Lübker Christopher, Bhavsar Jigish, Duque do Vale Ruben, Emerson Scott S, Nørtoft Emil, Plutzky Jorge, Roberts Geraint, Tarp Jens Magelund, Lincoff A Michael
Novo Nordisk A/S, Søborg, Denmark.
Novo Nordisk Inc., Plainsboro, NJ, USA.
Adv Ther. 2025 May;42(5):2513-2525. doi: 10.1007/s12325-025-03176-w. Epub 2025 Mar 29.
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.
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 (based upon the trial's composite primary endpoint of death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke), NNT (inclusive of NNT, hospitalization for any cause, coronary revascularization, and non-CV death), and NNT (inclusive of NNT, glycated hemoglobin level [HbA] ≥ 6.5%, and a 5-point nephropathy composite).
The relative risk reductions observed for the events comprising the NNTs were 20% (NNT), 20% (NNT), and 41% (NNT). At 1 and 4 years post initiation of semaglutide, NNT was 125 and 58, NNT was 49 and 25, and NNT was 20 and 11, respectively.
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.
需治疗人数（NNT）是一种从临床试验的估计风险结果中得出的疗效指标，通过确定需要治疗多少患者才能避免发生一次感兴趣的事件，被广泛用于向利益相关者证明价值。然而，为主要试验终点计算的NNT可能会因未考虑其他结果而低估一种治疗方法的价值。在对SELECT心血管（CV）结局试验数据的这项二次分析中，我们旨在确定司美格鲁肽治疗主要不良心血管事件（MACE）的NNT，以及纳入其他临床和医保相关结局时的NNT。
本研究是对SELECT试验（ClinicalTrials.gov NCT03574597）数据的二次分析，该试验为随机、双盲试验，将17604例超重或肥胖且患有已确诊心血管疾病（CVD）的患者（平均随访39.8个月）每周一次皮下注射司美格鲁肽与安慰剂进行比较。结局指标为NNT（基于试验的心血管原因死亡、非致命性心肌梗死、非致命性卒中的复合主要终点）、NNT（包括NNT、任何原因住院、冠状动脉血运重建和非CV死亡）以及NNT（包括NNT、糖化血红蛋白水平[HbA]≥6.5%和5分制肾病复合指标）。
构成NNT的事件的相对风险降低分别为20%（NNT）、20%（NNT）和41%（NNT）。司美格鲁肽起始治疗后1年和4年时，NNT分别为125和58，NNT分别为49和25，NNT分别为20和11。
当将SELECT试验中临床和医保相关结局纳入NNT计算时，与仅考虑主要终点相比，司美格鲁肽的风险降低幅度更大，NNT估计值更低。我们的研究结果表明，纳入司美格鲁肽在主要试验终点之外的更广泛影响可为利益相关者认识到更多价值。
