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

Table 1 Effects of drug warnings on the utilisation of rosiglitazone and pioglitazone in Australia

Drug authorities	Time	Warnings	Adjusted for	Coefficient^a	95% CI^b	pvalue
Rosiglitazone: ARIMA (1,0,2) model
EMA1_FDA1	May 2007	Ischemic heart	-	−15.04	[−21.86, −8.22]	<0.001 ^c
FDA2	Aug 2007	Label update heart related	EMA1_FDA1	−2.61	[−40.41, 35.20]	0.893
EMA2	Oct 2007	Ischemic heart	EMA1_FDA1, FDA2	1.94	[−95.49, 99.36]	0.969
TGA1	Dec 2007	Ischemic heart	EMA1_FDA1, FDA2, EMA2	−5.25	[−38.01, 27.51]	0.837
EMA3	Jan 2008	Ischemic heart	EMA1_FDA1, FDA2, EMA2, TGA1	−0.39	[−80.06, 79.28]	0.992
FDA3, TGA2, EMA4	Sep 2010	EU suspended,	EMA1_FDA1, FDA2, EMA2, TGA1, EMA3	1.25	[−8.99, 11.49]	0.811
FDA3, TGA2, EMA4	Sep 2010	US restriction	EMA1_FDA1, FDA2, EMA2, TGA1, EMA3	1.25	[−8.99, 11.49]	0.811
Pioglitazone: ARIMA (1,0,1) model
FDA	June 2011	Bladder cancer	-	−5.76	[−13.91, 2.39]	0.166
EMA, TGA	July 2011	Bladder cancer	-	−6.57	[−14.80, 1.65]	0.117

^aCoefficient = Percentage change in magnitude and direction after the intervention.
^bCI = confidence interval.
^cStatistical significance at p value <0.05.
TGA = Therapeutic Good Administration; EMA = European Medicines Agency; FDA = U.S. Food and Drug Administration; EU = European Union; US = United States of America.

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