Therapeutic equivalence of two amlodipine preparations (original and generic) in patients with arterial hypertension. Results of a double-blind, randomized cross-over study
The aim of the study was to assess in a double-blind, cross-over randomized trial the therapeutic equivalence of two amplodipine preparations (Cardilopin® and Norvasc®) in patients with arterial hypertension (AH). Thirty individuals with mild to moderate AH (mean age 61,2+1,7) were examined. All par...
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«FIRMA «SILICEA» LLC
2004-08-01
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| Series: | Российский кардиологический журнал |
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| Online Access: | https://russjcardiol.elpub.ru/jour/article/view/2297 |
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| author | S. Yu. Martsevich N. P. Kutishenko A. D. Deev E. V. Alimova Yu. E. Semenova |
| author_facet | S. Yu. Martsevich N. P. Kutishenko A. D. Deev E. V. Alimova Yu. E. Semenova |
| author_sort | S. Yu. Martsevich |
| collection | DOAJ |
| description | The aim of the study was to assess in a double-blind, cross-over randomized trial the therapeutic equivalence of two amplodipine preparations (Cardilopin® and Norvasc®) in patients with arterial hypertension (AH). Thirty individuals with mild to moderate AH (mean age 61,2+1,7) were examined. All participants were treated with Cardilopin® and Norvasc® in six-week courses; the course consequence was randomized. The initial daily dose of amlodipine was 5 mg, in non-responders it was increased to 10 mg 2 weeks later. Treatment efficacy was assessed by rest blood pressure (BP) dynamics. Patients started the treatment with Norvasc® or Cardilopin® did not differ by main clinical characteristics. During Cardilopin treatment, systolic BP (SBP) lowered from 155,7+2,1 mm Hg to 138,8 ±1,5 mm Hg (p<0,001), diastolic BP (DBP) decreased from 95,4±l,2 mm Hg to 87,l±l,5mm Hg(p<0,001). Heart rate (HR) slightly increased -from 74,1±1,7 beats per minute (bpm) to 77,8±2,2 (non-significant). During Norvasc® treatment, SBP lowered from 156,3+2,1 mm Hg to 135,3 ±2,0 mm Hg (p<0,001), and DBP-from 95,2+1,5 mm Hgto 84,6+1,0 mm Hg (p<0,001). HR increased from 74,0+1,6 79,1+1,7 bpm (p<0,05). Authors conclude that Cardilopin® is equal to the «gold standard» amlodipine preparation, Norvasc®, by main clinical characteristics, and both medications are therapeutically equivalent to each other. |
| format | Article |
| id | doaj-art-8dbdfa0ac40f4aafaa0becb031a8b5ff |
| institution | DOAJ |
| issn | 1560-4071 2618-7620 |
| language | Russian |
| publishDate | 2004-08-01 |
| publisher | «FIRMA «SILICEA» LLC |
| record_format | Article |
| series | Российский кардиологический журнал |
| spelling | doaj-art-8dbdfa0ac40f4aafaa0becb031a8b5ff2025-08-20T03:00:21Zrus«FIRMA «SILICEA» LLCРоссийский кардиологический журнал1560-40712618-76202004-08-010453572040Therapeutic equivalence of two amlodipine preparations (original and generic) in patients with arterial hypertension. Results of a double-blind, randomized cross-over studyS. Yu. Martsevich0N. P. Kutishenko1A. D. Deev2E. V. Alimova3Yu. E. Semenova4Государственный научно-исследовательский центр профилактической медицины МЗ и СР РоссииГосударственный научно-исследовательский центр профилактической медицины МЗ и СР РоссииГосударственный научно-исследовательский центр профилактической медицины МЗ и СР РоссииГосударственный научно-исследовательский центр профилактической медицины МЗ и СР РоссииГосударственный научно-исследовательский центр профилактической медицины МЗ и СР РоссииThe aim of the study was to assess in a double-blind, cross-over randomized trial the therapeutic equivalence of two amplodipine preparations (Cardilopin® and Norvasc®) in patients with arterial hypertension (AH). Thirty individuals with mild to moderate AH (mean age 61,2+1,7) were examined. All participants were treated with Cardilopin® and Norvasc® in six-week courses; the course consequence was randomized. The initial daily dose of amlodipine was 5 mg, in non-responders it was increased to 10 mg 2 weeks later. Treatment efficacy was assessed by rest blood pressure (BP) dynamics. Patients started the treatment with Norvasc® or Cardilopin® did not differ by main clinical characteristics. During Cardilopin treatment, systolic BP (SBP) lowered from 155,7+2,1 mm Hg to 138,8 ±1,5 mm Hg (p<0,001), diastolic BP (DBP) decreased from 95,4±l,2 mm Hg to 87,l±l,5mm Hg(p<0,001). Heart rate (HR) slightly increased -from 74,1±1,7 beats per minute (bpm) to 77,8±2,2 (non-significant). During Norvasc® treatment, SBP lowered from 156,3+2,1 mm Hg to 135,3 ±2,0 mm Hg (p<0,001), and DBP-from 95,2+1,5 mm Hgto 84,6+1,0 mm Hg (p<0,001). HR increased from 74,0+1,6 79,1+1,7 bpm (p<0,05). Authors conclude that Cardilopin® is equal to the «gold standard» amlodipine preparation, Norvasc®, by main clinical characteristics, and both medications are therapeutically equivalent to each other.https://russjcardiol.elpub.ru/jour/article/view/2297arterial hypertensionamlodipine |
| spellingShingle | S. Yu. Martsevich N. P. Kutishenko A. D. Deev E. V. Alimova Yu. E. Semenova Therapeutic equivalence of two amlodipine preparations (original and generic) in patients with arterial hypertension. Results of a double-blind, randomized cross-over study Российский кардиологический журнал arterial hypertension amlodipine |
| title | Therapeutic equivalence of two amlodipine preparations (original and generic) in patients with arterial hypertension. Results of a double-blind, randomized cross-over study |
| title_full | Therapeutic equivalence of two amlodipine preparations (original and generic) in patients with arterial hypertension. Results of a double-blind, randomized cross-over study |
| title_fullStr | Therapeutic equivalence of two amlodipine preparations (original and generic) in patients with arterial hypertension. Results of a double-blind, randomized cross-over study |
| title_full_unstemmed | Therapeutic equivalence of two amlodipine preparations (original and generic) in patients with arterial hypertension. Results of a double-blind, randomized cross-over study |
| title_short | Therapeutic equivalence of two amlodipine preparations (original and generic) in patients with arterial hypertension. Results of a double-blind, randomized cross-over study |
| title_sort | therapeutic equivalence of two amlodipine preparations original and generic in patients with arterial hypertension results of a double blind randomized cross over study |
| topic | arterial hypertension amlodipine |
| url | https://russjcardiol.elpub.ru/jour/article/view/2297 |
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