Adverse events associated with aprepitant pediatric bone cancer patients.

An eight-year long case series follow-up study with pediatric bone cancer patients was conducted to compare the occurrence of adverse events associated with aprepitant with official sources of drug information (manufacturer's leaflet, clinical trials, and European Medicines Agency leaflet). All patients admitted were analyzed, representing 192 aprepitant cycles. Anorexia, febrile neutropenia, and headache were observed in frequencies over 43.8 per 100 patients, which was higher than previous estimates. Adverse events were classified as probable or possible, by using Naranjo score. The increased rates of adverse events, especially on the risk febrile neutropenia, warrant further safety studies on this population.

Influence of sleep apnea severity on blood pressure variability of patients with hypertension.

PURPOSE: Obstructive sleep apnea (OSA) is a risk factor for the development of hypertension and cardiovascular disease. Apnea overloads the autonomic cardiovascular control system and may influence blood pressure variability, a risk for vascular damage independent of blood pressure levels. This study investigates the hypothesis that blood pressure variability is associated with OSA. METHODS: In a cross-sectional study, 107 patients with hypertension underwent 24-h ambulatory blood pressure monitoring and level III polysomnography to detect sleep apnea. Pressure variability was assessed by the first derivative of blood pressure over time, the time rate index, and by the standard deviation of blood pressure measurements. The association between the apnea-hypopnea index and blood pressure variability was tested by univariate and multivariate methods. RESULTS: The 57 patients with apnea were older, had higher blood pressure, and had longer duration of hypertension than the 50 patients without apnea. Patients with apnea-hypopnea index (AHI) ≥ 10 had higher blood pressure variability assessed by the standard deviation than patients with AHI < 10 during sleep (10.4 ± 0.7 versus 8.0 ± 0.7, P = 0.02) after adjustment for age, body mass, and blood pressure. Blood pressure variability assessed by the time rate index presented a trend for association during sleep (P = 0.07). Daytime blood pressure variability was not associated with the severity of sleep apnea. CONCLUSION: Sleep apnea increases nighttime blood pressure variability in patients with hypertension and may be another pathway linking sleep abnormalities to cardiovascular disease.

Effects of FTO RS9939906 and MC4R RS17782313 on obesity, type 2 diabetes mellitus and blood pressure in patients with hypertension.

BACKGROUND: Genetic variants of the FTO gene rs9939609 A/T and the MC4R gene rs17782313 C/T have been associated with obesity. Individuals with mutations in MC4R gene have lower blood pressure (BP), independently of obesity. This study aimed to investigate the association of FTO rs9939609 and MC4R rs17782313 with anthropometric indexes, BP, and type 2 diabetes mellitus among hypertensive patients. METHODS: We genotyped 217 individuals (86 men and 131 women) with hypertension (systolic or diastolic BP ≥ 140/90 mmHg or using antihypertensive drugs). Diabetes mellitus was diagnosed according to the American Diabetes Association criteria. Waist and neck circumferences (cm), Body Adiposity Index (BAI,%), Lipid Accumulation Product Index (LAP, cm.mmol.l) and body mass index (BMI, kg/m²) were analyzed using analysis of covariance or modified Poisson's regression. RESULTS: Rare allele frequencies were 0.40 for A for FTO rs9939609 and 0.18 for C for MC4R rs17782313. A positive association of FTO rs9939609 and MC4R rs17782313 with BMI was observed in the overall sample. Among men and women, neck circumference was associated with the FTO genotype and, for women, MC4R genotype. In contrast, in men we found a negative association of MC4R rs17782313 with diastolic BP (TT 90.1 ±12.2, TC/CC 83.2 ±12.1; P = 0.03) and borderline association for systolic BP after controlling for age and BMI. CONCLUSIONS: Common genetic variants of FTO rs9939609 have positive associations with BMI and neck circumference and MC4R rs17782313 in women, but a negative association with diastolic and mean blood pressure in men with hypertension.

Waist-to-Height Ratio: A Sensitive Tool for Assessing the Need for Nutritional Risk Management in Elderly Populations from Brazil.

