pioglitazone (Actos)

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Introduction

Tradename: Actos. Genetic August 2012[18]

Indications

Contraindications

(cautions)

Dosage

  • start 15 mg PO QD
  • increase by 15 mg QD every 4 weeks
  • maximum dose: 45 mg QD
  • stop after 12 weeks if no benefit

Tabs: 15, 30, 45 mg.

Monitor

  • ALT every 2 months for 1st year of therapy
    • prior to initiation of therapy then every 3-6 months[9][15]
  • avoid if ALT > 2.5 x upper limit of normal
  • discontinue of ALT > 3 x upper limit of normal or if jaundice occurs

Adverse effects

Mechanism of action

* PPAR: peroxisome proliferator-activated receptor

More general terms

Additional terms

Component of

References

  1. ↑ Kaiser Permanente Northern California Regional Drug Alert
  2. ↑ Kaiser Permanente Northern California Regional Drug Formulary, 1998
  3. ↑ 3.0 3.1 Prescriber's Letter 8(10):58 2001
  4. ↑ Geriatric Dosage Handbook, 6th edition, Selma et al eds, Lexi-Comp, Cleveland, 2001
  5. ↑ 5.0 5.1 Prescriber's Letter 9(4):22 2002
  6. ↑ 6.0 6.1 Journal Watch 22(8):60-61, 2002 May LD et al, Ann Intern Med 136:449, 2002
  7. ↑ 7.0 7.1 Journal Watch 23(24):189, 2003 Delea TE et al, Diabetes Care 26:2983, 2003 PMID: https://www.ncbi.nlm.nih.gov/pubmed/14578227
  8. ↑ 8.0 8.1 Prescriber's Letter 11(8):41 2004 Avandia and Actos for Psoriasis Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=200802&pb=PRL (subscription needed) http://www.prescribersletter.com
  9. ↑ 9.0 9.1 9.2 Prescriber's Letter 11(9): 2004 Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=200903&pb=PRL (subscription needed) http://www.prescribersletter.com
  10. ↑ 10.0 10.1 Prescriber's Letter 12(8): 2005 Does Actos Improve Lipids Better than Avandia? Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=210310&pb=PRL (subscription needed) http://www.prescribersletter.com
  11. ↑ 11.0 11.1 11.2 Lago RM et al. Congestive heart failure and cardiovascular death in patients with prediabetes and type 2 diabetes given thiazolidinediones: A meta-analysis of randomised clinical trials. Lancet 2007 Sep 29; 370:1129. PMID: https://www.ncbi.nlm.nih.gov/pubmed/17905165
    Cleland JGF and Atkin SL. Thiazolidinediones, deadly sins, surrogates, and elephants. Lancet 2007 Sep 29; 370:1103. PMID: https://www.ncbi.nlm.nih.gov/pubmed/17905146
    Montori VM et al. Patient-important outcomes in diabetes - time for consensus. Lancet 2007 Sep 29; 370:1104. PMID: https://www.ncbi.nlm.nih.gov/pubmed/17905147
  12. ↑ 12.0 12.1 Juurlink DN et al, Adverse cardiovascular events during treatment with pioglitazone and rosiglitazone: population based cohort study. BMJ 2009;339:b2942 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/19690342 <Internet> http://www.bmj.com/cgi/content/full/339/aug18_2/b2942
    de Vries CS and Russell-Jones DL Rosiglitazone or pioglitazone in type 2 diabetes? BMJ 2009;339:b3076 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/19690344 <Internet> http://www.bmj.com/cgi/content/extract/339/aug18_2/b3076
  13. ↑ 13.0 13.1 Singh S, Furberg CD. Long-term use of thiazolidinediones and fractures in type 2 diabetes: a meta-analysis. CMAJ. 2009 Jan 6;180(1):32-9. Epub 2008 Dec 10. PMID: https://www.ncbi.nlm.nih.gov/pubmed/19073651 PMCID: PMC2612065 Free PMC article
  14. ↑ 14.0 14.1 Tzoulaki I et al Risk of cardiovascular disease and all cause mortality among patients with type 2 diabetes prescribed oral antidiabetes drugs: retrospective cohort study using UK general practice research database BMJ 2009;339:b4731 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/19959591 <Internet> http://www.bmj.com/cgi/content/full/339/dec03_1/b4731
