Brown Gary C, Brown Melissa M, Gierhart Dennis, Olk R Joseph
The Center for Value-Based Medicine®, Box 3417, Hilton Head, SC, 29928, USA.
Wills Eye Hospital, Thomas Jefferson Medical University, Philadelphia, PA, USA.
Ophthalmol Ther. 2023 Oct;12(5):2583-2608. doi: 10.1007/s40123-023-00742-9. Epub 2023 Jul 10.
Oral administration of zeaxanthin (Zx) 20 mg daily in patients with unilateral neovascular age-related macular degeneration (nAMD) treated with triple therapy (photodynamic therapy/intravitreal bevacizumab/intravitreal dexamethasone) reduced fellow-eye 2-year nAMD incidence from 23 to 6% (p = 0.02) in a prior clinical trial. We questioned the long-term benefit and thus analyzed case-control 5-year patient data of trial participants and additional participants with 5-year follow-up, also performing cost-utility and cost-benefit analyses.
Consecutive, unilateral nAMD patient outcomes for those taking 20 mg Zx supplementation orally for ≥ 5 years were compared with the Comparison of AMD Treatments Trials (CATT) 5-year historical controls for fellow-eye nAMD conversion. Eleven-year mean life expectancy, cost-utility and cost-benefit models were undertaken employing a 3% discount rate and 2020 US real dollars.
Among 227 consecutive patients with nAMD/Zx-supplementation, 202 (90%) had 5-year follow-up. The fellow-eye nAMD 5-year conversion incidence using a Kaplan-Meier cumulative event estimate was 22% (49/227), versus 48% (167/348) with CATT control data (p < 0.0001). An 11-year cost-utility model with estimates for years 6-11 demonstrated a 0.42 (7.7%) QALY (quality-adjusted life-year) gain, including 3 months of life saved per patient due to decreased nAMD fellow-eye conversion. This yielded a direct ophthalmic medical cost perspective, incremental cost-utility ratio (CUR) of -$576/QALY and a societal cost perspective CUR of -$125,071/QALY. Zx supplementation for all 2020 US unilateral nAMD cases would have theoretically saved society, primarily patients, $6.0 billion over 11 years, a 1531% return on investment (ROI), or 31.3% annual ROI, on Zx costs.
Oral zeaxanthin supplementation for unilateral nAMD patients appears to decrease fellow-eye long-term incidence and is cost-effective and financially rewarding. It is dominant vs. no supplementation in patients presenting with unilateral nAMD.
ClinicalTrials.gov identifier, NCT01527435.
在一项先前的临床试验中，对于接受三联疗法（光动力疗法/玻璃体内注射贝伐单抗/玻璃体内注射地塞米松）治疗的单侧新生血管性年龄相关性黄斑变性（nAMD）患者，每日口服20毫克玉米黄质（Zx）可将对侧眼2年nAMD发病率从23%降至6%（p = 0.02）。我们对其长期益处提出质疑，因此分析了试验参与者以及另外有5年随访的参与者的病例对照5年患者数据，并进行了成本效用和成本效益分析。
将连续口服20毫克Zx补充剂≥5年的单侧nAMD患者的结果与年龄相关性黄斑变性治疗试验比较（CATT）对侧眼nAMD转化的5年历史对照进行比较。采用3%的贴现率和2020年美国实际美元进行11年平均预期寿命、成本效用和成本效益模型分析。
在连续227例接受nAMD/Zx补充剂治疗的患者中，202例（90%）有5年随访。使用Kaplan-Meier累积事件估计法得出的对侧眼nAMD 5年转化发生率为22%（49/227），而CATT对照数据为48%（167/348）（p < 0.0001）。一个对第6至11年进行估计的11年成本效用模型显示，质量调整生命年（QALY）增加了0.42（7.7%），包括由于对侧眼nAMD转化减少，每位患者多活了3个月。从直接眼科医疗成本角度来看，增量成本效用比（CUR）为 -$576/QALY，从社会成本角度来看，CUR为 -$125,071/QALY。理论上，对所有2020年美国单侧nAMD病例补充Zx，在11年内可为社会（主要是患者）节省60亿美元，Zx成本的投资回报率（ROI）为1531%，即年ROI为31.3%。
对单侧nAMD患者口服补充玉米黄质似乎可降低对侧眼的长期发病率，具有成本效益且有经济回报。对于单侧nAMD患者，补充Zx优于不补充。
ClinicalTrials.gov标识符，NCT01527435。
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