that change even during the course of the disease, for example by increasing the dose if glycemic control worsens and ongoing treatment does not satisfy. more patient needs. Furthermore, the possibility of associating the glp-1 receptor agonist with a therapy with an sglt-2 inhibitor, but also vice versa, increases the possibility of better management of the disease in a greater number of cases “.

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