review of literature on hypertension pdf

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American Heart Association High Blood Pressure Protocol 2017: A Literature Review

1 Medicine, CMH Lahore Medical College and Institute of Dentistry, Lahore, PAK

Muhammad Abu Zar

2 Hematology and Oncology, The University of Arizona, Tucson, USA

Ahmad Kamal

Amber e faquih.

3 Graduate, Dow University of Health Sciences, Karachi, PAK

Chandur Bhan

4 Internal Medicine, Chandka Medical College Hospital, Larkana, PAK

Waleed Iftikhar

5 Internal Medicine, CMH Lahore Medical College and Institute of Dentistry, Lahore, PAK

Muhammad Bilal Malik

6 Internal Medicine, Shifa College of Medicine, Islamabad, PAK

Malik Qistas Ahmad

7 Hematology-Oncology, University of Arizona Cancer Center, Tucson, USA

Nouman Safdar Ali

8 Medicine, Jinnah Hospital/Allama Iqbal Medical College, Lahore, PAK

Shahzad Ahmed Sami

Fnu jitidhar.

9 Internal Medicine, Orthopedic and Medical Institute, Karachi, PAK

Abbas M Cheema

10 Internal Medicine, Combined Military Hospital, Lahore, PAK

Annum Zulfiqar

11 Internal Medicine, Sheikh Zayed Medical College/Hospital, Lahore, PAK

Hypertension is the most prevalent clinical symptom arising from various cardiovascular disorders. Likewise, it is considered a precursor or sequelae to the development of acute coronary artery disease and congestive heath failure (CHF). Hypertension has been considered a cardinal criterion to determine cardiovascular function. According to the World Health Organization (WHO) global observatory data, hypertension causes more than 7.5 million deaths a year, about 12.8% of the total human mortality. Similarly, the Center for Disease Control (CDC) states that 35% of the American adults have been estimated to have a persistently high blood pressure, which makes it about one in every three adults. Hypertension is a modifiable symptom that can be managed through pharmacological and non-pharmacological methods and standard protocols set forth by the American Heart Association (AHA). With new findings from various clinical trials related to the management of hypertension, new developments and recommendations have been made to update the previously established protocols for hypertension. This article aims to discuss and dissect the modern updates of hypertension management as comprehensively elaborated in the 2017 Hypertension Clinical Practice Guidelines.

Introduction and background

Hypertension (HTN) is part of a clinical syndrome that results from multifaceted etiologies and can contribute to the development of complex cardiovascular disorders. In addition, it is a significant clinical symptom that directly relates to a dysfunctional cardiovascular system. HTN can be of two types: essential or secondary. In essential HTN, the etiology is unknown while in secondary HTN, a known pathological disorder is the cause. Hypertension (HTN) is primarily observed when there are pressure changes in the vascular system secondary to an abnormal cardiovascular fluid regulation and/or loss of vascular/arterial tone. It can also be due to abnormal contractility and/or aberrant electrical conductivity of the heart. Moreover, HTN can also be caused by conditions that are not organ-based and that predispose an individual to have these pressure changes.

The new definition of hypertension

HTN is diagnosed through non-invasive means with the application of a sphygmomanometer. It is necessary to ensure that blood pressure (BP) measurements are undertaken accurately. The apparatus determines the systolic blood pressure (SBP) and diastolic blood pressure (DBP) of an individual in millimeters of mercury (mm of Hg). According to the updated guideline [ 1 ] provided by the American Heart Association (AHA), a new approach for the classification of blood BP in adults is recommended. The new guideline recommends the use of an average SBP ≥130 mm Hg or an average DBP ≥80 mm Hg instead of the values from recent previous guidelines (average SBP ≥140 mm Hg or average DBP ≥90 mm Hg) to designate individuals with hypertension (HTN). With the proposed changes in these guidelines, it is expected that the prevalence of HTN would increase by 14%.

