Caucasian Ethnic Groups Research Articles

Do indication and demographics for colonoscopy affect completion? A large national database evaluation

Indication for colonoscopy has not been examined as a predictor of colonoscopy completion. We hypothesized that colonoscopy conducted for colorectal cancer screening might have higher in completion rates than colonoscopy conducted for other indications. The study design was a retrospective cohort. Colonoscopies recorded within the Clinical Outcomes Research Initiative database conducted between 1 January 2002 and 30 June 2003 were analyzed. Indication included: average-risk screening; surveillance; nonspecific abdominal symptoms; bleeding symptoms; or family history of colorectal carcinoma. Demographic factors and indication for colonoscopy were evaluated for the outcome of incomplete colonoscopy using logistic regression analysis. 129 549 Colonoscopy procedures were analyzed. Average risk screening seemed to be protective for completion (relative risk: 0.69; 95% confidence interval: 0.63-0.75). Bleeding and nonspecific symptoms had higher risk of incomplete procedure compared to other indications. Males had higher completion rates compared to females (relative risk: 0.62; 95% confidence interval: 0.58-0.66). Community setting had higher completion rates compared to academic or Veteran's administration sites. Increasing age was associated with higher rate of incomplete colonoscopy. Colonoscopy conducted for screening indication has comparable completion rates when compared with other indications. An overall completion rate of around 95% was noted in this study. This is the largest study to date verifying that completion rates are meeting recommended multisociety guidelines in the USA. Nonspecific abdominal symptoms in Caucasian population, female sex, advanced age, clinical setting, and ethnic groups African-American and Hispanic were found to have increased risk of incomplete procedure.

The dagestan gene pool: Analysis of the frequencies of classical genetic markers in Avars

This study is part of long-term research in the gene pool of Dagestan ethnic groups. The phenotype (in percent), gene, and haplotype frequencies in three Avar populations are reported. A total of 37 alleles of 13 loci of immune and biochemical genetic marker systems (ABO, Rhesus, P, Lewis, HP, GC, C'3, TF, 6PGD, GLO1, ESD, ACP, and PGM1) have been studied. Rare haplotypes of the Rhesus system (CDE, Cde, and cdE) have been found in the populations studied. In two out of three local populations (Khunzakh and Kharakhi), a typically "Caucasoid" rare gene ACP1c of the AcP1 locus has proved to be relatively frequent (0.030 and 0.023, respectively). The frequencies of the allele variants P2, le, and Hp1 of loci of the P, Lewis, and HP systems, respectively, have been found to be lower than in other Caucasian ethnic groups and the total northern Eurasian population. The mean allele frequencies for the GC, C'3, TF, 6PGD, GLO1, and ESD systems in the populations studied are comparable wit those for both Caucasian ethnic groups and the total population of the European historical ethnographic province. Statistical analysis of the results has shown 11 cases of significant deviations of the observed phenotype frequencies from the Hardy-Weinberg equilibrium.

P03-361 - Determination of CYP2C19 and CYP2D6 genotpes in a first-episode psychotic sample

Genetic factors Genetic factors contribute to psychotropic drug response. Some CYP2D6 and CYP2C19 genes polymorphisms have been described to have an important influence on the required therapeutic doses of antidepressants and antipsychotics. The knowledge on this can help to avoid and manage drug-drug interactions.ObjectivesTo describe the prevalence of the different phenotypes for genes CYP2C19 and CYP2D6 in a population of first episode psychotic patients and its relation to clinical outcome, dose and race during a 2 years follow-up period.MethodsPatients with a first psychotic episode were recruited form January 2006 to January 2009. Clinical and treatment related variables were registered at baseline and during a 2 years follow up period. CYP2D6 and CYP2C19 genotype were determined.ResultsFrom the 48 initially recruited patients, 21 (44%) were genetically determined. Amongst them, 13 subjects (62%) presented an efficient phenotype for the CYP2D6, 3(14%) presented an increased phenotype (ultra rapid metabolizers), 3 (14%) were intermediate metabolizers and 2 (9%) were poor metabolizers. All the patients presented an efficient phenotype for CYP2C19. The patients were Caucasian (71%) and other ethnic groups (29%). Patients were treated with risperidone (42,85%), olanzapine (47,61%), clozapine (4,76%) and aripiprazol (4,76%).ConclusionsMost of the patients presented an efficient phenotype. However a considerable proportion were ultrarapid or poor metabolizers. Due to the small sample size, differences between ethnic groups, relapse or drug intolerance could not be found, however first glance differences were not apparent. Further studies using larger samples and considering other confounding factors would be needed.

