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Results for “randomized crossover trial”

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At least 487 records · Page 27Linked to original sources

PubMed1993

Effects of histamine type 2-receptor antagonists cimetidine and famotidine on left ventricular systolic function in chronic congestive heart failure.

Twelve patients with stable congestive heart failure and left ventricular dysfunction were enrolled in a double-blind, randomized crossover trial of famotidine, cimetidine and placebo to determine whether histamine type 2 (H2) antagonists adversely affect left ventricular systolic performance. Two-dimensional echocardiograms were obtained at baseline, after 4 days of oral treatment with standard doses of famotidine and cimetidine, and placebo, and at the conclusion of the trial. The baseline mean ejection fraction was 19 +/- 7%. The changes in ejection fraction were +2 +/- 11% (95% confidence interval [CI] -5 to 9%) with famotidine, +3 +/- 10% (95% CI -3 to 10%) with cimetidine, and -3 +/- 7% (95% CI -8 to 2%) with placebo. There were no significant differences in changes in ejection fraction among the 3 experimental treatments (p = 0.22; analysis of variance). The changes in end-systolic wall stress/volume ratios from baseline were +6 +/- 21% (95% CI -6 to 18%) for famotidine, +8 +/- 29% (95% CI -8 to 25%) for cimetidine, and +2% +/- 29% (95% CI -15 to 18%) for placebo (p = 0.69; analysis of variance). No patient had a worsening of symptoms during therapy. Despite previous reports that H2 antagonists may depress left ventricular systolic function, at standard doses these agents result in no decrease in left ventricular systolic function in patients with chronic congestive heart failure.

Aged↗

PubMedDate not supplied

Comparison of two special infant formulas designed for the treatment of protracted diarrhea.

The nutritional management of intractable diarrhea and short bowel syndrome remains a challenging problem. The advantage of continuous nasogastric infusion is undisputed, but what to feed remains in question, and no studies, to these authors' knowledge, have yet compared two widely used specially designed protein hydrolysate formulas. A randomized crossover trial of two periods of 7 days was carried out with Alfare and Pregestimil administered by a constant infusion pump in six malnourished infants aged 1-13 months. Two had intractable diarrhea, and four the short bowel syndrome. Identical quantities of calories were administered during the two periods. There was good tolerance for both formulas and satisfactory weight gain. Despite compositional differences related to osmolality, the source of the hydrolysates and their profile, and the qualitative pattern of the carbohydrates, no difference was observed with regard to stool weight, Na+ and K+ losses, and the enteral absorption of fat, carbohydrate-derived energy, and total energy. The percent absorption of nitrogen was somewhat higher (p less than 0.01) with Pregestimil (83.8 +/- 2.7) than with Alfare (77.3 +/- 3.4), but nitrogen retention was unaffected. Energy absorption was the same on both formulas, but maldigested or malabsorbed carbohydrates accounted for 63% of total energy loss during Alfare feeding and 72% during the week of Pregestimil. These data call for studies with protein hydrolysate formulas reformulated with a lower concentration of carbohydrates and a higher one of fat.

Body Weight↗

PubMedDate not supplied

A pilot pharmacokinetic-pharmacodynamic study of benzodiazepine antagonism by flumazenil and aminophylline.

STUDY OBJECTIVES: To develop a pharmacokinetic-pharmacodynamic model using quantitative electroencephalographic (EEG) analysis to compare two separate benzodiazepine antagonists and generate data concerning response variability. DESIGN: A pilot study using a randomized, blinded, crossover design. SETTING: The Neurology Laboratory at the Akron City Hospital campus of SUMMA Health System. PATIENTS: Four healthy volunteers completed the protocol. INTERVENTIONS: Subjects received midazolam 0.1-0.2 mg/kg by intravenous bolus on 3 study days, separated by a minimum washout period of 1 week. Subjects participated in an initial open-label response phase followed by a randomized, crossover trial of each benzodiazepine antagonist. MEASUREMENTS AND MAIN RESULTS: Venous blood samples were obtained to characterize the pharmacokinetics of all study compounds. The EEG parameter of total number of waves/second (recorded from FP1-F3 and FP2-F4 electrodes) in the frequency of 12-30 Hz was used to quantify effect. Flumazenil appeared to prolong the elimination half-life of midazolam significantly (p < 0.05). Theophylline (aminophylline) also appeared to prolong the half-life of flumazenil (p < 0.05). Despite considerable variability, flumazenil resulted in reversal of sedation at concentrations achieved by routine dosing. Resedation was apparent for all subjects following flumazenil reversal. Only partial reversal of sedation by theophylline was achieved by an aminophylline dose of 1-2 mg/kg. CONCLUSIONS: Flumazenil was consistently effective in reversing sedation by midazolam at routinely recommended dosing. Further investigation of aminophylline as a reversal agent should use an estimated dose of 6-8 mg/kg aminophylline. To achieve adequate reversal, some patients may require aminophylline dosages that exceed safe clinical administration.

