Clinical outcome in hypertensive patients treated with amlodipine plus bisoprolol or plus valsartan.

Objective: Several guidelines do not recommend beta-blocker as the first-line treatment for hypertension because of its inferior efficacy in stroke prevention. Combination therapy with beta-blocker is commonly used for blood pressure control. We compared the clinical outcomes in patients treated with amlodipine plus bisoprolol (A + B), a ß1-selective beta-blocker and amlodipine plus valsartan (A + V).

Cost saving analysis of prediabetes intervention modalities in comparison with inaction using Markov state transition model-A multiregional case study.

Background: Prediabetes management is a priority for policymakers globally, to avoid/delay type 2 diabetes (T2D) and reduce severe, costly health consequences. Countries moving from low to middle income are most at risk from the T2D "epidemic" and may find implementing preventative measures challenging; yet prevention has largely been evaluated in developed countries.

Methods: Markov cohort simulations explored costs and benefits of various prediabetes management approaches, expressed as "savings" to the public health care system, for three countries with high prediabetes prevalence and contrasting economic status (Poland, Saudi Arabia, Vietnam).

Optimizing levothyroxine treatment for subclinical hypothyroidism during pregnancy.

The onset of pregnancy places additional stress of the thyroid gland, which must produce additional thyroid hormones to support the developing foetus. Hypothyroidism, including subclinical hypothyroidism (SCH), may appear at this time, or existing thyroid disease may become more severe. Accordingly, SCH is a relatively common complication of up to about 3% of pregnancies, with higher rates in some areas.

Contribution of single-pill combinations in the management of hypertension: perspectives from China, Europe and the USA.

Uncontrolled hypertension is associated with an increased risk of adverse clinical vascular outcomes and death. Hypertension management guidelines from China and the USA recommend initiation of antihypertensive pharmacotherapy with a single drug for patients without severe hypertension at presentation. Current European hypertension guidelines take a different approach and recommend the use of combination therapy from the time of diagnosis of hypertension for most patients.

Bioequivalence Evaluation in Healthy Volunteers: New Generic Formulations of Sitagliptin and Sitagliptin-Metformin Fixed-Dose Combination Compared with the Originator Products.

Introduction: Three studies compared the bioequivalence (BE) of new generic tablet formulations of sitagliptin (100 mg; fasting) and the fixed-dose combination (FDC) of sitagliptin/metformin (50/850 mg, 50/1000 mg; both fed) in healthy volunteers with the same tablet strengths of the reference products Januvia and Janumet.

Methods: The study design was open-label, single-dose, randomized with two-way crossover periods. Blood sampling was performed for 72/48 h in the sitagliptin/FDC studies, respectively.

Use of levothyroxine in the management of hypothyroidism: A historical perspective.

The thyroid operates within a complex system of homeostatic regulation, where the level of thyrotropin (TSH) influences the rate of secretion of the principal thyroid hormones, thyroxine (T4) and triiodothyronine (T3). The devastating consequences of untreated thyroid dysfunction have been evident for centuries. Indeed, sources from antiquity described goitre and cretinism, two of the clinical sequelae of untreated overt thyroid disease.

A novel point-of-care device accurately measures thyrotropin in whole blood, capillary blood and serum.

Objectives: Point-of-care (POC) measurement of thyrotropin (TSH) may facilitate prompt diagnosis of thyroid dysfunction. We evaluated the analytical performance of a new POC TSH assay (Wondfo).

Methods: TSH measurements were made from 730 consecutive, unselected subjects in an outpatient setting, using Wondfo in whole blood, capillary blood and serum or automated reference equipment (serum only).

Vascular complications in prediabetes and type 2 diabetes: a continuous process arising from a common pathology.

The term, "prediabetes", describes a state of hyperglycaemia that is intermediate between true normoglycaemia and the diagnostic cut-offs for indices of glycaemia that are used to diagnose type 2 diabetes. The presence of prediabetes markedly increases the risk of developing type 2 diabetes. Numerous randomized, controlled evaluations of various agents have demonstrated significant prevention or delay of the onset of type 2 diabetes in subjects with prediabetes.

Bioequivalence Studies of New Generic Formulations of Vildagliptin and Fixed-Drug Combination of Vildagliptin and Metformin Versus Respective Originator Products in Healthy Volunteers.

Introduction: Vildagliptin and metformin are two well-established oral antidiabetics with a complementary mechanism of action. Two new generic products, vildagliptin and its fixed-drug combination (FDC) with metformin, were tested for bioequivalence versus the approved originator reference products (Galvus® and Eucreas®).

Methods: Three randomized studies with two-treatment, two-period, two-sequence crossover design were conducted in healthy adults.

Getting the levothyroxine (LT4) dose right for adults with hypothyroidism: opportunities and challenges in the use of modern LT4 preparations.

Lifelong treatment with levothyroxine (LT4) is the mainstay of management for individuals with hypothyroidism. Many hypothyroid patients start LT4 treatment at a low dose (e.g.

