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1.
Lancet ; 403(10432): 1141-1152, 2024 Mar 23.
Artigo em Inglês | MEDLINE | ID: mdl-38461841

RESUMO

BACKGROUND: Intravitreal aflibercept 8 mg could improve treatment outcomes and provide sustained disease control in patients with neovascular age-related macular degeneration (nAMD), with extended dosing compared with aflibercept 2 mg. METHODS: PULSAR is a phase 3, randomised, three-group, double-masked, non-inferiority, 96-week trial conducted across 223 sites worldwide. Adults with nAMD were randomised 1:1:1 to aflibercept 8 mg every 12 weeks (8q12), aflibercept 8 mg every 16 weeks (8q16), or aflibercept 2 mg every 8 weeks (2q8), following three initial monthly doses in all groups. From week 16, patients in the aflibercept 8 mg groups had their dosing interval shortened if pre-specified dose regimen modification criteria denoting disease activity were met. The primary endpoint was change from baseline in best-corrected visual acuity (BCVA) at week 48. All patients with at least one dose of study treatment were included in the efficacy and safety analyses. This trial is registered with ClinicalTrials.gov (NCT04423718) and is ongoing. FINDINGS: Of 1011 patients randomised to aflibercept 8q12 (n=336), 8q16 (n=338), or 2q8 (n=337) between Aug 11, 2020, and July 30, 2021, 1009 patients received study treatment (aflibercept 8q12 n=335; aflibercept 8q16 n=338; and aflibercept 2q8 n=336). Aflibercept 8q12 and 8q16 showed non-inferior BCVA gains versus aflibercept 2q8 (mean BCVA change from baseline +6·7 [SD 12·6] and +6·2 [11·7] vs +7·6 [12·2] letters). The least squares mean differences between aflibercept 8q12 versus 2q8 and 8q16 versus 2q8, respectively, were -0·97 (95% CI -2·87 to 0·92) and -1·14 (-2·97 to 0·69) letters (non-inferiority margin at 4 letters). The incidence of ocular adverse events in the study eye was similar across groups (aflibercept 8q12 n=129 [39%]; aflibercept 8q16 n=127 [38%]; and aflibercept 2q8 n=130 [39%]). INTERPRETATION: Aflibercept 8 mg showed efficacy and safety with extended dosing intervals, which has the potential to improve the management of patients with nAMD. FUNDING: Bayer AG and Regeneron Pharmaceuticals.


Assuntos
Inibidores da Angiogênese , Degeneração Macular , Adulto , Humanos , Inibidores da Angiogênese/efeitos adversos , DEAE-Dextrano , Degeneração Macular/tratamento farmacológico , Receptores de Fatores de Crescimento do Endotélio Vascular/uso terapêutico , Proteínas Recombinantes de Fusão/efeitos adversos , Resultado do Tratamento
2.
Lancet ; 403(10432): 1153-1163, 2024 Mar 23.
Artigo em Inglês | MEDLINE | ID: mdl-38461843

