Overall, the data suggest that pioglitazone use may be linked to an increased risk of bladder cancer. Ramachandran A, Snehalatha C, Mary S, Selvam S, Kumar CK, Seeli AC, et al. Bladder cancer: There were two case reports and one case series of eight patients69,70,71. Diabetes Care (2018) 41(2):3417. Stepanova M, Rafiq N, Makhlouf H, Agrawal R, Kaur I, Younoszai Z, et al. This is the most important part of controlling your diabetes and will help the medicine work properly. We included a double-blind, placebo-controlled RCT of the effects of pioglitazone on patients aged between 18 and 70 with prediabetes or T2DM combined with NAFLD. Journal of Pharmacology & Pharmacotherapeutics, http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm173081.htm, http://www.fda.gov/Drugs/DrugSafety/ucm259150.htm, http://www.cdsco.nic.in/Minutes_63rd_dtab%20.pdf, http://articles.economictimes.indiatimes.com/2013-07-17/news/40635202_1_health-ministry-pioglitazone-gliptins, http://articles.timesofindia.indiatimes.com/2012-05-10/india/31654810_1_drug-companies-cdsco-drug-expert. Since we included fewer than 10 articles, publication bias testing was not recommended according to the Cochrane Collaboration Handbook. [2] [3] Use is recommended together with exercise and diet. Kamrai D, Sachdeva P. Prescribing trends of antidiabetics in diabetic patients and hypertensive diabetic patients in an urban secondary care hospital. Since then it has been estimated that sales of Actos have exceeded $24 billion. In conclusion, regional variation in pioglitazone use was observed in India, with higher use in north and west compared to south and central regions. This raises serious concerns. There were also significant differences in inflammation grade [RR2.05 (95% CI 1.50, 2.80, p<0.00001, I2 = 0%; SoF Table 1)] and ballooning grade [RR 1.74 (95% CI 1.26, 2.40, p= 0.0007, I2 = 48%; SoF Table 1)]. A check on the CDSCO website for the past minutes of the meeting of DTAB does not show any discussion on pioglitazone. We might have inadvertently missed out on some publications (retrieval bias). Careers, Unable to load your collection due to an error. To provide you with the most relevant and helpful information, and understand which doi:10.1111/dme.13565, 5. Clinical and biochemical profile of lean type 2 diabetes mellitus. doi:10.1007/s10620-013-2743-5, 18. Cialis will compete against Viatris' sildenafil-based Viagra Connect in the men's sexual health and wellness category, which has seen a proliferation of . In the GPRD (UK) database, pioglitazone is used most commonly with metformin at 30 mg4. Moher D, Liberati A, Tetzlaff J, Altman DG PRISMA Group. J Hepatol (2015) 62(1 Suppl):S4764. Nonalcoholic Steatohepatitis is the Fastest Growing Cause of Hepatocellular Carcinoma in Liver Transplant Candidates. government site. Eight were monotherapy43,44,45,46,47,48,49,50, one add-on to metformin51, four add-on to sulfonylurea52,53,54,55, and eight were add-on to sulphonylurea and metformin combination56,57,58,59,60,61,62,63. Copyright 2021 Lian and Fu. Clin Mol Hepatol (2020) 26(4):43043. Uses Warnings Before taking Side effects Dosage Interactions What is pioglitazone? With the recent ban of three popular drugs pioglitazone (a popular anti-diabetes drug), analgin (a painkiller) and deanxit (an anti-depressant) by the health ministry, there are a number of. Histopathological Stages of Nonalcoholic Fatty Liver Disease in Type 2 Diabetes: Prevalences and Correlated Factors. Was 21.99. However, the boxed warning does not provide any guidance on cumulative dose or duration of use. Pioglitazone, the commonly used antidiabetic drug was placed under suspension in June (June 18, 2013). The last date of PubMed alert was April 20, 2015. Letters / emails were written to authors and journal indices of articles included in SR were hand searched to identify any publication missed in the search. Although the studies we included are limited, it is the first time that we have used the gold standard of liver biopsy as the main result and used a meta-analysis to comprehensively analyze the therapeutic effects of pioglitazone on glucose metabolism and liver biological indicators in patients with NAFLD. There is a problem with Studies in India have been done in younger patients, with shorter duration of T2DM, shorter trial duration, and lower dose of pioglitazone; however, the decrease in HbA1c (efficacy) was found to be comparable to PROactive studies. The Role of Liver Fat and Insulin Resistance as Determinants of Plasma Aminotransferase Elevation in Nonalcoholic Fatty Liver Disease. Through the risk assessment using the Cochrane Collaboration risk assessment tool, it was found that the overall risk was moderate to low (Figure 2), which was mainly caused by allocation concealment, selective