Press Release: Institute for Quality and Efficiency in Health Care (IQWiG)
In its first evaluation of the existing market IQWiG sees evidence of additional benefits
No meaningful data for other Gliptine
In the free combination of sitagliptin with metformin, there is evidence for a small additional benefit compared to sulfonylureas, where 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 quite substantially. For other substances from the group of Gliptine an additional benefit, however, is not used. To this result, the Institute comes to quality and Efficiency in Health Care (IQWiG), which at first July 2013, the first dossier evaluations of drug market Restructuring Act (AMNOG) has presented for the so-called stock market. Were the subject of active substances from the group of Gliptine.
Major order package to Gliptinen
To the test came three drugs, either as single agent or as a fixed combination with metformin vildagliptin and vildagliptin / metformin, sitagliptin and sitagliptin / metformin and saxagliptin. This had been approved in Germany to treat people with type 2 diabetes mellitus respectively between 2007 and 2009. You are eligible if those concerned with diet and exercise alone can not lower their blood sugar enough or can not tolerate other oral antidiabetic agents.
At the same time, the Institute has also completed a dossier evaluation of fixed-dose combination of saxagliptin and metformin. This was first brought to market in late 2011 and assessed by IQWiG. She received an approval in early 2013 for an additional field of application, which has now also been studied by IQWiG.
Available studies for benefit assessment is not suitable
With the exception of sitagliptin as mono-preparation can be derived from the present study data for any of the Gliptine an additional benefit derived. Many of the studies conducted so far are not suitable to answer the question of the added value.
The reasons are varied: some indications for the manufacturers themselves have presented no data in the dossier, because there are no such studies. This applies, for example, sitagliptin and vildagliptin, each in combination with a sulphonylurea. In other cases, the manufacturers have introduced studies did not examine the patient population of interest (for example, vildagliptin in monotherapy).
Comparison therapies are often not used according to prescribing information
A part of the studies is therefore inappropriate, because the drugs were not used in the comparison group, as required by the respective prescribing information. Thus, the drugs were partially overdosed, sometimes the dose was increased too quickly and thus risking side effects. This penalizes the comparison therapy. Unlike many claims, so there is usually a substantive and not merely a "formal" reasoning when IQWiG does not accept such data as evidence for the added benefits.
Sitagliptin: adding value in one of five indications
For the evaluation of sitagliptin, the Federal Joint Committee (G-BA) has differentiated depending on the particular treatment between five indications and specified for these each have different appropriate comparator therapy.
Sitagliptin as sole therapy for the data presented showed no advantage of sitagliptin. For the combination with sulfonylurea in combination with metformin and sulfonylurea and combination with insulin, an additional benefit is not used because appropriate data were missing or no data were presented.
Sitagliptin versus glimepiride: Less hypoglycemia
In a study that compared metformin with glimepiride (the appropriate comparator therapy) and metformin tested the dual combination of sitagliptin, was for most endpoints no relevant difference. In the side effects, the picture was mixed: On the one hand were no severe hypoglycaemia (confirmed symptomatic hypoglycemia) in patients treated less frequently. However, participants in the therapy because of side effects in this study arm broke off frequently.
In the balance sheet, the IQWiG sees a clue for a small additional benefit. But this is true only for the patients in whom a reduction in blood sugar was aimed at a near normal value for the other an additional benefit has not been established.
Sitagliptin versus glipizide: survival benefit in men
Also in comparison with the non-approved in Germany to sulfonylurea glipizide, sitagliptin is superior in dual combination with metformin. As occurred in the sitagliptin group within the observation period of two years (104 weeks) on a death in the glipizide group, there were eight other hand - all nine were men. However, here the restriction applies to the standard-therapy target near normal blood sugar.
Sitagliptin in this study had advantages in terms of hypoglycaemia - regardless of gender: Both were severe and symptomatic hypoglycemia on rare here.
As the glimepiride compared with the results here are also fraught with uncertainty: There is no information on whether the hypoglycaemia, particularly in the early phase of the study, ie in the setting phase occurred. In addition, long-term data are lacking, especially with regard to vessel-related complications.
In the overall IQWiG therefore goes out with sitagliptin compared to glipizide (both plus metformin) in men of any indication of a considerable added value. There is also an additional benefit in women, but the extent is not quantified here, most significantly.
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Even six years after the authorization is still no long-term studies
None of the drugs evaluated long-term studies have been presented in the dossier, even though they are partially already on the market since 2007. "Already in earlier assessments of antidiabetic IQWiG came to this finding., It is totally unacceptable that just exist for drugs that patients must take over very long periods, even several years after the approval no data on how their application affects long-term "says Thomas Kaiser, Head of the Drug Assessment IQWiG. Because an important goal in the treatment of diabetes is to prevent micro-and macrovascular complications.
Shortly before the end of the stock market valuation of the manufacturer of saxagliptin has announced that results of a long-term study will be presented. Incomprehensible to the lack of long-term data is therefore particularly with sitagliptin and vildagliptin, have been approved as the first Gliptine already in March and September 2007 in Europe.
Bad data is unsatisfactory for all concerned
With the exception of an indication of sitagliptin IQWiG could summarize any of the Gliptine certify an additional benefit. "This is an unsatisfactory outcome for all concerned - not only for manufacturers but also for patients and their treating physicians," stated Director of IQWiG Jürgen Windeler the evaluation of the drug group.
"Manufacturers complain for Gliptine advantages, yes, a therapeutic progress. These subjective conviction, we do not deny. Our task, however, is soberly to consider. And we need to realize that the producers are not yet in a position that therapeutic progress to demonstrate in studies. There is an urgent need to catch up, "says Jürgen Windeler.
G-BA decides on the extent of added benefit
Dossier evaluation is part of the overall process for the early benefit assessment, forwarded to the G-BA. After the publication of manufacturer dossier and dossier evaluation of the G-BA is a method by opinion, provide complementary information and may subsequently lead to a different evaluation. The G-BA makes a decision on the extent of added benefit, which completes the early benefit assessment.
An overview of the results of the benefit assessment IQWiG has both a short version. In addition to the published by IQWiG website you will find all ingredients in a comprehensible short information.
On the website of the G-BA both general information on benefit assessment pursuant to § 35a SGB V, as well as for evaluation of the individual active ingredients are found.
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