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Various single‐pill combinations (SPCs) have been introduced to improve drug compliance and clinical efficacy. However, there is a lack of real‐world evidence regarding the effectiveness of these SPCs for hypertension. This study evaluated the real‐world clinical efficacy and safety of amlodipine/losartan‐based SPC therapies in patients with hypertension in a real‐world setting. A total of 15 538 patients treated with amlodipine/losartan‐based SPCs [amlodipine + losartan (AL), amlodipine + losartan + rosuvastatin (ALR), and amlodipine + losartan + chlorthalidone (ALC)] were selected from the database of three tertiary hospitals in Korea. The efficacy endpoints were target blood pressure (BP) and low‐density lipoprotein cholesterol (LDL‐C) achievement rates. Safety was evaluated based on laboratory parameters. Drug adherence was defined as the proportion of medication days covered (PDC). The target BP attainment rate was above 90% and was similar among the three groups. Although many patients in the AL and ALC groups took statins, the target LDL‐C attainment rate was significantly higher in the ALR group than in the AL and ALC groups. Safety endpoints were not significantly different among the groups, except serum uric acid level and incidence rate of new‐onset hyperuricemia, which were significantly lower in the AL and ALR groups than in the ALC group. The PDC was > 90% in all groups. In the real‐world hypertensive patients, amlodipine/losartan‐based SPC therapy demonstrated good target BP achievement rates. Especially, rosuvastatin‐combination SPC showed better target LDL‐C goal achievement rate compared to the other SPCs. All three amlodipine/losartan‐based SPC had excellent drug adherence.

On the verge of the second decade of our millennium, controlled hypertension was estimated at the range of approximately 30% to 50% among those European middle-age and older patients who were already treated. Experts agree that non-adherence to pharmacotherapy and physician-related clinical inertia are the utmost challenge in hypertension management. Although treatment with blood pressure lowering drugs with single pill combination (SPC) offers effective solution to that challenge, share of patients using SPC formulation is way under expectations. Few months of COVID-19 pandemic and repetitive lock-downs negatively impacted health condition of the whole societies. Experts report that overall cardiovascular risk profile of majority of patients worsened essentially over the course of several months of pandemic. Aggravated cardiovascular risk factors which clustered with uncontrolled hypertension calls for immediate action. Robust advocacy for wide use of SPC formulation composed of long-acting blood pressure lowering agents appears to be effective and timely getaway from this snare.

Aim. To study the prevalence of comorbidity affecting the choice of antihypertensive treatment, as well as the efficacy and safety of the application of a single pill combination of lysinopril, amlodipine and rosuvastatin (SPC LAR) in hypertensive patients.Material and methods. Observational epidemiological study with the participation of 626 doctors and 13037 hypertensive patients with high cardiovascular risk and dyslipidemia treated with SPC LAR were held in 24 cities of Russia from November 2020 to March 2021. Prevalence and types of comorbidity, changes of blood pressure (BP), of total cholesterol (TC) and blood glucose levels and adverse events were studied during observation. Patients had 3 visits – initially, after 4 and 12 weeks. The obtained data was recorded by doctors through a web portal.Results. Concominant cardiovascular diseases found in all patients (in 38.7% of cases – from 2 to 5 diseases). The most commonly diseases were coronary artery disease (43.1%), metabolic syndrome (36.6%), diabetes (25.2%), chronic heart failure (24.9%), cerebrovascular diseases (12.3%) and chronic obstructive pulmonary disease (0.5%). SPC LAR with minimal doses of components (in 41.1% of patients) or with reinforced antihypertensive or hypocholesterolemic effects, based on the experience of treatment, the patient was prescribed as starting treatment with doctors. Reducing the level of systolic and diastolic BP, as well as the level Tc, respectively, by 20.9%, 16.9% and 29.7% found during the study. Target levels of systolic BP were achieved in 97.6% of patients, diastolic BP – in 99.6%, and target levels TC ≤5 mmol/l, ≤4 mmol/l and ≤3 mmol/l were achieved, respectively, in 94.5%, 68.6% and 23.5% patients. No significant dynamics of the level of glycemia were not found. The treatment was well tolerated by patients. Side effects found in 0.53% of patients (more often there was a dry cough, feet edema and headache). Commitment to treatment was 92.7%.Conclusion. The modern hypertension phenotype has cardiovascular atherosclerosis-associated diseases, which justifies the need to combine antihypertensive and hypolipidemic therapy. Triple SPC LAR, which effectively controlled the blood pressure and improved the violation of lipid metabolism was prescribed to patients in this observational study. The low frequency of side effects and good tolerance of treatment was accompanied by a high adherence of patients to treatment.

