RESUMO
PURPOSE: To develop a severity scale for diabetic macular edema (DME) and to assess relationships between severity and duration of DME and visual acuity (VA). METHODS: From the Early Treatment Diabetic Retinopathy Study (ETDRS), mean baseline VA scores were tabulated for 7422 eyes cross-classified by (1) location of retinal thickening (RT) and its area within 1 disc diameter of the macular center, and (2) degree of RT at the center. Adjacent (row, column, and off-diagonal) cells with the greatest similarity in baseline VA (mean and SD) based on a Gaussian (normal) likelihood were merged. An initial eight-step scale was chosen using the Schwarz criterion (Bayesian information criterion; BIC) and was revised based on clinical judgment to nine steps. Relationships between baseline VA and other photographic and fluorescein angiographic characteristics were examined singly and in combination with the scale. RESULTS: Modeling baseline VA as a function of the nine-step scale yielded an R(2) of 38.0%, compared with 38.4% using the full cross-classification of these variables. Addition of each of the other baseline characteristics changed the adjusted R(2) for the combination very little. Between scale levels 1A and 5B mean (SD) VA decreased from 86.8 (5.8) letters to 59.8 (13.6) letters. In a model of change in VA as a function of time spent at each DME severity level, VA loss increased progressively from 1 letter per year at level 2 to 17 letters per year at level 5B. CONCLUSIONS: The scale facilitates documentation of the relationship of severity and duration of DME with VA.
Assuntos
Retinopatia Diabética/complicações , Macula Lutea/patologia , Edema Macular/diagnóstico , Retinopatia Diabética/diagnóstico , Retinopatia Diabética/fisiopatologia , Progressão da Doença , Angiofluoresceinografia , Seguimentos , Fundo de Olho , Humanos , Macula Lutea/fisiopatologia , Edema Macular/etiologia , Edema Macular/fisiopatologia , Prognóstico , Índice de Gravidade de Doença , Testes Visuais/métodos , Acuidade Visual/fisiologiaRESUMO
OBJECTIVES: To present the results for subgroups defined by center point (CP) measurement and to assess the repeatability of the Fast Retinal Thickness Map analysis results from the Stratus OCT3 machine. METHODS: Two hundred eighty-one replicate OCT3 scans from 134 operators' certification submissions to a reading center were analyzed, including scans from eyes that were reported to be normal and eyes with exudative age-related macular degeneration and with macular edema due to diabetic retinopathy or retinal vascular occlusion. RESULTS: The mean (SD) of the CP was 284 (150) microm and the center subfield (CC) was 301 (130) microm. The CP coefficient of repeatability (CR) was 49 microm and the CC CR was 27 microm. The CR increased by increasing retinal thickness for the CP and the CC within arbitrarily defined subgroups. For the 87 eyes with a session 1 CP of 175 microm or less, the CP CR was 17 microm and the CC CR was 10 microm. CONCLUSIONS: Among experienced operators, given the same operator, machine, and eye at the same sitting, OCT3 retinal thickness maps appear to have a CR that is likely to be less than the clinically important difference.
