Drug safety of rosiglitazone and pioglitazone in France: a study using the French PharmacoVigilance database

Berthet, S.; Olivier‐Abbal, Pascale; Montastruc, Jean‐Louis; Lapeyre‐Mestre, Maryse

doi:10.1186/1472-6904-11-5

Cited by 8 publications

(5 citation statements)

References 27 publications

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“…Regarding glitazones, these compounds have been associated with a higher risk of developing stroke, heart failure and all-cause mortality [ 14 – 17 ]. These excess risks were largest in people aged 65 years or older, and especially in patients treated with rosiglitazone [ 15 ].…”

Section: Reviewmentioning

confidence: 99%

Antidiabetic treatment with gliptins: focus on cardiovascular effects and outcomes

Fisman

Tenenbaum

2015

Cardiovasc Diabetol

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The traditional oral pharmacological therapy for type 2 diabetes mellitus (T2DM) has been based on the prescription of metformin, a biguanide, as first line antihyperglycemic agent world over. It has been demonstrated that after 3 years of treatment, approximately 50 % of diabetic patients could achieve acceptable glucose levels with monotherapy; but by 9 years this had declined to only 25 %. Therefore, the implementation of a combined pharmacological therapy acting via different pathways becomes necessary, and its combination with a compound of the sulfonylurea group was along decades the most frequently employed prescription in routine clinical practice. Meglitinides, glitazones and alpha-glucosidase inhibitors were subsequently developed, but the five mentioned groups of oral antihyperglycemic agents are associated with variable degrees of undesirable or even severe cardiovascular events. The gliptins—also called dipeptidyl peptidase 4 (DPP4) inhibitors—are an additional group of antidiabetic compounds with increasing clinical use. We review the status of the gliptins with emphasis on their capabilities to positively or negatively affect the cardiovascular system, and their potential involvement in major adverse cardiovascular events (MACE). Alogliptin, anagliptin, linagliptin, saxagliptin, sitagliptin, teneligliptin and vildagliptin are the compounds currently in clinical use. Regardless differences in chemical structure and metabolic pathways, gliptins as a group exert favorable changes in experimental models. These changes, as an almost general rule, include improved endothelial function, reduction of inflammatory markers, oxidative stress ischemia/reperfusion injury and atherogenesis. In addition, increased adiponectin levels and modest decreases in lipidemia and blood pressure were reported. In clinical settings, several trials—notably the longer one, employing sitagliptin, with a mean follow-up period of 3 years—did not show an increased risk for ischemic events. Anyway, it should be emphasized that the encouraging results from basic science were not yet translated into clinical evidence, probably due the multiple and pleiotropic enzymatic effects of DPP4 inhibition. Moreover, when employing saxagliptin, while the drug was not associated with an augmented risk for ischemic events, it should be pinpointed that the rate of hospitalization for heart failure was significantly increased. Gliptins as a group constitute a widely accepted therapy for the management of T2DM, usually as a second-line medication. Nonetheless, for the time being, a definite relationship between gliptins treatment and improved cardiovascular outcomes remains uncertain and needs yet to be proven.

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Section: Reviewmentioning

confidence: 99%

Antidiabetic treatment with gliptins: focus on cardiovascular effects and outcomes

Fisman

Tenenbaum

2015

Cardiovasc Diabetol

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“…A meta-analysis of clinical trials conducted by Nissen and Wolski [106] in 2007 suggested that the use of rosiglitazone was associated with a significant increase in the risk of myocardial infarction. This led to rosiglitazone’s withdrawal from the European market in 2010 and a rosiglitazone black-box warning in the U.S. [105,107]. In 2013, the FDA lifted some prescription restrictions in the U.S. market based on a reevaluation of the Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes (RECORD) trial (ClinicalTrials.gov Identifier NCT00379769) [108], but the European suspension is still in effect at the time of this writing.…”

Section: Resultsmentioning

confidence: 99%

Identifying plausible adverse drug reactions using knowledge extracted from the literature

Shang

Rindflesch

et al. 2014

Journal of Biomedical Informatics

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Pharmacovigilance involves continually monitoring drug safety after drugs are put to market. To aid this process; algorithms for the identification of strongly correlated drug/adverse drug reaction (ADR) pairs from data sources such as adverse event reporting systems or Electronic Health Records have been developed. These methods are generally statistical in nature, and do not draw upon the large volumes of knowledge embedded in the biomedical literature. In this paper, we investigate the ability of scalable Literature Based Discovery (LBD) methods to identify side effects of pharmaceutical agents. The advantage of LBD methods is that they can provide evidence from the literature to support the plausibility of a drug/ ADR association, thereby assisting human review to validate the signal, which is an essential component of pharmacovigilance. To do so, we draw upon vast repositories of knowledge that has been extracted from the biomedical literature by two Natural Language Processing tools, MetaMap and SemRep. We evaluate two LBD methods that scale comfortably to the volume of knowledge available in these repositories. Specifically, we evaluate Reflective Random Indexing (RRI), a model based on concept-level co-occurrence, and Predication-based Semantic Indexing (PSI), a model that encodes the nature of the relationship between concepts to support reasoning analogically about drug-effect relationships. An evaluation set was constructed from the Side Effect Resource 2 (SIDER2), which contains known drug/ADR relations, and models were evaluated for their ability to “rediscover” these relations. In this paper, we demonstrate that both RRI and PSI can recover known drug-adverse event associations. However, PSI performed better overall, and has the additional advantage of being able to recover the literature underlying the reasoning pathways it used to make its predictions.

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“…The incidence of TZD-induced edema depends on drug dose, the stage of glucose intolerance, and the magnitude of the underlying cardiovascular disease. The lowest incidence is in prediabetes (DREAM study), with intermediate incidence in T2D (ADOPT and French PharmacoVigilance studies), and the highest in those with advanced cardiovascular disease (PROactive and IRIS studies) [31•, 34, 64••, 65••, 66•]. The extent to which TZD use exacerbates fluid retention in congestive heart failure is unclear [67].…”

Section: Thiazolidinediones: Fluid Retention and Edemamentioning

confidence: 99%

Thiazolidinediones: the Forgotten Diabetes Medications

2019

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Purpose of ReviewThiazolidinediones (TZDs) are the only pharmacologic agents that specifically treat insulin resistance. The beneficial effects of TZDs on the cardiovascular risk factors associated with insulin resistance have been well documented. TZD use has been limited because of concern about safety issues and side effects.Recent FindingsRecent studies indicate that cardiovascular toxicity with rosiglitazone and increase in bladder cancer with pioglitazone are no longer significant issues. There are new data which show that pioglitazone treatment reduces myocardial infarctions and ischemic strokes. New data concerning TZD-mediated edema, congestive heart failure, and bone fractures improves the clinician’s ability to select patients that will have minimal significant side effects.SummaryThiazolidinediones are now generic and less costly than pharmaceutical company–promoted therapies. Better understanding of the side effects coupled with clear benefits on the components of the insulin resistance syndrome should promote TZD use in treating patients with type 2 diabetes.

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Drug safety of rosiglitazone and pioglitazone in France: a study using the French PharmacoVigilance database

Cited by 8 publications

References 27 publications

Antidiabetic treatment with gliptins: focus on cardiovascular effects and outcomes

Antidiabetic treatment with gliptins: focus on cardiovascular effects and outcomes

Identifying plausible adverse drug reactions using knowledge extracted from the literature

Thiazolidinediones: the Forgotten Diabetes Medications

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