INTRODUCTION: Nutritional status assessment commonly relies on body mass index (BMI), which overlooks lean mass and adipose tissue distribution. However, waist circumference (WC) and waist-to-height ratio (WHtR) provide additional insights into fat accumulation. By combining these indices, it may be possible to identify older adults needing weight management interventions. OBJECTIVES: To assess the WC and WHtR as strategies for identifying individuals requiring weight management. METHODS: A cross-sectional study was conducted with 509 elderly individuals in Northeast Brazil. Weight, height, hip circumference, and waist circumference were measured, and combined with indices such as BMI WC, WHR, and WHtR to identify those who require weight management. The DeLong test compared areas under the curves using receiver operating characteristic curves and statistical significance. Sensitivity, specificity, and positive and negative predictive values were calculated to verify usefulness for clinical application. A validation sample of 599 elderly individuals from the country's Southern region was used to confirm the results. RESULTS: Both WC and WHtR showed adequate diagnostic accuracy with no statistically significant difference in AUCs. WHtR ≥ 0.50 had 92% sensitivity in identifying men and women requiring nutritional management. WC presented lower sensitivity but 93% specificity, useful for excluding elderly individuals from the nutritional risk category. These results were consistent in the validation sample. CONCLUSION: WHtR is a valuable index for screening nutritional risk management in the elderly population, applicable to men and women. Conversely, WC performs better in excluding individuals who do not need nutritional risk management.

Efficacy of an Educational Intervention for Sodium Restriction in Patients with Hypertension: A Randomized Controlled Trial.

There is sound evidence showing the efficacy of non-pharmacological interventions in lowering blood pressure (BP); however, adherence is usually poor. Interventions to induce behavioral changes aim to improve the ability to read labels, choose foods, and eat low-sodium meals, reinforcing adherence to sodium restriction. In this randomized parallel-controlled trial, we assessed the effectiveness of an educational intervention using the Dietary Sodium Restriction Questionnaire (DSRQ) scores. A follow-up period of 6 months was conducted. Participants were randomized into (1) an educational intervention provided by a registered dietitian on individual visits and dietary planning; (2) a control group with the usual care and dietary recommendations. Patients underwent 24-h ambulatory BP monitoring, 12-h fasting blood tests, spot urine collection, and assessment using DSRQ. We randomized 120 participants (67.5% women and 68.3% Caucasians), and 25 participants were lost to follow-up. The 24-h sodium urinary excretion changed in the control (Δ -1610 mg/day; 95% confidence interval [CI] -1800 to -1410) and intervention groups (Δ -1670 mg/day; 95% CI -1800 to -1450) over time. There was no significant difference in the 24-h estimated sodium between groups. In hypertensive patients, DSRQ-based educational intervention is effective for improving the ability to detect and overcome obstacles to a low-sodium restriction diet but is as effective as dietary recommendations for lowering sodium.

Fruits and vegetables intake and characteristics associated among adolescents from Southern Brazil.

BACKGROUND: Increased body weight has been associated with an unhealthy diet, low consumption of fruits and vegetables. Our objective was to investigate whether adolescents had low intake of fruits and vegetables, and whether gender, age and education could affect the feeding patterns. METHODS: A population-based sample of adolescents, aged 12-19 years, were randomly selected in southern Brazil and included in this cross-sectional study. The total daily consumption of fruits, vegetables, rice and beans were investigated in standardized household interviews, using a food frequency questionnaire and questions, being categorized as five or more servings per day as the five-a-day diet. ANOVA, ANCOVA, and modified Poisson regression were used in the analysis. RESULTS: Adolescents (n = 568) were included, 49.5% boys, 14.3% had overweight and 8.8% obesity. Approximately 23% of participants consumed five daily servings of fruits and vegetables. It was observed that 36.7% of boys and 31.0% of girls consumed less than one serving of fruit per day, and 58.4% and 44.6%, respectively, consumed less than one serving of vegetables. The consumption of vegetables, fruits, and rice and beans were not independently associated with gender. Overweight was associated with higher intake of five-a-day, independently of confounding factors. CONCLUSIONS: Adolescents from southern Brazil have lower frequency of consumption of five servings a day of fruits and vegetables combined.

