Treatment of Intractable Diabetic Macular Edema with Pegaptanib Versus Bevacizumab, Both in Combination with Dexamethasone

BACKGROUND: Diabetic macular edema is a significant cause of vision loss, and some patients do not respond optimally to existing treatments. This study compared the response of intractable diabetic macular edema to intravitreal injection of two anti-VEGF drugs, bevacizumab and pegaptanib, both in combination with dexamethasone. METHODS: A retrospective chart review was conducted to examine patients from an ophthalmology practice in one year with diabetic macular edema (DME), recurrent or persistent, after focal laser or intravitreal bevacizumab. Patients received bevacizumab/dexamethasone or pegaptanib/dexamethasone. Outcome measures were improvement in best corrected visual activity (converted to LogMAR) and central macular thickness (CRT). Data on adverse effects also were collected. RESULTS: The bevacizumab/dexamethasone group included 25 eyes which had pre-treatment LogMAR = 0.69 ± 0.49 (mean ± SD) and CRT = 419 ± 131. Post-treatment LogMAR was 0.70 ± 0.48 and CRT = 377 ± 107. The pegaptanib/dexamethasone group included 14 eyes; pretreatment LogMAR = 0.80 ± 0.55 and CRT = 520 ± 108. Post-treatment LogMAR was 0.77 ± 0.49 and CRT = 46 4 ± 106. Neither treatment had a significant effect on visual acuity. Both groups experienced a significant decrease in CRT over time (p = 0.006). The pegaptanib/ dexamethasone group had higher CRT at all times (p = 0.020), but the trend in CRT decrease was not different between the two groups. Intraocular pressure increased in both groups (p = 0.038). No other adverse effects were reported. CONCLUSIONS: Neither bevacizumab/dexamethasone or pegaptanib/dexamethasone significantly improved visual acuity in intractable DME, but both decreased central macular thickness. Differences in outcome measures between the two treatment groups were not significant. The only adverse effect seen was a small increase in intraocular pressure

Glioblastoma and Increased Survival with Longer Chemotherapy Duration

Introduction The five-year survival rate for patients with glioblastoma (GBM) is low at approximately 4.7%. Radiotherapy plus concomitant and adjuvant temozolomide (TMZ) remains the standard of care. The optimal duration of therapy with TMZ is unknown. This study sought to evaluate the survival benefit of two years of treatment. Methods This was a retrospective chart review of all patients diagnosed with GBM and treated with TMZ for up to two years between January 1, 2002 and December 31, 2011. The Kaplan-Meier method with log-rank test was used to estimate the progression-free survival (PFS) and the overall survival (OS). The results were compared to historical controls and data from previous clinical trials of patients treated up to one year. Results Data from 56 patients with confirmed GBM were evaluated. The OS probability was 54% (SE = 0.068) at one year, 28.3% (SE = 0.064) at two years, 17.8% (SE = 0.059) at three years, and 4% (SE = 0.041) at five years. Seven patients (12.5%) were treated with TMZ for two years. Their median time-to-progression was 28 months (95% CI = 5.0 - 28.0), and they had an increased survival probability at three years compared to other patients (log-rank test χ2 (1, N = 56) = 19.2, p < 0.0001). Conclusions There may be an advantage for a longer duration of TMZ therapy among patients with GBM, but the sample size was too small for generalization. A multicenter prospective study is needed to dentify optimal duration of TMZ therapy

SUPREME-HN: a retrospective biomarker study assessing the prognostic value of PD-L1 expression in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.