In spite of optimization and simplification of arterial hypertension (AH) treatment, achieving blood pressure (BP) control is still challenging, with most patients requiring combination treatment to achieve target BP. Due to the multifactorial effect of AH, additional prevention of hypertension-mediated end-organ damage and the maintenance of vascular integrity achieved by antihypertensive medications in addition to the BP-lowering effect are beneficial for the optimal reduction of cardiovascular (CV) risk. The aim of VICTORY II, a multicenter, open, prospective clinical study with 100 patients included in the active phase was to assess the safety and the efficacy of single-pill combinations (SPC) of amlodipine/valsartan (Wamlox®) and amlodipine/valsartan/hydrochlorothiazide (Valtricom®) in naïve or previously treated but uncontrolled patients with grade 2 or 3 AH. All patients with grade 2 AH started the treatment with the SPC of amlodipine/valsartan 5 mg/80 mg, which if necessary could be up-titrated step by step to the final option – the SPC of amlodipine/valsartan/hydrochlorothiazide 10/160/12.5 mg to achieve the target levels of BP. Patients with grade 3 AH started the treatment with the SPC of amlodipine/valsartan 5 mg/160 mg, which could be up-titrated step-by-step to the SPC of amlodipine/valsartan/hydrochlorothiazide 10/160/25 mg if necessary to achieve the target levels of BP. In addition to achieving the target office BP in 90% of the patients after 16 weeks of therapy, the amlodipine/valsartan-based treatments also decreased the prevalence of albuminuria and the central aortic pressure, improved vessel elasticity, and exerted a positive effect on the vascular endothelial function through its effect on the markers involved in the endothelial function., Unatoč optimizaciji i pojednostavnjenju liječenja arterijske hipertenzije (AH), postizanje kontrole arterijskoga tlaka (AT) i dalje je izazov, a većini je bolesnika potrebno kombinirano liječenje da bi postigli ciljnu kontrolu AT-a. Zbog višefaktorskog učinka AH-a, uz smanjenje vrijednosti AT-a, dodatna prevencija oštećenja ciljnih organa te održavanje vaskularnog integriteta postignuta antihipertenzivima korisni su za optimalno smanjenje kardiovaskularnog (KV) rizika. Cilj multicentričnog, otvorenog, prospektivnog kliničkog ispitivanja VICTORY II u 100 bolesnika uključenih u aktivnu fazu bio je procijeniti sigurnost i djelotvornost fiksnih kombinacija amlodipina/valsartana (Wamlox®) i amlodipina/valsartana/ hidroklorotiazida (Valtricom®) u prethodno neliječenih ili prethodno liječenih bolesnika s AH-om 2. ili 3. stupnja u kojih nije postignuta kontrola vrijednosti AT-a. Svi bolesnici s AH-om 2. stupnja započeli su liječenje fiksnom kombinacijom amlodipina/ valsartana 5 mg / 80 mg, koja se po potrebi mogla titrirati naviše korak po korak do konačne opcije – fiksne kombinacije amlodipina/valsartana/hidroklorotiazida 10/160/12,5 mg kako bi se postigle ciljne vrijednosti AT-a. Bolesnici s AH-om 3. stupnja započeli su liječenje fiksnom kombinacijom amlodipina/valsartana 5 mg / 160 mg, koja se po potrebi mogla titrirati naviše korak po korak do fiksne kombinacije amlodipina/valsartana/hidroklorotiazida 10/160/25 mg kako bi se postigle ciljne vrijednosti. Uz postizanje ciljne vrijednosti AT-a mjerena u ordinaciji, u 90 % bolesnika nakon 16 tjedana liječenja, terapije na bazi kombinacije amlodipina/valsartana također su smanjile prevalenciju albuminurije i centralnoga aortalnog tlaka, poboljšale elastičnost krvnih žila i pokazale pozitivan učinak na funkciju vaskularnog endotela putem svojeg djelovanja na markere uključene u funkciju endotela.

In polish population many patients with comorbid hypertension and hypercholesterolemia present low compliance and adherence to medical advising. The achievement of therapeutic goals of blood pressure control and hypercholesterolemia control was about 5,4% in WOBASZ II study. The therapy with antihypertensive drugs and statin in a single-pill combination (SPC) has recently been strengthened in the European and Polish guidelines for the treatment of arterial hypertension and hypercholesterolemia. It seems that therapy induction with SPC by reducing the number of pills to be taken daily could contribute to solve the problem of not undertaking or discontinuing treatment. The combination product present in different doses give possibility of optimization treatment. The use SCP on a larger scale could improve blood pressure control and cholesterol concentration reduction and prevent many of cardiovascular events.

Various single-pill combinations (SPCs) have been introduced to improve drug compliance and clinical efficacy. However, there is a lack of real-world evidence regarding the effectiveness of these SPCs for hypertension. This study evaluated the real-world clinical efficacy and safety of amlodipine/losartan-based SPC therapies in patients with hypertension in a real-world setting. A total of 15 538 patients treated with amlodipine/losartan-based SPCs [amlodipine + losartan (AL), amlodipine + losartan + rosuvastatin (ALR), and amlodipine + losartan + chlorthalidone (ALC)] were selected from the database of three tertiary hospitals in Korea. The efficacy endpoints were target blood pressure (BP) and low-density lipoprotein cholesterol (LDL-C) achievement rates. Safety was evaluated based on laboratory parameters. Drug adherence was defined as the proportion of medication days covered (PDC). The target BP attainment rate was above 90% and was similar among the three groups. Although many patients in the AL and ALC groups took statins, the target LDL-C attainment rate was significantly higher in the ALR group than in the AL and ALC groups. Safety endpoints were not significantly different among the groups, except serum uric acid level and incidence rate of new-onset hyperuricemia, which were significantly lower in the AL and ALR groups than in the ALC group. The PDC was 90% in all groups. In the real-world hypertensive patients, amlodipine/losartan-based SPC therapy demonstrated good target BP achievement rates. Especially, rosuvastatin-combination SPC showed better target LDL-C goal achievement rate compared to the other SPCs. All three amlodipine/losartan-based SPC had excellent drug adherence.

The health effects of both primary or secondary prevention strategies outperform any method used to treat any acute cardiovascular diseases. The paper highlights basic impediments associated with individual implementation of recommended health preserving behaviors and treatments. The most critical barriers limiting possible health benefits of prevention are discussed. The health benefits of the use and popularization among physicians of single pill combination and hybrid therapy are also brought into focus.

Aim. To evaluate the single pill combination with lisinopril, amlodipine and indapamide ability in additional angioprotection achievement in patients with arterial hypertension and high pulse wave velocity (PWV) regardless on previous antihypertensive therapy (AHT).Material and methods. To the open non-randomized study duration 12 weeks 40 patients were included taking triple AHT during 6 months. All participants underwent ambulatory 24 hour blood pressure (BP) monitoring, applanation tonometry (augmentation index and central BP), pulse wave velocity assessment, laboratory tests (HbA1c, serum uric acid, high sensitive C-reactive protein [hsCRP], serum uric acid).Results. We observed additional systolic BP (SBP) and diastolic BP (DBP) reduction by 16.9% and 22.11% on lisinopril, amlodipine and indapamide single pill combination. Lisinopril, amlodipine and indapamide single pill combination decreased 24 h mean SBP by 16.77%, and 24 h mean DBP -23.5% (ABPM data), PWV by 19.7%, augmentation index by 14.81%, central SBP by 11.9% (pConclusion. Lisinopril, amlodipine and indapamide single pill combination provided control BP, arterial elastic properties improving (augmentation index, PWV, central BP) and favorable influence on inflammation and serum uric acid level.

