Personalized medicine for allergy treatment: Allergen immunotherapy still a unique and unmatched model.

The introduction of personalized medicine (PM) has been a milestone in the history of medical therapy, because it has revolutionized the previous approach of treating the disease with that of treating the patient. It is known today that diseases can occur in different genetic variants, making specific treatments of proven efficacy necessary for a given endotype. Allergic diseases are particularly suitable for PM, because they meet the therapeutic success requirements, including a known molecular mechanism of the disease, a diagnostic tool for such disease, and a treatment blocking the mechanism.

Relevant Patient Benefit of Sublingual Immunotherapy with Birch Pollen Allergen Extract in Allergic Rhinitis: An Open, Prospective, Non-Interventional Study.

Introduction: Sublingual immunotherapy (SLIT) with birch pollen extract has been shown to be an efficacious treatment of allergic rhinitis (AR). An as-yet unanswered question is whether and how clinical benefit translates into patient benefit, i.e.

Clinical efficacy of sublingual immunotherapy tablets for allergic rhinitis is unlikely to be derived from allergen-release data.

: Allergen bioavailability underpins the efficacy and safety of SLIT tablets. Three product-related factors are likely to influence this: tablet potency, formulation and sublingual holding time. : Tablet formulation determines the rate and extent of solubilized allergen release.

Treatment Satisfaction During Sublingual Immunotherapy with a Five-Grass Pollen Tablet for Allergic Rhinoconjunctivitis: A Prospective, Non-Interventional Study.

Background: Sublingual immunotherapy (SLIT) is a safe/well-tolerated alternative to allergen injection immunotherapy for allergic rhinoconjunctivitis (ARC). Patient adherence is essential and patient-related outcome measures including treatment satisfaction are informative/indicative of adherence.

Objective: The aim was to assess treatment satisfaction with five-grass pollen tablet SLIT under real-life conditions.

Management of Grass Pollen Allergy with 5-Grass Pollen Tablet: Results of a 2-Year Real-Life Study.

Introduction: Allergen immunotherapy is the only treatment option for allergic rhinitis with disease-altering potential. It was the objective of this study to assess the effectiveness and tolerability of a 5-grass pollen tablet in a large population of non-selected grass pollen allergic patients, i.e.

Optimum treatment strategies for polyallergic patients - analysis of a large observational trial.

Objectives: To document the effectiveness and safety of sublingual allergen immunotherapy (SLIT) with a five-grass pollen tablet (Oralair ) and compare different treatment options in a broad, non-selected population of patients in a real-world clinical setting.

Research Design And Methods: This was a 2 year, open, prospective, multicenter, single-arm, non-interventional study. Patients with a history of clinically relevant allergic symptoms caused by grass pollen, confirmed by skin prick testing, received treatment with the five-grass pollen tablet.

Sublingual Immunotherapy with a Five-Grass Pollen Tablet in Adult Patients with Allergic Rhinitis: An Open, Prospective, Noninterventional, Multicenter Study.

Background: Although the safety and efficacy of sublingual immunotherapy (SLIT) with a five-grass pollen tablet have been demonstrated in randomized clinical trials (RCTs), these outcomes must always be evaluated in real-life medical practice.

Methods: In a prospective, open-label, noninterventional, "real-life" study in Germany, we evaluated the safety, tolerability, and effectiveness of SLIT with a five-grass pollen tablet in adults with grass-pollen-induced allergic rhinoconjunctivitis.

Results: 808 adults were enrolled between September 2008 and December 2009.

An observational, real-life safety study of a 5-grass pollen sublingual tablet in children and adolescents.

Background: The safety and efficacy of pre- and coseasonal sublingual allergen immunotherapy (SLIT) with a 5-grass pollen sublingual tablet have been demonstrated in a randomized clinical trial (RCT) in children and adolescents. Observational, 'real-life' studies can usefully complement the results of RCTs.

Methods: A prospective, open-label, observational, multicentre post-marketing study of children and adolescents (aged 5-17, with grass pollen-induced allergic rhinitis) treated with the 5-grass pollen sublingual tablet was performed between June 2009 and January 2011 in Germany.

Downregulation of the proinflammatory state of circulating mononuclear cells by short-term treatment with pioglitazone in patients with type 2 diabetes mellitus and coronary artery disease.

Background. This study was performed to investigate the influence of a short-term treatment with pioglitazone versus placebo on inflammatory activation of mononuclear cells (mRNA expression/protein secretion of inflammatory markers). Methods and Results.

Increased prevalence of cardiovascular disease and risk biomarkers in patients with unknown type 2 diabetes visiting cardiology specialists: results from the DIASPORA study.

