Date of Approval:
Ibuprofen belongs to a group of painkillers called non-steroidal anti-inflammatory drugs (NSAID) and is available in a variety of formulations. Ibuprofen is used to ease mild to moderate pain, control fever and ease pain and inflammation in inflammatory conditions such as rheumatoid arthritis and osteoarthritis. A sub study of a clinical trial had shown that high dose ibuprofen (1800mg/day or more) was related to a substantial increase in systolic blood pressure (SBP) and a higher number of new cases of high blood pressure compared to celecoxib, another NSAID, in patients with rheumatoid arthritis or osteoarthritis who had pre-existing or were at high risk for cardiovascular disease. Data on the prescribing of high dose ibuprofen in the UK will be helpful in assessing the frequency of use at this dose. It will be useful to see how many patients with pre-existing high blood pressure are being prescribed high dose ibuprofen given that there is a warning to avoid ibuprofen for dose at 2400mg in these patients. This study will help to determine whether there would be a public health benefit in updating the product information of ibuprofen for use at 1800mg/2400mg per day.
The main objective of the study is to evaluate the prescribing of high dose ibuprofen (1800mg or more) using CPRD GOLD. The study will also look at prescribing of high dose ibuprofen in patients with pre-existing hypertension and duration of prescribing. This is a descriptive study, using a retrospective cohort design, of all patients in CPRD, regardless of age or indication, from 01/01/2013 to 31/12/2017 who have been prescribed high dose ibuprofen (1800mg/day or more). Absolute numbers and proportions of patients who were prescribed high dose ibuprofen will be calculated. The prevalence of patients with a prescription of high dose ibuprofen will also be presented. In addition, absolute numbers and proportions of prescriptions issued will be reported. The numbers and proportions patients with pre-existing hypertension, recorded within 3 months of an ibuprofen prescription, will be analysed. Results will be presented per calendar year and for all the years together. The duration of high dose ibuprofen treatment will be estimated from the prescribing information in CPRD which includes quantity of tablets and daily dose. Gaps of 91 days between prescriptions will be assumed to be breaks in treatment. Descriptive statistics i.e. mean, median, interquartile range, range, standard deviation will be calculated for duration of use.
Health Outcomes to be Measured:
NA as it is a drug usage study
Preeti Datta-Nemdharry - Chief Investigator - MHRA
Preeti Datta-Nemdharry - Corresponding Applicant - MHRA