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PubMed1996

A multicenter study of nebulized bronchodilator solutions in chronic obstructive pulmonary disease.

A multicenter, 85-day, double-blind, randomized study was conducted to compare the effects of a single-dose and chronic inhalation of ipratropium bromide solution (500 micrograms) to the beta-adrenergic agonist metaproterenol (5% solution, 15 mg) in patients with chronic obstructive pulmonary disease (COPD). Patients were required to have a relatively stable, moderately severe COPD, forced expiratory volume in 1 second (FEV1) < 65% of predicted normal, FEV1 <70% of forced vital capacity (FVC), and a smoking history of > 10 pack-years. Following a 2-week baseline period, patients were randomized into either the ipratropium bromide (106 patients) or metaproterenol (107 patients) study groups. Pulmonary function testing was performed on days 1, 43, and 85. Secondary efficacy variables examined included peak expiratory flow rates, physician's global evaluation, quality of life, COPD symptom score, and use of concomitant medications. FEV1 was comparable between the two groups on day 1 (1.00 and 1.02 liters, ipratropium bromide vs metaproterenol, respectively; p = nonsignificant). The baseline FEV1 increased significantly in the ipratropium bromide group between day 1 and 43 by 10% (from 1.00 to 1.10 liters, p < 0.002) and remained 7% elevated on day 85 (1.07 liters) compared to day 1 (p < 0.02); it did not change in the metaproterenol group across all three test days. A clinically significant (> 15%) mean FEV1 response was observed on each of the 3 test days following drug inhalation in both treatment groups. The median duration of action was similar between groups (5 hours) on test day 1, but on day 85 the median duration for ipratropium bromide was r.5 hours compared to 3.0 hours for metaproterenol (p < 0.04). The secondary efficacy variables were uniformly better in the ipratropium bromide than the metaproterenol group. Side effects were infrequent and generally mild in both groups. These data suggest that the availability of a high-dose ipratropium bromide solution offers a safe and effective means of producing prolonged bronchodilation in patients with COPD.

Administration, Inhalation↗
PubMed1994

Investigation into the duration of action of sustained-release ibuprofen in osteoarthritis and rheumatoid arthritis.

The duration of action of sustained-release ibuprofen ('Brufen Retard') was investigated in a 14-day double-blind study involving 14 osteoarthritis and 10 rheumatoid arthritis patients. The recommended once-daily dosage of this preparation (1600 mg taken in the evening) provided effective control of arthritic symptoms for both patient groups, with significant overall improvements in pain and stiffness compared to baseline. Substitution of placebo for a single dose of the active treatment resulted in a trend towards worsening of pain and stiffness in the rheumatoid group; however, the only statistically significant change involved impaired quality of sleep (p = 0.03) during the night after placebo administration, over 24-hours after the previous dose of active medication. In this particular study, symptom control was also clearly achieved for the osteoarthritis patients, as this group showed no deterioration within the same period. The 24-hour clinical action underlying these findings is consistent with ibuprofen plasma profiles obtained with the sustained-release preparation in earlier pharmacokinetic studies. It is likely that the greater sensitivity of rheumatoid patients to withdrawal of a single day's active treatment in this study reflects a more severe inflammatory disease process than that of the osteoarthritis patients.

Aged↗
PubMed2005

Inhibition of the metabolism of brotizolam by erythromycin in humans: in vivo evidence for the involvement of CYP3A4 in brotizolam metabolism.

AIMS: To obtain in vivo evidence for the involvement of cytochrome P450 (CYP) 3A4 in the metabolism of brotizolam. METHODS: Fourteen healthy male volunteers received erythromycin 1200 mg day(-1) or placebo for 7 days in a double-blind randomized crossover manner. On the 6th day they received a single oral 0.5-mg dose of brotizolam, and blood samplings were performed for 24 h. RESULTS: Erythromycin treatment significantly increased the peak plasma concentration (P < 0.05), total area under the plasma concentration-time curve (P < 0.01), and elimination half-life (P < 0.01) of brotizolam. CONCLUSIONS: The present study provides in vivo evidence for the involvement of CYP3A4 in brotizolam metabolism.

Administration, Oral↗
PubMed1996

Respiratory rehabilitation, exercise capacity and quality of life in chronic airways disease in old age.