Introduction Cardiovascular diseases (CVD) represent the first cause of mortality in western countries. Hypertension and dyslipidemia are strong risk factors for CVD, and are prevalent either alone or in combination. Although effective substances for the treatment of both factors are available, there is space for optimization of treatment regimens due to poor patient’s adherence to medication, which is usually a combination of several substances. Adherence decreases with the number of pills a patient needs to take. A combination of substances in one single-pill (single pill combination, SPC), might increase adherence, and lead to a better clinical outcome. Aim We conducted a meta-analysis to compare the effect of SPC with that of free-combination treatment (FCT) in patients with either hypertension, dyslipidemia or the combination of both diseases under conditions of daily practice. Methods Studies were identified by searching in PubMed from November 2014 until February 2015. Search criteria focused on trials in identical hypertension and/or dyslipidemia treatment as FCT therapy or as SPC. Adherence and persistence outcome included proportion-of-days-covered (PDC), medication possession ratio (MPR), time-to treatment gap of 30 and 60 days and no treatment gap of 30 days (y/n). Clinical outcomes were all cause hospitalisation, hypertension-related hospitalisation, all cause emergency room visits, hypertension-related emergency room visits, outpatient visits, hypertension-related outpatient visits, and number of patients reaching blood pressure goal. Randomized clinical studies were excluded because they usually do not reflect daily practice. Results 11 out of 1.465 studies met the predefined inclusion criteria. PDC ≥ 80% showed an odds ratio (OR) of 1.78 (95% CI: 1.30–2.45; p = 0.004) after 6 months and an OR of 1.85 (95% CI: 1.71; 2.37; p < 0.001) after ≥ 12 months in favour to the SPC. MPR ≥ 80% after 12 months also was in favour to SPC (OR 2.13; 95% CI: 1.30; 3.47; p = 0.003). Persistence was positively affected by SPC after 6, 12, and 18 months. Time to treatment gap of 60 days resulted in a hazard ratio (HR) of 2.03 (95% CI: 1.77; 2.33, p < 0.001). The use of SPC was associated with a significant improvement in systolic blood pressure reduction, leading to a higher number of patients reaching individual blood pressure goals (FCT vs SPC results in OR = 0.77; 95% CI: 0.69; 0.85, p < 0.001). Outpatient visits, emergency room visits and hospitalisations, both overall and hypertension-related were reduced by SPC: all-cause hospitalisation (SPC vs FCT: 15.0% vs 18.2%, OR 0.79, 95% CI 0.67; 0.94, p = 0.009), all-cause emergency room visits (SPC vs FCT: 25.7% vs 31.4%, OR 0.75, 95% CI 0.65; 0.87, p = 0.001) and hypertension related emergency room visits (SPC vs FCT: 9.7% vs 14.1%, OR 0.65, 95% CI 0.54; 0.80, p < 0.001). Conclusions SPC improved medication adherence and clinical outcome parameter in patients suffering from hypertension and/or dyslipidemia and led to a better clinical outcome compared to FCT under conditions of daily practice.

The home blood pressure control by a single-pill combination of cilnidipine and valsartan (HOPE-Combi) survey sought to evaluate the safety and efficacy of cilnidipine 10 mg/valsartan 80 mg single-pill combination (SPC of Cil/Val) treatment in patients with hypertension for over 12 months. Of 2622 subjects’ data; we analyzed 2572 cases for safety and 2372 cases for efficacy. Adverse drug reaction (ADR) incidence rate was 3.77% (97 of 2572 patients). The frequency of ADRs did not differ between patients aged P P : The SPC of Cil/Val was safe and effective in treating BP of hypertensive patients in real-world settings.

Globally more than 1 billion people have hypertension and it is predicted that because of ageing populations and increasing sedentary lifestyles, this figure will rise to about 1.5 billion by 2025. Elevated blood pressure (BP) is the leading cause of premature death and morbidity due to stroke and ischemic heart disease. Hypertension is also a major risk factor for heart failure, atrial fibrillation, chronic kidney disease, peripheral arterial disease and cognitive decline. This article discusses the current evidencebased treatment guidelines and pressing temporal issues in optimal blood pressure control.

