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PubMedDate not supplied

Patterns of orthostatic blood pressure change and their clinical correlates in a frail, elderly population.

OBJECTIVES: To determine patterns of within-day orthostatic blood pressure (BP) changes and clinical factors correlated with them in frail, elderly nursing home residents. DESIGN: Prevalence study of orthostatic BP change. SETTING: Sample of 45 nursing homes. PARTICIPANTS: A total of 911 long-stay residents, aged 60 years or older, able to stand for at least 1 minute. MAIN OUTCOME MEASURES: Supine and 1-minute and 3-minute standing BP measurements and heart rates, taken by a random-zero sphygmomanometer before and after breakfast and before and after lunch, symptoms upon standing, medication use, and clinical and functional assessments. RESULTS: Four orthostatic hypotension (OH) groups were defined based on the frequency of a 20 mm Hg or greater orthostatic BP decline during any of 8 postural change measures: no OH group (48.5%); isolated OH group (only once, 18.3%); variable OH group (2-3 times, 19.9%); and persistent OH group (> or =4 times, 13.3%). Orthostatic hypotension was most prevalent before breakfast, especially 1 minute after standing (21.3%), and least prevalent after lunch after 3 minutes of standing (4.9%) (P=.001). A regression approach to repeated measures analysis (method of general estimating equations) showed the following to be significantly associated with OH (P< or =.05): elevated supine systolic BP before breakfast, dizziness/light-headedness on standing, male sex, medication for Parkinson disease, time of day (particularly before breakfast), greater independence in activities of daily living, and low body mass index. CONCLUSIONS: Orthostatic hypotension occurs in more than half of frail, elderly nursing home residents, but is highly variable over time. It is most prevalent in the morning when subjects first arise and when supine BP is highest. The relationship of OH with elevated BP, but not antihypertensive medication use, suggests that the treatment of hypertension may improve postural BP regulation.

Aged↗

PubMed1997

[Preanesthetic meals in elective surgical patients].

This study investigated the effect of preanesthetic meals on the volume and pH of gastric contents in forty elective surgical patients ranging in ages from 20 to 60 years. Twenty patients who were given either isotonic beverage 250 ml or apple juice 250 ml on the morning of the operative day were subjected as control group and twenty patients of the breakfast group took two slices of bread with the above drink. About seven hours following drinking and feeding, the mean values of gastric volume were 20.9 +/- 18.3 ml in the control group and 19.2 +/- 16.3 ml in the breakfast group. The mean values of gastric pH were 4.3 +/- 2.3 in the drink group and 4.6 +/- 2.3 in the breakfast group. There were no significant differences in the gastric volume and pH between the two groups. However, very small amount of the bread was detected in the gastric fluid of three patients in the breakfast group. As preanesthetic drinking and feeding are advantageous for reducing the anxieties of preoperative patients and also for their nutrition during operation, it is encouraging that eating two slices of bread did not induce a significant effect of gastric volume or pH. The minute fragment of bread seems to have no clinically significant effect.

Adult↗

PubMed1998

[Role of food interaction pharmacokinetic studies in drug development. Food interaction studies of theophylline and nifedipine retard and buspirone tablets].

Due to several mechanism, meals may modify the pharmacokinetics of drug products, thereby eliciting to clinically significant food interaction. Food interactions with the drug substance and with the drug formulation should be distinguished. Food interaction of different drug products containing the same active ingredient can be various depending on the pharmaceutical formulation technology. Particularly, in the case of modified release products, the food/formulation interaction can play an important role in the development of food interaction. Well known example, that bioavailability of theophylline can be influenced in different way (either increased, decreased or unchanged) by concomitant intake of food in the case of different sustained release products. The role and methods of food interaction studies in the different kinds of drug development (new chemical entity, modified release products, generics) are reviewed. Prediction of food effect response on the basis of the physicochemical and pharmacokinetic characteristics of the drug molecule or formulations is discussed. The results of three food interaction studies carried out the products of EGIS Pharmaceuticals Ltd. are also reviewed. The pharmacokinetic parameters of theophyllin 400 mg retard tablet were practically the same in both fasting condition and administration after consumption of a high fat containing standard breakfast. The ingestion of a high fat containing breakfast, increased the AUC of nifedipine from 259.0 +/- 101.2 ng h/ml to 326.7 +/- 122.5 ng h/ml and Cmax from 34.5 +/- 15.9 ng/ml to 74.3 +/- 23.9 ng/ml in case of nifedipine 20 mg retard tablet, in agreement with the data of literature. The statistical evaluation indicated significant differences between the pharmacokinetic parameters in the case of two administrations (before and after meal). The effect of a high fat containing breakfast for a generic version of buspiron 10 mg tablet and the bioequivalence after food consumption were studied in a single-dose, three-way (test and reference products administered after consumption of standard breakfast, as well as test product in fasting condition), cross-over, food effect bioequivalence study. According to the results, the test product--which, in a former study proved to be bioequivalent with the reference product in fasting state--is bioequivalent with the reference product under feeding conditions and the food intake influenced the pharmacokinetics of the test tablets.

