Local allergic rhinitis is an independent rhinitis phenotype: The results of a 10-year follow-up study.

BACKGROUND: The knowledge about the natural history of local allergic rhinitis (LAR) is limited. One unmet question is to demonstrate whether LAR should be considered the first step in the development of allergic rhinitis (AR) or an independent phenotype. The aim of this study was to prospectively evaluate the natural history of a population with LAR, the potential conversion to AR with systemic atopy and the development of asthma during 10 years. METHODS: This is the second phase of a 10-year follow-up study of a cohort of 176 patients with LAR of recent onset and 115 age- and sex-matched healthy controls prospectively evaluated from 2005 to 2016. Clinical-demographic questionnaire, spirometry, skin prick test and specific IgE were evaluated yearly. Nasal allergen provocation tests (NAPT) with Dermatophagoides pteronyssinus, Alternaria alternata, Olea europaea and grass pollen were performed at baseline, and after 5 and 10 years. RESULTS: After 10-year LAR, patients experienced a significant and clinically relevant worsening of the rhinitis, with increase in emergency assistance, development of asthma, loss of allergen tolerance and impairment of the quality of life. This worsening became significant after 5 years and progressed throughout 10 years. A similar rate of development of AR with systemic atopy was detected in patients and controls (9.7% vs 7.8%, log-rank P=.623). In 5 patients, conversion to systemic atopy occurred >10 years (3%). CONCLUSIONS: LAR is a well-differentiated clinical entity with a low rate of development of systemic atopy, a natural evolution towards worsening and a risk factor for suffering asthma.

Anticonvulsant prescription patterns in patients covered by the Colombian Health System. / Patrones de prescripción de antiepilépticos en pacientes colombianos afiliados al Sistema General de Seguridad Social en Salud.

INTRODUCTION: Epilepsy is a group of long-term neurological disorders characterised by seizures that may respond to pharmacological treatment. OBJECTIVE: Determine the prescribing patterns of anticonvulsants for patients covered by the healthcare system in Colombia. METHODS: Cross-sectional study using a database containing 6.5 million people. From among residents in 88 Colombian cities, we selected patients of both sexes and all ages who were treated continuously with anticonvulsants between June and August 2012. We designed a drug consumption database and performed multivariate analysis for combination treatment and co-medication using SPSS 20.0. RESULTS: A total of 13,793 patients with mean age of 48.9±22.0 years were studied; 52.9% of the participants were women. Of the patient total, 74.4% were treated in monotherapy and 25.6% received two or more anticonvulsants. Globally, 72.9% of the patients were initially treated with classic anticonvulsants and 27.1% with new drugs. The most frequently used drugs were valproic acid (33.3%), carbamazepine (30.2%), clonazepam (15.7%), pregabalin (10.3%), phenytoin (10.0%) and levetiracetam (7.9%). Most agents were used in higher doses than recommended. The most common combinations were valproic acid+clonazepam (10.9%), valproic acid+carbamazepine (10.0%), carbamazepine+clonazepam (5.6%), valproic acid+phenytoin (4.4%). The most frequently prescribed co-medications were antihypertensives (61.0%), lipid-lowering drugs (45.8%), antidepressants (36.7%), antipsychotics (20.1%), anxiolytics (7.9%), and lithium (1.8%). DISCUSSION: Doctors predominantly prescribe drugs with a high therapeutic value and favour anticonvulsant monotherapy. Most agents were used in higher doses than recommended. This underlines the need to design educational strategies addressing these prescribing habits, and to undertake research on the effectiveness of treatment.

Use of ergotamine: do physicians in Colombia know how to prescribe it?

