Incidence of adverse events among adult users of insulin and apomorphine pumps in the United Kingdom Clinical Practice Research Datalink GOLD: a descriptive study

Date of ISAC Approval: 
11/11/2019
Lay Summary: 
Patients with diabetes or Parkinson's disease may receive drugs via a pump that automatically injects medicine directly under the skin. There is not enough good data about how often patients have complications when they are using these modes of treatment delivery. Also, there may be complications such as infections or skin reactions that are due to the pump system rather than to the medicine that the pump supplies. In this study we will look at how often patients with pump systems have these complications. As diabetes and Parkinson's diseases are very different diseases and their treatments are very different, similarities in the complications between diabetes treatment pumps and Parkinson's treatment pumps may be a result of the pump rather than to the diseases or their medicines. This data will provide an estimate of how common complications are for patients using pump systems. When regulators review data on new drugs that use pump systems, they can use these data as a comparison. If future treatments that use pump systems have more complications than we find in this study, it may be a sign of additional harm from the new treatments.
Technical Summary: 
Insulin pump therapy, also known as continuous subcutaneous insulin infusion (CSII), and apomorphine pump therapy, also known as continuous subcutaneous apomorphine infusion (CSAI) are used to deliver treatment as a subcutaneous infusion to patients with type 1 diabetes and Parkinson's disease, respectively. The rates of adverse events associated with these pump systems (particularly in real-world settings where user error may be higher than in clinical trials) are not clear. In addition, adverse events associated with these treatments may be caused by the pump system rather than the medication. Using data from CPRD GOLD, we will estimate the incidence rates and cumulative incidence of adverse events among new users of pump systems. Analyses will be stratified by age, sex, BMI, indication for use (diabetes vs. Parkinson's) and comorbidities to identify subgroups that may be at increased risk. These estimates will provide valuable data for patients and clinicians weighing different treatment options as well as for clinicians monitoring the use of these systems in their patients. These data will also provide a baseline for the expected rates of adverse events among pump users to be used by regulators in the evaluation of new treatments using pump systems.
Health Outcomes to be Measured: 
Treatment discontinuation; skin infections; skin nodules; skin allergic reaction; Steven(s)-Johnson syndrome; toxic epidermal necrolysis; dyskinesia; motor fluctuations; hallucinations/psychoses; impulse control disorder; somnolence; peripheral neuropathy; weight loss; suicidal behaviors
Collaborators: 

Dr Susan S Jick - Chief Investigator - BCDSP - Boston Collaborative Drug Surveillance Program
Catherine Vasilakis-Scaramozza - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Katrina Wilcox Hagberg - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Rebecca Persson - Collaborator - BCDSP - Boston Collaborative Drug Surveillance Program
Dr Susan S Jick - Corresponding Applicant - BCDSP - Boston Collaborative Drug Surveillance Program