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Use of renin-angiotensin-aldosterone system inhibitors and the risk of acute pancreatitis

Safe People

Organisation name

McGill University

Organisation sector

Academic Institute

Applicant name(s)

Samy Suissa - Chief Investigator - McGill UniversityLaurent Azoulay - Corresponding Applicant - McGill UniversityAlan Barkun - Collaborator - McGill UniversityEmily McDonald - Collaborator - McGill UniversityHui Yin - Collaborator - Sir Mortimer B Davis Jewish General HospitalJulie Rouette - Collaborator - McGill University

Safe Projects

Project ID

CPRD859

Lay summary

Angiotensin-converting enzyme inhibitors and angiotensin II receptor blockers are drugs that are commonly prescribed for the treatment of high blood pressure. While these drugs help patients lower their blood pressure, there are concerns that their use might lead to an increased risk of acute pancreatitis, which is a condition characterized by the inflammation of the pancreas. To date, this safety concern has not been thoroughly investigated. Thus, we will conduct a large study using the Clinical Practice Research Datalink to examine whether patients using angiotensin-converting enzyme inhibitors or angiotensin II receptor blockers are at a higher risk of acute pancreatitis. Because acute pancreatitis may be serious, results from this study will provide important information on the safety of these drugs.

Technical summary

Renin-angiotensin-aldosterone system inhibitors are antihypertensive drugs that include angiotensin-converting enzyme (ACE) inhibitors and angiotensin II receptor blockers (ARBs). While these drugs have clinical benefits, there is conflicting evidence on their effects on acute pancreatitis. On the one hand, some observational studies have associated the use of ACE inhibitors with an increased risk of acute pancreatitis, while others have associated the use of ARBs with a decreased risk of this outcome. Given that acute pancreatitis can be a serious and life-threatening condition, additional studies are needed to investigate the role of ACE inhibitors and ARBs on the incidence of acute pancreatitis. Using the Clinical Practice Research Datalink, the Hospital Episodes Statistics Repository, and the Office for National Statistics, we will address this question by comparing new users of ACE inhibitors and ARBs (separately) with new users of dihydropyridine calcium channel blockers between April 1, 1998 to December 31, 2018, with follow-up until March 31, 2019. Calendar time-specific propensity scores will be estimated and, using standardized mortality ratio weighting, weighted Cox proportional hazards models will be used to estimate hazard ratios with 95% confidence intervals for acute pancreatitis comparing 1) use of ACE inhibitors with use of dihydropyridine calcium channel blockers and 2) use of ARBs with use of dihydropyridine calcium channel blockers, with calendar year as stratification variable. The results from this study will provide much-needed information on the safety of ACE inhibitors and ARBs on the incidence of acute pancreatitis

Latest approval date

19/01/2021

Safe Data

Dataset(s) name

HES Admitted Patient Care

ONS Death Registration Data

Safe Setting

Access type

Release