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HANDOK Releases Clinical Phase 3 Results of Hypertension Combination Drug Aprovasc in International Journal
- 2024.05.07
- 254
HANDOK Releases Clinical Phase 3 Results of Hypertension Combination Drug Aprovasc in International Journal
HANDOK announced that the results of the Phase 3 clinical study of the hypertension combination drug Aprovasc have been published in the international journal ‘Clinical Therapeutics’. Aprovasc is the first combination drug of irbesartan and amlodipine developed jointly by HANDOK and Sanofi in South Korea.
The paper, which covers the results of two Phase 3 clinical trials of Aprovasc, was published in the international journal on May 3rd. The study involved 44 medical institutions in South Korea and targeted a total of 428 adult patients over 19 years old with essential hypertension whose blood pressure was not adequately controlled by irbesartan alone. The study administered a combination therapy of irbesartan and amlodipine for 8 weeks and analyzed the blood pressure-lowering effects and tolerability.
The results showed that after 8 weeks, patients who received 150/5mg and 150/10mg of the combination therapy had a significant mean sitting systolic blood pressure (MSSBP) reduction of 6.48mmHg and 12.79mmHg, respectively, compared to the group that received 150mg of irbesartan alone. Additionally, the group that received 300/5mg of the combination therapy showed a significant MSSBP reduction of 7.38mmHg compared to the group that received 300mg of irbesartan alone, confirming the superior blood pressure-lowering effect of the combination therapy in patients whose blood pressure was not controlled by irbesartan alone. During the study period, drug-related adverse events in patients who received the combination therapy and monotherapy were less than 2% in each clinical trial (1.48% in the I-DUO 301 study and 0.65% in the I-DUO 302 study).
Particularly, in the subgroup analysis of patients aged 65 and older and diabetic patients, the combination therapy of irbesartan and amlodipine showed a significant blood pressure reduction effect similar to the overall patient group compared to the irbesartan monotherapy group.
Aprovasc, launched in South Korea on February 1st this year, is a hypertension combination drug that combines irbesartan, an ARB (angiotensin receptor blocker) that has been playing a key role in the treatment of hypertension, and amlodipine, a CCB (calcium channel blocker). It can enhance blood pressure control and treatment sustainability for patients who have difficulty controlling blood pressure with a single drug or have trouble taking multiple medications. Among the main ingredients of Aprovasc, irbesartan is available as a single-agent product known as Aprovel, which is known not only for its blood pressure-lowering effect in hypertensive patients but also for its kidney-protective effect in patients with hypertension accompanied by diabetes. Amlodipine has also been confirmed through various studies to have a blood pressure-reducing effect and is a widely used ingredient in hypertension treatments.
Meanwhile, HANDOK not only holds leadership in the field of diabetes but has also accumulated extensive experience in providing various treatments in the hypertension market. Since the launch of the diuretic Lasix in 1964, HANDOK has continuously expanded its hypertension treatment pipeline with the ACE inhibitor Tritace, the CCB Munobal, and the combination drug Triapin, which includes both ACE inhibitor and CCB components.
The paper, which covers the results of two Phase 3 clinical trials of Aprovasc, was published in the international journal on May 3rd. The study involved 44 medical institutions in South Korea and targeted a total of 428 adult patients over 19 years old with essential hypertension whose blood pressure was not adequately controlled by irbesartan alone. The study administered a combination therapy of irbesartan and amlodipine for 8 weeks and analyzed the blood pressure-lowering effects and tolerability.
The results showed that after 8 weeks, patients who received 150/5mg and 150/10mg of the combination therapy had a significant mean sitting systolic blood pressure (MSSBP) reduction of 6.48mmHg and 12.79mmHg, respectively, compared to the group that received 150mg of irbesartan alone. Additionally, the group that received 300/5mg of the combination therapy showed a significant MSSBP reduction of 7.38mmHg compared to the group that received 300mg of irbesartan alone, confirming the superior blood pressure-lowering effect of the combination therapy in patients whose blood pressure was not controlled by irbesartan alone. During the study period, drug-related adverse events in patients who received the combination therapy and monotherapy were less than 2% in each clinical trial (1.48% in the I-DUO 301 study and 0.65% in the I-DUO 302 study).
Particularly, in the subgroup analysis of patients aged 65 and older and diabetic patients, the combination therapy of irbesartan and amlodipine showed a significant blood pressure reduction effect similar to the overall patient group compared to the irbesartan monotherapy group.
Aprovasc, launched in South Korea on February 1st this year, is a hypertension combination drug that combines irbesartan, an ARB (angiotensin receptor blocker) that has been playing a key role in the treatment of hypertension, and amlodipine, a CCB (calcium channel blocker). It can enhance blood pressure control and treatment sustainability for patients who have difficulty controlling blood pressure with a single drug or have trouble taking multiple medications. Among the main ingredients of Aprovasc, irbesartan is available as a single-agent product known as Aprovel, which is known not only for its blood pressure-lowering effect in hypertensive patients but also for its kidney-protective effect in patients with hypertension accompanied by diabetes. Amlodipine has also been confirmed through various studies to have a blood pressure-reducing effect and is a widely used ingredient in hypertension treatments.
Meanwhile, HANDOK not only holds leadership in the field of diabetes but has also accumulated extensive experience in providing various treatments in the hypertension market. Since the launch of the diuretic Lasix in 1964, HANDOK has continuously expanded its hypertension treatment pipeline with the ACE inhibitor Tritace, the CCB Munobal, and the combination drug Triapin, which includes both ACE inhibitor and CCB components.
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