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Monitoring and adverse events in relation to ACE inhibitor/angiotensin receptor blocker initiation in people with
L Mathieson1, A Severn, B Guthrie
1NHS Tayside, Dundee, UK. liusaidh.mathieson@hotmail.co.uk
Background And Aim:
To determine whether angiotensin-converting enzyme inhibitor/angiotensin receptor blocker (ACEI/ARB) initiation in people with diabetes is monitored as recommended by recent guidelines and the incidence of associated adverse renal events.
Design:
Retrospective population database analysis of 4056 people in Tayside, Scotland with type 2 diabetes prescribed an ACEI/ARB between 1 January 2005 and 31 December 2009.
Method:
Measurement of urea and electrolytes (U&Es) before and after ACEI/ARB initiation and renal adverse events; defined as a ≥30% rise in serum creatinine and post-initiation potassium of ≥5.6 mmol/L. Associations of adverse events with patient demographics or co-prescription of drugs with known renal effects were examined.
Results:
Overall, 89% of initiations were with an ACE inhibitor. A total of 18.84% (CI 95% 18.82-18.86) of patients initiating ACE inhibitor or ARB had U&Es measured in the 90 days before initiation and within 5-14 days after initiation. Only 1.7% of patients had an adverse renal event. Patients prescribed with an ARB were less likely to be monitored than those prescribed with an ACE inhibitor, but no less likely to suffer harm.
Conclusions:
Current clinical practice of biochemical monitoring of ACE inhibitor/ARB is poor, but adverse events are rare. Further studies with serial U&Es are needed to establish the critical time window for adverse renal events and evaluate whether intensive biochemical monitoring recommended is required in low-risk groups.
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Pharmacovigilance
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...