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PubMed2004

Cardiovascular changes after extraglottic airway insertion: a prospective, randomized comparison between the laryngeal mask or the new PAXpress.

STUDY OBJECTIVE: To compare hemodynamic responses induced with the new extraglottic airway, PAXpress, and the classic Laryngeal Mask Airway (LMA). DESIGN: Prospective, randomized study. SETTING: Anesthesia department of a university teaching hospital. PATIENTS: 70 ASA physical status I and II patients, aged 18 to 65 years, scheduled to receive general anesthesia for extraabdominal procedures of short duration. INTERVENTIONS: Patients were randomly allocated to receive either a LMA (n = 35) or a PAXpress (n = 35) placement. After midazolam premedication (0.05 mg kg-1) and general anesthesia induction (propofol 2.5 mg kg-1, and fentanyl 1 microg kg-1) the airways were placed according to manufacturer instructions; then general anesthesia was maintained with a 2% sevoflurane concentration and an air/oxygen mixture. MEASUREMENTS AND MAIN RESULTS: Arterial blood pressure [both systolic (SBP) and diastolic (DBP)] and heart rate (HR) values were recorded immediately before airway placement, immediately after airway placement, then every 1 minute during the first 5 minutes. During the first 5 minutes after airway insertion, both SBP and DBP values were higher with the PAXpress than the LMA (repeated measures analysis of variance:p = 0.02 and p = 0.006, respectively), whereas no differences were reported in HR values. Also, the maximum percentage increase in both SBP and DBP values was larger with PAXpress [+19% (range: -19% to +80%) for SBP and +26% (range: -17% to +96%) for DBP] than the LMA [+9% (range: -30% to +90%) for SBP and +10% (range: -30% to +92%) for DBP] (p = 0.006 and p = 0.001, respectively). CONCLUSIONS: Although further studies are required to evaluate safety and airway trauma of this new extraglottic airway, placing the PAXpress produces more marked changes in hemodynamic variables as compared with those produced by the LMA.

Adult↗
PubMed2005

Is there a role for reconstructive techniques to prevent periodontal defects after third molar surgery?

PURPOSE: Among patients at high risk for second molar (M2) periodontal defects after third molar (M3) removal, does active treatment at the time of extraction, when compared with no treatment, alter the risk of postextraction M2 periodontal defects? MATERIALS AND METHODS: We used a prospective cohort study design and a sample composed of subjects at high risk for developing M2 periodontal defects after M3 extraction, that is, age > or = 26 years, pre-existing periodontal defects (attachment level [AL] > or = 3 mm), and mesioangular or horizontal M3 impaction. The predictor variable was treatment status of the M3 extraction site. The M3 extraction sites were reconstructed with demineralized bone powder (DBP), bioresorbable guided tissue regeneration (GTR) therapy, or no treatment. The outcome variable was ALs measured at the M2 distobuccal line angle preoperatively and 26 weeks after extraction. Appropriate univariate, bivariate, and multivariate statistics were computed, and statistical significance was set at a value P < .05. RESULTS: The cohort was composed of 12 subjects contributing 18 high-risk M3s. Twenty-six weeks after M3 removal, the ALs for GTR-treated (3.0 +/- 1.2 mm), DBP-treated (1.4 +/- 0.5 mm), and control (3.8 +/- 0.9) M3 sites were statistically significantly different ( P = .002). Tukey post-hoc comparisons revealed a statistically significant difference between control and DBP ALs ( P = .001) and GTR-treated and DBP-treated ALs ( P = .037). There was no statistically significant difference in ALs between control and GTR-treated M3s ( P = .35). CONCLUSIONS: The results of this study suggest that subjects at high risk for developing M2 periodontal defects after M3 removal may benefit from the use of DBP placed at the time of M3 extraction to enhance periodontal healing.

Adult↗
PubMed2005

Alteration of gene expression of G protein-coupled receptors in endocrine disruptors-caused hyperactive rats.

