Trends and consequences of lipoprotein(a) testing: Cross-sectional and longitudinal health insurance claims database analyses.

Background And Aims: Lipoprotein(a) (Lp(a)) is associated with an increased risk of atherosclerotic cardiovascular disease (ASCVD). Our goal was to characterize patients undergoing Lp(a) testing and to assess the impact of Lp(a) testing on treatment changes and subsequent ASCVD events.

Methods: A cross-sectional and a longitudinal claims data analysis were performed on 4 million patient records in Germany.

Heart failure signs and symptoms, hospital referrals, and prescription patterns in patients receiving sacubitril/valsartan in primary care and cardiologist settings in Germany.

Aims: The aim of this paper was to analyse heart failure (HF) signs and symptoms, hospital referrals, and prescription patterns in patients receiving sacubitril/valsartan (sac/val) in primary care and cardiology settings in Germany.

Methods And Results: A retrospective cohort study of electronic medical records identified 1263 adults (aged ≥18 years) in the German IMS® Disease Analyzer database who were prescribed sac/val during 2016 and had at least 6 months of data following sac/val initiation. Clinical characteristics were collected during the 12 months before the first recorded sac/val prescription (index date) and 6 months post-index.

Angiotensin receptor neprilysin inhibition versus individualized RAAS blockade: design and rationale of the PARALLAX trial.

Aims: Although the effect of the angiotensin receptor blocker neprilysin inhibitor (ARNI) sacubitril/valsartan on heart failure (HF) hospitalizations and cardiovascular death has been evaluated, its effects on functional capacity in patients with HF and ejection fraction (EF) >40% has yet to be determined. In addition, no prior studies have compared sacubitril/valsartan with angiotensin-converting enzyme inhibitor therapy. We sought to compare the effect of ARNI to background-medication-based individualized comparators (BMICs) on N-terminal pro-B-type natriuretic peptide (NT-proBNP), functional capacity [6 min walk distance (6MWD)], symptoms, and quality of life [Kansas City Cardiomyopathy Questionnaire (KCCQ)] in patients with HF and EF >40% in a randomized clinical trial.

Real-world treatment patterns of sacubitril/valsartan: a longitudinal cohort study in Germany.

Aims: To analyse real-world treatment patterns of sacubitril/valsartan (sac/val) using data from a pharmacy database in Germany.

Methods And Results: A retrospective cohort study of 26 191 adult patients (aged ≥ 18 years) in the IMS® longitudinal prescriptions database in Germany who were dispensed sac/val from January 2016 to June 2017 was conducted. The analysis included sac/val dose titration assessed in the 6 months from first sac/val prescription; prescriptions of concomitant cardiovascular medications in the 6 months pre- and post-index and compliance and persistence during 12 months post-index.

Early insights into the characteristics and evolution of clinical parameters in a cohort of patients prescribed sacubitril/valsartan in Germany.

Objectives: This study aimed to provide early insights into sacubitril/valsartan (sac/val) prescription patterns and the demographic and clinical characteristics of patients prescribed sac/val in primary care and cardiology settings in Germany.

Methods: The study used electronic medical records from the German IMS® Disease Analyzer database. Patients with ≥1 prescription for sac/val during 1 January-31 December 2016 (n = 1643) were identified and followed up for ≤12 months from first prescription.

Treatment of chronic heart failure in Germany: a retrospective database study.

Background: Adherence to treatment guidelines affects outcomes in patients with chronic heart failure (HF). We investigated patient pathways and treatment patterns for HF in Germany.

Methods: This retrospective study used anonymous healthcare claims data from the German Health Risk Institute on individuals with statutory health insurance.

Epidemiology of heart failure in Germany: a retrospective database study.

Background: Chronic heart failure (HF) is associated with significant healthcare expenditure, morbidity, and mortality. This study investigated the epidemiology of HF in Germany.

Methods: This retrospective study used anonymous healthcare claims data from the German Health Risk Institute on individuals with statutory health insurance.

Evaluation of effectiveness and safety of amlodipine/valsartan/hydrochlorothiazide single-pill combination therapy in hypertensive patients: an observational study.

Objective: This study evaluated the effectiveness and safety of amlodipine/valsartan/hydrochlorothiazide (A + V + H) single-pill combination therapy in the treatment of hypertensive patients in daily practice.

Design And Methods: This prospective, open-label, observational study, enroled adults for whom their physician considered treatment with the single pill combination as indicated. The observational period per patient was ∼3 months.

Meta-analysis of three observational studies of amlodipine/valsartan in hypertensive patients with additional risk factors.

Objectives: In this study, the effectiveness of amlodipine/valsartan single-pill combination was assessed in hypertensive patients with diabetes, metabolic risk or overweight.

Methods: Data from 12,265 patients treated with amlodipine/valsartan from three studies were analyzed in a meta-analysis. These studies focused on (i) non-diabetic hypertensive patients suffering from abdominal obesity; (ii) hypertensive patients with at least one metabolic risk factor; and (iii) hypertensive patients with type 2 diabetes mellitus.

Pill burden in hypertensive patients treated with single-pill combination therapy--an observational study.

