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Adverse Reactions to Indoprofen: A Survey Based on a Total of 6764 Patients
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| Zeitschriftentitel: | Journal of International Medical Research |
|---|---|
| Personen und Körperschaften: | , , , , |
| In: | Journal of International Medical Research, 10, 1982, 5, S. 306-324 |
| Format: | E-Article |
| Sprache: | Englisch |
| veröffentlicht: |
SAGE Publications
|
| Schlagwörter: |
| author_facet |
Bruni, G Lavezzari, M Perbellini, A Battaglia, A Emanueli, A Bruni, G Lavezzari, M Perbellini, A Battaglia, A Emanueli, A |
|---|---|
| author |
Bruni, G Lavezzari, M Perbellini, A Battaglia, A Emanueli, A |
| spellingShingle |
Bruni, G Lavezzari, M Perbellini, A Battaglia, A Emanueli, A Journal of International Medical Research Adverse Reactions to Indoprofen: A Survey Based on a Total of 6764 Patients Biochemistry (medical) Cell Biology Biochemistry General Medicine |
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bruni, g |
| spelling |
Bruni, G Lavezzari, M Perbellini, A Battaglia, A Emanueli, A 0300-0605 1473-2300 SAGE Publications Biochemistry (medical) Cell Biology Biochemistry General Medicine http://dx.doi.org/10.1177/030006058201000502 <jats:p>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.</jats:p><jats:p>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events of any type occurred in 22% of patients in the first study and in 13% in the second, but treatment had to be withdrawn for drug-related reasons in less than 5% in both.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.</jats:p> Adverse Reactions to Indoprofen: A Survey Based on a Total of 6764 Patients Journal of International Medical Research |
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Adverse Reactions to Indoprofen: A Survey Based on a Total of 6764 Patients |
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Adverse Reactions to Indoprofen: A Survey Based on a Total of 6764 Patients |
| title_full |
Adverse Reactions to Indoprofen: A Survey Based on a Total of 6764 Patients |
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Adverse Reactions to Indoprofen: A Survey Based on a Total of 6764 Patients |
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Adverse Reactions to Indoprofen: A Survey Based on a Total of 6764 Patients |
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Adverse Reactions to Indoprofen: A Survey Based on a Total of 6764 Patients |
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adverse reactions to indoprofen: a survey based on a total of 6764 patients |
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Biochemistry (medical) Cell Biology Biochemistry General Medicine |
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http://dx.doi.org/10.1177/030006058201000502 |
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1982 |
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306-324 |
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<jats:p>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.</jats:p><jats:p>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.</jats:p> |
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| description | <jats:p>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.</jats:p><jats:p>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.</jats:p> |
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| spelling | Bruni, G Lavezzari, M Perbellini, A Battaglia, A Emanueli, A 0300-0605 1473-2300 SAGE Publications Biochemistry (medical) Cell Biology Biochemistry General Medicine http://dx.doi.org/10.1177/030006058201000502 <jats:p>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.</jats:p><jats:p>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.</jats:p> Adverse Reactions to Indoprofen: A Survey Based on a Total of 6764 Patients Journal of International Medical Research |
| spellingShingle | Bruni, G, Lavezzari, M, Perbellini, A, Battaglia, A, Emanueli, A, Journal of International Medical Research, Adverse Reactions to Indoprofen: A Survey Based on a Total of 6764 Patients, Biochemistry (medical), Cell Biology, Biochemistry, General Medicine |
| title | Adverse Reactions to Indoprofen: A Survey Based on a Total of 6764 Patients |
| title_full | Adverse Reactions to Indoprofen: A Survey Based on a Total of 6764 Patients |
| title_fullStr | Adverse Reactions to Indoprofen: A Survey Based on a Total of 6764 Patients |
| title_full_unstemmed | Adverse Reactions to Indoprofen: A Survey Based on a Total of 6764 Patients |
| title_short | Adverse Reactions to Indoprofen: A Survey Based on a Total of 6764 Patients |
| title_sort | adverse reactions to indoprofen: a survey based on a total of 6764 patients |
| title_unstemmed | Adverse Reactions to Indoprofen: A Survey Based on a Total of 6764 Patients |
| topic | Biochemistry (medical), Cell Biology, Biochemistry, General Medicine |
| url | http://dx.doi.org/10.1177/030006058201000502 |