Background: This study was a multicenter, randomized, double-blinded, placebo-controlled phase III clinical trial to investigate the efficacy and safety of an olmesartan/amlodipine single pill plus rosuvastatin combination treatment for patients with concomitant hypertension and dyslipidemia. Methods: Patients with both hypertension and dyslipidemia aged 20–80 were enrolled from 36 tertiary hospitals in Korea from January 2017 to April 2018. Patients were randomized to three groups in a 1:1:0.5 ratio, olmesartan/amlodipine single pill plus rosuvastatin (olme/amlo/rosu) or olmesartan plus rosuvastatin (olme/rosu) or olmesartan/amlodipine single pill (olme/amlo) combination. The primary endpoints were change of sitting systolic blood pressure (sitSBP) from baseline in the olme/amlo/rosu vs. olme/rosu groups and the percentage change of low-density lipoprotein cholesterol (LDL-C) from baseline in the olme/amlo/rosu vs. olme/amlo groups after 8 weeks of treatment. Results: A total of 265 patients were randomized, 106 to olme/amlo/rosu, 106 to olme/rosu and 53 to olme/amlo groups. Baseline characteristics among the three groups did not differ. The mean sitSBP change was significantly larger in the olme/amlo/rosu group with −24.30 ± 12.62 mmHg (from 153.58 ± 10.90 to 129.28 ± 13.58) as compared to the olme/rosu group, −9.72 ± 16.27 mmHg (from 153.71 ± 11.10 to 144.00 ± 18.44 mmHg). The difference in change of sitSBP between the two groups was −14.62± 1.98 mmHg with significance (95% CI −18.51 to −10.73, p < 0.0001). The mean LDL-C reduced significantly in the olme/amlo/rosu group, −52.31 ± 16.63% (from 154.52 ± 30.84 to 72.72 ± 26.08 mg/dL) as compared to the olme/amlo group with no change, −2.98 ± 16.16% (from 160.42 ± 32.05 to 153.81 ± 31.57 mg/dL). Significant difference in change was found in LDL-C between the two groups with −50.10 ± 2.73% (95% CI −55.49 to −44.71, p < 0.0001). Total adverse drug reaction rates were 10.48%, 5.66% and 3.7% in the olme/amlo/rosu, olme/rosu and olme/amlo groups, respectively with no statistical significance among the three groups. Serious adverse drug reactions did not occur. Conclusions: Olmesartan/amlodipine single pill plus rosuvastatin combination treatment for patients with both hypertension and dyslipidemia is effective and safe as compared to either olmesartan plus rosuvastatin or olmesartan plus amlodipine treatment.

Background and aims The role of single pill combination therapy for stroke prevention remains to be established. We explored the perspectives of stroke survivors and healthcare professionals on single pill combination therapy for stroke prevention. Methods We conducted focus groups involving stroke survivors and healthcare professionals. Results We recruited six stroke survivors: four (67%) were female and mean age was 70 ± 12 years; and eight healthcare professionals (three Stroke Consultants, two Nurse Specialists, three General Practitioners). Improved adherence is the main perceived benefit of single pill combination therapy, although concerns exist surrounding less individualised care, unsuitability for use in the acute setting, reduced ability to titrate doses and difficulty identifying the cause of side effects. The clinical stability of patients, alongside single pill combination therapy efficacy, cost, side effect profile and evidence base for impact on risk factors and clinical outcomes are key factors influencing acceptability. Stroke survivors and healthcare professionals feel single pill combination therapy is most suitable for stable patients, although there is no evidence base for its use in this context. Conclusion Stroke healthcare professionals and stroke survivors are most amenable to using single pill combination therapy for stable patients, although its role in this context should be evaluated in studies with risk factor targets and clinical outcomes as endpoints.

Objective: The present observational study evaluated long-term management of hypertension in patients who received treatment with valsartan and amlodipine in a single-pill combination (Val/Aml SPC)...

Aim. To investigate the impact of valsartan/amlodipine single-pill combination (V/A SPC) on arterial stiffness parameters and 24-hours blood pressure (BP) level in the middle-aged patients with stage II grade 1-2 essential arterial hypertension (HT). Material and methods. A group of patients with stage II grade 1-2 HT who had not previously received regular antihypertensive therapy (n=38, age 49.7±7.0 years) was retrospectively formed. All the patients were treated with V/A SPC and all of them achieved target office BP (9.0 from 31.6 to 10.5% (p=0,049). According to an assessment of arterial stiffness the augmentation index decreased significantly by 23.6±8.6% from -23.0±17.1 to -28.9±18.7 (p=0.034. Transthoracic echocardiography data has demonstrated decrease in effective arterial elastance from 1.73±0.35 to 1.60±0.32 mm Hg (p=0.016) and increase in the arterial compliance – from 1.30±0.38 to 1.43±0.34 mm Hg/ml (p=0.049). Conclusions. In naive patients 40-65 years old with stage II grade 1-2 HT antihypertensive therapy with V/A SPC provides effective 24 hours BP control and improves arterial stiffness parameters.

Background This study evaluated the effectiveness of treatment with an indapamide/amlodipine single-pill combination (SPC) in outpatients with uncontrolled isolated systolic hypertension (ISH) aged over 55 years in real-life clinical practice. Methods This was a post-hoc analysis of the subgroup of patients with ISH from ARBALET, a 3-month, multicenter, observational, open-label study conducted in Russia among patients with grade I or II hypertension who were either uncontrolled on previous antihypertensive treatment or treatment-naïve. The effectiveness of indapamide/amlodipine SPC was assessed by the change in office systolic blood pressure (SBP) and the rate of target SBP ( Results The ARBALET study recruited 2217 patients, of whom 626 had ISH and were included in this post-hoc analysis (mean age 66.1 ± 7.8 years; 165 men [26.4%] and 461 women [73.6%]). Target SBP Conclusion This post-hoc analysis of the observational ARBALET study showed that indapamide/amlodipine SPC was associated with significant reductions in BP and high rates of target BP achievement in a broad age range of patients with ISH treated in routine clinical practice. Study registration number ISRCTN40812831.

Introduction Although several studies have shown that a simplified cardiovascular drug treatment leads to better treatment adherence, limited and conflicting findings have been reported on the separate or single-pill combination of the now recommended association between a statin and ezetimibe. We addressed this issue in a large cohort of patients newly treated with statins to whom ezetimibe was additionally administered, either separately or as a single-pill combination. Methods A total of 256,012 patients (age 40–80 years) from the Lombardy Region (Italy) newly treated with statins during 2011–2013 were followed until 2018 to identify those to whom ezetimibe was added. The 2881 and 5351 patients who started a two-pill or a single-pill combination, respectively, of statin and ezetimibe were identified and matched for propensity score. Adherence to drug therapy at 1 year was measured as the ratio between the number of days in which the drug was available and the days of follow-up (the proportion of days covered; PDC). Patients who had a PDC > 75% or

