結果試験とは何ですか？
Outcomes Trials 結果試験 - 1 Considering this, it is imperative that only the most promising compounds/devices be identified prior to moving forward with pivotal cardiovascular (CV) outcomes trials. [1] Several novel classes of glucose-lowering, lipid-lowering, and weight-loss therapeutics have shown mortality benefits in outcomes trials. [2] Recent cardiovascular (CV) outcomes trials have shown CV benefits for several GLP-1 receptor agonists and SGLT2 inhibitors. [3]1 これを考慮すると、重要な心血管 (CV) アウトカム試験を進める前に、最も有望な化合物/デバイスのみを特定することが不可欠です。 [1] いくつかの新しいクラスのグルコース低下、脂質低下、および減量治療薬は、アウトカム試験で死亡率の利点を示しています。 [2] 最近の心血管 (CV) アウトカム試験では、いくつかの GLP-1 受容体アゴニストと SGLT2 阻害剤の CV の利点が示されています。 [3]
peptide 1 receptor ペプチド1受容体
Recent data from glucagon-like peptide-1 receptor agonist and sodium-glucose cotransporter-2 inhibitor cardiovascular and renal outcomes trials demonstrated additional protection from diabetes complications for some high-risk patients, which has impacted the guidelines for diabetes management. [1] Background: Sodium Glucose Co-transporter 2 inhibitors and glucagon-like peptide-1 receptor agonists (GLP-1RAs) were associated with a reduction in cardiovascular events in cardiovascular outcomes trials (CVOTs) in type 2 diabetes. [2] Sodium Glucose Co-transporter 2 inhibitors and glucagon-like peptide 1 receptor agonists (GLP-1RAs) were associated with a reduction in cardiovascular disease events in cardiovascular outcomes trials (CVOTs) in type 2 diabetes. [3] This post hoc analysis investigated the relationship between NLRs and CV outcomes in T2D CV outcomes trials for two formulations of semaglutide, a glucagon-like peptide-1 receptor agonist. [4] In this article, the authors review the study designs and results of CV outcomes trials conducted with sodium–glucose cotransporter 2 inhibitors and glucagon-like peptide 1 receptor agonists and discuss how these may affect clinical practice. [5] The advent of the CVOT (Cardiovascular Outcomes Trials) for new antidiabetes mellitus treatments has uncovered unexpected benefits of cardiovascular protection in some of the new classes of agents, such as the GLP-1 RAs (glucagon-like peptide-1 receptor agonists) and the SGLT-2 (sodium-glucose cotransporter-2) inhibitors. [6] In patients with diabetes, where cardiovascular morbidity is highly prevalent, recent cardiovascular outcomes trials have identified therapies in the modern glucagon-like peptide 1 receptor agonist (GLP-1RA) and sodium-glucose cotransporter 2 inhibitor (SGLT2i) classes that significantly reduce cardiovascular events. [7]グルカゴン様ペプチド-1受容体アゴニストおよびナトリウム-グルコース共輸送体-2阻害剤の心血管および腎転帰試験からの最近のデータは、一部の高リスク患者の糖尿病合併症からの追加の保護を示し、糖尿病管理のガイドラインに影響を与えました。 [1] 背景：ナトリウムグルコース共輸送体2阻害剤およびグルカゴン様ペプチド-1受容体アゴニスト（GLP-1RA）は、2型糖尿病の心血管転帰試験（CVOT）における心血管イベントの減少と関連していた。 [2] nan [3] nan [4] この記事では、著者らは、ナトリウム - グルコース共輸送体 2 阻害剤とグルカゴン様ペプチド 1 受容体アゴニストを使用して実施された CV 結果試験の研究デザインと結果をレビューし、これらが臨床診療にどのように影響するかについて説明します。 [5] 新しい抗糖尿病治療のための CVOT (心血管アウトカム試験) の出現により、GLP-1 RA (グルカゴン様ペプチド-1 受容体アゴニスト) やSGLT-2 (ナトリウム-グルコース共輸送体-2) 阻害剤。 [6] nan [7]
sodium glucose cotransporter