Development, Validation, and Reproducibility of Food Group-Based Frequency Questionnaires for Clinical Use in Brazil: A Pre-Hypertension and Hypertension Diet Assessment.

The Blood pressure control diet is well described; however, it has not been implemented in clinical care, possibly due to the impracticability of the diet assessment in these contexts. In order to facilitate the dietary assessment, we developed and assessed the validity and reproducibility of two food group-based food frequency questionnaires (FG-FFQs), with a one-week (7-day FG-FFQ) and a one-month (30-day FG-FFQ) period of coverage for patients with pre-hypertension or hypertension. In 2010, 155 men and women, 30-70 years old, were invited to participate in a prospective study in two outpatient clinics in Porto Alegre, southern Brazil. The participants responded to two 30-day, two 7-day FG-FFQ, four 24-h dietary recalls, and underwent demographic, anthropometric, and blood pressure assessments. The validity and reproducibility were assessed using partial correlation coefficients adjusted for sex and age, and the internal validity was tested using the intra-class correlation coefficient. The participants were aged 61 (±10) years and 60% were women. The validity correlation coefficient was higher than r = 0.80 in the 30-day FG-FFQ for whole bread (r = 0.81) and the 7-day FG-FFQ for diet/light/zero soda and industrialized juices (r = 0.84) in comparison to the 24-h dietary recalls. The global internal validity was α = 0.59, but it increased to α = 0.76 when 19 redundant food groups were excluded. The reproducibility was higher than r = 0.80 for pasta, potatoes and manioc, bakery goods, sugar and cocoa, and beans for both versions. The 30-day had a slightly higher validity, both had good internal validity, and the 7-day FG-FFQ had a higher reproducibility.

Effectiveness of chlorthalidone/amiloride versus losartan in patients with stage I hypertension and diabetes mellitus: results from the PREVER-treatment randomized controlled trial.

AIMS: To compare the blood pressure (BP)-lowering efficacy of a chlorthalidone/amiloride combination pill with losartan, during initial management of JNC 7 Stage I hypertension in patients with type 2 diabetes mellitus. METHODS: In an a priori subgroup analysis of a randomized, double-blind, controlled trial, volunteers aged 30-70 years, with stage I hypertension and diabetes mellitus, were randomized to 12.5/2.5 mg of chlorthalidone/amiloride (N = 47) or 50 mg of losartan (N = 50), and followed for 18 months in 21 clinical centers. If BP remained uncontrolled after three months, study medication dose was doubled, and if uncontrolled after six months, amlodipine (5 and 10 mg) and propranolol (40 and 80 mg BID) were added as open label drugs in a progressive fashion. RESULTS: Systolic BP decreased to a greater extent in participants allocated to diuretics compared to losartan (P < 0.001). After 18 months of follow-up, systolic BP was 128.4 ± 10.3 mmHg in the diuretic group versus 133.5 ± 8.0 in the losartan group (P < 0.01). In the diuretic group, 36 out of 43 participants (83.7%) had a JNC 7 normal BP, compared to 31/47 (66%) in the losartan group (P = 0.089). Serum cholesterol was higher in the diuretic arm at the end of the trial. Other biochemical parameters and reports of adverse events did not differ by treatment. CONCLUSIONS: Treatment of hypertension based on a combination of chlorthalidone and amiloride is more effective for BP lowering compared to losartan in patients with diabetes mellitus and hypertension. TRIAL REGISTRATION: Clinical trials registration number: NCT00971165.

Association between different measurements of blood pressure variability by ABP monitoring and ankle-brachial index.

