Association between Socioeconomic Status and Major Risk Factors of Stroke: Thai Epidemiologic Stroke (TES) Study.

OBJECTIVE: To investigate the association of socioeconomic status (SES) (education, personal income, and occupation) with four major risk factors of stroke, those are diabetes, hypertension, hypercholesterolemia, and current smoker MATERIAL AND METHOD: The Thai Epidemiologic Stroke Study is a community-based cohort study, which recruitedparticipants from the general population from five geographic regions around the country. Cross-sectional baseline data of 19,997 (6,803 men and 13,194 women) participants, aged 45 to 80 years were included in the present analysis. Multiple logistic regression analysis was used to estimate association ofsocioeconomic indicators with the major risk factors of stroke. RESULTS: SES was associated with a major risk factor of stroke. Among three indicators ofsocioeconomic status, education was more consistently associated with the risk factors than personal income and occupation, particularly in women. Education significantly inversely associated with diabetes (p = 0.015 in men and 0.002 in women, respectively), and current smoker in both sexes (p < 0.001), and with hypertension in women (p = 0.011). By contrast, education was significantly positively associated with hypercholesterolemia in women (p < 0.001). CONCLUSION: The differences in the prevalence of the major risk factors of stroke between SES groups were important, and should be considered in the development ofpolicies or tailored strategies for prevention of stroke.

Prognostic factors and treatment effect in the CHIMES study.

BACKGROUND: Stroke trials often analyze patients with heterogeneous prognoses using a single definition of outcome, which may not be applicable to all subgroups. We aimed to evaluate the treatment effects of MCL601 among patients stratified by prognosis in the Chinese Medicine Neuroaid Efficacy on Stroke Recovery (CHIMES) study. METHODS: Analyses were performed using data from the CHIMES study, an international, randomized, placebo-controlled, double-blind trial comparing MLC601 with placebo in patients with ischemic stroke of intermediate severity in the preceding 72 hours. All subjects with baseline data and the modified Rankin Scale (mRS) score at 3 months were included. RESULTS: Data from 1006 subjects were analyzed. The predictive variables for mRS score greater than 1 at month 3 were age older than 60 years (P < .001), baseline National Institutes of Health Stroke Scale score 10-14 (P < .001), stroke onset to initiation of study treatment of more than 48 hours (P < .001), and female sex (P = .026). A higher number of predictors was associated with poorer mRS score at month 3 for both placebo (P < .001) and treatment (P < .001) groups. The odds ratio (OR) for achieving a good outcome increased with the number of predictors and reached statistical significance in favor of MLC601 among patients with 2 to 4 predictors combined (unadjusted OR = 1.44, 95% confidence interval, 1.02-2.03; adjusted OR = 1.60, 95% confidence interval, 1.10-2.34). CONCLUSIONS: Age, sex, baseline National Institutes of Health Stroke Scale score, and time to first dose are predictors of functional outcome in the CHIMES study. Stratification by prognosis showed that patients with 2 or more predictors of poorer outcome have better treatment effect with MLC601 than patients with single or no prognostic factor. These results have implications on designing future stroke trials.

Factors predicting high estimated 10-year stroke risk: thai epidemiologic stroke study.

BACKGROUND: The purpose of the study was to determine the factors predicting high estimated 10-year stroke risk based on a risk score, and among the risk factors comprising the risk score, which factors had a greater impact on the estimated risk. METHODS: Thai Epidemiologic Stroke study was a community-based cohort study, which recruited participants from the general population from 5 regions of Thailand. Cross-sectional baseline data of 16,611 participants aged 45-69 years who had no history of stroke were included in this analysis. Multiple logistic regression analysis was used to identify the predictors of high estimated 10-year stroke risk based on the risk score of the Japan Public Health Center Study, which estimated the projected 10-year risk of incident stroke. RESULTS: Educational level, low personal income, occupation, geographic area, alcohol consumption, and hypercholesterolemia were significantly associated with high estimated 10-year stroke risk. Among these factors, unemployed/house work class had the highest odds ratio (OR, 3.75; 95% confidence interval [CI], 2.47-5.69) followed by illiterate class (OR, 2.30; 95% CI, 1.44-3.66). Among risk factors comprising the risk score, the greatest impact as a stroke risk factor corresponded to age, followed by male sex, diabetes mellitus, systolic blood pressure, and current smoking. CONCLUSIONS: Socioeconomic status, in particular, unemployed/house work and illiterate class, might be good proxy to identify the individuals at higher risk of stroke. The most powerful risk factors were older age, male sex, diabetes mellitus, systolic blood pressure, and current smoking.