Adult↗

PubMed2006

Brassica vegetable consumption reduces urinary F2-isoprostane levels independent of micronutrient intake.

Isothiocyanates and indoles (e.g. indole-3-carbinol) from Brassica vegetables (e.g. broccoli) induce Phase I and Phase II enzymes responsible for the oxidation, reduction and metabolism of endogenous and exogenous carcinogens. Brassica vegetables also contain micronutrients that may provide additional DNA protection from reactive oxygen species. This randomized crossover trial (n = 20) compares the effects of a Brassica Vegetable (BV) intervention against a Micronutrient and Fiber Supplementation (M+F) intervention on urinary F2-isoprostane levels (F2-iP), a stable biomarker of systemic oxidative stress. Brassica intake was monitored by repeated 24 h recalls, urinary ITC levels and questionnaire. Urinary F2-iP levels were measured by mass spectrometry from first-morning urine samples collected at Baseline and after each intervention, and change in natural log transformed urinary F2-iP levels were analyzed using repeated measures regression. Brassica consumption increased from 2 grams/day (g/d) during the Baseline or M+F intervention periods to 218 g/d during the BV intervention, whereas exposure to most antioxidant vitamins and minerals was greatest during the M+F intervention. F2-iP levels significantly decreased by 22.0 or 21.8% during the BV intervention compared with Baseline or the M+F intervention (P = 0.05, P = 0.05, respectively). Urinary F2-iP levels did not significantly differ between Baseline and the M+F intervention (difference = 0.2%; P = 0.98). Brassica intake has been associated with reduced risk of colon, lung, bladder, breast, prostate and other cancers. Our results suggest that Brassica consumption reduces systemic oxidative stress independent of the vitamin and mineral content of these vegetables.

Adult↗

PubMed1995

Comparison of fluid volumes with whole bowel irrigation in a simulated overdose of ibuprofen.

OBJECTIVE: To determine the effect of 2 different fluid volumes of polyethylene glycol whole bowel irrigation (WBI) solution on absorption of an ingested toxin in a simulated overdose model. DESIGN: Prospective, randomized, crossover trial. SETTING: Clinical research unit. PARTICIPANTS: Nine adult men. INTERVENTIONS: On 2 separate days, volunteers ingested approximately 75 mg/kg of ibuprofen. In treatment 1, 30 minutes after ingestion of ibuprofen, a 3-L WBI at 2 L/h was begun. This procedure was repeated in treatment 2 with an 8-L. WBI administered at 2 L/h. Fourteen timed serum samples were collected prior to and after drug ingestion for a 24-hour period and analyzed for ibuprofen concentration. The peak serum concentration, time to peak concentration, total area under the serum concentration-time curve (AUC), clearance, and volume of distribution were compared. RESULTS: The mean +/- SD AUCs did not differ between the 3-L (1185.3 +/- 216.9 mg.h/L) and 8-L (1153.5 +/- 251.5 mg.h/L) treatments (p = 0.710). Time to peak serum concentration, peak serum concentration, clearance, and volume of distribution were comparable for the 2 treatments (p > 0.05). CONCLUSIONS: These data indicated that a total WBI volume of 3 L would be expected to perform as well as 8 L administered at the same rate. We recommend that further research define the optimal dose of WBI in acute ingestion of toxins.

Adult↗

PubMed1990

[Effect of pancreatin on diabetes mellitus in chronic pancreatitis].

