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更新于：2026-10-01
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更新于：2026-10-01
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NCT07849348
Study on the Efficacy and Safety of Initial Combination of Finerenone and Semaglutide in Non-diabetic Adult Patients With Obesity Complicated by Chronic Kidney Disease With Albuminuria
CTR20211265
一项在中国健康男性受试者中评价BAY 2976217单次皮下给药的安全性、耐受性、药代动力学和药效学特征的单盲、安慰剂对照、随机、剂量递增I期研究
CTR20202670
在中国健康受试者中评估BAY 1101042单次和多次给药的药代动力学、安全性、耐受性和药效学的I期研究
100 项与 拜耳医药保健有限公司 相关的临床结果
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2026-02-01JAMA Ophthalmology
Aflibercept 8 mg in Polypoidal Choroidal Vasculopathy
Article
Importance:
In the Study of the Effects of High-Dose Aflibercept Injected Into the Eye of Patients With an Age-Related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye (PULSAR) phase 3 randomized clinical trial, treatment with aflibercept, 8 mg, demonstrated noninferior (4-letter margin) best-corrected visual acuity (BCVA) gains vs aflibercept, 2 mg, in participants with neovascular age-related macular degeneration (nAMD). This post hoc subgroup analysis evaluated clinical outcomes in participants with polypoidal choroidal vasculopathy (PCV).
Objective:
To compare the efficacy and safety of aflibercept, 8 mg vs 2 mg, monotherapy among participants with PCV in the PULSAR trial.
Design, Setting, and Participants:
This was a post hoc subgroup analysis of the PULSAR randomized clinical trial. The setting included hospitals and clinics in 12 countries where indocyanine green angiography (ICGA) was performed to identify PCV. Included were a subgroup of adults with nAMD enrolled in the PULSAR trial with ICGA-confirmed PCV. Study data were analyzed from August 2020 to July 2022.
Interventions:
Participants were randomly assigned 1:1:1 to aflibercept, 8 mg, every 12 weeks or 16 weeks, or aflibercept, 2 mg, every 8 weeks, each after 3 initial monthly doses. From week 16, dosing intervals in the treatment arms receiving 8 mg every 12 weeks and every 16 weeks were shortened if predefined disease activity criteria were met at prespecified visits.
Main Outcomes and Measures:
Least-squares (LS) mean change in BCVA from baseline at week 48.
Results:
A total of 139 participants were included in this analysis. ICGA-confirmed PCV was present in 44 participants in the treatment group receiving aflibercept, 8 mg, every 12 weeks (mean [SD] age, 72.2 [8.1] years; 50% male), 41 participants receiving 8 mg every 16 weeks (mean [SD] age, 73.2 [8.7] years; 63% male), and 54 participants receiving 2 mg every 8 weeks (mean [SD] age, 72.6 [8.2] years; 69% male). Mean baseline BCVA letter score (approximate Snellen) was 56.3 (20/80), 60.1 (20/63), and 57.6 (20/80), respectively, with 41, 37, and 51 participants completing week 48 and receiving a mean (SD) of 6.1 (0.4), 5.1 (0.5), and 7.0 (0.2) injections, including 68 of 78 (87%) treated with aflibercept, 8 mg, who maintained dosing intervals of 12 weeks or longer. In the treatment arms receiving aflibercept, 8 mg, every 12 and 16 weeks and aflibercept, 2 mg, every 8 weeks, LS mean BCVA change from baseline at week 48 was +9.5, +8.4, and +9.1 letters, respectively (estimated difference, 0.40; 95% CI, −4.4 to 5.2 letters for 8 mg every 12 weeks vs 2 mg every 8 weeks; −0.7; 95% CI, −4.6 to 3.2 letters for 8 mg every 16 weeks vs 2 mg every 8 weeks), and polypoidal lesions were absent in 37%, 47%, and 38% of participants, respectively, who completed week 48.
Conclusions and Relevance:
Results of this post hoc analysis of the PULSAR randomized clinical trial in participants with PCV demonstrated similar visual and anatomic outcomes with aflibercept, 8 mg vs 2 mg, as administered in this trial, supporting the use of aflibercept, 8 mg, as an alternative monotherapy for PCV.
Trial Registration:
ClinicalTrials.gov Identifier:
NCT04423718
2026-01-01OPHTHALMOLOGY
Intravitreal Aflibercept 8 mg in Neovascular Age-Related Macular Degeneration
Article
作者: Schulze, Andrea ; Hasanbasic, Zoran ; Zhang, Xin ; Zhao, Min ; Vitti, Robert ; Clark, W Lloyd ; Holz, Frank G ; Hirshberg, Boaz ; Yancopoulos, George D ; Reed, Kimberly ; Schmelter, Thomas ; Cheng, Yenchieh ; Bhore, Rafia ; Wong, Tien Y ; Lanzetta, Paolo ; Schmidt-Ott, Ursula ; Bai, Zhanying ; Sun, Xiaodong ; Chu, Karen W ; Morgan-Warren, Peter ; Korobelnik, Jean-François ; Leal, Sergio ; Berliner, Alyson J ; Eichenbaum, David ; Iida, Tomohiro
PURPOSE:
To report the efficacy, durability, and safety of intravitreal aflibercept 8 mg versus intravitreal aflibercept 2 mg every 8 weeks (2q8) in patients with neovascular age-related macular degeneration (nAMD) through 96 weeks, PULSAR (ClinicalTrials.gov identifier, NCT04423718).