We examined the effects of endocrine disruptors on rat behavioral and cellular responses. Single intracisternal administration of bisphenol A, p-octylphenol, nonylphenol, dibutylphthalate (DBP), dicyclohexylphthalate (DCHP), or diethylhexylphthalate (DEHP) into 5-day-old male Wistar rats caused significant hyperactivity at 4-5 weeks of age. It was about 1.3- to 1.6-fold more active in the nocturnal phase than control rats. Based on DNA macroarray analyses of the midbrain at 8 weeks of age, the endocrine disruptors altered the levels of gene expression of G protein-coupled receptors that were involved in not only dopaminergic neurotransduction but also many peptidergic neurotransduction. The gene expression of dopamine receptor D1A was decreased by nonylphenol, DBP, or DEHP by 0.23- to 0.4-fold, whereas that of dopamine D2 was increased by nonylphenol or DBP by 2- to 2.8-fold. It was notable that four of six endocrine disruptors tested, i.e. nonylphenol, DBP, DCHP, and DEHP largely downregulated the levels of gene expression of galanin receptor 2 by 0.11- to 0.28-fold. Bisphenol A, DBP or DCHP significantly decreased the levels of gene expression of dopamine transporter at 8 weeks more than 0.5-fold. Immunohistochemical analyses revealed that p-octylphenol impaired the immunoreactivity for tyrosine hydroxylase in substantia nigra pars compacta. Thus, endocrine disruptors caused hyperactivity in the rat, probably regulating the levels not only of gene expression but also of proteins of both G-protein-coupled receptors systems and dopaminergic neurotransduction system.

Animals↗
PubMed2005

Haemodynamic effects of mental stress during cardiac arrest simulation testing on advanced life support courses.

UNLABELLED: We investigated the haemodynamic response to the mental stress induced by being evaluated as a team leader in simulated advanced life support (ALS) scenarios. METHODS: Healthcare providers participating as candidates to ALS courses were monitored while acting as team leaders in a cardiac arrest testing scenario (CASTest). Heart rate (HR), systolic blood pressure (SBP) and diastolic blood pressure (DBP) were measured before, during and after the CASTest. The correlation between the haemodynamic responses and sex, age, body mass index (BMI) and marks on course multiple choice questions (MCQs) were studied using multiple linear regression. RESULTS: Eighty-eight subjects (46 women, 42 men, mean age 34.9+/-6.8 years) were enrolled. Mean HR, SBP and DBP increased significantly during the CASTest and reached a peak after a phase of the scenario which included an unsuccessful defibrillation. Ten minutes after the CASTest, HR, SBP and DBP were still significantly higher than their respective baseline values. A significant positive correlation was found between the DBP and SBP response during the scenario and the BMI, and between the DBP response and the candidates' age. The haemodynamic stress response was neither correlated with the candidates' marks in the course MCQ nor with their instructor potential (IP). CONCLUSION: During the testing scenario the ALS candidates showed a significant haemodynamic response to mental stress, which depended mainly on their age and BMI rather than on their knowledge and skills.

Adult↗
PubMed2006

Considerations for improving the accuracy of exposure to disinfection by-products by ingestion in epidemiologic studies.

Disinfection by-product (DBP) exposure characterization studies are often based on the analysis of a limited number of samples collected from a distribution system (DS) in which DBP levels are variable over time and space. A compositing technique was developed to simplify the sample collection procedures for integrating over temporal variations in DBPs measured in terms of trihalomethanes (THMs), haloacetic acids (HAAs), and total organic halogen (TOX). Over the course of 5 days analysis, the single composited sample was within 94-100% of the average THM concentration in all grab samples, 92-105% of HAAs, and 130% of the TOX concentration. Additionally, temporal variability factors such as timing of sample collection and the handling of tap water prior to consumption were found to influence DBP levels in consumers' drinking water. Included in our study of home water use are the effects of boiling which removed up to 98% of THMs and point of use (POU) devices which all showed DBP removal but differed depending on the device used. These factors should be taken into consideration in DBP exposure characterization for epidemiologic studies.

Acetates↗
PubMed2005

Urinary and amniotic fluid levels of phthalate monoesters in rats after the oral administration of di(2-ethylhexyl) phthalate and di-n-butyl phthalate.

