Number needed to harm in the post‐marketing safety evaluation: results for rosiglitazone and pioglitazone

Mendes, Diogo; Alves, Carlos; Marques, Francisco Batel

doi:10.1002/pds.3874

Cited by 20 publications

(10 citation statements)

References 50 publications

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“…The thiazolidinedione (TZD) rosiglitazone is associated with an increased risk of MI and CV mortality 12. Despite later data from the RECORD trial showing no increased risk in overall CV morbidity and mortality20 (although it did show an increase in HF), it is generally well accepted that the initial results from the meta-analysis are more reliable than RECORD, as this trial was unblinded 21,22. Conversely, patients treated with another TZD, pioglitazone, experienced a reduction in the progression of atherosclerosis, significantly reduced plasma lipid levels compared with rosiglitazone, and decreased apoptosis induced by ischemic injury, suggesting that the CV effects of TZDs are not a class effect 23.…”

Section: Overview Of the Relationship Between Cardiovascular Risk Andmentioning

confidence: 99%

<p>Cardiovascular risks in type 2 diabetes and the interpretation of cardiovascular outcome trials</p>

Hinnen¹,

Kruger²

2019

DMSO

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Background: Patients with type 2 diabetes (T2D) are at increased cardiovascular (CV) risk compared to subjects without diabetes, with some data estimating that CV disease (CVD) risk is doubled in these individuals. Additionally, CVD remains the leading cause of death in patients with T2D, so it is paramount to determine the relationship between these two diseases. Purpose: Older diabetes treatments have limited CV safety data. In 2008, the US Food and Drug Administration published guidance for manufacturers on antihyperglycemic agents, requiring studies to ensure CV safety of new therapies. Since then, manufacturers of many newer agents have conducted and published results from CV outcomes trials (CVOTs), with more trials due to publish soon. This review discusses the relationship between CVD and T2D and explores findings from the latest CVOTs of glucose-lowering agents to guide nurse practitioners in their prescribing patterns for patients with T2D. Conclusion: Patients with T2D are at high risk of CVD, so CV risk should be carefully considered when managing these patients, and CV risks and benefits of antidiabetic drugs should be included in prescribing decisions.

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Section: Overview Of the Relationship Between Cardiovascular Risk Andmentioning

confidence: 99%

<p>Cardiovascular risks in type 2 diabetes and the interpretation of cardiovascular outcome trials</p>

Hinnen¹,

Kruger²

2019

DMSO

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“…3 evidenzbasierte renale Protektion. 4 Nur bei Patienten, bei denen keine schweren Hypoglykämien bekannt sind. Bei der Gruppe der Sulfonylharnstoffe ist davon auszugehen, dass nicht alle Wirksubstanzen gleichermaßen nützen.…”

Section: Wirkungen Des Dpp-4-hemmstoffs Linagliptinunclassified

“…B. Rosiglitazon) oder sollen nur noch in begründeten Ausnahmefällen verordnet werden (z. B. Pioglitazon) [4]. Daraus haben die Aufsichtsbehörden die Lehre gezogen, dass für neue Antidiabetika spätestens in den ersten Jahren nach der Zulassung kardiovaskuläre Sicherheitsstudien vorliegen müssen, die zeigen, dass der chronische Gebrauch die kardiovaskulären Risiken nicht erhöht, im Idealfall sogar senkt.…”

Section: Introductionunclassified

Metabolische Wirkungen und kardiovaskuläre Sicherheit einer oralen Dreifachtherapie des Typ-2-Diabetes: das Beispiel Metformin, Empagliflozin und Linagliptin