INTRODUCTION: Ergot derivatives are drugs with vasoconstrictor effects that are used to abort migraine attacks. This study aims to determine how ergot derivatives are prescribed by physicians in Colombia, find variables associated with inappropriate prescribing, and review potential interactions in our patients. METHODS: We reviewed 86 411 formulas during April 2012, identifying the prescription by drug, dose, interval, duration of use, and indication. We interviewed 288 randomly selected patients in whom we also investigated concomitant use of a) antihypertensive agents b) ischaemic heart disease treatments c) antiretrovirals d) other antimigraine drugs, and e) macrolides, because of their potential for interactions. RESULTS: We identified 801 prescriptions from patients in 27 cities with a mean age of 35.1±14.1 years; 82.5% of the prescriptions were for women, 96.5% were written by primary care physicians, and 65.4% (n=524) corresponded to migraine treatments. There were 26 different prescription types and 797 prescriptions were incorrect with regard to usage recommendations (99.5%). Inappropriate prescribing was significantly associated with the health centre providing patient care (P=.005). Of the patients who were interviewed by telephone, 266 (92.4%) took the drug according to the erroneous indication. A total of 54 patients (6.7%) were treated with antihypertensive drugs, 24 (2.9%) with macrolides, and 5 (0.6%) with another concomitant antimigraine drug. DISCUSSION: Most patients take ergotamine improperly, apart from the fact that potential interactions may increase the risk of health problems such as ergotism and coronary events. Physicians will require assessment measures, updated information, and continuous training.

Stromal disrupting effects of nab-paclitaxel in pancreatic cancer.

BACKGROUND: Nab-paclitaxel and gemcitabine have demonstrated a survival benefit over gemcitabine alone in advanced pancreatic cancer (PDA). This study aimed to investigate the clinical, biological, and imaging effects of the regimen in patients with operable PDA. METHODS: Patients with operable PDA received two cycles of nab-paclitaxel and gemcitabine before surgical resection. FDG-PET and CA19.9 tumour marker levels were used to measure clinical activity. Effects on tumour stroma were determined by endoscopic ultrasound (EUS) elastography. The collagen content and architecture as well as density of cancer-associated fibroblasts (CAFs) were determined in the resected surgical specimen and compared with a group of untreated and treated with conventional chemoradiation therapy controls. A co-clinical study in a mouse model of PDA was conducted to differentiate between the effects of nab-paclitaxel and gemcitabine. RESULTS: A total of 16 patients were enrolled. Treatment resulted in significant antitumour effects with 50% of patients achieving a >75% decrease in circulating CA19.9 tumour marker and a response by FDG-PET. There was also a significant decrement in tumour stiffness as measured by EUS elastography. Seven of 12 patients who completed treatment and were operated had major pathological regressions. Analysis of residual tumours showed a marked disorganised collagen with a very low density of CAF, which was not observed in the untreated or conventionally treated control groups. The preclinical co-clinical study showed that these effects were specific of nab-paclitaxel and not gemcitabine. CONCLUSION: These data suggest that nab-paclitaxel and gemcitabine decreases CAF content inducing a marked alteration in cancer stroma that results in tumour softening. This regimen should be studied in patients with operable PDA.

Conservative approach versus urgent appendectomy in surgical management of acute appendicitis with abscess or phlegmon.

BACKGROUND: Surgical management of acute appendicitis with appendiceal abscess or phlegmon remains controversial. We studied the results of initial conservative treatment (antibiotics and percutaneous drainage if necessary, with or without interval appendectomy) compared with immediate surgery. METHODS: We undertook an observational, retrospective cohort study of patients with a clinical and radiological diagnosis of acute appendicitis with an abscess or phlegmon, treated in our hospital between January 1997 and March 2009. Patients younger than 14, with severe sepsis or with diffuse peritonitis were excluded. A study group of 15 patients with acute appendicitis complicated with an abscess or phlegmon underwent conservative treatment. A control group was composed of the other patients, who all underwent urgent appendectomy, matched for age and later randomized 1:1. The infectious risk stratification was established with the National Nosocomial Infections Surveillance System (NNIS) index. Dependent variables were hospital stay and surgical site infection. Analysis was with SPSS, with p < 0.05 considered significant. RESULTS: Interval appendectomy was performed in 7 study group patients. Surgical site infection episodes were more frequent in the control group (6 vs. 0, p < 0.001). A greater percentage of high risk patients (NNIS ≥ 2) was identified in the control group (80 vs. 28.7%, p < 0.03), mostly related with contaminated or dirty procedures in this group (p < 0.001). No significant difference between groups was found in hospital stay. CONCLUSION: Initial conservative treatment should be considered the best therapeutic choice for acute appendicitis with abscess or phlegmon.

