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Published in: BMC Health Services Research 1/2014

Open Access 01-12-2014 | Research article

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

Authors: Suvimol Niyomnaitham, Andrew Page, Adam La Caze, Karen Whitfield, Alesha J Smith

Published in: BMC Health Services Research | Issue 1/2014

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Abstract

Background

A 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.

Methods

We 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.

Results

Rosiglitazone 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.

Conclusions

Drug 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.
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Literature
1.
go back to reference Phillips LS, Grunberger G, Miller E, Patwardhan R, Rappaport EB, Salzman A: Once- and twice-daily dosing with rosiglitazone improves glycemic control in patients with type 2 diabetes. Diabetes Care. 2001, 24 (2): 308-315. 10.2337/diacare.24.2.308.CrossRefPubMed Phillips LS, Grunberger G, Miller E, Patwardhan R, Rappaport EB, Salzman A: Once- and twice-daily dosing with rosiglitazone improves glycemic control in patients with type 2 diabetes. Diabetes Care. 2001, 24 (2): 308-315. 10.2337/diacare.24.2.308.CrossRefPubMed
2.
go back to reference Aronoff S, Rosenblatt S, Braithwaite S, Egan JW, Mathisen AL, Schneider RL: Pioglitazone hydrochloride monotherapy improves glycemic control in the treatment of patients with type 2 diabetes: a 6-month randomized placebo-controlled dose–response study. The Pioglitazone 001 Study Group. Diabetes Care. 2000, 23 (11): 1605-1611. 10.2337/diacare.23.11.1605.CrossRefPubMed Aronoff S, Rosenblatt S, Braithwaite S, Egan JW, Mathisen AL, Schneider RL: Pioglitazone hydrochloride monotherapy improves glycemic control in the treatment of patients with type 2 diabetes: a 6-month randomized placebo-controlled dose–response study. The Pioglitazone 001 Study Group. Diabetes Care. 2000, 23 (11): 1605-1611. 10.2337/diacare.23.11.1605.CrossRefPubMed
4.
go back to reference Nissen SE, Wolski K: Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007, 356 (24): 2457-2471. 10.1056/NEJMoa072761.CrossRefPubMed Nissen SE, Wolski K: Effect of rosiglitazone on the risk of myocardial infarction and death from cardiovascular causes. N Engl J Med. 2007, 356 (24): 2457-2471. 10.1056/NEJMoa072761.CrossRefPubMed
5.
go back to reference Home PD, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Jones NP, Komajda M, McMurray JJ: Rosiglitazone evaluated for cardiovascular outcomes–an interim analysis. N Engl J Med. 2007, 357 (1): 28-38. 10.1056/NEJMoa073394.CrossRefPubMed Home PD, Pocock SJ, Beck-Nielsen H, Gomis R, Hanefeld M, Jones NP, Komajda M, McMurray JJ: Rosiglitazone evaluated for cardiovascular outcomes–an interim analysis. N Engl J Med. 2007, 357 (1): 28-38. 10.1056/NEJMoa073394.CrossRefPubMed
6.
go back to reference Bilik D, McEwen LN, Brown MB, Selby JV, Karter AJ, Marrero DG, Hsiao VC, Tseng CW, Mangione CM, Lasser NL, Crosson JC, Herman WH: Thiazolidinediones, cardiovascular disease and cardiovascular mortality: translating research into action for diabetes (TRIAD). Pharmacoepidemiol Drug Saf. 2010, 19 (7): 715-721. 10.1002/pds.1954.CrossRefPubMedPubMedCentral Bilik D, McEwen LN, Brown MB, Selby JV, Karter AJ, Marrero DG, Hsiao VC, Tseng CW, Mangione CM, Lasser NL, Crosson JC, Herman WH: Thiazolidinediones, cardiovascular disease and cardiovascular mortality: translating research into action for diabetes (TRIAD). Pharmacoepidemiol Drug Saf. 2010, 19 (7): 715-721. 10.1002/pds.1954.CrossRefPubMedPubMedCentral