PURPOSE OF REVIEW In recent years, there have been several cardiovascular outcomes trials (CVOT) of two new classes of glucose-lowering medications: sodium-glucose cotransporter-2 inhibitors (SGLT2-i) and glucagon-like peptide-1 receptor agonists (GLP-1 RA). [1] Sodium-glucose cotransporter-2 inhibitors (SGLT-2is) are a newer class of oral glucose-lowering therapies that were associated with significant reductions in the risk of major adverse CV events, CV death, and hospitalization for heart failure compared with placebo in CV outcomes trials (CVOTs) of patients with T2D and established CV disease or varying levels of CV risk. [2] The recent results of three large sodium-glucose cotransporter 2 inhibitor cardiovascular outcomes trials have demonstrated a reduction in heart failure hospitalisation and progressive renal failure. [3] The results of recently completed cardiovascular outcomes trials in patients with type 2 diabetes mellitus (T2DM) suggest that sodium-glucose cotransporter-2 (SGLT2) inhibitors and glucagon-like peptide (GLP) 1 receptor agonists have enhanced cardioprotective properties in patients with established cardiovascular disease (eCVD), but to a lesser degree in those without eCVD. [4]レビューの目的 近年、ナトリウム-グルコース共輸送体-2 阻害剤 (SGLT2-i) とグルカゴン様ペプチド-1 受容体アゴニスト (GLP-1 RA) の 2 つの新しいクラスのグルコース低下薬のいくつかの心血管アウトカム試験 (CVOT) が行われています。 ）。 [1] ナトリウム-グルコース共輸送体-2 阻害剤 (SGLT-2is) は、CV におけるプラセボと比較して、重大な有害な CV イベント、CV 死、および心不全による入院のリスクの大幅な減少と関連した新しいクラスの経口グルコース低下療法です。 T2D および確立された CV 疾患またはさまざまなレベルの CV リスクを有する患者の転帰試験 (CVOT)。 [2] nan [3] nan [4]
new glucose lowering 新しい血糖降下
Evidence assessing therapeutic efficacy of new glucose lowering drugs in minority groups is limited and many major cardiovascular outcomes trials do not report ethnic specific data. [1] To exclude an excess risk of cardiovascular (CV) events, CV outcomes trials (CVOTs) have assessed the effects of new glucose-lowering therapies, including glucagon-like peptide-1 receptor agonists (GLP-1RAs), in patients with type 2 diabetes and established CV disease or CV risk factors. [2]マイノリティグループにおける新しい血糖降下薬の治療効果を評価するエビデンスは限られており、多くの主要な心血管転帰試験は民族特有のデータを報告していません。 [1] 心血管（CV）イベントの過剰なリスクを排除するために、CVアウトカム試験（CVOT）は、2型糖尿病患者におけるグルカゴン様ペプチド-1受容体アゴニスト（GLP-1RA）を含む新しい血糖降下療法の効果を評価しました。確立されたCV疾患またはCVリスク要因。 [2]
omega 3 fatty オメガ3脂肪酸
We provide an overview of the pharmacology of omega-3 fatty acids, omega-3 fatty acid cardiovascular outcomes trials, landmark clinical data and pharmacology of icosapent ethyl (a stable and highly purified ethyl ester of eicosapentaenoic acid), and the critical differences between fish oil supplements and prescription omega-3 fatty acids. [1]オメガ3脂肪酸の薬理学、オメガ3脂肪酸の心臓血管転帰試験、画期的な臨床データとイコサペントエチル（エイコサペンタエン酸の安定した高度に精製されたエチルエステル）の薬理学、および魚間の重要な違いの概要を提供しますオイルサプリメントと処方オメガ3脂肪酸。 [1]
Cardiovascular Outcomes Trials 心血管転帰試験
There have been several cardiovascular outcomes trials (CVOTs) involving GLP-1RAs, which have supported the overall cardiovascular benefits of these drugs. [1] Results from cardiovascular outcomes trials (CVOTs) in people with Type 2 diabetes (T2D), such as the Researching Cardiovascular Events with a Weekly Incretin in Diabetes (REWIND) study with dulaglutide, have led to a shift toward glucose lowering therapies that provide broad benefits, including cardiovascular (CV) risk reduction and renoprotection. [2] The aim of this study was to analyze racial/ethnic patterns in the results of cardiovascular outcomes trials of antidiabetes medications in people with type 2 diabetes. [3] METHODS Of 16 cardiovascular outcomes trials in type 2 diabetes since 2013, seven reported outcomes stratified by estimated glomerular filtration rate (eGFR) category (<60 vs. [4] METHODS We searched MEDLINE and EMBASE through May 5, 2021 for randomized, placebo-controlled, cardiovascular outcomes trials of GLP-1 RAs in patients with type 2 diabetes that reported cardiovascular or