The effect of pancreatin on insulinopenic diabetes was studied in 10 patients with chronic pancreatitis and exocrine function impairment. All patients were treated for 4 days in a randomized crossover trial with either pancreatin (6 x 2 capsules, 6 x 300 mg/d) or placebo. Blood glucose levels were determined 7 times every day and night. On day 5, the patients were studied by a glucose sensor with adjustment of blood glucose to 120 mg/dl until 8.00 in the morning. A test meal was applied with 2 capsules pancreatin or placebo. Blood glucose and plasma levels of C-peptide, glucagon and pancreatic polypeptide (PP) were determined in regular intervals for 4 hours. Blood glucose levels were not significantly altered by pancreatin. As shown by M-value according to Schlichtkrull (21.6 +/- 2.9 versus 32.4 +/- 7.4), there was a tendency towards smaller oscillations of blood glucose with pancreatin treatment. C-peptide levels (basal 0.081 +/- 0.008 ng/ml; postprandial 0.119 +/- 0.013 ng/ml) were not significantly altered by the administration of pancreatin. Basal and postprandial glucagon and PP plasma levels were not influenced by pancreatin. From these results, we conclude that pancreatic enzyme supplementation does not significantly alter the requirement of insulin in patients with diabetes mellitus secondary to chronic pancreatitis. Possible disturbances of the enteroinsular axis are discussed in this paper.

Blood Glucose↗

PubMed2006

Fish oil increases bile acid synthesis in male patients with hypertriglyceridemia.

Fibrates are drugs of choice in patients with hypertriglyceridemia (HTG), but may increase the risk for gallstones by decreasing bile acid synthesis. Fish oil might be a therapeutic alternative, but its effect on bile acid metabolism in humans is unknown. We compared the effects of triglyceride-lowering therapy by fish oil or bezafibrate on cholesterol synthesis and bile acid metabolism in HTG. Cholesterol synthesis, bile acid pool sizes, and synthesis rates were compared between 9 male HTG patients and 10 normolipidemic controls matched for age, sex, and BMI. Effects of bezafibrate or fish oil were studied only in HTG patients in a randomized crossover trial. Patients had 14-fold higher serum triglyceride concentrations and greater cholesterol synthesis, as indicated by a 107% higher ratio of serum lathosterol to cholesterol (P < 0.01) than controls. The groups did not differ in bile acid metabolism. Both bezafibrate and fish oil reduced serum TG concentration (-68 and -51% vs. baseline, respectively). Compared with baseline, bezafibrate therapy was associated with reduced cholesterol synthesis (-25%, P = 0.009) without changes in bile acid synthesis rate and pool size. In contrast, fish oil increased bile acid synthesis (+31% vs. baseline, P = 0.07 and +53% vs. bezafibrate, P = 0.02) and altered bile acid distribution, as reflected by an increased ratio of the cholic acid (CA) synthesis rate to the chenodeoxycholic acid (CDCA) synthesis rate (+35% vs baseline, P = 0.05 and + 32% vs bezafibrate, P = 0.07) without effects on bile acid pool size or cholesterol synthesis. In conclusion, cholesterol synthesis is greater in HTG patients than in controls, whereas bile acid synthesis does not differ. Bezafibrate and fish oil have similar triglyceride-lowering capacities, but distinct effects on cholesterol synthesis. Bile acid synthesis is increased by fish oil, but not by bezafibrate therapy.

Bezafibrate↗

PubMed2004

Naltrexone treatment of tardive dyskinesia in patients with schizophrenia.