An anchored simulated treatment comparison of uptitration of amlodipine compared with a low-dose combination treatment with amlodipine 5 mg/bisoprolol 5 mg for patients with hypertension suboptimally controlled by amlodipine 5 mg monotherapy.

Objective: To compare changes in systolic and diastolic blood pressures (SBP, DBP) from baseline to following 8 weeks of treatment with a low dose combination of amlodipine 5 mg plus bisoprolol 5 mg versus up titration to the maximum daily dose of amlodipine 10 mg, in hypertensive patients uncontrolled by amlodipine 5 mg.

Methods: Individual patient data (IPD) from a randomized clinical trial (RCT) comparing the combination versus amlodipine 5 mg (EudraCT Number: 2019-000751-13) and aggregated data (AgD) from a published RCT comparing amlodipine 10 mg versus amlodipine 5 mg were utilized in an anchored simulated treatment comparison (STC). The RCT with IPD was used to create models assessing how patients might respond to the combination if they were more comparable to those patients in the RCT with AgD.

Low awareness and under-diagnosis of hypothyroidism.

Hypothyroidism is a common condition with a prevalence that varies according to local dietary iodine availability, gender and age. The symptoms of hypothyroidism are generally nonspecific, with considerable overlap with other conditions and with the consequences for the health of advancing age. These symptoms are not useful for diagnosing hypothyroidism and a thyroid function test is required for a firm clinical diagnosis.

Triiodothyronine alongside levothyroxine in the management of hypothyroidism?

The current guideline-based management of hypothyroidism recommends monotherapy with levothyroxine (LT4), titrated to maintain the level of thyrotropin within a euthyroid reference range. This has been successful for most people with hypothyroidism, but a substantial minority still report symptoms of hypothyroidism unexplained by a comorbid medical condition. LT4 is essentially a prodrug for triiodothyronine (T3), the thyroid hormone that acts on target tissues in the brain and the periphery.

Real world clinical experience with a new formulation of levothyroxine engineered to meet new and stricter regulatory requirements.

Objectives: A new LT4 formulation (Euthyrox [LT4 NF]) was developed to meet new regulatory standards, and has replaced the older formulation (LT4 OF) in a number of countries. We evaluated the possibility of tolerability/safety concerns associated with the switch by analysing spontaneous adverse event (AE) reports before and after switching.

Methods: We examined spontaneous reports of adverse events (AE) from 18 countries generated from individual case safety reports (ICSRs) submitted to the pharmaceutical sponsor's global safety database, over one year before/one year after the switch.

Understanding prediabetes: definition, prevalence, burden and treatment options for an emerging disease.

Prediabetes is defined as a state of abnormal glucose homeostasis where blood glucose levels are elevated above those considered normal, but not as high as those required for a diagnosis of diabetes. As a condition intermediate between normal glucose homeostasis and the pathological condition of diabetes, the characterization of prediabetes as a distinct pathogenic condition is controversial. Emerging evidence suggests that the condition of prediabetes is associated with pathophysiological changes in several tissues and organs, which would support its recognition as a distinct pathological entity; the recent inclusion of prediabetes and associated billable conditions in the most recent ICD-10 codes provides additional credence to this position.

Metformin prevents the development of severe chronic kidney disease and its associated mineral and bone disorder.

Chronic kidney disease (CKD) causes dysregulation of mineral metabolism, vascular calcification and renal osteodystrophy, an entity called 'CKD-Mineral and Bone Disorder' (CKD-MBD). Here we determine whether metformin, an anti-diabetic drug, exerts favorable effects on progressive, severe CKD and concomitant mineral metabolism disturbances. Rats with CKD-MBD, induced by a 0.

Management of Hypertension With a Fixed-Dose (Single-Pill) Combination of Bisoprolol and Amlodipine.

Hypertension is currently one of the greatest global health care challenges. Although many effective drugs are available, combinations of 2 or more medications are often required to meet clinical targets. Combination therapy has several advantages over monotherapy: lower doses of each drug can be used to achieve therapeutic goals; lower doses may lead to fewer adverse events, facilitating patient adherence; and using multiple drugs with different modes of action may be more effective in treating multifactorial diseases, including hypertension.

Bisoprolol/amlodipine combination therapy improves blood pressure control in patients with essential hypertension following monotherapy failure.

Objective: The efficacy of a bisoprolol/amlodipine fixed-dose combination (FDC) in patients with essential hypertension who had not responded to bisoprolol or amlodipine monotherapy was investigated.

Research Design And Methods: In an 18 week, multicenter, randomized, comparative phase III study (ClinicalTrials.gov identifier: NCT01977794), patients with blood pressure uncontrolled by bisoprolol or amlodipine monotherapy (5 mg OD) began treatment with bisoprolol/amlodipine FDC 5/5 mg OD.

Incidence of lactic acidosis in patients with type 2 diabetes with and without renal impairment treated with metformin: a retrospective cohort study.

Objective: To determine whether the use of metformin in type 2 diabetic patients with various kidney functions is associated with an increased risk of lactic acidosis (LA).

Research Design And Methods: This study was a retrospective analysis of U.K.