mortality outcomes by baseline metformin use. [5] Evidence from cardiovascular outcomes trials indicates a consistent finding of cardiovascular safety across the GLP‐1 RAs and suggests a class benefit for the long‐acting GLP‐1 RAs in reducing three‐point major adverse cardiovascular events, cardiovascular mortality and all‐cause mortality. [6] There are, however, many overlapping reviews based on relatively few cardiovascular outcomes trials. [7] Background: Sodium Glucose Co-transporter 2 inhibitors and glucagon-like peptide-1 receptor agonists (GLP-1RAs) were associated with a reduction in cardiovascular events in cardiovascular outcomes trials (CVOTs) in type 2 diabetes. [8] Whether RNA interference therapies aiming at lowering Lp(a) levels could be useful in reducing cardiovascular disease risk in both men and women with high Lp(a) levels needs to be determined in large-scale cardiovascular outcomes trials. [9] Cardiovascular outcomes trials often include interventions which could benefit patients but inherently also might incur harm. [10] Data on weight change with SGLT2is in patients with T2D were extracted from published cardiovascular outcomes trials (CVOTs). [11] Sodium Glucose Co-transporter 2 inhibitors and glucagon-like peptide 1 receptor agonists (GLP-1RAs) were associated with a reduction in cardiovascular disease events in cardiovascular outcomes trials (CVOTs) in type 2 diabetes. [12] Widely used risk equations for cardiovascular outcomes for individuals with type 2 diabetes mellitus (T2DM) have been incapable of predicting cardioprotective effects observed in recent cardiovascular outcomes trials (CVOTs) involving individuals with T2DM at high risk for or with established cardiovascular disease (CVD). [13] Accurate identification of clinical outcome events is critical to obtaining reliable results in cardiovascular outcomes trials (CVOTs). [14] We provide an overview of the pharmacology of omega-3 fatty acids, omega-3 fatty acid cardiovascular outcomes trials, landmark clinical data and pharmacology of icosapent ethyl (a stable and highly purified ethyl ester of eicosapentaenoic acid), and the critical differences between fish oil supplements and prescription omega-3 fatty acids. [15] This article reviews the general approach to DKD treatment and summarizes renal outcomes in four cardiovascular outcomes trials of SGLT2 inhibitors. [16] The cardiovascular (CV) safety of glucagon-like peptide 1 (GLP-1) receptor agonists has been established in robust cardiovascular outcomes trials (CVOTs) in patients with type 2 diabetes at high CV risk. [17] Evidence assessing therapeutic efficacy of new glucose lowering drugs in minority groups is limited and many major cardiovascular outcomes trials do not report ethnic specific data. [18] [13] report on a meta-analysis of ten cardiovascular outcomes trials (CVOTs) with five SGLT2i to highlight their broad actions in controlling and managing multiple cardio-metabolic perturbations. [19] However, cardiovascular outcomes trials (CVOTs) did not appear in theirmeta-analysis for RI (1). [20] METHODS PubMed, Embase, and Cochrane library were searched up to November 2020 for cardiovascular outcomes trials with GLP-1 RAs or SGLT2 inhibitors that reported results for older patients with type 2 diabetes. [21] However, clinical development of CETP inhibitors has proven disappointing, with a spectrum of results spanning from evidence of harm, to futility, to only modest benefit in