OBJECTIVE: Treatment of dyskinetic disorders, in general, and of tardive dyskinesia (TD), in particular, is difficult. The opiate peptide enkephalin coexits with gamma aminobutyric acid in the projection neurons of striatum forming the "indirect" pathway. Several lines of preclinical evidence implicate this enkephalin-comediated pathway in the pathophysiology and therapeutics of dyskinesia. However, previous studies, most using relatively low doses of opioid antagonists, showed mixed results. The goal of the current study was to test whether moderately high doses of naltrexone, alone or in combination with a subtherapeutic dose of a gamma aminobutyric acid agonist, improve TD. METHODS: In 2 double-blind, placebo-controlled, randomized, crossover trials, effects of naltrexone alone (n = 9) and in combination with clonazepam (n = 14) were tested on TD. In both trials, patients' antipsychotic medication and dose remained unchanged through the trial. Naltrexone dose was increased over a period of 3 weeks to 200 mg/d and maintained at that dose for another week. In the second study, patients were first stabilized on low dose (0.25 to 0.5 mg) of clonazepam for 4 weeks or longer. In addition to the TD scores, saccadic peak velocity and latency, as measures of vigilance, and antisaccade error rate were obtained during the fourth week of placebo and naltrexone in a subgroup of patients. RESULTS: There were no significant effects of naltrexone alone on TD (mean +/- SD decrease in TD score = 0.1 +/- 4.8), psychosis scores, or eye movement measures. Low dose of clonazepam had no effect on TD. However, addition of naltrexone significantly improved TD (mean, SD decrease in TD score 4.0 +/- 3.6). There was no clinical or laboratory evidence of increased sedation during treatment with naltrexone compared to placebo. There were no significant effects on the antisaccade error rate or psychosis scores. CONCLUSION: These findings suggest effectiveness of a strategy of combining a GABA(gamma aminobutyric acid)mimetic drug with an enkephalin antagonist to treat dyskinesia.

Adult↗

PubMed2005

Beneficial metabolic effects of regular meal frequency on dietary thermogenesis, insulin sensitivity, and fasting lipid profiles in healthy obese women.

BACKGROUND: Although a regular meal pattern is recommended for obese people, its effects on energy metabolism have not been examined. OBJECTIVE: We investigated whether a regular meal frequency affects energy intake (EI), energy expenditure, or circulating insulin, glucose, and lipid concentrations in healthy obese women. DESIGN: Ten women [x +/- SD body mass index (in kg/m(2)): 37.1 +/- 4.8] participated in a randomized crossover trial. In phase 1 (14 d), the subjects consumed their normal diet on 6 occasions/d (regular meal pattern) or followed a variable meal frequency (3-9 meals/d, irregular meal pattern). In phase 2 (14 d), the subjects followed the alternative pattern. At the start and end of each phase, a test meal was fed, and blood glucose, lipid, and insulin concentrations were determined before and for 3 h after (glucose and insulin only) the test meal. Subjects recorded their food intake on 3 d during each phase. The thermogenic response to the test meal was ascertained by indirect calorimetry. RESULTS: Regular eating was associated with lower EI (P < 0.01), greater postprandial thermogenesis (P < 0.01), and lower fasting total (4.16 compared with 4.30 mmol/L; P < 0.01) and LDL (2.46 compared with 2.60 mmol/L; P < 0.02) cholesterol. Fasting glucose and insulin values were not affected by meal pattern, but peak insulin concentrations and area under the curve of insulin responses to the test meal were lower after the regular than after the irregular meal pattern (P < 0.01 and 0.02, respectively). CONCLUSION: Regular eating has beneficial effects on fasting lipid and postprandial insulin profiles and thermogenesis.

Adult↗

PubMedDate not supplied

Influence of hyperbaric oxygen on the pharmacokinetics of single-dose gentamicin in healthy volunteers.

STUDY OBJECTIVE: To determine the single-dose pharmacokinetics of gentamicin in healthy humans undergoing hyperbaric oxygen (HBO) exposure. DESIGN: Randomized, crossover trial. SETTING: Specialized hyperbaric research facility within a United States Air Force medical center. SUBJECTS: Five healthy men between 28 and 43 years of age. INTERVENTIONS: Each subject received a total of two doses of intravenous gentamicin 1.5 mg/kg lean body weight spaced at least 2 weeks apart. One dose was infused under normobaric oxygen (NBO) conditions and the other under HBO conditions. MEASUREMENTS AND MAIN RESULTS: Gentamicin pharmacokinetic values were determined on 11 serum samples per subject collected sequentially out to 300 minutes after infusion. Using PCNONLIN, the following results demonstrated no difference between the pharmacokinetic values under HBO and NBO conditions, respectively: beta half-life (112, 115 min); volume of distribution (0.201, 0.184 L/kg); peak concentration (6.52, 7.23 mg/L); clearance (0.0754, 0.0676 L/kg/hr). CONCLUSIONS: Hyperbaric oxygen produced no changes in the measured pharmacokinetic values of gentamicin under the conditions specified in this study. It is possible that numerous HBO exposures could produce a cumulative effect on gentamicin pharmacokinetics that would not be discernible in a single-dose study. Because of the profound physiologic effects of HBO, drugs with narrow therapeutic indexes should be evaluated under HBO conditions if they are to be given to patients receiving HBO treatments.