Two studies were designed to examine amniotic fluid and maternal urine concentrations of the di(2-ethylhexyl) phthalate (DEHP) metabolite mono(2-ethylhexyl) phthalate (MEHP) and the di-n-butyl phthalate (DBP) metabolite monobutyl phthalate (MBP) after administration of DEHP and DBP during pregnancy. In the first study, pregnant Sprague-Dawley rats were administered 0, 11, 33, 100, or 300 mg DEHP/kg/day by oral gavage starting on gestational day (GD) 7. In the second study, DBP was administered by oral gavage to pregnant Sprague-Dawley rats at doses of 0, 100, or 250 mg/kg/day starting on GD 13. Maternal urine and amniotic fluid were collected and analyzed to determine the free and glucuronidated levels of MEHP and MBP. In urine, MEHP and MBP were mostly glucuronidated. By contrast, free MEHP and free MBP predominated in amniotic fluid. Statistically significant correlations were found between maternal DEHP dose and total maternal urinary MEHP (p=0.0117), and between maternal DEHP dose and total amniotic fluid MEHP levels (p=0.0021). Total maternal urinary MEHP and total amniotic fluid MEHP levels were correlated (Pearson correlation coefficient=0.968). Statistically significant differences were found in amniotic MBP levels between animals within the same DBP dose treatment group (p<0.0001) and between animals in different dose treatment groups (p<0.0001). Amniotic fluid MBP levels increased with increasing DBP doses, and high variability in maternal urinary levels of MBP between rats was observed. Although no firm conclusions could be drawn from the urinary MBP data, the MEHP results suggest that maternal urinary MEHP levels may be useful surrogate markers for fetal exposure to DEHP.

Administration, Oral↗
PubMed2005

Pharmacokinetics of monobutylphthalate, the active metabolite of di-n-butylphthalate, in pregnant rats.

Di-n-butylphthalate (DBP) is a phthalic acid ester used as a plasticizer and solvent. DBP is a developmental toxicant in rats and mice, with adverse effects arising from the monoester metabolite monobutyl phthalate (MBP). The objective of this study was to evaluate the pharmacokinetics of MBP and monobutyl phthalate glucuronide (MBP-G) in pregnant rats following intravenous (i.v.) dosing with MBP. Pregnant dams were i.v. dosed with aqueous MBP (10, 30, or 50mg MBP/kg body weight) on gestation day (GD) 19. The pharmacokinetics of MBP and MBP-G were rapid: MBP was metabolized to MBP-G within 5 min, and MBP and MBP-G disappeared from maternal and fetal plasma within 24h of dosing. Results were consistent with two previous studies that utilized oral doses of DBP, suggesting that chemical (DBP versus MBP), vehicle (oil versus aqueous), dose level, and route (oral versus i.v.) have minimal effects on the maternal pharmacokinetics of MBP and MBP-G. This study provides direct pharmacokinetic analysis for MBP and MBP-G in pregnant rats during fetal male reproductive development, and indicates that future pharmacokinetic or toxicology studies can reliably utilize oral dosing with DBP.

Animals↗
PubMed2003

Oral contraceptives: a risk factor for uncontrolled blood pressure among hypertensive women.

The objective of the study was to assess the association between systolic and diastolic blood pressure (SBP and DBP) and the use of oral contraceptives (OC) in hypertensive women. In a prospective cross-sectional study, we evaluated 171 women who were referred to the Hypertension Outpatient Clinic of Hospital de Clínicas de Porto Alegre; 66 current users of OC, 26 users of other contraceptive methods and 79 women who were not using contraception. The average of six blood pressure readings was used to establish the usual blood pressure of the participants. Current OC users were compared with users of other methods and with patients not using contraception. Main outcome measures were SBP and DBP among the different groups, and prevalence of uncontrolled hypertension (SBP >or= 140 mmHg and DBP >or= 90 mmHg). DBP was higher in OC users (100.2 +/- 15.9 mmHg) than in patients using other contraceptive methods (93.4 +/- 14.7 mmHg) and not using contraceptives (93.3 +/- 14.4 mmHg, p = 0.016). Women using OC for more than 8 years presented higher age-adjusted blood pressure levels than women using OC for shorter periods. Patients using OC had poor blood pressure control (p for trend = 0.046) and a higher proportion of them presented moderate-severe hypertension. These results were independent of antihypertensive drug use. In a logistic regression model, we found that current OC use was independently and significantly associated with prevalence of uncontrolled hypertension. It is concluded that hypertensive women using OC present a significant increase in DBP and poor blood pressure control, independent of age, weight and antihypertensive drug treatment.