Introduction: The perindopril 3.5 mg /amlodipine 2.5 mg is the only available angiotensin converting enzyme inhibitor and a calcium channel blocker single pill combination (SPC) with market approval as a first-line therapy indication for hypertension. Hypothesis: Effectiveness, tolerability of, and the compliance to this SPC in patients with newly diagnosed hypertension. Methods: National, prospective, open-label, non-interventional study. Patients (n=1179) were initially prescribed the lowest dose SPC perindopril 3.5 mg/amlodipine 2.5 mg with possible up-titration after 4-weeks treatment (to 7/5 mg up to 14/10 mg). Office blood pressure (BP) at baseline, 3 months (M3), 6 months (M6), and the percentage of patients with normalized BP were assessed. Data were stratified by age, systolic BP category at baseline, and diabetic status. Results: Significant early systolic/diastolic BP decreases from baseline (mean±SD) were observed since the first visit: -20.8±14.7/-11.7±9.2 (P Conclusions: The Canadian SIMPLE study confirms the early benefits, tolerability of and compliance to the SPC perindopril/amlodipine 3.5 mg/2.5 mg, with a possibility of up-titration. This supports the guidelines recommendation for SPC use in newly diagnosed patients with hypertension as a first-line therapeutic option in clinical practice.

Objective: Hypertension is a serious health problem in Egypt, with prevalence rate of 17% as reported in 2015. Despite receiving treatment, many do not achieve blood pressure (BP) control. The curr...

Bisher gelang eine Kontrolle des Bluthochdrucks bei weniger als der Halfte der Hypertoniker. Das konnte sich mit der neuen Europaischen Hypertonie-Leitlinie andern, die nun der Mehrzahl der Patienten bereits primar eine Fixdosis-Kombination in einer Tablette empfiehlt.

Introduction We conducted a prospective, non-interventional, multicenter study to examine the effect of a fixed-dose combination of perindopril/amlodipine in patients with arterial hypertension. Methods Patients who were previously untreated or required a change in medication were treated with a fixed combination of perindopril/amlodipine (3.5/2.5 or 7.0/5.0 mg) for 12 weeks. Changes in office, home and ambulatory blood pressure (BP) were recorded. Adherence was assessed by the Hill-Bone medication adherence scale. Results Overall, 1814 patients (mean age 60.0 ± 13.4 years) were included in 614 German practices, and data of 1770 patients were analyzed. At study entry, 97.7% of patients received perindopril/amlodipine at a daily dose of 3.5 mg/2.5 mg, and 47.9% of patients remained on this dose during the study period. Treatment with perindopril/amlodipine decreased mean office BP from 163.7/95.4 to 133.6/80.3 mmHg (p

The aim was to evaluate the efficacy of a single-pill combination of atorvastatin/amlodipine in patients with arterial hypertension, dyslipidemia and moderate to high cardiovascular risk. This prospective study included 243 patients with arterial hypertension, dyslipidemia and moderate to high cardiovascular risk, mean age 63.3±9.8 years. All patients were prescribed a treatment with one of the following doses of a single-pill combination of atorvastatin/amlodipine: 10/5, 10/10, 20/5 or 20/10 mg daily. The follow-up period was 3 months. The mean baseline values of the systolic and diastolic blood pressure were 155.7±16.2 and 92.0±9.2 mm Hg, respectively. At month 3, the respective mean systolic and diastolic blood pressure values were 136.9±26.9 and 80.6±5.1 mm Hg. The mean baseline values of total cholesterol and low-density lipoprotein cholesterol were 6.6±1.2 and 4.4±1.1 mmol/L, respectively. At month 3, the respective mean values of total cholesterol and low-density lipoprotein cholesterol were 5.1±0.9 and 2.9±1.0 mmol/L. Treatment was discontinued in 9 (3.7%) patients due to adverse events. In conclusion, treatment with the single-pill combination of atorvastatin/amlodipine was effective and well tolerated by the patients with arterial hypertension, dyslipidemia and moderate to high cardiovascular risk., Cilj ovoga istraživanja je bio ocijeniti učinkovitost kombinacije atorvastatina/amlodipina u jednoj tableti kod bolesnika s arterijskom hipertenzijom, dislipidemijom i umjerenim do visokim kardiovaskularnim rizikom. Ovo prospektivno istraži­vanje obuhvatilo je 243 bolesnika s arterijskom hipertenzijom, dislipidemijom i umjerenim do visokim kardiovaskularnim rizikom, srednje dobi od 63,3±9,8 godina. Bolesnicima je propisana terapija jednim od sljedećih režima doziranja kombinacije atorvastatina/amlodipina u jednoj tableti: 10/5, 10/10, 20/5 ili 20/10 mg na dan. Razdoblje praćenja bilo je 3 mjeseca. Srednje početne vrijednosti sistoličkog i dijastoličkog tlaka bile su 155,7±16,2 i 92,0±92,0 mm Hg. Krajem 3. mjeseca vrijednosti sistoličkog i dijastoličkog tlaka bile su 136,9±26,9 i 80,6±5,0 mg Hg. Srednje početne vrijednosti ukupnog kolesterola i kolesterola niske gustoće bile su 6,6±1,2 i 4,4±1,1 mmol/L. Krajem 3. mjeseca vrijednosti ukupnog kolesterola i kolesterola niske gustoće bile su 5,1±0,9 i 2,9±1,0 mmol/L. Terapija analiziranom kombinacijom lijekova prekinuta je kod 9 (3,7%) bolesnika zbog neželjenih nuspojava. U zaključku, terapija kombinacijom atorvastatina/amlodipina u jednoj tableti visoko je učinkovita i dobro ju podnose bolesnici s arterijskom hipertenzijom, dislipidemijom i umjerenim do visokim kardiovaskularnim rizikom.

