The Composite Number Needed to Treat for Semaglutide in Populations with Overweight or Obesity and Established Cardiovascular Disease Without Diabetes

IF 3.4 3区医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL

Advances in Therapy Pub Date : 2025-03-29 DOI:10.1007/s12325-025-03176-w

Christopher Lübker, Jigish Bhavsar, Ruben Duque do Vale, Scott S. Emerson, Emil Nørtoft, Jorge Plutzky, Geraint Roberts, Jens Magelund Tarp, A. Michael Lincoff

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引用次数: 0

Abstract

Introduction

Number needed to treat (NNT), an outcome measure derived from the estimated risk results of clinical trials, is widely used to demonstrate value to stakeholders by identifying how many patients require treatment to avoid one event of interest. However, NNTs calculated for primary trial endpoints may underestimate a treatment’s value by not considering other outcomes. In this secondary analysis of data from the SELECT cardiovascular (CV) outcomes trial, we aimed to determine the NNT for semaglutide for major adverse cardiovascular events (MACE), in addition to NNTs when other clinically and payer-relevant outcomes are included.

Methods

This study is a secondary analysis of data from the randomized, double-blind SELECT trial (ClinicalTrials.gov NCT03574597) of once-weekly subcutaneous administration of semaglutide compared with placebo in 17,604 patients with overweight or obesity and with established cardiovascular disease (CVD) (39.8 months mean follow-up). The outcomes were NNT_3P-MACE (based upon the trial’s composite primary endpoint of death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke), NNT_EXTENDED (inclusive of NNT_3P-MACE, hospitalization for any cause, coronary revascularization, and non-CV death), and NNT_CKM (inclusive of NNT_EXTENDED, glycated hemoglobin level [HbA_1c] ≥ 6.5%, and a 5-point nephropathy composite).

Results

The relative risk reductions observed for the events comprising the NNTs were 20% (NNT_3P-MACE), 20% (NNT_EXTENDED), and 41% (NNT_CKM). At 1 and 4 years post initiation of semaglutide, NNT_3P-MACE was 125 and 58, NNT_EXTENDED was 49 and 25, and NNT_CKM was 20 and 11, respectively.

Conclusion

When clinically and payer-relevant outcomes from the SELECT trial are included in calculations of NNT, semaglutide was associated with greater risk reductions and lower estimates of NNT than for the primary endpoint alone. Our findings suggest that including the broader effects of semaglutide beyond the primary trial endpoint recognizes additional value to stakeholders.

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西马鲁肽治疗超重或肥胖人群和无糖尿病心血管疾病患者所需的综合数量

需要治疗的数量（NNT）是一种从临床试验的估计风险结果中得出的结果度量，通过确定有多少患者需要治疗来避免一个感兴趣的事件，被广泛用于向利益相关者展示价值。然而，为主要试验终点计算的nnt可能因未考虑其他结果而低估了治疗的价值。在这项对SELECT心血管（CV）结局试验数据的二次分析中，我们旨在确定西马鲁肽治疗主要不良心血管事件（MACE）的NNT，以及包括其他临床和付款人相关结局的NNT。方法：本研究是对随机双盲SELECT试验（ClinicalTrials.gov NCT03574597）数据的二次分析，该试验在17,604例超重或肥胖并有心血管疾病（CVD）的患者（平均随访39.8个月）中，每周一次皮下给药semaglutide与安慰剂相比。结果为NNT3P-MACE（基于试验的心血管原因死亡、非致死性心肌梗死、非致死性卒中的复合主要终点）、NNT3P-MACE（包括NNT3P-MACE、任何原因住院、冠状动脉血运重建术和非cv死亡）和NNTCKM（包括NNT3P-MACE、糖化血红蛋白水平[HbA1c]≥6.5%和5点肾病复合）。结果：包含nnt的事件的相对风险降低为20% (NNT3P-MACE), 20% （nnextended）和41% （NNTCKM）。在西马鲁肽开始治疗后1年和4年，nntp3 - mace分别为125和58，nnextended分别为49和25，NNTCKM分别为20和11。结论：当SELECT试验的临床和支付者相关结果包括在NNT的计算中时，与单独的主要终点相比，semaglutide与更大的风险降低和更低的NNT估计值相关。我们的研究结果表明，包括西马鲁肽在主要试验终点之外的更广泛的影响，可以认识到利益相关者的额外价值。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Advances in Therapy 医学-药学

CiteScore

7.20

自引率

2.60%

发文量

353

审稿时长

6-12 weeks

期刊介绍： Advances in Therapy is an international, peer reviewed, rapid-publication (peer review in 2 weeks, published 3–4 weeks from acceptance) journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of therapeutics and interventions (including devices) across all therapeutic areas. Studies relating to diagnostics and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. The journal is of interest to a broad audience of healthcare professionals and publishes original research, reviews, communications and letters. The journal is read by a global audience and receives submissions from all over the world. Advances in Therapy will consider all scientifically sound research be it positive, confirmatory or negative data. Submissions are welcomed whether they relate to an international and/or a country-specific audience, something that is crucially important when researchers are trying to target more specific patient populations. This inclusive approach allows the journal to assist in the dissemination of all scientifically and ethically sound research.