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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.

Redekop W.K.,Erasmus University Rotterdam | Mladsi D.,RTI Health Solutions
Value in Health | Year: 2013

The objective of this article was to provide a framework for understanding the different definitions of the term "personalized medicine." The term personalized medicine is used regularly but interpreted in different ways. This article approaches the term by starting with a broad view of clinical medicine, where three components can be distinguished: the questions (e.g., what is the diagnosis?), the methods used to answer them (e.g., a test), and the available actions (e.g., to give or not give a particular drug). Existing definitions of personalized medicine disagree about which questions, methods, and actions fall within its domain. Some define the term narrowly, referring to the use of a diagnostic test to predict drug response, thereby clarifying whether or not a patient will benefit from that drug. An example of this combination is the HER2/neu test to predict the effectiveness of trastuzumab in breast cancer. Many who adopt this definition associate the concept of personalized medicine with fields such as genetics, genomics, and other types of "-omics." In contrast, others view personalized medicine as a concept that has always existed, because medicine has always considered the needs of the individual. One definition of personalized medicine that accommodates both interpretations is "the use of combined knowledge (genetic or otherwise) about a person to predict disease susceptibility, disease prognosis, or treatment response and thereby improve that person's health." This predictive ability can increase over time through innovations in various technologies, resulting in further improvements in health outcomes. Moreover, these developments can lead to a better understanding of the underlying causes of disease, which can eventually lead to breakthroughs in the treatment of individual patients. In that sense, a truly personalized form of medicine can also be seen as an ideal, a goal that will be achieved only after multiple advances in science. Although the term personalized medicine was rechristened somewhat recently, our ability to personalize medicine will continue to advance in unimaginable ways as we come to learn more about the heterogeneity that exists among individuals and diseases. © 2013 International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

Fehnel S.,RTI Health Solutions
Expert review of pharmacoeconomics & outcomes research | Year: 2013

Release of the US FDA patient-reported outcome (PRO) guidance raised expectations within the pharmaceutical industry for the use of PRO measures in support of labeling claims. The FDA developed the guidance with admirable intent, and the recommendations within this document are based on sound scientific principles. However, implementation of the guidance has been somewhat inconsistent within the Study Endpoints and Label Development (SEALD) and across the various FDA-reviewing divisions. Industry and regulatory bodies need to work toward gaining common ground to best support registration of treatments that could extend patients' lives, reduce symptoms, and/or improve health-related quality of life. PROs are valuable tools in communicating these messages, and realistic implementation of the FDA PRO Guidance may truly facilitate this process.

Mauskopf J.,RTI Health Solutions
Journal of medical economics | Year: 2013

The objective was to review the published literature on seasonal influenza to assess the differences between complications and mortality rates for those adults at high risk of influenza complications, including the resource use of those hospitalized with influenza complications. A targeted literature review was performed using electronic database keyword searches, specific inclusion criteria, quality rating of the reviewed full-text articles and abstraction of data to present published evidence on the incidence, complication rates and health service use associated with clinical influenza in different adult high-risk groups including those who are aged 65 years and older or those with different chronic underlying medical conditions. Key findings for incidence rates of clinical influenza were that incidence rates are similar among people with chronic cardiovascular or respiratory comorbidity, and may be higher in those with allogeneic stem cell transplants compared to those with autologous transplants. Rates of hospitalization and/or pneumonia or lower respiratory tract infection for those with chronic conditions or those who are immunocompromised are substantially higher than those in people over age 65 but without additional high-risk factors. A person who is hospitalized and has a laboratory-confirmed influenza diagnosis has a probability of intensive care unit admission of between 11.8-28.6% and of death of between 2.9-14.3%. These findings indicate that although the burden of influenza varied across high-risk groups, it also varied widely across studies within a single high-risk group. A key finding was that those over 65 years of age but without additional high-risk factors had a low risk of influenza complications. A limitation of the review is that most of the studies of hospitalized patients did not present outcomes data separately by high-risk group and only limited data were identified on rates of hospitalization or lower respiratory tract infection for most high-risk groups. Information about influenza complication rates and resource use, including influenza vaccines, chemoprophylaxis and/or treatment strategies for different high-risk groups, is needed to evaluate new interventions.

Gutierrez L.,RTI Health Solutions
Journal of medical economics | Year: 2011

To determine the incremental cost of healthcare and clinical outcomes in the 12 months following incident hip fractures among postmenopausal women in the UK. Retrospective cohort study of women aged 50 years or older hospitalized for an incident hip fracture within 1 week of the fracture date who were age- and comorbidity-matched to women without fracture. Cohorts were identified in the Health Improvement Network database, and followed up for 1 year. Among 2,427 women who had a hip fracture and a recorded hospitalization, the mean [SD] age was 81 [9.3] years. About 18% of women without fractures were hospitalized during follow-up and 18% of women with hip fractures and 4% of women without fractures had at least one emergency admission (RR, 4.7; 95% CI, 3.8-5.8). There were no major differences in use of general practitioner visit, referral visits, or in prescription of medications. Mortality was 18% in the hip fracture cohort and 7% in the non-fracture cohort (RR, 2.5; 95% CI, 2.1-3.0). The overall 1-year mean incremental cost of hip fractures was £4,222 (95% CI, £4,105-4,339); most of this cost (97%) was for hospitalizations, with an increment of £4,095. About 98% of the incremental cost occurred in the first 6 months following hip fracture. The results of this study indicate that the cost and clinical burden associated with hip fractures in postmenopausal women in the UK are considerable. The incremental cost is mostly related to the cost of hospitalization and treatment of the hip fracture. Key limitations were the inclusion of only those women with a recorded hospitalization, and that costs associated with rehabilitation services, social services, and long-term care were not recorded in this study, although these are important contributors to the total cost of fractures.

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