Real-world use of oral versus subcutaneous semaglutide in a cohort of type 2 diabetic patients: which option to which patient?

PURPOSE: To evaluate the variables influencing the therapeutic choice toward oral versus subcutaneous semaglutide in a cohort of diabetic subjects. METHODS: We retrospectively collected data of 292 patients followed at the Diabetes Unit of the University Hospital of Siena and the Hospital of Grosseto, who were prescribed oral (n = 115) or subcutaneous (n = 177) semaglutide between October 2021 and October 2022. RESULTS: Oral semaglutide was preferentially prescribed in older subjects with longer disease duration in replacement of other antidiabetic drugs, while subcutaneous semaglutide was preferentially prescribed in add-on to metformin in subjects with higher body weight and BMI. After 6 months, both formulations significantly improved glycemic control and body weight, however injectable semaglutide showed a greater efficacy on A1c levels, weight loss, BMI and waist circumference reduction. No differences were found in terms of adverse events. CONCLUSION: In our experience, injectable semaglutide is preferred in patients with excess weight and shorter disease duration, while the oral formulation was used later and especially after therapeutic failure of previous therapies. Follow-up data indicate similar tolerability and efficacy of both formulations, despite subcutaneous semaglutide demonstrated greater efficacy.

Clinical, echocardiographic and hemodynamic predictors of right heart failure after LVAD placement.

Right ventricular failure (RVF) after left ventricular assist device (LVAD) implant is associated with increasing morbidity and mortality. The aim of this study was to identify the best predictors of RVF post LVAD-implant among biochemical, haemodynamic and echocardiographic parameters. From 2009 to 2019, 38 patients who underwent LVAD implantation at our centre were prospectively enrolled. Preoperative clinical, laboratory, echocardiographic and haemodynamic parameters were reported. Overall, eight patients (21%) developed RVF over time, which revealed to be strongly related to overall mortality. Pulmonary artery pulsatility index (PAPi) resulted to be the most significant right heart catheterization index in discriminating RVF vs no RVF patients [(1.32 ± 0.26 vs. 3.95 ± 3.39 respectively) p = 0.0036]. Regarding transthoracic echocardiography, RVF was associated with reduced free wall right ventricular longitudinal strain (fw-RVLS) (- 7.9 ± 1.29 vs. - 16.14 ± 5.83) (p < 0.009), which was superior to other echocardiographic determinants of RVF. Among laboratory values, N-terminal pro-brain natriuretic peptide (NT-proBNP) was strongly increased in RVF patients [(10,496.13 pg/ml ± 5272.96 pg/ml vs. 2865, 5 pg/ml ± 2595.61 pg/ml) p = 0.006]. PAPi, NT-proBNP and fwRVLS were the best pre-operative predictors of RVF, a post-LVAD implant complication which was confirmed to have a great impact on survival. In particular, fwRVLS has been proven to be the strongest independent predictor.

Disinfection of roof harvested rainwater inoculated with E. coli and Enterococcus and post-treatment bacterial regrowth: Conventional vs solar driven advanced oxidation processes.

Solar driven advanced oxidation processes (AOPs) (an alternative solar photo Fenton like process (SPF), sunlight/H2O2 (SHP) and sunlight/chlorine (SCL)) and respective dark conditions, were compared for the first time to conventional (chlorination and UV-C radiation) disinfection processes, in the inactivation of E. coli and Entero strains inoculated in real roof-harvested rainwater (RHRW), to evaluate their possible safe use for crop irrigation. In this regard, bacterial regrowth was also evaluated 6, 12, 24 and 48 h after disinfection treatment. The SPF, using iminodisuccinic acid (IDS)-Cu complex as catalyst, was optimized (H2O2/IDS-Cu 55/1 best molar ratio) under mild conditions (spontaneous pH) and sunlight. The faster inactivation kinetics were observed for the SCL process (k = 1.473 min-1, t1/2 = 0.47 min for E. coli and k = 1.193 min-1, t1/2 = 0.57 min for Entero), while the most effective processes in controlling bacterial regrowth were SPF and SCL. Although UV-C radiation (0-1.3 × 104 µW s cm-2 dose range) was the second faster disinfection process (k = 1.242 min-1, t1/2 = 0.55 min for E. coli and k = 1.150 min-1, t1/2 = 0.60 min for Entero), it was the less effective process in controlling bacterial regrowth (>10 CFU 100 mL-1 already after 6 h post-treatment incubation). According to the bacterial inactivation and regrowth tests carried out in this work, SPF and SCL are interesting options for RHRW disinfection, in case of effluent use for crop irrigation.