large-scale cardiovascular outcomes trials. [22] Since then, significant progress has been made as a result of large cardiovascular outcomes trials. [23] Recent FindingsSGLT2-i and GLP1-ra are the first anti-hyperglycemics to demonstrate significant cardiovascular benefit in multiple cardiovascular outcomes trials (CVOTs), with benefits that are consistent across class of medication. [24] Three large cardiovascular outcomes trials have demonstrated consistent reductions in heart failure events among patients with type 2 diabetes mellitus with, or at risk for, atherosclerotic cardiovascular disease. [25] Several cardiovascular outcomes trials (CVOTs) have included renal endpoints, adding to the growing evidence of the potential renoprotective effects of these agents in patients with T2DM. [26] Objective To assess the eligibility of patients participating in DISCOVER (a 3-year, prospective, observational study program of 15 992 patients with type 2 diabetes [T2D] initiating a second-line glucose-lowering therapy across 38 countries) for four cardiovascular outcomes trials (CVOTs) of sodium–glucose cotransporter 2 inhibitors (CANagliflozin cardioVascular Assessment Study [CANVAS], Dapagliflozin effect on CardiovascuLAR Events trial [DECLARE-TIMI 58], EMPAgliflozin cardiovascular OUTCOME event trial [EMPA-REG OUTCOME], and eValuation of ERTugliflozin effIcacy and Safety CardioVascular outcomes trial [VERTIS-CV]). [27] This Perspective summarizes proposed mechanisms of action for SGLT2 inhibitors, integrates these data with results of recent cardiovascular outcomes trials, and discusses clinical applications for patients with DKD. [28] Especially among the glucagon-like peptide (GLP)-1 receptor agonists (GLP-1RA) class, results of cardiovascular outcomes trials (CVOT) have been heterogeneous. [29] Based on a focused literature search of cardiovascular outcomes trials (CVOTs), this review assessed the effects of SGLT-2 inhibitors in individuals with T2D with or without established cardiovascular disease (CVD). [30] The American Diabetes Association and the European Association for the Study of Diabetes have briefly updated their 2018 recommendations on management of hyperglycemia, based on important research findings from large cardiovascular outcomes trials published in 2019. [31] Cardiovascular outcomes trials have shown them to be neutral or beneficial. [32] We performed a meta‐analysis of cases of acute pancreatitis and pancreatic cancer as well as any malignant neoplasm reported in cardiovascular outcomes trials (CVOTs) with GLP‐1 receptor agonists and DPP‐4 inhibitors. [33] Salutary effects on the kidney were first demonstrated in cardiovascular outcomes trials and have now emerged from trials enriched in subjects with type 2 diabetes mellitus and chronic kidney disease. [34] Since then, significant progress has been made as a result of large cardiovascular outcomes trials. [35] Both are fully human monoclonal antibodies and both were studied in very large, randomized, double-blind, placebo-controlled, cardiovascular outcomes trials, which were entitled FOURIER and ODYSSEY Outcomes, respectively. [36] The cardiovascular outcomes trials performed to test the cardiovascular safety of the new glucose-lowering therapies offer compelling evidence in favour of the role of these drugs for cardiovascular prevention. [37] Although most cardiovascular outcomes trials continue to use time-to-first event analyses to assess the primary