The feasibility of examining cardiovascular event rates with different add-on therapies to metformin for type 2 diabetes mellitus using primary care data through benchmarking results against randomised controlled trials.
- Principal Investigator: Manuj Sharma
- 1 February 2018 to 30 September 2018
- Project No: 380
- Funding round: FR 13
Feasibility of using primary care data to examine cardiovascular events rates with different add-on therapies to metformin
Metformin is the recommended treatment for newly diagnosed patients with type 2 diabetes mellitus (T2DM). However, when metformin alone is insufficient, there are many different options a clinician could add-on to manage the T2DM, making decisions challenging. Examples of add-on treatments include sulphonylureas, DPP-4 inhibitors, GLP-1 analogues, SGLT-2 inhibitors and thiazolidinediones.
There are several factors a clinician would ideally assess before prescribing these add-on treatments to metformin such as the risk of developing serious heart problems. The risk of heart problems such as heart attacks is always increased following a diagnosis of T2DM and clinicians want to know if different treatment choices might affect this risk further. Though clinical trials have been undertaken for some of these treatments to examine this risk, for others this is not yet the case. Furthermore, it is sometimes found that participants of clinical trials have different characteristics to those seen in clinical practice. Therefore, clinical trial results may not necessarily apply in a “real world” setting.
This feasibility-study will help towards addressing this gap in knowledge. We will achieve this by identifying patients with T2DM who were prescribed different add-on treatments to metformin between 2007-2017 from a UK database containing anonymised healthcare records. We will determine the characteristics of the patients such as their age, gender and medical conditions at the point the add-on treatment was started. We will compare these characteristics to participant characteristics from clinical trials undertaken to identify differences. Finally, we will determine if it is possible to compare the rate of occurrence of serious heart problems in the “real world” group to the clinical trials for each treatment. Our findings will identify any limitations with the clinical trials and whether “real world” studies could help inform clinicians on risk of developing heart problems with different add-on treatments in the future.
Amount awarded: £31,069