Tolerating subretinal fluid in the treatment of neovascular age-related macular degeneration with intravitreal aflibercept

Objective: To compare the anatomical and functional outcomes of intensive and relaxed intravitreal aflibercept regimen in the management of neovascular age-related macular degeneration. Methods: The medical records of 50 eyes of 50 patients with treatment-naive neovascular age-related macular degeneration, who underwent intravitreal aflibercept therapy in the Retinal Department of University of Health Sciences Okmeydanı Training and Research Hospital (Istanbul, Turkey), were retrospectively reviewed. The demographic features and best-corrected visual acuities at baseline and at 1st-, 2nd-, 3rd-, 4th-, 6th-, 10th- and 12th- months, optical coherence tomography measurements, presence of intraretinal fluid, subretinal fluid and intraocular pressure values were studied. The patients were divided into two groups: intensive (subretinal fluid intolerant) and relaxed (<200 microns subretinal fluid tolerated) intravitreal aflibercept regimens. Results: The change in the mean best-corrected visual acuities from baseline to 12th month was 13.72 ± 33.97 letters in the intensive treatment group and 8.68 ± 27.22 in the relaxed group. There was no statistically significant difference between the groups ( p = 0.566). Similar proportions of both groups achieved ⩾10 letters gain (%48 vs. %40, respectively; p = 0.755) and ⩾10 letters loss (%20 vs. %24, respectively; p = 0.755). The mean central subfield thickness values decreased statistically significantly in both groups ( p < 0.001). There was no statistically significant difference between the groups (442.40 ± 161.32 to 318.0 ± 63.10 vs. 431.64 ± 151.52 to 303.08 ± 140.91, respectively; p = 0.724). The mean total injection numbers were significantly lower in the relaxed group (6.4 ± 1.65 vs. 4.8 ± 1.45, respectively; p = 0.01). Conclusion: Relaxed intravitreal aflibercept regimen has comparable efficiency and safety outcomes at 12 months with intensive intravitreal aflibercept regimen with fewer injections in the management of neovascular age-related macular degeneration.

Orthostatic Hypertension and Intensive Blood Pressure Control; Post-Hoc Analyses of SPRINT

We evaluated the association between orthostatic hypertension and cardiovascular outcomes and the effect of intensive blood pressure (BP) control on cardiovascular outcomes in patients with orthostatic hypertension. Post hoc analyses of the SPRINT (Systolic Blood Pressure Intervention Trial) data were conducted; orthostatic hypertension was defined as increase in systolic BP≥20 mm Hg or increase in diastolic BP≥10 mm Hg with standing. Of 9329 participants, 1986 (21.2%) had orthostatic hypertension at baseline. Within the intensive treatment group, participants with orthostatic hypertension were at higher risk of developing the composite cardiovascular outcome (hazard ratio, 1.44 [95% CI, 1.1–1.87], P =0.007) compared with participants without orthostatic hypertension. Within the standard treatment group, there were no significant differences in cardiovascular outcome between participants with and without orthostatic hypertension. In participants with orthostatic hypertension, there was no statistically significant difference in risk of the composite cardiovascular outcome between the intensive and the standard BP treatment group (hazard ratio, 1.07 [95% CI, 0.78–1.47], P =0.68). In participants without orthostatic hypertension at baseline, the intensive treatment group was associated with a lower risk of the composite cardiovascular outcome (hazard ratio, 0.67 [95% CI, 0.56–0.79], P <0.0001). Orthostatic hypertension was associated with a higher risk of cardiovascular outcomes in the intensive and not in the standard treatment group; intensive treatment of BP did not reduce the risk of cardiovascular outcomes compared with standard treatment in patients with orthostatic hypertension. These post hoc analyses are hypothesis generating and will need to be confirmed in future studies.

Effects of different ablation points of renal denervation on the efficacy of resistant hypertension

Objective To explore the blood pressure response to different ablation points of renal denervation (RDN) in patients with resistant hypertension Methods A total of 42 cases with resistant hypertension treated by RDN in our center from 2013 to 2015 were retrospectively analyzed. The patients were divided into two groups according to the different ablation points of RDN: the standard treatment group (spiral ablation from near to proximal, with less than 8 points per artery) and the intensive treatment group (from near to far by spiral ablation, with at least 8 points per artery), with 21 patients in each group. The ablation parameters, including points, impedance, actual wattage, and actual temperature, were recorded intraoperatively. Renal angiography was performed again after RDN. Ambulatory blood pressure (ABP) images were taken for all patients at the baseline and 6 months after operation. Results The mean 24-h blood pressure of the standard treatment group was lower than that of the baseline (24-h systolic blood pressure decreased by 7.4 ± 10.6 mmHg and 24-h diastolic blood pressure decreased by 4.6 ± 6.1 mmHg), and the mean 24-h blood pressure decreased significantly from baseline to 6 months in the intensive treatment group (24–h systolic blood pressure decreased by 27.4 ± 11.4 mmHg, P < 0.0001; 24–h diastolic blood pressure decreased by 10.9 ± 9.6 mmHg, P = 0.005). There was a positive correlation between the decrease of systolic/diastolic 24-hour mean and the number of ablation points used in the procedure. The mean value of systolic and diastolic blood pressure was positively correlated with ablation points at 24-hour (R2 = 0.777 and 0.633 respectively, P < 0.01). There were no adverse events in either group after the operation and during the follow-up. Conclusions RDN could significantly reduce BP in patients with resistant hypertension. Our study showed that the antihypertensive effect appeared to be positively correlated with the number of ablation points.