Do Caucasian and Asian clocks tick differently?

The Period 3 and Clock genes are important components of the mammalian molecular circadian system. Studies have shown association between polymorphisms in these clock genes and circadian phenotypes in different populations. Nevertheless, differences in the pattern of allele frequency and genotyping distribution are systematically observed in studies with different ethnic groups. To investigate and compare the pattern of distribution in a sample of Asian and Caucasian populations living in Brazil, we evaluated two well-studied polymorphisms in the clock genes: a variable number of tandem repeats (VNTR) in PER3 and a single nucleotide polymorphism (SNP) in CLOCK. The aim of this investigation was to search for clues about human evolutionary processes related to circadian rhythms. We selected 109 Asian and 135 Caucasian descendants. The frequencies of the shorter allele (4 repeats) in the PER3 gene and the T allele in the CLOCK gene among Asians (0.86 and 0.84, respectively) were significantly higher than among Caucasians (0.69 and 0.71, respectively). Our results directly confirmed the different distribution of these polymorphisms between the Asian and Caucasian ethnic groups. Given the genetic differences found between groups, two points became evident: first, ethnic variations may have implications for the interpretation of results in circadian rhythm association studies, and second, the question may be raised about which evolutionary conditions shaped these genetic clock variations.

Colorectal cancer: presentation and outcome in British South Asians

Colorectal cancer (CRC) has a lower incidence in patients of South Asian origin compared with British Caucasians. There are however little data available regarding the demographics of these patients, their presentation and outcome. Leicester has a high South Asian immigrant population, and we aim to define any potential differences in presentation, pathogenesis and outcome between our Caucasian and South Asian ethnic groups. All patients of South Asian origin were identified from the Leicester CRC database between June 1998 and April 2007. Data were analysed regarding the patients' demographics, the presentation and treatment details, tumour characteristics and clinical outcome. Data were compared with Caucasian patients from the same database. Patients from an ethnic background other than South Asia or Caucasians were excluded from analysis. 3435 patients were included in the analysis, of which 134 (3.9%) were of South Asian ethnicity. 61.9% of South Asian patients were male compared with 56% of Caucasians. South Asians were significantly younger at presentation (61.4 vs 70.6 years, P < 0.001). South Asian patients had significantly more rectal tumours than their Caucasian counterparts (P = 0.002). South Asian patients were more likely to require initial oncological therapy, and were less likely to have resectional surgery than Caucasians (P = 0.006). Of the patients undergoing resectional surgery, the ASA grade, mode of surgery, tumour characteristics and Dukes' stage were similar. There was no difference in 5-year survival between the South Asian and Caucasian patients. Patients of South Asian ethnicity are younger at their age of presentation and have a higher proportion of rectal tumours compared with British Caucasian patients. They are more likely to require initial oncological treatment and are less likely to undergo resectional surgery, therefore suggesting more advanced disease at presentation. Overall 5-year survival is the similar.

Longevity disparities in multiethnic Hawaii: an analysis of 2000 life tables.

We examined differences among seven major ethnic groups in Hawaii in life expectancy at birth (e[0]) and mortality at broad age groups. We constructed life tables for 2000 for Caucasian, Chinese, Filipino, Hawaiian, Japanese, Korean, and Samoan ethnic groups in Hawaii. We partitioned overall mortality into broad age groups: <15 (representing premature mortality), 15-65 (representing working age), and 66-84 and > or =85 (representing senescent mortality). The overall e(O) in Hawaii was 80.5 years, but the difference between the longest-living group (Chinese) and the shortest-living group (Samoan) was 13 years. Chinese had the lowest mortality rates in each age group except the > or =85 category. In this last age group, we observed anomalously low rates for some new immigrant groups (especially Samoan males) suggesting, as a cause, that elders in these immigrant groups may return to natal countries in their old age and die there. In the <15 age group, mortality rates for Samoans and Koreans were highest, especially for Korean girls, suggesting some continuance in the U.S. of a preference for boy children. Outside of these anomalies, ethnic differences in e(O) were likely explained by socioeconomic and behavioral variables known to affect mortality levels, which are closely associated with ethnicity in Hawaii. These findings confirm the need to disaggregate Asian and Pacific Islander data, to conduct ethnic-specific research, and to address socioeconomic disparities.

