Intravitreal Vascular Endothelial Growth Factor Inhibitor Therapy in Denmark and 5-Year Projections.
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ABSTRACT:
SUBMITTER: Thinggaard BS
PROVIDER: S-EPMC10517372 | biostudies-literature | 2023 Sep
REPOSITORIES: biostudies-literature
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Intravitreal Vascular Endothelial Growth Factor Inhibitor Therapy in Denmark and 5-Year Projections.
Thinggaard Benjamin Sommer BS Pedersen Frederik F Grauslund Jakob J Stokholm Lonny L
JAMA network open 20230905 9
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Project description:Adverse renal effects of systemic vascular endothelial growth factor (VEGF) inhibitor treatment are well documented. We aimed to identify associations between intravitreal VEGF inhibitor use and renal function decline in patients with diabetic retinopathy. We included 625 patients with diabetic retinopathy for regular renal function follow-ups and grouped them according to intravitreal therapy (67 with and 558 without treatment). We used a generalized estimating equation model to identify renal function decline risk factors. Increased age (p = 0.02), insulin use (p = 0.01), hypertension (p < 0.01), and ischemic heart disease (p < 0.01) were associated with significantly decreased estimated glomerular filtration rates (eGFRs) in patients with diabetic retinopathy after 1-year follow-up. Compared to the control group, patients who received intravitreal VEGF inhibitor injections showed a declining eGFR trend in the repeated measurement model without statistical significance (p = 0.06). In subgroup analysis, patients with initial eGFR ≤ 30 mL/min/1.73 m2 who received intravitreal VEGF inhibitors had significantly decreased renal function (p < 0.01) compared to those without treatment. Intravitreal VEGF inhibitor injection was associated with renal function deterioration among patients with diabetic retinopathy and advanced chronic kidney disease. Strategies to monitor renal function after treatment should be considered in these high-risk populations.
| S-EPMC9657653 | biostudies-literature
Project description:Pituitary adenomas are common in the general population. They can be complicated by intratumoral hemorrhage, otherwise known as apoplexy, which frequently presents with neurologic deficits that may necessitate urgent surgical decompression. Many risk factors for pituitary apoplexy have been suggested in the literature. We present a case of symptomatic apoplexy in a woman following the intravitreal administration of the vascular endothelial growth factor (VEGF) inhibitor ranibizumab. Ophthalmoplegia resolved and visual acuity significantly improved following gross total resection of the tumor via an endoscopic endonasal surgical approach. The association between intravitreal injection of a VEGF inhibitor and pituitary apoplexy has not been previously described, but physicians performing these procedures should be aware of this potential complication.
| S-EPMC4648717 | biostudies-other
Project description:ImportanceAlthough intravitreal anti-vascular endothelial growth factor (VEGF) treatment represents the first-line therapy for many retinal diseases, the issue of their systemic safety is debatable.ObjectivesTo assess whether intravitreal anti-VEGF therapy might be associated with increased risk of mortality and which variables are associated with the increase.Data sourcesPubMed, MEDLINE, and Embase databases, the Cochrane Library, and ClinicalTrials.gov were systematically searched from inception to May 6, 2019.Study selectionRandomized clinical trials comparing intravitreal anti-VEGF treatment with control groups and with follow-up of at least 6 months were selected.Data extraction and synthesisData were independently collected by 2 investigators. Meta-analyses were conducted using the frequentist and Bayesian methods. For the frequentist approach, random- and fixed-effects models were used, with random-effects models considered the primary technique. Odds ratios (ORs) with 95% CIs were computed. For the bayesian approach, uninformative and informative priors were used. Odds ratios with 95% credible intervals (CrIs) were computed. Meta-regression analyses were based on random-effects models.Main outcomes and measuresThe primary outcome measure was the all-cause death rate. Secondary outcomes included meta-regression analyses on the following variables: type of drug, number of injections, follow-up time, diagnosis, and cardiovascular risk.ResultsOf 2336 studies identified, 34 unique studies with 8887 unique participants were included in the present meta-analysis. For the frequentist analysis, fixed- and random-effects models yielded similar estimates (ORs, 1.34 [95% CI, 0.95-2.07; P = .09] and 1.34 [95% CI, 0.89-2.01; P = .17], respectively). For the Bayesian approach, noninformative and informative priors yielded similar results (ORs, 1.34 [95% CrI, 0.79-2.34; 0.13 probability of OR≤1.00] and 1.40 [95% CrI, 0.82-2.32; 0.11 probability of OR≤1.00], respectively). Meta-regression analyses showed the following risk for 1 injection more: frequentist OR of 1.12 (95% CI, 1.04-1.22; P = .005) and Bayesian OR of 1.06 (95% CrI, 0.98-1.15; 0.06 probability of OR≤1.00).Conclusions and relevanceIn this study, no difference was found in the mortality rate between intravitreal anti-VEGF treatment and control groups. Additional data seem warranted to determine whether the mortality rate is increased in patients receiving a greater number of injections.