Well-elaborated management guidelines

HTN is classically managed with a plethora of interventions, ranging from pharmacological to non-pharmacological measures to decrease or manage increased BP. According to the 2017 Hypertension Clinical Guidelines by AHA, decisions to manage HTN using BP-lowering medications, in addition to non-pharmacological interventions, should be determined by the level of BP and the patient's risk for atherosclerotic cardiovascular disease (ASCVD) [ 2 ]. The most important early interventions are stated to be weight loss, the Dietary Approaches to Stop Hypertension (DASH) [ 3 ] diet, sodium reduction, potassium supplementation, increased physical activity, and reduction in alcohol consumption. Moreover, the guidelines also provided condition-related pharmacological interventions on the treatment of HTN.

Thiazide diuretics, calcium channel blockers (CCBs), angiotensin receptor blockers (ARBs), or angiotensin-converting enzyme (ACE) inhibitors [ 4 ] have been recommended as the first-line agents [ 5 ] for the initiation of pharmacological therapy in a newly diagnosed patient. Two first-line agents of different classes are recommended in adults with stage 2 HTN, and for stage 1 HTN, a single first-line agent is warranted with an active dose adjustment and additional agents according to the BP.

Hypertension with comorbidities

In addition, the guidelines provide varied treatment strategies for individuals diagnosed with HTN and other clinical comorbidities. Many pathologies affect clinical decision-making [ 6 ] in HTN. These include ischemic heart disease (IHD), heart failure with reduced ejection fraction (HFrEF), chronic kidney disease (CKD) (including renal transplantation), cerebrovascular disease, atrial fibrillation (AF), peripheral arterial disease (PAD), diabetes mellitus (DM), and metabolic syndrome. We illustrate some of the specific treatment guidelines for patients with concomitant disorders other than HTN. Certain risk factors [ 7 ] are also to be considered in hypertension, which aids in screening high-risk groups and suggesting appropriate interventions aiding early diagnosis and management.

Heart Failure with Reduced Ejection Fraction (HFrEF)

According to these guidelines, the recommended goal for adults with HFrEF and HTN is set at 130/80 mmHg [ 8 - 9 ]. Guideline Determined Medical Therapy (GDMT) beta blockers that include carvedilol, metoprolol succinate, and bisoprolol are the recommended first-line agents for these patients. Calcium channel blockers (CCBs) are not recommended in this scenario. Medications with compelling indications for HFrEF that may be used as first-line therapy to treat high BP include ARBs or ACE inhibitors, mineralocorticoid receptor antagonists, diuretics, and GDMT beta-blockers [ 3 ]. 

Chronic Kidney Disease (CKD)

HTN is the most prevalent clinical symptom associated with chronic kidney disease CKD [ 10 ]. About 67%-92% of patients with CKD have HTN [ 11 ]. A treatment course can reduce intraglomerular pressure and thereby reduce albuminuria [ 12 ], and serum creatinine may increase up to 30% because of the concurrent reduction in glomerular filtration rate (GFR) [ 4 ]. Patients with CKD also have a target goal of 130/80 mmHg. An ACE inhibitor (or an ARB, in the case of ACE inhibitor intolerance) is the most preferred treatment for patients suffering from HTN and CKD [ 13 ]. The use of ACE inhibitors has been recommended for all patients with stage 3 CKD or higher. ACE inhibitors or ARBs are also suggested for patients with stage 1 or stage 2 CKD with significant albuminuria, which is defined as -≥300 mg/d or ≥300 mg/g of albumin-creatinine ratio or equivalent in the first void in the morning. There is, in fact, a significant decrease in HTN without a loss in GFR with treatment on enalapril even if taken for prolonged periods of time [ 14 ]. After renal transplantation, patients suffer from HTN as a result of pre-existing kidney disease, the effects of immunosuppressive medications, and/or the presence of an allograft pathology [ 15 ]. Some percentage of post-transplant recipient patients develops donor-associated hypertension [ 16 ]. Patients treated with calcineurin inhibitor-based immunosuppression regimens have an HTN prevalence of 70% to 90% [ 17 - 18 ]. On the basis of the Cochrane analysis [ 19 ], treatment with CCBs proves to be the best, as they prevent graft loss and maintain a higher glomerular filtration rate (GFR) [ 5 ]. Patients with CKD and resistant hypertension are found to have salt-sensitive hypertension and the primary approach can be with simple salt restriction followed by aggressive pharmacotherapy [ 20 ].