A Four-Month Randomized, Double-Blind Evaluation of the Efficacy of Botulinum Toxin Type A for the Treatment of Glabellar Lines in Women with Skin Types V and VI

Histologic differences (e.g., dermal thickness, collagen fibers) between Caucasian and other racial and ethnic groups may affect wrinkle formation and influence responses to treatment with botulinum toxin type A (BoNT-A). To evaluate the degree and duration of efficacy of 20 and 30 U of BoNT-A for the treatment of glabellar lines in African-American women with skin types V and VI. Women aged 18 to 65 with a glabellar rhytid score of 2 or more at maximum frown on an investigator-rated 4-point facial wrinkle scale (FWS; 0=none, 3=severe) were eligible for this study. Patients were randomly assigned to receive 20 U or 30 U of BoNT-A in the glabellar region. Evaluations were conducted at baseline and days 30, 60, 90, and 120 postinjection. The investigator and patient graded the severity of wrinkles at maximum frown and repose on the same 4-point FWS. BoNT-A was administered at the assigned dose, divided between five equal intramuscular injections into the procerus muscle, each corrugator muscle, and a site above the midpupillary line on each side. The percentage of responders at maximum frown did not differ significantly between the two groups. Although not statistically significant, the effect lasted somewhat longer in the subjects receiving the 30 U dose. No differences were evident between groups at repose through day 120. Adverse events were mild and transient and did not differ between the groups. These results indicate that doses of 20 and 30 U of BoNT-A demonstrate efficacy and safety in African-American women with skin types V and VI.

The dagestan gene pool: The genetic structure of the nine largest ethnic groups: Analysis based on data on the AB0 and Rhesus blood groups

Detailed analysis of the population structure of Dagestan ethnic groups based on data on the ABO and Rhesus blood groups has been carried out. A total of 32101 representatives of the nine largest ethnic groups of Dagestan (from 682 auls in 46 raions) have been examined. This allows a comprehensive genetic landscape of the Dagestan population to be drawn. Comparison of the ethnic groups studied with other Caucasian ethnic groups makes it possible to determine the position of the Dagestan gene pool in the total structure of the Caucasian gene pool.

The differences in the ankle range of motion in distinct ethnical groups measured by goniometry

SummaryThe aim of this study was to evaluate if there are any differences in the range of motion of the ankle joint for distinct ethnicities measured by goniometry. A total of 288 ankles of 152 individuals were evaluated and divided into four ethnic groups: 18 male and 20 female Caucasians (75 ankles), 11 male and 26 female Oriental individuals (72 ankles), 25 male and 16 female Black people (70 ankles) and 19 male and 17 female Mulattos (71 ankles). All of the participants were of similar ages and were examined in a single evaluation in the morning by the same examiner using the same goniometric device. Statistical analysis was achieved using means and standard deviation and a comparison of the scores, z-statistics of the normal distribution were calculated with an alpha error of 5% considered acceptable. The total mean obtained from all ethnical groups, considering both left and right legs and both genders, was 60.45°. The averages of the distinct ethnicities were: 63.84° for Caucasians, 66.91° for Orientals, 55.21° for Black people and 55.87° for Mulattos. All groups were significantly different in relation to ankle motion range compared to the other groups, except between Black people and Mulattos. There were statistically significant differences when separately analyzing the means of goniometric measures of the right and left ankles in men and women of the Caucasian and Oriental ethnic groups. Conclusion: There are significant differences in respect to the ankle motion range among the distinct pure ethnic groups and there is a predominance of characteristics of Black people in the Mulatto group in respect to this variable compared to Caucasian traits.