The Influence of Diabetes Mellitus on the Outcome of Superficial Femoral Artery Recanalization is Debatable.

Notwithstanding technological improvements in endovascular devices treatment of steno-obstructive lesions of the superficial femoral artery (SFA) remains a challenge for today's vascular surgeon. Current opinion dictates that the diabetic population may have worse outcome after revascularization of the lower extremities. Herein we examine the effects of endovascular treatment on steno-obstructive lesions of the SFA in diabetic and non-diabetic patients. METHODS: A retrospective analysis was carried out on 110 patients who had undergone endovascular treatment of the SFA from 2010 to 2017 comparing outcomes in diabetic (DM) vs non-diabetic patients (nDM). RESULTS: 56 (50.9%) of the patients were diabetic and 54 were non-diabetic (49.1%). 52.7% (62.7% DM vs 35.2% nDM, p = 0.0003) were patients with critical limb ischemia. SFA occlusion was present in 65.5% (60.7% DM vs 70.4% nDM, p = 0.29) of all patients. All had undergone PTA of the SFA and 40.9% had received adjunctive stenting (44.6% DM vs 37.0% nDM, p = 0.41). A multilevel treatment was executed in 39.1% (51.8% DM vs 25.9% nDM) of the cases whereas an infra-popliteal procedure was associated in 27.3% (37.5% DM vs 16.7% nDM). In both groups the presence of diabetes was significantly associated (p = 0.005 e p = 0.014, respectively). Reintervention rate was 22.7%; 13 in the diabetic group (23.2%) and 12 in the non-diabetic group (22.2%). Of those who had had reintervention (p = 0.77); 9 patients (8.2%) had undergone an open surgical operation, 6 of whom had diabetes (p = 0.32). 5 patients (4.5%) had had major amputation, 4 of whom were diabetic (p = 0.20). Curves assessing freedom from target lesion restenosis were substantially overlapping between the two groups. CONCLUSION: No statistical associations between diabetes and reintervention or amputation rates were found. Indication to treat the SFA were not influenced by the presence of diabetes but further investigation is required to verify our hypothesis.

Traditional and Novel Imaging of Right Ventricular Function in Patients with Heart Failure and Reduced Ejection Fraction.

PURPOSE OF REVIEW: This review attempts to summarize the role of standard and advanced echocardiographic techniques together with CMR in the evaluation of the RV in HF, providing an outlook on the recent evidence. RECENT FINDINGS: In the last decade, there has been growing interest in the study of the RV, and it is now widely established that RV function is a strong predictor of mortality, in several cardiovascular diseases, in particular in the setting of heart failure (HF). The evaluation of RV function might be particularly challenging, which justifies the necessity of multi-modality imaging. The echocardiographic assessment remains the mainstay technique even though it might be complex, due to RV crescent shape and its position in the chest, requiring both qualitative and quantitative parameters. Cardiac magnetic resonance (CMR) represents a complementary exam which is particularly useful when precise structural and functional assessment are needed, considering the most recently developed sequences. Despite the technological improvement attested over the last years, there is still no universally accepted parameter that univocally defines RV function, hence the necessity to evaluate several parameters, combining different imaging techniques.

Supporting clinical decision making in advanced melanoma by preclinical testing in personalized immune-humanized xenograft mouse models.

BACKGROUND: The mouse strains usually used to generate patient-derived xenografts (PDXs) are immunocompromised, rendering them unsuitable for immunotherapy studies. Here we assessed the value of immune-PDX mouse models for predicting responses to anti-PD-1 checkpoint inhibitor therapy in patients. PATIENTS AND METHODS: Melanoma biopsies contained in a retrospective biobank were transplanted into NOG mice or NOG mice expressing interleukin 2 (hIL2-NOG mice). Tumor growth was monitored, and comparisons were made with clinical data, sequencing data, and current in silico predictive tools. RESULTS: Biopsies grew readily in NOG mice but growth was heterogeneous in hIL2-NOG mice. IL2 appears to activate T-cell immunity in the biopsies to block tumor growth. Biopsy growth in hIL2-NOG mice was negatively associated with survival in patients previously treated with PD-1 checkpoint blockade. In two cases, the prospective clinical decisions of anti-PD-1 therapy or targeted BRAF/MEK inhibitors were supported by the observed responses in mice. CONCLUSIONS: Immune-PDX models represent a promising addition to future biomarker discovery studies and for clinical decision making in patients receiving immunotherapy.