efficacy end point, such analyses do not adequately reflect the impact of new treatments on the totality of the chronic disease burden. [38] Generalizability of findings from cardiovascular outcomes trials (CVOTs) to patients with type 2 diabetes (T2D) in clinical practice is unknown. [39] Recently published and ongoing cardiovascular outcomes trials in patients with diabetes will also help to inform the use of markers of injury and prognosis in this population. [40] IN BRIEF New treatments for type 2 diabetes are required to demonstrate cardiovascular safety in dedicated cardiovascular outcomes trials (CVOTs). [41] Further cardiovascular outcomes trials (CVOT) are needed to assess the safety of other pharmacotherapeutic options for weight loss. [42] Cardiovascular outcomes trials of some other T2DM agents (i. [43] The American Diabetes Association and the European Association for the Study of Diabetes have briefly updated their 2018 recommendations on management of hyperglycaemia, based on important research findings from large cardiovascular outcomes trials published in 2019. [44] Recent cardiovascular outcomes trials (CVOTs) have also shown that relative risk reductions in cardiovascular outcomes were observed with SGLT2 inhibition both in patients with current and prior heart failure. [45] In 2008 and 2012, the Federal Drug Administration (FDA) and the European Medicines Agency (EMA) respectively mandated cardiovascular outcomes trials (CVOTs) on all new anti-diabetic agents, as prospective trials statistically powered to rule out excess cardiovascular risk in patients with T2D. [46] PURPOSE OF REVIEW In recent years, there have been several cardiovascular outcomes trials (CVOT) of two new classes of glucose-lowering medications: sodium-glucose cotransporter-2 inhibitors (SGLT2-i) and glucagon-like peptide-1 receptor agonists (GLP-1 RA). [47] Beginning in 2015, long-term cardiovascular outcomes trials (CVOTs) have reported cardioprotective benefits for two classes of diabetes drugs. [48] Three large cardiovascular outcomes trials have demonstrated consistent reductions in heart failure events among patients with type 2 diabetes mellitus with, or at risk for, atherosclerotic cardiovascular disease. [49] Most cardiovascular outcomes trials analyze first events only; extending analyses to first and recurrent (total) events can provide clinically meaningful information. [50]GLP-1RAを含むいくつかの心血管転帰試験（CVOT）があり、これらの薬剤の全体的な心血管の利点をサポートしています。 [1] デュラグルチドを用いた毎週の糖尿病インクレチンによる心血管イベントの研究（REWIND）研究など、2型糖尿病（T2D）の人々を対象とした心血管転帰試験（CVOT）の結果は、幅広い利益をもたらす血糖降下療法への移行につながりました。 、心血管（CV）リスクの低減と腎保護を含みます。 [2] nan [3] nan [4] nan [5] nan [6] nan [7] 背景：ナトリウムグルコース共輸送体2阻害剤およびグルカゴン様ペプチド-1受容体アゴニスト（GLP-1RA）は、2型糖尿病の心血管転帰試験（CVOT）における心血管イベントの減少と関連していた。 [8] nan [9] nan [10] nan [11] nan [12] nan [13] nan [14] オメガ3脂肪酸の薬理学、オメガ3脂肪酸の心臓血管転帰試験、画期的な臨床データとイコサペントエチル（エイコサペンタエン酸の安定した高度に精製されたエチルエステル）の薬理学、および魚間の重要な違いの概要を提供しますオイルサプリメントと処方オメガ3脂肪酸。 [15] nan [16] nan [17] マイノリティグループにおける新しい血糖降下薬の治療効果を評価するエビデンスは限られており、多くの主要な心血管転帰試験は民族特有のデータを報告していません。 [18] nan [19] nan [20] nan [21] しかし、CETP 阻害剤の臨床開発は期待外れであることが証明されており、大規模な心血管アウトカム試験では、有害性の証拠から無益なもの、わずかな利益しか得られないものまで、さまざまな結果が得られています。 [22] それ以来、大規模な心血管アウトカム試験の結果として、大きな進歩が見られました。 [23] nan [24] nan [25] nan [26] nan [27] nan [28] nan [29] nan [30] 米国糖尿病協会と欧州糖尿病学会は、2019 年に発表された大規模な心血管転帰試験からの重要な研究結果に基づいて、高血糖の管理に関する 2018 年の推奨事項を簡単に更新しました。 [31] nan [32] nan [33] nan [34] nan [35] nan [36] nan [37] nan [38] nan [39] nan [40] nan [41] nan [42] nan [43] 米国糖尿病協会と欧州糖尿病学会は、2019 年に発表された大規模な心血管転帰試験からの重要な研究結果に基づいて、高血糖の管理に関する 2018 年の推奨事項を簡単に更新しました。 [44] nan [45] nan [46] レビューの目的 近年、ナトリウム-グルコース共輸送体-2 阻害剤 (SGLT2-i) とグルカゴン様ペプチド-1 受容体アゴニスト (GLP-1 RA) の 2 つの新しいクラスのグルコース低下薬のいくつかの心血管アウトカム試験 (CVOT) が行われています。 ）。 [47] nan [48] nan [49] nan [50]