RESUMO

BACKGROUND: A high-dose formulation of intravitreal aflibercept (8 mg) could improve treatment outcomes in diabetic macular oedema (DMO) by requiring fewer injections than the standard comparator, aflibercept 2 mg. We report efficacy and safety results of aflibercept 8 mg versus 2 mg in patients with DMO. METHODS: PHOTON was a randomised, double-masked, non-inferiority, phase 2/3 trial performed at 138 hospitals and specialty retina clinics in seven countries. Eligible patients were adults aged 18 years or older with type 1 or 2 diabetes and centre-involved DMO. Patients were randomly assigned (1:2:1) to intravitreal aflibercept 2 mg every 8 weeks (2q8), aflibercept 8 mg every 12 weeks (8q12), or aflibercept 8 mg every 16 weeks (8q16), following initial monthly dosing. From week 16, dosing intervals for the aflibercept 8 mg groups were shortened if patients met prespecified dose regimen modification criteria denoting disease activity. The primary endpoint was change from baseline in best-corrected visual acuity (BCVA) at week 48 (non-inferiority margin of 4 letters). Efficacy and safety analyses included all randomly assigned patients who received at least one dose of study treatment. This trial is registered with ClinicalTrials.gov (NCT04429503). FINDINGS: Between June 29, 2020, and June 28, 2021, 970 patients were screened for eligibility. After exclusions, 660 patients were enrolled and randomly assigned to receive aflibercept 8q12 (n=329), 8q16 (n=164), or 2q8 (n=167); two patients were randomly assigned in error and did not receive treatment. 658 (99·7%) patients were treated and included in the full analysis set and safety analysis set (8q12 n=328, 8q16 n=163, and 2q8 n=167). Mean patient age was 62·3 years (SD 10·4). 401 (61%) patients were male. 471 (72%) patients were White. Aflibercept 8q12 and 8q16 demonstrated non-inferior BCVA gains to aflibercept 2q8 (BCVA mean change from baseline 8·8 letters [SD 9·0] in the 8q12 group, 7·9 letters [8·4] in the 8q16 group, and 9·2 letters [9·0] in the 2q8 group). The difference in least squares means was -0·57 letters (95% CI -2·26 to 1·13, p value for non-inferiority <0·0001) between 8q12 and 2q8 and -1·44 letters (-3·27 to 0·39, p value for non-inferiority 0·0031) between aflibercept 8q16 and 2q8. Proportions of patients with ocular adverse events in the study eye were similar across groups (8q12 n=104 [32%], 8q16 n=48 [29%], and 2q8 n=46 [28%]). INTERPRETATION: Aflibercept 8 mg demonstrated efficacy and safety with extended dosing intervals and could decrease treatment burden in patients with DMO. FUNDING: Regeneron Pharmaceuticals and Bayer.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Adulto , Feminino , Humanos , Masculino , Inibidores da Angiogênese , Diabetes Mellitus/tratamento farmacológico , Edema Macular/etiologia , Edema Macular/induzido quimicamente , Receptores de Fatores de Crescimento do Endotélio Vascular/uso terapêutico , Proteínas Recombinantes de Fusão/efeitos adversos , Resultado do Tratamento , Pessoa de Meia-Idade , Idoso
3.
BMC Ophthalmol ; 24(1): 229, 2024 May 31.
Artigo em Inglês | MEDLINE | ID: mdl-38822279

RESUMO

BACKGROUND: This study evaluated impact of anti-vascular endothelial growth factor (VEGF) treatment on proliferative diabetic retinopathy (PDR) development among patients with non-proliferative diabetic retinopathy (NPDR) in US real-world clinical practice. METHODS: This was a retrospective analysis of electronic medical records (Vestrum Health; January 2013 to June 2019) of eyes with baseline NPDR, without DME, and naïve to anti-VEGF treatment at index DR diagnosis. Eyes that received anti-VEGF and/or laser treatment over the course of study before development of PDR constituted the treated cohort while the remaining including those treated with laser constituted the anti-VEGF naïve cohort. Survival analysis via Kaplan-Meier method evaluated time to DME and PDR development by baseline NPDR severity, with anti-VEGF treatment as censoring variable. Baseline factors affecting PDR development were analyzed using Cox multivariable regression, censoring for anti-VEGF treatment. RESULTS: Among anti-VEGF-naive eyes, cumulative incidence of DME in eyes with mild (n = 70,050), moderate (n = 39,116), and severe NPDR (n = 10,692) at baseline was 27.1%, 51.2%, and 60.6%. Multivariable regression analysis identified baseline NPDR severity as the most significant predictor of PDR development over 48 months (hazard ratio [HR] [95% confidence interval {CI}] of 2.69 (2.65-2.72) for moderate vs mild NPDR and 6.51 (6.47-6.55) for severe vs mild NPDR). Cumulative incidence (95% CI) of PDR was 7.9% (7.4%-8.3%), 20.9%, (20.0%-21.7%) and 46.8% (44.4%-49.2%) over 48 months in eyes with mild, moderate, and severe NPDR at baseline, respectively. Among treated eyes with baseline severe NPDR, cumulative incidence of PDR at 48 months was 50.1% in eyes treated with laser (n = 546; HR [95% CI] vs no treatment: 0.8 [0.7-1.0]), 27.4% in eyes treated with anti-VEGF (n = 923; HR [95% CI]: 0.4 [0.4-0.5]), and 25.6% in eyes treated with anti-VEGF plus laser (n = 293; HR [95% CI]: 0.5 [0.4-0.7]) compared with 49.9% in eyes with no treatment (n = 8930). CONCLUSIONS: DME and PDR development rates increased with increasing baseline NPDR severity. Approximately half of anti-VEGF‒naive eyes with severe NPDR progressed to PDR within 4 years in US clinical practice. The progression rate from severe NPDR to PDR was approximately halved with anti-VEGF versus no treatment.