BACKGROUND:Programmed cell death ligand-1 (PD-L1) expression on tumor cells (TCs) is associated with improved survival in patients with head and neck squamous cell carcinoma (HNSCC) treated with immunotherapy, although its role as a prognostic factor is controversial. This study investigates whether tumoral expression of PD-L1 is a prognostic marker in patients with recurrent and/or metastatic (R/M) HNSCC treated with standard chemotherapy. METHODS:This retrospective, multicenter, noninterventional study assessed PD-L1 expression on archival R/M HNSCC tissue samples using the VENTANA PD-L1 (SP263) Assay. PD-L1 high was defined as PD-L1 staining of ≥ 25% TC, with exploratory scoring at TC ≥ 10% and TC ≥ 50%. The primary objective of this study was to estimate the prognostic value of PD-L1 status in terms of overall survival (OS) in patients with R/M HNSCC. RESULTS:412 patients (median age, 62.0 years; 79.9% male; 88.2% Caucasian) were included from 19 sites in seven countries. 132 patients (32.0%) had TC ≥ 25% PD-L1 expression; 199 patients (48.3%) and 85 patients (20.6%) had TC ≥ 10% and ≥ 50%, respectively. OS did not differ significantly across PD-L1 expression (at TC ≥ 25% cutoff median OS: 8.2 months vs TC < 25%, 10.1 months, P = 0.55) or the ≥ 10% and ≥ 50% cutoffs (at TC ≥ 10%, median OS: 9.6 months vs TC < 10%, 9.4 months, P = 0.32, and at TC ≥ 50%, median OS 7.9 vs TC < 50%, 10.0 months, P = 0.39, respectively). CONCLUSIONS:PD-L1 expression, assessed using the VENTANA PD-L1 (SP263) Assay, was not prognostic of OS in patients with R/M HNSCC treated with standard of care chemotherapies. Trial registration ClinicalTrials.gov, NCT02543476. Registered September 4, 2015

May Measurement Month 2018: a pragmatic global screening campaign to raise awareness of blood pressure by the International Society of Hypertension

Aims Raised blood pressure (BP) is the biggest contributor to mortality and disease burden worldwide and fewer than half of those with hypertension are aware of it. May Measurement Month (MMM) is a global campaign set up in 2017, to raise awareness of high BP and as a pragmatic solution to a lack of formal screening worldwide. The 2018 campaign was expanded, aiming to include more participants and countries. Methods and results Eighty-nine countries participated in MMM 2018. Volunteers (≥18 years) were recruited through opportunistic sampling at a variety of screening sites. Each participant had three BP measurements and completed a questionnaire on demographic, lifestyle, and environmental factors. Hypertension was defined as a systolic BP ≥140 mmHg or diastolic BP ≥90 mmHg, or taking antihypertensive medication. In total, 74.9% of screenees provided three BP readings. Multiple imputation using chained equations was used to impute missing readings. 1 504 963 individuals (mean age 45.3 years; 52.4% female) were screened. After multiple imputation, 502 079 (33.4%) individuals had hypertension, of whom 59.5% were aware of their diagnosis and 55.3% were taking antihypertensive medication. Of those on medication, 60.0% were controlled and of all hypertensives, 33.2% were controlled. We detected 224 285 individuals with untreated hypertension and 111 214 individuals with inadequately treated (systolic BP ≥ 140 mmHg or diastolic BP ≥ 90 mmHg) hypertension. Conclusion May Measurement Month expanded significantly compared with 2017, including more participants in more countries. The campaign identified over 335 000 adults with untreated or inadequately treated hypertension. In the absence of systematic screening programmes, MMM was effective at raising awareness at least among these individuals at risk

A walking intervention to reduce inflammation in patients with diabetes and peripheral arterial/artery disease: A pilot study

Objectives: In this pilot study, we sought to determine whether walking reduces inflammation in patients with diabetes mellitus and peripheral arterial/artery disease. Methods: We obtained blood samples from patients with diabetes mellitus and peripheral arterial/artery disease. Intervention participants were advised to walk for 50 min 3 days per week for 6 months. Participants completed assessments of comorbidities and walking ability. Difference-in-difference analyses were used to assess the relationship between group assignment and each biomarker over time. Results: We randomized 55 participants (control = 25 and intervention = 30). At 6 months and based on p values of <0.20, vascular cellular adhesion molecule, beta-2 microglobulin, total cholesterol, and triglycerides demonstrated a greater decrease among participants randomized to the intervention compared to the control. Conclusions: Walking may reduce inflammation in persons with diabetes mellitus and peripheral arterial/artery disease. Further research is needed to determine the impact of walking on inflammation in persons with vascular disease

