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Meta-Analysis for Rare Events
Published in Ding-Geng (Din) Chen, Karl E. Peace, Applied Meta-Analysis with R and Stata, 2021
Ding-Geng (Din) Chen, Karl E. Peace
In a meta-analysis for the effect of rosiglitazone on the risk of myocardial infarction (MI) and death from cardiovascular causes, Nissen and Wolski (2007) searched the available published literature and found 116 potentially relevant studies where 42 of these met the inclusion criteria. Data were then extracted from the 42 publications and combined using a fixed-effects meta-analysis model. This yielded an OR for the rosiglitazone group to the control group of 1.43 with 95% confidence interval (CI) of (1.03, 1.98) and p-value = 0.03 for MI; and 1.64 with 95% CI of (0.98, 2.74) and p-value = 0.06 for death from cardiovascular causes. Based on these results, the authors concluded that rosiglitazone use was statistically significantly associated with the risk of MI and was borderline statistically significant with death from cardiovascular causes. Therefore, using rosiglitazone for the treatment of Type 2 diabetes could lead to serious adverse cardiovascular effects.
Novel treatment modalities
Published in Seema Chopra, Endometriosis, 2020
PPARs are ligand-activated nuclear receptors with a suggested role in inflammation and lipid and glucose metabolism. PPAR-g ligands have anti-inflammatory properties and reduce estrogen biosynthesis by inhibiting the aromatase enzyme. In experimental models, they have been shown to inhibit cell proliferation, increase apoptosis, and inhibit the growth of the endometriotic lesions by an effect on the angiogenic factor VEGF. There are concerns about the possible risk of myocardial infarction and cardiovascular side effects of rosiglitazone.
Impotent drug regulation
Published in Peter C. Gøtzsche, Richard Smith, Drummond Rennie, Deadly Medicines and Organised Crime, 2019
Peter C. Gøtzsche, Richard Smith, Drummond Rennie
No one seems willing to learn anything – or at least not much – from history when it comes to drug regulation. History repeats itself all the time. For the next 40 years after the UGDP trial, industry simply stopped performing trials that might have revealed that their diabetes drugs increased cardiovascular events, and our drug regulators let them get away with this,99 which is pretty scandalous. Rosiglitazone is a recent example of a diabetes drug that was approved based on its effect on blood glucose, but as this drug also increased the cardiovascular complications it was supposed to prevent, it was taken off the market in Europe in 2010 after having killed thousands of patients (seeChapter 16).
Effects of ginkgo leaf tablet on the pharmacokinetics of rosiglitazone in rats and its potential mechanism
Published in Pharmaceutical Biology, 2022
Xueting Xing, Mengzhu Kong, Qiaoyu Hou, Jiaqi Li, Wen Qian, Xijing Chen, Hanhan Li, Changqing Yang
Rosiglitazone (ROS), a thiazolidinedione insulin sensitiser, could be used for the treatment of type 2 diabetes mellitus due to the enhanced sensitivity of peripheral tissue to insulin and improved utilisation of glucose through activating peroxisome proliferator‑activated receptor γ (Dawed et al. 2016; Matsumoto et al. 2019; Ren et al. 2020; Zhou et al. 2021). It is rapidly absorbed, almost completely bioavailable from the gastrointestinal tract (Cox et al. 2000). ROS is metabolised mainly by CYP2C8 via N-demethylation and p-hydroxylation and by CYP2C9 to a lesser extent in the human liver (Naik et al. 2012; Wring et al. 2018). The metabolites are considerably less potent than the parent form (Park et al. 2004). Therefore, modulation of CYP2C8 or CYP2C9 activities may play a vital role in the pharmacokinetic profiles of ROS.
Peroxisome proliferator-activated receptor-gamma (PPARγ) and its immunomodulation function: current understanding and future therapeutic implications
Published in Expert Review of Clinical Pharmacology, 2022
Carlos Antonio Trindade da Silva, Juliana Trindade Clemente-Napimoga, Henrique Ballassini Abdalla, Rosanna Tarkany Basting, Marcelo Henrique Napimoga
The high-affinity synthetic ligands of PPARγ receptors are characterized by the drug class of the thiazolidinediones (TZDs) [38]. The TZDs target insulin resistance in type 2 diabetes mellitus, enhancing insulin sensitivity [39]. There are two commercial drugs on the market, pioglitazone and rosiglitazone [39]. The most common collateral effects of TZDs include fluid retention, weight gain and adipogenesis, inflammation in cardiovascular tissues, bone loss, and atherosclerosis [39–42]. The concerns about the adverse effects result in rosiglitazone being withdrawn from the European market in 2010 [40,43]. The United States Food and Drug Administration (FDA) restricted access to rosiglitazone in 2011 but removed its prescribing restrictions in 2013. More recently, new data show that TZD, main pioglitazone, reduces myocardial infarctions and ischemic strokes and is a useful tool in the arsenal for clinical use [44,45].
Coadministration of metformin or spironolactone enhances efficacy of rosiglitazone in management of PCOS
Published in Gynecological Endocrinology, 2020
Mohd Ashraf Ganie, Aafia Rashid, Mona Sood, Nighat Yaseen Sofi, Ishfaq A. Wani, Sobia Nisar, Tabasum Parvaiz Butt, Nandita Gupta, Dilafroze Bhat, Naseer Choh, Shariq Rashid Masoodi
In this study, while comparing addition of metformin or spironolactone to rosiglitazone, we observed that rosiglitazone alone or in combination is effective in terms of improving the number of menstrual cycles per year, hair growth, lowering fasting and post OGTT insulin, HOMA-IR, QUICKI, and serum total testosterone levels. Rosiglitazone showed significant benefit in improving the number of menstrual cycles per year, hair growth, insulin sensitivity, and serum total testosterone with no significant effect on anthropometric parameters, liver functions, gonadotrophins, and lipid profile. The results are in accordance with the earlier published data on the subject [24,27,28]. Batista et al. reported improvement in hyperandrogenism with 3-month trial of rosiglitazone in 60 PCOS females with significant decline in the free testosterone fraction. These changes were most likely caused by an improvement in insulin sensitivity, resulting in the amelioration of hyperinsulinemia and thus the reduction of ovarian androgen production [28]. Although long-term rosiglitazone use has been incriminated in negative health consequences for bone and ischemic risk with worsening of heart failure [21,22], we did not observe any such adverse effect except mild fluid retention in few cases, owing to short duration of the study.