reporting, incomplete data, and unclear blind reporting in some studies. However, because all of the studies we included were under 18 months, there is no proof so far that therapy with pioglitazone beyond 18 months brings additional histological benefits, and research in the future needs to clarify the optimal therapy duration and whether lower doses are beneficial. [7] A large study from the United Kingdom reported no increase in bladder cancer with pioglitazone use. The drug utilization data from India were compared with that of the General Practice Research Database (GPRD), United Kingdom4. PloS One (2015) 10(8):e0134172. Byrne CD, Targher G. NAFLD: A Multisystem Disease. The overall use of pioglitazone (percentage) in each region was calculated from the data provided in individual studies (usage and number of prescriptions). An open level study to assess the glycemic control effect of metformin and Pioglitazone as add on therapy along with sulfonylurea in uncomplicated type 2 diabetes mellitus. Diabetes Metab J (2019) 43(3):30218. However, the directions of the associations remained unchanged. Currently, there are no drugs available for the treatment of NAFLD. For each of the included studies, we extracted data such as study time, trial design, intervention measures and time, demographics, and baseline characteristics. Sultana G, Kapur P, Aqil M, Alam MS, Pillai KK. However, to get an estimate of spontaneous reports for pioglitazone, a summary of adverse drug reactions (ADRs) associated with pioglitazone was obtained from the WHO-UMC VigiBase, global individual case safety report (ICSR) database through personal communication. The study included members of the KPNC diabetes registry between January 1, 1997, and December 31, 2002. Second, we did not conduct a separate analysis of NASH and only analyzed it as an advanced NAFLD state. The search was further expanded using other search terms safety, efficacy, bladder cancer, drug utilization and thiazolidinedione. Compared to the interim 5-year results, these final 10-year results found weaker associations that were not statistically significant. There were two deaths in the pioglitazone arms and two in the placebo arms but insufficient power to detect an overall effect. Eight cases of bladder cancer in pioglitazone users from India. Vengurlekar S, Shukla P, Patidar P, Bafna R, Jain S. Prescribing pattern of antidiabetic drugs in Indore city hospital. With this background, we plan to study the risk of bladder cancer in male type 2 diabetes subjects aged more than 50 years who are on pioglitazone therapy as compared to never-users of pioglitazone in a retrospective cohort design and . Meshram DM, Langade DG, Kinagi SB, Naikwadi AA, Morye V, Chopra D. Evaluation of efficacy and safety of fixed dose combination of glimepiride 2 mg pluspioglitazone 15 mg plus metformin SR 500 mg in the management of patients with type-2 diabetes mellitus. However, there was no significant increase in the risk of pioglitazone discontinuation due to adverse events compared to placebo [RR 1.30 (95% CI 0.81, 2.09, p= 0.27, I2 = 0%; Figure 6B)]. Diabetes Obes Metab (2011) 13(6):50510. Sharma PK, Bhansali A, Sialy R, Malhotra S, Pandhi P. Effects of pioglitazone and metformin on plasma adiponectin in newly detected type 2 diabetes mellitus. [Last accessed on 2013 Aug 09]. In CTs, case reports and spontaneous reports in the Pharmacovigilance Programme of India (PvPI), most common ADRs reported were weight gain, oedema and hypoglycaemia48,73, all of which are listed in summary of product characteristics (SmPC) and EMA-AR for pioglitazone. Before This content does not have an English version. Diabetes Care (2008) 31(1):1659. It also helps to protect the cells in the pancreas, allowing them to carry on producing insulin for longer. Pioglitazone should not have been banned. Figure 5 The effect of pioglitazone in plasma AST (A); the effect of pioglitazone in plasma ALT (B); the effect of pioglitazone in HDL (C); the effect of pioglitazone in LDL (D); and the effect of pioglitazone on triglyceride levels (E). -amylase expression in Indian type 2 diabetic patients. Other meta-analyses also agreed on the beneficial effects of pioglitazone on lobular inflammation; however, there were still conflicting results for hepatic fibrosis (25, 26). Singh S, Khera R, Allen AM, Murad MH, Loomba R. Comparative Effectiveness of Pharmacological Interventions for Nonalcoholic Steatohepatitis: A Systematic Review and Network Meta-Analysis. Pandit V, Suresh S, Sanath B, Shekhar HS, Daniel D, Matalia HB. Never users were followed for an average of 8.9 years, whereas ever users were followed for an average of 6.1 years. 5705185. It based the decision on the interim analysis from the Kaiser Permanente Northern California diabetes registry and also acknowledged the French a population-based cohort study.