BACKGROUND: Blood pressure (BP) variability has been associated with cardiovascular outcomes, but there is no consensus about the more effective method to measure it by ambulatory blood pressure monitoring (ABPM). We evaluated the association between three different methods to estimate BP variability by ABPM and the ankle brachial index (ABI). METHODS AND RESULTS: In a cross-sectional study of patients with hypertension, BP variability was estimated by the time rate index (the first derivative of SBP over time), standard deviation (SD) of 24-hour SBP; and coefficient of variability of 24-hour SBP. ABI was measured with a doppler probe. The sample included 425 patients with a mean age of 57 ± 12 years, being 69.2% women, 26.1% current smokers and 22.1% diabetics. Abnormal ABI (≤ 0.90 or ≥ 1.40) was present in 58 patients. The time rate index was 0.516 ± 0.146 mmHg/min in patients with abnormal ABI versus 0.476 ± 0.124 mmHg/min in patients with normal ABI (P = 0.007). In a logistic regression model the time rate index was associated with ABI, regardless of age (OR = 6.9, 95% CI = 1.1- 42.1; P = 0.04). In a multiple linear regression model, adjusting for age, SBP and diabetes, the time rate index was strongly associated with ABI (P < 0.01). None of the other indexes of BP variability were associated with ABI in univariate and multivariate analyses. CONCLUSION: Time rate index is a sensible method to measure BP variability by ABPM. Its performance for risk stratification of patients with hypertension should be explored in longitudinal studies.

Performance of the ISAAC questionnaire to establish the prevalence of asthma in adolescents: a population-based study.

BACKGROUND: The epidemiology of asthma has been investigated with questionnaires, such as the International Study of Asthma and Allergies in Childhood protocol. AIM: To investigate the performance of the questions of the International Study of Asthma and Allergies in Childhood questionnaire to diagnose asthma in adolescents. METHODS: This is a population-based cross-sectional study of adolescents in the Syndrome of Obesity and Risk Factors for Cardiovascular Disease study. The validity of the asthma symptoms of the International Study of Asthma and Allergies in Childhood protocol was assessed by calculating sensitivity, specificity, positive and negative posttest probabilities, and Youden's Index, taking as a gold standard the history of a medical diagnosis of asthma. Risk ratios (RRs) and 95% confidence intervals (CIs), adjusting for sex and age, were calculated using Cox regression model. RESULTS: In total, 575 adolescents were investigated. Overall, 28.7% reported a lifetime medical diagnosis of asthma, and 40.0% reported at least one episode of wheezing. Ever wheezing had the highest sensitivity (80.6%) for the diagnosis of asthma, compared with the other ISAAC questions. Adolescents who reported ever wheezing were about 8 times more likely (adjusted RR: 8.3; 95% CI: 4.9-14.2) to have ever had asthma, independent of age and sex. Symptoms within the last 12 months (wheezing, cough without cold or respiratory infection, sleep disturbed due to wheezing, wheezing due to exercise, speech limited due to wheezing) had specificity of 92.0% or higher. Dry cough at night without cold or respiratory infection was the strongest independent predictor of asthma (adjusted RR: 8.8; 95% CI: 6.1-12.7). CONCLUSIONS: Ever wheezing is the most sensitive indicator of the diagnosis of asthma but falsely identifies a portion of adolescents as asthmatic. Symptoms of asthma in the last 12 months, such as cough without cold or respiratory infection, are rarely positive in the absence of a lifetime asthma diagnosis. The combination of ever wheezing for screening and the presence of other symptoms within the past 12 months to confirm the diagnosis could be an effective strategy to identify the prevalence of asthma in communities.

Self-reported adherence to physical activity recommendations compared to the IPAQ interview in patients with hypertension.

BACKGROUND: Physical activity (PA) is recommended as adjuvant therapy to control blood pressure (BP). The effectiveness of simple recommendations is not clear. We aimed to assess the agreement between self-report of adherence to PA in clinical routine and International Physical Activity Questionnaire (IPAQ) interview and its association with BP control. METHODS: A cross-sectional study was conducted with hypertensive outpatients. Adherence to recommendation to PA was assessed by the physician and IPAQ interview. A cutoff of 150 minutes/week was used to classify active or nonactive patients. High sitting time was considered >4 hours/day. A total of 127 individuals (SBP 144.9±24.4 mmHg/DBP 82.0±12.8 mmHg) were included. RESULTS: A total of 69 subjects (54.3%) reported to be active to their physician, whereas 81 (63.8%) were classified as active by IPAQ (6.3% active in leisure time PA). Kappa test was 0.22 (95% CI, 0.06-0.37). The rate of BP control was 45.7%. There was no association with the reported PA assessed by both methods nor with sitting time. Our results demonstrated poor agreement between self-report adherence and IPAQ interview, and neither evaluation was associated with BP control. CONCLUSION: Our findings underpin evidences that a simple PA recommendation has low association with BP control in clinical settings.