Effects of the Temperature and Ethanol on the Kinetics of Proanthocyanidin Adsorption in Model Wine Systems.

The kinetics and quantitative and qualitative effects of grape proanthocyanidin (PA) adsorption to grape skin-derived cell wall material (CWM) were investigated in five different temperature-ethanol conditions. Progress curves for each condition were constructed by monitoring the decrease in concentration of PA solutions after exposure to CWM over 720 min. Adsorption isotherms were constructed for each condition, and a Langmuir equation model was applied to each via regression analysis. Compositional changes in the PA solutions after exposure to CWM were determined using phloroglucinolysis and gel permeation chromatography (GPC). A negative correlation between PA adsorption and both the temperature and ethanol concentration was found. Progress curves suggested that both the temperature and ethanol affect the equilibration rate of the adsorption reactions. Additionally, equilibration rates for lower temperature and ethanol concentration conditions were found to be much longer than previously reported, taking up to 720 min. Phloroglucinolysis results showed no discernible correlation between the temperature or ethanol concentration and percent galloylation or percent gallo units of adsorbed compounds. Analyses by phloroglucinolysis and GPC indicate a preferential adsorption of larger molecular weight PAs under all conditions, although no discernible impact on PA composition was detected. Additionally, findings suggest that both the temperature and ethanol concentration impact the percent reduction in molar mass of the PA solution. Data from this study were ultimately utilized to develop a computational model for predicting phenolic extraction during red wine fermentations.

A prospective observational study of the clinical and pathological impact of stereotactic body radiotherapy (SBRT) as a neoadjuvant strategy of chemoradiation in pancreatic cancer.

PURPOSE/OBJECTIVE(S): To improve the curative resection rates and prognoses, a variety of neoadjuvant (NA) strategies have been explored in PDAC. In our institution, non-metastatic PDACs have been treated with a NA intent with induction multiagent chemotherapy and SBRT. The primary endpoint was to increase R0 resection rate. The secondary endpoints were the analysis of the clinical tolerance, the pathological response, the local control (LC) and the OS. MATERIALS/METHODS: All consecutive patients with non-metastatic PDAC underwent SBRT as part of the NA strategy were included. A total dose of 40-62 Gy were delivered in 5-10 fractions. Surgery was performed after SBRT and restaging. RESULTS: Since February 2014 to December 2018, 45 patients were enrolled. Thirty-two patients underwent surgery (71.1%), 10 out of 15 were initially unresectable disease patients (66.75%). R0 resection rate was 93% (30 patients) and pN0 status was achieved in 20 patients (60.6%). Tumour regression grade (TRG): 12 patients with complete response or marked response (TRG 0-1: 37.5%), 16 patients with moderate response (TRG 2: 50%) and four patients with poor response (TRG 3: 12.5%). The median follow-up was 16.2 m (range 6.6-59.6 m) since diagnosis. The LC rate achieved was very high (95.5%). Actuarial 12 and 24 m OS was 67.4% and 35.9% respectively. No grade 3 or higher toxicity related to SBRT was observed. CONCLUSION: The results are encouraging, suggesting that SBRT has a significant role in the management of these patients and further studies will be necessary to prove these findings.

An alternative method of reconstruction of hepatic venous outflow in domino liver transplantation.

The double piggyback technique has been proposed for domino liver transplantation. To make this possible, it is necessary to reconstruct the venous outflow of the domino liver graft on the back table. We describe an alternative method of reconstruction of hepatic venous outflow, in which a neocaval segment is obtained using both common iliac veins from the cadaveric donor.

Influence of immunosuppression and effect of hepatitis C virus on new onset of diabetes mellitus in liver transplant recipients.