Blood pressure control among stroke patients in Thailand--the i-STROKE study.

BACKGROUND: Direct correlation between stroke mortality and hypertension calls for a tight blood pressure (BP) control. Our study determined the prevalence of the BP control and evaluated current clinical practices on hypertension management in stroke patients in Thailand. METHODS: This multicenter, cross-sectional, retrospective, observational study was carried out between February 2010 and January 2011 and enrolled stroke patients aged 45 years or older with ictus incidence 12,030 days before the enrollment. The events were confirmed by either computerized tomography scan or magnetic resonance imaging. Patient data including demographics, medical, and clinical history were collected. RESULTS: At enrollment, 274 of 558 (49.1%) patients had controlled arterial BP with an average pressure of 134.220.4/78.812.8 mm Hg; 412 (73.8%) patients received antihypertensive medications and the most common use was angiotensin-converting enzyme inhibitors (ACEIs), reported in 200 (35.8%) patients. With questionnaire, insufficient antihypertensive use and lack of patients' awareness were the 2 most common reasons given by physicians for the patients' uncontrolled BP. Factors identified to have adverse association with the controlled BP at enrollment were diabetes at baseline, stage II hypertension, stage I hypertension, and the use of ACEIs at discharge (odds ratio of .18, .24, .30 [P < .001], and .53 [P = .009], respectively). CONCLUSIONS: Despite clinical evidence of the benefits of the BP control in reduction of secondary stroke events, a substantial number of stroke patients in Thailand do not achieve their BP targets, and this could possibly be a result of inadequate use of antihypertensive therapies and lack of compliance to BP management guidelines.

Effect of CYP3A5 genotypes on the pharmacokinetics of carbamazepine when used as monotherapy or co-administered with phenytoin, phenobarbital or valproic acid in Thai patients.

PURPOSE: To determine the effects of CYP3A5 polymorphisms on carbamazepine (CBZ) pharmacokinetic parameters when CBZ is used either as monotherapy or co-administered with phenytoin (PHT), phenobarbital (PB) or valproic acid (VPA). METHODS: Retrospective data were collected from an electronic database and medical records. Blood samples were obtained and drug concentrations analyzed as a part of routine therapeutic drug monitoring (TDM). Screening for wild-type CYP3A5*1 and CYP3A5*3 single nucleotide polymorphism (rs776746) by allelic discrimination assay using real-time polymerase chain reaction technique (real-time PCR) was performed. Pharmacokinetic parameters of CBZ; clearance and dose-adjusted CBZ levels in patients with different genotypes were calculated and compared. RESULTS: Of the 70 patients assessed, 8 (11%) patients were homozygous CYP3A5*1/*1, 28 (40%) patients were heterozygous CYP3A5*1/*3, and 34 (49%) patients were homozygous CYP3A5*3/*3. The CBZ clearance and dose-adjusted CBZ levels did not significantly differ between patients with CYP3A5*1 and CYP3A5*3 alleles when CBZ was used as monotherapy. For patients who used CBZ in combination with an enzyme-inducing antiepileptic drug (AED: PHT or PB), individuals carrying the CYP3A5*1 allele (CYP3A5 expressers) showed a trend of having higher CBZ clearance and lower dose-adjusted CBZ level as compared to individuals carrying the CYP3A5*3 allele, even though no statistical significance was recorded. Nevertheless, it was observed that AEDs significantly increased CBZ clearance only in patients carrying the active CYP3A5*1 allele. CONCLUSIONS: When CBZ was used in combination with enzyme-inducing AED, CYP3A5 expressers yielded a trend toward greater susceptibility to change in CBZ clearance and showed lower dose-adjusted CBZ levels compared to CYP3A5 non-expressers. The dosage regimen should be adjusted accordingly to gain a better clinical outcome.This article is open to POST-PUBLICATION REVIEW. Registered readers (see "For Readers") may comment by clicking on ABSTRACT on the issue's contents page.

