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Biomedical subjects

A Emanueli

Publications and source records attributed to A Emanueli.

At least 19 recordsLinked to original sources
PubMed1984

A study on the treatment of arterial hypertension with atenolol/chlorthalidone tablets: preliminary results of a post-marketing surveillance clinical trial on 2449 patients.

A post-marketing clinical trial was carried out in ambulatory patients to assess the efficacy and toleration of atenolol (100 mg)/chlorthalidone (25 mg) tablets in the treatment of arterial hypertension. Data are reported on a cut-off at 2449 patients. Analysis of results in the different age groups has shown that after 4 weeks of treatment there was a mean fall of 16-17% in systolic and of 16-18% in diastolic blood pressure. Adequate blood pressure reduction was obtained for all age groups. The frequency of adverse reactions/events was low, these being reported in only 5.7% of cases. As discontinuation of treatment on account of adverse reactions/events occurred in 3.8% of patients, the risk-to-benefit relationship of atenolol/chlorthalidone tablets was very favourable.

Adult↗
PubMed1982

Adverse reactions to indoprofen: a survey based on a total of 6764 patients.

Safety data on indoprofen are presented, deriving from three sources: the first was a phase 4 multicentre clinical study based on 4042 patients suffering from osteoarthritis and treated with 400-800 mg daily by mouth for about 4 weeks; the second was a survey based on a heterogeneous series of 2722 subjects belonging to phase 1, 2 and 3 investigations, and treated with 200 to 1200 mg daily by the oral and/or parenteral route for from 1 to more than 180 days; the third was a safety laboratory study conducted in 472 patients, most of whom had participated in the first study, while the remainder were included in the second. Adverse events of any type occurred in 22% of patients in the first study and in 13% in the second, but treatment had to be withdrawn for drug-related reasons in less than 5% in both. Potentially life-threatening events were rare, overall including 16 instances of clinically overt gastro-intestinal bleeding and 2 anaphylactic reactions. Unfavourable laboratory changes, i.e. shifting from normal to abnormal values, were recorded in about 10% of the series studied. The adverse reaction profile of indoprofen was similar to that of most NSAIDs, with gastro-intestinal troubles prevailing over the other events, a distribution which, however, was clear-cut only with oral indoprofen. Tolerability problems appeared to be dose-related up to some point between 400 and 600 mg daily plateauing thereafter, and were less frequent following parenteral than following oral administration.

Adult↗
PubMed1981

Indoprofen in the treatment of osteoarthritis. Results of a phase IV multiclinic study in 1629 patients.

This paper contains a detailed account of the results obtained in 1629 patients with osteoarthritis treated with indoprofen, a recently introduced non-steroidal anti-inflammatory drug. Several traditional objective variables were selected for evaluation of efficacy, and they were shown to be highly correlated. After four weeks' treatment with doses of indoprofen ranging in the great majority of cases from two to four 200 mg tablets daily, highly significant improvement of pain was observed along with amelioration of joint motion as measured with a new arthrogoniometer specially developed for the trial. On a 5 point semiquantitative scale, pain severity decreased on the average ofrom 2.31 (0.03 S.E.M.) to 0.66 (0.02); knee flexion increased on the average from 71.8 (2 . 00) degrees to 93.0 (1.74) (p less than 0.001). These results have confirmed on a much larger scale the conclusions of phase 2 studies. The multiclinic trial disclosed more adverse reactions than those found in phase 3 studies, thus confirming that phase 4 studies are more suitable for supplying information on the acceptance of drugs by practising physicians. The risk/benefit ratio turned out to be very favourable on account of the acceptable frequency of adverse reactions which were mainly confined to the gastrointestinal tract and forced withdrawal in only 6.0% of patients. Untoward clinical events were validated with a new algorithm: their relationship with the drug was in 51.5% probable and 35.6% definite. The results of this study have confirmed the usefulness of indoprofen in the treatment of osteoarthritis.

Anti-Inflammatory Agents, Non-Steroidal↗
PubMed1981

A study of the possible interaction of indoprofen with hypoglycemic sulfonylureas in diabetic patients.

Phenylbutazone was shown to impair tolbutamide metabolism with resulting potentiation of its hypoglycemic effect and increased danger of hypoglycemia. As indoprofen is widely used for treating rheumatic conditions, and in particular osteoarthritis, the possibility that it may increase the effect of sulfonylureas on blood glucose levels has been investigated. Clinical studies have been carried out in 24 patients with osteoarthritis. All of them had maturity-onset diabetes mellitus and were on sulfonylurea drugs (tolbutamide or glipizide). The trials were double-blind and were carried out according to two different experimental designs. Twelve patients were treated with 600 mg/daily of indoprofen for five days and placebo for an equivalent period of time according to a cross-over scheme. Another group of patients was treated with indoprofen for eight days preceded and followed by a four-day placebo treatment. In both studies concomitant treatment with the hypoglycemic drug was maintained with a fixed dosage. No important differences were found between blood glucose levels when the periods of treatment with indoprofen and placebo were compared. Consequently, it is unlikely that indoprofen treatment at the doses employed may interfere at the clinical level with the effect of tolbutamide or glipizide on glucose metabolism.