Lack of association between the Pro12Ala polymorphism of the PPAR-γ2 gene and type 2 diabetes mellitus in the Qatari consanguineous population

Peroxisome proliferators-activated receptor gamma (PPAR gamma) is a nuclear hormone receptor that serves as a master regulator for adipocytes-specific genes contributing to adipocytes differentiation, insulin sensitivity and lipid metabolism. The substitution of proline to alanine at codon 12 of the PPAR gamma 2 gene (Pro12Ala polymorphism) is most widely studied, and the associations with diabetes, obesity, and other clinical parameters have been reported and discussed in several ethnic groups. Among native Qatar ethnicity, however, there is no report about this polymorphism. The aim of this study was to estimate the allele frequency of the Pro12Ala polymorphism of PPAR gamma 2 gene among Qatari population and investigate the association between this polymorphism and obesity or type 2 diabetes. This is a matched case-control study. It was carried out among diabetic patients and healthy subjects at the Primary Healthcare Clinics, and the survey was conducted from February 2003 to March 2006 in Qatari male and female nationals aged 35 to 60 years. The study was based on matched age, sex, and ethnicity of 400 cases (with diabetes) and 450 controls (without diabetes). Face-to-face interviews were based on a questionnaire that included variables such as age, sex, sociodemographic status, body mass index (BMI), and obesity. Their health status was assessed by medical conditions, family history, and blood pressure measurements. The allele frequency of Pro12Ala polymorphism in PPAR gamma 2 gene among Qataris is lower than that in many Caucasian ethnic groups. No association is seen between the Pro12Ala and type 2 Diabetes (0.055 vs 0.059, OR = 1.1311, P = 0.669). Nearly half of the diabetic type 2 patients (48.5%) were obese (BMI > 30) compared to nondiabetic subjects (29.8%) (P < 0.001). In this study, no association is seen between the Pro12Ala polymorphism in PPAR gamma 2 gene and the type 2 diabetes in Qatar.

Secular trends in the cardiovascular risk profile and mortality of stroke admissions in an inner city, multiethnic population in the United Kingdom (1997–2005)

Our objective was to study ethnic differences in the cardiovascular risk profile and mortality of stroke admissions to an inner city teaching hospital serving a multiethnic population in Birmingham, UK, over a 9-year period (1997-2005). Hospital case notes and registry data of 3083 patients admitted with a first onset stroke were reviewed. Secular trends in the prevalence of risk factors (hypertension, diabetes, hyperlipidaemia, atrial fibrillation and myocardial infarction), hospital admission rates and 30-day mortality among Afro-Caribbean, European Caucasian and South Asian ethnic groups were analysed. Between 1997 and 2005, there were 3083 first onset strokes, of whom 47.6% (1595) were men, 9.3% Afro-Caribbean, 57.8% European Caucasian and 15.1% South Asian. There was a significant trend towards a reduction in non-haemorrhagic stroke admissions over the study period (P<0.001), with no ethnic variation (P=0.07). Increases in hypertension and hyperlipidaemia were observed (P<0.001), whereas myocardial infarction showed a decline (P<0.001). Compared to other ethnic groups, South Asian patients were younger on admission (P<0.001), had more hyperlipidaemia (P<0.05) and poorer survival at 30 days (P=002). We conclude that cardiovascular risk profiles among patients admitted with non-haemorrhagic stroke have changed over the last decade. In particular, hyperlipidaemia has increased, especially among South Asians. The reduced decline in stroke admissions and 30-day survival of stroke in South Asians in recent years warrants further investigation and highlights the importance of a targeted health-care approach in the migrant ethnic minorities.

On the History of the North Caucasian Diaspora in Turkey

AbstractThe preservation of the ethno-linguistic and cultural identity of the majority of the North Caucasian ethnic groups for almost one and a half centuries following their migration to Turkey and other Near Eastern countries is a unique ethno-social phenomenon. The paper discusses several aspects of the history, socio-political life, and the ethnic development of the North Caucasian migrants in the Ottoman Empire (resp. the Republic of Turkey). The author takes into account the following factors in discussing the problem: the state regimes and the legal status of the ethnic minorities in Turkey; the ethnic characteristics and the level of social, economic, and cultural development of the local population; the intensity of the contacts with the historical homeland; and the character of interrelations between the country of habitation (Turkey) and Russia/USSR.