INTRODUCTION: New-onset posttransplantation diabetes mellitus (PTDM), with an incidence of 10% to 30%, increased graft and patient morbidity and mortality. Such causal factors as age, obesity, therapy, immunosuppression, and hepatitis C virus (HCV) contribute to this disease. OBJECTIVE: We sought to determine the incidence of PTDM and impaired fasting glucose (IFG) concentration in transplant recipients to define the causal variables. MATERIAL AND METHODS: The study included 127 patients. Patients with pretransplantation diabetes and those with less than 6 months of follow-up were excluded. A descriptive observational study to assess the association between PTDM and IFG and the immunosuppression therapy used was performed by monitoring the potential confounding variables of age, obesity, and HCV. RESULTS: During mean follow-up of 73.7 months (range, 7-120 mo), 93 patients received cyclosporine A (CyA) and 34 received tacrolimus (Tac) therapy. Thirty patients (23.6%) developed PTDM or IFG including 15 (16%; PTDM, six IFG, nine) in the CyA group and 15 (PTDM, seven; IFG, eight) in the Tacrolimus group (P = .001; odds ratio [OR], 4.1). They were homogeneous with respect to confounding variables except for HCV (P = .01). Of the 55 patients with HCV infection, 12 developed PTDM or IFG, including three in the CyA group and nine in the tacrolimus group (P = .03; OR, 7.7), whereas in the 72 patients without HCV infection, the CyA or tacrolimus association with PTDM or IFG was significant (P = .05), Mantel-Haenszel test; OR, 4.9). The interaction between HCV and immunosuppression therapy was primarily produced in the IFG group (HCV-positive; P = .008; OR, 8). CONCLUSION: We observed an association between the use of tacrolimus and the development of PTDM or IFG. There is greater risk in HCV-positive patients, in particular in relation to IFG. The choice of immunosuppressive treatment might be decided on the basis of the patient's pretransplantation status.

Impact of donor age on the results of liver transplantation in hepatitis C virus-positive recipients.

OBJECTIVE: Hepatitis C virus (HCV)-cirrhosis is the most frequent indication for orthotopic liver transplantation (OLT) among adults in most European and American transplant centers. The aim of this study was to analyze the impact of donor age on graft survival among HCV-positive cirrhotic transplant patients. MATERIALS AND METHODS: We performed an observational, retrospective study between March 1997 and December 2004, analyzing 340 liver transplantations. The patients were divided into 4 groups, considering whether the HCV infection was the indication for OLT and whether the age of the donor was older or younger than 48 years: group 1 (HCV, <48 years); group 2 (HCV, >48 years); group 3 (non-HCV, <48 years); and group 4 (non-HCV, >48 years). RESULTS: A univariate analysis showed that posttransplantation graft survival was clearly influenced by recipient HCV serologic status (P = .018). However, no graft survival differences were found when the analysis variable was age (>48 or <48 years). When both variables were studied, a positive HCV serology did not modify graft survival when the donor age was <48 years (P = .32), but had a statistically significant negative impact when the age was >48 years (P = .02). CONCLUSIONS: The use of older donors for HCV recipients resulted in worse graft and patient survivals in our study. This difference in survival was not present in non-HCV recipients or when grafts for HCV recipients were procured from younger donors. Donor age <30 years was a protective factor for graft survival among HCV recipients.

Organic matter humification in olive oil mill wastewater by abiotic catalysis with manganese(IV) oxide.

The chemical changes occurring in an olive oil mill wastewater (OMW) sample digested catalytically with MnO2 for 30 and 60 days were evaluated comparatively with those occurring in the same OMW left standing for the same time in an open-air lagoon. Both treatments increased the pH and electrical conductivity and decreased the contents of dry matter, total organic C and total N, and C/N ratio of OMW. The humic acid (HA)-like fraction isolated from the fresh OMW was characterized by a marked aliphatic character, small O and acidic functional group contents, marked presence of proteinaceous materials, partially modified lignin moieties and polysaccharides-like structures, extended molecular heterogeneity, and small degrees of aromatic ring polycondensation, polymerization and humification. With increasing the time of either lagooning or catalytic digestion, a loss of aliphatic materials and an increase of extraction yield, oxygenation, acidic functional groups, carbohydrates and aromaticity occurred in the HA-like fractions. The more evident changes measured for the HA-like fractions from catalytically-digested OMW, with respect to those from lagooned OMW, indicated that MnO2 was able to catalyze organic matter humification in OMW.

