Basing approval of drugs for type 2 diabetes on real world outcomesBMJ 2015; 351 doi: https://doi.org/10.1136/bmj.h5829 (Published 03 November 2015) Cite this as: BMJ 2015;351:h5829
- Andrew McGovern, clinical researcher1,
- Robert Hinchliffe, senior lecturer in vascular surgery2,
- Neil Munro, visiting professor1,
- Simon de Lusignan, professor of primary care1
- 1Section of Clinical Medicine and Ageing, University of Sussex, Guildford GU2 7PX, UK
- 2St George’s Vascular Institute, Division of Cardiovascular Sciences, St George’s, University of London, London, UK
Naci and colleagues rightly point out that although drugs are often approved on the basis of glucose lowering efficacy, we really need agents that reduce important outcomes such as symptomatic microvascular disease and cardiovascular events.1 The authors suggest that real world evidence of clinical effectiveness should be required from the drug industry, using routine healthcare data to monitor outcomes.
At the University of Surrey we have entered into partnership with Eli Lilly to provide some of these essential outcomes data using primary care records. Our preliminary analysis further highlights the need to extend studies into the real world. In practice people treated with glucagon-like peptide-1 (GLP1) agonists and sodium-glucose co-transporter-2 (SGLT2) inhibitors have a significantly higher body mass index than those in clinical trials (GLP1 agonists: 37.5 in practice, 31.8 in aggregated trials; P<0.001; SGLT2 inhibitors: 34.7 in practice, 30.6 in trials; P<0.001). Trial populations are not representative of the people treated with these new drugs, and the effectiveness in practice may be less certain.
If this investigation into real world outcomes is to be funded by the drug industry, stringent precautions must be taken to minimise the biases identified in industry funded research.2 Non-trial research should be registered in a similar way to clinical trials, with demands for high quality research protocols to be recorded before data extraction and analysis.
We agree that drug outcomes data must include outcomes relevant to patients. Only well constructed studies in the real world will confirm the effectiveness of new and existing drugs.
Cite this as: BMJ 2015;351:h5829
Competing interests: AMcG, NM, and SdeL undertake research as part of the newly developed University of Surrey-Lilly Real World Evidence Centre funded by Eli Lilly and Company. RH has no competing interests to declare.
Full response at: www.bmj.com/content/351/bmj.h5260/rr-0.
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