Assuntos
Inibidores da Angiogênese , Retinopatia Diabética , Injeções Intravítreas , Fator A de Crescimento do Endotélio Vascular , Humanos , Retinopatia Diabética/tratamento farmacológico , Retinopatia Diabética/diagnóstico , Estudos Retrospectivos , Feminino , Masculino , Inibidores da Angiogênese/uso terapêutico , Fator A de Crescimento do Endotélio Vascular/antagonistas & inibidores , Pessoa de Meia-Idade , Idoso , Ranibizumab/uso terapêutico , Ranibizumab/administração & dosagem , Acuidade Visual/fisiologia , Bevacizumab/uso terapêutico , Seguimentos , Adulto , Incidência
4.
Retina ; 43(2): 254-262, 2023 02 01.
Artigo em Inglês | MEDLINE | ID: mdl-36265076

RESUMO

PURPOSE: To characterize diabetic macular edema (DME) incidence in fellow eyes of patients treated for DME in the study eye. METHODS: This post hoc analysis of VISTA/VIVID data evaluated fellow eyes without DME at baseline through Week 100. Diabetic macular edema presence in the fellow eye was inferred by investigator-reported DME adverse events and use of DME treatments. RESULTS: Over 100 weeks, 44.9%, 44.2%, and 42.9% of fellow eyes developed DME in the intravitreal aflibercept injection 2 mg every 4 weeks (n = 245), intravitreal aflibercept injection 2 mg every 8 weeks (n = 258), and laser control (n = 252) groups, respectively. Mean time to DME development in combined treatment groups was ∼6 months. Multivariable regression analysis confirmed patients with shorter diabetes duration (hazard ratio per 10-year decrease, 1.16; 95% confidence interval, 1.03-1.30; P = 0.0160) and thicker baseline study eye central subfield thickness (hazard ratio per 10- µ m increase, 1.01; 95% confidence interval, 1.01-1.02; P = 0.0002) were at higher risk of developing DME in the fellow eye. CONCLUSION: Among patients with DME in one eye at baseline, almost half developed DME in the fellow eye over 2 years. Shorter duration of diabetes and thicker study eye central subfield thickness were predictors of DME development in the fellow eye.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Humanos , Edema Macular/diagnóstico , Edema Macular/tratamento farmacológico , Edema Macular/epidemiologia , Retinopatia Diabética/complicações , Retinopatia Diabética/diagnóstico , Retinopatia Diabética/tratamento farmacológico , Incidência , Inibidores da Angiogênese , Fotocoagulação a Laser , Fator A de Crescimento do Endotélio Vascular , Receptores de Fatores de Crescimento do Endotélio Vascular/uso terapêutico , Injeções Intravítreas , Proteínas Recombinantes de Fusão/uso terapêutico
7.
J Gerontol Soc Work ; 59(7-8): 572-586, 2016.
Artigo em Inglês | MEDLINE | ID: mdl-27585987

RESUMO

This article presents findings from an annual program survey of residents of a horizontal neighborhood naturally occurring retirement community (NNORC). The study explored the relationship between several factors (age, co-residents, number of chronic illnesses, self-reported health, loneliness, sense of mastery, locus of control, pain, and psychological distress) and their ability to predict general health, level of psychological distress, and the quantity and type of help-seeking behaviors. Although residents generally reported moderate to high levels of chronic disease, pain, loneliness, and concerns about life issues, 25% of them sought no help from any of the listed resources, and 65% sought help from only one of seven resources. The most common source of help for most (70%) was a primary care physician (PCP), and comparatively few respondents sought help from other sources. Older adults, especially those with chronic illness, generally consider their PCP to be the first, and perhaps only, source to consult. However, research indicates that the most effective health promotional programs for older adults are social and educational group activities, rather than individual health-focused interventions. Possible means of redirecting residents toward NNORC services include more vigorous outreach and creating collaborative partnerships between local PCPs serving older populations and the NNORC.


