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Association of lercanidipine plus enalapril to control blood pressure
AJH–May 2003–VOL. 16, NO. 5, PART 2
POSTERS: Antihypertensive Drugs
Aim: To assess the efficacy and safety of spironolactone in pts with refractory hypertension treated with at least two other anti-hypertensive drugs. Methods: We used spironolactone in a total of 60 pts who were referred to our department for treatment of refractory hypertension. Criteria for inclusion in this study were: 1- Primary hypertension ⬎12 months, treated with at least two anti-hypertensive drugs;2- SBPⱖ50 mm Hg or DBP ⱖ95 mm Hg measured by 24 h ambulatory blood pressure monitoring (ABPM). Criteria for exclusion: 1- Creatinine ⬎1,5 mg/dL; 2 - K⫹ level ⬎ 5 mEq/l. 3- Prior intake of spironolactone. Spironolactone (1mg/Kg/day) was given to all pts; this drug could be taken in association with other anti-hypertensive drugs, with the exception of ACE inhibithors and angiotensin antagonists, that were stopped prior to the beginning of the study. Creatinine and K⫹ levels were monitored during the follow-up (3 and 6 months). Results: 54 of 60 pts (90%) presented ABPM ⬍ 150/ 90 mm Hg after 30 days of treatment with spironolactone (table I): Table 1. ABPM Before and After Spironolactone Before spironolactone After 30 days of spironolactone After 6 months of spironolactone
SBP
DBP
159 ⫾ 4 mm Hg* 129 ⫾ 2 mm Hg* 127 ⫾ 2 mm Hg*
99 ⫾ 2 mm Hg 82 ⫾ 2 mm Hg* 81 ⫾ 2 mm Hg*
SBP
ABP
159 ⫾ 4 mm Hg 129 ⫾ 2 mm Hg* 127 ⫾ 2 mm Hg*
99 ⫾ 2 mm Hg 82 ⫾ 2 mm Hg* 81 ⫾ 2 mm Hg*
Hg for DBP. The association of lercanidipine with a betablocker, ACE inhibitor or ARA II results in a similar reduction in blood pressure and equal safety.Patients with other cardiovascular risk factors (diabetes, hyperlipemia, and obesity) were shown to have the worse control. Adverse events were reported in 3.9% of patients (37/960) but none of these were severe. The association of a second antihypertensive drug achieved control ⬍140/90 mm Hg in 58% of the hypertensive population included in our study. These results emphasize the possibility of achieving better control and better response in hypertensive patients using more than one antihypertensive drug. Lercanidipine is a good option to combine with a betablocker, ACE inhibitor or ARA II, to optimize control of BP, even in patients with other cardiovascular risk factors such as obesity, hyperlipemia or diabetes. It has an agonistic effect, decreasing HBP without increasing adverse events. Adverse Events Adverse Events Due to Vasodilatation
Number
%*
Edemas Headaches Tachycardia Flush
13 8 2 2
1.4 0.8 0.2 0.2
* Percentage of the total sample of patients (960)
Key Words: Lercanidipine, hypertension, combined therapy
Table 2. ABPM before spironolactone After 30 days of spironolactone after 6 months of spironolactone
123A
*-p⬍0.001
After 6 months, 12 patients were controlled only with spironolactone alone (dosage of 50-75 mg/day), 36 required 2 anti-hypertensive drugs and 13 required three drugs. Spironolactone was decreased (from 75 to 25 mg/day) in 3 males due to gynaecomasty. The drug was stopped in 1 pts due to increased creatinine and K⫹ level ( respectively 2.4 mg/dL and 6.1. mEq/l). Conclusion: These findings confirm the efficacy and safety of spironolactone in the treatment of refractory hypertension. Key Words: Spironolactone, refractory hypertension, resistant hypertension
P-235 ASSOCIATION OF LERCANIDIPINE PLUS ENALAPRIL TO CONTROL BLOOD PRESSURE Nieves Martell, Asocyten Study Group. Unidad de Hipertension Arterial, Hospital Clinico San Carlos, Madrid, Madrid, Spain. In Spain, blood pressure control is achieved in not more than 28.8% of all treated hypertensive patients. To demonstrate that the association of a second antihypertensive drug may increase the number of patients with BP control.To evaluate the efficacy and safety of the association of lercanidipine (a new calcium channel blocker of third generation) with a betablocker, ACE inhibitor or ARA II. An open, multicentric, prospective, comparative study carried out in a primary care setting.Hypertensive patients treated with a betablocker, ACE inhibitor or ARA II for at least 2 months with good tolerability and blood pressure ⬎140/90 mm Hg, to which lercanidipine, 10 or 20 mg once daily, was added for six month. Blood pressure control (⬍140/90 mmHg) and responder rates (reductions in SBP ⬎10 mm Hg and in DBP ⬎5 mm Hg) were evaluated. A total of 1013 patients were enrolled in the study. Of these, 960 patients were evaluable. Safety of the treatment was assessed and recorded for all of these and efficacy for 914. After six months of treatment with dual antihypertensive therapy 58% (528/914) of patients had a BP ⬍140/90 mm Hg and 94% (847/914) of patients were responders. The average reduction in SBP for the whole group was 28 mm Hg and 15 mm