[10]. Effectiveness of Exercise Intervention in Reducing Body Weight and Glycosylated Hemoglobin Levels in Patients With Type 2 Diabetes Mellitus in Korea: A Systematic Review and Meta-Analysis. However, analysis of studies from India has brought out important differences in drug utilization. Hypoglycaemia, haematemesis, myocardial infarction, renal stone and fracture were reported in CTs44,48. Younossi Z, Stepanova M, Ong JP, Jacobson IM, Bugianesi E, Duseja A, et al. Nonalcoholic fatty liver disease (NAFLD) is a liver disease caused by damage to the liver unrelated to alcohol; NAFLD can develop into nonalcoholic steatosis (NASH), advanced fibrosis and hepatocellular carcinoma (HCC) (1). In India, it is mostly used in combination with metformin and sulphonylurea at a dose of 15-30 mg/day26,28. Pioglitazone significantly increases the risk of adverse events, including hypoglycemia, chronic lower limb edema, atypical chest pain or epigastralgia and back or joint pain. Drug information provided by: Merative, Micromedex Along with its needed effects, a medicine may cause some unwanted effects. Follow your doctor's orders or the directions on the label. Pioglitazone is a prescription drug indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings.. Pioglitazone exerts its antihyperglycemic effect only in the presence of endogenous insulin.Pioglitazone should not be used to treat type 1 diabetes or diabetic ketoacidosis, as it would not be effective in these . Our SR had certain limitations. Long-term glycaemic effects of pioglitazone compared with placebo as add-on treatment to metformin or sulphonylurea monotherapy in PROactive (PROactive 18), Scheen AJ, Tan MH, Betteridge DJ, Birkeland K, Schmitz O, Charbonnel B. PROactive investigators. (A) Funnel plots for hepatic histologic scores(steatosis grade); (B) Funnel plots for hepatic histologic scores(Inflammation grade); (C) Funnel plots for hepatic histologic scores(ballooning grade); (D) Funnel plots for hepatic histologic scores(fibrosis stage); Funnel plots for resolution of NASH (E); Funnel plots for reduction of at least 2 points in hepatic histologic scores (F). information and will only use or disclose that information as set forth in our notice of showed that treatment with the antidiabetic drug pioglitazone reverses the more advanced stages of liver disease in NASH regardless of the presence of diabetes, but he combined T2DM with NAFLD and T2DM without NAFLD in a comprehensive analysis, which is still different from the study we included (27). Inclusion & exclusion criteria: As per the PICO (population, intervention, control and outcome) criteria5, studies included in the SR were those: (i) that were carried out in Indian T2DM patients (and carried out in India) (population); (ii) with pioglitazone either alone or in combination with other antidiabetic drugs (intervention); (iii) comparing it with baseline or other antidiabetic drugs (comparison); and (iv) efficacy parameters such as percentage decrease in glycosylated haemoglobin (HbA1c), changes in lipid profile; safety parameters such as cases of bladder cancer and utilization pattern such as prescribed dose and combination of pioglitazone (outcomes). Two studies evaluated add-on to metformin, sulphonylurea and insulin64,65; three evaluated and noted decrease in -amylase, glucokinase and gamma-glutamyl transferase activities66,67,68. He L, Liu X, Wang L, Yang Z. Thiazolidinediones for Nonalcoholic Steatohepatitis: A Meta-Analysis of Randomized Clinical Trials. Neumann A, Weill A, Ricordeau P, Fagot JP, Alla F, Allemand H. Pioglitazone and risk of bladder cancer among diabetic patients in France: a population-based cohort study. Part I: Epidemiology and Diagnosis. In conclusion, our results suggest that although pioglitazone has no significant effect on liver fibrosis, it can significantly improve liver histology, such as steatosis, inflammation and ballooning. Neumann A, Weill A, Ricordeau P, Fagot JP, Alla F, Allemand H. Pioglitazone and risk of bladder cancer among diabetic patients in France: A population-based cohort study. GRADE Pro (V.3.6) software was used to rate the overall quality of evidence for each outcome based on five evaluation criteria: risk of bias, inconsistency, indirectness, imprecision, and publication bias. Your doctor may adjust your dose as needed. The efficacy in clinical trials (CTs) was similar to those in EMA-AR. In one study, it was used in combination with metformin, sulphonylurea and dipeptidyl peptidase-IV inhibitor at 15 mg/day dose11. Intervention duration < 4 weeks or any cause of chronic liver disease other than NAFLD and suffering from other types of chronic diseases, such as hypertension and coronary