Gallwitz

Schmieder

2020

Diabetologie und Stoffwechsel

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ZusammenfassungBasierend auf neuen Erkenntnissen und Leitlinien wird die orale Dreifachtherapie des Typ-2-Diabetes am Beispiel der Kombination aus Metformin, Empagliflozin und Linagliptin diskutiert. Der SGLT-2-Hemmstoff Empagliflozin verbessert im Vergleich zu Placebo den kombinierten Endpunkt aus kardiovaskulärem Tod oder nicht tödlichem Myokardinfarkt oder Schlaganfall (MACE-3) und reduziert die Wahrscheinlichkeit einer Klinikaufnahme wegen Herzinsuffizienz sowie die Gesamtsterblichkeit. Eine neu auftretende oder sich verschlechternde Nephropathie wird ebenfalls seltener beobachtet. Der DPP-4-Hemmstoff Linagliptin senkt Blutzucker und HbA1c und hat keine Wirkungen auf den kardiovaskulären Endpunkt MACE-3, während die Progression der Albuminurie im Vergleich zu Placebo vermindert wird. Im Vergleich zum Sulfonylharnstoff Glimepirid sind die kardiovaskulären Wirkungen ähnlich, Hypoglykämien aber deutlich seltener. Die Kombination des insulinotropen Linagliptin mit dem insulinunabhängigen Glukose ausscheidenden Wirkprinzip von Empagliflozin verbessert im Vergleich zu Placebo bei mit Metformin unzureichend behandelten Patienten die metabolische Situation. Bei solchen Patienten ist die Fixkombination aus Empagliflozin und Linagliptin die erste, bei der Langzeitwirkungen der Einzelkomponenten in drei kardiovaskulären Endpunktstudien bestätigt wurden.

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“…CVD risks are often considered the main indicator of safety issues in the evaluation of glucose-lowering therapies [2,3]. For example, medications such as thiazolidinediones were found to be associated with an increased risk of serious cardiovascular events including congestive heart failure [4][5][6]. As a novel antidiabetic treatment, glucagon-like peptide 1 receptor agonists (GLP-1 RAs) not only demonstrated an antidiabetic effect and cardiovascular safety [7][8][9][10][11][12][13] but also potential cardiovascular protective effects [14].…”

Section: Introductionmentioning

confidence: 99%

Generalizability of the Results of Cardiovascular Outcome Trials of Glucagon-Like Peptide 1 Receptor Agonists in Chinese Patients with Type 2 Diabetes Mellitus

Cai

2021

Diabetes Ther

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Introduction: This study aimed to investigate the generalizability of the results of cardiovascular outcome trials (CVOTs) of glucagon-like peptide 1 receptor agonists (GLP-1 RAs) to Chinese patients with type 2 diabetes mellitus (T2DM). Methods: The 3B (Blood Glucose, Blood Pressure, and Blood Lipid) population, a nationally representative population of patients with T2DM in China (n = 25,411), was examined for eligibility of enrollment in four GLP-1 RAs CVOTs (Dulaglutide-REWIND, Exenatide-EXSCEL, Liraglutide-LEADER, and Semaglutide-SUSTAIN-6). We first estimated the proportion of 3B population who would meet the six inclusion and exclusion (I/E) criteria, namely age, hemoglobin A1c (HbA1c), body mass index (BMI), estimated glomerular filtration rate (eGFR), history of cardiovascular disease (CVD), and antidiabetic medication, in each CVOT. Then we compared 11 baseline characteristics, namely age, gender, duration of diabetes, HbA1c, BMI, eGFR, history of CVD, prior myocardial infarction (MI), low-density lipoprotein cholesterol (LDL-c), diastolic blood pressure (DBP), and systolic blood pressure, between the population in each CVOT and the 3B population. Lastly, we estimated the proportion of 3B population that matched the characteristics in each CVOT population. Results: On the basis of the I/E criteria, 31.1% of the 3B population would have been eligible for enrollment in REWIND, 15.0% for SUSTAIN-6, 12.9% for LEADER, and 11.3% for EXSCEL. On the basis of the baseline characteristics, REWIND most closely matched the 3B population on gender, duration of diabetes, HbA1c, DBP, LDL-c, history of CVD, and prior MI. The proportion of 3B population matching on at least eight or at least ten baseline characteristics with CVOT populations was highest for REWIND compared to other CVOTs. Conclusion: Among the four GLP-1 RA CVOTs, the REWIND trial using once-weekly dulaglutide is most generalizable to Chinese patients with T2DM. TrialRegistration: Trial registration: NCT01128205 (www.clinicaltrials.gov).

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Number needed to harm in the post‐marketing safety evaluation: results for rosiglitazone and pioglitazone

Cited by 20 publications

References 50 publications

<p>Cardiovascular risks in type 2 diabetes and the interpretation of cardiovascular outcome trials</p>

<p>Cardiovascular risks in type 2 diabetes and the interpretation of cardiovascular outcome trials</p>

Metabolische Wirkungen und kardiovaskuläre Sicherheit einer oralen Dreifachtherapie des Typ-2-Diabetes: das Beispiel Metformin, Empagliflozin und Linagliptin

Generalizability of the Results of Cardiovascular Outcome Trials of Glucagon-Like Peptide 1 Receptor Agonists in Chinese Patients with Type 2 Diabetes Mellitus

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