Buspirone↗

PubMed2006

Trends in the association of poverty with overweight among US adolescents, 1971-2004.

CONTEXT: Prevalence of adolescent overweight in the United States has increased substantially during the past 3 decades. Whether socioeconomic disparities in adolescent overweight increased, decreased, or remained constant during this period is not known. OBJECTIVE: To examine trends in adolescent overweight from 1971 to 2004 by family poverty status, as well as trends in potentially relevant eating and physical activity behaviors. DESIGN, SETTING, AND PARTICIPANTS: Four cross-sectional, nationally representative surveys (US National Health and Nutrition Examination Surveys [NHANES] of 1971-1974, 1976-1980, 1988-1994, and 1999-2004) were examined for trends in the prevalence of overweight among adolescents aged 12 to 17 years by family poverty status. MAIN OUTCOME MEASURES: Prevalence of adolescent overweight, defined as body mass index at or above the 95th percentile for age and sex in the 2000 Centers for Disease Control and Prevention growth charts. Intermediate outcomes were physical inactivity in the past 30 days, proportion of caloric intake from sweetened beverages (24-hour recall), and whether respondent skipped breakfast (24-hour recall). RESULTS: Trends in the association of adolescent overweight with family poverty differed by age stratum (P = .01). In 12- to 14-year-old adolescents, prevalence did not significantly differ by family poverty status in any of the surveys; however, among non-Hispanic black adolescents, overweight prevalence increased faster in nonpoor vs poor families. In contrast, a widening disparity that disfavored adolescents from poor families was present in the 15- to 17-year-old adolescents. This trend was similar among male, female, non-Hispanic white, and non-Hispanic black adolescents, resulting in an overall prevalence of overweight in 1999-2004 more than 50% higher among adolescents in poor vs nonpoor families (23.3% vs 14.4%, respectively; P<.001). Additional analyses suggest that physical inactivity, sweetened beverage consumption, and skipping breakfast may contribute to these disparities. CONCLUSIONS: Trends of increasing overweight showed a greater impact in families living below the poverty line vs not living below the poverty line among older (15-17 years) but not younger (12-14 years) adolescents. Furthermore, physical inactivity, high consumption of sweetened beverages, and breakfast skipping may be candidate targets for prevention programs aimed at reducing this recently emerged disparity.

Adolescent↗

PubMed1998

The influence of food on the disposition of the antiepileptic rufinamide in healthy volunteers.

The effect of food on the pharmacokinetics of the antiepileptic rufinamide was investigated in healthy volunteers. Twelve subjects were treated with single pre-oral doses of 600 mg of rufinamide after overnight fasting or a fat and protein rich breakfast. Mean (+/- S.D.) areas under the plasma concentration-time curves (AUCs) of the unchanged compound were 57.2 (16) micrograms mL-1 h when given to the fasted volunteers and 81.7 (22.2) micrograms mL-1 h (p = 0.0001) when given after the breakfast. The average AUC was increased by 44% when rufinamide was given with food and the maximum concentration (Cmax) by about 100%. The time at which Cmax was reached (tmax) was shorter (8 h in fasted conditions and 6 h in fed after breakfast); the terminal half-life was not influenced by concomitant intake of food.

Administration, Oral↗

PubMed1993

Influence of food on the disposition of the monoamine oxidase-A inhibitor brofaromine in healthy volunteers.

