Blood pressure normalization by fixed perindopril/indapamide combination in hypertensive patients with or without associate metabolic syndrome: results of the OPTIMAX 2 study

The aim of the observational pharmaco-epidemiological study Optimax II was to seek whether the pre-existence of a metabolic syndrome (MS) defined by the NCEP-ATP III criteria impacts blood pressure (BP) control in hypertensive patients receiving a fixed perindopril/indapamide combination therapy. The primary objective of the study was to compare in patients with and without MS the rate of BP control defined as a systolic BP ≤140 mmHg and a diastolic BP ≤90 mmHg. Patients were prospectively included and the follow-up lasted 6 months. The study population consisted of 24,069 hypertensive patients (56% men; mean age 62 ± 11 years; 18% diabetics; mean BP at inclusion 162 ± 13/93 ± 9 mmHg). MS was found in 30.4% of the patients (n = 7322): 35.2% women and 20.1% men. Three therapeutic subgroups were constituted: Group A, previously untreated, received the combination therapy as initial treatment; Group B, previously treated but with unsatisfactory results and/or treatment intolerance, had its previous treatment switched to perindopril/indapamide; and Group C, previously treated, with good treatment tolerance but uncontrolled BP, received the study treatment in adjunction to the previous one. The normalization rate was 70.3% in group A, 68.4% in Group B, and 64.1% in Group C (p < 0.0001). The pre-existence of MS did not show any significant influence on these rates since BP lowering was −22.7 ± 13.7 (SBP) and −12.0 ± 10.0 mmHg (DBP) in patients without MS and −22.6 ± 13.3 (SBP) and −12.1 ± 9.7 (DBP) in those with MS. The results of this study show a significant effect of perindopril/indapamide treatment on systolic BP lowering, whatever the treatment status: initiation, switch, or adjunctive therapy, and independently from the presence or not of MS. This effect may be related to the specific vascular effect of the perindopril/indapamide combination, which has recently demonstrated in the ADVANCE trial its ability to reduce mortality, and cardiovascular and renal complications in diabetic patients

BP lowering (difference from baseline) in the population as a whole and in the three subgroups of patients

Significant differences were found both on the comparison between groups (p < 0.0001 for all) and on BP difference from baseline (p < 0.0001).<p><b>Copyright information:</b></p><p>Taken from "Blood pressure normalization by fixed perindopril/indapamide combination in hypertensive patients with or without associate metabolic syndrome: results of the OPTIMAX 2 study"</p><p></p><p>Vascular Health and Risk Management 2008;4(2):443-451.</p><p>Published online Jan 2008</p><p>PMCID:PMC2496983.</p><p>© 2008 Dove Medical Press Limited. All rights reserved</p

Rates of BP control among the study patients distributed by treatment group and according to the presence or not of MS

No significant difference was observed between the group of patients with MS vs the group of patients without MS (p = NS), but significant differences were found between subgroups A, B, and C among the two patient groups “with MS” and “without MS”. <p><b>Copyright information:</b></p><p>Taken from "Blood pressure normalization by fixed perindopril/indapamide combination in hypertensive patients with or without associate metabolic syndrome: results of the OPTIMAX 2 study"</p><p></p><p>Vascular Health and Risk Management 2008;4(2):443-451.</p><p>Published online Jan 2008</p><p>PMCID:PMC2496983.</p><p>© 2008 Dove Medical Press Limited. All rights reserved</p

Incidence of hypertension-related cofactors of cardiovascular risk in the study population distributed by therapeutic group

For all parameters, significant differences (p < 0.0001) were found between groups except for the familial history of hypertension (ns between Group A and Group B), and tobacco consumption (ns between Group B and Group C).<p><b>Copyright information:</b></p><p>Taken from "Blood pressure normalization by fixed perindopril/indapamide combination in hypertensive patients with or without associate metabolic syndrome: results of the OPTIMAX 2 study"</p><p></p><p>Vascular Health and Risk Management 2008;4(2):443-451.</p><p>Published online Jan 2008</p><p>PMCID:PMC2496983.</p><p>© 2008 Dove Medical Press Limited. All rights reserved</p

A Possible Hypophosphatemia-induced, Life-Threatening Encephalopathy in Diabetic Ketoacidosis: A Case Report

International audienc

Management of diabetic macular edema with visual impairment in real-life practice in France: findings from the cross-sectional BOREAL DME study

