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Pioglitazone for type 2 diabetes mellitus

Diseases of the heart and blood vessels account for approximately 70% of all mortality in people with diabetes. Compared to their non‐diabetic counterparts the relative risk of mortality caused by disorders of the heart and blood vessels is two to three for men and three to four for women with diabetes. Type 2 diabetes is mainly characterised by a reduced ability of the hormone insulin to stimulate glucose uptake in body fat and muscles (insulin resistance) and affects most people suffering from diabetes. Several medications are on the market to treat diabetes, amongst them pioglitazone as a member of the 'glitazones' reduced risk factors for diseases of the heart and blood vessels. Since the two biggest trials in people with type 2 diabetes showed that improved blood glucose alone is not enough to reduce the risk of the above mentioned diseases we looked for longer‐term studies investigating 24 weeks as a minimum of pioglitazone treatment on patient‐oriented outcomes. As patient‐oriented outcomes we defined mortality, complications of diabetes, side effects of the medication, health‐related quality of life, costs and metabolic control (lowering of blood glucose to near normal levels).

Cochrane Database of Systematic Reviews: Plain Language Summaries [Internet] - John Wiley & Sons, Ltd.

Version: 2009

Clinical effectiveness and cost-effectiveness of pioglitazone and rosiglitazone in the treatment of type 2 diabetes: a systematic review and economic evaluation

The aim of this review was to evaluate the use of pioglitazone and rosiglitazone, in terms of both clinical and cost-effectiveness in the treatment of type 2 diabetes.

NIHR Health Technology Assessment programme: Executive Summaries - NIHR Journals Library.

Version: 2004

Comparative clinical and budget evaluations of rosiglitazone and pioglitazone with other anti-diabetic agents

Bibliographic details: Boucher M, McAuley L, Brown A, Keely E, Skidmore B.  Comparative clinical and budget evaluations of rosiglitazone and pioglitazone with other anti-diabetic agents. Ottawa, ON, Canada: Canadian Coordinating Office for Health Technology Assessment (CCOHTA). Technology Overview; 9. 2003 Available from: http://www.cadth.ca/index.php/en/hta/reports-publications

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2003

Risk of cardiovascular disease and all-cause mortality among diabetic patients prescribed rosiglitazone or pioglitazone: a meta-analysis of retrospective cohort studies

BACKGROUND: The difference of cardiovascular effects between rosiglitazone and pioglitazone treatment for diabetic patients has not been thoroughly studied. We performed a meta-analysis to compare the risk of cardiovascular adverse effects in patients with type 2 diabetes treated with rosiglitazone compared to pioglitazone.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2012

Pioglitazone prescription increases risk of bladder cancer in patients with type 2 diabetes: an updated meta-analysis

Pioglitazone is widely used for glycemic control in patients with type 2 diabetes mellitus, but evidence regarding the association between pioglitazone and bladder cancer risk is confusing. A systematic search of databases was carried out, and other relevant papers were also identified. Then, the analyses were conducted according to the PRISMA and MOOSE guidelines. After quality assessment, nine datasets from 10 available studies were included on the basis of inclusion criteria. The incidence of bladder cancer among pioglitazone ever users and never users, pooled from four cohort and one randomized studies, were 84.51 and 66.68 per 100,000 person-years, respectively. Nine studies representing 2,596,856 diabetic patients were recognized as eligible for overall study; the result suggested an increased risk of bladder cancer in patients exposed to pioglitazone. A persistent significance was detected after being adjusted by age, gender, and use of other diabetes medications. Subgroup analyses indicated that the significantly increased incidence of bladder cancer was found in men, but not in women. Additionally, the analyses addressing increasing exposure to pioglitazone observed a dose-response relation between exclusive ever use of pioglitazone and bladder cancer in terms of cumulative duration of use and cumulative dosage. With some limitations, our results suggest an increased risk of bladder cancer in diabetic patients using pioglitazone, especially for men with long-term and high-dose exposure. Additional studies are needed to provide more precise evidences to support our results.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2014

Pioglitazone and risk of bladder cancer: a meta-analysis of controlled studies

AIMS: Pioglitazone, a thiazolidinedione, was approved for treatment of Type 2 diabetes. However, several observational studies suggest an association of pioglitazone with an increased risk of bladder cancer in patients with diabetes. Therefore, we sought to perform a systematic review and meta-analysis to evaluate the magnitude of this association and the quality of the supporting evidence.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2013

Increased risk of bladder cancer with pioglitazone therapy in patients with diabetes: a meta-analysis

AIMS: Emerging studies suggest a possible increased risk of bladder cancer with pioglitazone therapy. We therefore pooled data available to examine the association between pioglitazone therapy and bladder cancer in patients with diabetes.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2012

Meta-analysis: pioglitazone improves liver histology and fibrosis in patients with non-alcoholic steatohepatitis

BACKGROUND: Thiazolidinediones (TZDs) have been used in the treatment of non-alcoholic steatohepatitis (NASH). However, the magnitude of treatment response associated with TZDs in improving liver histology in NASH has not been quantified systematically.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2012

Effect of pioglitazone on in-stent restenosis after coronary drug-eluting stent implantation: a meta-analysis of randomized controlled trials

BACKGROUND: In-stent restenosis (ISR) remains a common life-threatening complication and some studies have shown that pioglitazone can reduce the incidence of ISR in patients with drug-eluting stents (DES) implantation. We conducted a meta-analysis to assess the effect of pioglitazone in preventing ISR after DES implantation.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2014

A systematic review and meta-analysis of randomized controlled trials comparing pioglitazone versus metformin in the treatment of polycystic ovary syndrome