Removal of carbamazepine, diclofenac and trimethoprim by solar driven advanced oxidation processes in a compound triangular collector based reactor: A comparison between homogeneous and heterogeneous processes.

Contaminants of emerging concern (including pharmaceuticals) are not effectively removed by municipal wastewater treatment plants (WWTPs), so particular concern is related to agricultural wastewater reuse due to their possible uptake in crops irrigated with WWTPs effluents. Advanced oxidation processes (AOPs) and solar AOPs have been demonstrated to effectively remove pharmaceuticals from different aqueous matrices. In this study, an heterogeneous photocatalytic process using powdered nitrogen-doped TiO2 immobilized on polystyrene spheres (sunlight/N-TiO2) was compared to the benchmark homogenous AOP sunlight/H2O2 in a compound triangular collector reactor, to evaluate the degradation of three pharmaceuticals (carbamazepine (CBZ), diclofenac (DCF), trimethoprim (TMP)) in water. The degradation of the contaminants by sunlight and sunlight-AOPs well fit the pseudo-first order kinetic model (but for TMP under sunlight). High removal efficiency by solar photolysis was observed for DCF (up to 100%, half-life sunlight cumulative energy QS,1/2 = 2 kJ L-1, half-life time t1/2 = 32 min), while CBZ (32%, QS,1/2 = 28 kJ L-1, t1/2 = 385 min) and TMP (5% removal after 300 min) removal was poor. The degradation rate of CBZ, TMP and DCF was found to be slower during sunlight/H2O2 (QS,1/2 = 5 kJ L-1, t1/2 = 77 min; QS,1/2 = 20 kJ L-1, t1/2 = 128 min; QS,1/2 = 4 kJ L-1, t1/2 = 27 min, respectively) compared to sunlight/N-TiO2 (QS,1/2 = 4 kJ L-1, t1/2 = 55 min; QS,1/2 = 3 kJ L-1, t1/2 = 42 min; QS,1/2 = 2 kJ L-1, t1/2 = 25 min, respectively). These results are promising in terms of solar technology upscale because the faster degradation kinetics observed for sunlight/N-TiO2 process would result in smaller treatment volume, thus possibly perspective compensating the cost of the photocatalyst.

Impact on short-lived climate forcers increases projected warming due to deforestation.

The climate impact of deforestation depends on the relative strength of several biogeochemical and biogeophysical effects. In addition to affecting the exchange of carbon dioxide (CO2) and moisture with the atmosphere and surface albedo, vegetation emits biogenic volatile organic compounds (BVOCs) that alter the formation of short-lived climate forcers (SLCFs), which include aerosol, ozone and methane. Here we show that a scenario of complete global deforestation results in a net positive radiative forcing (RF; 0.12 W m-2) from SLCFs, with the negative RF from decreases in ozone and methane concentrations partially offsetting the positive aerosol RF. Combining RFs due to CO2, surface albedo and SLCFs suggests that global deforestation could cause 0.8 K warming after 100 years, with SLCFs contributing 8% of the effect. However, deforestation as projected by the RCP8.5 scenario leads to zero net RF from SLCF, primarily due to nonlinearities in the aerosol indirect effect.

Interleukin 31 is involved in intrahepatic cholestasis of pregnancy.

Intrahepatic cholestasis of pregnancy (ICP) is a liver disorder characterized by maternal itching and altered liver function. Interleukin (IL)-31 is known to be involved in the pathogenesis of pruritic inflammatory skin diseases. In a three-year period, 13 women with a singleton pregnancy and a diagnosis of intrahepatic cholestasis (ICP) were enrolled together with 26 healthy single pregnant women who concluded an uncomplicated pregnancy. The inclusion criteria were itching and elevated levels of liver transaminases. Median serum levels of IL-31 were significantly higher in ICP patients than in the control group (p = 0.004). Furthermore, IL-31 values were directly dependent on liver transaminase levels.

Inflammation, neurotrophism and oxidative stress and childhood psychopathology in a large community sample.