Risk for Obstructive Sleep Apnea by Berlin Questionnaire, but not daytime sleepiness, is associated with resistant hypertension: a case-control study.

BACKGROUND: Obstructive Sleep Apnea Syndrome (OSAS) is a risk factor for resistant hypertension. Overnight polysomnography and portable sleep monitors are not generally available and questionnaires may be useful for screening OSAS. In a case-control study, we investigate the association between resistant hypertension and sleep disorders evaluated by the Berlin Questionnaire and Epworth Sleepiness Scale (ESS). METHODS: Cases were 63 patients with resistant hypertension (either systolic blood pressure (BP) > or =140 mm Hg or diastolic BP > or =90 mm Hg using at least three BP-lowering drugs, including a diuretic). Controls were 63 patients with controlled BP under drug treatment. All the patients were submitted to ambulatory BP monitoring and level III polysomnography by means of a portable monitor. The prevalence of high risk in the Berlin Questionnaire and high score in the ESS (>10) was compared between the groups. Diagnostic performance for OSAS of both questionnaires was calculated. RESULTS: The prevalence of high score in ESS was 44% in both groups. There was a higher prevalence of high risk for OSAS in Berlin Questionnaire in the cases group (78% vs. 48%; P < 0.001). In a logistic regression model, high risk for OSAS in Berlin Questionnaire was independently associated with resistant hypertension (odds ratio 4.1; confidence interval 95% 1.80-9.31; P < 0.01). Sensitivity and specificity for the diagnosis of OSAS was 85.5% (75.3-92.0%) and 65.0% (52.0-76.0%), respectively. CONCLUSIONS: High risk for OSAS assessed by the Berlin Questionnaire is highly prevalent and associated with resistant hypertension. This questionnaire may be used as screening for OSAS in patients with this clinical condition.

Stressful life events and current psychological distress are associated with self-reported hypertension but not with true hypertension: results from a cross-sectional population-based study.

BACKGROUND: The evidence linking stress to hypertension has been scarcely documented in population-based studies. METHODS: Participants were selected through a multi-stage probability sampling and interviewed at home, being submitted to measures of demographics, anthropometrics, blood pressure (BP), and risk factors for hypertension. Hypertension was defined as BP >or= 140/90 mm Hg or use of BP-lowering drugs or as self-reported hypertension. Stressful life events were investigated through an inventory of nine major life events occurring in the year preceding the interview. Psychological distress was evaluated through a facial scale of expression of emotion in the last month. RESULTS: In the total, 1,484 adult individuals were investigated. Prevalence of hypertension was lower in individuals who reported any stressful life event in comparison with individuals who did not reported an event (34.3 versus 44.2%, P < 0.01), such as relative or friend death, loss of job, divorce, violence and migration. There was a trend for higher prevalence of hypertension in individuals with higher psychological distress in the last month, which was not longer significant after adjustment for confounding. In contrast, individuals who self-reported hypertension, but actually had normal blood pressure and were not using antihypertensive medication, reported higher numbers of stressful events. CONCLUSION: Recent stressful life events and current psychological distress are not associated with hypertension. Associations between stress events and distress with self-reported hypertension are not intermediated by effects of stress on blood pressure, and may be ascribed to negative feeling about disease and not to the disease itself.

Technologies for Innovative Monitoring to Reduce Blood Pressure and Change Lifestyle Using Mobile Phones in Adult and Elderly Populations (TIM Study): Protocol for a Randomized Controlled Trial.