P-236 CLINICAL EFFICACY OF THE THERAPY BY NORMODIPINE AND DIROTON IN PATIENTS WITH ARTERIAL HYPERTENSION AND ISCHAEMIC HEART DISEASE S.A. Matveeva. Medical University, Ryazan, Russian Federation. The aim of this study is analysis of therapy by normodipine, diroton and combination of normodipine ⫹ diroton in patients with arterial hypertension of II-III stages and ischaemic heart disease, stenocardia of II-III functional classes. We examined 131 patients (78 males, 53 females, mean age 56,7). The programme of investigation included clinical data, laboratory analysis (lipid spectrum, enzymes, carbohydrare metabolism, functional tests of liver.and kidneys), instrumental methods (ECG, EchoCG). 39 (29.8%) patients had therapy by normodipine in dose of 5-10 mg in day, 34 (25.9%) patients received diroton in dose 10-20 mg in day, 58 (44.3%) patients had combination of normodipine and diroton. Clinical effect was evaluated in a month, 3 month and 6 month. The results showed that stabilization of blood pressure and clinical signs of stenocardia had 131(100%) patients. Normodipine was prescribed 56 (42,7%) patients with arterial hypertension of II stage and stenocardia of II functional class, diroton received 48 (36.6%) patients with arterial hypertension II stage and stenocardia of III functional class. In 27 (20.7%) patients in the presence of arterial hypertension of III stage and stenocardia of III functional class combination normodipine and diroton were used. Thus, the observation has shown that individualized treatment using normodipine, diroton and combination of normodipine ⫹ diroton have produced stabilization in the course of the arterial hypertension and ischaemic heart disease. Key Words: Normodipine, diroton, arterial hypertension
P-237 IMPACT OF AMLODIPINE ALONE OR AS ADD-ON THERAPY ON SYSTOLIC BLOOD PRESSURE REDUCTION AND JNC VI GOAL ATTAINMENT Trent McLaughlin, Craig Roberts, Simon Tang, David Battleman. Outcomes Research, NDC Health, Phoenix, AZ; Global Outcomes Research, Pfizer, Inc., New York, NY. Purpose: Systolic blood pressure (SBP) control is a strong predictor of CV risk; however, 57% of hypertensive adults in the US are not at JNC
POSTERS: Antihypertensive Drugs
Aim: To assess the efficacy and safety of spironolactone in pts with refractory hypertension treated with at least two other anti-hypertensive drugs. Methods: We used spironolactone in a total of 60 pts who were referred to our department for treatment of refractory hypertension. Criteria for inclusion in this study were: 1- Primary hypertension ⬎12 months, treated with at least two anti-hypertensive drugs;2- SBPⱖ50 mm Hg or DBP ⱖ95 mm Hg measured by 24 h ambulatory blood pressure monitoring (ABPM). Criteria for exclusion: 1- Creatinine ⬎1,5 mg/dL; 2 - K⫹ level ⬎ 5 mEq/l. 3- Prior intake of spironolactone. Spironolactone (1mg/Kg/day) was given to all pts; this drug could be taken in association with other anti-hypertensive drugs, with the exception of ACE inhibithors and angiotensin antagonists, that were stopped prior to the beginning of the study. Creatinine and K⫹ levels were monitored during the follow-up (3 and 6 months). Results: 54 of 60 pts (90%) presented ABPM ⬍ 150/ 90 mm Hg after 30 days of treatment with spironolactone (table I): Table 1. ABPM Before and After Spironolactone Before spironolactone After 30 days of spironolactone After 6 months of spironolactone
SBP
DBP
159 ⫾ 4 mm Hg* 129 ⫾ 2 mm Hg* 127 ⫾ 2 mm Hg*
99 ⫾ 2 mm Hg 82 ⫾ 2 mm Hg* 81 ⫾ 2 mm Hg*
SBP
ABP
159 ⫾ 4 mm Hg 129 ⫾ 2 mm Hg* 127 ⫾ 2 mm Hg*
99 ⫾ 2 mm Hg 82 ⫾ 2 mm Hg* 81 ⫾ 2 mm Hg*
Hg for DBP. The association of lercanidipine with a betablocker, ACE inhibitor or ARA II results in a similar reduction in blood pressure and equal safety.Patients with other cardiovascular risk factors (diabetes, hyperlipemia, and obesity) were shown to have the worse control. Adverse events were reported in 3.9% of patients (37/960) but none of these were severe. The association of a second antihypertensive drug achieved control ⬍140/90 mm Hg in 58% of the hypertensive population included in our study. These results emphasize the possibility of achieving better control and better response in hypertensive patients using more than one antihypertensive drug. Lercanidipine is a good option to combine with a betablocker, ACE inhibitor or ARA II, to optimize control of BP, even in patients with other cardiovascular risk factors such as obesity, hyperlipemia or diabetes. It has an agonistic effect, decreasing HBP without increasing adverse events. Adverse Events Adverse Events Due to Vasodilatation