Testicular self-examination: change in rates of practice in European university students, from 13 countries, over a 10-year period

Background The objective of this study was to compare testicular self-examination (TSE) practice in 13 European countries over a 10-year period. Testicular cancer predominantly affects young men. It is rare but on the increase and is most common in Caucasian ethnic groups living in industrialised nations, particularly northern Europe. Stage and prognosis are related to early diagnosis and TSE has been advocated to help achieve this. Over the last 15 years there have been efforts to increase disease awareness and self-examination practice. Recent reductions in patients’ delay in seeking help have been attributed to the success of this education, although no evidence has been available to substantiate this claim. Methods Data from two successive international surveys in male student populations in Europe ( n = 4322, n = 4358) carried out in 1990 and 2000, respectively, are described. Results Although TSE practice rates are low, there have been significant increases over this 10-year period. Conclusions Increased TSE may reflect greater awareness of testicular cancer and could contribute to more timely help-seeking.

P01.05: The effect of ethnicity on first‐trimester nasal bone assessment

To determine whether first-trimester nasal bone assessment varies with ethnicity. Nasal bone was prospectively evaluated in 5,193 patients undergoing first-trimester combined ultrasound and biochemical screening in the United States. Among these patients 19 had absent nasal bone and in 1075 patients nasal bone length was evaluated. Nasal Bone length was adjusted for gestational age and the nasal bone MoM values were then compared with maternal weight and ethnicity. Median nasal bone MoM vales for ethnic groups were compared using the Kruskal-Wallis test. ×CRL.6415. Using this formula, expected nasal bone length was 1.6 at 45 CRL and 2.3 at 84 CRL. The correlation of maternal weight with nasal bone MoM was statistically (P = 0.036) but not clinically significant. Expected nasal bone MoM = 0.96,1.02,1.06 at 100, 200 and 300 lbs., respectively. The median nasal bone MoM was 0.98 for Caucasions (n = 766), 0.99 for African Americans (n = 45), 1.02 for Asian Indians (n = 52), 0.98 for Asians (n = 65), 1.00 for Hispanics (n = 82) and 1.00 in others (n = 65). The differences were not significant (P = 0.779). The rate of absent nasal bone was 13/3835 (0.3%), 0 of 266 (0.0%), 2 of 152 (1.3%), 1 of 313 (0.3%), 3 of 343 (0.9%), 0 of 284 (0.0%) for the Caucasian, African American, Asian Indian, Asian, Hispanic and Other ethnic groups, respectively. Nasal bone was absent in 13/3835 (0.3%) Caucasian, 0/266 (0.0%) African American, 2/152 (1.3%) of Asian Indian, 1/313 (0.3%) Asian, 3/343 (0.9%) Hispanic and 0/284 (0%) Other ethnic groups. These percentages were not significantly different (X2 = 8.3, P = 0.140). The data indicate that any differences in nasal bone length or absent/presence amongst the various ethnic groups are likely to be insignificant or can be accounted for with minor adjustments.

Prevalence of Prothrombotic Abnormalities in Patients with Acute Mesenteric Ischemia

Acute mesenteric ischemia (AMI) is a rare condition that may be associated with a variety of congenital prothrombotic disorders (PDs). The purpose of this study was to assess the prevalence of these disorders in 28 AMI patients compared with 103 healthy individuals from the northeastern region of Turkey. They were screened for protein C, antithrombin III, and protein S deficiencies; and gene analysis was performed using the polymerase chain reaction. A PD was revealed in 16 (57%) patients and 33 (32%) controls (p = 0.020). Factor V Leiden (FVL), prothrombin G20210A mutation, and TT677 homozygous mutation of methylenetetrahydrofolate reductase was detected in 10 (36%) patients versus 16 (15%) controls (p = 0.035), 3 (11%) patients versus 10 (9%) controls (p = 1.00), and 1 (3%) patient versus no controls, respectively. Consistent with caucasian ethnic groups, there was high prevalence of PDs, especially FVL; and these abnormalities might be a significant predisposing factor in the pathogenesis of AMI.

