Patients Achieving Blood Pressure Goals Research Articles

Abstract P207: The Feasibility Of A 6-week, Pharmacist-Led, Self-Monitored Blood Pressure Treatment Program

Background: Guidelines recommend concomitant out-of-office blood pressure (BP) measurements with telehealth counseling for titration. While high quality home BP measurement coupled with pharmacist care reduces the time needed to achieve BP goal, it remains unclear how rapidly BP titrations can be applied in clinical practice. Objective: To examine the impact of home BP monitoring coupled with a rapid, biweekly, pharmacist-led BP medication titration program on BP control and patient safety. Methods: Forty patients were referred if BP ≥140/90, using ≤2 anti-hypertensive medications, and failed a trial of lifestyle modification. The initial visit with the pharmacist included validation of home BP monitor compared with an Omron HEM-907XL. Patients monitored BP twice daily in the morning and evening for a week then had their medication regimen adjusted every 2 weeks until reaching their goal or completing a 6-week follow-up period. Results: Of the 29 patients completing the program, mean enrollment SBP/DBP was 155.2 (SD, 15.8)/89.7 (SD, 11.5) mm Hg. The completion SBP/DBP was 132.1 (SD, 10.9)/ 77.6 (SD, 10). The number of HTN medications prescribed increased by an average of 0.3 (from 1.3 to 1.6) over the follow-up period. There were no incidences of falls or hypotension. One patient had a clinically significant electrolyte change requiring medication adjustment. Two patients had a clinically significant change in serum creatinine, but both stabilized after altering their hypertension medication regimen. Conclusion: A 6-week, pharmacist-led, home BP monitoring program with rapid titration had high retention and increased the percentage of patients achieving BP goals without safety concerns.

Community Pharmacist-Provided Wellness and Monitoring Services in an Employee Wellness Program: A Four-Year Summary.

Objective: To assess the clinical outcomes of participants of an employee wellness program during four years of service implementation. Methods: A prospective cohort study was conducted at 15 independent community pharmacy chain locations in northwest and central Missouri. A total of 200 participants were enrolled in an employee wellness program, and the program included five monitoring groups—cholesterol, blood pressure, blood glucose, weight, and healthy participant groups. Participants selected a pharmacist wellness coordinator and wellness appointments were conducted, consisting of education, goal-setting, and monitoring through physical assessment and point of care testing. The primary outcome measures were total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C), systolic blood pressure (SBP), diastolic blood pressure (DBP), fasting blood glucose (FBG), body mass index (BMI), and waist circumference (WC). The secondary outcome measures were the proportion of patients who achieved the clinical value goals at baseline versus 48 months. The primary outcome measures among data collection time points were compared using one-way analysis of variance (ANOVA) tests, and the secondary outcomes were compared between baseline and 48 months by Chi-square or Fisher’s exact tests. One-way ANOVA post hoc tests were also performed using least significant difference, to further identify which time points differed from each other. Results: At baseline, there were 134 patients in the cholesterol monitoring group, 129 in the weight monitoring group, 117 in the blood pressure monitoring group, 46 in the blood glucose monitoring group, and 26 in the healthy participant monitoring group. For patients in the blood pressure monitoring group, compared with baseline, there was a significant decrease in DBP at months 12, 24, 36, and 48, and a significant increase in the proportion of patients achieving blood pressure goals at 48 months. For patients in the blood glucose monitoring group, compared with baseline, there was a significant decrease in FBG at months 12, 24, 36, and 48, and a significant increase in the proportion of patients achieving blood glucose goals at 48 months. Conclusions: Pharmacist-led wellness visits provided to employee wellness patients in a community pharmacy may lead to improvements in BP and FBG values.

Clinical characteristics and management of patients with atrial fibrillation treated with direct oral anticoagulants according to blood pressure control

ObjectiveTo determine the clinical characteristics and management of hypertensive patients with nonvalvular atrial fibrillation (AF) treated with direct oral anticoagulants (DOACs) according to blood pressure (BP) control. MethodsFor this purpose, data from two observational, cross-sectional and multicenter studies were combined. In both studies, patients on chronic treatment with anticoagulants and that were on current treatment with DOACs at least for 3 months were included. Adequate BP was defined as a systolic BP<140mmHg and a diastolic BP<90mmHg (<140/85mmHg if diabetes). ResultsOverall, 1036 patients were included. Of these, 881 (85%) had hypertension that were finally analyzed. The presence of other risk factors and cardiovascular disease was common. Mean BP was 132.6±14.3/75.2±9.2mmHg and 70.5% of patients achieved BP goals. Those patients with a poor BP control had more frequently diabetes, and a history of prior labile INR. Patients had a high thromboembolic risk, but without significant differences according to BP control. By contrast, more patients with a poor BP control had a higher bleeding risk (HAS-BLED ≥3: 24.0% vs 35.4%; P<0.001). HAS-BLED score was an independent predictor of poor BP control (odds ratio 1.435; 95% confidence interval 1.216–1.693; P<0.001). Satisfaction with anticoagulant treatment was independent of BP control. ConclusionsMore than two thirds of our patients with hypertension and AF anticoagulated with DOACs achieve BP targets, what is clearly superior to that reported in the general hypertensive population.