Respiratory rehabilitation improves exercise capacity and quality of life in younger patients but is untried in the aged. We aimed to: (a) assess repeatability of the 6-minute walk test, factors affecting it and its relation to quality of life in elderly patients with chronic obstructive airways disease (COAD); (b) assess compliance of such patients with an intensive respiratory rehabilitation protocol; (c) pilot the assessment of the effect of respiratory rehabilitation on the 6-minute walk test in these patients. Seventeen subjects with stable, symptomatic COAD were recruited, 15 (six men), 70-89 (mean 76) years, completed the study. Mean (standard deviation) 1-second forced expiratory volume (FEV1) = 49 (5)% predicted. Six-minute walk tests were repeated single-blind, 2-10 days apart. Quality of life was measured using Guyatt respiratory questionnaire. Patients underwent 12 weeks incremental respiratory rehabilitation (x4/day step-ups, unweighed arm raises, inflating balloons). Baseline 6-minute walk was repeatable and was correlated with the log Guyatt dyspnoea score (r = 0.65, p = 0.006). In multiple regression neither age nor FEV1 predicted walk distance: body mass index, maximal expiratory mouth pressure; calorie intake. Mean (SEM) 6-minute walk distance after-rehabilitation was greater than baseline (p = 0.003). Elderly patients with COAD tolerate intensive respiratory rehabilitation and a controlled, blinded study is needed.

Aged↗
PubMed1996

[The relationship between single-oral dose kinetics of alprazolam and cytochrome P4503A and cytochrome P4502C19].

To clarify the involvement of cytochrome P4503A (CYP3A) and CYP2C19 in the metabolism of alprazolam, the effects of pretreatment with erythromycin, which is an inhibitor of CYP3A and S-mephenytoin 4-hydroxylation capacity on the single-oral dose kinetics of alprazolam were studied in 12 healthy male volunteers. Six each were extensive metabolizers (EMs) and poor metabolizers (PMs) of S-mephenytoin 4-hydroxylation. Each subject received erythromycin 1,200 mg/day or placebo for 10 days in a double-blind, crossover manner. At 9 AM of day 8 alprazolam 0.8 mg was given orally, and blood samplings were performed up to 48 hours postdosing. Erythromycin treatment compared with placebo treatment increased significantly plasma alprazolam concentrations from 6 to 48 hours postdosing. Erythromycin significantly decreased the apparent oral clearance and prolonged the elimination half-life of alprazolam. No significant difference was found in plasma concentrations and pharmacokinetic parameters of alprazolam between the EM and PM groups. The present study thus suggests that CYP3A, but not CYP2C19, is involved in the metabolism of alprazolam.

Administration, Oral↗
PubMed1969

Evaluation of amantadine hydrochloride in the treatment of A2 influenzal disease.

Amantadine hydrochloride is the first drug to show promise as a practical anti-influenza agent. Several studies demonstrating a prophylactic effect in volunteers with induced A2 disease as well as in patients during A2 outbreaks have created the impetus for therapeutic trials. The widespread A2 influenza epidemic that occurred early in 1968 provided the opportunity for therapeutic evaluation in the USA.A total of 197 prison inmates with proven influenza agreed to participate in the 10-day double-blind evaluation of amantadine (100 mg, twice daily). Onset of therapy was approximately 20 hours after first subjective awareness of illness.Assessment of drug effectiveness was based on rapidity of resolution of illness. There was a significant increase in the number of drug-treated as against placebo patients in the "rapid resolver" group whereas individuals receiving placebo dominated the "slow resolver" group. Analysis of febrile responses indicated that amantadine-treated patients had significantly more rapid defervescence. Virus isolation studies revealed etiologically related virus in 90% of all volunteers during the first 5 days of therapy. It was apparent that clinical improvement was not correlated with disappearance of the virus. Nevertheless, the trials conducted during the influenza season of early 1968 indicated the therapeutic effect of amantadine hydrochloride. Administration of 100 mg, twice daily, for 10 days did not cause any adverse effects.

Amantadine↗
PubMed2006

Rifampicin markedly decreases plasma concentration and hypnotic effect of brotizolam.