OBJECTIVE: To investigate the association between peripheral biomarkers and child psychopathology in a large community sample. METHOD: A total of 625 aged 6- to 13-year old subjects were recruited from a community school-based study. Psychopathology was assessed using the Child Behaviour Checklist (CBCL). Psychiatric diagnosis was evaluated using the Development and Well-Being Assessment. The following biomarkers were examined in peripheral blood: brain-derived neurotrophic factor, cytokines (IL-2, IL-4, IL-6, IL-10, IL-17, IFN-g, and TNF-α), chemokines (eotaxin/CCL11, IP-10, MCP-1), cytokine receptors (sTNFR1 and sTNFR2), and the oxidative stress marker TBARS. RESULTS: We found significant associations between sTNFR2, eotaxin/CCL11 and CBCL total score, as well as with specific dimensions of psychopathology. There were different patterns of association between these biomarkers and psychological and behavioural symptoms in children with and without a mental disorder. TBARS, IL-6 and MCP-1 were more specific to some clusters of symptoms in children with a psychiatric diagnosis. CONCLUSION: Our data support the potential use of biomarkers, especially those involved in immune-inflammatory pathways, in investigating neurodevelopmental psychopathology. Their association with different dimensions of symptoms might be of useful when analyzing illness severity and clusters of symptoms within specific disorders.

INCLUSIÓN DE HARINAS DE FOLLAJES ARBÓREOS Y ARBUSTIVOS TROPICALES (Morus alba, Erythrina poeppigiana, Tithonia diversifolia E Hibiscus rosa-sinensis) EN LA ALIMENTACIÓN DE CUYES (Cavia porcellus Linnaeus) / LEAF MEALS AND TROPICAL SHRUBBY FOLIAGE (Morus alba, Erythrina poeppigiana, Tithonia diversifolia AND Hibiscus rosa-sinensis) IN FEEDING GUINEA PIGS (Cavia porcellus Linnaeus)

La investigación se ejecutó en la Finca Experimental "La María" propiedad de la Universidad Técnica Estatal de Quevedo (UTEQ) localizada en el km 7¹/2 de la vía Quevedo-Mocache; Provincia de Los Ríos cuya ubicación geográfica de 1º 6' 23" de latitud sur y 79º 29' 12" de longitud oeste y a una altura de 73 m.s.n.m. El objetivo principal fue evaluar el comportamiento productivo de cuyes con la inclusión del 20% de harinas derivadas de follajes arbustivos y arbóreos tropicales. Se utilizaron 40 cuyes macho de 30 días de edad. Se empleó un diseño completamente al azar con cinco tratamientos, cuatro réplicas y la unidad experimental estuvo conformado por dos cuyes. Para determinar las diferencias entre medias de tratamientos se aplicó la prueba de Tukey (P≤0.05). Se evaluaron cinco dietas-tratamientos: (T0) dieta 100% balanceado, (T1) 80% dieta y 20% harina de Morus alba, (T2) 80% dieta y 20% harina de Erythrina poeppigiana, (T3) 80% dieta y 20% harina de Tithonia diversifolia, (T4) 80% dieta y 20% harina de Hibiscus rosa-sinensis. Las variables bajo estudio fueron: consumo de alimento de balanceado en materia seca (CABMS, g), ganancia de peso (GP, g), índice de conversión alimenticia (ICA) y rendimiento en canal (RC, %). La rentabilidad de los tratamientos se determinó a través de la relación beneficio-costo (R b/c). Los mayores (P<0.01) CABMS, GP-ICA y RC-Rentabilidad, la registraron los tratamientos: T0 (48.34 g MS animal-1 d-1), T1 (8.80 g animal-1 d-1 y 5.04) y el T3 (77.67% y 26.20%), respectivamente.

