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Modern Recommendations and Real Clinical Practice: the Results of the SILA Study

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Aim. To assess efficacy and safety of single-pill combination (SPC) amlodipine/perindopril and amlodipine/indapamide/perindopril in patients with uncontrolled hypertension (HT) in routine clinical practice.

Material and methods. 16144 patients with uncontrolled HT were included into this multicenter observational study. Eventually 6% of patients were excluded owing to violations of protocol. 15193 patients became subjects to the final statistical analysis; they all were prescribed with single-pill combination amlodipine/perindopril or amlodipine/indapamide/perindopril and subsequently purchased these drugs. Study lasted for 3 months; during this time researchers performed office blood pressure (BP) and heart rate measurements on a monthly basis. Additionally, the researchers registered adverse effects and assessed efficacy and safety using 7-point scale.

Results. Initially, patients had an average systolic BP of 1 64.2 ± 1 1.4 mm Hg, diastolic BP - 94.8±8.1 mm Hg, and they also had antihypertensive therapy in 85-89% of cases (in different regions). Patients received ACE inhibitors in 50-54% of cases, angiotensin receptor blockers - in 1 9-23%, calcium channel blockers - in 24-31 %, thiazide diuretics - in 29-36%, beta-blockers - in 27-32%. Monotherapy with ACE inhibitors was used in 1 2-18% of patients, and monotherapy with other antihypertensive drugs - in 1 -4%. Mean age was 60.5 years, mean body mass index - 29.3 kg/m2, 43% of patients had a very high risk by SCORE scale. Prescribed therapy: SPCs amlodipine/perindopril (54%) and amlodipine/indapamide/ perindopril (46%) in different doses. By the end of treatment course, the following results have been got: 88% of patients achieved target BP levels (92% and 85% among patients who took SPCs amlodipine/perindopril and amlodipine/indapamide/perindopril, respectively). Systolic BP decreased by 36,6±11,4 mm Hg (22.0±5.9%), diastolic BP - by 15.6±8.5 mm Hg (16.0±8.1%), pulse BP decreased by 21.0±11.4 mm Hg (28.8±13.9%). Mean efficacy assessment rate was 6.9±0.37 points out of 7; mean safety assessment rate was 6.9±0.37 points out of 7. Adverse events were recorded in 257 patients, which constituted 1.7% of the entire patients' population.

Conclusion. Using SPC amlodipine/perindopril and amlodipine/indapamide/perindopril is associated with fast achievement of the target BP levels among most patients with a small number of adverse effects.

About the Authors

O. A. Kislyak
Pirogov Russian National Research Medical University
Russian Federation

Oksana A. Kislyak - MD, PhD, Professor, Head of Chair of Faculty Therapy, Pirogov RNRMU; Principal Investigator of the SILA study.

Ostrovitianova ul. 1, Moscow, 117997

I. I. Chukaeva
Pirogov Russian National Research Medical University
Russian Federation

Irina I. Chukaeva - MD, PhD, Professor, Head of Chair of Polyclinic Therapy.

Ostrovitianova ul. 1, Moscow, 117997

V. A. Vygodin
National Medical Research Center for Preventive Medicine
Russian Federation

On behalf of participants of the SILA study

Vladimir A. Vygodin - Senior Researcher, Laboratory of Biostatistics, National Medical Research Center for Preventive Medicine.

Petroverigsky per. 1 0, Moscow, 101990


1. 2018 ESC/ESH Guidelines for the management of arterial hypertension. The Task Force for the management of arterial hypertension of the European Society of Cardiology (ESC) and the European Society of Hypertension (ESH). Eur Heart J. 2018;39(33):3021 -104. doi:10.1093/eurheartj/ehy339.

2. Chazova I.E., Zhernakova Yu.V on behalf of experts. Diagnosis and treatment of arterial hypertension. Clinical guidelines. Russian Medical Society for Arterial Hypertension (RMSAH). Systemic Hypertension. 2019;16(1 ):6-32 (In Russ.) doi:10.26442/2075082Х.2019.1.190179.

3. Muromtseva G.A. , Kontsevaya A.V, Konstantinov V.V. et al. on behalf of the participants of the ESSE-RF study. Prevalence of risk factors for noncommunicable diseases in the Russian population in 20122013 The results of the ESSE-RF study. Cardiovascular Therapy and Prevention. 2014;13(6):4-11. doi:10.15829/1728-8800-2014-6-4-113 (In Russ.)

4. Dahlof B., Sever P., Poulter N.R. et al., ASCOT Investigators. Prevention of cardiovascular events with antihypertensive regimen of amlodipine adding perindopril as required versus atenolol adding bend-oflumethiazideas required in the Anglo-Scandinavian Cardiac Outcomes Trial - Blood Pressure Lowering Arm (ASCOT-BPLA): a multicentre randomized controlled trial. Lancet. 2005;366:895-906. doi:10.1016/S0140-6736(05)67185-1.

5. Final report. Postmarketing survieillance study of efficacy and safety of fixed dose combination perindopril and amlodipine (Amlessa) in the treatment of arterial hypertension. Data of file Krka, d.d., Novo mesto, Slovenia, 2014. [cited by Apr 17, 2019]. Available from:

6. Chukaeva I.I., Spiryakina Ya.G., Glibko K.V., et al. Achieving the main goals of therapy with the use of the triple fixed combination of amlodipine, indapamide, and perindopril (Ko-Dalneva®) in patients with arterial hypertension. Systemic Hypertension. 2017;14(2):36-40 (In Russ.)


For citations:

Kislyak O.A., Chukaeva I.I., Vygodin V.A. Modern Recommendations and Real Clinical Practice: the Results of the SILA Study. Rational Pharmacotherapy in Cardiology. 2019;15(2):166-173. (In Russ.)

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