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Biomedical subjects

M Weintraub

Publications and source records attributed to M Weintraub.

18 recordsLinked to original sources

Digoxin-prescribing. Mostly good news.

We examined digoxin-prescribing in 47,000 prescriptions written predominantly by physicians in a large family medicine practice. Two hundred fifty-four patients received 511 digoxin prescriptions. Dose adjustments for age (16% decrease in patients older than 64 years), for renal disease (33% decrease), and for atrial fibrillation (39% increase) followed good prescribing practices. Appropriately lower loading doses were used for digitalization. However, despite continuing concern over the bioavailability of generic digoxin tablets, less than 40% of digoxin prescriptions in this study were written for the innovator's brand-name product (Lanoxin).

Adult

Methodology for demonstrating sustained efficacy of hypnotics: a comparative study of triazolam and flurazepam.

To test for sustained hypnotic efficacy, triazolam (0.6 mg) or flurazepam (30 mg) was given to chronic insomniac patients for 7 consecutive nights in parallel, double-blind design. Triazolam at this dose was an effective hypnotic by all usual subjective measures and did not produce appreciable hangover. Flurazepam performed similarly. For either drug, comparison of the mean scores for the first 2 nights with that for the last 2 nights for any of the parameters did not reveal any significant difference. Thus, both triazolam and flurazepam showed sustained efficacy for 1 week at these doses. Some interesting theoretical and practical questions about the measurement of sustained efficacy of hypnotics in situations of repetitive dosing were addressed by the study. While a placebo control is desirable, the results obtained may be uninterpretable. An acute-care hospital setting may not be the ideal setting for doing such studies. There were indications from the study that the first-night results in a hypnotic clinical trial may be atypical.

Adult

Relationship of serum and myocardial digoxin concentration to electrocardiographic estimation of digoxin intoxication.

Serum and myocardial digoxin levels were studied in 18 patients who came to autopsy. An independent analysis of electrocardiograms prior to death was made to ascertain the relationship between serum and tissue levels of digoxin and clinical estimation of drug toxicity. Patients with arrhythmias of digoxin toxicity had higher mean serum and tissue digoxin levels than patients without arrhythmia. There was overlap in the patient groups, however, and the differences were not statistically significant. The tissue to serum ratio was lower in the toxic patients. The latter phenomenon is unexplained but may be related to decreased tissue binding.

Aged

Acetazolamide-induced interference with primidone absorption. Case reports and metabolic studies.

Effects of acetazolamide on primidone plasma levels were studied in three patients. Apparent interaction occurred in two patients. Primidone was not detected in the plasma when given orally with acetazolamide in one patient. In another, peak serum concentration was delayed, with corresponding delays in urinary excretion of primidone and metabolites. Plasma and urine concentrations of the two metabolites, phenylethylmalonamide and phenobarbital, were also studied.

Acetazolamide

Free-living volunteer's motivations and attitudes toward pharmacologic studies in man.

Two groups of volunteers who had participated in pharmacologic studies were interviewed about their impressions of such studies. One group was from a university community, the other from the pharmaceutical industry. The differences between the two groups were correlated with their respective backgrounds. Both groups had favorable impressions about drug studies and investigators. Most were satisfied with the information given them about the nature and risks of the studies, but some believed that a written description of the study that they could consult at home would improve their understanding of the information. Financial reward was the primary reason given by both groups for volunteering, but the perceived risk of the study was the ultimate deciding factor. The volunteers disliked having their mobility restricted and for this reason might not be willing to participate in long-term studies, such as those formerly carried out in prisons. Alternative sources of volunteers for long-term studies will have to be found.

Adult

Uricosuric effects of niridazole.