Assuntos
Serviços de Saúde Comunitária/estatística & dados numéricos , Comportamento de Busca de Ajuda , Estresse Psicológico/psicologia , Idoso , Idoso de 80 Anos ou mais , Moradias Assistidas/normas , Moradias Assistidas/estatística & dados numéricos , Feminino , Humanos , Modelos Lineares , Solidão/psicologia , Masculino , Dor/complicações , Dor/psicologia , Psicometria/instrumentação , Psicometria/métodos , Psicometria/estatística & dados numéricos , Características de Residência/estatística & dados numéricos , Estresse Psicológico/complicações , Inquéritos e Questionários
8.
Ophthalmol Retina ; 2024 Oct 16.
Artigo em Inglês | MEDLINE | ID: mdl-39424059

RESUMO

We report changes in DR severity over time from the PANORAMA study of aflibercept versus sham in patients with moderately severe/severe NPDR that can help physicians and patients make informed management decisions for optimal outcomes.

9.
J Health Commun ; 18(11): 1279-92, 2013.
Artigo em Inglês | MEDLINE | ID: mdl-23941586

RESUMO

Health interventions often draw attention to the risks associated with unhealthy choice but in the process produce a boomerang effect such that those targeted become more committed to risky behavior. In 2 studies designed to promote condom use among sexually active college students, the authors document strategies for highlighting risk while promoting healthy choices. Study 1 demonstrated that optimistic perceptions regarding the likelihood of contracting sexually transmitted diseases (STDs) can be counteracted by drawing attention to the emotional consequences of contracting STDs, instead of its likelihood. Rather than promoting condom use, however, this procedure generated a boomerang effect: It decreased commitment to using condoms, especially among high self-esteem individuals. Study 2 showed that this unwanted effect could be reversed when emotional vulnerability was paired with a self-affirmation. This finding suggests that there can be benefits to adding threatening content to health interventions, provided that the message also contains elements designed to protect feelings of self-worth.


Assuntos
Preservativos/estatística & dados numéricos , Comunicação em Saúde/métodos , Promoção da Saúde/métodos , Assunção de Riscos , Autoimagem , Comportamento Sexual/psicologia , Estudantes/psicologia , Adolescente , Feminino , Humanos , Masculino , Medição de Risco , Comportamento Sexual/estatística & dados numéricos , Infecções Sexualmente Transmissíveis/psicologia , Estudantes/estatística & dados numéricos , Universidades , Adulto Jovem
10.
Eye (Lond) ; 37(10): 2020-2025, 2023 07.
Artigo em Inglês | MEDLINE | ID: mdl-35440699

RESUMO

AIMS: To assess time to, cumulative incidence of, and functional benefit of achieving sustained ≥2-step Diabetic Retinopathy Severity Scale (DRSS) improvement in diabetic macular oedema (DMO). METHODS: Post hoc analysis of VISTA/VIVID including eyes with DMO treated with intravitreal aflibercept injections (IAI), 2 mg q4 weeks (2q4, n = 250) or q8 weeks after 5 monthly doses (2q8, n = 249), or laser control (n = 249). Changes from baseline in best-corrected visual acuity (BCVA) and central subfield thickness (CST) were evaluated in sustained (≥2 consecutive visits) DRSS subgroups (≥1-step worsening, no change, ≥2-step improvement). RESULTS: Time to sustained ≥2-step DRSS improvement was shorter for both the IAI 2q4 and IAI 2q8 groups versus laser (both log-rank p < 0.001). Cumulative incidences of sustained ≥2-step DRSS improvement with IAI 2q4 and IAI 2q8 versus laser were 40.0% and 42.8% versus 15.5% (both p < 0.001) through week 100. Mean differences (95% CI) in BCVA gains from baseline at weeks 52 and 100 between eyes with sustained ≥2-step DRSS improvement versus sustained ≥1-step DRSS worsening were -3.0 (-8.9, 2.9) and 6.2 (0.2, 12.2) letters with laser, and 4.2 (0.8, 7.6) and 4.9 (1.3, 8.4) letters with IAI combined, respectively. Difference (95% CI) in CST reduction was significantly greater only with IAI combined at week 100 (-83.0 [-140.8, -25.3]). Correlations between BCVA and CST changes were weak. CONCLUSIONS: DMO eyes treated with IAI achieved sustained ≥2-step DRSS improvement significantly earlier and more frequently versus laser. This improvement was associated with greater BCVA gains, independent of CST reductions. TRIAL REGISTRATION: ClinicalTrials.gov ( https://clinicaltrials.gov/ ) identifiers: NCT01363440 and NCT01331681 .