The research was carried out at the Experimental farm "La María" property of the State Technical University of Quevedo located at km 7¹/2 in road Quevedo-Mocache; Los Ríos province, with a geographical location of 1° 6' 23" south latitude and 79º 29' 12" west longitude, at 73 meters altitude. The aim was to evaluate the productive effect of leaf meal and tropical shrubs with inclusion 20%. Were used 40 male guinea pigs of 30 days age and a completely randomized design with five treatments and four repetitions, two male guinea pigs was used to study. A 56-days experiment was conducted, and was applied the Tukey test (P≤0.05) to determine differences. Five treatments in diets were evaluated: (T0) 100% balanced diet; (T1) 80% and 20% leaf meal Morus alba flour (T2); 80% diet and 20% Erythrina poeppigiana flour; (T3) 80% diet and 20% Tithonia diversifolia flour; (T4) 80% diet and 20% Hibiscus rosa-sinensis flour. The following variables were used: Balanced feed consumption in dry matter (CABMS, g), weight obtained (GP, g), alimentary conversion index (ICA), performance distribution channel (RC, %). The profitability of the treatments was determined using the benefit-cost ratio (R b/c) ratio. The higher (P<0.01) CABMS, GP-ICA, RC- yield, assigned treatments: T0 (48.34 g DM animal-1 d-1), T1 (8.80 g animal-1 d-1 and 5.04) and T3 (77.67 % and 26.20%), respectively.

Hemodynamic changes in Chevalier eversion versus conventional carotid endarterectomy.

OBJECTIVES: The eversion carotid endartectomy (E-CEA), mainly performed by means of Vanmaele technique, has been associated with loss of the baroreceptor reflex and postoperative hypertension. The purpose of this paper is to determine whether the eversion endarterectomy performed by means of Chevalier technique (C-CEA) modifies the function and the efficiency of baroreceptors, leading to lower postoperative hemodynamic change. METHODS: A retrospective review of 380 patients who underwent carotid endarterectomy (120 Chevalier-CEA; 260 Standard-CEA) from December 2002 to November 2012 has been performed. The changes of blood pressure baseline during the postoperative course in C-CEA and S-CEA group were analysed and compared. Postoperative hypertension was defined as an elevation of systolic pressure >180 mm Hg or >40% rise above baseline. RESULTS: The patients with Chevalier eversion technique did not develop a significantly higher blood pressure in the postoperative course compared to those operated with the standard technique. In the recovery room, the mean systolic blood pressure was 134 ± 21.9 mm Hg in C-CEA group versus 132 ± 24.6 mm Hg in S-CEA group. In the first postoperative day it was 132 ± 17.2 mm Hg in C-CEA versus 133 ± 17.4 mm Hg in S-CEA group. During the first six hours in the recovery room, the need for intravenous antihypertensive drugs was similar in the two groups. Fourteen patients in C-CEA group (11%) and thirty patients (11.5%) in the S-CEA group required vasodilators, without any significant difference (p = 1). The dosage of current preoperative antihypertensive therapy was increased in six patients (4.9%) of C-CEA group and in twelve patients (4.9%) of S-CEA group, without significant difference (p = 1). CONCLUSIONS: C-CEA has the same rate of postoperative hypertension of standard-CEA, which is probably related to the sparing of baroreceptor apparatus, compared to standard E-CEA. The Chevalier procedure could represent an E-CEA technique with its inherent advantages, without penalties related to postoperative hypertension, commonly observed after E-CEA.

Isolation and characterisation of the fungus Spiromastix asexualis sp. nov. from discospondylitis in a German Shepherd dog, and review of Spiromastix with the proposal of the new order Spiromastixales (Ascomycota).

The genus Spiromastix consists of several fungal species that have been isolated from soil and animal dung in various parts of the world. However, these species are considered to be of low pathogenic potential, as no cases of infections caused by these fungi have been reported. Here, we describe the clinical course of discospondylitis in a dog from which a fungus was cultured from a biopsy and identified as a Spiromastix species by morphologic characteristics and sequencing. Phylogenetic analysis determined this to be a new species, Spiromastix asexualis, which is described, and a new order, Spiromastixales, is proposed.

Disinfection of urban wastewater by solar driven and UV lamp - TiO2 photocatalysis: effect on a multi drug resistant Escherichia coli strain.