Organic matter humification by vermicomposting of cattle manure alone and mixed with two-phase olive pomace.

The chemical changes occurring in a cattle manure (CM) and a mixture of two-phase olive pomace and CM (OP+CM) after vermicomposting with Eisenia andrei for eight months were evaluated. Further, humic acid (HA)-like fractions were isolated from the two substrates before and after the vermicomposting process, and analyzed for elemental and acidic functional group composition, and by ultraviolet/visible, Fourier transform infrared and fluorescence spectroscopies. Before vermicomposting, the HA-like fractions featured a prevalent aliphatic character, large C contents, small O and acidic functional group contents, a marked presence of proteinaceous materials and polysaccharide-like structures, extended molecular heterogeneity and small degrees of aromatic ring polycondensation, polymerisation and humification. After vermicomposting, the total extractable C and HA-C contents in the bulk substrates increased, and the C and H contents, aliphatic structures, polypeptidic components and carbohydrates decreased in the HA-like fractions, whereas O and acidic functional group contents increased. Further, an adequate degree of maturity and stability was achieved after vermincomposting, and the HA-like fractions, especially that from OP+CM, approached the characteristics typical of native soil HA. Vermicomposting was thus able to promote organic matter humification in both CM alone and in the mixture OP+CM, thus enhancing the quality of these materials as soil organic amendments.

Choice of pyrolysis parameters for urban wastes affects soil enzymes and plant germination in a Mediterranean soil.

The production of organic waste has steadily increased in recent years, with subsequent impact on the environment. The European Union committed to diminish the volume of biodegradable municipal waste disposed of in landfills by 2016-2020. The synthesis of biochar from urban waste and its application to improve soil quality can constitute a novel route for valorization. The aim of this paper was to study the effect of three biochars originated from pyrolysis of the organic fraction of urban waste at two different temperatures (300°C and 500°C) and two residence times (1h and 5h) on the biochemical properties of an agricultural soil. Soil was amended with biochars at a rate of 8% and incubated for 74days. A phytotoxicity assay, using garden cress as the test species, was conducted. CO2 emissions, microbial biomass C and the enzymes dehydrogenase, phosphomonoesterase and ß-glucosidase were measured in tested soils. Biochars prepared at 300°C resulted in lower germination index values, which could partly be ascribed to a higher bioavailability of heavy metals and higher soluble organic matter, while the biochar prepared as 500°C exhibited a phytostimulant effect. Biochars produced at 300°C (B300-1h, B300-5h) augmented soil CO2 emissions while there was no effect on microbial respiration in the soil amended with the biochar prepared at 500°C. Pyrolysis temperature and, for some enzymes, residence time, controlled soil enzymatic activity.

Transfusion requirements during liver transplantation: impact of a temporary portacaval shunt.

UNLABELLED: We evaluated the consumption of blood products during liver transplantation in cirrhotic patients association with the placement of a temporary portacaval shunt (TPCS). PATIENTS AND METHODS: We retrospectively divided 349 cirrhotic patients transplanted in our unit between March 1997 and October 2005 into two groups: transplants without a TPCS (group I, 189 cases) and those with a TPCS (group II, 160 cases). In all cases, we preserved the inferior vena cava (piggyback). The dependent variables were consumption of blood-derived products (banked red cells, recovered red cells, fresh frozen plasma, platelets), surgery time, kidney function, intensive care unit stay, and hospital stay. RESULTS: Consumption of blood products was significantly lower among patients who received a TPCS. In group II, no platelet transfusion was required in 54% of the patients, and no banked red cells in 12% compared with 18% and 3%, respectively, among group I patients (P < .005). The mean overall transplant procedure time was 74 minutes shorter in group II (361 minutes) compared with group I (435 minutes) (P < .001). The overall hospital stay was shorter among patients transplanted after TPCS. CONCLUSION: Liver transplantation with a TPCS was accompanied by a reduction in the intraoperative use of blood-derived products, especially platelet transfusion. Among other advantages, this reduction resulted in a shorter posttransplant hospital stay.