Preliminary Benefits of Information Therapy

Information therapy (ie, information prescriptions) is a potential new tool for primary care physicians that could improve patient knowledge, decision making, and communication between physicians and patients. Although patients have access to numerous health-related articles online, the availability of this health information does not ensure improved knowledge or better health decisions by patients. Communication between patients and physicians is often limited and messages are commonly misunderstood. Information therapy offers a potential solution for the primary care environment. Method: Two employers, in different geographical locations of the Midwest, offered the MedEncentive program to employees and their dependents as a part of their health plans. This program also offers primary care physicians the opportunity to prescribe information to patients during office visits. Patients were then eligible to participate in this information therapy (Ix) through a Web-based platform. Both primary care physicians and patients were financially incentivized for participation. Physicians received a monetary stipend for prescribing evidence-based information therapy and patients were refunded part or all of their copayment for reading their condition-specific Ix and answering questions about knowledge, compliance, health status, and satisfaction with the care they received compared to the evidence from the Ix. Results: Patients received information therapy from their primary care physicians and reported a high level of satisfaction with care, improved health status, and compliance with pharmaceutical prescriptions. Discussion: This case study had a number of limitations and as such the results should be interpreted with caution. However, there is a need for an immediate solution as patient satisfaction with their care and compliance with pharmaceutical prescriptions continue to decrease, despite the amounts of widely available health information. These preliminary findings suggest that information therapy through a Web-based platform, augmented by doctor-patient mutual accountability, could be part of the solution for the current ambulatory health care environment

A pooled analysis of outcomes according to cytogenetic abnormalities in patients receiving ixazomib- vs placebo-based therapy for multiple myeloma

Abstract Some cytogenetic abnormalities (CAs) are associated with poorer prognosis in multiple myeloma (MM); proteasome inhibitors appear to benefit patients with high-risk CAs. We evaluated 2247 MM patients from the TOURMALINE-MM1/-MM2/-MM3/-MM4 trials to assess the PFS benefit of ixazomib plus lenalidomide-dexamethasone (Rd) vs placebo-Rd (TOURMALINE-MM1/-MM2) or ixazomib vs placebo (TOURMALINE-MM3/-MM4) in specific high-risk CAs. After a pooled median follow-up of 25.6 months, the hazard ratio (HR) for PFS with ixazomib- vs placebo-based therapy for high-risk patients was 0.74 (95% confidence interval [CI]: 0.59–0.93; median PFS [mPFS] 17.8 vs 13.2 months), and 0.70 (95% CI: 0.62–0.80; mPFS 26.3 vs 17.6 months) for complementary standard-risk patients. The HR for expanded high-risk patients was 0.75 (95% CI: 0.64–0.87; mPFS 18.1 vs 14.1 months), and 0.71 (95% CI: 0.59–0.85; mPFS 36.1 vs 21.4 months) for complementary standard-risk patients. The HR for PFS with ixazomib- vs placebo-based therapy was 0.68 in patients with t(4;14) (95% CI: 0.48–0.96; mPFS 22.4 vs 13.2 months), and 0.77 for patients with amp1q21 (95% CI: 0.63–0.93; mPFS 18.8 vs 14.5 months). A PFS benefit was demonstrated with ixazomib- vs placebo-based therapy regardless of cytogenetic status, with greatest benefit observed in patients with t(4;14) and amp1q21

Food insecurity and pre-hypertension, pre-diabetes in adult women: results from the 2007-2010 National Health and Nutrition Examination Survey

Background Being food insecure is generally defined as the limited or uncertain availability of safe and nutritious foods and is linked to poor nutrition and fully progressed diet-sensitive chronic diseases. However, little is known about the association between food insecurity and pre-clinical disease such as pre-hypertension and pre-diabetes. This study sought to examine the associations between food insecurity and pre-clinical disease among a racially/ethnically diverse population of women. Methods Using data from 2007-2010 NHANES, we examined associations between food security and pre-clinical disease among women 18-65 years. Chi-square tests were used to examine differences in demographic variables. Bivariate and multivariable generalized logistic regressions were used to generate odds ratios (ORs) with 95% confidence intervals (CIs) to assess the magnitude of associations between the presence of pre-clinical disease, sociodemographic characteristics, and food security. Results Food insecure women with very low food security (OR=2.69; 95% CI= 1.76-4.13) and low food security (OR=1.90; 95% CI= 1.20-3.02) had increased odds of having self-reported pre-hypertension. Food insecure women with very low food security (OR = 3.34; 95% CI= 1.40- 7.95), and low food security (OR = 2.81; 95% CI= 1.33- 5.93) had increased odds of pre-diabetes and pre-hypertension compared to food secure women. Conclusions Food insecurity is associated with having pre-hypertension alone or having a comorbidity of pre-hypertension and pre-diabetes among an adult female population