The effect of food on the bioavailability of brofaromine hydrochloride was investigated in a randomized cross-over study. Eight healthy male volunteers were given single peroral doses of 75 mg brofaromine hydrochloride after overnight fasting or a fat- and protein-rich breakfast. Mean (+/- SD) areas under the plasma concentration-time curves (AUC) were 9.66 (2.35) mumol l-1 h when given to the fasted volunteers and 11.82 (3.78) mumol l-1 h (p = 0.0413) when given after a substantial breakfast. Mean (+/- SD) maximum plasma concentrations (Cmax) were 0.71 (0.13) mumol l-1 when given to the fasted volunteers and 0.85 (0.22) mumol l-1 (p > 0.05) when given after breakfast. Thus, both the average AUC and Cmax were increased by approximately 20 per cent when brofaromine hydrochloride was given with food. The times when Cmax was reached (tmax) as well as the elimination half-lives were not influenced by concomitant intake of food. The tolerability was the same whether brofaromine was given before or after food in healthy volunteers. The slight effect of food on the bioavailability of brofaromine should be of little therapeutic consequence because of the observed wide inter-subject variability of the plasma levels.

Adult↗

PubMed1994

The influence of food on the disposition of the antiepileptic oxcarbazepine and its major metabolites in healthy volunteers.

The effect of food on the pharmacokinetics of the antiepileptic oxcarbazepine (OXC) was investigated in healthy volunteers. Six healthy male volunteers were treated with single peroral doses of 600 mg of oxcarbazepine (Trileptal) after overnight fasting or a fat- and protein-rich breakfast. Mean (+/- SD) areas under the plasma concentration-time curves (AUC) of the major component in plasma, the active monohydroxy metabolite (MHD), which is responsible for the therapeutic effect in man, were 672 (25) mumol L-1 h when given to the fasted volunteers and 780 (31) mumol L-1 h (p = 0.042) when given after a substantial breakfast. Mean (+/- SD) maximum concentrations (Cmax) were 25.5 (4.8) mumol L-1 when given to the fasted volunteers and 31.4 (5.3) mumol L-1 (p = 0.025) when given after breakfast. Thus, the average AUC was increased by 16% and Cmax by 23% when oxcarbazepine was given with food. The times at which Cmax was reached (tmax) as well as the terminal half-lives were not influenced by concomitant intake of food. The tolerability was the same whether oxcarbazepine was given before or after food in healthy volunteers. The slight effect of food on the kinetics of oxcarbazepine should be of little therapeutic consequence.

Administration, Oral↗

PubMed1995

The influence of food intake on the effect of two controlled release formulations of furosemide.

Differences in the urinary excretion rate of furosemide may explain discrepancies observed between the bioavailability and the total diuretic effect of different formulations of this drug. Furosemide was given at a dose of 60 mg as two oral controlled release (CR) formulations (FR and LR), with and without breakfast, in a randomized, four-treatment, four-period, crossover design to 28 healthy volunteers. Urinary volume, and contents of furosemide and sodium, were measured in samples taken over 24 h. The extent and rate of absorption of furosemide from FR were decreased after breakfast as compared to fasting: the mean (SD) of total furosemide excreted decreased from 11.38 (3.12) to 7.73 (1.67) mg, p < 0.0001, and the median (range) mean residence time increased from 6.3 (4.1-9.3) to 9.5 (5.9-11.8) h, p < 0.001. On the other hand, the extent of absorption of LR was increased after breakfast, from 8.04 (3.32) to 9.45 (1.83) mg, p < 0.05, without a significant change in MRT. FR had a higher extent and rate of absorption than LR during fasting, but its extent of absorption was lower than that of LR in the postprandial state. Interestingly, the total fraction of furosemide absorbed, as estimated from total furosemide excretion, was not correlated with the total diuresis (r2 = 0.079) and the differences in drug response compared among the four periods were much smaller than would be expected from the differences in amount absorbed. This discrepancy may be explained by differences in urinary excretion rate of furosemide and, related to this, differences in efficiency profiles between the four treatments. Therefore, the urinary excretion profile of a formulation of furosemide may be more important for the cumulated drug effect than the amount absorbed.

Adult↗

PubMedDate not supplied

Food increases the bioavailability of isotretinoin.

