Pharmacoepidemiologists have a constant and ever-evolving need for high quality and up-to-date epidemiological data on comorbidity profiles for certain patient populations. Such data are essential to support activities across the clinical development and post-marketing phases. These activities include the design of trial inclusion and exclusion criteria, safety evaluations in development and post-marketing settings, and the completion of studies required by regulatory authorities. We developed an approach to estimate disease comorbidities at the population level in a manner consistent with the existing Global Burden of Disease (GBD) study framework, and generated comorbidity estimates for nearly 900 disease pairs, by age and sex, among the adult population in the United States, using this approach. A web-based tool called the Multimorbidity Explorer is available to provide ready access to these insights. In this paper, we describe the methods used to generate estimates of disease comorbidity leveraging GBD data, present the tool developed to house these estimates, and provide an overview of practical applications.

Purpose Guidelines recommend low-molecular-weight heparins (LMWHs) for patients with cancer associated thrombosis. However, until recently, only dalteparin and tinzaparin were approved in the European Economic Area (EEA) for these patients. This study compares the benefit–risk profile of enoxaparin with dalteparin and tinzaparin, based on real-world evidence (RWE) for the extended treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrence in adult patients with active cancer. Methods A semi-quantitative structured benefit–risk assessment was conducted for the label-extension application of enoxaparin employing the following steps of the benefit–risk action team descriptive framework: define decision context; determine key benefit and risk outcomes; identify data sources; extract data; interpret results. Results The key benefits were defined as reduced all-cause mortality and VTE recurrence (including symptomatic DVT, fatal PE and non-fatal PE); the key risks were major and non-major bleeding of clinical significance. When compared with other EEA-approved LMWHs (dalteparin, tinzaparin), enoxaparin demonstrated a trend toward favourable effects for the reduction of VTE recurrence and all-cause mortality. There was a trend in favour of other LMWHs for major bleeding, and a trend in favour of enoxaparin for non-major bleeding with no evidence of significant difference between enoxaparin and the comparator groups. Conclusions The assessment using RWE demonstrated a favourable benefit–risk profile for enoxaparin similar to that of other EEA-approved LMWHs for the treatment of DVT and PE and the prevention of recurrence in patients with active cancer and thus supported the label-extension approval.