Background It is well established that single pill combination (SPC) therapies have the potential to improve patient adherence versus multi-pill regimens, thereby improving blood pressure control and clinical outcomes in populations with hypertension. Purpose To develop a microsimulation model, capturing different treatment pathways, to project the impact on clinical outcomes of using single pill combination therapies for the management of hypertension in five countries (Italy, Russia, China, South Korea and Mexico). Methods The model was designed to project health outcomes between 2020 and 2030 for populations with hypertension managed according to four different treatment pathways: current treatment practices [CTP], single drug with dosage titration first then sequential addition of other agents [start low and go slow, SLGS], free choice combination with multiple pills [FCC] and combination therapy in the form of a single pill [SPC]. Model inputs were derived from Global Burden of Disease 2017 dataset, including demographics, health status/risk factors, transition probabilities and treatment attributes/healthcare utilization, and the model incorporated real-world challenges to healthcare delivery such as access to care, SBP measurement error, adherence and therapeutic inertia. Simulated outcomes of mortality, incidence of chronic kidney disease (CKD), stroke and ischemic heart disease (IHD), and disability-adjusted life years (DALYs) due to these conditions were estimated for population of 1,000,000 simulated patients for each treatment pathway and country. Results SPC therapy was projected to improve health outcomes over SLGS, FCC and CTP over 10 years in all five countries. SPC was forecast to reduce mortality by 5.4% (Italy), 4.9% (Russia), 4.5% (China), 2.3% (South Korea) and 3.6% (Mexico) versus CTP and showed greater projected reductions in mortality than SLGS and FCC. DALYs were projected to be reduced with SPC therapy by between 5.7% (Italy) and 2.2% (South Korea) compared with CTP and reductions in the incidence of clinical events were also projected with SPC therapy, with decreases in the range of 11.5% (Italy) to 4.9% (South Korea) versus CTP. Conclusions Ten-year projections of clinical outcomes associated with different anti-hypertensive treatment pathways in five countries indicated that both combination therapies (FCC and SPC) are likely to reduce the disease burden of hypertension compared with conventional management approaches, with SPC showing the greatest overall benefits due to improved adherence. Funding Acknowledgement Type of funding source: Private company. Main funding source(s): Sanofi, Gentilly, France

Objectives: The current international, 12-week, double-blind, randomized, controlled trial assessed the efficacy and safety of indapamide sustained release/amlodipine single-pill combination (SPC) in mild-to-moderate hypertensive patients.\ud \ud Methods: Following a 4-week run-in period on amlodipine 5 mg, patients (SBP 150–180 mmHg and/or DBP < 110 mmHg) were randomized to indapamide 1.5 mg sustained release/amlodipine 5 mg SPC or amlodipine 5 mg/valsartan 80 mg SPC with conditional uptitration at week 6. Office blood pressure (BP) was assessed at baseline, weeks 6 and 12; ambulatory and home blood pressure monitoring (ABPM/HBPM) at baseline and week 12.\ud \ud Results: Baseline characteristics were similar in both groups (57 years, 51% men, BP 160/92 mmHg). 233 patients were randomized to IndSR/Aml and 232 to amlodipine/valsartan, of whom 48 and 57% were uptitrated, respectively. After 12 weeks, office SBP/DBP decreased similarly with both treatments (−21/−8 vs. −20/−8 mmHg) leading to BP control in 50% and BP response in 70% of patients. Uptitration was effective (P < 0.001) with both regimens, in favour of IndSR/Aml (SBP/DBP −12/−6 vs. −7/−3 mmHg, respectively). ABPM (n = 273) and HBPM (n = 194) confirmed 24-h efficacy of both regimens. In the subgroup of patients with sustained uncontrolled hypertension assessed by ABPM (n = 216), office SBP/DBP decreased by −23/−13 vs. −18/−10 mmHg, respectively (P = 0.016/P = 0.135, post-hoc analysis). Both treatments were generally well tolerated.\ud \ud Conclusion: Both regimens produced effective BP reductions confirmed by ABPM/HBPM. Both treatments were well tolerated, in accordance with the individual agents’ safety profile.\ud \ud Trial registration number: EUDRA CT no. 2012-001690-84.

Background Simplicity of regimen is known to be an important determinant of medication adherence and using single-pill combination (SPC) in hypertension treatment resulted in better adherence and persistence than free-equivalent combination. However, this finding has been studied only in dual-component antihypertensive treatments and in observational studies using medication possession ratio as an index of adherence. Medication event monitoring system (MEMS) is considered to be the gold standard in estimating medication adherence. Purpose To investigate the superiority in adherence of triple-component SPC compared to equivalent two-pill regimen using MEMS Methods This is a multi-center open-label randomized controlled trial. Inclusion criteria were hypertensive patients whose clinic blood pressure is not adequately controlled (systolic >140 mmHg or diastolic >90 mmHg) with combination antihypertensive regimen comprising two of three classes (angiotensin receptor blocker, calcium channel blocker and thiazide diuretics) for at least 4 weeks. Eligible patients were randomized either to single-pill (triple-component SPC, olmesartan/amlodipine/ hydrochlorothiazide 20/5/12.5 mg) or two-pill (dual-component SPC + one free pill, olmesartan/hydrochlorothiazide 20/12.5 mg + amlodipine 5 mg) groups and maintained for 12 weeks. Medications were dispensed in MEMS. Primary outcomes were the difference of percentage of dose taken (PDT) and percentage of days with prescribed dose taken correctly (PDTc) between single- and two-pill therapy, calculated from MEMS data. Results From 8 hospitals, 146 hypertensive patients were randomized into single- and two-pill groups. Final analysis was done in 65 and 66 patients in each group from which adherence index could be obtained. Baseline clinical characteristics of the two groups were not different. The single-pill group had significantly higher PDT and PDTc compared to the two-pill group. (median (25–75 percentile) (%), PDT 95.1 (87.9 - 100.0) vs 91.2 (79.8 - 96.5); PDTc 93.1 (79.8 - 96.5) vs 91.3 (70.7 - 96.4), p = both 0.04, by Wilcoxon rank sum test) Percent dose taken Conclusion Single-pill combination of triple-component antihypertensive regimen showed superior adherence compared to equivalent two-pill therapy. Reducing pill burden by using SPC is a relevant strategy to enhance the adherence to multi-drug antihypertensive therapy. Acknowledgement/Funding Daiichi-Sankyo