Background: Patients with diabetes mellitus and IGT have a high risk for cardiovascular events. It is tempting to speculate that these patients are often first seen by cardiologists.

Design: This cross-sectional study investigates the diabetes prevalence in cardiology care units and the correlated metabolic conditions as assessed by several circulating biomarkers.

Differences in the results and interpretation of oxidized LDL cholesterol by two ELISA assays--an evaluation with samples from the PIOstat study.

Background: The oxidized LDL-particles (oxLDL) are considered to be an important driving factor in the pathophysiology of arteriosclerosis. Few methods exist today to directly determine oxLDL in human plasma. We evaluated the plausibility of results derived from a new ELISA (Immundiagnostik, Bensheim, Germany) in comparison to a different ELISA test (Mercodia, Uppsala, Sweden).

Competact, a fixed combination of pioglitazone and metformin, improves metabolic markers in type 2 diabetes patients with insufficient glycemic control by metformin alone--results from a post-marketing surveillance trial under daily routine conditions.

Background: In patients with type 2 diabetes, glycemic control to target goals can only be achieved for a while by single-drug treatment. Antidiabetes therapy has to be adapted according to the individual course of the disease. This trial investigates the impact of Competact (Takeda Pharma, Aachen, Germany) (marketed as ActoplusMet in the United States)-a fixed combination of 850 mg of metformin with 15 mg of pioglitazone-for diabetes treatment in patients with insufficient glycemic control by metformin alone.

The IRIS V study: pioglitazone improves systemic chronic inflammation in patients with type 2 diabetes under daily routine conditions.

Background: The peroxisome proliferator-activated receptor-gamma agonist pioglitazone is established as a drug to treat patients with type 2 diabetes mellitus. In addition to lowering blood glucose levels, one of the favorable effects of pioglitazone is improvement of systemic chronic inflammation particularly affecting vessel walls. The effect can be monitored by the measurement of the biomarker C-reactive protein in the range of 0-10 mg/L (high-sensitivity C-reactive protein [hsCRP]).

Effects of pioglitazone and/or simvastatin on low density lipoprotein subfractions in non-diabetic patients with high cardiovascular risk: A sub-analysis from the PIOSTAT study.

Background: We analyzed the efficacy and possible synergistic actions of pioglitazone and simvastatin monotherapy versus their combination on LDL subfractions from a subpopulation from the PIOSTAT three-arm randomized controlled trial. PPARgamma agonists, such as pioglitazone, improve insulin sensitivity and glycemic control and appear to lower the concentration of atherogenic small dense LDL particles. Insulin resistance frequently occurs in non-diabetic patients with cardiovascular disease.

Pioglitazone improves metabolic markers in patients with type 2 diabetes independently from physical activities: results from the IRIS III study.

Aim: Pioglitazone is an established peroxisome proliferator-activated receptor gamma agonist for the treatment of insulin resistance in patients with type 2 diabetes mellitus. This analysis of the observational IRIS III study was performed to evaluate the effects of pioglitazone treatment in relation to the degree of physical exercise activities in a large patient population under daily life conditions.

Methods: A total of 1298 patients out of 2092 enrolled into the IRIS III study who had provided information about their exercise level could be included in the final analysis (622 female, 676 male; age: 63.

Effect of simvastatin and/or pioglitazone on insulin resistance, insulin secretion, adiponectin, and proinsulin levels in nondiabetic patients at cardiovascular risk--the PIOSTAT Study.

We investigated the effect of pioglitazone in comparison with and in combination with simvastatin on insulin resistance, plasma adiponectin, postprandial plasma glucose, insulin, and intact proinsulin levels in a nondiabetic population at cardiovascular risk. One hundred twenty-five nondiabetic patients at cardiovascular risk were randomized to pioglitazone (PIO), pioglitazone and simvastatin (PIO/SIM), or simvastatin (SIM) treatments. Blood samples were taken for the measurement of adiponectin and lipid levels.

Anti-inflammatory effects of pioglitazone and/or simvastatin in high cardiovascular risk patients with elevated high sensitivity C-reactive protein: the PIOSTAT Study.

Objectives: The purpose of this study was to test the safety and efficacy of pioglitazone and simvastatin in combination versus each drug individually in non-diabetic subjects with cardiovascular disease (CVD) and elevated high-sensitivity C-reactive protein (hs-CRP) levels.

Background: Low-grade inflammation is a pathogenic factor for atherosclerosis. High-sensitivity CRP, matrix metalloproteinase (MMP)-9, and plasminogen activator inhibitor (PAI)-1 are markers of inflammation.