Extended-Release Versus Immediate-Release Triamcinolone Acetonide in Patients Who Have Knee Osteoarthritis and Type 2 Diabetes Mellitus.

Background: Intra-articular corticosteroid injections may cause hyperglycemia (glucose level >180 mg/dL). In a phase 2 study of 33 patients who had osteoarthritis of the knee and type 2 diabetes mellitus, triamcinolone acetonide extended-release (TA-ER) was associated with minimal glycemic control disruption compared with triamcinolone acetonide immediate-release (TA-IR). This post hoc analysis characterizes the clinical relevance of these results.

Opioid-related respiratory and gastrointestinal adverse events in patients with acute postoperative pain: prevalence, predictors, and burden.

Opioid-induced respiratory depression (OIRD) and postoperative nausea and vomiting (PONV) are challenging, resource-intensive, and costly opioid-related adverse events (ORAEs). Utilizing the Premier Healthcare Database, we identified patients > 18 years old, who underwent at least one surgical procedure of interest (i.e.

Practice Patterns and Treatment Challenges in Acute Postoperative Pain Management: A Survey of Practicing Physicians.

Introduction: The management of acute postoperative pain remains a significant challenge for physicians. Poorly controlled postoperative pain is associated with poorer overall outcomes.

Methods: Between April and May 2017, physicians from an online database who regularly prescribe intravenous (IV) medications for acute postoperative pain completed a 47-question survey on topics such as patient demographics, IV analgesia preferences, factors that influence prescribing decisions, and the challenges and unmet needs for the treatment of acute postoperative pain.

The Early Engagement Model in Product Development: Linking "Proof of Concept" to "Proof of Medical Value".

In a rapidly changing health care environment, it is more important than ever that pharmaceutical manufacturers improve the quality and efficiency of their research and development efforts in order to help ensure the right drug gets to the right patient at the right time. The evolving role of the Medical Affairs, Health Economics & Outcomes Research (HEOR) and other functions engaged in evidence generation within the pharmaceutical industry is leading to earlier involvement in the clinical development process so that the proof of concept for new therapies can be more strongly linked to the proof of medical value. In this article, the authors outline key components of an Early Engagement Model that connects the proof of concept to proof of medical value through a systematic approach linking molecular profile with early insights on disease, unmet needs, stakeholder requirements, and patient-centric differentiation.

Using Certification to Promote Uptake of Real-World Evidence by Payers.

Most randomized controlled trials are unable to generate information about a product's real-world effectiveness. Therefore, payers use real-world evidence (RWE) generated in observational studies to make decisions regarding formulary inclusion and coverage. While some payers generate their own RWE, most cautiously rely on RWE produced by manufacturers who have a strong financial interest in obtaining coverage for their products.

A VELOUR post hoc subset analysis: prognostic groups and treatment outcomes in patients with metastatic colorectal cancer treated with aflibercept and FOLFIRI.

Background: The VELOUR study demonstrated a survival benefit for FOLFIRI + aflibercept versus FOLFIRI + placebo in metastatic colorectal cancer (mCRC) patients who progressed on oxaliplatin-based chemotherapy. Continued divergence of overall survival (OS) curves in the intension to treat (ITT) population, with the survival advantage persisting beyond median survival time, suggested subpopulations might have different magnitudes of survival gain. Additionally, 10% of patients within VELOUR had recurrence during or within 6 months of completing oxaliplatin-based adjuvant therapy (adjuvant fast relapsers)--previously identified as having poorer survival outcomes.

Health resource utilization and cost associated with myeloproliferative neoplasms in a large United States health plan.

Myelofibrosis (MF), polycythemia vera (PV) and essential thrombocythemia (ET) may lead to bone marrow fibrosis. Because the disease course of ET and PV are long and the disease course of MF may be fatal, healthcare resource utilization (HRU) associated costs of these neoplasms are especially important to understand. We used a large US health insurance claim database to describe the costs of these diseases.

Epidemiology of myeloproliferative neoplasms in the United States.

Myelofibrosis (MF), polycythemia vera (PV) and essential thrombocythemia (ET) are three classic BCR ABL fusion gene-negative chronic myeloproliferative neoplasms (MPNs). Though rare, it is important to understand the burden of illness of these disorders for public health planning, healthcare insurers and pharmaceutical manufacturers. Therefore, we have described the incidence of MF and prevalence of MF, ET and PV in the United States between 2008 and 2010 based on data from two large health plans.

The association of adherence to osteoporosis therapies with fracture, all-cause medical costs, and all-cause hospitalizations: a retrospective claims analysis of female health plan enrollees with osteoporosis.

Background: Osteoporosis affects approximately 10 million people in the United States and is associated with increased fracture risk and fracture-related costs. Poor adherence to osteoporosis medications is associated with higher general burden of illness compared with optimal adherence.

Objective: To examine the associations of adherence to osteoporosis therapies with (a) occurrence of closed fracture, (b) all-cause medical costs, and (c) all-cause hospitalizations.

Pharmacoeconomic evaluation of antidepressants : a critical appraisal of methods.

In recent years, there has been much debate regarding the real cost effectiveness of new antidepressants. This review is an attempt to identify key contentious methodological issues that can impact the reliability, validity and quality of the research on this subject. There are inherent complexities between inputs and outcomes related to depression, and the choice of pharmacoeconomic methodology requires a crucial balance between the study design and its ability to capture relevant information.

Health services research in rheumatology: a great deal accomplished, a great deal left to do.

Although rheumatology has been on the cutting edge of health services research for decades, there are many unresolved issues for patients, clinicians, insurers, and policy makers. This article explore three areas in which methodologic controversies present tradeoffs to a health care system that is grappling with larger issues around cost and access to care. Specifically, we examine issues around the use of large databases, the appropriate instruments for measuring patient-centered outcomes, and the questions that are raised from cost effectiveness studies of new treatments for rheumatoid arthritis.