7.
go back to reference Gerrits CM, Bhattacharya M, Manthena S, Baran R, Perez A, Kupfer S: A comparison of pioglitazone and rosiglitazone for hospitalization for acute myocardial infarction in type 2 diabetes. Pharmacoepidemiol Drug Saf. 2007, 16 (10): 1065-1071. 10.1002/pds.1470.CrossRefPubMed Gerrits CM, Bhattacharya M, Manthena S, Baran R, Perez A, Kupfer S: A comparison of pioglitazone and rosiglitazone for hospitalization for acute myocardial infarction in type 2 diabetes. Pharmacoepidemiol Drug Saf. 2007, 16 (10): 1065-1071. 10.1002/pds.1470.CrossRefPubMed
9.
go back to reference Weatherby LB, Nordstrom BL, Fife D, Walker AM: The impact of wording in “Dear doctor” letters and in black box labels. Clin Pharmacol Ther. 2002, 72 (6): 735-742. 10.1067/mcp.2002.129503.CrossRefPubMed Weatherby LB, Nordstrom BL, Fife D, Walker AM: The impact of wording in “Dear doctor” letters and in black box labels. Clin Pharmacol Ther. 2002, 72 (6): 735-742. 10.1067/mcp.2002.129503.CrossRefPubMed
16.
go back to reference Lincoff AM, Wolski K, Nicholls SJ, Nissen SE: Pioglitazone and risk of cardiovascular events in patients with type 2 diabetes mellitus: a meta-analysis of randomized trials. JAMA. 2007, 298 (10): 1180-1188. 10.1001/jama.298.10.1180.CrossRefPubMed Lincoff AM, Wolski K, Nicholls SJ, Nissen SE: Pioglitazone and risk of cardiovascular events in patients with type 2 diabetes mellitus: a meta-analysis of randomized trials. JAMA. 2007, 298 (10): 1180-1188. 10.1001/jama.298.10.1180.CrossRefPubMed
17.
go back to reference Erdmann E, Spanheimer R, Charbonnel B: Pioglitazone and the risk of cardiovascular events in patients with Type 2 diabetes receiving concomitant treatment with nitrates, renin-angiotensin system blockers, or insulin: results from the PROactive study (PROactive 20). J Diabetes. 2010, 2 (3): 212-220. 10.1111/j.1753-0407.2010.00082.x.CrossRefPubMed Erdmann E, Spanheimer R, Charbonnel B: Pioglitazone and the risk of cardiovascular events in patients with Type 2 diabetes receiving concomitant treatment with nitrates, renin-angiotensin system blockers, or insulin: results from the PROactive study (PROactive 20). J Diabetes. 2010, 2 (3): 212-220. 10.1111/j.1753-0407.2010.00082.x.CrossRefPubMed
19.
go back to reference Lewis JD, Ferrara A, Peng T, Hedderson M, Bilker WB, Quesenberry CP, Vaughn DJ, Nessel L, Selby J, Strom BL: Risk of bladder cancer among diabetic patients treated with pioglitazone: interim report of a longitudinal cohort study. Diabetes Care. 2011, 34 (4): 916-922. 10.2337/dc10-1068.CrossRefPubMedPubMedCentral Lewis JD, Ferrara A, Peng T, Hedderson M, Bilker WB, Quesenberry CP, Vaughn DJ, Nessel L, Selby J, Strom BL: Risk of bladder cancer among diabetic patients treated with pioglitazone: interim report of a longitudinal cohort study. Diabetes Care. 2011, 34 (4): 916-922. 10.2337/dc10-1068.CrossRefPubMedPubMedCentral
20.
go back to reference Mamtani R, Haynes K, Bilker WB, Vaughn DJ, Strom BL, Glanz K, Lewis JD: Association between longer therapy with thiazolidinediones and risk of bladder cancer: a cohort study. J Natl Cancer Inst. 2012, 104 (18): 1411-1421. 10.1093/jnci/djs328.CrossRefPubMedPubMedCentral Mamtani R, Haynes K, Bilker WB, Vaughn DJ, Strom BL, Glanz K, Lewis JD: Association between longer therapy with thiazolidinediones and risk of bladder cancer: a cohort study. J Natl Cancer Inst. 2012, 104 (18): 1411-1421. 10.1093/jnci/djs328.CrossRefPubMedPubMedCentral
24.