Genetic Demographic Structure of the Belgorod Population: Age, Ethnicity, Education, and Occupation

Data from marriage records of the city of Belgorod for 1960, 1985, and 1995 have been used to determine some parameters of population structure in this city. The coefficients of correlation with respect to age of marriage between spouses in the couples contracting marriages in these years were 0.74, 0.62, and 0.80, respectively. Women of reproductively unfavorable age (under 20 or over 30 years) accounted for 5.5, 0.83, and 19% of all women contracting marriages in these years, respectively. The proportions of interethnic marriages in these years were 16.9, 14.9, and 15.6%, respectively. The percentage of Slavs decreased from 99 to 97% during the 35 years studied, whereas the proportion of Russians insignificantly increased (from 90.4 to 91.4%). The proportion of Caucasian ethnic groups increased by six time (from 0.3 to 1.8%), and that of other non-Slavic ethnic groups increased by almost two times (from 0.7 to 1.2%). The marriage convergence (K) with respect to ethnicity (0.095, 0.106, and 0.090 in 1960, 1985, and 1995, respectively) was lower than that with respect to education (0.296 and 0.350 in 1985 and 1995, respectively) or occupation (0.212 and 0.231 in 1985 and 1995, respectively). The maximum coefficients of ethnically, educationally, and occupationally assortative marriage have been found, respectively, in ethnic minority groups (A' = 20%); in persons with higher and primary education (A' = 37.5 and A' = 49.9%, respectively); and in the military officers/soldiers, engineers, healthcare professionals, and researchers (the respective A' values are 65.6, 32.2, 31.5, and 39.8%).

Molecular screening and association analyses of the interleukin 6 receptor gene variants with type 2 diabetes, diabetic nephropathy, and insulin sensitivity.

IL-6 levels and polymorphisms have been implicated in type 2 diabetes mellitus (T2DM) and insulin resistance. The IL-6 receptor (IL-6R) comprises two subunits, IL-6R and gp130, of which IL-6R confers specificity to IL-6 action and is located in a region of replicated linkage to T2DM on chromosome 1q21. We screened this gene for variation in Northern European Caucasian and African-American ethnic groups. We identified 11 variants with a minor allele frequency over 5%, including two amino acid changes (D358A and V385I) and four variants in the 3' untranslated region. No variant was associated with obesity or measures of insulin sensitivity, but two single nucleotide polymorphisms in the 3' untranslated region showed a trend to an association with T2DM in all Caucasians, and three single nucleotide polymorphisms, including D358A, showed a trend (P < 0.06) to an association with T2DM among the subset of Northern European Caucasians. Variant V385I was unique to African-Americans and was significantly associated with diabetes and diabetic nephropathy (P < 0.05). Among individuals heterozygous for the four variants in the transcribed sequence, one allele was significantly overrepresented, thus suggesting the existence of a regulatory variant controlling mRNA stability or expression. IL-6R is not likely to explain the linkage to diabetes in this region, but our work supports a minor role of variants in T2DM risk and suggests that sequence variants may alter IL-6R mRNA levels and possibly levels of soluble IL-6R.

Prevalence and HLA association of GAD65 antibodies in Hungarian schoolchildren

Pancreas β-cell autoantibodies are important tools in prediction of type 1 diabetes, however, background frequencies of these markers reveal considerable population-specific variations. The aim of current study was to determine the frequency of glutamic acid decarboxylase (65kD) antibodies (GADA) in healthy Hungarian schoolchildren ( n = 2,664) and to correlate development of GADA with HLA DQ genotypes. GADA was determined using a radioligand assay (cut-off limit: 97.5th percentile); HLA DQ genotypes were identified with allele-specific polymerase chain reaction. Thirty-five children (1.3%) tested positive for GADA among which the proportion of girls was significantly higher when compared with boys (1.8% and 0.8%, p = 0.03). The study population was followed for 5.2 years and one girl in the whole cohort, who tested positive for GADA, has developed diabetes. HLA DQ2/DQ8 and DQ2/y genotypes (where y ≠ DQB1*0302, *0301, *0602, *0603) were significantly more prevalent in the GADA positive group than in antibody negative children (17.1% vs 1.7%, p = 0.0003 and 25.7% vs 10.3%, p = 0.027, respectively). In conclusion, the prevalence of GADA in the Hungarian general population is in the middle of the range found in other Caucasian ethnic groups. Individuals carrying HLA DR3-DQ2 haplotype and females were more prone to develop GADA. We suggest that for future screening programs it is important to determine predictive value of islet-cell antibodies in populations with varying disease incidence.

