Trial reportBritish journal of clinical pharmacology2003
The pharmacokinetics of pioglitazone in patients with impaired renal function.
Trial report in British journal of clinical pharmacology, 2003. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 33 papers, 1 of them a synthesis that pooled it.
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Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
33 citing papers in PubMed, 1 synthesis or guideline pooled it, 141 citations in OpenAlex.
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- Diabetic foot ulcer in Southern Jordan: A cross-sectional Study of Clinical and Microbiological Aspects.Annals of medicine and surgery (2012) · 2022Article
- Pioglitazone in diabetic kidney disease: forgotten but not gone.Archives of medical sciences. Atherosclerotic diseases · 2022Article
- Prediction of hepatic drug clearance with a human microfluidic four-cell liver acinus microphysiology system.Toxicology · 2021Article
- Antidiabetic and Other Therapies Used in Subjects with Diabetes and Chronic Kidney Disease in a Hospital-Based Clinic Population in Greece.Journal of clinical medicine · 2021Article
- Autosomal dominant polycystic kidney disease and pioglitazone for its therapy: a comprehensive review with an emphasis on the molecular pathogenesis and pharmacological aspects.Molecular medicine (Cambridge, Mass.) · 2020Review
- Evidence-based treatment of hyperglycaemia with incretin therapies in patients with type 2 diabetes and advanced chronic kidney disease.Diabetes, obesity & metabolism · 2020Review
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- Use of Physiologically Based Pharmacokinetic Modeling to Evaluate the Effect of Chronic Kidney Disease on the Disposition of Hepatic CYP2C8 and OATP1B Drug Substrates.Clinical pharmacology and therapeutics · 2019Article
- Pioglitazone, a PPAR-γ Activator, Stimulates BKFrontiers in pharmacology · 2018Article
- Therapeutic Considerations for Antihyperglycemic Agents in Diabetic Kidney Disease.Journal of the American Society of Nephrology : JASN · 2017Review
- Update on the treatment of type 2 diabetes mellitus.World journal of diabetes · 2016Review
- Toxicological evaluation of subchronic use of pioglitazone in mice.Iranian journal of basic medical sciences · 2016Article
- Diabetes treatments and risk of amputation, blindness, severe kidney failure, hyperglycaemia, and hypoglycaemia: open cohort study in primary care.BMJ (Clinical research ed.) · 2016Article
- Management of diabetes mellitus in individuals with chronic kidney disease: therapeutic perspectives and glycemic control.Clinics (Sao Paulo, Brazil) · 2016Review
- Management of Hyperglycemia in Diabetic Kidney Disease.Diabetes spectrum : a publication of the American Diabetes Association · 2015Article
Corrections and comments
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Authors and funding
6 authors at 3 institutions in 3 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
aimsTo evaluate the effect of renal impairment on the pharmacokinetics and safety of pioglitazone and its metabolites M-III and M-IV with impaired renal function and normal renal function.
methodsIn a phase-I, open-label, parallel-group study, six healthy subjects with normal renal function (creatinine clearance> 80 ml min-1), nine patients with moderate renal impairment (creatinine clearance 30-60 ml min-1) and 12 patients with severe renal impairment (creatinine clearance < 30 ml min-1) received single and multiple oral doses of pioglitazone 45 mg. The serum pharmacokinetic profiles of pioglitazone and its metabolites M-III and M-IV were assessed for the first and last dose administered (day 1 and day 12, respectively).
resultsPharmacokinetic data revealed no significant accumulation of pioglitazone or its metabolites M-III and M-IV in patients with renal impairment. There was no significant difference in the pharmacokinetic profile of pioglitazone in subjects with normal and with moderately impaired renal function. After single oral doses, mean area under the concentration-time curve (AUC) values were decreased in patients with severe renal impairment compared with healthy subjects with normal renal function for pioglitazone (13 476 vs 17 387, P = 0.371; -23%; confidence interval (CI) -57, 38), M-III metabolite (13 394 vs 15 071, P = 0.841; -11%; CI -74, 194) and M-IV metabolite (27 991 vs 49 856, P = 0.006; -44%; CI -62, -17). After repeated oral doses of pioglitazone, mean AUC values (microg.h l-1) were decreased in patients with severe renal impairment compared with healthy subjects with normal renal function for pioglitazone (8744 vs 14,565, P = 0.004; -40%; CI -57, -16), M-III (3991 vs 7,289, P = 0.0009; -45%; CI -60, -25) and M-IV (21 080 vs 25 706, P = 0.181; -18%; CI 39, 10). The tolerability and safety profile of pioglitazone was comparable between groups.
conclusionsPioglitazone was well tolerated in patients with varying degrees of renal impairment. Although mean serum concentrations of pioglitazone and its metabolites are increased in patients with severe renal impairment, adjustment of starting and maintenance doses in these patients is probably unwarranted.
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