Cv Outcomes Trials Cv結果試験
This letter considers how recently postulated mechanisms of action of sodium-glucose co-transporter-2 (SGLT2) inhibitors might contribute to the observed risk reduction in cardiovascular (CV) mortality and hospitalization for heart failure (HF), as reported in CV outcomes trials in patients with and without type 2 diabetes mellitus (T2DM); namely, stimulation of haematocrit/erythropoietin (EPO) and sympatho-inhibition. [1] To exclude an excess risk of cardiovascular (CV) events, CV outcomes trials (CVOTs) have assessed the effects of new glucose-lowering therapies, including glucagon-like peptide-1 receptor agonists (GLP-1RAs), in patients with type 2 diabetes and established CV disease or CV risk factors. [2] This post hoc analysis investigated the relationship between NLRs and CV outcomes in T2D CV outcomes trials for two formulations of semaglutide, a glucagon-like peptide-1 receptor agonist. [3] In patients with T2D and atherosclerotic CV diseases, multiple CV outcomes trials have shown reductions in major adverse CV events. [4] Taken together with results from large CV outcomes trials of SGLT-2is and GLP-1RAs, combination therapy with these agents potentially provides effective durable glycemic control and CV benefits due to their complementary actions on the defects of T2D. [5] Oral semaglutide has been shown to be noninferior to placebo for cardiovascular (CV) safety although additional CV outcomes trials are ongoing. [6] In addition to improvements in glycemic control and CV risk factors, CV outcomes trials (CVOTs) of empagliflozin (EMPA-REG OUTCOME), canagliflozin (CANVAS), and dapagliflozin (DECLARE–TIMI 58) showed significant glucose-independent reductions in the risk of major adverse CV events and/or hospitalization for HF, as well as reductions in the risk of kidney disease progression, versus placebo. [7] In 2008, the US Food and Drug Administration mandated that all new glucose‐lowering drugs undergo CV outcomes trials (CVOTs) to determine their CV safety. [8] Because of the aggregate results from dedicated CV outcomes trials conducted in response to the FDA guidance statement, the contemporary paradigm for treatment of patients with type 2 diabetes has evolved substantially. [9] In this article, the authors review the study designs and results of CV outcomes trials conducted with sodium–glucose cotransporter 2 inhibitors and glucagon-like peptide 1 receptor agonists and discuss how these may affect clinical practice. [10] Since then, manufacturers of many newer agents have conducted and published results from CV outcomes trials (CVOTs), with more trials due to publish soon. [11] Sodium-glucose cotransporter-2 inhibitors (SGLT-2is) are a newer class of oral glucose-lowering therapies that were associated with significant reductions in the risk of major adverse CV events, CV death, and hospitalization for heart failure compared with placebo in CV outcomes trials (CVOTs) of patients with T2D and established CV disease or varying levels of CV risk. [12] In CV outcomes trials of SGLT-2is in patients with T2D and established CVD or varying levels of CV risk, empagliflozin, canagliflozin, and dapagliflozin