Lower is better: ENHANCE affair
Ezetimibe lowers the intestinal absorption of cholesterol, being complementary to the effects of statin. To check its efficacy in lowering the carotid intima-media thickness, in 2002 a multicenter international trial called ENHANCE was started, in order to assess by ultrasound the regression of athe...
| Main Authors: | , , |
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| Format: | Article |
| Language: | English |
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PAGEPress Publications
2016-01-01
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| Series: | Monaldi Archives for Chest Disease |
| Subjects: | |
| Online Access: | https://www.monaldi-archives.org/index.php/macd/article/view/421 |
| _version_ | 1817987658179149824 |
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| author | Sabino Scardi Paolo Umari Bianca Maria D’Agata |
| author_facet | Sabino Scardi Paolo Umari Bianca Maria D’Agata |
| author_sort | Sabino Scardi |
| collection | DOAJ |
| description | Ezetimibe lowers the intestinal absorption of cholesterol, being complementary to the effects of statin. To check its efficacy in lowering the carotid intima-media thickness, in 2002 a multicenter international trial called ENHANCE was started, in order to assess by ultrasound the regression of atherosclerotic plaques. The protocol tested the use of simvastatin 80 mg + placebo versus simvastatin 80 mg + ezetimibe 10 mg in 720 randomized patients. Both drugs were well tolerated. Combination therapy was associated with a larger reduction in LDL cholesterol, but there were no differences in the intima-media thickness measured at three sites in the carotid arteries, nor differences in cardiovascular events between the two groups in the trial. These results provoked disappointment of sponsors (Merck, Schering Plough) who, although the results of the trial were available since march 2007, delayed official communication of about 18 months. This led to speculations and rumors among media, American Government, cardiologic scientific associations, and consequences in the Ezetimibe market and at Wall Street. In particular, the American College of Cardiology didn’t accept the communication of ENHANCE results to the Late Breaking Trial Session of the Chicago congress, diverting it to another secondary forum. In conclusion, the experience of the ENHANCE trial suggests to pharmaceutical companies, researchers, clinicians, scientific companies and media a deep meditation in order to avoid in the future similar problems in the management of results of medical research. |
| first_indexed | 2024-04-14T00:24:48Z |
| format | Article |
| id | doaj.art-eaaa5926cb304cf185a869c2b2c8e2f5 |
| institution | Directory Open Access Journal |
| issn | 1122-0643 2532-5264 |
| language | English |
| last_indexed | 2024-04-14T00:24:48Z |
| publishDate | 2016-01-01 |
| publisher | PAGEPress Publications |
| record_format | Article |
| series | Monaldi Archives for Chest Disease |
| spelling | doaj.art-eaaa5926cb304cf185a869c2b2c8e2f52022-12-22T02:22:49ZengPAGEPress PublicationsMonaldi Archives for Chest Disease1122-06432532-52642016-01-0170210.4081/monaldi.2008.421Lower is better: ENHANCE affairSabino Scardi0Paolo Umari1Bianca Maria D’Agata2Scuola di Specializzazione in Cardiologia - Università degli Studi di TriesteScuola di Specializzazione in Cardiologia - Università degli Studi di TriesteScuola di Specializzazione in Cardiologia - Università degli Studi di TriesteEzetimibe lowers the intestinal absorption of cholesterol, being complementary to the effects of statin. To check its efficacy in lowering the carotid intima-media thickness, in 2002 a multicenter international trial called ENHANCE was started, in order to assess by ultrasound the regression of atherosclerotic plaques. The protocol tested the use of simvastatin 80 mg + placebo versus simvastatin 80 mg + ezetimibe 10 mg in 720 randomized patients. Both drugs were well tolerated. Combination therapy was associated with a larger reduction in LDL cholesterol, but there were no differences in the intima-media thickness measured at three sites in the carotid arteries, nor differences in cardiovascular events between the two groups in the trial. These results provoked disappointment of sponsors (Merck, Schering Plough) who, although the results of the trial were available since march 2007, delayed official communication of about 18 months. This led to speculations and rumors among media, American Government, cardiologic scientific associations, and consequences in the Ezetimibe market and at Wall Street. In particular, the American College of Cardiology didn’t accept the communication of ENHANCE results to the Late Breaking Trial Session of the Chicago congress, diverting it to another secondary forum. In conclusion, the experience of the ENHANCE trial suggests to pharmaceutical companies, researchers, clinicians, scientific companies and media a deep meditation in order to avoid in the future similar problems in the management of results of medical research.https://www.monaldi-archives.org/index.php/macd/article/view/421ENHANCE trialezetimibesimvastatin |
| spellingShingle | Sabino Scardi Paolo Umari Bianca Maria D’Agata Lower is better: ENHANCE affair Monaldi Archives for Chest Disease ENHANCE trial ezetimibe simvastatin |
| title | Lower is better: ENHANCE affair |
| title_full | Lower is better: ENHANCE affair |
| title_fullStr | Lower is better: ENHANCE affair |
| title_full_unstemmed | Lower is better: ENHANCE affair |
| title_short | Lower is better: ENHANCE affair |
| title_sort | lower is better enhance affair |
| topic | ENHANCE trial ezetimibe simvastatin |
| url | https://www.monaldi-archives.org/index.php/macd/article/view/421 |
| work_keys_str_mv | AT sabinoscardi lowerisbetterenhanceaffair AT paoloumari lowerisbetterenhanceaffair AT biancamariadagata lowerisbetterenhanceaffair |