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Next Course 23-24 May 2012
Staying Current and in Control in the Constantly Changing Global Regulatory Pharmacovigilance Environment

Monitoring the safety of pioglitazone: results of a prescription-event monitoring study

Background

Pioglitazone is a drug used to treat diabetes (high blood sugar levels) which was launched in the UK in November 2000. The objective of this study was to monitor the safety of pioglitazone in the primary care setting in England using prescription-event monitoring (PEM).

Methods

Patients were identified from prescriptions for pioglitazone issued by GPs between November 2000 and June 2001. Questionnaires were sent to the prescribing doctor at least 8 months after the first prescription for an individual patient. These requested information on use of the drug and all clinical events which had occurred during this period. Information on any deaths, events suspected to be side-effects and the reasons why treatment was stopped were also collected. The rates which events occurred were calculated on a monthly basis and the analysis used to assess the safety of pioglitazone.

Results

Useful information was received for 12,772 patients. The average age was 62 years and 53% were male. Nearly a third of patients were also taking metformin - another treatment for diabetes. Of the 3,690 patients who stopped pioglitazone during the study period, nearly one-third did so because of poor control of the diabetes. Other fairly common reasons for stopping were fluid retention and weight gain. General malaise and nausea/vomiting were the most commonly reported side-effects. Other events occurring in some patients early in treatment which were considered to be possible side-effects included dizziness, headache, diarrhoea and blood tests which were abnormal in relation to the function of the liver.

Conclusion

Pioglitazone was considered to be reasonably well-tolerated with the main reasons why treatment needed to be stopped being relating to the drug not being effective in some patients. The frequency of side-effects with pioglitazone was similar to what was expected, apart from for nausea/vomiting and diarrhoea which are not listed as side effects in the prescribing information. These results should be considered alongside related published information. Further research into the safety of pioglitazone is needed.