go back to reference Starner CI, Schafer JA, Heaton AH, Gleason PP: Rosiglitazone and pioglitazone utilization from January 2007 through May 2008 associated with five risk-warning events. J Manag Care Pharm. 2008, 14 (6): 523-531.PubMed Starner CI, Schafer JA, Heaton AH, Gleason PP: Rosiglitazone and pioglitazone utilization from January 2007 through May 2008 associated with five risk-warning events. J Manag Care Pharm. 2008, 14 (6): 523-531.PubMed
25.
go back to reference Cohen A, Rabbani A, Shah N, Alexander GC: Changes in glitazone use among office-based physicians in the U.S., 2003–2009. Diabetes Care. 2010, 33 (4): 823-825. 10.2337/dc09-1834.CrossRefPubMedPubMedCentral Cohen A, Rabbani A, Shah N, Alexander GC: Changes in glitazone use among office-based physicians in the U.S., 2003–2009. Diabetes Care. 2010, 33 (4): 823-825. 10.2337/dc09-1834.CrossRefPubMedPubMedCentral
26.
go back to reference Stewart KA, Natzke BM, Williams T, Granger E, Casscells SW, Croghan TW: Temporal trends in anti-diabetes drug use in TRICARE following safety warnings in 2007 about rosiglitazone. Pharmacoepidemiol Drug Saf. 2009, 18 (11): 1048-1052. 10.1002/pds.1819.CrossRefPubMed Stewart KA, Natzke BM, Williams T, Granger E, Casscells SW, Croghan TW: Temporal trends in anti-diabetes drug use in TRICARE following safety warnings in 2007 about rosiglitazone. Pharmacoepidemiol Drug Saf. 2009, 18 (11): 1048-1052. 10.1002/pds.1819.CrossRefPubMed
27.
go back to reference Ruiter R, Visser LE, van Herk-Sukel MP, Geelhoed-Duijvestijn PH, Bie SD, Straus SM, Mol PG, Romio SA, Herings RM, Stricker BH: Prescribing of Rosiglitazone and Pioglitazone Following Safety Signals: Analysis of Trends in Dispensing Patterns in the Netherlands from 1998 to 2008. Drug Saf. 2012, 35 (6): 471-480. 10.2165/11596950-000000000-00000.CrossRefPubMed Ruiter R, Visser LE, van Herk-Sukel MP, Geelhoed-Duijvestijn PH, Bie SD, Straus SM, Mol PG, Romio SA, Herings RM, Stricker BH: Prescribing of Rosiglitazone and Pioglitazone Following Safety Signals: Analysis of Trends in Dispensing Patterns in the Netherlands from 1998 to 2008. Drug Saf. 2012, 35 (6): 471-480. 10.2165/11596950-000000000-00000.CrossRefPubMed
30.
go back to reference Hollingworth S, Duncan EL, Martin JH: Marked increase in proton pump inhibitors use in Australia. Pharmacoepidemiol Drug Saf. 2010, 19 (10): 1019-1024. 10.1002/pds.1969.CrossRefPubMed Hollingworth S, Duncan EL, Martin JH: Marked increase in proton pump inhibitors use in Australia. Pharmacoepidemiol Drug Saf. 2010, 19 (10): 1019-1024. 10.1002/pds.1969.CrossRefPubMed
31.
go back to reference Islam MM, Conigrave KM, Day CA, Nguyen Y, Haber PS: Twenty-year trends in benzodiazepine dispensing in the Australian population. Intern Med J. 2014, 44 (1): 57-64. 10.1111/imj.12315.CrossRefPubMed Islam MM, Conigrave KM, Day CA, Nguyen Y, Haber PS: Twenty-year trends in benzodiazepine dispensing in the Australian population. Intern Med J. 2014, 44 (1): 57-64. 10.1111/imj.12315.CrossRefPubMed
47.
go back to reference Box GEP TG: Intervention analysis with applications to economic and environmental problems. J Am Stat Assoc. 1975, 70: 70-74. 10.1080/01621459.1975.10480264.CrossRef Box GEP TG: Intervention analysis with applications to economic and environmental problems. J Am Stat Assoc. 1975, 70: 70-74. 10.1080/01621459.1975.10480264.CrossRef
48.