Chinese medicine neuroaid efficacy on stroke recovery: a double-blind, placebo-controlled, randomized study.

BACKGROUND AND PURPOSE: Previous clinical studies suggested benefit for poststroke recovery when MLC601 was administered between 2 weeks and 6 months of stroke onset. The Chinese Medicine Neuroaid Efficacy on Stroke recovery (CHIMES) study tested the hypothesis that MLC601 is superior to placebo in acute, moderately severe ischemic stroke within a 72-hour time window. METHODS: This multicenter, double-blind, placebo-controlled trial randomized 1100 patients with a National Institutes of Health Stroke Scale score 6 to 14, within 72 hours of onset, to trial medications for 3 months. The primary outcome was a shift in the modified Rankin Scale. Secondary outcomes were modified Rankin Scale dichotomy, National Institutes of Health Stroke Scale improvement, difference in National Institutes of Health Stroke Scale total and motor scores, Barthel index, and mini-mental state examination. Planned subgroup analyses were performed according to age, sex, time to first dose, baseline National Institutes of Health Stroke Scale, presence of cortical signs, and antiplatelet use. RESULTS: The modified Rankin Scale shift analysis-adjusted odds ratio was 1.09 (95% confidence interval, 0.86-1.32). Statistical difference was not detected between the treatment groups for any of the secondary outcomes. Subgroup analyses showed no statistical heterogeneity for the primary outcome; however, a trend toward benefit in the subgroup receiving treatment beyond 48 hours from stroke onset was noted. Serious and nonserious adverse events rates were similar between the 2 groups. CONCLUSIONS: MLC601 is statistically no better than placebo in improving outcomes at 3 months when used among patients with acute ischemic stroke of intermediate severity. Longer treatment duration and follow-up of participants with treatment initiated after 48 hours may be considered in future studies. CLINICAL TRIAL REGISTRATION: URL: http://www.clinicaltrials.gov. Unique identifier: NCT00554723.

Rivastigmine patch for treatment of Alzheimer's disease in clinical practice in Thailand.

BACKGROUND: Rivastigmine is a cholinesterase inhibitor for treatment of mild to moderate Alzheimer's disease (AD) and dementia associated with Parkinson's disease. The new patch formulation was recently made available. We assessed the safety, tolerability, and cognitive outcome of rivastigmine patch in treatment of mild to moderate AD in clinical practice in Thailand. METHODS: A multicentre, hospital-based, prospective observational study was conducted in nine hospitals across Thailand. Patients with probable mild to moderate AD who received the rivastigmine patch were enrolled. Data were collected data at baseline, weeks 4-8 and after week16. RESULTS: A total of 116 AD patients were screened, and three were excluded. Of 113 patients, 62.8% were women with a mean age of 73.3 ± 9.2 years; 79.7% were newly diagnosed. One-third of all patients had been using antipsychotic or antidepressant medication. Common comorbidities were hypertension and dyslipidemia. The Thai Mental State Examination score significantly increased from 18.6 to 20.3 (weeks 4-8) and 20.4 (week 16+) (P < 0.001). Scores based on physicians' (Clinical Global Impression) and caregivers' (Patients' Caregiver Global Impression of Change) impressions of improvement suggested minimal improvement. Because of adverse events, seven patients's dosages were reduced 10 cm(2) to 5 cm(2) or from 5 cm(2) to nothing. Itching was the most common adverse symptom. CONCLUSIONS: During the first 16 weeks after initiation of rivastigmine patch therapy, patients with probable mild to moderate AD had statistically significant improvement in cognitive function, but clinically marginal benefit. Rivastigmine was safe and well tolerated.

Influence of the UGT2B7 -161C>T polymorphism on the population pharmacokinetics of lamotrigine in Thai patients.