Intracranial Hemorrhage

Elevated BP is highly prevalent in the setting of acute intracranial hemorrhage (ICH) [ 21 ]. It is linked to hematoma expansion, neurological worsening, death, and dependency after ICH. An immediate lowering of SBP to less than 140 mmHg is not advised in adults who present within six hours of the event with an SBP of 150-220 mmHg [ 22 ]. The use of intravenous anti-hypertensive agents has been recommended for all ICH patients with an SBP of 220 mmHg or higher. For acute ischemic stroke patients, the advantage of lowering BP early in reducing death and dependency is uncertain. Restarting antihypertensive therapy to improve long-term BP control is reasonable in these patients after the first 24 hours if they have pre-existing HTN and are neurologically stable.

Peripheral Arterial Disease

HTN is a common factor for patients with peripheral arterial disease (PAD) [ 23 - 24 ]. These patients are included in various clinical trials of antihypertensive drug therapy. However, the outcomes of various randomized controlled trials (RCTs) suggest that no superior drug has been noted for the treatment of HTN in patients with PAD. So, it has been recommended that HTN is treated in patients with concomitant PAD similarly to HTN patients with no PAD [ 25 ].

Atrial Fibrillation

Patients with atrial fibrillation (AF) have HTN in 80% of the cases [ 26 ] and it's the most common condition, regardless of age [ 27 ]. HTN has long been recognized as a risk factor for AF [ 28 ] because it is associated with left ventricular hypertrophy, deranged diastolic function with impaired left ventricular filling, raised left atrial pressures with left atrial hypertrophy and enlargement, increased atrial fibrosis, and slowing of intra-atrial and inter-atrial electrical conduction velocities. In addition, five randomized controlled trials RCTs were conducted to determine the best medication therapy and the results showed a superiority of renin-angiotensin system (RAS) blockade over CCBs [ 6 , 29 ]. Thus, ARBs are advised to prevent the recurrence of AF in HTN patients [ 30 ].

Diabetes Mellitus

The prevalence of HTN among adults with diabetes mellitus (DM) is approximately 80% [ 31 ], and HTN is at least twice as common in individuals with type 2 DM than in age-matched individuals without DM. In patients with DM, a threshold of 130/80 mmHg is set for the initiation of antihypertensive therapy. All first-line agents have been deemed equally effective in patients with DM and HTN. Various controlled trials and meta-analyses showed that ACE inhibitors and ARBs have the best efficacy among the HTN drug classes on urinary albumin excretion [ 32 ]. According to one meta-analysis of RCTs, ACE inhibitors or ARBs prevent moderate to severe albuminuria in patients with DM. According to these guidelines, in the presence of albuminuria, ACE inhibitors and ARBs might be used for patients with DM and HTN.

Treatment monitoring and the follow-up routine were also amended in the new guidelines. Substantial changes to various stages of HTN were included. For patients with normal BP, the guidelines suggest a yearly follow-up assessment. For patients with an elevated BP and stage 1 HTN, assessment should be made every three to six months with an assessment and optimized adherence therapy. Follow-up assessment every month is advised for patients with stage 2 HTN.

Conclusions

Improving treatment and blood pressure (BP) control in adults with hypertension (HTN) involves a system of techniques and strategies that are individualized according to the needs of the patient. Hypertension Clinical Guidelines 2017 provides us with a well-researched tool that effectively improves current HTN management. It is a systematic algorithm for healthcare professionals who follow evidence-based clinical practice to restrain the complications brought by elevated BP.

The content published in Cureus is the result of clinical experience and/or research by independent individuals or organizations. Cureus is not responsible for the scientific accuracy or reliability of data or conclusions published herein. All content published within Cureus is intended only for educational, research and reference purposes. Additionally, articles published within Cureus should not be deemed a suitable substitute for the advice of a qualified health care professional. Do not disregard or avoid professional medical advice due to content published within Cureus.

The authors have declared that no competing interests exist.

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Hypertension literature review

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Annual reports on hypertension research 2020

Affiliations.