go back to reference Shah ND, Montori VM, Krumholz HM, Tu K, Alexander GC, Jackevicius CA: Responding to an FDA warning–geographic variation in the use of rosiglitazone. N Engl J Med. 2010, 363 (22): 2081-2084. 10.1056/NEJMp1011042.CrossRefPubMed Shah ND, Montori VM, Krumholz HM, Tu K, Alexander GC, Jackevicius CA: Responding to an FDA warning–geographic variation in the use of rosiglitazone. N Engl J Med. 2010, 363 (22): 2081-2084. 10.1056/NEJMp1011042.CrossRefPubMed
49.
go back to reference Hurren KM, Taylor TN, Jaber LA: Antidiabetic prescribing trends and predictors of thiazolidinedione discontinuation following the 2007 rosiglitazone safety alert. Diabetes Res Clin Pract. 2011, 93 (1): 49-55. 10.1016/j.diabres.2011.02.035.CrossRefPubMed Hurren KM, Taylor TN, Jaber LA: Antidiabetic prescribing trends and predictors of thiazolidinedione discontinuation following the 2007 rosiglitazone safety alert. Diabetes Res Clin Pract. 2011, 93 (1): 49-55. 10.1016/j.diabres.2011.02.035.CrossRefPubMed
51.
go back to reference Leal I, Romio SA, Schuemie M, Oteri A, Sturkenboom M, Trifiro G: Prescribing pattern of glucose lowering drugs in the United Kingdom in the last decade: a focus on the effects of safety warnings about rosiglitazone. Br J Clin Pharmacol. 2013, 75 (3): 861-868.PubMedPubMedCentral Leal I, Romio SA, Schuemie M, Oteri A, Sturkenboom M, Trifiro G: Prescribing pattern of glucose lowering drugs in the United Kingdom in the last decade: a focus on the effects of safety warnings about rosiglitazone. Br J Clin Pharmacol. 2013, 75 (3): 861-868.PubMedPubMedCentral
52.
go back to reference Kostapanos MS, Elisaf MS, Mikhailidis DP: Pioglitazone and cancer: angel or demon?. Curr Pharm Des. 2012, 19 (27): 4913-4929.CrossRef Kostapanos MS, Elisaf MS, Mikhailidis DP: Pioglitazone and cancer: angel or demon?. Curr Pharm Des. 2012, 19 (27): 4913-4929.CrossRef
53.
go back to reference Buckley NA, Rossi S: Bringing greater transparency to “black box” warnings. Clin Toxicol (Phila). 2011, 49 (6): 448-451. 10.3109/15563650.2011.593523.CrossRef Buckley NA, Rossi S: Bringing greater transparency to “black box” warnings. Clin Toxicol (Phila). 2011, 49 (6): 448-451. 10.3109/15563650.2011.593523.CrossRef
54.
go back to reference Esterly JS, Steadman E, Scheetz MH: Impact of the FDA warning of potential ceftriaxone and calcium interactions on drug use policy in clinical practice. Int J Clin Pharm. 2011, 33 (3): 537-542. 10.1007/s11096-011-9503-4.CrossRefPubMed Esterly JS, Steadman E, Scheetz MH: Impact of the FDA warning of potential ceftriaxone and calcium interactions on drug use policy in clinical practice. Int J Clin Pharm. 2011, 33 (3): 537-542. 10.1007/s11096-011-9503-4.CrossRefPubMed
55.
go back to reference Sen EF, Verhamme KM, Felisi M, t Jong GW, Giaquinto C, Picelli G, Ceci A, Sturkenboom MC: Effects of safety warnings on prescription rates of cough and cold medicines in children below 2 years of age. Br J Clin Pharmacol. 2011, 71 (6): 943-950. 10.1111/j.1365-2125.2010.03860.x.CrossRefPubMedPubMedCentral Sen EF, Verhamme KM, Felisi M, t Jong GW, Giaquinto C, Picelli G, Ceci A, Sturkenboom MC: Effects of safety warnings on prescription rates of cough and cold medicines in children below 2 years of age. Br J Clin Pharmacol. 2011, 71 (6): 943-950. 10.1111/j.1365-2125.2010.03860.x.CrossRefPubMedPubMedCentral
Metadata
Title
Utilisation trends of rosiglitazone and pioglitazone in Australia before and after safety warnings
Authors
Suvimol Niyomnaitham
Andrew Page
Adam La Caze
Karen Whitfield
Alesha J Smith
Publication date
01-12-2014
Publisher
BioMed Central
Published in
BMC Health Services Research / Issue 1/2014
Electronic ISSN: 1472-6963
DOI
https://doi.org/10.1186/1472-6963-14-151

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