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Trulicity® (dulaglutide), approved by the EMA in November 2014 for the treatment of Type 2 diabetes in adults, is the first diabetes drug to have a Patient Reported Outcome.
Trulicity® (dulaglutide), approved by the EMA in November 2014 for the treatment of Type 2 diabetes in adults, is the first diabetes drug to have a Patient Reported Outcome (PRO) (other than self-monitored blood glucose profiles) included in it’s summary of product characteristics ("label"). The following text has been included under the clinical efficacy and safety section: "Dulaglutide significantly improved total treatment satisfaction compared to exenatide twice daily. In addition, there was significantly lower perceived frequency of hyperglycaemia and hypoglycaemia compared to exenatide twice daily."
This claim is important for multiple reasons. Not only does it exemplify EMA’s stance on the use of PROs in new medical product development, but also because the developer–Eli Lilly–has garnered important insight into patients’ perspectives of dulaglutide. Demonstrating improvements from baseline in treatment satisfaction with dulaglutide, and showing that this improvement was greater with dulaglutide when compared to exenatide twice daily allows Eli Lilly to summarize with one metric both the relative balance (from the users’ perspective) between positive clinical outcomes and negative side-effects of dulaglutide, and the patient perceived benefit of improved clinical efficacy and reduced injection frequency versus an efficacious comparator. It also loosely allows them to hypothesize patients’ adherence to dulaglutide in clinical practice. As indicated in a press release by Eli Lilly when the data was published in 2013, "These results, coupled with dulaglutide's positive clinical data, suggest that…(dulaglutide) may be an attractive treatment option for patients with Type 2 diabetes."
The data is derived from a Phase III trial comparing dulaglutide to exenatide twice daily (open-label) and placebo (double-blind) when added to maximally tolerated doses of metformin and pioglitazone1. The treatment satisfaction data was presented at the American Diabetes Association meeting in 2013.2.
Since Type 2 diabetes is a chronic self-management condition, patients are asked to engage with many aspects of self care, including the routine taking of medication to control their blood glucose. Adherence rates for medication in Type 2 diabetes is poor, despite patients' acknowledgement about the importance of their medication (and the clinical and economic detriments of non-adherent behavior).
A patient who is satisfied with their treatment is more likely to engage and will therefore derive the maximal therapeutic benefit that medication can offer. Treatment satisfaction is therefore a relevant endpoint for clinical research in Type 2 diabetes, and perhaps more importantly, a key point for discussion between provider and patient in evidence-based prescribing. The inclusion of treatment satisfaction data in the label for dulaglutide shows that the EMA is acknowledging the relevance of the patient perspective as it pertains to the saturated market of Type 2 diabetes treatment.
Additional editorials/commentaries related to this topic include; selecting PRO measures in diabetes research3, interpreting diabetes PRO data4, and the importance of understanding patient preferences in diabetes research5,6.