Galantamine Pharmacokinetics, Safety, and Tolerability Profiles Are Similar in Healthy Caucasian and Japanese Subjects

The aim of this study was to compare the pharmacokinetics of galantamine in healthy Japanese and Caucasian subjects and assess the safety and tolerability of galantamine in both ethnic groups. Parallel groups of healthy Japanese (n = 13; 6 males and 7 females)and Caucasian (n = 12; 6 males and 6 females) subjects matched for weight and age received single oral doses of galantamine 4 mg, or galantamine 8 mg, or placebo in a double-blind, three-way crossover trial according to a randomized dosing schedule. Concentrations of galantamine and norgalantamine were determined in plasma and urine samples taken up to 48 and 24 hours after dosing, respectively. Safety and tolerability were monitored throughout the trial by recording adverse events, laboratory tests, and cardiovascular parameters. The mean plasma concentration-time profiles of galantamine were very similar after single doses of galantamine (4 and 8 mg), and there was an approximate dose proportionality of galantamine pharmacokinetic parameters in both Caucasian and Japanese ethnic groups. The mean (+/- SD) pharmacokinetic parameters in the two ethnic groups did not show any clinically relevant differences. The ratios for the area under the plasma-concentration curve from time zero to infinity (AUC)0-infinity) in Japanese:Caucasian subjects with 4 and 8 mg doses were 103% (90% confidence interval [CII = 92-116) and 107% (90% CI = 94-121), respectively. Ratios for maximum plasma concentration (Cmax) values were 107% (90% CI= 90-127) and 108% (90% CI= 95-123), respectively. These ratios and associated 90% CIs were within the 80% to 125% range limit of bioequivalence. Analysis of variance (ANOVA) showed that these ratio values demonstrated no statistically significant difference between the two ethnic groups. There was no overt difference in the adverse event profile in Japanese subjects compared with Caucasian subjects. There were no serious adverse events, and no subjects discontinued from the study because of adverse events. No consistent or clinically relevant pattern of blood chemistry, hematology, or cardiovascular changes was seen. These results suggest that the pharmacokinetic profiles of galantamine after single-dose administration are not statistically significantly different between Caucasian and Japanese groups. Galantamine was well tolerated. The safety and tolerability of galantamine were very similar in the two ethnic groups.

Predicting risk of preterm birth: the roles of stress, clinical risk factors, and corticotropin-releasing hormone.

The relationships and predictive abilities of perceived stress, selected clinical risk factors, and corticotropin-releasing hormone (CRH) levels in maternal plasma were investigated for their association with preterm labor (PTL), preterm birth, and gestational age at delivery. An exploratory, prospective, longitudinal research design was used to measure CRH 4 times over pregnancy, perceived stress at 24 and 32 weeks of pregnancy, clinical risk factors, and genitourinary infections in low-income women. Multiple regression analyses revealed that a model of measurement ofperceived stress at 24 or 32 weeks, CRH at 24 or 32 weeks, and PTL (indicated by a diagnosis by the physicians on the medical record and greater than 5 contractions per hour on the fetal monitor) was predictive of as much as 0.23 to 0.27 of the variance in gestational age at birth. Entering ethnicity as a variable into a model did not improve the predictive value. An analysis of variance between Caucasian and Hispanic ethnic groups revealed differences in CRH levels. However, simple regression analysis of ethnicity as a predictor showed a weak r2 with no significance for prediction. There was some evidence of an association of smoking with stress and both PTL and preterm birth. The measurement of stress combined with the measurement of CRHfrom maternal plasma may improve the prediction of which pregnant women are at riskfor pretern birth. The measurement of CRH has potential as an early biological marker of preterm birth.