Preoperative treatment with gemcitabine plus nab-paclitaxel is a safe and effective chemotherapy for pancreatic adenocarcinoma.

INTRODUCTION: Recently, novel chemotherapeutic agents like nab-paclitaxel and gemcitabine demonstrated a survival benefit over gemcitabine alone in metastatic pancreatic cancer. However, there are limited clinical results using this chemotherapy in potentially resectable pancreatic adenocarcinoma. Our aim is to report the oncological results of patients affected by potentially resectable pancreatic adenocarcinoma that underwent surgery after a combination of gemcitabine and nab-paclitaxel. METHODS: A total of 25 patients have been included. We evaluated: (1) Drug toxicity; (2) tumoral response (tumoral size at CT scan, SUV of FDG PET-CT scan and CA 19.9; (3) resection rate; (4) R0 resection rate and histopathological response and (5) survival and disease free survival. RESULTS: Overall treatment was well tolerated. Treatment resulted in a statistical decrease of CA19-9 (p = 0.019) tumoral size (p = 0.04) and SUV (p = 0.004). The resection rate was 68% (17/25 patients). All specimens were R0 and 13 of 17 specimens had major pathological regressions (complete and important response). Median survival and medial disease free survival of patients that underwent surgery was 21 months and 19 months, respectively at a mean follow up of 38.5 months. CONCLUSIONS: This data suggests that nab-paclitaxel and gemcitabine is a safe and effective neoadjuvant treatment for potentially resectable pancreatic adenocarcinoma. This promising data should be confirmed in larger, randomized studies.

Array of biosensors for discrimination of grapes according to grape variety, vintage and ripeness.

A bioelectronic tongue based on nanostructured biosensors specific for the simultaneous detection of sugars and phenols has been developed. The array combined oxidases and dehydrogenases immobilized on a lipidic layer prepared using the Langmuir-Blodgett technique where Glucose oxidase, d-Fructose dehydrogenase, Tyrosinase or Laccase were imbibed. A phthalocyanine was co-immobilized in the sensing layer and used as electron mediator. The array thus formed has been used to analyze grapes and provides global information about the samples while providing specific information about their phenolic and their sugar content. Using Principal Component Analysis (PCA) the array of voltammetric biosensors has been successfully used to discriminate musts prepared from different varieties of grapes (Tempranillo, Garnacha, Cabernet-Sauvignon, Prieto Picudo and Mencía). Differences could be also detected between grapes of the same variety and cultivar harvested in two successive vintages (2012 and 2013). Moreover, the ripening of grapes could be monitored from veraison to maturity due to the changes in their phenolic and sugar content. Using Partial Least Squares (PLS-1) analysis, excellent correlations have been found between the responses provided by the array of biosensors and classical parameters directly related to phenols (total polyphenol index, TPI) and sugar concentration (degree Brix) measured by chemical methods with correlation coefficients close to 1 and errors close to 0. It is also worthy to notice the good correlations found with parameters associated with the pH and acidity that can be explained by taking into account the influence of the pH in the oxidation potentials of the phenols and in the enzymatic activity. This bioelectronic tongue can assess simultaneously the sugar and the phenolic content of grapes and could be used to monitor the maturity of the fruit and could be adapted easily to field analysis.

Lipid transport across the intestinal epithelial cell. Effect of colchicine.