DESIGN:
Phase 3, randomized, noninferiority, 96-week trial.
PARTICIPANTS:
Treatment-naive adults ≥ 50 years with nAMD.
METHODS:
Patients were randomized 1:1:1 to intravitreal aflibercept 8 mg every 12 or 16 weeks (8q12 or 8q16), or 2q8, after 3 initial monthly doses; dosing intervals in 8-mg groups were modified based on prespecified criteria.
MAIN OUTCOME MEASURES:
Change from baseline in best-corrected visual acuity (BCVA) and central retinal thickness (CRT), proportion of patients maintaining or extending the randomized dosing intervals, and safety outcomes.
RESULTS:
Of 1009 patients treated, 869 patients (8q12, n = 291; 8q16, n = 292; 2q8, n = 286) completed treatment through week 96. Least squares (LS) mean change from baseline in BCVA at week 96 was +5.6 (95% confidence interval [Cl], 4.1-7.1), +5.5 (95% Cl, 4.0-7.0), and +6.6 (95% Cl, 5.2-8.0) letters in the 8q12, 8q16, and 2q8 groups, respectively; 8q12 and 8q16 differences versus 2q8 in LS mean BCVA changes at week 96 met the noninferiority criteria specified for the primary end point at week 48. Mean (standard deviation) change in CRT from baseline was -143.9 (123.6) μm, -153.4 (140.8) μm, and -135.8 (133.1) μm in the 8q12, 8q16, and 2q8 groups, respectively. Patients completing 96 weeks of treatment in the 8q12, 8q16, and 2q8 groups received a mean of 9.7, 8.2, and 12.8 active injections, respectively. Of these, 87% of patients in the 8q12 group had last assigned dosing intervals of 12 weeks or more, whereas 78%, 53%, and 31% of patients in the 8q16 group qualified for last assigned dosing intervals of ≥ 16 weeks, ≥ 20 weeks, and 24 weeks, respectively. Incidence of ocular treatment-emergent adverse events was similar across groups.
CONCLUSIONS:
Aflibercept 8 mg delivered sustained disease control in patients with nAMD, maintaining improvements in visual and anatomic outcomes through week 96 with extended dosing intervals and similar safety profile to aflibercept 2 mg.
FINANCIAL DISCLOSURE(S):
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
2025-12-01NUTRITION REVIEWS
Clinical Benefits and Safety of Multiple Micronutrient Supplementation During Preconception, Pregnancy, and Lactation: A Review
Article
作者: Kaufmann, Ligaya ; Liu, Jue ; Qi, Hongbo ; Campos Goenaga, Zigor ; Kuroda, Keiji ; Gromova, Olga ; Tetruashvili, Nana ; Di Renzo, Gian Carlo ; Mantantzis, Konstantinos
Abstract:
Objective:
In this review we sought to determine the clinical benefits and safety of a multiple micronutrient supplement/supplementation (MMS) throughout preconception, pregnancy, and lactation in the mother and their child.
Background:
No guidelines for pregnancy specifically recommend supplementation with micronutrients other than folic acid and iron or continuing the use of MMS beyond the first trimester. Yet micronutrients are essential during all stages of pregnancy for healthy fetal growth and development and maternal health, with an increased intake of many micronutrients recommended during pregnancy and lactation. The MMS reviewed (Elevit, Bayer) is the most studied prenatal form of MMS, supported by 30 publications reporting studies conducted worldwide over 30 years and used by millions of women over a period of 40 years. Until now, the data have not yet been consolidated.
Methods:
We performed a literature search to identify published studies for trials that used MMS at any stage of the pregnancy journey.
Results:
Outcomes reported in 30 trials suggested that MMS improves micronutrient status, leads to a healthier reproductive environment during preconception, and can significantly reduce neural tube defects and congenital abnormalities in early pregnancy above and beyond supplementation with folic acid alone. We also found that MMS can reduce adverse pregnancy outcomes during the second and third trimesters, including miscarriage, pre-eclampsia, anemia, preterm birth, and placental insufficiency, and improve docosahexaenoic acid status. In addition, MMS improves the quality of breastmilk and reduces postpartum depression. Using MMS containing 800 μg folic acid is more effective than supplementing with 400 μg folic acid alone. Very few adverse events were reported in infants, almost all of which were considered unrelated to MMS intake. In one cohort, periconceptual MMS in children was linked to higher rates of otitis media and atopic dermatitis than placebo, but these results may be partly attributed to multiple hypothesis testing and differences in family history, respectively.
Conclusion:
Improving micronutrient status with MMS in women who are trying to conceive, pregnant, or breastfeeding may have beneficial effects on fertility, the integrity of the embryonic environment, development of the embryonic brain and nervous system, and the growth, development, and long-term health of the child.
100 项与 拜耳医药保健有限公司 相关的药物交易
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