Adolescent↗
PubMed1998

The conjoint trait of low high-density lipoprotein cholesterol and high triglycerides in adolescent black and white males.

To evaluate the interrelationships among body composition, blood pressure, and lipid phenotypes in adolescent black and white boys, we assessed racial distributions of lipids, blood pressure, and obesity and their joint occurrence in black and white boys aged 10 to 15 years. Subjects were recruited from Cincinnati (OH) schools. Because the differences in high-density lipoprotein cholesterol (HDL-C) and triglycerides (TGs) are the most profound coronary heart disease (CHD) risk factor differences between black and white males, we assigned subjects to one of four low-HDL-C and high-TG categories (normal and increased risk) using the age/race-specific 25th (HDL-C) and 75th (TG) percentiles. We then assessed racial distributions of lipids, blood pressure, and obesity by these phenotypes. Age differences between the black and white participants were significant, with the former about 3 months younger (P=.03), but black boys were more mature and were significantly taller and heavier and had a greater body mass index ([BMI] weight in kilograms divided by height in centimeters squared). Differences in the sum of the triceps, subscapular, and suprailiac skinfolds were not significant. Blacks had significantly higher HDL-C, lower TG, and higher diastolic blood pressure (DBP), but differences in systolic blood pressure (SBP) were not significant. In both racial groups, the body composition measures were significantly correlated with HDL-C, TG, and blood pressure levels; the correlations between HDL-C and both weight and BMI were significantly stronger in white boys. The proportion of boys of each race with low HDL-C and high TG was similar by design. In both racial groups, subjects with the conjoint trait had a significantly greater BMI, triceps skinfold, and sum of skinfolds than subjects in the other phenotypic groups. For white boys, participants with the conjoint trait had the highest SBP and DBP; differences in SBP were significant for comparisons to the normal- and high-TG group alone, and differences in DBP were significant for the comparison between normal and low HDL-C alone. For black boys, subjects with both normal HDL-C and TG had significantly lower SBP than boys with either the conjoint trait or high TG alone; none of the group differences in DBP were significant. Black had significantly less dense LDL (more LDL-C per apolipoprotein [apo] B). In each racial group, boys with the conjoint trait had the most dense LDL, significantly more dense than in any of the other phenotypes in black boys and significantly more dense than in boys with low HDL-C alone and normal boys in the white group. In both racial groups, the occurrence of no risk factors (>75th percentile TG, BMI, SBP, and DBP or <25th percentile HDL-C) and three or more risk factors was greater than expected by chance alone, and the occurrence of exactly one risk factor and two factors was less. When examined by phenotypic groups within race, boys in each racial group with the normal phenotype had a greater than expected percentage with no risk factors, and white boys with the conjoint trait were more likely to have a marked increase in multiple risk factors. Possible mechanisms for this clustering of risk factors and for the racial differences in the patterns are discussed.

Adolescent↗
PubMed2001

Effect of chemopreventive agents on DNA adduction induced by the potent mammary carcinogen dibenzo[a,l]pyrene in the human breast cells MCF-7.

Over 1500 structurally diverse chemicals have been identified which have potential cancer chemopreventive properties. The efficacy and mechanisms of this growing list of chemoprotective agents may be studied using short-term bioassays that employ relevant end-points of the carcinogenic process. In this study, we have examined the effects of eight potential chemopreventive agents, N-acetylcysteine (NAC), benzylisocyanate (BIC), chlorophyllin, curcumin, 1,2-dithiole-3-thione (D3T), ellagic acid, genistein, and oltipraz, on DNA adduction of the potent mammary carcinogen dibenzo[a,l]pyrene (DBP) using the human breast cell line MCF-7. Bioactivation of DBP by MCF-7 cells resulted in the formation of one predominant (55%) dA-derived and several other dA- or dG-derived DNA adducts. Three test agents, oltipraz, D3T, and chlorophyllin substantially (>65%) inhibited DBP-DNA adduction at the highest dose tested (30 microM). These agents also significantly inhibited DBP adduct levels at a lower dose of 15 microM, while oltipraz was effective even at the lowest dose of 5 microM. Two other agents, genistein and ellagic acid were moderate (45%) DBP-DNA adduct inhibitors at the highest dose tested, while NAC, curcumin, and BIC were ineffective. These studies indicate that the MCF-7 cell line is an applicable model to study the efficacy of cancer chemopreventive agents in a human setting. Moreover, this model may also provide information regarding the effect of the test agents on carcinogen bioactivation and detoxification enzymes.