The purpose of the present study was to examine the effects of rifampicin on the single oral dose pharmacokinetics and pharmacodynamics of brotizolam. Thirteen healthy male volunteers received rifampicin 450 mg/day, or matched placebo, for 7 days in a double-blind randomized crossover manner. On the sixth day they received a single oral 0.5-mg dose of brotizolam, and blood sampling was performed for 24 hours, together with an assessment of psychomotor function using the Digit Symbol Substitution Test and the Stanford Sleepiness Scale. Rifampicin treatment significantly (P<0.001) decreased the peak plasma concentration (69%), total area under the plasma concentration-time curve (90%) and elimination half-life (79%) of brotizolam. Rifampicin significantly increased the area under the score-time curve of the Digit Symbol Substitution Test (P<0.01), and decreased that of the Stanford Sleepiness Scale (P<0.05). The present study suggests that rifampicin markedly decreases plasma concentration and hypnotic effect of brotizolam and, therefore, this combination is not recommended in clinical practice.

Adult↗
PubMed1994

Synthetic food coloring and behavior: a dose response effect in a double-blind, placebo-controlled, repeated-measures study.

OBJECTIVE: To establish whether there is an association between the ingestion of synthetic food colorings and behavioral change in children referred for assessment of "hyperactivity." PARTICIPANTS: From approximately 800 children referred to the Royal Children's Hospital (Melbourne) for assessment of suspected hyperactivity, 200 were included in a 6-week open trial of a diet free of synthetic food coloring. The parents of 150 children reported behavioral improvement with the diet, and deterioration on the introduction of foods noted to contain synthetic coloring. A 30-item behavioral rating inventory was devised from an examination of the clinical histories of 50 suspected reactors. Thirty-four other children (23 suspected reactors, 11 uncertain reactors) and 20 control subjects, aged 2 to 14 years, were studied. DESIGN: A 21-day, double-blind, placebo-controlled, repeated-measures study used each child as his or her own control. Placebo, or one of six dose levels of tartrazine (1, 2, 5, 10, 20, 50 mg), was administered randomly each morning, and behavioral ratings were recorded by parents at the end of each 24 hours. RESULTS: The study identified 24 children as clear reactors (19 of 23 "suspected reactors," 3 of 11 "uncertain reactors," and 2 of 20 "control subjects"). They were irritable and restless and had sleep disturbance. Significant reactions were observed at all six dose levels. A dose response effect was obtained. With a dose increase greater than 10 mg, the duration of effect was prolonged. CONCLUSION: Behavioral changes in irritability, restlessness, and sleep disturbance are associated with the ingestion of tartrazine in some children. A dose response effect was observed.

Adolescent↗
PubMed2006

The effect of montelukast (10mg daily) and loratadine (10mg daily) on wheal, flare and itching reactions in skin prick tests.

UNLABELLED: Antileukotriene agents are widely used for the treatment of allergic conditions including bronchial asthma and allergic rhinitis. The influence of montelukast on skin reactivity has not been clearly evaluated. The aim of this study was to determine the effect of montelukast on wheal, flare and itching in skin prick tests (SPTs). METHODS: Fifteen atopic patients (5 women and 10 men) with average age 28.04 (SD+/-8.24) were tested with histamine, codeine, negative control solution and allergen extract (grasses). Montelukast (10mg), loratadine (10mg) or placebo were given to the volunteers for 5 days in a double-blind manner, followed by SPT, with 14 days of wash-out period. RESULTS: There was no differences in wheal, flare and itching (p=0.205; 0.086 and 0.069, respectively, Wilcoxon rank-sum test) between SPT performed after placebo and wash-out period. The analysis revealed a statistically significant suppression of wheal and flare by loratadine (p<0.05 for all tested solutions). Pre-treatment with montelukast did not influence wheal size (p=0.099, 0.21, 0.066 for histamine, codeine and allergens, respectively), but significantly reduced flare (p=0.005; 0.003; 0.02 for histamine, codeine and allergens, respectively). We found a significant suppression of itching produced by montelukast (p=0.02) and loratadine (p=0.03) as compared to placebo (p=0.068 vs. wash out). CONCLUSIONS: Our data show a tendency to suppressive effect of montelukast on flare and itching but not on wheal which is basic for SPT interpretation. We conclude that found suppression have little impact on clinical effectiveness of SPT as a diagnostic tool.

Acetates↗
PubMed1998

Effect of intravenous ranitidine and omeprazole on intestinal absorption of water, sodium, and macronutrients in patients with intestinal resection.