Young-Mi Ah,1 Jaekyu Shin,2 Ju-Yeun Lee3 1College of Pharmacy, Yeungnam University, Gyeongsangbuk-do, Republic of Korea; 2Department of Clinical Pharmacy, School of Pharmacy, University of California San Francisco, San Francisco, CA, USA; 3College of Pharmacy and Research Institute of Pharmaceutical Sciences, Seoul National University, Seoul, Republic of Korea Purpose: We compared treatment adherence and persistence during treatment with an angiotensin receptor blocker (ARB)-based single pill combination (SPC) and free equivalent combination (FEC) and between SPCs of an ARB with a thiazide diuretic (TD) and an ARB with a calcium channel blocker (CCB) as initial treatment in uncomplicated hypertensive patients who received pre-packaged medications from the pharmacy. Patients and methods: Uncomplicated hypertensive patients who started combination treatment consisting of ARB and either TD or CCB were identified from a Korean national claims database. We used propensity score matching to construct two pairs of cohorts: SPC and FEC cohorts (20,175 patients per cohort) and SPC cohorts of ARB + TD and ARB + CCB (45,253 patients per cohort). We compared adherence measured via the medication possession ratio as well as overall 1-year and initial treatment persistence. Results: Compared with the FEC cohort, the SPC cohort had significantly higher medication adherence (OR 1.31, 95% CI 1.25–1.37), overall persistence (HR 1.33, 95% CI 1.28–1.38), and initial treatment persistence (HR 1.61, 95% CI 1.56–1.64). Neither the rate of medication adherence nor the rate of treatment persistence differed significantly between the ARB + TD and ARB + CCB cohorts. However, the ARB + CCB cohort had a significantly higher rate of initial treatment persistence than did the ARB + TD cohort (HR 1.12, 95% CI 1.10–1.14). Conclusion: Our data suggest that, compared with FEC therapy, initiating an ARB-based SPC therapy may increase adherence and persistence in patients with uncomplicated hypertension who also receive pre-packaged medication from the pharmacy. Although using an ARB + CCB SPC may improve initial treatment persistence, it does not increase adherence or overall persistence when compared with an ARB + TD SPC. Keywords: single pill combination, persistence, adherence, hypertension, angiotensin receptor blocker

Introduction: The 2017 AHA guidelines advocate the use of ambulatory blood pressure monitoring (ABPM) for assessing the response to anti-hypertensive therapy and favor the use of single pill combination therapy for patients on multiple drugs. We aimed to investigate whether single pill combination therapy was superior to free pill combination therapy for attainment of goal blood pressure. Methods: We used data from 1074 consecutive ABPM studies performed between February 2017 and March 2018 to identify patients who received the following drug combinations as either single pill or free pills: ACEI/HCTZ, ARB/HCTZ, ACEI/CCB, ARB/CCB. Goal blood pressure was defined as an average awake blood pressure below 130/80 mmHg. Results: There were 193 patients in the single pill combination group and 136 patients in the free pill combination group. There was no difference between the groups regarding age, gender, number of antihypertensive drugs, and previous cardiovascular disease except for previous stroke which was more common in the free pill combination group. Compared to single pill combination, free pill combination showed a trend to superiority in the rate of blood pressure control in all drug combinations, with statistical significance reached only when comparing pooled groups (see table). Conclusions: Single pill combination therapy was not superior to free pill combination therapy for attainment of goal blood pressure.

Objective:to investigate effects of single-pill combination (SPC) of valsartan/amlodipine (V/A) on left ventricular (LV) and left atrial (LA) myocardial stiffness (MS) parameters and LV mass index (LVMI) in the middle-aged patients with stage II grade 1–2 essential arterial hypertension (EAH) withou

Introduction The use of dipeptidyl peptidase-4 inhibitors in combination with metformin is increasing in Japanese patients with type 2 diabetes mellitus (T2DM), but no single-pill combination (SPC) is currently available in Japan. The objective of this study was to assess the efficacy and safety of vildagliptin/metformin SPC in Japanese patients with T2DM inadequately controlled with vildagliptin monotherapy. Methods This was a 14-week, randomized, double-blind, parallel-group, placebo-controlled trial. 171 patients with T2DM inadequately controlled [HbA1c (glycosylated hemoglobin) 7.0–10.0%] with vildagliptin 50 mg twice daily (bid) were randomized (2:1) to receive either a vildagliptin/metformin SPC (n = 115) or matching vildagliptin/placebo SPC (n = 56). Results Baseline demographics and background characteristics were generally comparable between the treatment groups. The change in HbA1c [mean ± standard error (SE)] was −0.8 ± 0.1% in the vildagliptin/metformin SPC (baseline HbA1c, 7.9 ± 0.1%) group and 0.1 ± 0.1% in the vildagliptin/placebo SPC (baseline HbA1c, 8.0 ± 0.1%) group, with a between-treatment difference of −1.0 ± 0.1% (P

Despite the availability of new drugs and devices, the treatment of cardiovascular disease remains suboptimal. Single-pill combination therapy offers a number of potential advantages. It can combine different classes of drugs to increase efficacy while mitigating the risks of treatment-related adverse events, reduce pill burden, lower medical cost, and improve patient adherence. Furthermore, in hypertension, single pill combinations include lower doses of each drug than would be necessary to achieve goals with monotherapy, which may explain their better tolerability compared with higher dose monotherapy. Combination therapy is now established in the treatment of hypertension. In ischaemic heart disease, the concept of a preventative polypill has been studied, but its benefits have not been established conclusively. However, the combination of ivabradine and beta-blockers has proven efficacy in patients with stable angina pectoris. This combination has also demonstrated benefits in patients with chronic heart failure.