BACKGROUND: Hypertension is a growing problem worldwide, markedly in low- and middle-income countries, where the rate of control slightly decreased. The overall prevalence of hypertension in Brazil is 28.7% among adult individuals and 68.9% in the population aged 60 years and older, and less than a third of patients have controlled blood pressure (BP). The use of technologies-mobile phones and the internet-to implement interventions to reduce blood pressure can minimize costs and diminish cardiovascular risk. Interventions through text messaging and electronic BP monitoring present divergent results. OBJECTIVE: This trial evaluates the effectiveness of interventions-personalized messages and telemonitoring of BP-to reduce systolic BP and improve lifestyle compared to the usual care of patients with hypertension (control group). METHODS: This factorial randomized controlled trial enrolls individuals aged 30 to 75 years who have a mobile phone and internet access with the diagnosis of hypertension under drug treatment with up to 2 medications and uncontrolled BP. Eligible participants should have both increased office BP and 24-hour BP with ambulatory BP monitoring. Participants with severe hypertension (systolic BP ≥180 or diastolic BP ≥110 mm Hg), life threatening conditions, low life expectancy, recent major cardiovascular event (last 6 months), other indications for the use of antihypertensive medication, diagnosis of secondary hypertension, pregnant or lactating women, or those unable to understand the interventions are excluded. Participants are randomly allocate to 1 of 4 experimental arms: (1) Telemonitoring of blood pressure (TELEM) group: receives an automatic oscillometric device to measure BP, (2) telemonitoring by text message (TELEMEV) group: receives personalized, standardized text messages to stimulate lifestyle changes and adhere with BP-lowering medication, (3) TELEM-TELEMEV group: receives both interventions, and (4) control group: receives usual clinical treatment (UCT). Data collection is performed in a clinical research center located in a referent hospital. The primary outcomes are reduction of systolic BP assessed by 24-hour ambulatory BP monitoring (primary outcome) and change of lifestyle (based on dietary approaches to stop hypertension (DASH)-type diet, sodium restriction, weight loss or control, increase of physical activity). RESULTS: This study was funded by two Brazilian agencies: the National Council for Scientific and Technological Development and Fundação de Amparo à Pesquisa do Estado do Rio Grande do Sul. Enrollment was completed at the end of 2017 (N=231), the follow-up is ongoing, and data analysis is expected to begin in early 2019. A reduction of 24-hour systolic BP of approximately 8.8 [SD 13.1] mm Hg for participants in the BP monitoring group versus 3.4 [SD 11.6] mm Hg in the UCT group is expected. A similar reduction in the text messaging group is expected. CONCLUSIONS: The use of mobile technologies connected to the internet through mobile phones promotes time optimization, cost reduction, and better use of public health resources. However, it has not been established whether simple interventions such as text messaging are superior to electronic BP monitoring and whether both outperform conventional counseling. TRIAL REGISTRATION: ClinicalTrials.gov NCT03005470; https://clinicaltrials.gov/ct2/show/NCT03005470 (Archived by WebCite at http://www.webcitation.org/70AoANESu). Plataforma Brasil CAAE 31423214.0.0000.5327. REGISTERED REPORT IDENTIFIER: RR1-10.2196/9619.

Effect of Diacerein on Metabolic Control and Inflammatory Markers in Patients with Type 2 Diabetes Using Antidiabetic Agents: A Randomized Controlled Trial.