Niridazole, an antischistosomal drug, caused a 44% decrease in the serum uric acid (SUA) concentration in 11 patients with schistosomiasis. The mean SUA (+/- SE) was 6.3 +/- 1.4 mg/100 ml at baseline and 3.5 +/- 1.5 mg/100 ml (p less than 0.01) on day 7 of treatment. There was a significant increase in the urinary uric acid/creatinine ratio, from 0.446 +/- 0.165 at baseline to 0.550 +/- 0.145 on day 3. There was no significant difference on day 7. The fractional clearance of uric acid rose from 7.2 +/- 6.8% to 13.9 +/- 17.3% (p less than 0.01), indicating a uricosuric effect. Oxypurine excretion was unchanged. In a separate study on 7 other patients, the SUA remained low for 4 to 7 days after the last dose. Niridazole, although not an organic acid, has uricosuric effects.

Creatinine

Piroxicam (CP 16171) in rheumatoid arthritis: a controlled clinical trial with novel assessment techniques.

Piroxicam (CP 16171), a new nonsteroidal anti-inflammatory agent, decreased pain, stiffness, and inflammation and increased the patient's ability to perform tasks in a double-blind study of patients with active, definite rheumatoid arthritis, poorly controlled despite standard therapy. Clinically and statistically significant improvement occurred in grip strength, walking time, and morning stiffness, and in patient and physician evaluation. Seventy-five per cent of the piroxicam-treated patients increased their daily activities. Three patients treated with the tablet form of piroxicam developed gastrointestinal ulcerations. Another patient developed iron deficiency anemia.

Activities of Daily Living

"Uniformed" consent and the wealthy volunteer: an analysis of patient volunteers in a clinical trial of a new anti-inflammatory drug.

After a 16-week clinical trial of a new anti-inflammatory drug, the participants were given a factual test to determine whether they had understood and remembered the information given them when consent was solicited. They filled out a questionnaire about their reasons for volunteering and their views on clinical studies and on medical practice in general. Demographic information was also obtained. Two thirds of the participants did not remember that they had been informed about potential risk (gastrointestinal ulceration). Some subjects remembered, but misunderstood, what they had been told; others developed erroneous ideas about the trial and the study drug. The volunteers agreed to participate in the study to help both their own arthritis and that of other patients. They took pride in their self-sacrifice and in being commended by their friends for their altruism. Analysis of the demographic data shows that indigent persons are not necessarily the most likely to participate in clinical trials. Two thirds of the subjects were from the middle class. The median family income was $13,000. To improve the informed consent procedure, we recommend group meetings in which the participants in a clinical trial can discuss the protocol and the risks of the study. Obtaining consent again, after initial anxiety has decreased, may improve comprehension.

Adult

Caffeine in the "sundown syndrome." Report of negative results.

This paper reports the results of a double blind study in patients with senile dementia to determine if the quality and quantity of sleep could be changed with various amounts of caffeine. Twelve patients with dementia were studied in a nursing home setting. Patients were medication free for a month prior to the study. Four treatments were given in a double blind technique. These included an uncaffeinated liquid and coffee with various amounts of caffeine. Measurements checked included sleep induction time, quality of sleep, total length of sleep, time awake during the night, and a global rating. No significant differences were noted between the noncaffeinated placebo and the coffee containing various amounts of caffeine.

Aged

Interpretation of the serum digoxin concentration.

Significant problems exist in the interpretation of serum digoxin concentration data. Failure to distinguish between results that do not require precise clinical correlation (proof of absorption, presence of drug, etc) and those which depend upon clinical correlation for their meaning ('toxicity' or 'effectiveness') can result in interpretive errors. Problems relating to the source of the serum digoxin concentration can also confound interpretation. Such difficulty may be controllable (obtaining the sample at the proper time, haemolysis, etc) or related to the laboratory technique (cross-reactivity with digoxin metabolites or other medications, technical errors, or lack of precision). Variation within the same patient over time or between patients related to disease (alterations in electrolytes, adrenergic or parasympathomimetic tone, or other medications) may prevent the direct attribution of an observed phenomenon to a particular digoxin concentration. Techniques for determining the effect of digoxin do exist and can be used to gather data for clinical correlations. Ways of improving the interpretaion of serum digoxin concentrations also exist and should be used to improve their value in patient management. The serum digoxin concentration seems to have an important future role. However, we need to know how better to interpret and exploit serum digoxin concentration data.

Adenosine Triphosphatases