Assuntos
Certificação/normas , Degeneração Macular/diagnóstico , Edema Macular/diagnóstico , Retina/patologia , Tomografia de Coerência Óptica/normas , Ensaios Clínicos como Assunto/normas , Humanos , Reprodutibilidade dos TestesRESUMO
BACKGROUND: Inhibition of cholesteryl ester transfer protein (CETP) has been shown to have a substantial effect on plasma lipoprotein levels. We investigated whether torcetrapib, a potent CETP inhibitor, might reduce major cardiovascular events. The trial was terminated prematurely because of an increased risk of death and cardiac events in patients receiving torcetrapib. METHODS: We conducted a randomized, double-blind study involving 15,067 patients at high cardiovascular risk. The patients received either torcetrapib plus atorvastatin or atorvastatin alone. The primary outcome was the time to the first major cardiovascular event, which was defined as death from coronary heart disease, nonfatal myocardial infarction, stroke, or hospitalization for unstable angina. RESULTS: At 12 months in patients who received torcetrapib, there was an increase of 72.1% in high-density lipoprotein cholesterol and a decrease of 24.9% in low-density lipoprotein cholesterol, as compared with baseline (P<0.001 for both comparisons), in addition to an increase of 5.4 mm Hg in systolic blood pressure, a decrease in serum potassium, and increases in serum sodium, bicarbonate, and aldosterone (P<0.001 for all comparisons). There was also an increased risk of cardiovascular events (hazard ratio, 1.25; 95% confidence interval [CI], 1.09 to 1.44; P=0.001) and death from any cause (hazard ratio, 1.58; 95% CI, 1.14 to 2.19; P=0.006). Post hoc analyses showed an increased risk of death in patients treated with torcetrapib whose reduction in potassium or increase in bicarbonate was greater than the median change. CONCLUSIONS: Torcetrapib therapy resulted in an increased risk of mortality and morbidity of unknown mechanism. Although there was evidence of an off-target effect of torcetrapib, we cannot rule out adverse effects related to CETP inhibition. (ClinicalTrials.gov number, NCT00134264 [ClinicalTrials.gov].).
Assuntos
Anticolesterolemiantes/efeitos adversos , Doenças Cardiovasculares/tratamento farmacológico , Doenças Cardiovasculares/mortalidade , Proteínas de Transferência de Ésteres de Colesterol/antagonistas & inibidores , HDL-Colesterol/sangue , Doença das Coronárias/prevenção & controle , Quinolinas/efeitos adversos , Idoso , Anticolesterolemiantes/uso terapêutico , Atorvastatina , Doenças Cardiovasculares/induzido quimicamente , LDL-Colesterol/sangue , Doença das Coronárias/mortalidade , Método Duplo-Cego , Quimioterapia Combinada , Feminino , Ácidos Heptanoicos/efeitos adversos , Ácidos Heptanoicos/uso terapêutico , Humanos , Masculino , Pessoa de Meia-Idade , Mortalidade , Pirróis/efeitos adversos , Pirróis/uso terapêutico , Quinolinas/uso terapêuticoRESUMO
BACKGROUND: The prognosis associated with metabolic syndrome and high-sensitivity C-reactive protein (hs-CRP) in patients with stable coronary artery disease has not been well established. METHODS: The WIZARD study was to determine the effects of 12 weeks of antibiotic therapy on coronary heart disease events in patients with stable coronary artery disease and known Chlamydia pneumoniae exposure. Baseline metabolic risk factors were available for 3319 patients enrolled from 1997 to 1998. The primary outcome was the first occurrence of death, recurrent myocardial infarction, coronary revascularization procedure, or hospitalization for angina. RESULTS: Of the 3319 subjects, 825 patients experienced the primary outcome during the mean follow-up of 37 months. For the composite outcome, there was an increased hazard ratio (HR) for metabolic syndrome (HR 1.40, 95% CI 1.22-1.61) (unadjusted) and for hs-CRP (HR 1.60, 95% CI 1.38-1.85) (unadjusted). Both the metabolic syndrome and hs-CRP indicated, in a multivariable model including age and sex, an increased HR for the primary outcome (metabolic syndrome: HR 1.33, 95% CI 1.15-1.53; hs-CRP: HR 1.52, 95% CI 1.30-1.76). CONCLUSIONS: Although related, the presence of the metabolic syndrome and increased levels of hs-CRP were associated with increased risk of adverse cardiovascular outcomes.