INTRODUCTION: Studies have shown that T2DM is an inflammatory disease. Thus, the present study was aimed at evaluating whether diacerein could improve the metabolic and inflammatory profile among patients with T2DM under long-term treatment with glucose-lowering agents. METHODS: This is a double-blind, parallel, placebo-controlled trial with 72 participants randomly assigned to diacerein 50 mg or placebo for 12 weeks. The primary endpoint was the between-group difference in change in HbA1c. Secondary endpoints included the proportion of patients achieving metabolic control [HbA1c ≤ 7.0% (53 mmol/mol)] and change in inflammatory mediators. RESULTS: Participants in the diacerein group had greater reductions in mean HbA1c level in comparison to placebo (-0.98; 95% CI: -2.02 to 0.05, P = 0.06), independently of confounding factors. The difference in HbA1c level was -1.3 (95% CI: -2.3 to -0.4) in favor of diacerein (P = 0.007) in those with <14 years of diabetes duration versus 0.05 (-0.7 to 0.8; P = 0.9) in those with longer duration. The diacerein group had a 50% increase in the number of participants at the lowest TNF-α level (≤1.46 pg/mL). CONCLUSIONS: In patients with long-established T2DM under long-term treatment with glucose-lowering agents, diacerein improves metabolic control as measured by HbA1c level and has a favorable impact on inflammatory profile. CLINICAL TRIAL REGISTRY: This trial is registered with Brazilian Clinical Trials Registry (ReBEC) number RBR-29j956.

Effectiveness of low-dose diuretics for blood pressure reduction to optimal values in prehypertension: a randomized clinical trial.

BACKGROUND: To determine the effectiveness of low-dose diuretic therapy to achieve an optimal level of blood pressure (BP) in adults with prehypertension. METHODS: The PREVER-prevention trial was a randomized, parallel, double-blinded, placebo-controlled trial, with 18 months of follow-up, conducted at 21 academic medical centers in Brazil. Of 1772 individuals evaluated for eligibility, 730 volunteers with prehypertension who were aged 30-70 years, and who did not reach optimal blood pressure after 3 months of lifestyle intervention, were randomized to a fixed association of chlorthalidone 12.5 mg and amiloride 2.5 mg or placebo once a day. The main outcomes were the percentage of participants who achieved an optimal level of BP. RESULTS: A total of 372 participants were randomly allocated to diuretics and 358 to placebo. After 18 months of treatment, optimal BP was noted in 25.6% of the diuretic group and 19.3% in the placebo group (P < 0.05). The mean net reduction in SBP and DBP for the diuretic group compared with placebo was 2.8 mmHg (95% CI 1.1 to 4.5) and 1.1 mmHg (95% CI -0.09 to 2.4), respectively. Most participants in the active treatment group (74.5%) and in the placebo group (80.7%) continued to have BP in the prehypertension range or progressed to hypertension. CONCLUSION: Low-dose diuretic therapy increased the probability of individuals with prehypertension to achieve optimal BP but most of those treated continued to have a BP in the prehypertension range or progressed to having overt hypertension.

Detection of arteriolar narrowing in fundoscopic examination: evidence of a low performance of direct ophthalmoscopy in comparison with a microdensitometric method.

BACKGROUND: Retinal abnormalities, particularly arteriolar narrowing, are powerful predictors of cardiovascular events. The precision of internists and ophthalmologists in the assessment of retinal vessels widths has been disputed but not evaluated against a technology of edge detection. METHODS: Fifty-two patients with hypertension had optic fundi examination done by an internist and an ophthalmologist, and had retinographies taken and digitized to determine vessel diameters by a new technology of edge detection (microdensitometric method). Physicians asserted the presence of arteriolar narrowing (

Adverse events of blood-pressure-lowering drugs: evidence of high incidence in a clinical setting.

OBJECTIVES: Our primary objective was to determine the incidence of AEs of antihypertensive drugs in a cohort of outpatients attending a specialized clinic. The secondary objectives were to determine the incidence of AEs by classes of blood-pressure-lowering drugs used in monotherapy and to identify risk factors for the occurrence of AEs. METHODS: In a prospectively planned cohort study, patients attending a hypertension outpatient clinic were systematically interrogated about the occurrence of AEs of blood-pressure-lowering drugs. We compared the incidence of AEs by classes of drugs employed in monotherapy and identified risk factors for the occurrence of AEs in a logistic regression model. RESULTS: Participants were followed for 12.3 +/- 12.2 months. In total, 534 (35.4%) of 1,366 patients treated with blood pressure drugs complained of at least one AE during the follow-up, corresponding to an incidence of 31.3 AEs per 1,000 patients/month [95% confidence interval (CI) 28.6-33.9). The systolic blood pressure in the initial evaluation (P = 0.002) and use of two or more drugs (P < 0.001) were associated with higher incidence of AEs. The incidence of AEs was higher among patients treated with calcium channel blockers in monotherapy than in patients treated with diuretics (47.2 vs. 7.6%, P < 0.001). CONCLUSION: Adverse events of blood-pressure-lowering drugs are quite frequent in a clinical context, and may influence the adherence to treatment. Patients under treatment with diuretics in monotherapy have the lower incidence of AEs.

