A COMPARATIVE STUDY OF THE EFFICACY AND TOLERABILITY OF ORIGINAL AND GENERIC BISOPROLOL IN MONOTHERAPY OR IN COMBINATION WITH S-AMLODIPINE AND INDAPAMIDE IN PATIENTS WITH ARTERIAL HYPERTENSION 1-2 DEGREES. RESULTS OF THE CLINICAL RANDOMIZED CROSSOVER STUDY
Aim. To study the clinical equivalence of original and generic drugs of bisoprolol in patients with arterial hypertension (HT) 1-2 degrees according to protocol recommended by the Society of Cardiology of the Russian Federation for comparative studies. Material and methods. 30 patients with HT 1-2 d...
Saved in:
| Main Authors: | , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Столичная издательская компания
2016-01-01
|
| Series: | Рациональная фармакотерапия в кардиологии |
| Subjects: | |
| Online Access: | https://www.rpcardio.online/jour/article/view/745 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1849227883350851584 |
|---|---|
| author | S. Yu. Martsevich S. N. Tolpygina V. P. Voronina O. V. Lerman Yu. V. Lukina N. A. Dmitrieva I. V. Vashurina |
| author_facet | S. Yu. Martsevich S. N. Tolpygina V. P. Voronina O. V. Lerman Yu. V. Lukina N. A. Dmitrieva I. V. Vashurina |
| author_sort | S. Yu. Martsevich |
| collection | DOAJ |
| description | Aim. To study the clinical equivalence of original and generic drugs of bisoprolol in patients with arterial hypertension (HT) 1-2 degrees according to protocol recommended by the Society of Cardiology of the Russian Federation for comparative studies. Material and methods. 30 patients with HT 1-2 degrees were examined. Patients were randomized into group 1 (original bisoprolol 5 mg/day) or group 2 (generic bisoprolol 5 mg/day). In case of insufficient antihypertensive effect bisoprolol dose was increased or S-amlodipine and then indapamide were added. After the first treatment period (8 weeks) was completed 2-week wash-out period started and then the second period (8 weeks) of treatment (taking alternative medicine of bisoprolol) began. Blood pressure (BP), heart rate, ECG, adverse effects were recorded in patients. Results. After 8 weeks of therapy BP reduction was 27.2±12.2/12.0±6.1 mm Hg in group 1 and 29.9±10.5/12.5±7.2 mm Hg in group 2 (p<0.001 for both groups), intergroup differences were insignificant. Target BP levels were achieved in 79.3% of patients in both groups. Heart rate decrease was 11.1±12.9 in group 1 and 8.5±8.6 beats/min in group 2 (p<0.05 for both groups). Significant dynamics of PQ interval were not found in both groups. The groups were comparable in terms of treatment safety and tolerability. Conclusion. Therapeutic equivalence of original and generic bisoprolol is shown in patients with HT 1-2 degrees. |
| format | Article |
| id | doaj-art-9cc793bf774f4a7396fe6b444745a09f |
| institution | Kabale University |
| issn | 1819-6446 2225-3653 |
| language | English |
| publishDate | 2016-01-01 |
| publisher | Столичная издательская компания |
| record_format | Article |
| series | Рациональная фармакотерапия в кардиологии |
| spelling | doaj-art-9cc793bf774f4a7396fe6b444745a09f2025-08-23T10:00:22ZengСтоличная издательская компанияРациональная фармакотерапия в кардиологии1819-64462225-36532016-01-017216717310.20996/1819-6446-2011-7-2-167-173744A COMPARATIVE STUDY OF THE EFFICACY AND TOLERABILITY OF ORIGINAL AND GENERIC BISOPROLOL IN MONOTHERAPY OR IN COMBINATION WITH S-AMLODIPINE AND INDAPAMIDE IN PATIENTS WITH ARTERIAL HYPERTENSION 1-2 DEGREES. RESULTS OF THE CLINICAL RANDOMIZED CROSSOVER STUDYS. Yu. Martsevich0S. N. Tolpygina1V. P. Voronina2O. V. Lerman3Yu. V. Lukina4N. A. Dmitrieva5I. V. Vashurina6State Research Center for Preventive MedicineState Research Center for Preventive MedicineState Research Center for Preventive MedicineState Research Center for Preventive MedicineState Research Center for Preventive MedicineState Research Center for Preventive MedicineState Research Center for Preventive MedicineAim. To study the clinical equivalence of original and generic drugs of bisoprolol in patients with arterial hypertension (HT) 1-2 degrees according to protocol recommended by the Society of Cardiology of the Russian Federation for comparative studies. Material and methods. 