Anticarcinogenic Agents↗
PubMedDate not supplied

Diurnal rhythms of blood pressure, heart rate, and locomotor activity in adult and old male Wistar rats.

The diurnal rhythms of systolic blood pressure (SBP), diastolic BP (DBP), heart rate (HR), and spontaneous locomotor activity (SLA) were determined in adult (6-month-old) and old (24-month-old) male Wistar rats by using radiotelemetry. The rhythm parameters (mesor, amplitude, acrophase, and percent rhythm) were analyzed by Fast-Fourier Transform and Cosinor methods. We found that the 12-h mean values of SBP, DBP, HR, and SLA were significantly (p<0.001) higher in the dark phase than in the light phase in both adult and old rats. The nocturnal 12-h mean value of HR was significantly (p<0.01) lower in old than in adult rats. In addition, the differences between diurnal and nocturnal 12-h mean values of SBP and HR were reduced in old rats. There was no significant difference in the 12-h mean values of SBP, DBP, and SLA between old and adult rats. Otherwise, the diurnal HR rhythm amplitude was significantly (p<0.01) reduced in old rats (32+/-2 vs. 46+/-2 bpm). A nearly 1-h delay in SBP and DBP acrophases (03h55 +/- 00h19 vs. 02h57 +/- 00h14 and 03h17 +/- 00h13 vs. 01h53 +/- 00h22, respectively) was found in old rats comparing to adult rats. No significant change in SLA diurnal rhythm was observed in old rats. In conclusion, these results show a decrease in the nocturnal 12-h mean value of HR and an alteration in cardiovascular diurnal rhythms by a 1-h delay of SBP and DBP acrophases and a reduction of HR rhythm amplitude in old Wistar rats.

Aging↗
PubMed2001

Conjugation reactions catalyzed by bifunctional proteins related to beta-oxidation in bile acid biosynthesis.

The conjugation reactions of hydration and dehydrogenation catalyzed by the dehydratase and dehydrogenase activities of D-3-hydroxyacyl-CoA dehydratase/D-3-hydroxyacyl-CoA dehydrogenase bifunctional protein (DBP) and enoyl-CoA hydratase/3-hydroxyacyl-CoA dehydrogenase bifunctional protein (LBP) in the side chain degradation step of bile acid biosynthesis were investigated using chemically synthesized C27-bile acid CoA esters as substrates. The hydration catalyzed by DBP showed high diastereoselectivity for (24E)-3alpha,7alpha,12alpha-trihydroxy- and (24E)-3alpha,7alpha-dihydroxy-5beta-cholest-24-en-26-oyl CoA to give (24R,25R)-3alpha,7alpha,12alpha,24-tetrahydroxy- and (24R,25R)-3alpha,7alpha,24-trihydroxy-5beta-cholestan-26-oyl CoAs, respectively, and the dehydrogenation catalyzed by DBP also showed high stereospecificity for the above (24R,25R)-isomers to give 3alpha,7alpha,12alpha-trihydroxy- and 3alpha,7alpha-dihydroxy-24-oxo-5beta-cholestan-26-oyl CoAs, respectively. On the other hand, the dehydratase activity of LBP displayed a different diastereoselectivity producing the (24S,25S)-isomer, and dehydrogenase activity of LBP was stereospecific for the (24S,25R)-isomer to give the above 24-oxo-derivative. The hydration and dehydrogenation reactions catalyzed by DBP were effectively conjugated to convert (24E)-5beta-cholestenoyl CoA to 24-oxo-5beta-cholestanoyl CoA. However, the reactions catalyzed by LBP were not conjugated. These results indicate that DBP plays an important role in the biosynthesis of bile acid.

17-Hydroxysteroid Dehydrogenases↗
PubMed2003

Biodegradation of phthalate esters during the mesophilic anaerobic digestion of sludge.