were associated with significant improvements in the risk of composite CV and renal outcomes compared with placebo that extended beyond their glycemic effects. [13] In CV outcomes trials (CVOTs) of patients with T2D and established CVD or multiple CV risk factors, empagliflozin and canagliflozin were associated with significant reductions in the risks of major adverse CV events (MACE), hospitalization for heart failure (HF) and kidney disease progression. [14] Although LVH is a good surrogate marker of cardiovascular (CV) outcome, conclusive evidence for the cardio-protective role of metformin is required from large CV outcomes trials. [15] 73 m2 with the CV outcomes trials remains unclear. [16]この手紙は、CVアウトカム試験で報告されているように、ナトリウム-グルコース共輸送体-2（SGLT2）阻害剤の最近想定される作用機序が、心血管（CV）死亡率および心不全（HF）入院の観察されたリスク低下にどのように寄与するかを考察します2型糖尿病（T2DM）のある患者とない患者。すなわち、ヘマトクリット/エリスロポエチン（EPO）の刺激と交感神経抑制。 [1] 心血管（CV）イベントの過剰なリスクを排除するために、CVアウトカム試験（CVOT）は、2型糖尿病患者におけるグルカゴン様ペプチド-1受容体アゴニスト（GLP-1RA）を含む新しい血糖降下療法の効果を評価しました。確立されたCV疾患またはCVリスク要因。 [2] nan [3] nan [4] SGLT-2is および GLP-1RA の大規模な CV アウトカム試験の結果と合わせて考えると、これらの薬剤との併用療法は、2 型糖尿病の欠陥に対する補完的な作用により、効果的で持続的な血糖コントロールと CV の利点を提供する可能性があります。 [5] 経口セマグルチドは心血管 (CV) の安全性に関してプラセボよりも劣っていないことが示されていますが、追加の CV アウトカム試験が進行中です。 [6] nan [7] nan [8] FDA のガイダンス ステートメントに対応して実施された専用の CV 結果試験から得られた集計結果により、2 型糖尿病患者の治療に関する現代的なパラダイムは大幅に進化しました。 [9] この記事では、著者らは、ナトリウム - グルコース共輸送体 2 阻害剤とグルカゴン様ペプチド 1 受容体アゴニストを使用して実施された CV 結果試験の研究デザインと結果をレビューし、これらが臨床診療にどのように影響するかについて説明します。 [10] nan [11] ナトリウム-グルコース共輸送体-2 阻害剤 (SGLT-2is) は、CV におけるプラセボと比較して、重大な有害な CV イベント、CV 死、および心不全による入院のリスクの大幅な減少と関連した新しいクラスの経口グルコース低下療法です。 T2D および確立された CV 疾患またはさまざまなレベルの CV リスクを有する患者の転帰試験 (CVOT)。 [12] nan [13] nan [14] nan [15] nan [16]
Clinical Outcomes Trials 臨床転帰試験
Available data of event-based clinical outcomes trials show that little evidence supports the guidelines recommendations to lower blood pressure (BP) to <130/80 mmHg in middle-aged and elderly peop. [1] Purpose Available data of event-based clinical outcomes trials show that little evidence supports the guidelines recommendations to lower blood pressure (BP) to <130/80 mmHg in middle-aged and elderly people with type 2 diabetes mellitus and hypertension. [2] Clinical outcomes trials depend on complete subject follow-up for accurate assessment of the safety and efficacy of investigational therapies. [3] Third, although PCSK9i drugs are proven to reduce ASCVD events, clinical outcomes trials with inclisiran are still in progress. [4] In the case of clinical outcomes trials, this important principle plays out through trial operations, which inherently influence the science and the robustness of the experiment. [5] Clinical outcomes trials with SGLT2 inhibitors revealed a cardioprotective benefit among patients with diabetes mellitus, with a consistent reduction in hospitalization for heart failure. [6] Larger clinical outcomes trials are needed to test this hypothesis. [7]イベントベースの臨床転帰試験の入手可能なデータは、中高年の人々の血圧（BP）を<130/80mmHgに下げるためのガイドラインの推奨を裏付ける証拠はほとんどないことを示しています。 [1] 目的イベントベースの臨床転帰試験の入手可能なデータは、2型糖尿病と高血圧のある中高年の人々の血圧（BP）を<130/80mmHgに下げるためのガイドラインの推奨を裏付ける証拠はほとんどないことを示しています。 [2] nan [3] nan [4] 臨床転帰試験の場合、この重要な原則は試験操作を通じて発揮され、科学と実験の堅牢性に本質的に影響を与えます。 [5] SGLT2 阻害剤を用いた臨床転帰試験では、真性糖尿病患者の心臓保護効果が明らかになり、心不全による入院が一貫して減少しました。 [6] nan [7]
Large Outcomes Trials