Adult↗

PubMed2006

Diagnostic performance of urinary resveratrol metabolites as a biomarker of moderate wine consumption.

BACKGROUND: Nutritional biomarkers may be better measures of dietary exposure than self-reported dietary data. We evaluated resveratrol metabolites, potential biomarkers of wine consumption, in humans after moderate consumption of sparkling, white, or red wines. METHODS: We performed 2 randomized, crossover trials and a cohort study. In the first study, 10 healthy men consumed 30 g of ethanol/day as sparkling wine or gin for 28 days. In the second trial, 10 healthy women consumed 20 g of ethanol/day as white or red wine for 28 days. We also evaluated 52 participants in a study on the effects of a Mediterranean diet on primary prevention of cardiovascular disease (the PREDIMED Study). We used liquid chromatography-tandem mass spectrometry to analyze urinary total resveratrol metabolites (TRMs) and predictive values and ROC curve analyses to assess the diagnostic accuracy. RESULTS: We observed significant increases in TRMs [72.4 (95% confidence interval, 48.5-96.2; P = 0.005), 211.5 (166.6-256.3; P = 0.005), and 560.5 nmol/g creatinine (244.9-876.1; P = 0.005)] after consumption of sparkling, white, or red wine, respectively, but no changes after the washout or gin periods. In the cohort study, the reported daily dose of wine consumption correlated directly with TRMs (r = 0.654; P < 0.001). Using a cutoff of 90 nmol/g, we were able to use TRMs to differentiate wine consumers from abstainers with a sensitivity of 72% (60%-84%); and a specificity of 94% (87%-100%). CONCLUSIONS: Resveratrol metabolites in urine may be useful biomarkers of wine intake in epidemiologic and intervention studies.

Adult↗

PubMed1992

The evaluation of analgesic effects in cancer patients as exemplified by a double-blind, crossover study of immediate-release versus controlled-release morphine.

We compared the effects of controlled-release and immediate-release morphine preparations in adult patients with moderate-to-severe cancer pain and report methodologic approaches to pain evaluation. The study consisted of a two-phase randomized crossover trial preceded by a titration phase; all phases were conducted under double-blind conditions. To evaluate pain intensity, a visual analogue scale (VAS) and the Present Pain Intensity scale of the McGill Pain Questionnaire were used. Additional morphine solution for breakthrough pain was used as an outcome measure. Pain was evaluated nine times daily, which permitted correlation of pain scores with the pharmacokinetic patterns of the test drugs. Side effects were rated once daily, using a scale from 0 to 3. To assess the relative importance of side effects, a toxicity index was designed based on both the intensity and duration of each side effect. The overall VAS pain scores during treatment with controlled-release and immediate-release morphine were 1.3 (SD = 0.1) and 1.4 (SD = 0.2), respectively. Use of supplemental morphine solution for breakthrough pain expressed as the percentage of the daily dose of the test drug was 5.5% for the controlled-release drug and 10.9% for the immediate-release drug. Differences in pain scores, side effects, and supplemental morphine requirement between the two groups were not significant. We discuss methodologic issues in double-blind clinical trials of analgesics, in particular the validity of "Patient Preference" as an outcome measure and problems related to the titration phase.

Adult↗

PubMed1993

Comparative efficacy of nifedipine gastrointestinal therapeutic system versus diltiazem when added to beta blockers in stable angina pectoris.

