Institute For Klinische Forschung Und Entwicklung

Mainz, Germany

Institute For Klinische Forschung Und Entwicklung

Mainz, Germany
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Schondorf T.,Institute For Klinische Forschung Und Entwicklung | Schondorf T.,Bonn-Rhein-Sieg University of Applied Sciences | Schondorf T.,Universitatsklinikum Cologne | Pfutzner A.,Institute For Klinische Forschung Und Entwicklung | And 4 more authors.
Diabetes, Stoffwechsel und Herz | Year: 2010

Type 2 diabetes therapy requires regular revision and tailoring when indicated. A fixed combination of 850 mg metformin + 15 mg pioglitazone (Competact®) is a treatment option for patients with insufficient metabolic control with metformin alone. This non-interventional study examined safety and efficacy of a therapy with the fixed combination under routine conditions. The study was conducted in 1 480 centres throughout Germany. Clinical data, as well as metabolic markers (e.g., blood pressure, HbA1c, fasting glucose, lipid profile), were collected at baseline and after 16 weeks of the therapy. The treatment was carried out according to the manufacturer's recommendations. In total, 4 866 patients were enrolled (45 % women, 55 % men, mean (± SD) age 60.8 ± 9.6 years, mean disease duration 6.7 ± 4.7 years). All investigated parameters improved significantly (all, p < 0.001) after four months on the fixed combination, except BMI which remained constant. The safety profile resembled that of each drug if taken individually. This non-interventional study revealed the benefits a pioglitazone/metformin combination therapy has on the metabolic markers of diabetes patients under daily routine conditions.


Forst T.,Institute For Klinische Forschung Und Entwicklung | Forst T.,Profil Mainz GmbH & Co. KG
Diabetologe | Year: 2016

Background: Metformin and sulfonylureas (SUs) are the most established oral drugs for the treatment of type 2 diabetes mellitus. While increasing evidence indicates cardioprotective effects of metformin treatment, the safety of SUs has been debated for more than 30 years now. Studies: In the UK Prospective Diabetes Study (UKPDS), mortality and cardiovascular risk were reduced during treatment with metformin, while combination of metformin with SUs was found to increase the risk of diabetes-related death and all-cause mortality. Numerous population-based surveys of cardiovascular and all-cause mortality further intensified the doubt about cardiovascular safety of SUs. In contrast, controversial results with regard to the safety of SUs have been obtained from randomised controlled clinical trials. Available randomised, controlled studies were not designed to provide conclusive answers on the cardiovascular safety of this class of drugs. Most of them included only small patient numbers, had an observational time that was too short, or were performed in patients groups not prone to develop cardiovascular complications within the duration of the study. Conclusion: Therefore, the question of the cardiovascular and overall safety profile of sulfonylurea treatment remains unanswered and still leaves reason for the critical administration of these types of drugs. Until reliable studies regarding the cardiovascular risk profile of SU are available, clinical use of these drugs should be limited, especially when alternative drugs with proven safety profiles could be used. © 2016, Springer-Verlag Berlin Heidelberg.


Forst T.,Institute For Klinische Forschung Und Entwicklung | Forst T.,Johannes Gutenberg University Mainz | Weber M.M.,Johannes Gutenberg University Mainz | Hohberg C.,Institute For Klinische Forschung Und Entwicklung | Pfutzner A.,Institute For Klinische Forschung Und Entwicklung
Diabetes, Stoffwechsel und Herz | Year: 2010

Diabetic neuropathy is one of the most frequent and serious complications in patients with diabetes mellitus, of which about 16-26 % suffer from painful symptoms. Clinical diagnosis must distinguish between asymptomatic and symptomatic manifestations of diabetic neuropathy. Treatments are based on those that normalize blood glucose levels, those that target the pathogenetic mechanisms of nerve damage, and those that relieve symptoms. Although improving blood glucose control has been found to reduce the risk of developing diabetic neuropathy, or hindering its progression, in type 1 diabetic patients, its significance in type 2 diabetic patients is less clear. Despite the fact that several different molecular pathways in the development of diabetic nerve damage have been identified in recent years, only alpha-lipoic acid is currently registered as a treatment of diabetic neuropathy in Europe. In the past, there was only limited scientific evidence as to the efficacy of drugs used in the treatment of neuropathic pain. For many years, mainly tricyclic anti-depressants, carbamazepine, gabapentin, or opioids were the standard medications. More recently, significant pain relief has been reported in clinical trials using agents such as the dual-selective serotonin noradrenalin re-uptake inhibitor, duloxetin, and a modulator of the voltage-dependent calcium channel, pregabalin.The aim of this review is to provide a scientific update on the latest treatments for diabetic neuropathy.

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