Large outcomes trials have compared the currently approved PCSK9 inhibitors with placebo and established that PCSK9 inhibitors lowered LDL-C by more than 50% below the statin-treated baseline and reduce cardiovascular outcomes. [1] Patients with obstructive coronary artery disease more likely have HF with reduced EF, rather than HFpEF, secondary to acute ischemic injury resulting in myocardial infarction, and large outcomes trials of treatments with neurohumoral inhibition have documented reduced adverse outcomes. [2] Fifteen years later, investigators have completed two large outcomes trials of monoclonal antibody inhibitors of PCSK9 (PCSK9Is). [3]nan [1] 閉塞性冠動脈疾患の患者は、心筋梗塞をもたらす急性虚血性損傷に続発して、HFpEF よりも EF が低下した HF を有する可能性が高く、神経液性阻害による治療の大規模なアウトカム試験では、有害アウトカムの減少が実証されています。 [2] 15 年後、研究者は PCSK9 (PCSK9Is) のモノクローナル抗体阻害剤の 2 つの大規模な結果の試験を完了しました。 [3]
Major Outcomes Trials
This manuscript summarises the major outcomes trials of the PCSK9 mAbs and the secondary analyses that have assessed their benefits in high risk patient groups, and describes the consensus of authors on which patients would most likely benefit from PCSK9 mAb therapy. [1] However, several analyses of major outcomes trials with DOACs have demonstrated that serum concentrations do affect both the thrombotic benefits and the hemorrhagic risks of these agents. [2]この原稿は、PCSK9 mAb の主な転帰試験と、高リスク患者グループにおけるその利点を評価した二次分析を要約し、どの患者が PCSK9 mAb 療法から最も利益を得る可能性があるかについての著者のコンセンサスを説明しています。 [1] しかし、DOAC を使用した主要なアウトカム試験のいくつかの分析では、血清中濃度がこれらの薬剤の血栓の利点と出血のリスクの両方に影響を与えることが実証されています。 [2]
Renal Outcomes Trials 腎転帰試験
Safety and efficacy endpoints in monotherapy, combination therapy, cardiovascular and renal outcomes trials have been identified and presented. [1] Recent data from glucagon-like peptide-1 receptor agonist and sodium-glucose cotransporter-2 inhibitor cardiovascular and renal outcomes trials demonstrated additional protection from diabetes complications for some high-risk patients, which has impacted the guidelines for diabetes management. [2]単剤療法、併用療法、心血管および腎転帰試験における安全性と有効性のエンドポイントが特定され、提示されています。 [1] グルカゴン様ペプチド-1受容体アゴニストおよびナトリウム-グルコース共輸送体-2阻害剤の心血管および腎転帰試験からの最近のデータは、一部の高リスク患者の糖尿病合併症からの追加の保護を示し、糖尿病管理のガイドラインに影響を与えました。 [2]
outcomes trials published
The American Diabetes Association and the European Association for the Study of Diabetes have briefly updated their 2018 recommendations on management of hyperglycemia, based on important research findings from large cardiovascular outcomes trials published in 2019. [1] The American Diabetes Association and the European Association for the Study of Diabetes have briefly updated their 2018 recommendations on management of hyperglycaemia, based on important research findings from large cardiovascular outcomes trials published in 2019. [2]米国糖尿病協会と欧州糖尿病学会は、2019 年に発表された大規模な心血管転帰試験からの重要な研究結果に基づいて、高血糖の管理に関する 2018 年の推奨事項を簡単に更新しました。 [1] 米国糖尿病協会と欧州糖尿病学会は、2019 年に発表された大規模な心血管転帰試験からの重要な研究結果に基づいて、高血糖の管理に関する 2018 年の推奨事項を簡単に更新しました。 [2]
outcomes trials conducted
Because of the aggregate results from dedicated CV outcomes trials conducted in response to the FDA guidance statement, the contemporary paradigm for treatment of patients with type 2 diabetes has evolved substantially. [1] In this article, the authors review the study designs and results of CV outcomes trials conducted with sodium–glucose cotransporter 2 inhibitors and glucagon-like peptide 1 receptor agonists and discuss how these may affect clinical practice. [2]FDA のガイダンス ステートメントに対応して実施された専用の CV 結果試験から得られた集計結果により、2 型糖尿病患者の治療に関する現代的なパラダイムは大幅に進化しました。 [1] この記事では、著者らは、ナトリウム - グルコース共輸送体 2 阻害剤とグルカゴン様ペプチド 1 受容体アゴニストを使用して実施された CV 結果試験の研究デザインと結果をレビューし、これらが臨床診療にどのように影響するかについて説明します。 [2]