Rats injected with colchicine (0.5 mg/100 g of body weight) 1 h before ingestion of a margarine emulsion (1 g in 2 ml of saline) do not show the rise in plasma triacylglycerol concentration found in controls during the subsequent hours. The effect of colchicine is more dramatic when the experiment is performed after prior administration of Triton WR-1339, a substance known to inhibit the catabolism of lipoproteins. Colchicine-treated rats also showed a five-fold increase in the content of triacylglycerol in proximal jejunum, when compared to controls. These results are consistent with the idea that colchicine interferes with the intracellular phase of fat absorption, suggesting that the microtubular-microfilamentous system could be involved in the release of chylomicrons from the intestinal cell into the circulation.

Copper(II) complexation by humic and fulvic acids from pig slurry and amended and non-amended soils.

The effect of the consecutive annual additions of pig slurry at rates of 0 (control), 90 and 150 m3 ha(-1) y(-1) over a 4-year period on the binding affinity for Cu(II) of soil humic acids (HAs) and fulvic acids (FAs) was investigated in a field plot experiment under semiarid conditions. A ligand potentiometric titration method and a single site model were used for determining the Cu(II) complexing capacities and the stability constants of Cu(II) complexes of HAs and FAs isolated from pig slurry and control and amended soils. The HAs complexing capacities and stability constants were larger than those of the corresponding FA fractions. With respect to the control soil HA, pig-slurry HA was characterized by a much smaller binding capacity and stability constant. Amendment with pig slurry decreased the binding affinity of soil HAs. Similar to the corresponding HAs, the binding affinity of pig-slurry FA was much smaller while that of amended-soil FAs were slightly smaller when compared to the control soil FA. The latter effect was, however, more evident with increasing the amount of pig slurry applied to soil per year and the number of years of pig slurry application.

[Valsartan in patients with arterial hypertension and type 2 diabetes mellitus. The lapaval study]. / Efecto del valsartin sobre la presión arterial y función renal en pacientes con hipertensión arterial y diabetes mellitus tipo 2. Estudio Lapaval.

UNLABELLED: Arterial hypertension and diabetes mellitus give rise to a situation of high cardiovascular risk. The potential renoprotection from inhibition of the renin-angiotensin system is a valid option in this type of patient. OBJECTIVE: Evaluate the effect of valsartan on blood pressure (BP) and renal function in albuminuric patients with type 2 diabetes and arterial hypertension. PATIENTS AND METHODS: This was a prospective, observational study. Seventy-four diabetic patients with a blood pressure of > or = 140/90 mmHg, with micro or macroalbuminuria and a) blood creatinine levels lower 1.5 mg/dl (group 1) or b) blood creatinine levels between 1.5 and 2 mg/dl (group 2), were studied and followed up for a 12-week period. Treatment was started with valsartan 80 mg/d, increasing to 160 mg/d, adding torasemide at a dose of 5 mg/d if the target blood pressure of 130/85 mmHg has not been achieved. The degree of BP reduction was analyzed comparatively using a mercury sphygmomanometer and a semi-automatic monitor, the Omron HEM 705 CP. RESULTS: All patients showed a significant reduction of the systolic (SBP) and diastolic (DBP) blood pressures (p< 0.001) over the study period, decreasing from 150.7 +/- 12.8 to 130.8 +/- 9.6 and from 94.7 +/- 7.7 to 76.8 +/- 6.3 mmHg, respectively. A significant reduction was observed only for diastolic blood pressure (101.4 +/- 8.8 to 79.4 +/- 5.6; p < 0.001) in the group 2 of patients. Lowest BP values were always obtained with the semiautomatic device. At the end of the study, 9.5% maintained valsartan 80 mg/d and 36.5% reqcuired the addition of a second or third drug to valsartan 160 mg in order to achieve the therapeutic target BP A significant reduction was observed in the microalbuminuria (75.5 +/- 9.5 to 54.7 +/- 7.3 microg/min; p < 0.001) and macroalbuminuria (n = 20; 0.93 +/- 0.4 to 0.68 +/- 0.4 g/day; p < 0.001). CONCLUSION: Valsartan significantly reduced SBP and DBP Valsartan at 160 mg/d had a significantly greater effect in reducing micro and macroalbuminuria. No changes were observed in renal function, HbA1c or serum potassium. The rate of adverse events was very low.