Adiposity phenotypes are associated with type-2 diabetes: LAP index, body adiposity index, and neck circumference.

BACKGROUND AND AIMS: Adiposity phenotypes can be detected by anthropometric indexes associated with type-2 diabetes mellitus (T2DM). Besides body mass index (BMI) and waist circumference (WC), new indices seem to be able to identify T2DM. This study aimed to evaluate independent associations of T2DM with lipid accumulation product (LAP index), neck circumference (NC) and body adiposity index (BAI) in patients with hypertension. METHODS: A cross-sectional study was carried out among 430 patients with hypertension. The T2DM diagnosed was standardized. WC and NC (cm) were measured and BMI was calculated. LAP index was calculated separately for men [(WC-65) × TG] and women [(WC-58) × TG]; BAI was evaluated in percentiles according to hip (cm)/[height (m)1.5]-18. RESULTS: Participants were aged 58.3 ± 11.7 years, had systolic blood pressure (SBP) 154.2 ± 24.9 mmHg, diastolic blood pressure (DBP) 89.0 ± 14.7 mmHg, and BMI 30.1 ± 6.0 kg/m2. There was 145 men and 285 women, and 142 participants had T2DM. Analyses carried out separately by gender showed that among men, BAI at the 75th percentile increased about 60% the risk of T2DM, while among women, those in the upper quartile of LAP and NC had increased risk of T2DM (prevalence ratio (PR): 2.93; 95%CI: 1.62-5.28 and 3.30; 95%IC: 1.78-6.14, respectively), after adjustment for potential confounders. CONCLUSIONS: Adiposity phenotypes such as LAP index and neck circumference were independently associated with T2DM in hypertensive women, and BAI was associated with T2DM in men.

Effect of diacerein on renal function and inflammatory cytokines in participants with type 2 diabetes mellitus and chronic kidney disease: A randomized controlled trial.

Diacerein seems to improve metabolic control and reduce inflammatory marker levels in individuals with type 2 diabetes mellitus (Type 2 DM), but for participants with chronic kidney disease (CKD) its effect is unknown. This study aimed to evaluate the effect of diacerein vs. placebo on urinary albumin/creatinine ratio (ACR), glomerular filtration rate (GFR), and inflammatory cytokines in type 2 DM participants with CKD. Blood pressure (BP) and metabolic control were secondary outcomes. This randomized, placebo-controlled, parallel trial of adjuvant treatment of type 2 DM with diacerein enrolled seventy-two participants with CKD, aged 30-80 years, with glycated hemoglobin levels from 53-97 mmol/mol (7.0-11.0%), receiving angiotensin-converting enzyme inhibitors or angiotensin receptor blockers and antidiabetic agents. Participants randomized to diacerein or placebo were followed-up up to 90 days. Both groups had a marked reduction in ACR, but there was no effect on glomerular filtration rate. While the diacerein group had reduced TNF-α levels at the 75th percentile with a borderline significance (P = 0.05), there were no changes in the IL levels at the 75th percentile. Diacerein prevented the increase in blood glucose to the level observed in the placebo group (P = 0.04), improving metabolic control by 74%, reducing 24-hour diastolic BP, nighttime systolic and diastolic BP compared to the placebo group. In conclusion, among patients with type 2 DM and CKD, diacerein does not have an effect on ACR or GFR, but slows metabolic control deterioration and is associated with lower nighttime systolic and diastolic blood pressure. TRIAL REGISTRATION: Brazilian Clinical Trials Registry (Registro Brasileiro de Ensaios Clinicos; ReBeC) U1111-1156-0255.