BACKGROUND AND OBJECTIVES: A high inter-individual variability in the pharmacokinetics of lamotrigine has been observed. Lamotrigine is primarily metabolized by UGT1A4 and UGT2B7, both of which show genetic polymorphisms. Both genetic and non-genetic factors may influence the pharmacokinetics of lamotrigine. The aim of this study was to determine the pharmacokinetic parameters of lamotrigine and to investigate the effect of genetic variants of UGT1A4 and UGT2B7 and various non-genetic factors on its pharmacokinetics. METHODS: Four single nucleotide polymorphisms (SNPs; UGT1A4 142 T>G, UGT1A4 70C>T, UGT2B7 372A>G, UGT2B7 -161C>T) were identified using the TaqMan Allelic Discrimination Assay. Data were analyzed using NONMEM. Model evaluation was performed using the bootstrap approach and predictive check. RESULTS: A total of 116 samples were obtained from 75 patients and included in the population analysis. The use of enzyme inducers, valproic acid, and the UGT2B7-161 C>T SNP were found to significantly influence lamotrigine apparent clearance (CL/F). Lamotrigine CL/F in patients carrying the UGT2B7 -161 CT or TT SNP was 18% lower than that in patients carrying the UGT2B7 -161 CC SNP. CONCLUSION: Both genetic and non-genetic factors were found to influence lamotrigine pharmacokinetics. These factors should be considered when determining lamotrigine dosing. The model presented here could be useful for lamotrigine dose adjustment in clinical practice.

Risk of metabolic syndrome for stroke is not greater than the sum of its components: Thai Epidemiologic Stroke (TES) study.

Limited information is available on the association between the metabolic syndrome (MetS) and stroke. Whether or not MetS confers a risk greater than the sum of its components is controversial. This study aimed to assess the association of MetS with stroke, and to evaluate whether the risk of MetS is greater than the sum of its components. The Thai Epidemiologic Stroke (TES) study is a community-based cohort study with 19,997 participants, aged 45-80 years, recruited from the general population from 5 regions of Thailand. Baseline survey data were analyzed in cross-sectional analyses. MetS was defined according to criteria from the National Cholesterol Education Program (NCEP) Adult Treatment Panel III, the American Heart Association/National Heart, Lung, and Blood Institute (revised NCEP), and International Diabetes Federation (IDF). Logistic regression analysis was used to estimate association of MetS and its components with stroke. Using c statistics and the likelihood ratio test we compared the capability of discriminating participants with and without stroke of a logistic model containing all components of MetS and potential confounders and a model also including the MetS variable. We found that among the MetS components, high blood pressure and hypertriglyceridemia were independently and significantly related to stroke. MetS defined by the NCEP (odds ratio [OR], 1.64; 95% confidence interval [CI], 1.32-2.04), revised NCEP (OR, 2.27; 95% CI, 1.80-2.87), and IDF definitions (OR, 1.70; 95% CI, 1.37-2.13) was significantly associated with stroke after adjustment for age, sex, geographical area, education level, occupation, smoking status, alcohol consumption, and low-density lipoprotein cholesterol. After additional adjustment for all MetS components, these associations were not significant. There were no statistically significant difference (P=.723-.901) in c statistics between the model containing all MetS components and potential confounders and the model also including the MetS variable. The likelihood ratio test also showed no statistically significant (P=.166-.718) difference between these 2 models. Our findings suggest that MetS is associated with stroke, but not to a greater degree than the sum of its components. Thus, the focus should be on identification and appropriate control of its individual components, particularly high blood pressure and hypertriglyceridemia, rather than of MetS itself.

Appropriate body mass index and waist circumference cutoffs for middle and older age group in Thailand: data of 19,621 participants from Thai epidemiologic stroke (TES) study.