BACKGROUND: H2 receptor blockers and proton pump inhibitors reduce intestinal output in patients with short bowel syndrome. AIMS: To evaluate the effect of intravenous omeprazole and ranitidine on water, electrolyte, macronutrient, and energy absorption in patients with intestinal resection. METHODS: Thirteen patients with a faecal weight above 1.5 kg/day (range 1.7-5.7 kg/day and a median small bowel length of 100 cm were studied. Omeprazole 40 mg twice daily or ranitidine 150 mg twice daily were administered for five days in a randomised, double blind, crossover design followed by a three day control period with no treatment. Two patients with a segment of colon in continuation were excluded from analysis which, however, had no influence on the results. RESULTS: Omeprazole increased median intestinal wet weight absorption compared with no treatment and ranitidine (p<0.03). The effect of ranitidine was not significant. Four patients with faecal volumes below 2.6 kg/day did not respond to omeprazole; in two absorption increased by 0.5-1 kg/day; and in five absorption increased by 1-2 kg/day. Absorption of sodium, calcium, magnesium, nitrogen, carbohydrate, fat, and total energy was unchanged. Four high responders continued on omeprazole for 12-15 months, but none could be weaned from parenteral nutrition. CONCLUSION: Omeprazole increased water absorption in patients with faecal output above 2.50 kg/day. The effect varied significantly and was greater in patients with a high output, but did not allow parenteral nutrition to be discontinued. Absorption of energy, macronutrients, electrolytes, and divalent cations was not improved. The effect of ranitidine was not significant, possibly because the dose was too low.

Adult↗
PubMed1992

Verapamil inhibits ethanol elimination and prolongs the perception of intoxication.

Ten young healthy men received verapamil (80 mg every 8 hours for 6 days) or placebo in a blinded, randomized, crossover design. On the sixth day, ethanol was administered as a single oral dose (0.8 gm/kg), and blood samples were collected over the following 12 hours for determination of verapamil, norverapamil, and ethanol concentrations. Compared with placebo, verapamil increased the peak blood ethanol concentration (106.45 +/- 21.40 to 124.24 +/- 24.74 mg/dl, p less than 0.05) and area under the ethanol concentration versus time curve (365.67 +/- 93.52 to 475.07 +/- 97.24 mg.hr/dl, p less than 0.005). Verapamil areas under the concentration versus time curves (AUC) were positively correlated (r = 0.71, p less than 0.05) to increased ethanol blood AUC values. Each subject's perception of ethanol intoxication was measured by use of a simple visual analog scale. Compared with placebo, verapamil significantly increased area under the effect versus time curve (10.19 +/- 7.6 to 13.83 +/- 7.81 cm.hr, p less than 0.002) but did not change the peak effect or time to peak effect. Ethanol effect versus concentration plots were not significantly different between verapamil and placebo treatment phases when increased ethanol concentrations during verapamil therapy were taken into account. The findings of our study suggest that verapamil significantly inhibits ethanol elimination, resulting in elevated blood ethanol concentrations that prolong the intoxicating effects of alcohol.

Adult↗
PubMed1987

Double-blind controlled clinical trial of oral S-adenosylmethionine versus piroxicam in knee osteoarthritis.

A double-blind, randomized, 84-day controlled clinical trial was carried out to compare orally administered S-adenosylmethionine (SAMe) (1,200 mg per day) with oral piroxicam therapy (20 mg per day) in the management of unilateral knee osteoarthritis. The ability of each drug to maintain the results achieved at the end of the treatment period was also evaluated during a 56-day follow-up period. Forty-five patients completed the study, 22 in the SAMe group and 23 in the piroxicam group. Both SAMe and piroxicam proved effective in inducing a significant improvement in the total pain score after 28 days of treatment. With regard to the other clinical parameters (i.e., morning stiffness, the distance walked before the onset of pain, active and passive motility), improvement started from about Day 56 in both groups. No significant difference was found between the two treatments in terms of efficacy and tolerability. Patients treated with SAMe maintained clinical improvement achieved at the end of treatment longer than did patients receiving piroxicam.

Aged↗
PubMed2002

[Chronobiological research on antidepressant drugs: the effect of the antidepressant drugs, trazodone and imipramine on the circadian rhythm using electroencephalography in healthy volunteers].