30 patients with HT 1-2 degrees were examined. Patients were randomized into group 1 (original bisoprolol 5 mg/day) or group 2 (generic bisoprolol 5 mg/day). In case of insufficient antihypertensive effect bisoprolol dose was increased or S-amlodipine and then indapamide were added. After the first treatment period (8 weeks) was completed 2-week wash-out period started and then the second period (8 weeks) of treatment (taking alternative medicine of bisoprolol) began. Blood pressure (BP), heart rate, ECG, adverse effects were recorded in patients. Results. After 8 weeks of therapy BP reduction was 27.2±12.2/12.0±6.1 mm Hg in group 1 and 29.9±10.5/12.5±7.2 mm Hg in group 2 (p<0.001 for both groups), intergroup differences were insignificant. Target BP levels were achieved in 79.3% of patients in both groups. Heart rate decrease was 11.1±12.9 in group 1 and 8.5±8.6 beats/min in group 2 (p<0.05 for both groups). Significant dynamics of PQ interval were not found in both groups. The groups were comparable in terms of treatment safety and tolerability. Conclusion. Therapeutic equivalence of original and generic bisoprolol is shown in patients with HT 1-2 degrees.https://www.rpcardio.online/jour/article/view/745beta-blockersbisoprololarterial hypertensionoriginal druggenerictherapeutic equivalence |
| spellingShingle | S. Yu. Martsevich S. N. Tolpygina V. P. Voronina O. V. Lerman Yu. V. Lukina N. A. Dmitrieva I. V. Vashurina A COMPARATIVE STUDY OF THE EFFICACY AND TOLERABILITY OF ORIGINAL AND GENERIC BISOPROLOL IN MONOTHERAPY OR IN COMBINATION WITH S-AMLODIPINE AND INDAPAMIDE IN PATIENTS WITH ARTERIAL HYPERTENSION 1-2 DEGREES. RESULTS OF THE CLINICAL RANDOMIZED CROSSOVER STUDY Рациональная фармакотерапия в кардиологии beta-blockers bisoprolol arterial hypertension original drug generic therapeutic equivalence |
| title | A COMPARATIVE STUDY OF THE EFFICACY AND TOLERABILITY OF ORIGINAL AND GENERIC BISOPROLOL IN MONOTHERAPY OR IN COMBINATION WITH S-AMLODIPINE AND INDAPAMIDE IN PATIENTS WITH ARTERIAL HYPERTENSION 1-2 DEGREES. RESULTS OF THE CLINICAL RANDOMIZED CROSSOVER STUDY |
| title_full | A COMPARATIVE STUDY OF THE EFFICACY AND TOLERABILITY OF ORIGINAL AND GENERIC BISOPROLOL IN MONOTHERAPY OR IN COMBINATION WITH S-AMLODIPINE AND INDAPAMIDE IN PATIENTS WITH ARTERIAL HYPERTENSION 1-2 DEGREES. RESULTS OF THE CLINICAL RANDOMIZED CROSSOVER STUDY |
| title_fullStr | A COMPARATIVE STUDY OF THE EFFICACY AND TOLERABILITY OF ORIGINAL AND GENERIC BISOPROLOL IN MONOTHERAPY OR IN COMBINATION WITH S-AMLODIPINE AND INDAPAMIDE IN PATIENTS WITH ARTERIAL HYPERTENSION 1-2 DEGREES. RESULTS OF THE CLINICAL RANDOMIZED CROSSOVER STUDY |
| title_full_unstemmed | A COMPARATIVE STUDY OF THE EFFICACY AND TOLERABILITY OF ORIGINAL AND GENERIC BISOPROLOL IN MONOTHERAPY OR IN COMBINATION WITH S-AMLODIPINE AND INDAPAMIDE IN PATIENTS WITH ARTERIAL HYPERTENSION 1-2 DEGREES. RESULTS OF THE CLINICAL RANDOMIZED CROSSOVER STUDY |
| title_short | A COMPARATIVE STUDY OF THE EFFICACY AND TOLERABILITY OF ORIGINAL AND GENERIC BISOPROLOL IN MONOTHERAPY OR IN COMBINATION WITH S-AMLODIPINE AND INDAPAMIDE IN PATIENTS WITH ARTERIAL HYPERTENSION 1-2 DEGREES. RESULTS OF THE CLINICAL RANDOMIZED CROSSOVER STUDY |
