ORIENTIR Study: design and results
The paper summarizes the specific features of post-marketing studies, which are performed after the medication registration, in the settings close to the real-world clinical practice. In particular, the authors discuss the design and results of the Russian post-marketing study of nifedipine CR (cont...
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| Format: | Article |
| Language: | Russian |
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«SILICEA-POLIGRAF» LLC
2011-06-01
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| Series: | Кардиоваскулярная терапия и профилактика |
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| Online Access: | https://cardiovascular.elpub.ru/jour/article/view/1840 |
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| author | S. Yu. Martsevich Yu. V. Lukina I. B. Bondareva |
| author_facet | S. Yu. Martsevich Yu. V. Lukina I. B. Bondareva |
| author_sort | S. Yu. Martsevich |
| collection | DOAJ |
| description | The paper summarizes the specific features of post-marketing studies, which are performed after the medication registration, in the settings close to the real-world clinical practice. In particular, the authors discuss the design and results of the Russian post-marketing study of nifedipine CR (controlled release) — ORIENTIR Study. The aim of the study was to assess antihypertensive effectiveness and tolerability of nifedipine CR in patients with arterial hypertension (AH). Results. The study included 38 doctors from 24 clinical centres in 16 Russian cities, as well as 3179 patients with AH. Mean blood pressure (BP) reduction reached 22,9±6,75/16,56±8,74 mm Hg. Target BP levels were achieved in 94,9 % of AH patients without diabetes mellitus (DM), and in 72,1 % patients with a combination of AH and DM. At the last visit, 98 % of the participants continued taking the study medication. Adverse effects were registered in 1,5 % of the participants. Doctor-assessed effectiveness, tolerability, and therapy compliance for nifedipine CR were “excellent” or “good” in 95,8 %, 96,4 %, and 97,7 % of the patients, respectively. Conclusion. The results of this study are consistent with the data from other post-marketing studies of nifedipine CR, confirming its antihypertensive effectiveness and good tolerability. |
| format | Article |
| id | doaj-art-2d907d3f956d4efc8cededa5b61316bb |
| institution | Kabale University |
| issn | 1728-8800 2619-0125 |
| language | Russian |
| publishDate | 2011-06-01 |
| publisher | «SILICEA-POLIGRAF» LLC |
| record_format | Article |
| series | Кардиоваскулярная терапия и профилактика |
| spelling | doaj-art-2d907d3f956d4efc8cededa5b61316bb2025-08-20T03:43:29Zrus«SILICEA-POLIGRAF» LLCКардиоваскулярная терапия и профилактика1728-88002619-01252011-06-01103899610.15829/1728-8800-2011-3-89-961555ORIENTIR Study: design and resultsS. Yu. Martsevich0Yu. V. Lukina1I. B. Bondareva2State Research Centre for Preventive Medicine; I.M. Sechenov First Moscow State Medical UniversityState Research Centre for Preventive Medicine; I.M. Sechenov First Moscow State Medical UniversityResearch Institute of Physico-Chemical MedicineThe paper summarizes the specific features of post-marketing studies, which are performed after the medication registration, in the settings close to the real-world clinical practice. In particular, the authors discuss the design and results of the Russian post-marketing study of nifedipine CR (controlled release) — ORIENTIR Study. The aim of the study was to assess antihypertensive effectiveness and tolerability of nifedipine CR in patients with arterial hypertension (AH). Results. The study included 38 doctors from 24 clinical centres in 16 Russian cities, as well as 3179 patients with AH. Mean blood pressure (BP) reduction reached 22,9±6,75/16,56±8,74 mm Hg. Target BP levels were achieved in 94,9 % of AH patients without diabetes mellitus (DM), and in 72,1 % patients with a combination of AH and DM. At the last visit, 98 % of the participants continued taking the study medication. Adverse effects were registered in 1,5 % of the participants. Doctor-assessed effectiveness, tolerability, and therapy compliance for nifedipine CR were “excellent” or “good” in 95,8 %, 96,4 %, and 97,7 % of the patients, respectively. Conclusion. The results of this study are consistent with the data from other post-marketing studies of nifedipine CR, confirming its antihypertensive effectiveness and good tolerability.https://cardiovascular.elpub.ru/jour/article/view/1840post-marketing studyarterial hypertensionnifedipine crtherapy effectiveness and safety |
| spellingShingle | S. Yu. Martsevich Yu. V. Lukina I. B. Bondareva ORIENTIR Study: design and results Кардиоваскулярная терапия и профилактика post-marketing study arterial hypertension nifedipine cr therapy effectiveness and safety |
| title | ORIENTIR Study: design and results |
| title_full | ORIENTIR Study: design and results |
| title_fullStr | ORIENTIR Study: design and results |
| title_full_unstemmed | ORIENTIR Study: design and results |
| title_short | ORIENTIR Study: design and results |
| title_sort | orientir study design and results |
| topic | post-marketing study arterial hypertension nifedipine cr therapy effectiveness and safety |
| url | https://cardiovascular.elpub.ru/jour/article/view/1840 |
| work_keys_str_mv | AT syumartsevich orientirstudydesignandresults AT yuvlukina orientirstudydesignandresults AT ibbondareva orientirstudydesignandresults |