| S-EPMC6902107 | biostudies-literature
Project description:PurposeTo determine intraocular pharmacokinetic properties of intravitreally injected vascular endothelial growth factor (VEGF)-Trap in a rabbit model.MethodsVEGF-Trap was intravitreally injected in 18 rabbit eyes. Eyes were enucleated 1 h and 1, 2, 5, 14, and 30 days after injections and immediately frozen at -80 °C. Concentration of VEGF-Trap in vitreous, aqueous humor, and retina/choroid was determined using an indirect enzyme-linked immunosorbent assay and analyzed to obtain pharmacokinetic properties.ResultsMaximum concentration of VEGF-Trap was achieved at 1 h in all three tissues. A one-compartment model of distribution was selected as the final model for all tissues studied. Estimated half-life of VEGF-Trap in vitreous, aqueous humor, and retinal/choroid was 87.1, 36.8, and 35.0 h, respectively, and estimated mean residence time was 125.7, 53.1, and 50.5 h, respectively. Area under the curve from time 0 to the end point was 10009.8, 3945.1, and 1189.3, respectively. Total exposure of the aqueous humor and retina/choroid to VEGF-Trap was 39.4% and 11.9% of vitreous exposure, respectively.ConclusionThe vitreous half-life of VEGF-Trap is 3.63 days. This is shorter than that of bevacizumab (6.99 days) and longer than that of ranibizumab (2.51 days), as shown in studies using the same experimental settings. The concentration of VEGF-Trap peaked at 1 h after injections in all eye tissues studied.
| S-EPMC4816356 | biostudies-literature
Project description:IntroductionIntravitreal dexamethasone and anti-vascular endothelial growth factor (anti-VEGF) medications have revolutionized ocular disease management and favorable ocular safety profiles, but few studies have compared their systemic adverse events (SAEs). This study investigated the SAEs of intravitreal dexamethasone and anti-VEGFs by using real-world data.MethodsThis retrospective cohort study sourced medical records from the largest multi-institutional database in Taiwan. Patients who received intravitreal dexamethasone (n = 137) or anti-VEGFs (n = 10,345) between 2014 and 2019 were enrolled. Propensity score matching was performed to achieve homogeneity between the two groups. Subdistribution hazard ratios (SHRs) and 95% confidence intervals (CIs) were calculated using the Fine-Gray model. Systemic as well as ocular clinical events and systemic biomarkers after 1-year follow-up were compared.ResultsBoth groups demonstrated comparable risks of major cardiac adverse events (SHR 1.57, 95% CI 0.29-8.55), heart failure (SHR 0.62, 95% CI 0.07-5.33), major bleeding (SHR 0.23, 95% CI 0.03-1.77), all-cause admission (SHR 0.73, 95% CI 0.41-1.30), and all-cause death (SHR 2.11, 95% CI 0.35-12.71). There were no significant differences in longitudinal changes in systolic and diastolic blood pressure, glycated hemoglobin, low-density lipoprotein, estimated glomerular filtration rate, or alanine aminotransferase between the groups. Both groups had a similar incidence of cataract surgery. Although the dexamethasone group exhibited a relatively high prevalence of antiglaucomatous medication use, there was not a significantly higher incidence of glaucoma surgery.ConclusionIntravitreal dexamethasone and anti-VEGF medications had comparable systemic safety profiles in our study. Both drugs represent efficacious and safe therapies for ocular diseases.