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Humanos , Inibidores da Angiogênese/uso terapêutico , Retinopatia Diabética/diagnóstico , Retinopatia Diabética/tratamento farmacológico , Retinopatia Diabética/cirurgia , Injeções Intravítreas , Fotocoagulação a Laser/efeitos adversos , Edema Macular/diagnóstico , Edema Macular/tratamento farmacológico , Edema Macular/cirurgia , Receptores de Fatores de Crescimento do Endotélio Vascular/uso terapêutico , Proteínas Recombinantes de Fusão/uso terapêutico , Tomografia de Coerência Óptica , Resultado do Tratamento , Fator A de Crescimento do Endotélio Vascular/uso terapêutico , Ensaios Clínicos como Assunto
11.
JAMA Ophthalmol ; 141(9): 834-842, 2023 09 01.
Artigo em Inglês | MEDLINE | ID: mdl-37535382

RESUMO

Importance: Aflibercept, 8 mg, may have greater therapeutic benefits compared with aflibercept, 2 mg, in patients with neovascular age-related macular degeneration (nAMD), including potentially improved outcomes and decreased treatment burden. Objective: To assess safety and efficacy of aflibercept, 8 mg, in patients with nAMD. Design, Setting, and Participants: The CANDELA trial was a phase 2, randomized, single-masked, open-label, 44-week clinical trial conducted in the US. Treatment-naive patients with active subfoveal choroidal neovascularization secondary to nAMD and a best-corrected visual acuity score of 78 to 24 letters (approximately 20/32 to 20/320) in the study eye were enrolled between November 2019 and November 2021. Interventions: Eligible participants were randomized 1:1 to receive 3 monthly doses of 8 mg (70 µL) or 2 mg (50 µL) of aflibercept followed by doses at weeks 20 and 32. Main Outcomes and Measures: Coprimary end points were the proportion of eyes without fluid (absence of intraretinal and subretinal fluid) in the central subfield at week 16 and safety. Results: All 106 eligible eyes were randomized to receive aflibercept, 8 mg (n = 53), or aflibercept, 2 mg (n = 53). Overall, 66 participants (62.3%) were female. The proportion of eyes without fluid in the central subfield with 8-mg vs 2-mg aflibercept was 50.9% (n = 27) vs 34.0% (n = 18) (difference, 17.0 [95% CI, -1.6 to 35.5] percentage points; P = .08) at week 16 and 39.6% (n = 21) vs 28.3% (n = 15) (difference, 11.3 [95% CI, -6.6 to 29.2] percentage points; nominal P = .22) at week 44. At week 44, mean (SE) change in central retinal thickness was -159.4 (16.4) vs -137.2 (22.8) µm with 8 mg vs 2 mg of aflibercept, respectively (least squares mean difference, -9.5 [95% CI, -51.4 to 32.4]; nominal P = .65) and mean (SE) change in best-corrected visual acuity score was +7.9 (1.5) vs +5.1 (1.5) letters (least squares mean difference, +2.8 [95% CI, -1.4 to +7.0]; nominal P = .20). No differences in safety profiles between the groups were observed. Conclusions and Relevance: Although aflibercept, 8 mg, did not achieve the primary efficacy end point at week 16 at the 2-sided significance level of 5%, the observed trends in anatomic and visual improvements over 44 weeks with aflibercept, 8 mg, indicate potential additional therapeutic benefit over aflibercept, 2 mg. No new safety signals were observed over 44 weeks. These findings support further evaluation of aflibercept, 8 mg, in pivotal trials of exudative retinal diseases including nAMD and diabetic macular edema. Trial Registration: ClinicalTrials.gov Identifier: NCT04126317.