Number
%*
Edemas Headaches Tachycardia Flush
13 8 2 2
1.4 0.8 0.2 0.2
* Percentage of the total sample of patients (960)
Key Words: Lercanidipine, hypertension, combined therapy
Table 2. ABPM before spironolactone After 30 days of spironolactone after 6 months of spironolactone
123A
*-p⬍0.001
After 6 months, 12 patients were controlled only with spironolactone alone (dosage of 50-75 mg/day), 36 required 2 anti-hypertensive drugs and 13 required three drugs. Spironolactone was decreased (from 75 to 25 mg/day) in 3 males due to gynaecomasty. The drug was stopped in 1 pts due to increased creatinine and K⫹ level ( respectively 2.4 mg/dL and 6.1. mEq/l). Conclusion: These findings confirm the efficacy and safety of spironolactone in the treatment of refractory hypertension. Key Words: Spironolactone, refractory hypertension, resistant hypertension
P-235 ASSOCIATION OF LERCANIDIPINE PLUS ENALAPRIL TO CONTROL BLOOD PRESSURE Nieves Martell, Asocyten Study Group. Unidad de Hipertension Arterial, Hospital Clinico San Carlos, Madrid, Madrid, Spain. In Spain, blood pressure control is achieved in not more than 28.8% of all treated hypertensive patients. To demonstrate that the association of a second antihypertensive drug may increase the number of patients with BP control.To evaluate the efficacy and safety of the association of lercanidipine (a new calcium channel blocker of third generation) with a betablocker, ACE inhibitor or ARA II. An open, multicentric, prospective, comparative study carried out in a primary care setting.Hypertensive patients treated with a betablocker, ACE inhibitor or ARA II for at least 2 months with good tolerability and blood pressure ⬎140/90 mm Hg, to which lercanidipine, 10 or 20 mg once daily, was added for six month. Blood pressure control (⬍140/90 mmHg) and responder rates (reductions in SBP ⬎10 mm Hg and in DBP ⬎5 mm Hg) were evaluated. A total of 1013 patients were enrolled in the study. Of these, 960 patients were evaluable. Safety of the treatment was assessed and recorded for all of these and efficacy for 914. After six months of treatment with dual antihypertensive therapy 58% (528/914) of patients had a BP ⬍140/90 mm Hg and 94% (847/914) of patients were responders. The average reduction in SBP for the whole group was 28 mm Hg and 15 mm
P-236 CLINICAL EFFICACY OF THE THERAPY BY NORMODIPINE AND DIROTON IN PATIENTS WITH ARTERIAL HYPERTENSION AND ISCHAEMIC HEART DISEASE S.A. Matveeva. Medical University, Ryazan, Russian Federation. The aim of this study is analysis of therapy by normodipine, diroton and combination of normodipine ⫹ diroton in patients with arterial hypertension of II-III stages and ischaemic heart disease, stenocardia of II-III functional classes. We examined 131 patients (78 males, 53 females, mean age 56,7). The programme of investigation included clinical data, laboratory analysis (lipid spectrum, enzymes, carbohydrare metabolism, functional tests of liver.and kidneys), instrumental methods (ECG, EchoCG). 39 (29.8%) patients had therapy by normodipine in dose of 5-10 mg in day, 34 (25.9%) patients received diroton in dose 10-20 mg in day, 58 (44.3%) patients had combination of normodipine and diroton. Clinical effect was evaluated in a month, 3 month and 6 month. The results showed that stabilization of blood pressure and clinical signs of stenocardia had 131(100%) patients. Normodipine was prescribed 56 (42,7%) patients with arterial hypertension of II stage and stenocardia of II functional class, diroton received 48 (36.6%) patients with arterial hypertension II stage and stenocardia of III functional class. In 27 (20.7%) patients in the presence of arterial hypertension of III stage and stenocardia of III functional class combination normodipine and diroton were used. Thus, the observation has shown that individualized treatment using normodipine, diroton and combination of normodipine ⫹ diroton have produced stabilization in the course of the arterial hypertension and ischaemic heart disease. Key Words: Normodipine, diroton, arterial hypertension
P-237 IMPACT OF AMLODIPINE ALONE OR AS ADD-ON THERAPY ON SYSTOLIC BLOOD PRESSURE REDUCTION AND JNC VI GOAL ATTAINMENT Trent McLaughlin, Craig Roberts, Simon Tang, David Battleman. Outcomes Research, NDC Health, Phoenix, AZ; Global Outcomes Research, Pfizer, Inc., New York, NY. Purpose: Systolic blood pressure (SBP) control is a strong predictor of CV risk; however, 57% of hypertensive adults in the US are not at JNC