Renal Medicine ACF Project 2021

A list of ACF 2021 projects within the speciality of renal medicine

Project lead: Prof Kamlesh Khunti kk22@leicester.ac.uk

Project 1. Incidence and prevalence of cardiometabolic-renal multimorbidities using the Clinical Practice Research Datalink

In the last decades, research into diabetes has been conducted in the attempt to improve medication, blood glucose monitoring and identification of risk factors. To assess the impact of these and other changes in diabetes treatment, it is important to examine trends in mortality rates over time. This research aims to use the Clinical Practice Research Datalink (CPRD) data to provide a real-world view of the change in mortality rates over time in people with and without diabetes in the UK and other countries. Although previous observational cohort studies have shown declining mortality rates over time among in people with diabetes, mainly from the USA and Sweden, data from other countries are limited. The objective of this epidemiological project is to examine trends in the incidence and prevalence of cardio-renal-metabolic disease in the UK population with and without type 2 diabetes, with data extracted from the CPRD, and to compare them with those of other countries. The exposure measure is a diagnosis of type 2 diabetes and the outcome measures are: all-cause mortality and cardio-renal-metabolic disease incidence, prevalence and mortality. As in CPRD several baseline characteristics and lifestyle factors associated with the risk of death are available, adjusting for  these confounders will give an aetiological perspective to this research; likewise, the results of this project will provide a contemporary real-world assessment of overall and cardio-renal-metabolic disease burden, thus allowing comparisons with across countries (descriptive epidemiology/demography).

 

  1. 2. Use of Clinical Practice Research Datalink to assess the clinical effectiveness of SGLT-2 and GLP-1RAs in a real-world setting

 

Randomised controlled trials (RCTs) must be carried out to ensure high internal validity and reduce the risk bias when quantifying treatment effects. To be clinically useful, trial results must also be externally valid and reflect treatment effect in a definable group of patients and in a specific clinical setting. Lack of external validity is the most frequent criticism by clinicians of RCTs. Unfortunately, the results of RCTs might not be relevant to all patients and all settings and hence the effectiveness of drug treatments in real world settings is becoming increasingly important for informing clinical practice (pharmacoepidemiological comparative effectiveness study). To aim of this project is to compare the effectiveness of sodium-glucose co-transporter-2 (SGLT-2) inhibitors and glucagon like peptide-1 receptor agonists (GLP-1RAs), two new classes of glucose-lowering medications, in RCTs vs “real world evidence”. The project will consist in three complementary objectives. First, to use population matching techniques to extract patient data from the Clinical Practice Research datalink (CPRD) and assess whether the effects on metabolic outcomes from the main trials are replicable in a real-world UK setting. Second, to assess effectiveness of SGLT-2 inhibitors and GLP-1RA agonists in major cardiovascular outcome trials and compare them with the clinical population who receive the treatment in the UK and assess the impact of patient characteristics such as age, ethnicity, gender and co-morbidities on clinical effectiveness. Third, in all patients within CPRD who have been prescribed SGLT-2 inhibitors and GLP1RA agonists, clinical effectiveness will be assessed also in terms of absolute efficacy as this is more relevant given the dissimilar baseline risk of outcomes in RCTs vs “real-world” patients with diabetes.

Project 3. Association between drug adherence and outcomes in patients with multimorbidity: A Clinical Practice Research Datalink epidemiological study

Multiple lines of evidence have shown that adherence to prescribed therapies is suboptimal and can be considered one of the largest unmanaged issues in modern medicine, with a significant cost burden on healthcare systems. Poor adherence, moreover, is an independent risk factor for poor health outcomes, such as cardiovascular diseases and death. With the increase in life expectancy, a growing number of people suffer from more than one serious long-term medical condition such as diabetes, kidney disease or depression - a condition known as multimorbidity (MM). Patients having more than one medical condition are at greater risk of frailty and disability and have a lower quality of life and shorter life expectancy. Because the number of medications prescribed to patients with multimorbidity is, by definition, higher, individuals with multimorbidity may be at most risk of adherence. Therefore, nonadherence could be the potential link between the presence of multimorbidity and the risk of long-term outcomes and the shorter life expectancy in patients with multiple medical conditions. Using the Clinical Practice Research datalink, this project will help clarify: 1) the burden of MM; 2) the pattern of nonadherence and its risk factors; 3) the interaction between MM and nonadherence on the risk of long-term outcomes. If the results will indicate that nonadherence is a key determinant of poor outcomes in patients with MM, the clinical and public health impact would be very relevant. In fact, initiatives focusing at both individual and population level to underpin the importance of taking medications should be implemented.


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