Assuntos
Retinopatia Diabética , Edema Macular , Humanos , Feminino , Masculino , Inibidores da Angiogênese/uso terapêutico , Retinopatia Diabética/tratamento farmacológico , Edema Macular/tratamento farmacológico , Receptores de Fatores de Crescimento do Endotélio Vascular/uso terapêutico , Proteínas Recombinantes de Fusão/efeitos adversos
12.
J Vitreoretin Dis ; 6(4): 295-301, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-37007930

RESUMO

Purpose: This work aimed to assess the incidence of proliferative diabetic retinopathy (PDR) events and improvement to mild non-PDR (NPDR) or better after intravitreal aflibercept injection (IAI) or laser treatment (control) in diabetic macular edema (DME). Methods: PDR events in the VISTA (NCT01363440) and VIVID (NCT01331681) phase 3 clinical trials were evaluated in a combined IAI-treated group (IAI 2 mg every 4 weeks or 2 mg every 8 weeks after 5 initial monthly doses; n = 475) and a macular laser control group (n = 235) through week 100 in eyes without PDR at baseline (Diabetic Retinopathy Severity Scale [DRSS] score ≤ 53). Improvement in the DRSS score to 35 or better was evaluated in those with a baseline DRSS score of 43 or greater. Results: A lower proportion of eyes in the IAI group than in the laser group developed a PDR event through week 100 (4.4% vs 11.1%; adjusted difference, -6.7%; 97.5% CI, -11.7 to -1.6; nominal P = .0008). All PDR events occurred in eyes with a baseline DRSS score of 43, 47, or 53 and not in those with a score of 35 or less. A greater proportion of eyes in the IAI group than in the control group achieved a DRSS score of 35 or less (20.0% vs 3.8%; nominal P < .0001). Conclusions: Fewer eyes with NPDR and DME treated with IAI than eyes treated with a laser had a PDR event. More eyes treated with IAI improved to mild NPDR or better (DRSS score ≤ 35) through 100 weeks.

13.
J Gerontol Soc Work ; 54(1): 6-28, 2011 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-21170777

RESUMO

Anxiety disorders and related symptoms commonly occur in older people with cognitive impairment or dementia, significantly worsening functioning and reducing quality of life. This review of the literature outlines the extent of the problem, and focuses on current best practices in psychosocial interventions anxiety in persons with dementia. Discussion follows on promising nonpharmacological interventions that are recommended for further consideration and future research.


Assuntos
Transtornos de Ansiedade , Ansiedade/prevenção & controle , Terapia Comportamental , Transtornos Cognitivos , Demência , Pessoas com Deficiência Mental/reabilitação , Terapia Socioambiental , Atividades Cotidianas/psicologia , Idoso , Ansiedade/psicologia , Transtornos de Ansiedade/psicologia , Transtornos de Ansiedade/terapia , Ensaios Clínicos como Assunto , Transtornos Cognitivos/psicologia , Transtornos Cognitivos/terapia , Demência/psicologia , Demência/terapia , Humanos , Competência Mental/psicologia , Pessoas com Deficiência Mental/psicologia , Guias de Prática Clínica como Assunto , Qualidade de Vida
14.
JAMA Ophthalmol ; 139(9): 946-955, 2021 Sep 01.
Artigo em Inglês | MEDLINE | ID: mdl-34351414