OBJECTIVE: To determine the appropriate body mass index (BMI) and waist circumference (WC) cutoff point for identification of at least one cardiovascular risk factor (hypertension, dyslipidemia, and type 2 diabetes) in Thailand, and to compare the discrimination ability of BMI with that of WC for discrimination of at least one cardiovascular risk factor. MATERIAL AND METHOD: Baseline health survey data of participants of Thai Epidemiologic Stroke (TES) Study, who were free from stroke, enrolled from five geographic regions around the country, were studied as cross-sectional analysis. Receiver operating characteristics curve (ROC) analysis was performed to determine the appropriate cutoff points of BMI and WC in identifying those with presence of at least one cardiovascular risk factors. The BMI or WC value with the shortest distance on the ROC curve was considered to be appropriate cutoffs. Comparing the ability of BMI in discrimination of at least one cardiovascular risk factor with that of WC was performed by comparing ROC area under curve (AUC). RESULTS: Among 19,621 (6,608 men and 13,013 women) participants with age range of 45 to 80 years, the average age was 59.8 years for men and 58.5 years for women. The appropriate cutoff point of BMI was 23 kg/m2 in men and 24 kg/m2 in women. The cutoffs of WC were 80 cm and 78 cm in men and women, respectively. In both gender, waist circumference (WC) (AUC in men = 0.684; 95% CI, 0.672-0.695, AUC in women = 0.673; 95% CI, 0.665-0.681) was significantly (p < 0.001) better than BMI (AUC in men = 0.667; 95% CI, 0.656-0.679, AUC in women = 0.636; 95% CI, 0.628-0.644) in discrimination of at least one cardiovascular risk factor. CONCLUSION: In Thai adults aged 45 to 80 years, the cutoff points of BMI should be 23 kg/m2 in men and 24 kg/m2 in women. For WC, 80 cm and 78 cm should be considered to be appropriate cutoffs for men and women, respectively. Waist circumference (WC) as a simple obesity index should be advocated for public health screening.

Prevalence of stroke and stroke risk factors in Thailand: Thai Epidemiologic Stroke (TES) Study.

OBJECTIVE: To assess stroke prevalence and stroke risk factors in Thailand. MATERIAL AND METHOD: Thai Epidemiologic Stroke (TES) Study is an ongoing, community based cohort study that has been conducted in five geographic regions of Thailand. Baseline health status survey was started in 2004 and enrollment continued until the end of 2006. All participants who were suspicious of being stroke victims were verified. In this analysis, baseline data of 19,997 participants aged 45 to 80 years were identified and analyzed as a cross-sectional analysis. RESULTS: Three hundred and seventy six subjects were proved to have a stroke thus resulting the crude prevalence of stroke to be 1.88% (95% CI, 1.69 to 2.07). Age standardization to Segi world standard population was 1.81% (95% CI, 1.62 to 1.99). Crude prevalence among adults aged > or = 65 years was 2.70% (95% CI, 2.28 to 3.11). Stroke prevalence differed among five geographic regions of the country (Bangkok 3.34%, Central region 2.41%, Southern 2.29%, Northern 1.46% and Northeastern 1.09%). Using multiple logistic regression analysis, factors associated with higher stroke prevalence were male gender (p < 0.001), occupational class (p < 0.001), geographic region (p < 0.001), hypertension (p < 0.001), diabetes mellitus (p = 0.002) and hypercholesterolemia (p = 0.026). CONCLUSION: Stroke prevalence in Thailand from TES study is higher than previous studies, but it is lower than developed countries, probably due to high case fatality rate in Thai population. Geographic variation in stroke prevalence is found more in Bangkok, Central and Southern regions. Longitudinal follow-up of TES cohort study will provide further information on risk factors and incidence of stroke.

Prophylactic botulinum type A toxin complex (Dysport®) for migraine without aura.

OBJECTIVE: To evaluate the efficacy, safety, and optimum dose of a highly purified Clostridium botulinum type A toxin-hemagglutinin complex (Dysport) for migraine prophylaxis. BACKGROUND: Botulinum toxin type-A has demonstrated good efficacy in several open-label studies of patients with migraine, involving either individualized or standardized protocols, although data from placebo-controlled trials have been conflicting. METHODS: A 12-week, double-blind, randomized trial of Dysport (120 or 240 units) vs placebo was conducted in 6 centers in Thailand to evaluate the efficacy, safety, and optimum dose of botulinum toxin type-A (Dysport) for migraine prophylaxis. A total of 128 patients with migraine without aura were enrolled. The primary end point was the change in the mean number of migraine attacks per 4-week period from the pre-treatment period to 8-12 weeks post injection. Secondary efficacy measures included the change in the mean total intensity score from the pre-treatment period to 8-12 weeks, the investigator and patient global assessments of change at each visit compared with pre-treatment, and Migraine Disability Assessment and Short Form-36 scores. RESULTS: Change in number of migraine attacks from pre-treatment to weeks 8-12 was not significantly different. There was a greater improvement in total intensity score at weeks 8-12 with Dysport-240 (not significant), and interim visit data showed that this was significant at weeks 0-4 (P = .03 Dysport-240 vs placebo). The mean duration of headache during weeks 0-4 was lower with Dysport-240 (P = .04 vs placebo). Improvements in patient and investigator global assessments of change between weeks 0-4 and 8-12 were significant for the Dysport-240 group (both P < .05 vs placebo). CONCLUSIONS: Limitations in study design and assessment tools employed may have contributed to the inconclusive nature of the primary end point data. Dysport-240 showed significant benefit over placebo at some end points and further trials with more appropriate outcome measures are required to evaluate effectively this treatment.