Aged↗
PubMed1980

An algorithm for the classification of untoward events in large scale clinical trials.

The algorithm described in this paper derives from a proposal by Karch and Lasagna and was developed for analysis of events reported in large scale clinical trials. It is presented in the form of a decision table which allows classification of events on a five-point scale according to the probability of their relationship with the drug under study. The degree of reproducibility of judgements made with the algorithm has been assessed and the decision table has been utilized for classifying all untoward events reported during an extended clinical trial with an anti-inflammatory drug.

Clinical Trials as Topic↗
PubMed1979

Indoprofen, a new non-steroidal anti-inflammatory drug, in the treatment of osteoarthrosis: report on a multi-centre study in 1629 patients.

A multi-centre trial was carried out in 1629 patients with osteoarthrosis in 233 clinical centres to investigate the therapeutic efficacy and tolerability of indoprofen in this clinical condition. The results from assessments of both subjective and objective variables were comparable to those obtained in Phase 3 studies. Moreover, 87.2% of patients expressed a 'good' or 'very good' opinion on the product's efficacy after treatment, usually with 3 tablets (600 mg) daily for 4 weeks. The benefit/risk relationship was confirmed as very favourable on account of the marked activity of the drug and the acceptable frequency of adverse reactions, which were mainly subjective and slight and confined to the gastro-intestinal tract.

Adult↗
PubMed1978

A controlled study of the analgetic effect of two non-steroidal anti-inflammatory drugs in cancer pain.

With a subjective response technique the analgetic activity of two non-steroidal anti-inflammatory agents which greatly differ in kinetics is compared. The double-blind cross-over trial was carried out in 18 patients of both sexes suffering from pain due to malignant tumours who received single doses of 200 mg indoprofen and 250 mg naproxen p.o. Both compounds were efficacious and there was no difference in the duration of their activity in spite of the great difference between their half-lives.

Adult↗
PubMed1976

Indoprofen in the treatment of osteoarthrosis. A controlled trial in comparison with ibuprofen.

A controlled research has been carried out in 39 patients with osteoarthrosis in order to evaluate the efficacy of Indoprofen, a new analgesic-antiinflammatory compound. This product, a phenylpropionic acid derivative, was given by mouth at the dose of 600 mg daily for 7 days. For comparison a treatment with 900 mg daily of Ibuprofen for the same length of time was given to patients according to a double-blind cross-over experimental design. Significant decrease in overall pain intensity was observed together with significant improvement in motility. Indoprofen at the daily dose of 600 mg was comparable in efficacy with 900 mg of Ibuprofen in the relief of pain related to osteoarthrosis. Toleration of the drugs was very good.

Aged↗
PubMed1975

[Therapy of senile diabetes].

Changes in intermediate metabolism (amino acids, carbohydrates and plasma NEFA) noted in diabetes, obesity and old age are discussed. Results obtained in a series of 1200 cases treated with sulphanylurea with or without biguanides are presented. Metabolic compensation was obtained with the association in a larger number of obese and aged diabetics (about 15%).

Age Factors↗
PubMed1975

Indoprofen, a new analgesic and anti-inflammatory drug in cancer pain.

Evaluation of the analgesic activity of indoprofen was carried out in patients with cancer pain under double-blind conditions and compared with aspirin and placebo. A randomized experimental design was followed. Single oral doses were given of the test drug (100 and 200 mg), aspirin (600 and 1,000 mg), and placebo. For measuring analgesia, 5-point pain intensity and pain relief semiquantitative scales were used. Potency ratio between drugs was calculated on SPID (sum of pain intensity differences) and TOTPAR (total pain relief) and resulted in 10.3 by combination of estimates. In a group of only 24 patients, the data supported the following conclusions: indoprofen at 100 and 200 mg single doses is effective in relieving cancer pain; it displays a dose-related analgesic effect comparable to that of aspirin with only one-tenth the dose.

Adult↗
PubMed1975

A controlled study of the hypoglycemic and insulinopoietic effect of glipizide and glibenclamide in non-diabetic human subjects.

The authors studied in 12 non-diabetic women the effect on blood glucose and IRI of 2.5 mg of N-(4-[2-5-methylpyrazine-2-carboxamido)-ethyl]-benzenesulphonyl)-N'-cyclohexyl-urea (glipizide) and N-4[2-5(-chloro-2-methoxy-benzamido)-ethyl]-phenylsulphonyl-N'-cyclohexyl-urea (glibenclamide) given orally as a single dose according to a single blind crossover experimental design. After glipidide the effect on blood glucose was prompter and Immuno Reactive Insulin (IRI) levels higher. These results are in agreement with kinetic studies showing rapid and practically complete absorption of the product from the gastrointestinal tract. This fact together with the fast excretion of the drug and metabolites renders delayed hypoglycemic reactions very unlikely after administration of glipizide.

Adult↗