A 52-year-old man with a history of HIV-1 infection and poor medication adherence presents for evaluation. A single-pill regimen is considered. For some patients with HIV-1 infection, combination regimens consisting of one pill to be taken daily can improve adherence.

Objective:Efficacy of a single-pill combination of perindopril arginine/indapamide (Per/Ind) at full dose (10 mg/2.5 mg) in patients with arterial hypertension, depending on the initial body mass index (BMI).Design and method:1963 treated, uncontrolled hypertensive patients from the FORSAGE study (2

Objective:To evaluate effectiveness of indapamide/ amlodipine single-pill combination (SPC) in patients older than 55 years with grade 1 or 2 arterial hypertension who did not achieve blood pressure (BP) targets on the previous therapy or who were not previously treated for hypertension.Design and m

Objective: Evidence suggests that most hypertensive patients require two drugs or more to achieve optimal and sustained blood pressure control. It is well known that fixed-dose combinations, also known as single pill combinations, which incorporate two antihypertensive drugs or more into one pill, can improve control rates without increasing the risk of adverse events. The aim of this study was to determinate frequency of using single pill combinations among hypertensive patients in nephrology outpatient clinic and difference in blood pressure and other biochemical parameters among two groups of patients. Design and method: The study included 201 subjects, 112 (55.7%) men aged 68.5 (59.3 – 75.8) years and 89 (44.3%) women aged 68 (59.5 - 73) years. Data for age, gender, type and number of antihypertensive drugs were recorded. Serum values of urea, creatinine, haemoglobin and potassium have been measured and glomerular filtration rate (GFR) was calculated for each patient. The device Agedio B900 was used to measure parameters of arterial pressure. Peripheral and central systolic and diastolic arterial pressure were measured. Also, pulse pressure and mean arterial pressure were calculated for peripheral and central arterial pressure. Results: 67 (33.3%) patient were taking single pill combination. Those patients with single pill combination had statistically lower urea (8.1 (6– 2–10.6) vs. 10 (7–15.93), p = 0.01), creatinine (101 (76 - 139) vs. 134 (89.75 – 198.75), p =

Background:The China STATUS II is a prospective, multicentre, open-label, post-marketing, observational study including Chinese adults (aged ⩾ 18 years) with essential hypertension who were prescribed once-daily valsartan/amlodipine (Val/Aml 80/5 mg) single-pill combination. In order to examine gender differences in treatment response to Val/Aml, we further analysed data from the China STATUS II study.Methods:A total of 11,312 patients (6456 (57%) men and 4856 (43%) women) received the Val/Aml treatment for 8 weeks. After the treatment, we compared the proportion of patients not achieving the target systolic blood pressure (SBP: < 140 mm Hg) or diastolic blood pressure (DBP: < 90 mm Hg) in different age groups (by Fisher exact probability test) and estimated the changes in blood pressure (BP) according to age and gender, using a mixed model.Results:At enrolment, mean SBP was higher in the female versus the male patients (160.0 ± 12.71 versus 159.3 ± 12.31 mm Hg; p = 0.003), whereas the mean DBP was higher in the male versus the female patients (96.4 ± 10.65 versus 94.5 ± 10.72 mm Hg; p < 0.001). The overall proportion of women not achieving the target BP was less than that of men (57.41% versus 59.59%; p < 0.05) at 4 weeks and (22.22% versus 23.78%; p < 0.05) at 8 weeks after the Val/Aml treatment. Among both men and women, the proportion of patients not achieving the target SBP increased with age; however, the proportion not achieving the target DBP decreased with age. The mixed-model analysis showed that the changes in SBP were closely related to gender, indicating that the SBP-lowering effect after Val/Aml treatment might be better in women. In addition, the changes in DBP were closely related to age.Conclusions:Gender might be a factor for consideration in the decision-making process of individualised antihypertensive therapy, in the future.

International guidelines emphasize the importance of blood pressure (BP) control to reduce cardiovascular risk. Telmisartan, an angiotensin II receptor blocker, provides large BP reductions and also prevents cardiovascular events in patients at high risk. The thiazide diuretic, hydrochlorothiazide (HCTZ), has a complementary mode of action, and combination with telmisartan is an established and rational treatment option for patients uncontrolled on monotherapy. A single-pill combination (SPC) of telmisartan 80 mg with high-strength HCTZ 25 mg (T80/H25) is widely available.Clinical data on T80/H25 SPC for the management of hypertension was identified via MEDLINE searches. T80/H25 SPC provides greater BP reductions and higher goal achievement rates in patients who cannot achieve BP goal with T80/HCTZ 12.5 mg SPC, and also as initial therapy compared with T80 monotherapy. T80/H25 also reduced BP significantly more than valsartan 160 mg/H25 combination, and demonstrated favorable tolerability in clinical trials.Patients with hypertension often do not achieve BP goal, even when treated, leaving them at increased cardiovascular risk. In part this is due to poor adherence, which can be exacerbated by treatment side effects. High BP goal achievement with SPC T80/H25, with maintained tolerability, provides a treatment option for increasing BP control.

This randomized, double-blind study evaluated efficacy of a single-pill combination of amlodipine/valsartan (Aml/Val) in Asian patients with hypertension not responding to Val 80 mg. Patients with mean sitting diastolic blood pressure (DBP) ≥90-≤110 mmHg were randomized to Aml/Val 5/80, Val 80, or Val 160 mg for 8 weeks. At week-8 endpoint, significantly greater reductions in BP were seen with Aml/Val 5/80 mg than valsartan monotherapies (p < 0.0001). The BP control was greater with Aml/Val 5/80 (70.5%) than Val (44.1-58.6%) monotherapies. The combination was well tolerated. In conclusion, single-pill combination with Aml/Val provided significant additional BP reduction and control in hypertensive patients not responding to Val 80 mg.