OBJECTIVE: Evidence indicates that metformin and pioglitazone both improve insulin resistance and hirsutism among patient with polycystic ovarian syndrome (PCOS). However, the effectiveness of pioglitazone versus metformin in the treatment of PCOS remains controversial. To summarize the relative efficacy of pioglitazone and metformin in PCOS patients, a systematic review and meta-analysis of randomized controlled trials (RCTs) was performed.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2012

Role of pioglitazone in the prevention of restenosis and need for revascularization after bare-metal stent implantation: a meta-analysis

OBJECTIVES: We performed a meta-analysis to evaluate the impact of pioglitazone in the prevention of in-stent restenosis (ISR) and need for revascularization after bare-metal stent (BMS) implantation.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2011

Clinical effectiveness and cost-effectiveness of pioglitazone and rosiglitazone in the treatment of type 2 diabetes: a systematic review and economic evaluation

OBJECTIVES: To evaluate the use of pioglitazone and rosiglitazone, in terms of both clinical and cost-effectiveness in the treatment of type 2 diabetes.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2004

Pioglitazone and the risk of myocardial infarction and other major adverse cardiac events: a meta-analysis of randomized, controlled trials

The authors concluded that pioglitazone did not appear to increase myocardial infarction (MI) and may reduce stroke and revascularisation. Conclusions regarding myocardial infarction appeared supported by the evidence, but the results for stroke and revascularisation were not statistically significant and may not be reliable.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2008

Adding pioglitazone to insulin containing regimens in type 2 diabetes: systematic review and meta-analysis

The review concluded that when added to insulin regimens, pioglitazone conferred a small advantage in terms of glycated haemoglobin in type 2 diabetes patients with previous inadequate glucose control, but at the cost of increased hypoglycaemia and weight gain. The review was well conducted and the authors' conclusions appear likely to be reliable.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2009

Effects on lipid profile of dipeptidyl peptidase 4 inhibitors, pioglitazone, acarbose, and sulfonylureas: meta-analysis of placebo-controlled trials

This review concluded that the available glucose-lowering drugs could have different effects on lipids, which could contribute to variations in cardiovascular risk. Limitations to the evidence, and a lack of information on dosages and trial quality, mean that the reliability of this review's findings is unclear; the tentative authors' conclusion is apt.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2012

The addition of pioglitazone in type 2 diabetics poorly controlled on insulin therapy: a meta-analysis

This review concluded that pioglitazone may improve glucose metabolism and lipid parameters in patients with type 2 diabetes inadequately controlled on insulin. The inappropriate synthesis employed means that the authors' conclusions should be treated with a considerable degree of caution since they are not based on randomised data.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2010

Pioglitazone and cardiovascular risk: a comprehensive meta-analysis of randomized clinical trials

This review found that pioglitazone was not associated with increased risk of cardiovascular events. Insufficient information presented and the conduct of the review made it difficult to draw any conclusions about the evidence presented and the reliability of the authors' conclusions.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet] - Centre for Reviews and Dissemination (UK).

Version: 2008

Glitazones in the treatment of diabetes mellitus type 2: Executive summary of final report A05-05A, Version 1.0

The aims of this research were the comparative benefit assessments of long-term treatment with pioglitazone or rosiglitazone vs. placebo, pioglitazone or rosiglitazone vs. another glucose-lowering drug or non-drug intervention, pioglitazone vs. rosiglitazone, in each case as monotherapy or in combination with another glucose-lowering therapy, in patients with diabetes mellitus type 2 treated within the framework of the valid drug approval criteria.

Institute for Quality and Efficiency in Health Care: Executive Summaries [Internet] - Institute for Quality and Efficiency in Health Care (IQWiG).

Version: November 26, 2008

Drug Class Review: Newer Diabetes Medications, TZDs, and Combinations: Final Original Report [Internet]

To compare the effectiveness and adverse event profiles of amylin agonists, DPP-4 inhibitors, incretin mimetics, TZDs, and certain combination products for people with type 2 diabetes and for people with type 1 diabetes for pramlintide only.

Drug Class Reviews - Oregon Health & Science University.

Version: February 2011
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Second- and Third-Line Pharmacotherapy for Type 2 Diabetes — Update of CADTH 2010 Reviews — Project Protocol [Internet]

In August 2010, the Canadian Agency for Drugs and Technologies in Health (CADTH) published an Optimal Therapy Report which assessed the clinical and cost-effectiveness of second-line therapies for patients with type 2 diabetes inadequately controlled on metformin. The results from the CADTH review indicated that there were no apparent differences in efficacy across drug classes, and that sulfonylureas were the most cost-effective treatment option. Based on these analyses, the Canadian Optimal Medication Prescribing and Utilization Service (COMPUS) Expert Review Committee (CERC) recommended that most patients requiring a second treatment after metformin should be prescribed a sulfonylurea. CADTH followed this report with a Therapeutic Review which examined the evidence for third-line treatment options for adults with type 2 diabetes inadequately controlled on metformin and a sulfonylurea. The results demonstrated that insulins (basal, biphasic, bolus), dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) analogues, and thiazolidinediones (TZDs) all produced statistically significant reductions in hemoglobin A1C in combination with metformin and a sulphonylurea. Meglitinides and alpha-glucosidase inhibitors, however, did not. The addition of insulin neutral protamine Hagedorn (NPH) to metformin plus a sulfonylurea was associated with the most favourable cost-effectiveness estimates. CADTH’s Therapeutic Review Panel (TRP) recommended that, for most adults with type 2 diabetes inadequately controlled on metformin and a sulfonylurea, insulin NPH should be added as the third-line agent. Long-acting insulin analogues at prices similar to insulin NPH were also considered an option for patients inadequately controlled on metformin and a sulfonylurea.

CADTH Optimal Use Report - Canadian Agency for Drugs and Technologies in Health.

Version: November 2012
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