| S-EPMC10011242 | biostudies-literature
Project description: Not available
| S-EPMC6494419 | biostudies-literature
Project description:PURPOSE:To assess systemic vascular endothelial growth factor (VEGF)-A levels after treatment with intravitreous aflibercept, bevacizumab, or ranibizumab. DESIGN:Comparative-effectiveness trial with participants randomly assigned to 2 mg aflibercept, 1.25 mg bevacizumab, or 0.3 mg ranibizumab after a re-treatment algorithm. PARTICIPANTS:Participants with available plasma samples (N = 436). METHODS:Plasma samples were collected before injections at baseline and 4-week, 52-week, and 104-week visits. In a preplanned secondary analysis, systemic-free VEGF levels from an enzyme-linked immunosorbent assay were compared across anti-VEGF agents and correlated with systemic side effects. MAIN OUTCOME MEASURES:Changes in the natural log (ln) of plasma VEGF levels. RESULTS:Baseline free VEGF levels were similar across all 3 groups. At 4 weeks, mean ln(VEGF) changes were -0.30±0.61 pg/ml, -0.31±0.54 pg/ml, and -0.02±0.44 pg/ml for the aflibercept, bevacizumab, and ranibizumab groups, respectively. The adjusted differences between treatment groups (adjusted confidence interval [CI]; P value) were -0.01 (-0.12 to +0.10; P = 0.89), -0.31 (-0.44 to -0.18; P < 0.001), and -0.30 (-0.43 to -0.18; P < 0.001) for aflibercept-bevacizumab, aflibercept-ranibizumab, and bevacizumab-ranibizumab, respectively. At 52 weeks, a difference in mean VEGF changes between bevacizumab and ranibizumab persisted (-0.23 [-0.38 to -0.09]; P < 0.001); the difference between aflibercept and ranibizumab was -0.12 (P = 0.07) and between aflibercept and bevacizumab was +0.11 (P = 0.07). Treatment group differences at 2 years were similar to 1 year. No apparent treatment differences were detected at 52 or 104 weeks in the cohort of participants not receiving injections within 1 or 2 months before plasma collection. Participants with (N = 9) and without (N = 251) a heart attack or stroke had VEGF levels that appeared similar. CONCLUSIONS:These data suggest that decreases in plasma free-VEGF levels are greater after treatment with aflibercept or bevacizumab compared with ranibizumab at 4 weeks. At 52 and 104 weeks, a greater decrease was observed in bevacizumab versus ranibizumab. Results from 2 subgroups of participants who did not receive injections within at least 1 month and 2 months before collection suggest similar changes in VEGF levels after stopping injections. It is unknown whether VEGF levels return to normal as the drug is cleared from the system or whether the presence of the drug affects the assay's ability to accurately measure free VEGF. No significant associations between VEGF concentration and systemic factors were noted.
| S-EPMC6568257 | biostudies-literature
Project description: Not available
| S-EPMC6829182 | biostudies-literature
Project description:PurposeTo study the prevalence of sustained intraocular pressure (IOP) elevation associated with intravitreal injection of anti-vascular endothelial growth factor (anti-VEGF) agents.MethodsProspective comparative study. Non-glaucomatous patients scheduled to receive intravitreal injection of anti-VEGF therapy were recruited from an outpatient eye clinic, Songklanagarind Hospital between April 2013 and March 2014. The IOP was measured by Goldmann applanation tonometer before and at 1 hour, 1 week, 1 month, 3 months, and 6 months after injection. The IOP was compared using the repeated measures analysis. Sustained IOP elevation was defined as either an IOP > 21 mmHg or an increase from baseline ≥ 5 mmHg on two consecutive visits.ResultsSeventy eyes of 54 patients met the inclusion criteria. The most common diagnosis was diabetic macular edema (48%). The mean IOP ± standard deviation (SD) before treatment was 13.7 ± 2.8 mmHg. The means ± SDs after treatment at 1 hour, 1 week, 1 month, 3 months, and 6 months were 11.3 ± 2.6, 13.7 ± 3.6, 14.1 ± 3.3, 14.0 ± 2.3, and 13.7 ± 2.4 mmHg, respectively. A mean of IOP difference at 1 hour postinjection and at baseline was -2.36 ± 2.5 mmHg (P < 0.001). Four of 70 treated eyes (5.7%) developed sustained IOP elevation (IOP ≥ 5 mmHg from baseline on two consecutive visits). The IOP returned to baseline levels after 1 month, in three eyes. One eye had sustained IOP elevation at 3 and 6 months follow-up. Thereafter, IOP returned to baseline level. There was no need of anti-glaucoma medication.ConclusionsAfter receiving intravitreal injection of anti-VEGF agent, a small proportion of non-glaucomatous eyes developed a sustained IOP elevation without requiring IOP-lowering treatment. At 1 hour postinjection, there was a significant reduction of the mean IOP compared with the baseline level.
| S-EPMC4567346 | biostudies-literature
Project description:Neo-angiogenesis is a critical process for tumor growth and invasion and has become a promising target in cancer therapy. This manuscript reviews three currently relevant anti-angiogenic agents targeting the vascular endothelial growth factor system: bevacizumab, ramucirumab and sorafenib. The efficacy of anti-angiogenic drugs in adjuvant therapy or as neo-adjuvant treatment has been estimated in clinical trials of advanced breast cancer. To date, the overall observed clinical improvements are unconvincing, and further research is required to demonstrate the efficacy of anti-angiogenic drugs in breast cancer treatments. The outcomes of anti-angiogenic therapy have been highly variable in terms of tumor response. New methods are needed to identify patients who will benefit from this regimen. The development of biomarkers and molecular profiling are relevant research areas that may strengthen the ability to focus anti-angiogenic therapy towards suitable patients, thereby increase the cost-effectiveness, currently estimated to be inadequate.
| S-EPMC4284752 | biostudies-literature