To determine the relative efficacy of nifedipine gastrointestinal therapeutic system (GITS) and diltiazem, 20 patients with angina pectoris and coronary artery disease were studied in a double-blinded, placebo-controlled randomized crossover trial. All patients were taking concomitant beta blockers. Efficacy was assessed by symptoms, exercise treadmill testing, and ambulatory ST-segment monitoring at baseline and after 6 weeks on each medication. Mean daily dose was titrated to 119 +/- 7 mg (nifedipine GITS) and 342 +/- 59 mg (diltiazem). The addition of either nifedipine GITS or diltiazem resulted in a significant reduction in angina frequency, improvement in exercise treadmill duration (7 vs 7 and 8 minutes; baseline vs nifedipine GITS and diltiazem), time to angina onset (4 vs 7 and 7 minutes; baseline vs nifedipine GITS and diltiazem), and time to ST-segment depression (5 vs 6 and 7 minutes; baseline vs nifedipine GITS and diltiazem). There was no significant difference between nifedipine GITS and diltiazem with respect to the magnitude of improvement in anginal symptoms or exercise test parameters. Both nifedipine GITS and diltiazem reduced the overall frequency and duration of ischemic episodes on ambulatory monitoring, but this reduction was not statistically different. Thus, nifedipine GITS and diltiazem at maximally tolerated doses were equally effective at reducing angina and increasing exercise tolerance as beta blockers alone.

Adrenergic beta-Antagonists↗

PubMed2001

Effect of grapefruit juice on the pharmacokinetics of losartan and its active metabolite E3174 in healthy volunteers.

Grapefruit juice (GJ), a cytochrome P450 (CYP) 3A4 inhibitor, may affect the pharmacokinetics of drugs metabolized through CYP 3A4. Losartan, an angiotensin II antagonist, is converted into its main active metabolite E3174 by CYP 3A4 and CYP 2C9. The effect of GJ on losartan pharmacokinetics was assessed in a randomized crossover trial. Losartan was given to 9 volunteers with and without GJ. Concentrations of losartan and its E3174 metabolite were determined in serum by a high-performance liquid chromatography method (HPLC). Significant differences were observed in some of the pharmacokinetic parameters of losartan and its metabolite E3174 after losartan administration with and without co-administered GJ. The lag time (time to drug appearance in serum) of losartan increased significantly with co-administered GJ. The mean residence time (MRT) and half-life (t(1/2)) of the E3174 metabolite were significantly longer and the area under the concentration--time curve (AUC) of the E3174 metabolite was significantly smaller after concomitant GJ administration. The ratio AUC(losartan)/AUC(E3174) was significantly increased after concurrent grapefruit juice intake. The increased lag time of losartan and the increased MRT and t1/2 and decreased AUC of E3174 were considered indicative of simultaneous CYP 3A4 inhibition and P-glycoprotein activation. The significantly increased AUC(losartan)/AUC(E3174) ratio, however, indicates reduced losartan conversion to E3174 by CYP 3A4 metabolism as a result of co-administered GJ.

Adult↗

PubMed1980

Treatment of benign essential hypertension with frusemide in different doses.

A double-blind, randomized, crossover trial was carried out in 26 hypertensive patients to investigate the hypotensive effects of three different dosages of frusemide (40 mg, 60 mg, and 80 mg twice daily) and the effects on serum potassium and urinary output. The study included a 4-week treatment period with placebo, three periods of 6 weeks with frusemide, and an intervening placebo period of 4 weeks. The mean arterial blood pressure fell about 10 mmHg within the first 2 weeks and was independent of the frusemide dosage. During the following weeks of treatment, there was a constant, slow fall in blood pressure. The period on placebo was too brief for values to return to the initial level. In contrast, the increase in urinary output, which was dose-dependent, ceased when medication was withdrawn. The diuretic effect was maintained throughout the treatment periods. There was a correlation between the fall in serum potassium and the diuretic effect whereas no correlation with the fall in blood pressure could be shown. Except for a significant increase in serum zinc, no changes were observed in other electrolyte parameters. Body weight, pulse, haemoglobin and erythrocyte sedimentation rate remained unchanged. Side-effects were few and mild, but tended to increase with higher doses.

Adult↗

PubMed1992

Use of a microprocessor-equipped tablet box in monitoring compliance with antihypertensive treatment.