heart disease, were excluded, and studies that did not differentiate patients in the subgroup analysis were excluded. Nonalcoholic Fatty Liver Disease in Diabetes. J Clin Endocrinol Metab (2015) 100(6):22318. T2DM patients with NAFLD have higher all-cause, cardiovascular (CV), and liver-related mortality (3, 16). In hindsight, this entire fiasco of suddenly suspending an established and commonly used drug looks murky, ill-informed and at its worst an attempt to make scarce a drug while costlier alternative is made available. Two reviewers independently assessed study eligibility, continuous data extraction, independent assessment of bias risk, and graded the strength of evidence. Expert Opin Investig Drugs (2020) 29(2):2058. doi:10.1002/hep.27678, Keywords: NAFLD, type 2 diabetes mellitus, pioglitazone, meta-analysis, prediabetes, Citation: Lian J and Fu J (2021) Pioglitazone for NAFLD Patients With Prediabetes or Type 2 Diabetes Mellitus: A Meta-Analysis. In the WHO-UMC, VigiBase, there were 101 spontaneous reports on pioglitazone from India, most common ones being hypoglycaemia (19.8%) and oedema (19.8%) but none on bladder abnormalities while globally there were 1862 reported cases of bladder carcinoma associated with pioglitazone. In India, probably due to lower dose, lower background incidence of bladder cancer and smaller sample size in epidemiological studies, association of bladder cancer with pioglitazone was not found to be significant. Our results show that pioglitazone can also significantly alleviate NASH in patients with prediabetes or T2DM combined with NAFLD. Warning Professional info Summary Commonly reported side effects of pioglitazone include: upper respiratory tract infection, edema, and hypoglycemia. Gupta S, Sharma T, Dhasmana D, Dher M, Bisht M. Comparison of the effect of glitazones and DPP-IV inhibitors in type 2 diabetics as add on therapy on insulin sensitivity and serum hs-CRP levels. This research was funded by the National Natural Science Foundation of China (81670736). In India, pioglitazone is used more often as triple drug combination instead of dual drug therapy with metformin and at lower doses compared to UK. Recently Pioglitazone was banned from India without any evidence of increased bladder cancer in our population. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). For continuity variables, we used the standardized mean difference (SMD) and 95% CI for analysis. Effects of metformin and pioglitazone on impaired glucose tolerance patients An open level prospective study. Clin Gastroenterol Hepatol (2019) 17(4):74855. A multicenter, prospective, randomized, double-blind study to evaluate the safety and efficacy of saroglitazar 2 and 4 mg compared to pioglitazone 45 mg in diabetic dyslipidemia (PRESS V). Mazumdar G, Swaika B, Dasgupta A. Diabetes Med (2018) 35(3):36875. The fully adjusted HR for bladder cancer with pioglitazone use compared with no thiazolidinedione use was 1.63 (95% CI=1.22-2.19). Prescribing patterns of antidiabetic medications in a tertiary care teaching hospital, Bareilly, UP, India. Compared to KPNC or French studies which found significant association between incidence of bladder cancer and pioglitazone cumulative dose >28,000 mg and duration of use more than one year, in retrospective cohort study from India with 15-30 mg pioglitazone taken for more than two years, association between incidence of bladder cancer and pioglitazone use was not seen. European Association for the Study of The L, European Association for the Study Of D, European Association for the Study Of O. Easl-Easd-Easo Clinical Practice Guidelines for the Management of non-Alcoholic Fatty Liver Disease. Takeda Announces Completion of the Post-marketing Commitment to Submit Data to the FDA, the EMA and the PMDA for Pioglitazone Containing Medicines Including ACTOS. Joshi H, Mary R, Padil GM, Shastry CS, Pathak R. Investigation of in-patient prescribing patterns of oral antidiabetic drugs in a tertiary care teaching hospital. Pioglitazone, a thiazolidinedione derivative, is a peroxisome proliferatoractivated receptor (PPAR) agonist that ameliorates insulin resistance and improves glucose and lipid metabolism in type 2 diabetes (7, 8). Compared with placebo, pioglitazone significantly improved steatosis grade, inflammation grade and ballooning grade, while in the fibrosis stage, there was no significant improvement in pioglitazone compared with placebo. An official website of the United States government. Of these 10 patients, nine were males, age being 65 yr and 64 yr in the case reports and 43-76 yr in the case series, dose used was 15-30 mg/day, duration of use was 1-9 years, eight had developed transitional cell carcinoma, one had bladder dysplasia while the nature of malignancy of one patient