Phthalic acid esters (PAE) are commonly found in the sludge generated in the wastewater treatment plants. Anaerobic digestion followed by land application is a common treatment and disposal practice of sludge. To date, many studies exist on the anaerobic biodegradation rates of PAE, especially of the easily biodegradable ones, whereas the higher molecular weight PAE have reported to be non-biodegradable under methanogenic conditions. Furthermore, there is no information on the effect of the PAE on the performance of the anaerobic digesters treating sludge. In this study, the anaerobic biodegradation of di-n-butyl phthalate (DBP), di-ethyl phthalate (DEP) and di-ethylhexyl phthalate (DEHP) was investigated and their relative rates of anaerobic degradation were calculated. Also, the biological removal of PAE during the anaerobic digestion of sludge in bench-scale digesters was investigated using DBP and DEHP as model compounds of one biodegradable and one recalcitrant PAE respectively. The degradation of all the PAE tested in this study (DEP, DBP and DEHP) is adequately described by first-order kinetics. Batch and continuous experiments showed that DEP and DBP present in sludge are rapidly degraded under mesophilic anaerobic conditions (a first-order kinetic constant of 8.04 x 10(-2) and 13.69 x 10(-2)-4.35 day(-1) respectively) while DEHP is degraded at a rate between one to two orders of magnitude lower (0.35 x 10(-2)-3.59 x 10(-2) day(-1)). It is of high significance that experiments with anaerobic sludge of different origin (US and Europe) showed that degradation of DEHP occurs under methanogenic conditions. Accumulation of high levels of DEHP (more than 60 mg/l) in the anaerobic digester has a negative effect on DBP and DEHP removal rates as well as on the biogas production.

Anaerobiosis↗
PubMed2002

Cytocompatibility study of organic matrix extracted from Caribbean coral porites astroides.

Since 1980, natural coral exoskeleton has been widely used as bone graft substitute. Despite numerous in vitro and in vivo studies. there is still a lack of knowledge concerning the organic matrix associated with coral exoskeleton (COM). In fact, some surgical interventions have failed and this has sometimes been attributed to the exoskeleton organic matrix. For others, only amino acids are present in the matrix after coral preparation for clinical use. The objective of this study was to extract the exoskeleton organic matrix to carry out biochemical analysis and study its specific cytocompatibility. Demineralized bone powder (DBP) was used as control. A decalcification process was used to extract COM and DBP. Protein, carbohydrate and glycosaminoglycan analysis was carried out in DBP and COM using classical staining methods. Human bone marrow cells were cultured in the presence of 20, 40, 80, 160 microg of COM or DBP for 24, 48 and 72 h. The methods used to analyze COM and DBP effects were scanning electron microscopy immunocytochemistry, manual cell count, and cyto-compatibility assay (Neutral red and MTT tests). Results showed that in spite of treating coral before clinical use, a COM was present in which GAG, protein and carbohydrate were found. The in vitro cytocompatibility of COM was confirmed for 20 and 40 microg values but was less pronounced for 80 and 160 microg levels.

Alkaline Phosphatase↗
PubMed2001

Telmisartan plus hydrochlorothiazide versus telmisartan or hydrochlorothiazide monotherapy in patients with mild to moderate hypertension: a multicenter, randomized, double-blind, placebo-controlled, parallel-group trial.