Twenty healthy male subjects received 80 mg (2 X 40 mg SEG capsules) oral isotretinoin separated by two-week washout periods in an open randomized crossover design. Isotretinoin was administered during a complete fast, 1 hour after a standard breakfast, with a standard breakfast, or 1 hour before a standard breakfast. Blood samples were obtained at specific times over a 72-hour period. Isotretinoin blood concentrations were determined by a specific HPLC method. The relative bioavailability (AUC) of isotretinoin was found to be approximately 1.5 to 2 times greater when the dose was administered 1 hour before, concomitantly with, or 1 hour after a meal than when it was given during a complete fast. In addition, because the Cmax value is lower when the dose is administered with food rather than 1 hour after a meal, coadministration of isotretinoin with food may be the best method of administration.

Adult↗

PubMed1988

Pharmacokinetics and pharmacodynamics of oral nizatidine.

Nizatidine was studied in six high-acid-secretor (basal secretion, greater than or equal to 5 mEq/hr) male volunteers in a randomized, double-blind, nonbalanced, cross-over, placebo and standard drug-controlled study. Doses of 75 mg, 150 mg, and 300 mg bid were compared with placebo and cimetidine 300 mg qid. Nocturnal acid output was significantly reduced (P less than .01) by all doses of nizatidine (36 +/- 22, 36 +/- 31, and 26 +/- 20 mEq) with 75 mg, 150 mg and 300 mg, respectively, and also by cimetidine (43 +/- 39 mEq) as compared with placebo (101 +/- 61 mEq). Nizatidine also significantly reduced meal-stimulated acid secretion at breakfast (14 +/- 9, 9 +/- 7, and 5 +/- 6 mEq/2 hours with 75 mg, 150 mg, and 300 mg, respectively, P less than .01), at lunch (50 +/- 22, 57 +/- 22 and 50 +/- 35 mEq/2 hours, P less than .05) but did not have any effect at dinner (65 +/- 16, 78 +/- 24, and 71 +/- 17 mEq/2 hours) whereas cimetidine, given every 6 hours, significantly (P less than .01) reduced meal-stimulated acid secretion (25 +/- 16, 27 +/- 20 and 31 +/- 15 mEq/2 hours, breakfast, lunch, and dinner, respectively) as compared with placebo (81 +/- 30, 76 +/- 25, and 66 +/- 16 mEq/2 hours, breakfast, lunch, and dinner, respectively). Both drugs have a similar pharmacokinetic profile. Nizatidine seems to be a promising H2 antagonist, more potent than cimetidine (on an mg/mg basis), and efficacy studies on gastric acid disorders should be performed.

Administration, Oral↗

PubMed1992

Circadian changes of valproate kinetics depending on meal condition in humans.

The objective of this study was to examine the effect of meal condition on circadian changes in valproic acid (VPA) kinetics. Two experiments were performed in 16 healthy men that were synchronized with diurnal activity and nocturnal rest as their routine life. In both experiments, four 200-mg tablets of VPA were given orally on two occasions in the morning (8:30 AM) or in the evening (8:30 PM). In each study, a randomized, single-dose, two-way crossover design was used, and 2 weeks elapsed between morning and evening trials. In experiment 1, eight subjects took a light meal as breakfast between 8:00 and 8:15 AM and a heavy meal as dinner between 6:00 and 6:30 PM to fit the subject's usual food amount. The mean peak plasma concentration (Cmax) was significantly higher (P less than .01), the time to peak concentration (tmax) was shorter (P less than .05), and the absorption rate (Ka) was larger (P less than .05) after the morning dose than after the evening dose. In experiment 2, the size and contents of meal in breakfast and dinner were prepared in the same manner as the standard breakfast for the subjects. Namely, eight subjects took the same light meal between 8:00 and 8:15 AM in the morning and between 8:00 and 8:15 PM in the evening. There was no significant circadian change in VPA kinetics under this same meal condition. These results suggest that the differences of meal condition between morning and evening in our daily life play a major role in the mechanism underlying the circadian changes of VPA absorption in man.

Absorption↗

PubMed1999

Meal patterns in middle-aged men in Southern Germany: results from the MONICA Augsburg dietary survey 1984/85.