Introduction: Hypertension is a condition which in many cases is treated with more than one drug. Additionally, patients with hypertension often suffer from other concomitant diseases, such as diabetes mellitus or dyslipidemia, which adds to the number of pills that patients need to take (pill burden). The aim of this study was to investigate the impact of this pill burden on patients with hypertension in clinical practice in Germany.

Effects of the combinations of amlodipine/valsartan versus losartan/hydrochlorothiazide on left ventricular hypertrophy as determined with magnetic resonance imaging in patients with hypertension.

Background: Left ventricular hypertrophy (LVH), a marker of cardiac end-organ damage, is frequently found in patients with arterial hypertension and is associated with cardiovascular and cerebrovascular morbidity and mortality. Therefore, LVH regression is an important treatment goal. For amlodipine plus valsartan (A/V) no specific study on LVH has been reported to date.

Efficacy and tolerability of aliskiren 300 mg/hydrochlorothiazide 25 mg (± amlodipine 5 mg) in hypertensive patients not controlled by candesartan 32 mg plus HCT 25 mg.

Aims: The majority of patients with essential hypertension of moderate severity (WHO grade 2) require combination therapy. We aimed to investigate whether the single-pill combination of aliskiren 300  mg and hydrochlorothiazide (HCT) 25  mg (ALIS 300/HCT 25) improves the BP reduction in hypertensive patients not adequately controlled by the free combination of candesartan 32  mg and HCT 25  mg (CAN 32 + HCT 25).

Methods: In an open-label, single-arm study, patients with mean sitting diastolic blood pressure (DBP) between 100-109  mmHg at baseline received 4-week treatment with CAN 32 + HCT 25 (Phase 1), followed - in patients whose BP was not controlled - by 4-week treatment with ALIS 300/HCT 25 (Phase 2).

Impact of supportive measures on drug adherence in patients with essential hypertension treated with valsartan: the randomized, open-label, parallel group study VALIDATE.

Objective: The majority of treated hypertensive patients do not achieve target blood pressure (BP) levels of less than 140/90 mmHg. One key reason is inadequate adherence with the prescribed drug regimen. Dosing regimens are either not executed as prescribed (noncompliance) or patients stop taking the medication (nonpersistence).

Valsartan in combination with lisinopril versus the respective high dose monotherapies in hypertensive patients with microalbuminuria: the VALERIA trial.

Objectives: Microalbuminuria is known as an independent predictor for stroke, myocardial infarction, and death. The purpose of the VALERIA trial was a comparison of the efficacy and safety of combination therapy of valsartan and lisinopril with valsartan and lisinopril high-dose monotherapy in patients with hypertension and microalbuminuria.

Methods: This was a randomized, double-blind, interventional, parallel-group study.

Effective and safe reduction of blood pressure with the combination of amlodipine 5 mg and valsartan 160 mg in hypertensive patients not controlled by calcium channel blocker monotherapy.

Introduction: The addition of an angiotensin II receptor blocker to calcium channel blocker-based antihypertensive therapy may be associated with enhanced efficacy and reduced risk of adverse events.

Methods: This 8-week, open-label, single-arm trial evaluated the efficacy and tolerability of the combination of amlodipine and valsartan in patients not responding adequately to treatment with amlodipine or felodipine alone. Patients aged > or =18 years with moderate essential hypertension (defined as mean sitting systolic blood pressure [MSSBP] > or =160 and <180 mmHg) were treated for 4 weeks with once-daily amlodipine 5 mg or felodipine 5 mg.

Steroid-sparing effect of pimecrolimus cream 1% in children with severe atopic dermatitis.

Objective: To investigate if pimecrolimus cream 1% reduces the need for steroids in the long-term management of severe pediatric atopic dermatitis (AD).

Methods: A total of 184 pediatric patients (aged 2-17 years) with a history of severe AD according to Rajka and Langeland were enrolled. Patients were randomized to treatment with pimecrolimus cream or vehicle cream for a 24-week period.

Detection of H-2 alleles by PCR-RFLP-an alternative to flow cytometry in the screening of transgenic mice.

An increasing number of experimental models is based on well-defined transgenic mice in medical and biological research. Particularly in settings in which transgenic recombinants are used, a fast and reliable method is needed to screen for a defined H-2 background. For this purpose, flow cytometry with specific monoclonal antibodies is the standard procedure.

Allogeneic adrenocortical transplantation: glucocorticosteroid-independent immunomodulatory properties of adrenal cortex cells.

Background: Hormone substitution for the treatment of adrenocortical insufficiency does not adequately substitute the physiologic circadian secretion of corticosteroids and leads to long-term sequelae and reduced quality of life. The lack of adaptation to physical and psychologic stress situations may lead to life-threatening Addison's crises. Allogeneic transplantation of adrenal cortex could offer an intriguing alternative.

Transplantation of adrenal tissue fragments in a murine model: functional capacities of syngeneic and allogeneic grafts.

Oral hormone substitution for the treatment of Addison's disease inadequately replaces the physiologic circadian secretion of corticosteroids. Alternative therapeutic approaches are reimplantation of healthy autologous adrenal tissue and allogeneic transplantation (Tx), respectively. The aim of our study was to evaluate the functional capacity of adrenal grafts and the influence of intercellular adhesion molecule-1 (ICAM-1) on graft survival.