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Background and Objectives: Although single-pill, fixed-dose combinations (FDCs) are widely endorsed for the reduction of blood pressure and cardiovascular risk, studies to date have not evaluated the differences between FDCs and free associations using matched drugs and doses. The objective of this study was to determine whether switching from a free association of perindopril/amlodipine to the FDC formulation led to significant improvements in efficacy and tolerability., Methods: In this subanalysis of the previously published SYMBIO study, we looked at the effect of switching patients from a free association of perindopril/amlodipine to an equivalent dose of FDC (N = 335). In the SYMBIO study, concomitant antihypertensive medications were allowed; however, they remained unchanged till the end of the study. Blood pressure was measured at baseline, 1, and 3 months. Targets were defined as blood pressure <140/90 mmHg or <130/80 mmHg for patients with type 2 diabetes mellitus or at high cardiovascular risk., Results: Compared to baseline, mean blood pressure decreased significantly after 1 and 3 months of treatment with FDC perindopril/amlodipine. Mean changes from baseline were -15.6 ± 14.3/-7.7 ± 9.1 mmHg at 1 month (p < 0.0001) and -23.3 ± 16.4/-11.3 ± 9.8 mmHg at 3 months (p < 0.0001). The percentage of patients who reached their blood pressure target increased from 16.0 % at baseline to 50.6 % at 1 month, to 75.9 % at 3 months. The incidence of ankle edema decreased from 14.9 % at baseline, to 9.9 % at 1 month, to 5.4 % at 3 months. The relative risk reduction for ankle edema was -37.5 % at 1 month (vs. baseline; p < 0.001) and -57.2 % at 3 months (vs. baseline; p < 0.001)., Conclusions: These data suggest that switching from a free association of perindopril/amlodipine to the same dose of the FDC formulation led to significant improvements in efficacy and tolerability.

Introduction: The efficacy and safety of single-pill amlodipine/atorvastatin for reducing blood pressure (BP), low-density lipoprotein cholesterol (LDLC), and predicted 10-year cardiovascular (CV) risk have been demonstrated in low CV risk countries. The Slovak Trial on Cardiovascular Risk Reduction Following National Guidelines with CaDUET® (amlodipine besylate/atorvastatin calcium; Pfizer, Morrisville, PA, USA; STRONG DUET) study evaluated its clinical utility in Slovakia, one of the highest CV risk regions in Europe., Methods: This was a two-phase study involving 100 outpatient cardiologist and internist departments in Slovakia. Phase 1 assessed BP control and CV risk profiles in adults with treated hypertension, and phase 2 was an open-label, multicenter, observational study. In the phase 2 study, patients with treated but uncontrolled hypertension and three or more coronary heart disease risk factors received single-pill amlodipine/atorvastatin (5/10 or 10/10 mg) for 12 weeks. Major outcomes were the percentage of patients achieving target BP (≤140/90 mmHg) and/or LDL-C (≤3 mmol/L) and reductions in predicted 10-year CV risk., Results: Of the 4,672 phase 1 patients, 80.8% had uncontrolled hypertension and 61.4% had dyslipidemia. Of the 1,406 phase 2 patients, 90.3% of patients achieved target BP at week 12, 66.3% achieved target LDL-C, and 60.7% achieved both. The mean 10-year CV risk was reduced by 49% (P < 0.0001); treatment was well-tolerated and safe., Conclusion: Single-pill amlodipine/atorvastatin was associated with significant improvements in BP, LDL-C target attainment, and 10-year CV risk in patients with uncontrolled hypertension in Slovakia. The treatment was well-tolerated and safe. Use of single-pill amlodipine/atorvastatin in high CV-risk countries could lead to significant improvements in CV risk management.

Background: Fixed-dose combination treatments using an angiotensin-converting enzyme (ACE) inhibitor, such as perindopril, plus a calcium channel blocker (CCB), such as amlodipine, have been endorsed by guidelines because they improve blood pressure control and cardiovascular outcomes in hypertensive patients, while being well tolerated and well adhered to by patients., Objective: This study aimed to assess the blood pressure-lowering effects of fixed-combination perindopril/amlodipine in patients previously treated with an ACE inhibitor and/or a CCB., Methods: This was a prospective, real-life, open-label, longitudinal, phase IV study conducted in 223 outpatient medical centres across Slovakia. 2132 previously treated patients whose hypertension was insufficiently controlled at baseline or who tolerated treatment poorly were included. Patients were treated for 3 months with fixed-combination perindopril/amlodipine 5 mg/5 mg, 5 mg/10 mg, 10 mg/5 mg and 10 mg/10 mg. The main outcome measure was a reduction in mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) and achievement of blood pressure targets (SBP/DBP <140/90 mmHg or <130/80 mmHg for patients with type 2 diabetes mellitus or high cardiovascular risk)., Results: After 3 months of treatment, mean ± SD SBP/DBP had decreased from 158.5 ± 17.5/93.6 ± 9.8 mmHg to 132.9 ± 10.6/80.7 ± 6.2 mmHg (p < 0.0001). In patients with grade 3 hypertension, mean ± SD changes from baseline in SBP/DBP were -45.4 ± 16.4/-20.0 ± 11.5 mmHg after 3 months (p < 0.0001). Blood pressure targets were reached by 74% of the overall patient population, 84% of patients with grade 1 hypertension, and 52% of difficult-to-treat patients with grade 3 hypertension. This treatment was associated with a 58% reduction in the number of patients with amlodipine-related ankle oedema compared with baseline., Conclusion: Fixed-combination perindopril/amlodipine was well tolerated and resulted in statistically significant and clinically meaningful decreases in blood pressure.