Seven-day food records of the MONICA project Augsburg dietary survey, which were collected in 1984/85 from 899 men aged 45-64 years (random sample), were used to analyse meal patterns. The combination of the three traditional meals (breakfast, lunch, dinner) with one eating event between was most frequent, followed by two meals with two eating events between and three main meals without any other eating event (31.4 vs. 31.0 vs. 15.6% of all reported days). Breakfast delivered 17, lunch 29 and dinner 33% of the total daily energy intake; all other eating events delivered 21%. The mean contribution of the three meals, breakfast, lunch and dinner to daily protein intake was 14, 36 and 36%, to fat intake 17, 33 and 35% and to carbohydrate intake 23, 25 and 29%, respectively. Data on meal patterns are important in a comprehensive description of dietary habits of a population for a variety of reasons.

Diet↗

PubMed2002

An appropriate tool for appetite testing and evaluation in young children in Benin.

Appetite measurements were performed in 109 Beninese children aged 18-30 months to develop a tool for appetite evaluation in young children in nutritional intervention programmes. Two test foods were identified as appropriate for these children: a maize porridge (aklui) and rice (riz-au-gras). Ad libitum intakes of the foods served after an overnight fast according to a standardized offering procedure were measured on 3 days. The children's habitual intakes were measured during 3 consecutive days not overlapping with the days when the test meals were provided. Energy intake from the test foods was comparable to breakfast energy intake which was 0.8-1.0 MJ, representing 21% of total daily energy intake. Energy intake from aklui was significantly correlated with daily intake (r=0.41, n=38, p<0.05) and with energy intake from breakfast (r=0.52, p<0.01). Correlations concerning riz-au-gras were less pronounced and non-significant. Reproducibility (as coefficient of variation) of the appetite test as calculated from the triplicate measurements was 40% for aklui and 25% for riz-au-gras. This reproducibility is better than that of the habitual breakfast intake (43-45%). In conclusion, the appetite test used in our studies can be considered as an appropriate tool in appetite evaluations.

Appetite↗

PubMed1993

The effect of different dosage schedules of cisapride on gastric emptying in idiopathic gastroparesis.

The aim of this study was to determine the optimal dosage regimen of cisapride for the treatment of idiopathic gastroparesis. We studied 17 patients with documented idiopathic gastroparesis in a three-way, cross-over, double-blind study with three 4-day treatment periods separated by at least 3 days without treatment. In each period, the patients were preloaded with cisapride (10 mg tid) for three days. On the fourth day (the test day) they took either 10 mg or 20 mg before breakfast and placebo before lunch (1 x 10 mg), (1 x 20 mg), or 10 mg before breakfast and 10 mg before lunch (2 x 10 mg). The medications were taken 30 min before meals. Gastric emptying of solids (99mTc-sulphur colloid) was measured at lunch time under basal conditions and during each treatment period. Plasma concentrations of cisapride were determined before the breakfast dose, before the lunch dose, and at 1, 2, 3, 4 and 5 h after. The greatest acceleration in gastric emptying occurred with the 2 x 10 mg regimen. Although the single morning dose of 20 mg also significantly accelerated gastric emptying (P = 0.05), the reduction was not as substantial. Plasma concentrations of cisapride were significantly higher after 2 x 10 mg than after 1 x 20 mg or 1 x 10 mg. There was a significant relation between cisapride plasma concentrations and changes in gastric emptying. Peak concentrations of cisapride greater than 60 ng.ml-1 were invariably associated with acceleration of gastric emptying. We conclude that cisapride 10 mg tid before meals is the optimal dose for the treatment of idiopathic gastroparesis.

Adult↗

PubMed1986

Effects of the alpha-glucosidase inhibitor 1 desoxynojirimycin (Bay m 1099) on postprandial blood glucose, serum insulin and C-peptide levels in type II diabetic patients.

Bay m 1099 is a newly developed inhibitor of intestinal alpha-glucosidase. Its ability to lower postprandial plasma glucose, serum insulin and C-peptide levels in Type II diabetics has been investigated. Fifteen obese Type II diabetic patients with inadequate metabolic control during sulphonylurea treatment received a standardized diet and were treated either with Bay m 1099, b.d. (100 mg before breakfast and dinner) or placebo for 3 days, according to a double-blind cross-over design. The postprandial blood glucose level was significantly lower during Bay m 1099 treatment compared to placebo after breakfast and dinner (AUC after breakfast p less than 0.001). The reduced postprandial hyperglycaemia was associated with a decrease in meal stimulated serum insulin and C-peptide levels. Thus, Bay m 1099 may be a useful addition in the treatment of Type II diabetic patients.

