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Colosia A.D.,RTI Health Solutions | Palencia R.,Boehringer Ingelheim GmbH | Khan S.,RTI Health Solutions
Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy | Year: 2013

Background: Hypertension and obesity are known to contribute, directly or indirectly, to the development of long-term complications of type 2 diabetes mellitus (T2DM). Knowing the prevalence of these comorbidities is important for determining the size of the population that may beneft from strategies that reduce blood pressure and weight while controlling blood glucose. Methods: In this systematic literature review, electronic searches of PubMed, Embase, and the Cochrane Library were conducted to identify observational studies of hypertension and/or obesity prevalence in patients with T2DM throughout the world. The searches were limited to studies reported in English from January 1, 2001 to February 16, 2012. Results: From a total of 2,688 studies, 92 observational studies provided prevalence rates for hypertension and/or obesity specifcally in adults with T2DM. Fifteen studies of specifc subtypes of hypertension or subpopulations with T2DM were subsequently excluded, leaving 78 studies (in 77 articles) for inclusion in this article. Of these, 61studies reported hypertension prevalence, 44 reported obesity prevalence, and 12 reported the prevalence of hypertension with obesity. Most studies had a low risk of bias regarding diagnosis of T2DM (70/78), hypertension (59/69), or obesity (45/47). The continental regions with the most observational studies of hypertension or obesity prevalence were Europe (n = 30) and Asia (n = 26). Hypertension rates typically were high in all regions; most studies presented rates above 50%, and many presented rates above 75%. Obesity rates exceeded 30% in 38 of 44 studies and 50% in 14 of 44 studies, especially those assessing central obesity (based on waist circumference). Among obese adults, hypertension rates were at or above 70% in Asia and above 80% in Europe; rates were lower in North and South America but still above 30%. Conclusion: Around the world, hypertension and obesity, separately or together, are common comorbidities in adults with T2DM. © 2013 Colosia et al. This work is published by Dove Medical Press Ltd.

Owens D.R.,University of Cardiff | Swallow R.,Boehringer Ingelheim | Dugi K.A.,Boehringer Ingelheim GmbH | Woerle H.J.,Boehringer Ingelheim
Diabetic Medicine | Year: 2011

Aims: To examine the efficacy and safety of the dipeptidyl peptidase-4 inhibitor linagliptin in persons with Type2 diabetes mellitus inadequately controlled [HbA 1c 53-86mmol/mol (7.0-10.0%)] by metformin and sulphonylurea combination treatment. Methods A multi-centre, 24-week, randomized, double-blind, parallel-group study in 1058 patients comparing linagliptin (5mg once daily) and placebo when added to metformin plus sulphonylurea. The primary endpoint was the change in HbA 1c after 24weeks. Results At week24, the linagliptin placebo-corrected HbA 1c adjusted mean change from baseline was -7mmol/mol (-0.62%) [95%CI -8 to -6mmol/mol (-0.73 to -0.50%); P<0.0001]. More participants with baseline HbA 1c≥53mmol/mol (≥7.0%) achieved an HbA 1c <53mmol/mol (<7.0%) with linagliptin compared with placebo (29.2% vs. 8.1%, P<0.0001). Fasting plasma glucose was reduced with linagliptin relative to placebo (-0.7mmol/l, 95%CI -1.0 to -0.4; P<0.0001). Improvements in homeostasis model assessment of β-cell function were seen with linagliptin (P<0.001). The proportion of patients who reported a severe adverse event was low in both groups (linagliptin 2.4%; placebo 1.5%). Symptomatic hypoglycaemia occurred in 16.7 and 10.3% of the linagliptin and placebo groups, respectively. Hypoglycaemia was generally mild or moderate; severe hypoglycaemia was reported in 2.7 and 4.8% of the participants experiencing hypoglycaemic episodes in the linagliptin and placebo groups, respectively. No significant weight changes were noted. Conclusions In patients with Type 2 diabetes, adding linagliptin to metformin given in combination with a sulphonylurea significantly improved glycaemic control and this was well tolerated. Linagliptin could provide a valuable treatment option for individuals with inadequate glycaemic control despite ongoing combination therapy with metformin and a sulphonylurea. © 2011 The Authors. Diabetic Medicine © 2011 Diabetes UK.