Thai venous stroke prognostic score: TV-SPSS.

BACKGROUND AND OBJECTIVE: Prognosis of cerebral venous sinus thrombosis (CVST) has never been studied in Thailand. A simple prognostic score to predict poor prognosis of CVST has also never been reported. The authors are aiming to establish a simple and reliable prognostic score for this condition. MATERIAL AND METHOD: The medical records of CVST patients from eight neurological training centers in Thailand who received between April 1993 and September 2005 were reviewed as part of this retrospective study. Clinical features included headache, seizure, stroke risk factors, Glasgow coma scale (GCS), blood pressure on arrival, papilledema, hemiparesis, meningeal irritation sign, location of occluded venous sinuses, hemorrhagic infarction, cerebrospinal fluid opening pressure, treatment options, length of stay, and other complications were analyzed to determine the outcome using modified Rankin scale (mRS). Poor prognosis (defined as mRS of 3-6) was determined on the discharge date. RESULTS: One hundred ninety four patients' records, 127 females (65.5%) and mean age of 36.6 +/- 14.4 years, were analyzed Fifty-one patients (26.3%) were in the poor outcome group (mRS 3-6). Overall mortality was 8.4%. Univariate analysis and then multivariate analysis using SPSS version 11.5 revealed only four statistically significant predictors influencing outcome of CVST They were underlying malignancy, low GCS, presence of hemorrhagic infarction (for poor outcome), and involvement of lateral sinus (for good outcome). Thai venous stroke prognostic score (TV-SPSS) was derived from these four factors using a multiple logistic model. CONCLUSION: A simple and pragmatic prognostic score for CVST outcome has been developed with high sensitivity (93%), yet low specificity (33%). The next study should focus on the validation of this score in other prospective populations.

Seizure attacks while driving: quality of life in persons with epilepsy.

OBJECTIVE: To study the effect on quality of life (QOL) of a seizure attack while driving in persons with epilepsy (PWE). METHODS: From four provincial and eight university hospitals in Thailand, we enrolled epileptic patients who drove a car or motorcycle or used to drive. The SF-36 questionnaire was used to evaluate QOL. The mean SF-36 score for all dimensions was calculated and compared with patients who either had or did not have a seizure attack while driving and in those who either had or had not been involved in a traffic accident while driving. RESULTS: We had 245 adult PWE who drove a car or motorcycle or used to drive. Of these, 69 cases (28%) had a seizure attack whilst driving. Over half (36/69; 57%) had had seizure-related accidents, most of which were mild but about 20% needed hospitalization. PWE having a seizure attack while driving had a significantly lower QOL in four of the eight categories compared with patients who had not. PWE who had a seizure-related accident had a significantly lower mean value in the vitality category than those who did not. CONCLUSIONS: Seizure attacks while driving diminished QOL in PWE even though they only suffered minor injuries. Driving as a QOL issue should be discussed with patients. A good public transportation system would ease the need to drive.

Steady-state serum phenytoin concentrations after nasogastric tube administration of immediate-release phenytoin tablets and extended-release phenytoin capsules: an open-label, crossover, clinical trial.