1-Deoxynojirimycin↗

PubMed1976

Postprandial plasma glucose, insulin, glucagon and triglyceride responses to a standard diet in normal subjects.

Postprandial plasma glucose, insulin and triglyceride responses were determined in 12 normal subjects (7 male and 5 female) fed a standard diet composed of typical American foods; the three meals were identical for each subject. A significant postprandial rise in glucose and insulin was observed. They were closely related temporally in the early postabsorptive period. However, in the late post-absorptive phase insulin decline was generally slower than the glucose decline. A considerable difference in the glucose and insulin response was observed between males and females. Fasting plasma glucose and insulin concentrations were lower in the women. Following each meal the peak plasma glucose was lower in the women, but the difference was significant only following breakfast (p less than 0.02). The area under the glucose curve following breakfast was also lower (p less than 0.01) in the women. In the men the maximal postprandial glucose concentration and the postprandial glucose area remained stable throughout the day, but there was an increase in peak insulin concentration and insulin area after dinner. In contrast, in the women the maximal postprandial glucose concentration and the postprandial glucose area increased throughout the day, but the peak insulin concentration and insulin area did not change. Plasma trigylcerides increased with breakfast and remained elevated throughout the day. Both fasting and postprandial mean triglycerides were higher in the men, but this did not reach statistical significance. The circulating pancreatic glucagon concentration, determined in 4 subjects, was unaffected by meals and remained stable throughout the day.

Adult↗

PubMed1977

Plasma glucagon suppression by phenformin in man.

In an attempt to elucidate the mechanism of action of phenformin, eleven juvenile-onset, insulin-requiring diabetic subjects underwent four different treatment regimens during standard breakfast tests. These four treatments were: control (no insulin or phenformin); insulin alone (15 U regular insulin administered subcutaneously one-half hour before breakfast); phenformin alone (50 mg of the timed-release capsule given twice daily for three days before the study and two and one-half hours before breakfast on the day of study); and phenformin plus insulin (in the amounts and at the times stated above). Phenformin was found to decrease postprandial hyperglycaemia significantly when compared with control values, and its addition to insulin further decreased the postprandial glucose rise below that found with insulin alone (p less than 0.005). These effects were associated with a reduction in early (30-min) postprandial hyperglucagonaemia (p less than 0.05). Triglyceride levels, gastrin secretion, growth hormone levels, and increments of alpha-amino nitrogen were not affected by phenformin. Thls, suppression of postprandial hyperglucagonaemia may be an additional mechanism in the reduction of postprandial hyperglycaemia after phenformin.

Adult↗

PubMed1991

Gastric emptying of indigestible tablets in relation to composition and time of ingestion of meals studied by metal detector.

Enteric-coated tablets leave the stomach mainly during the interdigestive phase. Composition as well as time of ingestion of meals may influence their gastric emptying considerably. In 12 normal volunteers gastric emptying of a plastic tablet with a metal core was followed by a metal detector in relation to different compositions and various times of ingestion of meals. With an empty stomach and after ingestion of 250 ml water, the mean time for gastric emptying of the tablet was 38 +/- 11 min (mean +/- SEM) and 38 +/- 8 min. Two hundred fifty milliliters of milk (652 kJ) and a formula diet (1000 kJ) delayed gastric emptying time to 128 +/- 14 and 152 +/- 6 min, respectively (P less than 0.05). Breakfast (2200 kJ) further retarded gastric emptying compared with both liquids to 249 +/- 24 min (P less than 0.05). There was a close correlation between nutritive density and gastric emptying of the tablet (r = 0.92; P less than 0.001). Main meals also delayed gastric emptying of tablets when compared to empty stomach (P less than 0.05). A snack after breakfast further delayed gastric emptying from 201 +/- 10 to 278 +/- 19 min (P less than 0.05). The largest delay was observed following ingestion of breakfast, lunch, dinner, and additional snacks (509 +/- 220 min). We conclude that the delay of gastric emptying of enteric-coated tablets by food is related to its nutritive density and eating habits. The gastric emptying of an enteric coated tablet that is ingested early in the morning may be delayed until late at night when several meals and snacks are ingested during the day, leading to unwanted alterations in bioavailability and to possible adverse effects.

Adult↗