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Biomedical subjects

L Lasagna

Publications and source records attributed to L Lasagna.

At least 19 recordsLinked to original sources
PubMed1979

Drugs for pain.

Explore the source record for details and available documents.

Humans↗
PubMed1979

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↗
PubMed1979

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↗
PubMed1979

Problems in publication of clinical trial methodology.

The literature on analgesic testing in man reveals a series of informational gaps. These include a failure to document the occurrence of "trials that failed", the problems associated with recruiting patients and in dealing with dropouts, the relative advantages and disadvantages of different methods of assessing relief from pain, the importance of baseline variables, and the utility of global and comparative judgments by patients. A trial is described in which only 100 subjects of a total of over 8,000 patients theoretically available for study proved suitable. Significant differences between consenters and nonconsenters and selection factors that are used in choosing an experimental population have implications for the generalization of a study. Such conclusions have been largely ignored both in and out of the scientific literature.

Analgesics↗
PubMed1979

Toxicological barriers to providing better drugs.

The unmet needs of the sick demand that toxicologic requirements do not stifle the rational search for new and better remedies. A number of conceptual problems hamper the rational use of toxicological testing. These include: a misplaced confidence in the value of animal testing, a failure to make sophisticated risk-benefit analyses, the proliferation of new tests of uncertain validity, and improperly executed retrospective case control studies. Rugulatory barriers include the ever increasing bureaucratic demand for toxicological testing, the unseemly willingness of regulatory agencies to yield to hysterical or cynical consumer group pressures, the unreasonable demand for "superiority" of new products before the granting of registration, and the temptation to institute expensive but untested post-marketing surveillance schemes. Economic obstacles to new drug development have become formidable, and new demands for toxicologic studies in animals and humans are adding to these problems. Finally, some examples of unwise regulatory decisions involving saccharin, spray adhesives, Depo-Provera, and a new anti-metabolite are given.

Animals↗
PubMed1978

The development and regulation of new medications.

The unmet needs of many patients make the successful search for new and better drugs an urgent goal. Increasing regulatory demands have generated delays in the availability of new drugs and concerns about the long-term profitability of the innovative pharmaceutical industry. A rational and flexible approach to drug regulation could ease some of the most worrisome constraints without jeopardizing the public welfare. Changes in our national drug regulatory policy and in the performance of the Food and Drug Administration will serve our society better than drastic legislative mandates intended either to emasculate the FDA or to grant the agency broad new powers.

Drug Evaluation↗
PubMed1978

The rate of development of new drugs in the United States, 1963 through 1975.

Information was obtained on 1,103 new chemical entities (NCEs) first tested in man from 1963 through mid-1975 by 36 U. S.-owned and 10 foreign-owned pharmaceutical companies operating in the U. S. Of these NCEs 1,029 reached the stage of IND filing. The portion of the U. S. industry responsible for the NCEs was relatively concentrated; 7 of the 36 companies accounted for half of the NCEs and 4 of these accounted for one-third. Although the annual worldwide rate of testing of NCEs by U. S. companies appeared to rise and then fall from 1963 through 1966, since 1966 the rate has been fairly constant. With time, however, a higher proportion of U. S.-owned NCEs is being first studied in man abroad. The annual rate of IND filings for U. S.-owned NCEs generally declined from 1965 to 1972, whereas the rate was fairly constant for foreign-owned NCEs over the entire period. The overall success rate in drug development has been low; nearly 90% of the NCEs studied in man are dropped prior to NDA submission, but about 88% of the NDAs submitted are approved for market. The 1974-1975 data indicate that the mean durations of the IND and NDA phase were then 4 and 2 years, respectively. However, there were variations in the time required for DNA approval between different pharmacologic areas. The data described in this paper represent the first baselines against which future trends in the processes of drug development and approval can be measured.

Chemistry, Pharmaceutical↗
PubMed1978

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↗