Honickel M.,RWTH Aachen | Treutler S.,RWTH Aachen | van Ryn J.,Boehringer Ingelheim GmbH | Tillmann S.,RWTH Aachen | And 2 more authors.
Thrombosis and Haemostasis | Year: 2015

Urgent surgery or life-threatening bleeding requires prompt reversal of the anticoagulant effects of dabigatran. This study assessed the ability of three- and four-factor prothrombin complex concentrate (PCC) and idarucizumab (specific antidote for dabigatran) to reverse the anticoagulant effects of dabigatran in a porcine model of trauma. Twelve animals were given dabigatran etexilate (DE) orally and dabigatran intravenously, before infliction of trauma. Six animals received tranexamic acid plus fibrinogen concentrate 12 minutes post-injury. Six PCCs (each 30 and 60 U/kg) and idarucizumab (30 and 60 mg/kg) were added to blood samples ex vivo. Coagulation was assessed by several coagulation assays. All coagulation parameters were altered after dabigatran infusion (plasma level: 442 ± 138 ng/ml). Both threeand four-factor PCCs mostly or completely reversed the effects of dabigatran on thromboelastometry variables and PT but not on aPTT. Idarucizumab neutralised plasma concentrations of dabigatran, and reversed the effects of the drug on coagulation variables. Thrombin generation showed dose-dependent over-correction following the addition of PCC, implying that elevated levels of thrombin are required to overcome dabigatran-induced coagulopathy. In contrast, treatment with idarucizumab returned thrombin generation to baseline levels. Following trauma, therapy with tranexamic acid plus fibrinogen improved correction of coagulation parameters by PCC, and thromboelastometry parameters by idarucizumab. All investigated PCCs improved dabigatran- and trauma-induced coagulopathy to a similar degree. In conclusion, this study shows that three- and four-factor PCCs are similarly effective for dabigatran reversal. Idarucizumab also reversed the effects of dabigatran and, unlike PCCs, was not associated with over-correction of thrombin generation. © 2015 Schattauer.

Nalysnyk L.,United Biosource Corporation | Cid-Ruzafa J.,United Biosource Corporation | Rotella P.,United Biosource Corporation | Esser D.,Boehringer Ingelheim GmbH
European Respiratory Review | Year: 2012

Idiopathic pulmonary fibrosis (IPF) is a chronic, progressive, fibrosing interstitial pneumonia of unknown aetiology. It is a rare disease, and its incidence and prevalence are not clear. Therefore, we sought to review the published evidence on the global epidemiology of IPF. A comprehensive review of English language literature was performed by searching Medline and EMBASE for studies on IPF epidemiology published between January 1990 and August 2011. Studies providing quantitative data on IPF incidence and/or prevalence were identified and key data collected. 15 studies reporting on the incidence and/or prevalence of IPF were identified and summarised. IPF prevalence estimates in the USA varied between 14 and 27.9 cases per 100,000 population using narrow case definitions, and 42.7 and 63 per 100,000 population using broad case definitions. In Europe, IPF prevalence ranged from 1.25 to 23.4 cases per 100,000 population. The annual incidence of IPF in the USA was estimated at 6.8-8.8 per 100,000 population using narrow case definitions and 16.3-17.4 per 100,000 population using broad case definitions. In Europe, the annual incidence ranged between 0.22 and 7.4 per 100,000 population. IPF prevalence and incidence increase with age, are higher among males and appear to be on the increase in recent years. IPF is an orphan disease that affects a potentially increasing number of people in Europe and the USA. The observed variability in IPF incidence and prevalence may be explained by the differences in diagnostic criteria used, case definition, study population and study design. © 2012.

Grottke O.,RWTH Aachen | Van Ryn J.,Boehringer Ingelheim GmbH | Spronk H.M.H.,Maastricht University | Rossaint R.,RWTH Aachen
Critical Care | Year: 2014

Introduction: New oral anticoagulants are effective alternatives to warfarin. However, no specific reversal agents are available for life-threatening bleeding or emergency surgery. Using a porcine model of trauma, this study assessed the ability of prothrombin complex concentrate (PCC), activated PCC (aPCC), recombinant FVIIa (rFVIIa) and a specific antidote to dabigatran (aDabi-Fab) to reverse the anticoagulant effects of dabigatran.Methods: Dabigatran etexilate (DE) was given orally for 3 days (30 mg/kg bid) and intravenously on day 4 to achieve consistent, supratherapeutic concentrations of dabigatran. Blood samples were collected at baseline, after oral DE, after intravenous dabigatran, and 60 minutes post-injury. PCC (30 and 60 U/kg), aPCC (30 and 60 U/kg), rFVIIa (90 and 180 μg/kg) and antidote (60 and 120 mg/kg) were added to blood samples ex-vivo. Coagulation was assessed by thromboelastometry, global coagulation assays and diluted thrombin time.Results: Plasma concentrations of dabigatran were 380 ± 106 ng/ml and 1423 ± 432 ng/ml after oral and intravenous administration, respectively, and all coagulation parameters were affected by dabigatran. Both PCCs and aDabi-Fab, but not rFVIIa, reversed the effects of dabigatran on thromboelastometry parameters and prothrombin time. In contrast, aPTT was only normalised by aDabi-Fab. Plasma concentration (activity) of dabigatran remained elevated after PCC and rFVIIa therapy, but was not measureable after aDabi-Fab.Conclusion: In conclusion, PCC and aPCC were effective in reducing the anticoagulant effects of dabigatran under different conditions, while aDabi-Fab fully corrected all coagulation measures and decreased the plasma concentration of dabigatran below the limit of detection. No significant effects were observed with rFVIIa. © 2014 Grottke et al.; licensee BioMed Central Ltd.

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