BACKGROUND: When phenytoin is prescribed for administration via nasogastric tube, immediate-release OR) phenytoin tablets are crushed before use and extended-release (ER) phenytoin capsules are opened and only the granules are used. However, it is unknown whether the same dose of these 2 different formulations will result in the same steady-state serum phenytoin concentration. OBJECTIVE: The aim of this study was to determine whether ER phenytoin capsules can be used interchangeably with IR phenytoin tablets for prophylaxis of posttraumatic seizures. METHODS: Inpatients at the neurosurgical ward at Prasat Neurological Institute, Bangkok, Thailand, between October 2004 and October 2005 were enrolled in the study. All patients were initially prescribed IR phenytoin tablets 300 mg/d as a maintenance dose for prophylaxis of posttraumatic seizures. The serum phenytoin concentration was measured after ≥5 days of treatment with IR phenytoin tablets 300 mg/d (two 50-mg tablets every 8 hours) that had been crushed before being administered concomitantly with a blenderized diet through the nasogastric tube. Without a washout period, the dosage form was changed to ER phenytoin capsules (three 100-mg capsules QD). The capsules were opened and the contents were administered concomitantly with the blenderized diet through the nasogastric tube for ≥5 days. The serum phenytoin concentration was again determined. The patients were closely monitored for seizures and adverse events (AEs). RESULTS: Thirty-three patients enrolled in the study and 17 (10 women, 7 men; mean [SD] age, 62.94 [15.94] years [range, 18-89 years]) completed the study. The mean (SD) serum phenytoin concentrations after administration of phenytoin tablets and capsules were 6.03 (5.92) µg/mL and 3.80 (2.71) µg/mL, respectively (P = 0.019). The mean serum phenytoin concentrations, adjusted for low serum albumin concentrations after administration of tablets and capsules, were calculated and reported to be 10.33 (11.60) µg/mL and 6.28 (4.76) µg/mL, respectively (P = 0.035). The maximum phenytoin metabolic rate (Vmax) (assuming the substrate concentration at which the rate of metabolism is one half Vmax = 4 mg/L) after the administration of phenytoin tablets and capsules was 8.37 (2.42) mg/kg · d(-1) and 10.38 (6.48) mg/kg · d(-1), respectively. These values were not significantly different. All patients were seizure-free and no AEs were observed. CONCLUSION: The steady-state serum phenytoin concentration was significantly lower with ER phenytoin capsules 300 mg/d than IR phenytoin tablets 300 mg/d administered via nasogastric feeding tube concomitantly administered with a blenderized diet in these neurosurgical patients. Key words: phenytoin nasogastric tube feeding extended-release capsule immediate-release tablet.

Chrono impact versus enteric coated valproate in Thai epileptic patients.

BACKGROUND: Since its first clinical use more than 30 years ago, Valproic acid is still being widely prescribed It has been available in Thailand for more than 20 years. Sodium valproate slow-released (SVSR) form has been used in clinical practice in Thailand since 1990. The objectives of this open study were to access the compliance and satisfaction consequences in the epileptic patients. MATERIAL AND METHOD: In this prospective, multi-center study, the authors compared the compliance and satisfaction consequences in epileptic patients switched from more than two times daily sodium valproate enteric-coated tablet (SVEC) regimen to the same total daily dose of SVSR form given once or twice daily. RESULTS: Eighty-nine of the 100 patients completed the study. 43.8% were male (39 of 89 patients). Mean age was 34.74 +/- 12.67 years. Most common etiology of epilepsy was idiopathic 40.4%. Patients were very/fairly happy with the SVSR form 94.4% compared to the SVEC form 56.2% (p = 0.000). Patients had been experiencing no problem with the SVSR form 67.4% compared to SVEC form 38.2% (p = 0.000) and also never missing taking SVSR. form 77.5% compared to SVEC form 40.4% (p = 0.000). According to convenience, patients preferred to administer SVSR form once a day 92.1% and never over taking dosed the antiepileptic drug 96.6%. SVSR form had fewer side effects than the enteric-coated form interms of memory problem (40.4% vs 48.3%) (p = 0.000), sleepiness (30.3% vs 42.7%) (p = 0.041) and difficulty in thinking clearly (38.2% vs 44.9%) (p = 0.001). The patients were seizure free during the study period comparing SVSR form 76.4% to SVEC form 65.2% (p = 0.011). CONCLUSION: Patients preferred once daily regime. Switching from SVEC to SVSR form increased seizure free, reduced side effects, improved patient's compliance and satisfaction.