| title_sort | comparative study of the efficacy and tolerability of original and generic bisoprolol in monotherapy or in combination with s amlodipine and indapamide in patients with arterial hypertension 1 2 degrees results of the clinical randomized crossover study |
| topic | beta-blockers bisoprolol arterial hypertension original drug generic therapeutic equivalence |
| url | https://www.rpcardio.online/jour/article/view/745 |
| work_keys_str_mv | AT syumartsevich acomparativestudyoftheefficacyandtolerabilityoforiginalandgenericbisoprololinmonotherapyorincombinationwithsamlodipineandindapamideinpatientswitharterialhypertension12degreesresultsoftheclinicalrandomizedcrossoverstudy AT sntolpygina acomparativestudyoftheefficacyandtolerabilityoforiginalandgenericbisoprololinmonotherapyorincombinationwithsamlodipineandindapamideinpatientswitharterialhypertension12degreesresultsoftheclinicalrandomizedcrossoverstudy AT vpvoronina acomparativestudyoftheefficacyandtolerabilityoforiginalandgenericbisoprololinmonotherapyorincombinationwithsamlodipineandindapamideinpatientswitharterialhypertension12degreesresultsoftheclinicalrandomizedcrossoverstudy AT ovlerman acomparativestudyoftheefficacyandtolerabilityoforiginalandgenericbisoprololinmonotherapyorincombinationwithsamlodipineandindapamideinpatientswitharterialhypertension12degreesresultsoftheclinicalrandomizedcrossoverstudy AT yuvlukina acomparativestudyoftheefficacyandtolerabilityoforiginalandgenericbisoprololinmonotherapyorincombinationwithsamlodipineandindapamideinpatientswitharterialhypertension12degreesresultsoftheclinicalrandomizedcrossoverstudy AT nadmitrieva acomparativestudyoftheefficacyandtolerabilityoforiginalandgenericbisoprololinmonotherapyorincombinationwithsamlodipineandindapamideinpatientswitharterialhypertension12degreesresultsoftheclinicalrandomizedcrossoverstudy AT ivvashurina acomparativestudyoftheefficacyandtolerabilityoforiginalandgenericbisoprololinmonotherapyorincombinationwithsamlodipineandindapamideinpatientswitharterialhypertension12degreesresultsoftheclinicalrandomizedcrossoverstudy AT syumartsevich comparativestudyoftheefficacyandtolerabilityoforiginalandgenericbisoprololinmonotherapyorincombinationwithsamlodipineandindapamideinpatientswitharterialhypertension12degreesresultsoftheclinicalrandomizedcrossoverstudy AT sntolpygina comparativestudyoftheefficacyandtolerabilityoforiginalandgenericbisoprololinmonotherapyorincombinationwithsamlodipineandindapamideinpatientswitharterialhypertension12degreesresultsoftheclinicalrandomizedcrossoverstudy AT vpvoronina comparativestudyoftheefficacyandtolerabilityoforiginalandgenericbisoprololinmonotherapyorincombinationwithsamlodipineandindapamideinpatientswitharterialhypertension12degreesresultsoftheclinicalrandomizedcrossoverstudy AT ovlerman comparativestudyoftheefficacyandtolerabilityoforiginalandgenericbisoprololinmonotherapyorincombinationwithsamlodipineandindapamideinpatientswitharterialhypertension12degreesresultsoftheclinicalrandomizedcrossoverstudy AT yuvlukina comparativestudyoftheefficacyandtolerabilityoforiginalandgenericbisoprololinmonotherapyorincombinationwithsamlodipineandindapamideinpatientswitharterialhypertension12degreesresultsoftheclinicalrandomizedcrossoverstudy AT nadmitrieva comparativestudyoftheefficacyandtolerabilityoforiginalandgenericbisoprololinmonotherapyorincombinationwithsamlodipineandindapamideinpatientswitharterialhypertension12degreesresultsoftheclinicalrandomizedcrossoverstudy AT ivvashurina comparativestudyoftheefficacyandtolerabilityoforiginalandgenericbisoprololinmonotherapyorincombinationwithsamlodipineandindapamideinpatientswitharterialhypertension12degreesresultsoftheclinicalrandomizedcrossoverstudy |