Comparative effectiveness of an angiotensin receptor blocker, olmesartan medoxomil, in older hypertensive patients

The efficacy and safety of olmesartan medoxomil (OM) vs active control (AC) monotherapy among elderly patients aged 60-79years (N=4487) was evaluated by meta-analysis (25 studies). In all patients, change from baseline to end point in blood pressure (BP) was significantly greater with OM vs AC (-19.5/-11.9 vs -16.8/-10.7mm Hg). Greater proportions of OM- vs AC-treated patients achieved BP goals. In patients with impaired renal function (estimated glomerular filtration rate <60mL/min/1.73m2 ), OM treatment resulted in a greater mean change from baseline in systolic BP vs AC (-21.2 vs -18.7mm Hg, respectively) and a greater proportion of patients achieving BP goals. These parameters were similar in both groups for elderly patients with diabetes. OM was well tolerated with few adverse events. OM monotherapy can be used as an initial treatment for hypertension in elderly patients, including those with renal impairment or diabetes.

Examining the Effect of a Medication Synchronization or an Education Program on Health Outcomes of Hypertensive Patients in a Community Pharmacy Setting

Objective: To examine the effect of a medication synchronization or education program on hypertensive health outcomes.&#x0D; Methods: This study used a design of randomized controlled trial lasting four months taking place within a family-owned community pharmacy chain in a U.S. Midwestern state. A total of 302 hypertensive patients were randomized into 3 study groups - control, medication synchronization, and education. Interventions included management of medication refills through a medication synchronization program for the medication synchronization group, and monthly hypertension (HTN) education for the education group. Outcome measures included systolic blood pressure (SBP), diastolic blood pressure (DBP), percentage of patients at blood pressure (BP) goal, self-rated change in medication adherence, and patients' HTN knowledge.&#x0D; Results: All groups had significant decline of SBP from baseline; however the final analysis showed no significant SBP differences among study groups. The proportion of patients achieving BP goals in both the control (p=0.005) and education (p=0.019) groups increased at Month 4. Changes in self-reported adherence were not significant for any groups. All groups showed positive changes on HTN knowledge questions with the education group showing the greatest change.&#x0D; Conclusion: Compared to the control group, there was no difference in the primary outcomes. However, this study demonstrated that educational materials written at an appropriate level and presented by community pharmacists to patients may have been associated with an increase in HTN knowledge and a significant increase in the proportion of patients achieving their BP goal. These educational interventions had a greater impact on helping patients achieve their blood pressure goals than medication synchronization. This may indicate that further intervention is needed to impact adherence aside from ensuring that patients have their medication on hand. Taking the time to educate patients about hypertension led to self-reported positive change with being more careful about taking medications and with not forgetting to take medications when they felt better.&#x0D; &#x0D; Type: Original Research

Blood pressure control and management of very elderly patients with hypertension in primary care settings in Spain

This study aimed to determine the clinical profile, blood pressure (BP) control rates, therapeutic management and physicians' therapeutic behavior regarding very elderly hypertensive patients. A total of 1540 hypertensive patients 80 years old on antihypertensive therapy and receiving care in primary care settings in Spain were included in this cross-sectional study. The mean patient age was 83.4±3.1 years, 61.9% of patients were women and 49.3% of patients had cardiovascular disease. Of the patients, 27.7% were on monotherapy and 72.3% were on combined therapy (47.4% on two antihypertensive agents and 24.9% on three or more antihypertensive agents). A total of 40.8% (95% confidence interval (CI): 38.4-43.3%) of patients achieved BP goals (<140/90 mm Hg; <130/80 in patients with diabetes, chronic renal disease or cardiovascular disease). Patients with uncontrolled BP were more likely to have metabolic syndrome, diabetes, obesity, a history of cardiovascular disease, ischemic heart disease, renal disease and stroke and were more frequently smokers. Physicians modified the antihypertensive regimens for 27.4% (95% CI: 23.9-30.8%) of the patients with uncontrolled BP, and the addition of another antihypertensive agent was the most frequent modification. With regard to the physicians' perception of patients' BP control, the BPs of 44.1% of the patients with uncontrolled BP were considered well controlled by the physicians.