Background: The objective of the FALCO FORTE programme was to demonstrate the efficacy and safety of 3 months of therapy with the fixed combination perindopril/indapamide in hypertensive patients in everyday medical practice., Design and Methods: Patients with blood pressure >140/90 mmHg or with blood pressure >130/85 mmHg and three or more risk factors were prescribed perindopril/indapamide 2.5/0.625 mg or 5/1.25 mg. Dosage could be increased to 10/2.5 mg at any time during the study., Results: Of the 2327 patients included, 69% of patients had been unsuccessfully treated with other antihypertensives, 4.6% had not tolerated previous antihypertensive treatments, and 26.8% were newly diagnosed hypertensive patients. Roughly half the cohort was at high or very high cardiovascular risk. After 3 months of therapy, systolic blood pressure decreased from 156.9 ± 13.7 to 132.3 ± 10.6 mmHg (p < 0.0001) and diastolic blood pressure from 94.9 ± 8.2 to 81.3 ± 6.3 mmHg (p < 0.0001). Target blood pressure was reached by 87.1% of patients. Similar changes from baseline were observed in patients with diabetes mellitus, metabolic syndrome or left ventricular hypertrophy (p < 0.0001). When blood pressure decreases were analysed by dose, changes from baseline increased with increasing doses. Perindopril/indapamide was well tolerated with no significant changes in laboratory parameters being observed. Quality of life improved significantly., Conclusions: Therapy with fixed combination perindopril/indapamide was effective and well tolerated in a wide range of patients.

Background: There are few studies detailing the prevalence of prehypertension and hypertension in India., Methods: Men and women, over 25 years of age were included. After completion of a dietitian-administered questionnaire followed evaluation by a physician, physical examination and blood pressure measurement. Cross-sectional survey screened 6940 subjects, (3507 men (M), 3433 women (W): 1993-96) from cities located in five corners of India (Kolkata, n = 900; Nagpur, n = 894; Mumbai, n = 1542; Thiruanantpuram, n = 1602; Moradabad, n = 2002). Prehypertension (BP 130-139/85-89 mm Hg) and hypertension (BP > or = 140/90 mm Hg) were diagnosed according to the European Society of Cardiology criteria., Results: Prevalence of prehypertension and hypertension, respectively, was significantly greater in South India (Trivandrum:W 31.5; 31.9%; M 35.1; 35.5%) and West India (Mumbai: W 30.0; 29.1%; M 34.7; 35.6%) compared to North India (Moradabad: W 24.6; 24.5%; M 26.7; 27.0%) and East India (Kolkata: W 20.9; 22.4%; M 23.5; 24.0%). Subjects with prehypertension and hypertension were older, had a higher BMI, central obesity and a sedentary lifestyle. They had a higher salt and alcohol intake, with greater oral contraceptive usage (W). Multivariable logistic regression analysis revealed strong positive associations of hypertension with age, central obesity, BMI, sedentary lifestyle, salt and alcohol intake and oral contraceptive usage (W). Fruit, vegetable and legume intake showed inverse associations, tobacco intake showed none. One in four with hypertension was aware of their diagnosis and of those receiving treatment, one in three had well-controlled hypertension., Conclusions: There is little awareness that prehypertension and hypertension are public health issues in India. Ageing population, central obesity, sedentary lifestyle, excessive salt and alcohol, lower fruit, vegetable and legumes intake increase risk for blood pressure elevation.

Background: The objective of the FALCO FORTE programme was to demonstrate the efficacy and safety of 3 months of therapy with the fixed combination perindopril/indapamide in hypertensive patients in everyday medical practice. Design and methods: Patients with blood pressure >140/90mmHg or with blood pressure >130/85mmHg and three or more risk factors were prescribed perindopril/indapamide 2.5/0.625mg or 5/1.25 mg. Dosage could be increased to 10/2.5mg at any time during the study. Results: Of the 2327 patients included, 69% of patients had been unsuccessfully treated with other antihypertensives, 4.6% had not tolerated previous antihypertensive treatments, and 26.8% were newly diagnosed hypertensive patients. Roughly half the cohort was at high or very high cardiovascular risk. After 3 months of therapy, systolic blood pressure decreased from 156.9 ± 13.7 to 132.3 ± 10.6mmHg (p < 0.0001) and diastolic blood pressure from 94.9 ± 8.2 to 81.3 ± 6.3mmHg (p < 0.0001). Target blood pressure was reached by 87.1%of patients. Similar changes from baseline were observed in patients with diabetes mellitus, metabolic syndrome or left ventricular hypertrophy (p < 0.0001).When blood pressure decreases were analysed by dose, changes from baseline increased with increasing doses. Perindopril/indapamide was well tolerated with no significant changes in laboratory parameters being observed. Quality of life improved significantly. Conclusions: Therapy with fixed combination perindopril/indapamide was effective and well tolerated in a wide range of patients. [ABSTRACT FROM AUTHOR]