  15. ↑ 15.0 15.1 Prescriber's Letter 17(7): 2010 Recommended Lab Monitoring for Common Medications Liver Function Test Scheduling Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=260704&pb=PRL (subscription needed) http://www.prescribersletter.com
  16. ↑ 16.0 16.1 FDA Medwatch: Posted 09/17/2010, 06/15/2011 Actos (pioglitazone): Ongoing Safety Review - Potential Increased Risk of Bladder Cancer http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226257.htm
  17. ↑ 17.0 17.1 Loke YK et al Comparative cardiovascular effects of thiazolidinediones: systematic review and meta-analysis of observational studies BMJ 2011; 342:d1309 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/21415101 <Internet> http://www.bmj.com/content/342/bmj.d1309.full
    Montori VM and Shah ND What have we learnt from the rosiglitazone saga? BMJ 2011; 342:d1354 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/21415102 <Internet> http://www.bmj.com/content/342/bmj.d1354
  18. ↑ 18.0 18.1 Prescriber's Letter 19(4): 2012 CHART: Anticipated Availability of First-Time Generics Detail-Document#: http://prescribersletter.com/(5bhgn1a4ni4cyp2tvybwfh55)/pl/ArticleDD.aspx?li=1&st=1&cs=&s=PRL&pt=3&fpt=25&dd=280401&pb=PRL (subscription needed) http://www.prescribersletter.com
    Physician's First Watch, Aug 27 2012 Massachusetts Medical Society http://www.jwatch.org
    FDA News Release: Aug. 17, 2012 FDA approves first generic Actos to treat type 2 diabetes http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm315951.htm
  19. ↑ 19.0 19.1 Idris I et al Association Between Thiazolidinedione Treatment and Risk of Macular Edema Among Patients With Type 2 Diabetes Arch Intern Med. 2012;():1-7, June 2012 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/22688528 <Internet> http://archinte.jamanetwork.com/article.aspx?articleID=1182550
    Singh S and Segal JB Thiazolidinediones and Macular Edema: Comment on "Association Between Thiazolidinedione Treatment and Risk of Macular Edema Among Patients With Type 2 Diabetes" Arch Intern Med. 2012 Jun 11:1-2 PMID: https://www.ncbi.nlm.nih.gov/pubmed/22688825
  20. ↑ 20.0 20.1 Azoulay L et al. The use of pioglitazone and the risk of bladder cancer in people with type 2 diabetes: Nested case-control study. BMJ 2012 May 31; 344:e3645 PMID: https://www.ncbi.nlm.nih.gov/pubmed/22653981
  21. ↑ 21.0 21.1 21.2 21.3 Lewis JD, Habel LA, Quesenberry CP et al Pioglitazone Use and Risk of Bladder Cancer and Other Common Cancers in Persons With Diabetes. JAMA. 2015 Jul 21;314(3):265-277 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/26197187 <Internet> http://jama.jamanetwork.com/article.aspx?articleid=2397834
  22. ↑ 22.0 22.1 Prost S et al. Erosion of the chronic myeloid leukaemia stem cell pool by PPAR-gamma agonists. Nature 2015 Sep 17; 525:380. PMID: https://www.ncbi.nlm.nih.gov/pubmed/26331539
    Holyoake T and Vetrie D.Cancer: Repositioned to kill stem cells. Nature 2015 Sep 17; 525:328 PMID: https://www.ncbi.nlm.nih.gov/pubmed/26331538
  23. ↑ 23.0 23.1 23.2 23.3 Medical Knowledge Self Assessment Program (MKSAP) 17, American College of Physicians, Philadelphia 2015
  24. ↑ 24.0 24.1 24.2 Elia J, Hefner JE Pioglitazone for Secondary Prevention in Vascular Disease? Physician's First Watch, Feb 18, 2016 David G. Fairchild, MD, MPH, Editor-in-Chief Massachusetts Medical Society http://www.jwatch.org