The effect of TiO2 photocatalysis on the inactivation of an antibiotic resistant Escherichia coli strain selected from an urban wastewater treatment plant (UWWTP) effluent was investigated. Different light sources including a 250 W wide spectrum lamp, a 125 W UV-A lamp and solar radiation, as well as, photocatalysts loadings (TiO2 Degussa P25) in the range from 0.05 to 2.00 g TiO2 L(-1) were evaluated. The higher efficiency (total bacterial inactivation after 10 min of irradiation) was observed in the absence of TiO2 when the wastewater was irradiated using the 250 W lamp. In the presence of TiO2 a decreasing inactivation trend was observed (99.76% and 72.22% inactivation after 10 min irradiation at 0.10 and 2.00 g TiO2 L(-1) respectively). Under solar simulated conditions the highest inactivation efficiency (93.17%) after 10 min of irradiation was achieved at the lower photocatalyst loading (0.05 g TiO2 L(-1)). The concept of "reactor optical thickness" was introduced to explain the rates of disinfection observed. The optimum photocatalyst loading estimated by radiation absorption-scattering modeling was found to be 0.1 g TiO2 L(-1) for all lamps. The difference between experimental tests and modeling may be due to TiO2 particles aggregation. Comparative kinetic tests between solar and solar simulated photocatalytic (SSP) processes using 0.05 g TiO2 L(-1) in suspension showed a quite similar inactivation behavior up to 30 min of irradiation, but only the SSP process resulted in a total inactivation of bacteria after 60 min of exposure. Antibiotic resistant test (Kirby-Bauer) on survived colonies showed that the SSP and SP processes affected in different ways the resistance of E. coli strain to the target antibiotics.

In vitro, in vivo and in silico analysis of the anticancer and estrogen-like activity of guava leaf extracts.

Anticancer drug research based on natural compounds enabled the discovery of many drugs currently used in cancer therapy. Here, we report the in vitro, in vivo and in silico anticancer and estrogen-like activity of Psidium guajava L. (guava) extracts and enriched mixture containing the meroterpenes guajadial, psidial A and psiguadial A and B. All samples were evaluated in vitro for anticancer activity against nine human cancer lines: K562 (leukemia), MCF7 (breast), NCI/ADR-RES (resistant ovarian cancer), NCI-H460 (lung), UACC-62 (melanoma), PC-3 (prostate), HT-29 (colon), OVCAR-3 (ovarian) and 786-0 (kidney). Psidium guajava's active compounds displayed similar physicochemical properties to estradiol and tamoxifen, as in silico molecular docking studies demonstrated that they fit into the estrogen receptors (ERs). The meroterpene-enriched fraction was also evaluated in vivo in a Solid Ehrlich murine breast adenocarcinoma model, and showed to be highly effective in inhibiting tumor growth, also demonstrating uterus increase in comparison to negative controls. The ability of guajadial, psidial A and psiguadials A and B to reduce tumor growth and stimulate uterus proliferation, as well as their in silico docking similarity to tamoxifen, suggest that these compounds may act as Selective Estrogen Receptors Modulators (SERMs), therefore holding significant potential for anticancer therapy.

Pulmonary embolism due to popliteal vein aneurysm: approach and surgical treatment - a case report.

Pulmonary embolism is the first presentation in 70-80% in patients with aneurysm of popliteal vein. We present a case of young man admitted in our hospital with respiratory distress, tachycardia and D-dimer >3000 mg/dL. The observation of pulmonary embolism required the placement of a caval temporary filter before the surgical treatment. The use of temporary filter is recommended in symptomatic patients for thromboembolic phenomena, and when ultrasound detects the presence of floating thrombus.

Non-inferiority trial between two dry-powder inhalers containing fluticasone/salmeterol in asthmatic patients.

Asthma is an increasing pathology with poor compliance. Achievement of control is possible but under intensive treatment. In this setting, fluticasone/salmeterol association delivered by dry powder inhalers is a valuable and proved option. A prospective, parallel, open-label, phase IV, multicentre non-inferiority study was conducted to determine therapeutic similarity between 2 different inhalers: Generic DPI and Diskus®, which both deliver a fluticasone/salmeterol association (CAS 80474-14-2/CAS 89365-50-4). A 103 uncontrolled asthmatic patients were randomly assigned in 2 groups, Generic (G) and Diskus® (D), and received the association for 18 weeks through the appropriate device. They were evaluated according to Asthma Quality of Life Questionnaire and GINA/NIH guidelines. To demonstrate non-inferiority, the estimation of the Relative Risk between the Global Score Rate per group with its 95% confidence interval was calculated and compared against a non-inferiority margin obtained from a previous study. The Global Score Rate was 82% for G Group and 83% for D Group. The RR was 1.0124 (95% CI: 0.847-1.210). The margin set at 0.832 was not reached by the lower 95% CI (z=-2.097; p=0.018) pointing out non-inferiority. The results have demonstrated non-inferiority between groups. Thus, the 2 products are therapeutically similar.