Utilisation trends of rosiglitazone and pioglitazone in Australia before and after safety warnings

Abstract

BackgroundA see on cardiovascular diseases and bladder cancer. The changes to the patterns of rosiglitazone and pioglitazone utilisation in Australia following the timing of these various health authority warnings such as the Australian Therapeutic Good Administration (TGA), European Medicines Agency (EMA) press releases or U.S. Food and Drug Administration (FDA) is unknown. This study investigated the utilisation patterns of rosiglitazone and pioglitazone in Australia before and after warnings of major drug authorities.MethodsWe evaluated rosiglitazone and pioglitazone dispensing using the Pharmaceutical Benefit Scheme (PBS) subsidised drug dispensing data for the Australian population from February 2004 to July 2012. The World Health Organisation Anatomic Therapeutic Chemical (ATC)/Defined Daily Dose (DDD) system was used to compare the drug utilisation patterns following the announcements of EMA, FDA, and TGA safety warnings, which first occurred in May 2007. The DDD/1000population/day were examined in a series of time-series regression analysis with the drug safety warnings specified as interventions.ResultsRosiglitazone utilisation increased steadily from 2004 until reaching a peak at 1.96/1000population/day in January 2007. Then rosiglitazone use decreased significantly after the initial EMA press release and FDA warning on cardiovascular risk in May 2007 (with a 15.04% average monthly decline, p-value <0.001), however use did not significantly decrease after the TGA warning or subsequent EMA and FDA warnings. Pioglitazone utilisation proceeded rosiglitazone in September 2008 and remained above 1.5/1000/day during 2009–2010. However, pioglitazone utilisation has slightly declined after the FDA, EMA, and TGA warnings related to bladder cancer.ConclusionsDrug safety warnings were associated with a decrease in rosiglitazone and pioglitazone utilisation in Australia. Rosiglitazone began to decline prior to TGA warnings in December 2007, which suggests that Australian prescribers may have acted in response to scientific evidence or international safety warnings (EMA, FDA), prior to the response of the TGA. Minor effects were observed after bladder cancer warnings on pioglitazone utilisation.

Impact of clinical evidence communications and drug regulation changes concerning rosiglitazone on prescribing patterns of antidiabetic therapies

“…Our findings were consistent with the results described in previous studies conducted in other countries. In Canada, the number of rosiglitazone users declined substantially by 85% between 2011 and 2012; in the UK, the incidence of its use also fell steeply from 0.8/1000 person‐years to 0.2/1000 person‐years in 3 months post the publication of safety signals in May 2007, and similar trends were observed in the US, the Netherlands, and Australia . Our results suggested that clinicians and administrative authorities in Korea heeded the clinical evidence published in literature and related safety alerts communicated to the medical community, domestically and globally alike, regarding suspected serious CV risks associated with medication use.…”

“…Besides prevalent use of metformin as mono or dual therapy, of note 12 and similar trends were observed in the US, the Netherlands, and Australia. 13,17,18 Our results suggested that clinicians and administrative authorities in Korea heeded the clinical evidence published in literature and related safety alerts communicated to the medical community, domestically and globally alike, regarding suspected serious CV risks associated with medication use. Although the domestic regulations allowed conditional access, albeit heavily restricted, to rosiglitazone for only those patients whose glycemic control cannot be achieved without the TZD agent, 16 health care providers seemed to strictly comply with the safety communications as well as the FIGURE 4 Concomitancy among the most commonly prescribed antidiabetic drug classes 2007 to 2015.…”

“…In November 2013, however, after an extensive review of readjudicated data from a postmarketing clinical trial, the FDA announced the elimination of previous access restrictions . Several studies have been conducted previously in the USA and in European countries to investigate the effect of each milestone event concerning rosiglitazone safety on AD use trends . To our knowledge, however, this is the first research with a study period long enough to encompass the entire course of developments on suspected CV risks of rosiglitazone, including the FDA's latest decision to lift the restrictive actions on the TZD drug.…”

“…[9][10][11] Several studies have been conducted previously in the USA and in European countries to investigate the effect of each milestone event concerning rosiglitazone safety on AD use trends. [12][13][14][15] To our knowledge, however, this is the first research with a study period long enough to encompass the entire course of developments on suspected CV risks of rosiglitazone, including the FDA's latest decision to lift the restrictive actions on the TZD drug. Despite Asia being projected as the fastest-growing diabetes market in the world, little is known about AD use patterns in Asia following the release of CV safety issues associated with rosiglitazone.…”

Clinical audit for the adherence to safety monitoring for pioglitazone use in patients with type 2 diabetes in the Al-Wazarat primary care center, Saudi Arabia

“…10 Despite the safety warnings issued for pioglitazone, its utilization continued in several countries without significant reduction. 11,12 In addition, pioglitazone is still considered by ADA as a useful alternative to nontolerated metformin monotherapy, with modest cardiovascular benefits. 13,14 However, individualized patient risk-benefit assessment has been advised before the use of pioglitazone.…”