Purpose: Diabetic macular edema (DME) is the leading cause of visual impairment (VI) in patients with diabetes. With the introduction of anti-vascular endothelial growth factor (anti-VEGF) agents, management of DME has evolved. The aim of this study was to identify the routine practice for the management of patients with VI due to DME (best-corrected visual acuity [BCVA] ≤ 20/40) in France in 2014. Methods: The cross-sectional, observational BOREAL DME study was conducted in a real-life practice in France on request of health authority. The study included patients with Type 1 or 2 diabetes aged ≥ 18 years who had a reduction in BCVA due to DME ( ≤ 20/40) irrespective of treatment prescribed at inclusion (including monitoring alone). The following medical data were collected from patients’ medical files: general patient characteristics, disease characteristics (including diabetes and DME), previous treatment for VI due to DME, and treatment prescribed at inclusion. Results: Of the 1023 screened patients, 918 were included in the study (Figure 1). The mean age of the patients was 67.0 years with an average 18.9 years of diabetes; 53.1% were male and 67.3% had bilateral DME (Table 1). For this analysis we included 1321 eyes with VI due to DME (BCVA ≤ 20/40; Figure 1). The majority of eyes (64.6%) had received prior treatment for reduction in BCVA due to DME. In the analyzed eyes, anti-VEGF (49.6%) was the most frequently prescribed treatment at inclusion followed by monitoring alone (41.1%). 65.9% of eyes with monitoring alone had received prior treatment. Corticosteroids were prescribed for 6.5% of eyes, while only 2.2% of eyes received laser. The mean BCVA and central retinal thickness were 53.5 letters and 415 μ m, respectively. Overall, 57.8% of eyes presented non-proliferative DR. In the treatment naïve eyes (n=459), 50.5% received ranibizumab, 40.5% had monitoring alone, and 3.9% each received laser and corticosteroids, respectively. Conclusions: The BOREAL DME study findings suggest that, in real-life practice in France, anti-VEGFs, primarily ranibizumab 0.5 mg, are the primary treatment for VI due to DME, followed by monitoring alone in 2014. Macular laser is currently rarely used in the French population

Management of diabetic macular edema with visual impairment in real-life practice in France: findings from the cross-sectional BOREAL DME study

Purpose: Diabetic macular edema (DME) is the leading cause of visual impairment (VI) in patients with diabetes. With the introduction of anti-vascular endothelial growth factor (anti-VEGF) agents, management of DME has evolved. The aim of this study was to identify the routine practice for the management of patients with VI due to DME (best-corrected visual acuity [BCVA] ≤ 20/40) in France in 2014. Methods: The cross-sectional, observational BOREAL DME study was conducted in a real-life practice in France on request of health authority. The study included patients with Type 1 or 2 diabetes aged ≥ 18 years who had a reduction in BCVA due to DME ( ≤ 20/40) irrespective of treatment prescribed at inclusion (including monitoring alone). The following medical data were collected from patients’ medical files: general patient characteristics, disease characteristics (including diabetes and DME), previous treatment for VI due to DME, and treatment prescribed at inclusion. Results: Of the 1023 screened patients, 918 were included in the study (Figure 1). The mean age of the patients was 67.0 years with an average 18.9 years of diabetes; 53.1% were male and 67.3% had bilateral DME (Table 1). For this analysis we included 1321 eyes with VI due to DME (BCVA ≤ 20/40; Figure 1). The majority of eyes (64.6%) had received prior treatment for reduction in BCVA due to DME. In the analyzed eyes, anti-VEGF (49.6%) was the most frequently prescribed treatment at inclusion followed by monitoring alone (41.1%). 65.9% of eyes with monitoring alone had received prior treatment. Corticosteroids were prescribed for 6.5% of eyes, while only 2.2% of eyes received laser. The mean BCVA and central retinal thickness were 53.5 letters and 415 μ m, respectively. Overall, 57.8% of eyes presented non-proliferative DR. In the treatment naïve eyes (n=459), 50.5% received ranibizumab, 40.5% had monitoring alone, and 3.9% each received laser and corticosteroids, respectively. Conclusions: The BOREAL DME study findings suggest that, in real-life practice in France, anti-VEGFs, primarily ranibizumab 0.5 mg, are the primary treatment for VI due to DME, followed by monitoring alone in 2014. Macular laser is currently rarely used in the French population

Real-world outcomes after 36 months treatment with ranibizumab 0.5 mg in patients with visual impairment due to diabetic macular edema (BOREAL-DME)

International audienceTo assess the efficacy, safety and follow-up of 36 months treatment with ranibizumab in patients with diabetic macular edema (DME) in real life setting. Methods This is a prospective phase 4 observational study. Between December 2013 and April 2015, 84 ophthalmologists enrolled a total of 290 adult patients initiating ranibizumab for visual impairment due to diabetic macular edema (DME) and treated them according to their routine practice. The primary outcome (mean change in best-corrected visual acuity [BCVA] after 12 months) was previously reported. Here we present outcomes after 36 months of follow-up for BCVA, change in central subfield thickness (CSFT) and report how participating ophthalmologists treated DME over a 3 year period (number of visits and injections, and evolution of treatment strategy). Results Of the 290 patients enrolled, 187 (64.5%) completed the 36 months of the study (entire cohort). In the entire cohort, 97 patients were treated exclusively with ranibizumab throughout the study and 90 patients switched to other intravitreal treatments. Mean BCVA was 64.2 (20.1) letters, representing a gain of +4.1 (19.9) letters from baseline to Month 36 (M36). CSFT improved over the study, and by M36 had decreased by 127 (138) µm compared to baseline. Over the 36 months of follow-up, patients in the entire cohort paid their ophthalmologists a mean of 30.9 (12.2) visits and had a mean of 7.6 (5.2) any injections Results for quality of life questionnaires NEI-VFQ25 and HUI-3 remained stable throughout the study. Multivariate analysis on the 145 patients with evaluable BCVA data at M36 found that male gender and milder baseline DME characteristics (BCVA ≥59 and CSFT <500 µm) were predictive factors for achieving a BCVA of ≥70 letters at M36. This study did not find any new safety signals, compared to the known profile of ranibizumab. Conclusions Gains in BCVA in this real life study were lower than those observed in randomized clinical trials with ranibizumab, mainly due to under treatment. Safety analysis of ranibizumab did not yield any new safety concerns