• 1 Deparment of Pharmacology, Ehime University Graduate School of Medicine, Tohon, Ehime, Japan. [email protected].
• 2 Department of Cardiovascular Regeneration and Medicine, Research Institute for Radiation Biology and Medicine, Hiroshima University, Hiroshima, Hiroshima, Japan.
• 3 Divivsion of Regeneration and Medicine, Medical Center for Translational and Clinical Research, Hiroshima University Hospital, Hiroshima, Hiroshima, Japan.
• 4 Department of Endocrinology and Hypertension, Tokyo Women's Medical University, Shinjuku, Tokyo, Japan.
• 5 Division of Nephrology, Department of Medicine, Jichi Medical University School of Medicine, Shimotsuke, Tochigi, Japan.
• 6 Department of Cardiovascular Medicine, Saga University, Saga, Saga, Japan.
• 7 Department of Geriatric and General Medicine, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
• 8 General and Geriatric Medicine, Kawasaki Medical University, Okayama, Okayama, Japan.
• 9 Department of Endocrinology, Metabolism, Rheumatology and Nephrology, Faculty of Medicine, Oita University, Yufu, Oita, Japan.
• 10 Division of Cardiovascular Medicine, Department of Medicine, Jichi Medical University School of Medicine, Shimotsuke, Tochigi, Japan.
• 11 Department of Metabolic Medicine, Osaka University Graduate School of Medicine, Suita, Osaka, Japan.
• PMID: 34650193
• DOI: 10.1038/s41440-021-00766-3

In 2020, 199 papers were published in Hypertension Research. Many excellent papers have contributed to progress in research on hypertension. Here, our editorial members have summarized eleven topics from published work and discussed current topics in depth. We hope you enjoy our special feature, Annual Reports on Hypertension Research.

Keywords: Annual topics; Hypertension Research; Publication in 2020.

© 2021. The Author(s), under exclusive licence to The Japanese Society of Hypertension.

Publication types

• Hypertension* / epidemiology

• Introduction
• Conclusions
• Article Information

Abbreviations: BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); BP, blood pressure; CV, cardiovascular; HDL, high-density lipoprotein; RCT, randomized controlled trial.

Abbreviation: QALY, quality-adjusted life year.

eTable 1. Assumed Patient Characteristics for Pharmacist Hypertension Intervention, Based on Observed Population in Tsuyuki et al 10 Clinical Trial

eTable 2. Model US Cost Inputs

eFigure 1. Association Between Cumulative Cost Savings and QALY Benefit Across a Range of Hypothetical SBP Reductions Associated With the Pharmacist Intervention

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Dixon DL , Johnston K , Patterson J , Marra CA , Tsuyuki RT. Cost-Effectiveness of Pharmacist Prescribing for Managing Hypertension in the United States. JAMA Netw Open. 2023;6(11):e2341408. doi:10.1001/jamanetworkopen.2023.41408

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Cost-Effectiveness of Pharmacist Prescribing for Managing Hypertension in the United States

• 1 Department of Pharmacotherapy and Outcomes Science, Center for Pharmacy Practice Innovation, Virginia Commonwealth University School of Pharmacy, Richmond
• 2 Broadstreet Health Economics and Outcomes Research, Vancouver, British Columbia, Canada
• 3 School of Pharmacy, University of Otago, Dunedin, New Zealand
• 4 Department of Medicine (Cardiology), Faculty of Medicine and Dentistry, University of Alberta, Edmonton, Alberta, Canada

Question   What would be the cost-effectiveness of implementing a pharmacist-prescribing intervention to improve blood pressure control in the United States?

Findings   In this simulated cost-effectiveness analysis of a 5-state Markov model, 50% uptake of a pharmacist-prescribing intervention to improve blood pressure control was associated with a $1.137 trillion in cost savings and could save an estimated 30.2 million life years over 30 years.

Meaning   These findings suggest that pharmacist-prescribing interventions to improve blood pressure control would provide high economic value compared with usual care.

Importance   Pharmacist-led interventions can significantly improve blood pressure (BP) control. The long-term cost-effectiveness of pharmacist-prescribing interventions implemented on a large scale in the US remains unclear.

Objective   To estimate the cost-effectiveness of implementing a pharmacist-prescribing intervention to improve BP control in the US.

Design, Setting, and Participants   This economic evaluation included a 5-state Markov model based on the pharmacist-prescribing intervention used in The Alberta Clinical Trial in Optimizing Hypertension (or RxACTION) (2009 to 2013). In the trial, control group patients received an active intervention, including a BP wallet card, education, and usual care. Data were analyzed from January to June 2023.

