The University of Southampton
University of Southampton Institutional Repository

Risk management and outcomes of adverse events to pioglitazone in primary care in the UK: an observational study

Risk management and outcomes of adverse events to pioglitazone in primary care in the UK: an observational study
Risk management and outcomes of adverse events to pioglitazone in primary care in the UK: an observational study
Background: Pioglitazone is an antidiabetic drug that belongs to the thiazolidinedione (TZD) class of insulin-sensitizing agents. Adverse events to pioglitazone of potential severity are listed in the `special warnings and special precautions for use' section of the pioglitazone summary of product characteristics (SPC), with recommendations for monitoring and management.

Objective: To describe the risk management and outcomes of recognized TZD class effects in patients prescribed pioglitazone.

Methods: An observational study of risk management and event outcomes for the adverse events of cardiac failure, fluid retention/oedema, weight gain, anaemia and abnormal liver function tests (LFTs) was performed. Patients were identified from within a prescription-event monitoring (PEM) postmarketing cohort of first-users of pioglitazone. Patients with pre-existing events or alternative causes, or with no possibility of collecting further information, were excluded. Outcomes included (i) the method of detection of the adverse event, i.e. whether the patient or the prescriber identified the problem; (ii) whether responsibility for risk management was taken at a primary- or secondary-care level; (iii) interventions taken to manage the event, including discontinuation of treatment; (iv) resolution and/or other outcomes of the event; and (v) general practitioner (GP) opinion of relatedness of the event to pioglitazone.

Results: Acute events such as cardiac failure and oedema were more likely to be detected by the patient presenting with the event rather than at regular follow-up. GPs were more likely to take responsibility for management of abnormal LFTs, anaemia and oedema events, whereas hospital admissions occurred mainly in patients with cardiac failure (45.3%). Pioglitazone was stopped in more than 50% of each type of event, apart from anaemia. Oedema events were the most likely to resolve (87.6%) and anaemia the least likely (42.9%). Oedema events were the most likely to be attributed to the drug by GPs, whereas cardiac failure was the event least attributed to pioglitazone.

Conclusions: Timely drug withdrawal and/or interventions such as corrective treatment or referral to a specialist can lead to successful resolution of class-effect adverse events of pioglitazone. Regular follow-up of patients on antidiabetic agents is essential to detect certain events, but more acute events are more likely to be reported spontaneously. Treatment options for patients with diabetes mellitus and cardiovascular risk factors are limited, requiring careful benefit-risk assessment of pioglitazone use in these patients and careful monitoring for signs of worsening cardiac function.
0114-5916
229-237
Fogg, Carole
42057537-d443-462a-8944-c804252c973b
Kasliwal, R.
538c068f-af50-4d61-b10c-88b8996567b6
Shakir, S.
5ffe3242-2132-4a59-acc9-cc498529817d
Fogg, Carole
42057537-d443-462a-8944-c804252c973b
Kasliwal, R.
538c068f-af50-4d61-b10c-88b8996567b6
Shakir, S.
5ffe3242-2132-4a59-acc9-cc498529817d

Fogg, Carole, Kasliwal, R. and Shakir, S. (2009) Risk management and outcomes of adverse events to pioglitazone in primary care in the UK: an observational study. Drug Safety, 32 (3), 229-237. (doi:10.2165/00002018-200932030-00005).

Record type: Article

Abstract

Background: Pioglitazone is an antidiabetic drug that belongs to the thiazolidinedione (TZD) class of insulin-sensitizing agents. Adverse events to pioglitazone of potential severity are listed in the `special warnings and special precautions for use' section of the pioglitazone summary of product characteristics (SPC), with recommendations for monitoring and management.

Objective: To describe the risk management and outcomes of recognized TZD class effects in patients prescribed pioglitazone.

Methods: An observational study of risk management and event outcomes for the adverse events of cardiac failure, fluid retention/oedema, weight gain, anaemia and abnormal liver function tests (LFTs) was performed. Patients were identified from within a prescription-event monitoring (PEM) postmarketing cohort of first-users of pioglitazone. Patients with pre-existing events or alternative causes, or with no possibility of collecting further information, were excluded. Outcomes included (i) the method of detection of the adverse event, i.e. whether the patient or the prescriber identified the problem; (ii) whether responsibility for risk management was taken at a primary- or secondary-care level; (iii) interventions taken to manage the event, including discontinuation of treatment; (iv) resolution and/or other outcomes of the event; and (v) general practitioner (GP) opinion of relatedness of the event to pioglitazone.

Results: Acute events such as cardiac failure and oedema were more likely to be detected by the patient presenting with the event rather than at regular follow-up. GPs were more likely to take responsibility for management of abnormal LFTs, anaemia and oedema events, whereas hospital admissions occurred mainly in patients with cardiac failure (45.3%). Pioglitazone was stopped in more than 50% of each type of event, apart from anaemia. Oedema events were the most likely to resolve (87.6%) and anaemia the least likely (42.9%). Oedema events were the most likely to be attributed to the drug by GPs, whereas cardiac failure was the event least attributed to pioglitazone.

Conclusions: Timely drug withdrawal and/or interventions such as corrective treatment or referral to a specialist can lead to successful resolution of class-effect adverse events of pioglitazone. Regular follow-up of patients on antidiabetic agents is essential to detect certain events, but more acute events are more likely to be reported spontaneously. Treatment options for patients with diabetes mellitus and cardiovascular risk factors are limited, requiring careful benefit-risk assessment of pioglitazone use in these patients and careful monitoring for signs of worsening cardiac function.

This record has no associated files available for download.

More information

Published date: 1 March 2009

Identifiers

Local EPrints ID: 437011
URI: http://eprints.soton.ac.uk/id/eprint/437011
ISSN: 0114-5916
PURE UUID: 46d12a80-6c30-460c-85c6-7465aa9853e7
ORCID for Carole Fogg: ORCID iD orcid.org/0000-0002-3000-6185

Catalogue record

Date deposited: 15 Jan 2020 17:30
Last modified: 17 Mar 2024 03:56

Export record

Altmetrics

Contributors

Author: Carole Fogg ORCID iD
Author: R. Kasliwal
Author: S. Shakir

Download statistics

Downloads from ePrints over the past year. Other digital versions may also be available to download e.g. from the publisher's website.

View more statistics

Atom RSS 1.0 RSS 2.0

Contact ePrints Soton: eprints@soton.ac.uk

ePrints Soton supports OAI 2.0 with a base URL of http://eprints.soton.ac.uk/cgi/oai2

This repository has been built using EPrints software, developed at the University of Southampton, but available to everyone to use.

We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we will assume that you are happy to receive cookies on the University of Southampton website.

×