The effect of training GPs in motivational interviewing on incident cardiovascular disease and mortality in people with screen-detected diabetes. Results from the ADDITION-Denmark randomised trial

BackgroundThere is no long-term evidence on the effectiveness of training for motivational interviewing in diabetes treatment.AimWithin a trial of intensive treatment of people with screen-detected diabetes, which included training in motivational interviewing for GPs, the study examined the effect of the intervention on incident cardiovascular disease (CVD) and all-cause mortality.Design & settingIn the ADDITION-Denmark trial, 181 general practices were cluster randomised in a 2:1:1 ratio to: (i) to screening plus routine care of individuals with screen-detected diabetes (control group); (ii) screening plus training and support in intensive multifactorial treatment of individuals with screen-detected diabetes (intensive treatment group); or (iii) screening plus training and support in intensive multifactorial treatment and motivational interviewing for individuals with screen-detected diabetes (intensive treatment plus motivational interviewing group). The study took place from 2001–2009.MethodAfter around 8 years follow-up, rates of first fatal and non-fatal CVD events and all-cause mortality were compared between screen-detected individuals in the three treatment groups.ResultsCompared with the routine care group, the risk of CVD was similar in the intensive treatment group (hazard ratio [HR] 1.11, 95% confidence interval [CI] = 0.82 to 1.50) and the intensive treatment plus motivational interviewing group (HR 1.26, 95% CI = 0.96 to 1.64). The incidence of death was similar in all three treatment groups.ConclusionTraining of GPs in intensive multifactorial treatment, with or without motivational interviewing, was not associated with a reduction in mortality or CVD among those with screen-detected diabetes.

BP Reduction, Kidney Function Decline, and Cardiovascular Events in Patients without CKD

Background and objectivesIn the Systolic Blood Pressure Intervention Trial (SPRINT), intensive systolic BP treatment (target <120 mm Hg) was associated with fewer cardiovascular events and higher incidence of kidney function decline compared with standard treatment (target <140 mm Hg). We evaluated the association between mean arterial pressure reduction, kidney function decline, and cardiovascular events in patients without CKD.Design, setting, participants, & measurementsWe categorized patients in the intensive treatment group of the SPRINT according to mean arterial pressure reduction throughout follow-up: <20, 20 to <40, and ≥40 mm Hg. We defined the primary outcome as kidney function decline (≥30% reduction in eGFR to <60 ml/min per 1.73 m2 on two consecutive determinations at 3-month intervals), and we defined the secondary outcome as cardiovascular events. In a propensity score analysis, patients in each mean arterial pressure reduction category from the intensive treatment group were matched with patients from the standard treatment group to calculate the number needed to treat regarding cardiovascular events and the number needed to harm regarding kidney function decline.ResultsIn the intensive treatment group, 1138 (34%) patients attained mean arterial pressure reduction <20 mm Hg, 1857 (56%) attained 20 to <40 mm Hg, and 309 (9%) attained ≥40 mm Hg. Adjusted hazard ratios for kidney function decline were 2.10 (95% confidence interval, 1.22 to 3.59) for mean arterial pressure reduction between 20 and 40 mm Hg and 6.22 (95% confidence interval, 2.75 to 14.08) for mean arterial pressure reduction ≥40 mm Hg. In propensity score analysis, mean arterial pressure reduction <20 mm Hg presented a number needed to treat of 44 and a number needed to harm of 65, reduction between 20 and <40 mm Hg presented a number needed to treat of 42 and a number needed to harm of 35, and reduction ≥40 mm Hg presented a number needed to treat of 95 and a number needed to harm of 16.ConclusionsIn the intensive treatment group of SPRINT, larger declines in mean arterial pressure were associated with higher incidence of kidney function decline. Intensive treatment seemed to be less favorable when a larger reduction in mean arterial pressure was needed to attain the BP target.

Analysis of the Performance of the Software/Hardware Product MyDiaBase+RxChecker for Assessing Treatment Regimens

In 2008, the Action to Control Cardiovascular Risk in Diabetes trial was halted due to an unexpected number of deaths in the intensive treatment group (aiming for hemoglobin A1c levels less than 6%). Hypoglycemic episodes were thought by some to be a contributing cause, underscoring again the challenge of maintaining tight control while avoiding dangerous excursions into hypoglycemic territory. Albisser and colleagues present a set of articles in this issue of Journal of Diabetes Science and Technology that describe a clinical product developed specifically for this timeless clinical conundrum.