Date of ISAC Approval:
Glaucoma is an incurable disease that is characterized by the gradual loss of eyesight over time. It shrinks the field of vision and if left untreated, can lead to blindness. It is often an age-related disease and is one of the most common causes of blindness worldwide. Glaucoma can be caused by an increase of pressure inside the eye and most glaucoma treatments aim to reduce this pressure. Beta-blocker eye drops are effective at reducing the pressure but should not be used in patients with a specific set of diseases that affect the lungs, heart or blood vessels as they can cause unwanted side effects. This aim of this study is to discover if UK patients with these specific diseases are being prescribed these treatments even though they are not suitable. Previous studies have found that this was true but in recent years there have been other medications available that may have changed this outcome. The findings of this study will be important to help report the current risk to patients and to potentially emphasize the need for prescribing more suitable medications for glaucoma patients.
Objectives: This study is to elucidate the recent prescribing trends of topical beta-blocker therapy for newly diagnosed Primary Open Angle Glaucoma (POAG) and Ocular Hypertension (OHT) patients in the UK. In particular, it will describe whether POAG and OHT patients with contraindicated comorbidities for topical beta-blockers are still receiving topical beta-blocker therapy in spite of explicit guidelines against their use and recent improvements in availability of alternative medications. It will also examine (i) the number of patients diagnosed with contraindicated comorbidities before diagnosis, after diagnosis, after diagnosis but before topical beta-blocker therapy and after topical beta-blocker treatment, (ii) the treatment line for topical beta-blocker treatments, (iii) if the patients are in receipt of concurrent contraindicated treatments and (iv) the number of topical beta-blocker prescriptions in the 6 months after the first topical beta-blocker prescription. An analysis of this data is required to potentially highlight the need for more appropriate treatments to be prescribed for POAG and OHT and to inform a potential prescribing policy change in the UK. Methods: This is a descriptive study and therefore no complex statistical methods will be applied. Only descriptive statistics such as frequency counts, percentages, mean, standard deviation, range, median and interquartile range will be reported. Data analysis: Patients diagnosed with POAG or OHT between 2013 and 2016 in the CPRD database will be included. This is to assess more recent prescribing trends and to allow at least one year of follow-up data for prescribing patterns.
Health Outcomes to be Measured:
- Primary: Patient counts/frequencies for Primary Open Angle Glaucoma (POAG) and Ocular Hypertension (OHT) patients with selected cardiovascular and respiratory comorbidities contraindicated for topical beta-blocker use - Secondary: Patient counts/frequencies for POAG/OHT with selected cardiovascular and respiratory comorbidities in specific time intervals: (i) before POAG/OHT diagnosis, (ii) after diagnosis, (iii) after diagnosis but before topical beta-blocker treatment, (iv) and after topical beta-blocker treatment - Secondary: the number of topical beta-blocker prescriptions in POAG and OHT patients 6 months after first topical beta-blocker prescription - Secondary: Patient counts/frequencies for topical beta-blocker treatment line for POAG and OHT patients - Secondary: Patient counts/frequencies for concurrent use of topical beta-blocker and beta-agonist or systemic beta-blocker
Dr Yong Soo Kim - Chief Investigator - NOVARTIS
Dr Ailis Fagan - Corresponding Applicant - NOVARTIS
Martin McSharry - Collaborator - NOVARTIS
Dr Vladimir Bezlyak - Collaborator - NOVARTIS