BACKGROUND: Recent surveys reveal continuing deficiencies in the awareness, treatment, and control of hypertension. In many cases, failure to achieve blood pressure targets may be attributable to the use of antihypertensive monotherapy. OBJECTIVES: This study was undertaken to identify combinations of telmisartan, a new oral angiotensin II type 1-receptor antagonist, and hydrochlorothiazide (HCTZ) that might provide greater antihypertensive efficacy than monotherapy with either agent in the treatment of mild to moderate hypertension. It also examined the dose-response surface for the 2 drugs alone and in combination. METHODS: This was a multicenter, randomized, double-blind, placebo-controlled, parallel-group study that employed all cells of a 4 x 5 factorial design. After a 4-week, single-blind, placebo run-in period, men and women between 18 and 80 years of age with mild to moderate hypertension (defined as mean supine diastolic blood pressure [DBP] between 95 and 114 mm Hg during the last 2 weeks of the placebo run-in period and systolic blood pressure [SBP] between 114 and 200 mm Hg immediately before randomization) were eligible to enter the 8-week, double-blind, double-dummy treatment period. Study comparisons were between once-daily telmisartan monotherapy (20, 40, 80, or 160 mg), HCTZ monotherapy (6.25, 12.5, or 25 mg), 12 combinations of these telmisartan/HCTZ doses, and placebo. The focus was on 2 combinations: telmisartan 40 mg/HCTZ 12.5 mg and telmisartan 80 mg/HCTZ 12.5 mg. The primary efficacy variable was change in supine trough DBP from baseline to the last evaluable measurement during double-blind treatment. Plasma renin activity and safety parameters, including treatment-emergent adverse events, physical findings, electrocardiograms, and serum electrolyte levels (which are known to increase with HCTZ treatment), were also assessed. RESULTS: Of 1293 patients screened, 818 (63.3%) were enrolled at 47 centers. Of these 818, 749 (91.6%) completed the study. The intent-to-treat population (randomized with > or = 1 postrandomization blood pressure measurement) consisted of 807 patients (98.7%). Telmisartan 80 mg/HCTZ 12.5 mg significantly decreased mean supine trough SBP/DBP by 23.9/14.9 mm Hg, a benefit of 8.5/3.4 mm Hg compared with telmisartan 80 mg and of 17.0/7.6 mm Hg compared with HCTZ 12.5 mg (both comparisons, P < 0.01). Telmisartan 40 mg/HCTZ 12.5 mg significantly reduced mean supine SBP by 18.8 mm Hg, a benefit of 6.6 mm Hg compared with telmisartan 40 mg and 11.9 mm Hg compared with HCTZ 12.5 mg (both, P < 0.01). This same combination significantly reduced mean supine DBP by 12.6 mm Hg, a benefit of 5.3 mm Hg compared with HCTZ 12.5 mg (P < 0.01), but was not significantly different from telmisartan 40 mg. Telmisartan 80 mg/HCTZ 12.5 mg was significantly more effective than telmisartan 40 mg/HCTZ 12.5 mg in reducing mean supine DBP and SBP (both, P < 0.05). The response surface and responder analyses confirmed the additive antihypertensive efficacy of the combination of telmisartan and HCTZ. All regimens were well tolerated. CONCLUSIONS: Once-daily telmisartan 80 mg/HCTZ 12.5 mg was effective and well tolerated when used to reduce SBP and DBP in patients with mild to moderate hypertension. In addition to enhancing efficacy, this combination protected against potassium depletion, a common side effect of thiazide monotherapy.

Adolescent↗
PubMed2003

Once-daily fixed-combination irbesartan 300 mg/ hydrochlorothiazide 25 mg and circadian blood pressure profile in patients with essential hypertension.

BACKGROUND: More than 60% of patients with hypertension included in morbidity and mortality trials needed >or=2 drugs to achieve a substantial, sustained reduction in blood pressure. Tolerable combinations using higher doses of antihypertensive drugs are frequently required to control blood pressure. OBJECTIVE: The goal of this study was to assess the effect of a once-daily fixed combination of irbesartan 300 mg/hydrochlorothiazide (HCTZ) 25 mg on the circadian blood pressure profile in patients with essential hypertension that was not controlled with full-dose single therapy or low-dose combined therapy. METHODS: Study patients were recruited consecutively from the outpatient hypertension clinics of 3 university hospitals in Spain. After a 1-week washout period, patients with a mean daytime blood pressure >135/85 mm Hg were treated with irbesartan 300 mg/HCTZ 25 mg once daily for 12 weeks. Twenty-four-hour ambulatory blood pressure monitoring was performed at the end of the washout period and during the last week of treatment. RESULTS: Fifty-seven patients with essential hypertension (28 men, 29 women) were enrolled; their mean (SD) age was 60.4 (7.2) years (range, 45-78 years). After treatment, a significant reduction in both clinic and ambulatory mean (SD) blood pressure values was observed in the whole group of 57 patients (from 146.0 [11.0] mm Hg to 123.3 [13.3] mm Hg, P < 0.001 for 24-hour systolic blood pressure [SBP]; from 89.9 [8.2] mm Hg to 76.5 [9.4] mm Hg, P < 0.001 for 24-hour diastolic blood pressure [DBP]. The mean lowering of ambulatory SBP and DBP at peak was 25.2 (14.5) mm Hg and 14.7 (9.5) mm Hg, respectively, and at trough, 22.3 (18.3) mm Hg and 12.3 (10.9) mm Hg. The trough-to-peak ratio of the group was 0.92 for SBP (0.97 in responders) and 0.84 for DBP (0.89 in responders). The smoothness index, calculated as the mean of all individual values, was 1.7 (1.0) for SBP (1.8 [0.9] in responders) and 1.3 (0.8) for DBP (1.5 [0.6] in responders). Seven side effects in 6 patients were reported. No metabolic changes were observed, and no patient discontinued the study because of treatment-related adverse effects. CONCLUSIONS: The fixed combination of irbesartan 300 mg/HCTZ 25 administered once daily produced a crude meaningful effect in reducing 24-hour blood pressure and was well tolerated. The circadian profile was preserved, as shown by trough-to-peak ratios and smoothness index values for both SBP and DBP.