Compliance with antihypertensive therapy is usually monitored by questionnaire, tablet counts, or estimation of drug levels in blood or in urine. The aim of this study was to examine patient compliance by means of an "electronic monitor." After 2 weeks of run-in on placebo, 34 moderately hypertensive patients were included in an open, randomized, crossover trial examining the efficacy and tolerance of nitrendipine, 20 mg as a single daily dose (morning or evening) for 1 month. We analyzed the results in 26 patients. Patients were supplied with tablet boxes equipped with a microprocessor (MENS) that registered the timing and duration of opening of the box over both the placebo and nitrendipine periods. Compliance (%) was calculated as the ratio of the number of days that the pill box was opened to the number of days between visits. The compliance was analyzed for each treatment group, namely placebo and nitrendipine morning and evening, over 1 month. Compliance (mean + SD) was 96.5 +/- 7.4% on placebo and 94.4 +/- 10.7% in the morning and 90.6 +/- 15.4% in the evening. Nitrendipine was taken in the morning at 0700 h +/- 2 h and in the evening at 1859 h +/- 2 h 12 min. The frequency of 24 h +/- 1 h intervals between medication was 83.5% on placebo. This frequency was 72.6% for morning dosage and 71.8% for evening dosage on nitrendipine. There were no differences in compliance between the morning and evening groups when analyzed according to age and sex. There was a negative correlation with time (r = -0.57, p less than 0.001).(ABSTRACT TRUNCATED AT 250 WORDS)

Blood Pressure↗

PubMed2004

Drug delivery and adherence in young children.

The aim of this pilot study was to compare a the HaloLite Paediatric Nebulizer (HPN) with a pressurized metered dose inhaler and valved holding chamber (pMDI VHC, Aerochamber) in terms of drug delivery, adherence to treatment, compliance with device, true adherence, and acceptability. Fourteen children aged 11-36 months with asthma on regular treatment with inhaled corticosteroids were enrolled into an open, randomized, crossover trial. They received budesonide for 2 weeks with each delivery system. Both devices incorporated a datalogger which recorded information on how the device was used. The HPN was preprogrammed to deliver 25 microg of budesonide to the patient. A single actuation of budesonide 200 microg was used with the pMDI VHC. The median delivered dose of budesonide was 36 microg (range, 31-45 microg; CV, 15%) for the HPN and 53 microg (range, 17-85 microg; CV, 47%) for the pMDI VHC. The median adherence was 68% (range, 11-96%) with the HPN and 71% (range, 11-100%) with the pMDI VHC. The median device compliance was 30% and 51% and the median true adherence was 23% and 36%, respectively. The shape, size, and weight of the HaloLite Paediatric Nebulizer were generally less acceptable than the shape, size, and weight of the pMDI VHC with datalogger. These results indicate that reproducible quantities of drug can be delivered to very young children using AAD technology such as that incorporated into the HPN. Drug delivery with the pMDI VHC was more variable, but parents preferred this device.

Asthma↗

PubMed2006

Effects of various rinsing protocols after the use of amine fluoride/stannous fluoride toothpaste on the acid production of dental plaque and tongue flora.

The aim of this clinical study was to evaluate the effect of various rinsing protocols on oral acid production 6 h after tooth brushing with an amine fluoride/stannous fluoride (AmF/SnF2) toothpaste. After a 14-day period of using F-free toothpaste, 30 participants followed three experimental protocols each, followed by F-free washout periods in a randomized crossover trial. They used AmF/SnF2 toothpaste twice daily for 1 week, and after brushing, they either rinsed with tap water, omitted the post-brush rinse, or rinsed with an AmF/SnF2 mouthwash. In the F-free washout periods, the participants brushed their teeth without further instructions. Six hours after the last brushing (+/-rinsing) of each period, subjects rinsed with 10 ml 10% sucrose solution for 2 min. A tongue film sample and a buccal plaque sample were taken 4 and 8 min after the sucrose challenge, respectively. Metabolic acid ions were determined by capillary electrophoresis. The results show that (1) omitting the post-brush water rinse did not reduce the production of lactic, acetic or minor acids in plaque, nor on the tongue, and that (2) the additional use of AmF/SnF2 mouthwash after brushing reduced the acid production in plaque and tongue samples for at least 6 h. The distributions of acids produced in the plaque or tongue samples were not statistically different between experimental periods. It is concluded that an increase in the antimetabolic effect of AmF/SnF2 toothpaste in between two daily brushing exercises is not achieved by omitting the post-brush water rinse. The additional use of AmF/SnF2 mouthwash after brushing is effective in reducing the acid metabolism in dental plaque and tongue flora.

Acids↗