Assuntos
Proteína C-Reativa/análise , Doença das Coronárias/sangue , Doença das Coronárias/epidemiologia , Síndrome Metabólica/sangue , Síndrome Metabólica/epidemiologia , Idoso , HDL-Colesterol/sangue , Diabetes Mellitus/epidemiologia , Feminino , Humanos , Hipertensão/sangue , Hipertensão/epidemiologia , Masculino , Pessoa de Meia-Idade , Análise Multivariada , Prevalência , Prognóstico , Medição de Risco , Fatores de Risco , Triglicerídeos/sangueRESUMO
OBJECTIVES: To examine the histopathologic features of iridectomy specimens from patients undergoing glaucoma surgery and to compare histologic abnormalities in a group of patients with a history of latanoprost therapy with those in a group of patients who had no history of prostaglandin therapy (controls). METHODS: Iridectomy specimens and patient history forms were submitted to the central Latanoprost Pathology Center. These were independently examined by 3 ophthalmic pathologists in a masked fashion. Specimens were evaluated for malignant, premalignant, and other changes including differences in levels of pigmentation, degrees of cellularity, inflammation, vascular abnormalities, and changes in the iris pigment epithelium. RESULTS: Specimens were received from 449 patients with a history of latanoprost treatment and 142 patients who had no history of treatment with latanoprost or other prostaglandin analogues. No evidence of malignant or premalignant changes was found. In latanoprost-treated irides, the prevalence of iris freckles was higher (P = .001) than in control irides, as was the combined number of stromal fibroblasts and melanocytes (P<.001). In a subgroup of specimens received through June 2002, there was no significant difference in mean melanocyte counts (P=.35) obtained by immunohistochemical staining techniques between the latanoprost-treated and control groups. CONCLUSIONS: These findings support previous studies indicating that latanoprost-induced eye color changes are due to an increased amount of melanin within the iris stromal melanocytes. The increased numbers of freckles may be a focal manifestation of this effect.
Assuntos
Anti-Hipertensivos/efeitos adversos , Glaucoma/tratamento farmacológico , Iridectomia , Iris/efeitos dos fármacos , Iris/patologia , Melanose/induzido quimicamente , Prostaglandinas F Sintéticas/efeitos adversos , Anti-Hipertensivos/uso terapêutico , Cor de Olho , Feminino , Glaucoma/cirurgia , Humanos , Pressão Intraocular/efeitos dos fármacos , Iris/cirurgia , Latanoprosta , Masculino , Melaninas/metabolismo , Melanócitos/efeitos dos fármacos , Melanócitos/metabolismo , Melanose/patologia , Prostaglandinas F Sintéticas/uso terapêuticoRESUMO
CONTEXT: Several lines of evidence have implied an association between Chlamydia pneumoniae infection and atherogenesis. OBJECTIVE: To determine the effect of 12 weeks of antibiotic therapy on coronary heart disease events in patients with stable coronary artery disease and known C pneumoniae exposure. DESIGN, SETTING, AND PARTICIPANTS: Randomized, placebo-controlled trial of 7747 adults with previous myocardial infarction that had occurred at least 6 weeks previously (median, 2.6 years) and a C pneumoniae IgG titer of 1:16 or more. Patients were recruited from 271 clinical practices in North America, Europe, Argentina, and India, from October 10, 1997, to July 22, 2001. INTERVENTION: The patients received either azithromycin (600 mg/d for 3 days during week 1, then 600 mg/wk during weeks 2-12; n = 3879) or placebo (n = 3868). MAIN OUTCOME MEASURES: The primary event was the first occurrence of death from any cause, nonfatal reinfarction, coronary revascularization, or hospitalization for angina. Patients were followed up until 1038 events accrued. RESULTS: After a median of 14 months of follow-up, there was no significant risk reduction in the likelihood of a primary event with azithromycin vs placebo (7% [95% confidence interval, -5% to 17%], P =.23). Analysis of hazard ratios suggested early benefits of azithromycin on the primary event and on death or reinfarction, but these decreased over time. There were no significant risk reductions for any of the components of the primary end point including death (8%), recurrent myocardial infarction (7%), revascularization procedures (5%), or hospitalizations for angina (-1%). Adverse events related to study drug were reported by 13.2% of those randomized to receive azithromycin, predominantly a result of diarrhea, compared with 4.6% randomized to receive placebo, and resulted in discontinuation of drug in 1.6% of those taking azithromycin and 0.4% taking placebo. CONCLUSION: Among stable patients with previous myocardial infarction and with evidence of C pneumoniae exposure, a 3-month course of azithromycin did not significantly reduce the clinical sequelae of coronary heart disease.