Aged↗
PubMed2002

Vitamin D binding protein gene and genetic susceptibility to type 2 diabetes mellitus in a Polish population.

Polymorphisms of the genes involved in the metabolism of vitamin D may predispose to type 2 diabetes mellitus (T2DM). For example, there is evidence suggesting that vitamin D binding protein (DBP) amino acid variants at codons 416 (aspartic acid-->glutamic acid) and 420 (threonine-->lysine) may affect genetic susceptibility to T2DM. The aims of this study are: (1) to determine the allele, genotype, haplotype and haplotype combination frequencies of those DBP amino acid variants in a Polish population and (2) to examine their role in the genetic susceptibility to T2DM in a Polish population. Overall 393 individuals were included in this study: 231 T2DM patients and 162 controls. The sequence of DBP exon 11, which contains both examined variants, was amplified by polymerase chain reaction (PCR). Alleles and genotypes were determined based on electrophoresis of the DNA digestion products by specific restriction enzymes HaeIII and StyI. Since variants of DBP were in very strong linkage disequilibrium, haplotypes could be assigned to phase-unknown individuals. Differences in distributions between the groups were examined by chi(2) test. At codon 416 the frequency of Asp/Glu alleles was 44.6/55.4% in T2DM patients and 40.7/59.3% in controls (chi(2)=2.1, d.f.=1, P=0.28). At codon 420 the frequency of Thr/Lys alleles were 69.4/30.6% and 71.6/28.4%, (chi(2)=0.41, d.f.=1, P=0.52), respectively. Distribution of genotypes, haplotypes and haplotype combinations were similar in both groups. In conclusion, the frequency of amino acid variants at codons 416 and 420 of vitamin D binding protein gene in a Polish population is similar to other Caucasian populations, but differs significantly from other races. No evidence was found for an association between DBP frequent polymorphisms and T2DM in this population.

Age of Onset↗
PubMed2000

[Evaluation and validation of Omron Hem 705 CP and Hem 706/711 monitors for self-measurement of blood pressure].

OBJECTIVE: To validate two devices for self-measurement of blood pressure--The Omron Hem-705CP and the Omron Hem 706/711--according to the revised protocol of the British Hypertension Society (BHS). The results were also analysed according to the criteria for accuracy of the revised standard of the Association for the Advancement of Medical Instrumentation (AAMI). DESIGN: The British Hypertension protocol for the evaluation of blood pressure measuring devices. SETTING: Primare care. Zone III Health Care in Albacete (Spain). PARTICIPANTS: 95 subjects to validate the Omron 706/711 and 100 subjets to Omron 705. RESULTS: Two monitors surpassed the validation according to the standars set out by the BHS protocol (705 with a A grading for SBP and DBP, 706/711 obtained a B grading for SBP and an A grading for DBP and a PASS for SBP and DBP. Upon analyzing the behavior of the appliances by subgroups of BP measures (high, mid, and low), 705 for SBP > 160 mmHg obtained a B grading for the BHS protocol, but it did not pass the accuracy AAMI criteria (SD, 8.5, but difference between observers-device is -0.1 mmHg). The rest of subgroups of BP obtained a A grading for the BHS protocol and a PASS (AAMI). 706/711 surpassed in all BP subgroups BHS protocol, for DBP 80-100, SBP > 160 and DBP > 100 with a B grading, for the rest of BP subgroups obtained a B grading and a PASS (AAMI). CONCLUSIONS: On the basis of these results, we conclude both monitors Omron HEM 706/711 and the Omron 705CP surpassed the accuracy criteria required for BHS and AAMI, and can be recommended for clinical use.

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