was not reported. doi:10.1111/j.1478-3231.2011.02482.x, 23. Panikar V, Chandalia HB, Joshi SR, Fafadia A, Santvana C. Beneficial effects of triple drug combination of pioglitazone with glibenclamide and metformin in type 2 diabetes mellitus patients on insulin therapy. Federal government websites often end in .gov or .mil. The government could have put some restrictions [on it] but still allowed marketing of the drug because there is no clear-cut indication that it does. Front Pharmacol (2019) 10:877. doi:10.3389/fphar.2019.00877, 19. Pioglitazone: hype and hope. In the recent past, we had cases of drug approvals being given based upon recommendation by eminent doctors of the country. Major drug makers in the country including Sun Pharmaceutical Industries and Lupin react to the Indian government's move to ban the popular anti-diabetic drug pioglitazone and they claim that. Risk of bladder cancer among diabetic patients treated with pioglitazone: Interim report of a longitudinal cohort study. [2] It may be used with metformin, a sulfonylurea, or insulin. The VigiBase data were provided as a spreadsheet which included summary of all ADRs, country-wise and year-wise ADRs. ADRs have not been reported to PvPI and it is required that spontaneous reporting must be encouraged. In India, pioglitazone was used at 15-30 mg/day mostly with metformin and sulphonylurea, being prescribed to 26.7 and 8.4 per cent patients in north and south, respectively. The Scientific Advisory Group in Diabetes/Endocrinology of EMA concluded that pioglitazone was useful in the treatment of T2DM as second-line drug when metformin was not effective or contraindicated and that its use should be restricted in duration (less than two years), cumulative dose (>28,000 mg) and patients with bladder cancer risks 4. In terms of the resolution of NASH (Figure 3E), compared with placebo, pioglitazone also significantly improved the rate of NASH resolution [RR1.76 (95% CI 1.18, 2.62, p= 0.005, I2 = 30%; SoF Table 1)]. Diabetes Care (2011) 34(5):113944. In order for our online pharmacy team to ensure this product is appropriate for you to buy we will ask you to complete a questionnaire with a few simple questions. [3] Rosiglitazone, another member of the same family was dropped because of the associated risk of myocardial infarction. National Institute for Research in Reproductive Health (ICMR), Mumbai, India. We found a total of 137 articles from the target database, among which 138 full-text papers were qualified, and 20 full-text papers were excluded according to the research exclusion criteria (Figure 1). A study of drug prescribing pattern and cost analysis among diabetic patients in a tertiary care teaching institute in North India. The aim of this systematic review and meta-analysis is to assess the effects of pioglitazone treatment on the secondary prevention of CVD. Sberna AL, Bouillet B, Rouland A, Brindisi MC, Nguyen A, Mouillot T, et al. In total, four deaths were reported across 1 trial, two in the pioglitazone group and two in the placebo group. EMA Assessment Report was chosen for comparison as it is freely available in the public domain and gives comprehensive information on benefit-risk evaluation of pioglitazone4. The suspension was promulgated in the Government gazette. In May 2023, Frontiers adopted a new reporting platform to be Counter 5 compliant, in line with industry standards. Glen J, Floros L, Day C, Pryke R. Non-Alcoholic Fatty Liver Disease (NAFLD): Summary of NICE Guidance. The systematic review scheme used in this study is reported in accordance with the preferred reporting items listed in the guidelines for systematic review and meta-analysis (PRISMA-P) (9). Data from India were compared with the data and publications with similar methodology/data sets analyzed in references from the EMA-AR. NASH is a more serious and progressive form of NAFLD and is characterized by inflammation and hepatocyte ballooning that set off fibrosis and pose a risk of developing cirrhosis and hepatocellular carcinoma (18, 19). As a library, NLM provides access to scientific literature. Methods: The Cochrane Central Register of Controlled Trials (CENTRAL), Embase, and ClinicalTrials databases were searched until August 2020 for publications written in English. Stepanova M, Ong JP, Jacobson IM, Bugianesi E, Duseja a, Snehalatha C, R.! 'S orders or the directions of the associations remained unchanged, UP, India not according., 5 effects of pioglitazone treatment on the CDSCO website for the minutes. Metab ( 2011 ) 34 ( 5 ):113944 Side effects Dosage Interactions What is pioglitazone the Role Liver... Was not recommended according to the Cochrane Collaboration Handbook front Pharmacol ( 2019 ) 10:877.,... 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