RESUMO

IMPORTANCE: Proactive treatment of nonproliferative diabetic retinopathy (NPDR) reduces the risk of progression to vision-threatening complications. OBJECTIVE: To evaluate vascular endothelial growth factor blockade therapy with intravitreal aflibercept injections in eyes with severe NPDR without diabetic macular edema (DME). DESIGN, SETTING, AND PARTICIPANTS: The Study of the Efficacy and Safety of Intravitreal Aflibercept for the Improvement of Moderately Severe to Severe Nonproliferative Diabetic Retinopathy (PANORAMA) was a double-masked 100-week randomized clinical trial conducted in multiple centers worldwide. The study included 402 adults with Diabetic Retinopathy Severity Scale (DRSS) level 47 or 53 with no DME and best-corrected visual acuity of 20/40 or better. INTERVENTIONS: Intravitreal injections of aflibercept, 2 mg, every 16 weeks after 3 initial monthly doses and one 8-week interval (aflibercept 2q16 group); intravitreal injections of aflibercept, 2 mg, every 8 weeks after 5 initial monthly doses, with pro re nata (PRN) dosing beginning at week 56 (aflibercept 2q8/PRN group); or sham injections (control group). MAIN OUTCOMES AND MEASURES: Proportions of eyes with a 2-step or greater improvement in DRSS level, vision-threatening complications, and center-involved DME from baseline to weeks 24, 52, and 100. RESULTS: Among 402 participants (1 eye per participant), the mean (SD) age was 55.7 (10.5) years; 225 (56.0%) were male, and 310 (77.1%) were White. A total of 135 were randomized to the aflibercept 2q16 group, 134 to the aflibercept 2q8/PRN group, and 133 to the control group. At 24 weeks, treatment with aflibercept resulted in a 2-step or greater improvement in DRSS level in 157 of 269 eyes (58.4%) in the combined aflibercept groups vs 8 of 133 eyes (6.0%) in the control group (adjusted difference, 52.3%; 95% CI, 45.2%-59.5%; P < .001). At 52 weeks, 88 of 135 eyes (65.2%) in the aflibercept 2q16 group (adjusted difference, 50.1%; 95% CI, 40.1%-60.1%) and 107 of 134 eyes (79.9%) in the aflibercept 2q8/PRN group (adjusted difference, 64.8%; 95% CI, 55.8%-73.9%) compared with 20 of 133 eyes (15.0%) in the control group (P < .001 for both comparisons) showed a 2-step or greater improvement in DRSS level. Fewer eyes treated with aflibercept vs sham injections developed vision-threatening complications and/or center-involved DME through week 100 (22 of 135 eyes [16.3%] in the 2q16 group [adjusted difference, -34.2%; 95% CI, -44.6 to -23.8] and 25 of 134 eyes [18.7%] in the 2q8/PRN group [adjusted difference, -31.7%; 95% CI, -42.5 to -20.9] compared with 67 of 133 eyes [50.4%] in the control group; P < .001 for both comparisons). No new safety signals were identified. CONCLUSIONS AND RELEVANCE: In this study, significantly more eyes with moderately severe to severe NPDR that were treated with aflibercept showed a 2-step or greater improvement in DRSS level at 24, 52, and 100 weeks, and significantly fewer eyes treated with aflibercept vs sham developed vision-threatening complications and center-involved DME. Outcomes on the DRSS between year 1 and 2 emphasize the need for ongoing vascular endothelial growth factor suppression and adherence. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02718326.


Assuntos
Diabetes Mellitus , Retinopatia Diabética , Edema Macular , Adulto , Inibidores da Angiogênese/uso terapêutico , Diabetes Mellitus/tratamento farmacológico , Retinopatia Diabética/complicações , Retinopatia Diabética/diagnóstico , Retinopatia Diabética/tratamento farmacológico , Feminino , Humanos , Injeções Intravítreas , Edema Macular/diagnóstico , Edema Macular/tratamento farmacológico , Edema Macular/etiologia , Masculino , Pessoa de Meia-Idade , Receptores de Fatores de Crescimento do Endotélio Vascular/uso terapêutico , Proteínas Recombinantes de Fusão/uso terapêutico , Resultado do Tratamento , Fator A de Crescimento do Endotélio Vascular , Acuidade Visual
17.
Am J Manag Care ; 12(2): 93-100, 2006 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-16464138