Olmesartan/amlodipine: blood pressure lowering and beyond in special populations

Clinical studies and population-based analyses show that in patients with hypertension, the majority cannot control their blood pressure (BP) by treatment with a single antihypertensive agent. Combining agents from different antihypertensive classes with complementary modes of action significantly increases efficacy and is a treatment strategy recommended by European treatment guidelines, particularly in patients at high cardiovascular risk. The combinations of antihypertensive agents recommended by the European guidelines include an angiotensin receptor blocker (ARB) with a calcium channel blocker (CCB). The single-pill combination formulation of the ARB olmesartan medoxomil plus the CCB amlodipine is an effective and well-tolerated treatment that provides greater blood pressure lowering and control than the component monotherapies and favours compliance by not increasing pill burden. Importantly, the efficacy and tolerability of olmesartan plus amlodipine is not affected by age, gender, hypertension severity, diabetes status, race or body mass index. Additional blood pressure lowering effects are observed with stepwise uptitration of olmesartan plus amlodipine with or without hydrochlorothiazide, with more patients achieving blood pressure goals. In addition, olmesartan plus amlodipine has demonstrated effects beyond BP lowering by showing beneficial effects on markers of inflammation, endothelial dysfunction and oxidative stress, as well as metabolic improvements and a reduction in new-onset diabetes incidence in hypertensive patients with metabolic syndrome.

Achieving blood preSsure goals sTudy in uncontrolled hypeRtensive pAtients treated with a fixed-dose combination of ramipriL / hydrochlorothiazide : the ASTRAL study

Hypertension is a common cardiovascular disease, affecting adults worldwide and it accounts for up to 30% of all deaths. The need for better control of arterial hypertension justifies observational studies designed to better understand the real-life management of hypertensive patients. The ASTRAL study was primarily designed to evaluate the percentage of hypertensive patients achieving blood pressure goals after eight weeks of treatment with a fixeddose combination of ramipril/hydrochlorothiazide (HCTZ). The study was a multi-centre, non-comparative, Open-label, observational study conducted in 36 centres in five sub-Saharan African countries, namely Cameroon, Congo Brazzaville, Democratic Republic of Congo (DRC), Madagascar and Nigeria. Four hundred and forty-nine men and women 18 years of age or older with hypertension not controlled by an ACE inhibitor, a diuretic or any other monotherapy or anti-hypertensive combination not containing a diuretic in a fixed dose were considered eligible for inclusion in this eight-week study. The study consisted of three visits, visit one (V1) at baseline, visit two (V2) after four weeks and visit three (V3) after eight weeks. The mean age of the patients was 54.7 ± 11.7 years (20-90 years) and most were categorised by the WHO criteria as either overweight or obese (71.6%). After four and eight weeks of treatment with the study drug, systolic and diastolic blood pressures significantly changed from baseline: -24.7/-14.2 mmHg (p < 0.001) and -31.7/-17.9 mmHg (p < 0.001), respectively. There were 60.2% of the non-diabetics on prior monotherapy who, at eight weeks, fulfilled the primary blood pressure goal for SBP and DBP, versus 26.5% of the diabetic patients, also on monotherapy. Few adverse events were reported, with facial oedema and dry cough recurring twice in two patients. Fixed-dose combination of ramipril/HCTZ is therefore effective, tolerable and has a good safety profile for blood pressure control in black Africans.

Olmesartan Medoxomil/Amlodipine/Hydrochlorothiazide

The antihypertensive agents olmesartan medoxomil, amlodipine and hydrochlorothiazide (HCTZ) are now available as a fixed-dose combination tablet (olmesartan medoxomil/amlodipine/HCTZ). In a 12-week, randomized, double-blind, multicentre trial (TRINITY) in adults with moderate to severe hypertension, olmesartan medoxomil + amlodipine + HCTZ triple combination therapy produced significantly greater least squares mean reductions from baseline in seated diastolic blood pressure (BP) [primary endpoint] and seated systolic BP than olmesartan medoxomil/amlodipine, olmesartan medoxomil/HCTZ or amlodipine + HCTZ. Furthermore, significantly more patients achieved BP goals and targets with the triple combination regimen than with any of the dual combination regimens at week 12, with olmesartan medoxomil + amlodipine + HCTZ also demonstrating benefit over the dual regimens in terms of ambulatory BP control. According to subgroup analyses of the TRINITY trial, olmesartan medoxomil + amlodipine + HCTZ was more effective in reducing BP and achieving BP goals than each of the dual therapies, irrespective of hypertension severity, age, sex, race or diabetes mellitus status. Data from a number of smaller clinical studies indicated that olmesartan medoxomil + amlodipine + HCTZ triple combination therapy provides antihypertensive efficacy in patients whose BP is not adequately controlled with olmesartan medoxomil + amlodipine. Olmesartan medoxomil + amlodipine + HCTZ was generally well tolerated in the TRINITY study, with adverse events usually being mild or moderate in severity.

Olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide triple combination for hypertension

Hypertension is an increasingly prevalent cardiovascular risk factor associated with high rates of morbidity and mortality. Lowering blood pressure (BP) to recommended levels reduces the risk of hypertension-associated cardiovascular events. Despite current treatment options and recommendations, the BP of many patients remains suboptimally controlled. There is a need for more effective management in patients not achieving BP goals on current monotherapy or combination therapy. Regimens combining three or more antihypertensive agents have been shown to increase the proportion of patients achieving BP goals. Recent data suggest that the combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide is a rational treatment option offering safe and effective BP reductions and goal attainment in a greater proportion of patients compared with dual-combination regimens. As the understanding of the importance of BP control grows, treatment options that enable patients to achieve BP goals quickly and safely will become increasingly important in hypertension management.

Safety and Tolerability of an Olmesartan Medoxomil-Based Regimen in Patients with Stage 1 Hypertension

One of the reasons for suboptimal blood pressure (BP) control in patients with hypertension is poor adherence to treatment, which may be caused by treatment-emergent adverse events. Therefore, it is crucial for an antihypertensive agent to provide a high level of efficacy without compromising tolerability. To evaluate the safety and tolerability of a titrate-to-goal, olmesartan medoxomil-based therapy in patients with stage 1 hypertension (seated systolic BP [SeSBP] of 140-159 mmHg or seated diastolic BP [SeDBP] of 90-99 mmHg). This was a pre-specified analysis of data from a randomized, double-blind, placebo-controlled, multicentre (29 sites) clinical study conducted from January to October 2007 in the US. Male and female patients (n = 130) aged >or=18 years with stage 1 hypertension were included in the analysis. Patients were treated with either placebo or an olmesartan medoxomil-based titration regimen, which comprised treatment with olmesartan medoxomil plus hydrochlorothiazide (HCTZ) as required to achieve a target BP of <120/80 mmHg. The current analysis focused on the safety of olmesartan medoxomil in patients with stage 1 hypertension, particularly in terms of discontinuation rates and the incidence of dizziness and orthostatic hypotension. Safety and tolerability were assessed throughout the study. The primary efficacy outcome was the least-squares (LS) mean change from baseline in SeSBP after 12 weeks' double-blind treatment. Additional efficacy variables included LS mean change from baseline in SeDBP at 12 weeks and the proportions of patients achieving BP goals at study end and at each titration step. In patients with stage 1 hypertension, the olmesartan medoxomil-based regimen was generally well tolerated at all titration steps, and discontinuation due to adverse events was similar between olmesartan medoxomil and placebo. Treatment-emergent adverse events occurred in 16.1% up to 27.6% of olmesartan medoxomil recipients and between 8.3% and 24.3% of placebo recipients, across treatment regimens; a slight increase in the incidence of treatment-emergent adverse events was observed with olmesartan medoxomil/HCTZ versus olmesartan medoxomil alone (<or=27.6% vs <or=19.3%). In addition, one or more drug-related events were reported in up to 10.3% of olmesartan medoxomil recipients and up to 5.7% of placebo recipients. Gastrointestinal disorders (<or=10.0%), nervous system disorders (<or=10.3%), and infections/infestations (<or=7.1%) were the most commonly reported treatment-emergent adverse events in the olmesartan medoxomil treatment group. The most common nervous system disorders in the olmesartan medoxomil treatment group were dizziness (<or=6.9%) and headache (<or=5.4%). Orthostatic hypotension was not reported. The LS mean differences between olmesartan medoxomil and placebo for change from baseline in SeSBP (-22.0 mmHg; 95% confidence interval [CI] -26.9, -17.3) and SeDBP (-12.2 mmHg; 95% CI -14.9, -9.4; both p < 0.0001) significantly favoured olmesartan medoxomil at week 12 with last observation carried forward. At study end, a BP goal of <140/90 mmHg was achieved by 81.0% of patients in the olmesartan medoxomil group versus 43.1% of patients in the placebo group (p < 0.0001). Olmesartan medoxomil-based therapy was well tolerated in this study among patients with stage 1 hypertension and demonstrated a placebo-like safety and tolerability profile. This regimen was also effective in terms of BP lowering and enabling patients to achieve BP goals without an adverse effect on tolerability.