The effects of the antidepressant drugs trazodone and imipramine on the circadian rhythm were studied by means of the sleep propensity test (SPT; sleep latency was examined by 35-minute EEG records at 09:00, 11:00, 13:00, 15:00, 17:00). The subjects were 11 healthy male volunteers (mean age, 23.6 years old). The drugs were administered 4 times a day with single blind trials using an inactive placebo as a control. The dosages of the drugs were trazodone 50-100 mg/day and imipramine 20-40 mg/day. We discussed the circadian rhythm referring to previous polysomnograhy (PSG) studies using the same drugs and dosages with most of the same subjects. As a result, the mean sleep latency of SPT was the shortest at 09:00 (p<0.1) with a placebo, at 11:00 (p<0.05) with trazodone and at 13: 00 (not significantly) with imipramine administration. These results suggested that neither drug affected sleepiness. They affected the circadian rhythm during the daytime (=the day rhythm). They delayed the day rhythm. Delay of the day rhythm was due to trazodone and have been caused by not only trazodon administration itself, but also by the increase of slow-wave sleep obtained in the previous night's PSG study. And the day-rhythm delay was due to imipramine and might have been caused by not only imipramine administration itself, but also by the decrease in the percentage of slow-wave sleep and REM sleep, and an increase in REM latency obtained in the previous night's PSG study. Therefore, we concluded that neither drug affected the tendency toward sleepiness, but did affect the day rhythm in healthy subjects.

Adult↗
PubMed1989

Axonal transport and central visual projections of ganglion cells in congenitally blind chickens.

The rd (retinal degenerate) strain of chicken is an example of a recessively inherited mutation characterized by blindness at the time of hatching, as defined by behavioral and electrophysiological tests. Paradoxically, blind mutants have normal retinal morphology, even at the ultrastructural level. Eventually, however, the entire retina degenerates in this strain, perhaps as a result of disuse atrophy. Results of preliminary studies imply that a defect in the visual transduction cascade in photoreceptor cells is responsible for the lack of vision. As well as being an important animal model for studies on photochemistry and transduction, the rd chicken may afford a paradigm for studies on inner retinal physiology and pathology, as electrical input to this inner neuronal system appears to be absent. In the current study we examined axonal transport (both retrograde and anterograde) in rd retinal ganglion cells and connectivity of ganglion cells to visual centers in the brain and compared these to normally sighted chicks. All visuorecipient nuclei were present in rd animals and appeared normal at the light microscopic level. When 3H-proline was injected into one eye of a blind chicken on the day of hatching, labeled polypeptides or proteins were transported via a fast transport mechanism to the same visual centers in roughly the same quantities as in normally sighted chicks. When horseradish peroxidase (HRP) was injected in the optic tectum of blind and normal 1 day old chicks, this label was transported retrogradely to the soma of retinal ganglion cells.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗
PubMed1989

Dose dependent effect of diltiazem on the pharmacokinetics of nifedipine.

The effect of diltiazem pretreatment on the pharmacokinetics of nifedipine were determined in six healthy male volunteers. Placebo or diltiazem (30 mg and 90 mg) was given orally three times daily for 3 days in a double-blind, Latin square method. On the fourth day, a 20-mg nifedipine was given orally 1 hour after the last dose of placebo or diltiazem. The mean elimination half-life of nifedipine prolonged significantly following diltiazem (2.54 hours on placebo vs 3.40 hours on 30 mg diltiazem and 3.47 on 90 mg diltiazem, both P less than .01). The mean AUC of nifedipine increased during diltiazem (1726.6 nmol X hr/ml on placebo vs 3838.0 on 30 mg diltiazem, and 5370.0 on 90 mg diltiazem, both P less than .05, 30 mg vs 90 mg, 0.1 less than P less than .05). The ratio of the AUC of primary metabolite (nitropyridine form) to the AUC of nifedipine was reduced by diltiazem pretreatment in a dose-dependent manner. ICG clearance was not influenced following diltiazem. These results indicate that diltiazem dose-dependently alters the pharmacokinetic profiles of nifedipine. The ICG clearance test showed that the liver blood flow did not decrease during diltiazem therapy, therefore, the reduction in the metabolic clearance of nifedipine might be caused by inhibiting effect of diltiazem on the activity of drug oxidizing enzymes.

