Arterial Hypertension, HTN
Conditions
Brief summary
This is a multi-centre, observational, ambispective study, which will retrospectively and prospectively collect clinical and socio-demographic data from medical records of patients with HTN and dyslipidemia initiated with SPC of amlodipine/atorvastatin/perindopril in real clinical settings. A total of 80 general practitioners and outpatient cardiologists will participate in this non-interventional study 400 patients should be included in the study.
Detailed description
Treatment with the studied drug: * Amlodipine 5 mg + atorvastatin 10 mg + perindopril arginine 5 mg * Amlodipine 5 mg + atorvastatin 20 mg + perindopril arginine 5 mg * Amlodipine 5 mg + atorvastatin 20 mg + perindopril arginine 10 mg This is non-interventional study that is observational by its nature. Therefore there will be no any assignments of subjects to a particular therapeutic strategies defined by this protocol. Decision to treat a patient with SPC of amlodipine/ atorvastatin/ perindopril should be at the descretion of a treating investigator and made in accordance to local standards and protocols.
Interventions
DRUGAmlodipine 5 mg + atorvastatin 10 mg + perindopril arginine 5 mg
a triple fixed combination of atorvastatin, perindopril and amlodipinedose combinations, was in a 3-month in accordance to the instruction for medical use approved in the Russian Federation
DRUGAmlodipine 5 mg + atorvastatin 20 mg + perindopril arginine 5 mg
a triple fixed combination of atorvastatin, perindopril and amlodipinedose combinations, was in a 3-month in accordance to the instruction for medical use approved in the Russian Federation
DRUGAmlodipine 5 mg + atorvastatin 20 mg + perindopril arginine 10 mg
a triple fixed combination of atorvastatin, perindopril and amlodipinedose combinations, was in a 3-month in accordance to the instruction for medical use approved in the Russian Federation
Sponsors
Servier Russia
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Inclusion criteria
* Obtained signed informed consent from the patient * Patients of 18 years and older and younger than 80 years. * Start of the treatment with SPC of amlodipine/atorvastatin/perindopril within 1 month from the Index date in accordance with the indication in Russian SmPC. * Presence of the parameters of interest\* in the medical records dated with the nearest to the start of SPC amlodipine/atorvastatin/perindopril treatment date. * Parameters of interest include measured at rest office BP and LDL-C.
Exclusion criteria
* Subjects who are unwilling or unable to provide a signed informed consent form; * Any contraindication to the treatment with the SPC of amlodipine/atorvastatin/perindopril according to its' approved instruction for medical use in the Russian Federation; * Concomitant use of any other ACE inhibitors, CCBs, ARBs and statins. * Supposed low treatment adherence to the assigned SPC and the risk for poor collaboration between the patient and the investigator during the study; * Any severe, decompensated or unstable somatic diseases or states that according to investigator discretion are life-threatening or worsen the prognosis for the patient: myocardial infarction in the past 3 months, unstable angina, current decompensation of diabetes mellitus, autoimmune or oncological diseases, severe cardiac arrhythmia, gastrointestinal disorders affecting absorbtion, severe hepatic diseases, pancreatic diseases, severe allergic reactions, connective tissue diseases etc; * Secondary arterial hypertension; * Alcohol or any drug abuse; * Surgical intervention on heart or coronary vessels (i.e., heart valve(s) replacement, stent implantation or CABG), or any non-cardiological serious surgical intervention that are planned within next 3 months and may require withdrawal or changes in current therapy; * Glomerular filtration rate less than 60 ml/min/1,72m2; * Participating in any other clinical trial currently or during 30 days period before informed consent was signed.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To describe antihypertensive effectiveness of a triple single-pill combination of amlodipine, atorvastatin and perindopril at 12 weeks in patients with arterial hypertension (HTN) and dyslipidemia in the daily clinical practice. | 12 weeks | Mean change from baseline in SBP (systolic blood pressure) and DBP (diastolic blood pressure) assessed at week 12 of the observational period. |
| To describe hypolipidaemic effectiveness of a triple single-pill combination of amlodipine, atorvastatin and perindopril at 12 weeks in patients with arterial hypertension (HTN) and dyslipidemia in the daily clinical practice. | 12 weeks | Mean change from baseline in LDL-C ( low density lipoprotein cholesterol) assessed at week 12 of the observational period |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To determine the proportion of patients who reached LDL-C target goals at week 12 of the observation period. | 12 weeks | — |
| To evaluate the quality of life of patients at visit 1 (V1) and visit 2 (V2) as compared to visit 0 (V0) respectively | 12 weeks | Mean change from V0 in scores of the SF-36 questionnaire assessed at V1 and V2; |
| To evaluate predictors of reaching LDL-C target goals in the study population | 12 weeks | Proportion of patients achieving target levels LDL C depending on baseline LDL-C level. |
| To evaluate predictors of reaching BP target goals in the study population | 12 weeks | Proportion of patients achieving target BP levels depending on baseline SBP and DBP; |
| To evaluate the adherence to treatment with the fixed dose combination of amlodipine/atorvastatin/perindopril in patients included into the study at V1 and V2 as compared to V0 | 12 weeks | Proportion of patients with high, moderate and low adherence to the treatment with SPC (single pill combination) of amlodipine/atorvastatin/perindopril at V1 as compared to V0 via medication adherence scale; Proportion of patients with high, moderate and low adherence to the treatment with SPC of amlodipine/atorvastatin/perindopril at V2 as compared to V0 via medication adherence scale; |
| To determine the proportion of patients who reached systolic (SBP) and diastolic blood pressure (DBP) target goals at weeks 4 and 12 of the observation period respectively. | 12 weeks | — |
Countries
Russia
Outcome results
None listed