Benefits from Metformin, sitagliptin and Gliptinen

Advantage for sitagliptin

In a first benefit assessment in the stock market after AMNOG rules IQWiG has reduced for the group of DPP-4 inhibitors mainly the thumb. Only for sitagliptin sees indications of an additional benefit. Now the ball is in the GBA, which decides on the added value.


IQWiG recognizes in Gliptinen on
When standard therapy target near normal blood glucose lowering sitagliptin has an advantage.

COLOGNE. According to an order of the JCC, IQWiG has evaluated the group of DPP-4 inhibitors on their added value in recent months, either as a single agent or as a fixed combination with metformin vildagliptin and vildagliptin / metformin, sitagliptin and sitagliptin / metformin and saxagliptin.

These medicines were registered between 2007 and 2009.

Only for sitagliptin could IQWiG evidence for a small additional benefit compared to sulfonylureas recognize when near-normal blood sugar levels are the goal of therapy.

Compared to the non-approved in Germany sulfonylurea glipizide, the additional benefit in men is even significantly, in women but not quantifiable.

Study unsatisfactory situation

With the exception of sitagliptin as mono-preparation inferred from the present study data for any of the Gliptine derive an additional benefit, the IQWiG. Many of the studies conducted so far are not suitable for the Institute considers to provide answers to the additional benefits.

IQWiG sees several reasons for this: some indications for the manufacturers themselves could not provide data in the dossier, because there were no studies.

This applies for instance for sitagliptin and vildagliptin each in combination with a sulfonylurea. In other cases, the manufacturer had submitted studies in which no interest was the group of patients studied.

Studies are therefore unsuitable partly because the drugs were not used in the comparison group, as is provided by the SPC. The comparison drugs were partially overdosed partially the dose was increased too quickly.

So that side effects were risking which would have discriminated the comparison therapy. There are substantive, not merely formal arguments, emphasizing the IQWiG, overlooking the rejection of such data to demonstrate the added value of innovative therapy.

IQWiG has recognized a study in which the combination of sitagliptin / metformin compared glimepiride / metformin was tested and, in most endpoints, no relevant difference was shown.

Uniform picture side effects

In the side effects the picture was mixed: On the one hand were no severe hypoglycaemia with sitagliptin rare on the other hand, broke participants in this study arm frequently therapy due to adverse events.

In the balance sheet, the IQWiG sees this as a clue for a small additional benefit, if the goal of therapy is a near-normal blood sugar.

Compared to the non-approved in Germany sulfonylurea glipizide, sitagliptin was superior in combination with metformin.

In the Glipzid group, eight deaths in the sitagliptin group, only one (all men). Regardless of gender sitagliptin were rarely severe and symptomatic hypoglycemia.

In the overall balance of the IQWiG assessment of the Gliptine the Federal Committee faces a difficult decision.

If no additional benefit recognized in comparison with an old generic therapy, then the linagliptin decision could be a precedent. The generic price would be the immovable scale.

The Institute's recommendations to the JCC at a Glance
Substance / Indications benefit category
Sitagliptin
Monotherapy no additional benefit
A add on to metformin) vs.. Glimepiride and metformin therapy in low ZN near-normal blood glucose goal setting
b) vs. Glipizide and metformin: ZN significant for men, non-quantifiable ZN (most significant) for women, all at near-normal blood glucose treatment goal setting
Add on SU * no additional benefit
Add on to metformin and SU * no additional benefit
Add on insulin + / - metformin no additional benefit
Sitagliptin / metformin
Add on to metformin no additional benefit
Add on to metformin and SU * no additional benefit
Add on insulin + / - metformin no additional benefit
Saxagliptin
Add on to metformin no additional benefit
Add on SU * no additional benefit
Add on to metformin and SU * no additional benefit
Add on insulin + / - metformin no additional benefit
Saxagliptin / metformin
Add on to metformin and SU * no additional benefit
Vildagliptin
Monotherapy no additional benefit
Add on to metformin no additional benefit
Add on SU * no additional benefit
Add on to metformin and SU * no additional benefit
Add on insulin + / - metformin no additional benefit
Vildagliptin / metformin
Add on to metformin no Zuatznutzen
Add on to metformin and insulin no additional benefit
Add on insulin + / - metformin no additional benefit
* SU = sulfonylurea table: Ärztezeitung