Adult↗
PubMed1983

[Ketoprofen-aspirin interaction].

Eighteen patients with chronic inflammatory joint disease were treated for two successive five day sequences, in a double blind crossover study, with 300 mg per day ketoprofen given alone or combined with 1,500 mg aspirin. Bioavailability and pharmacokinetics of total serum ketoprofen studied in eight patients did not appear to be significantly modified by addition of aspirin. Measurements of Ritchie's articular index and Lee's functional index demonstrated that ketoprofen was clinically as effective when given alone as in association with aspirin. Measurement of the sedimentation rate by the sigma ESR technique showed that aspirin produced a marked reduction of the antiinflammatory biological activity of ketoprofen which did not however reach statistical significance. This study of interactions between ketoprofen and aspirin shows that it is useless and perhaps harmful to combine the two medications.

Aspirin↗
PubMed2006

Short-term efficacy of intravenous pulse glucocorticoids in acute discogenic sciatica. A randomized controlled trial.

STUDY DESIGN: Double-blinded randomized controlled trial. OBJECTIVE: To test the short-term efficacy of a single intravenous (IV) pulse of glucocorticoids on the symptoms of acute discogenic sciatica. SUMMARY OF BACKGROUND DATA: The use of glucocorticoids in the treatment of acute discogenic sciatica is controversial. A potential advantage of the IV pulse therapy is the ability to distribute high glucocorticoid concentrations to the area surrounding the prolapsed disc without the risks and inconveniences of an epidural injection. METHODS: Patients with acute sciatica (<6-week duration) of radiologically confirmed discogenic origin were randomized to receive either a single IV bolus of 500 mg of methylprednisolone or placebo. Clinical evaluation was performed in a double-blind manner on days 0, 1, 2, 3, 10, and 30. The primary outcome was reduction in sciatic leg pain during the first 3 days following the infusion; secondary outcomes were reduction in low back pain, global pain, functional disability, and signs of radicular irritation. The analysis was performed on an intent-to-treat basis using a longitudinal regression model for repeated measures. RESULTS: A total of 65 patients were randomized, and 60 completed the treatment and the follow-up assessments. A single IV bolus of glucocorticoids provided significant improvement in sciatic leg pain (P = 0.04) within the first 3 days. However, the effect size was small, and the improvement did not persist. IV glucocorticoids had no effect on functional disability or clinical signs of radicular irritation. CONCLUSIONS: Although an IV bolus of glucocorticoids provides a short-term improvement in leg pain in patients with acute discogenic sciatica, its effects are transient and have small magnitude.

Double-Blind Method↗
PubMed1998

Randomised controlled trial of inhaled corticosteroids in patients with chronic obstructive pulmonary disease.

BACKGROUND: Inhaled corticosteroids are known to be beneficial for patients with asthma, but their role in treating patients with stable chronic obstructive pulmonary disease (COPD) remains controversial. A study was undertaken to determine whether inhaled corticosteroids are of functional benefit in patients who did not show improvement with a trial of oral corticosteroids. METHODS: In phase I patients with stable COPD were given a two week course of oral placebo followed by two weeks of prednisone 40 mg per day in a single blind manner to distinguish between responders and non-responders to oral corticosteroids. In phase II a double blind, randomised, parallel group trial of inhaled budesonide 1600 micrograms per day versus placebo was carried out in 79 nonresponders to oral corticosteroids. The primary outcome measure was forced expiratory volume in one second (FEV1), and secondary outcome measures were exercise capacity, dyspnoea with exertion, quality of life, peak expiration flow rate, and respiratory symptoms. RESULTS: Randomisation allocated 39 subjects to inhaled corticosteroids and 40 to placebo. There was no difference in the change in FEV1 from baseline between the treatment and placebo groups; mean difference -12 ml (95% CI -88 to 63) at three months and -4 ml (95% CI -95 to 87) at six months. The proportion of patients with a 15% or greater improvement was no higher among those receiving inhaled corticosteroids than in the placebo group at any of the follow up visits. Changes in secondary outcomes were also no different. CONCLUSIONS: Inhaled corticosteroids, even at high doses, were of no physiological or functional benefit in these patients with advanced COPD.

Administration, Inhalation↗