    Kernan WN et al Pioglitazone after Ischemic Stroke or Transient Ischemic Attack. N Engl J Med. February 17, 2016 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/26886418 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMoa1506930
    Semenkovich CF Insulin Resistance and a Long, Strange Trip. N Engl J Med. February 17, 2016 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/26886417 <Internet> http://www.nejm.org/doi/full/10.1056/NEJMe1600962
  25. ↑ 25.0 25.1 Tuccori M et al Pioglitazone use and risk of bladder cancer: population based cohort study. BMJ 2016;352:i1541 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27029385 <Internet> http://www.bmj.com/content/352/bmj.i1541
    Montori VM Selecting the right drug treatment for adults with type 2 diabetes. BMJ 2016;352:i1663 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27029501 <Internet> http://www.bmj.com/content/352/bmj.i1663
  26. ↑ 26.0 26.1 Cusi K, Orsak B, Bril F et al Long-Term Pioglitazone Treatment for Patients With Nonalcoholic Steatohepatitis and Prediabetes or Type 2 Diabetes Mellitus: A Randomized, Controlled Trial. Ann Intern Med. Published online 21 June 2016 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27322798 <Internet> http://annals.org/article.aspx?articleid=2529686
    Vilar-Gomez E, Adams LA Pioglitazone: An Addition to Our Toolbox for Patients With Diabetes and Nonalcoholic Steatohepatitis? Ann Intern Med. Published online 21 June 2016 <PubMed> PMID: https://www.ncbi.nlm.nih.gov/pubmed/27322890 <Internet> http://annals.org/article.aspx?articleid=2529687
  27. ↑ 27.0 27.1 Korhonen P et al. Pioglitazone use and risk of bladder cancer in patients with type 2 diabetes: Retrospective cohort study using datasets from four European countries. BMJ 2016 Aug 16; 354:i3903 PMID: https://www.ncbi.nlm.nih.gov/pubmed/27530399 Free PMC Article
  28. ↑ 28.0 28.1 FDA Safety Alert. Dec 12, 2016 Pioglitazone-containing Medicines: Drug Safety Communication - Updated FDA Review, Increased Risk of Bladder Cancer. Includes Actos, Actoplus Met, Actoplus Met XR, Duetact, and Oseni. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm532772.htm
    FDA Drug Safety Communication. Dec 12, 2016 Updated FDA review concludes that use of type 2 diabetes medicine pioglitazone may be linked to an increased risk of bladder cancer. http://www.fda.gov/Drugs/DrugSafety/ucm519616.htm
  29. ↑ 29.0 29.1 Viscoli CM et al. Pioglitazone and risk for bone fracture: Safety data from a randomized clinical trial. J Clin Endocrinol Metab 2017 Mar; 102:914 PMID: https://www.ncbi.nlm.nih.gov/pubmed/27935736 https://academic.oup.com/jcem/article-abstract/102/3/914/3061916/Pioglitazone-and-Risk-for-Bone-Fracture-Safety
  30. ↑ 30.0 30.1 30.2 Therapeutics Letter #108. Therapeutics Initiative Drugs to Avoid. http://www.ti.ubc.ca/2018/01/04/108-drugs-avoid/
  31. ↑ 31.0 31.1 31.2 Monaco K Old Drug May Help Protect People With Diabetes Against Dementia. Those with history of ischemic heart disease or stroke saw greatest protection with pioglitazone. MedPage Today February 15, 2023 https://www.medpagetoday.com/neurology/dementia/103123
    Ha J, Choi DW, Kim, Kim KY, Nam CM, Kim E. Pioglitazone Use and Reduced Risk of Dementia in Patients With Diabetes Mellitus With a History of Ischemic Stroke. Neurology. 2023. Feb 15 PMID: https://www.ncbi.nlm.nih.gov/pubmed/36792375 https://n.neurology.org/content/early/2023/02/15/WNL.0000000000207069

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