INFLUENCE OF FIXED VERSUS FREE PHARMACOLOGICAL COMBINATIONS IN THE MANAGEMENT OF ARTERIAL HYPERTENSION: PP.5.170

Objectives: To compare the effect of fixed-dose combinations (FiDC) versus free-dose combinations (FrDC) in hypertensive patients, in terms of reduction of blood pressure (BP) values and achievement of BP goals. Design and Method: Longitudinal retrospective cohort study in patients attended at our Hypertension Unit from january 2006 until september 2009. All consecutive hypertensive patients treated with monotherapy, who did not achieve BP goals, were included in the study. A second farmacological agent according to usual clinical practice was added in the initial visit with evaluation one year later. Results: We included 169 hypertensive patients on monotherapy (90 men, 53,3 %, median age 57,7 years) and a BMI of 30,2 kg/m2. 84 patients initiated a second antiypertensive agent on a free basis, the resting 85 patients received a fixed-dosed combination. There were no statistically significant differences in age or initial office BP. The most prevalent combination strategies in both groups were ACEI/diuretics and ARB/diuretics, accounting for almost 90 % of the combination treatment (86% in the FrDC versus 94% in the FiDC-group). In the FiDC-group arterial BP was reduced from initially 149/85 to 128/75 mmHg, in the FrDC-group from 147/84 to 134/77 mmHg. Differences between intitial and final systolic (20.6 vs. 12.2, p = 0.001) and diastolic (10.1 vs. 6.8, p = 0.029) BP were significantly greater in the FiDC than in the FrDC-group. The proportion of patients achieving blood pressure goals in the FiDC-group was significantly greater (88%) than the corresponding proportion in the FrCD-group (69%, p < 0,01). There were no statistical differences between groups in the number of antihypertensive drugs (2.12 FrDC versus 2.22 FiDC). Conclusions: Management of hypertension based on fixed-dose combinations, compared to free-dose combinations, leads to a greater reduction of initial systolic and diastolic BP and to a higher proportion of patients achieving BP goals, suggesting that strategies based on fixed-dose combinations improve the patients' compliance as a determinant factor of BP control.

Amlodipine besylate/olmesartan medoximil fixed combination for the treatment of hypertension

National and international guidelines recommend the use of combination drugs as a first-line therapy for persons with stage 2 hypertension (blood pressure >160/100 mmHg). Although hypertension is common (30% of adults in the USA), its control to recommended blood pressure levels of under 140/90 mmHg remains low, at 36.8%. In the past, fixed-drug combinations included a diuretic with another antihypertensive drug. Recently, combinations of angiotensin-converting enzyme inhibitors or angiotensin receptor blockers mostly with dihydropyridine calcium channel blockers have been developed and approved for the treatment of hypertension. One of these, olmesartan medoxomil in combination with amlodipine besylate has been shown to be effective and safe for the treatment of hypertension. In a large, randomized, placebo-controlled study (Combination of Olmesartan medoxomil and Amlodipine besylate in Controlling High blood pressure [COACH]) of 1940 patients, the high-dose combinations of olmesartan medoxomil and amlodipine besylate 40/10 mg/day reduced the sitting systolic and diastolic blood pressure by 29/19 mmHg from baseline (p < 0.001) and resulted in 54% of patients achieving blood pressure goals. It also decreased the pedal edema induced by amlodipine monotherapy 10 mg/day by 36.1%. This drug combination, besides being effective, is also safe and well tolerated.

Efficacy and safety of olmesartan medoxomil alone and in combination with hydrochlorothiazide

In at least 50% of patients with hypertension, particularly those with stage 2 hypertension, combination drug therapy is required to achieve the currently recommended blood pressure (BP) goals. It is likely that future hypertension guidelines will recommend lowering BP beyond the currently recommended systolic/diastolic BP goals of lower than 140/90 mmHg for all patients with hypertension and lower than 130/80 mmHg for patients with diabetes or chronic kidney disease. In a series of clinical trials, the combination of olmesartan medoxomil, a well-established angiotensin receptor blocker, and hydrochlorothiazide, a thiazide diuretic, has produced greater reductions in systolic BP and diastolic BP and greater proportions of patients achieving BP goals than monotherapy with either component. Additionally, the increased efficacy resulting from the combination with hydrochlorothiazide does not appear to significantly affect the tolerability profile of olmesartan medoxomil. This article provides a comprehensive evaluation of the chemistry, clinical efficacy, safety and tolerability of this combination and discusses its role in the management of hypertension.