RESUMO

OBJECTIVE: To evaluate the Advanced Illness Coordinated Care Program (AICCP), delivered by allied health personnel to improve care for patients coping with advanced illness and in need of preparation for end-of-life (EOL) care. STUDY DESIGN: Clinical trial involving 275 patients and 143 surrogates in 6 settings who were randomly assigned to the AICCP or usual care (UC). METHODS: The AICCP participants met with a care coordinator for assistance with provider communication, care coordination, and support. The AICCP was evaluated for effects on satisfaction with care, advance planning, consistency of care with patient preferences, and healthcare costs. RESULTS: The AICCP increased patient satisfaction with care and communication (P = .03), and AICCP surrogates reported fewer problems with provider support (P = .03). More AICCP than UC participants completed an advance directive (AD) (69.4% vs 48.4%; P = .006), and the AICCP group completed more ADs per participant (P = .01). Median time to AD documentation was 46 days for AICCP and 238 days for UC (P = .02). There was no difference in survival (AICCP 43% vs UC 42%). Six-month costs were lower with AICCP than with UC (12,123 US dollars vs 16,295 US dollars); however, the difference did not reach statistical significance. CONCLUSIONS: The AICCP improved satisfaction with care and helped patients develop and revise more ADs, sooner, without affecting mortality. This program may be delivered in a range of managed care, fee-for-service, and group-model settings.


Assuntos
Planejamento Antecipado de Cuidados/organização & administração , Custos de Cuidados de Saúde , Satisfação do Paciente , Consentimento do Representante Legal , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estados Unidos
18.
Clin Geriatr Med ; 21(2): 365-82, 2005 May.
Artigo em Inglês | MEDLINE | ID: mdl-15804556

RESUMO

Elder financial abuse is one of the most difficult types of elder abuse to diagnose given its lack of overt physical symptomatology. Unusual bank account activity, sudden changes of beneficiaries or agents in estate planning or advance directive documents, and worsening of medical conditions due to lack of follow-up or unfilled prescriptions are indicators of potential financial abuse. Federal laws are aimed at education and prevention (not treatment), whereas state laws are more comprehensive. Criminal and civil legal remedies exist to bring the abuser to justice, but the emotional trauma of financial exploitation lasts a long time.


Assuntos
Abuso de Idosos/economia , Financiamento Pessoal/economia , Idoso , Idoso de 80 Anos ou mais , Direitos Civis , Atenção à Saúde , Abuso de Idosos/diagnóstico , Abuso de Idosos/prevenção & controle , Feminino , Financiamento Pessoal/legislação & jurisprudência , Ocupações em Saúde/educação , Ocupações em Saúde/normas , Humanos , Masculino , Notificação de Abuso
19.
20.
Nutr Rev ; 70(5): 301-10, 2012 May.
Artigo em Inglês | MEDLINE | ID: mdl-22537216

RESUMO

Non-communicable diseases (NCDs), which include cardiovascular disease, cancer, and diabetes, all of which are associated with the common risk factors of poor diet and insufficient physical activity, caused 63% of all deaths globally in 2008. The increasing discussion of global NCDs, including at the 2011 United Nations General Assembly High-level Meeting on the Prevention and Control of Non-communicable Diseases, and a request for multi-stakeholder engagement, prompted the International Food Information Council Foundation to sponsor the Global Diet and Physical Activity Communications Summit: "Insights to Motivate Healthful, Active Lifestyles" on September 19, 2011, in New York City. The Summit brought together a diverse group of stakeholders, representing 34 nations from governments; communication, health, nutrition, and fitness professions; civil society; nonprofits; academia; and the private sector. The Summit provided expert insights and best practices for the use of science-based, behavior-focused communications to motivate individuals to achieve healthful, active lifestyles, with the goal of reducing the prevalence of NCDs. Presented here are some of the highlights and key findings from the Summit.


Assuntos
Doença Crônica/prevenção & controle , Comunicação , Dieta/normas , Exercício Físico/fisiologia , Saúde Global , Doença Crônica/epidemiologia , Congressos como Assunto , Humanos , Estilo de Vida , Prevalência
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