Main Outcomes and Measures   Cardiovascular (CV) events, end-stage kidney disease events, life years, quality-adjusted life years (QALYs), lifetime costs, and lifetime incremental cost-effectiveness ratio (ICER). CV risk was calculated using Framingham risk equations. Costs were based on the reimbursement rate for level 1 encounters, medication costs from published literature, and event costs from national surveys and pricing data sets. Quality of life was determined using a published catalog of EQ-5D utility values. One-way sensitivity analyses were used to assess alternative reimbursement values, a reduced time horizon of 5 years, alternative assumptions for BP reduction, and the assumption of no benefit to the intervention after 10 years. The model was expanded to the US population to estimate population-level cost and health impacts.

Results   Assumed demographics were mean (SD) age, 64 (12.5) years, 121 (49%) male, and a mean (SD) baseline BP of 150/84 (13.9/11.5) mm Hg. Over a 30-year time horizon, the pharmacist-prescribing intervention yielded 2100 fewer cases of CV disease and 8 fewer cases of kidney disease per 10 000 patients. The intervention was also associated with 0.34 (2.5th-97.5th percentiles, 0.23-0.45) additional life years and 0.62 (2.5th-97.5th percentiles, 0.53-0.73) additional QALYs. The cost savings were $10 162 (2.5th-97.5th percentiles, $6636-$13 581) per person due to fewer CV events with the pharmacist-prescribing intervention, even after the cost of the visits and medication adjustments. The intervention continued to produce benefits in more conservative analyses despite increased costs as the ICER ranged from $2093 to $24 076. At the population level, a 50% intervention uptake was associated with a $1.137 trillion in cost savings and would save an estimated 30.2 million life years over 30 years.

Conclusion and Relevance   These findings suggest that a pharmacist-prescribing intervention to improve BP control may provide high economic value. The necessary tools and resources are readily available to implement pharmacist-prescribing interventions across the US; however, reimbursement limitations remain a barrier.

Hypertension (HTN) is the leading preventable cause of death and disability throughout the world. 1 More than 100 million people in the US have HTN, a significant risk factor for the development of cardiovascular disease (CVD) and kidney disease. 2 Health care costs associated with HTN in the US alone exceeded $130 billion between 2003 and 2014. 3 Despite affordable medications and lifestyle interventions proven to reduce blood pressure (BP), BP control rates in the US are declining. 4 Currently, only 1 in 4 adults with HTN has their BP under control (ie, less than 130/80 mm Hg). 2

In 2020, the US Surgeon General issued a Call to Action to Control Hypertension, 5 which “seeks to avert the negative health effects of HTN across the US by identifying interventions that can be implemented, adapted, and expanded across diverse settings.” The goals include making HTN a national priority; ensuring the places where people live, learn, work, and play support HTN control; and optimizing patient care for HTN. One of the primary strategies promotes standardized treatment approaches and guideline-recommended care with an emphasis on team-based care. 5

Pharmacists are well placed in the community to screen and manage HTN because they see patients up to 10 times more frequently than physicians. 6 Numerous randomized clinical trials 7 - 10 of pharmacist-led case-finding and prescribing interventions have improved HTN outcomes. Given this evidence and the compelling need for new solutions to reduce the clinical and economic burden of uncontrolled HTN, we conducted a cost-effectiveness analysis of implementing pharmacist prescribing for HTN management in the US.

This economic evaluation followed the Consolidated Health Economic Evaluation Reporting Standards ( CHEERS ) reporting guideline. Per the Common Rule, institutional review and informed consent were not required because this research did not involve human participants.

A pharmacoeconomic model was developed in Microsoft Excel to assess the potential impact of pharmacist prescribing for HTN compared with usual care (status quo) on long-term costs and health outcomes in the US. The implementation of the model for a Canadian population has been previously described in greater detail 11 ; this structure was used and updated to reflect the US population and health care system. Briefly, the model was structured as a 5-state Markov model, with patients entering the model with uncontrolled HTN and no additional history of cardiovascular (CV) or kidney disease. Over time, patients were at risk of developing CV and/or kidney disease and subsequent death ( Figure 1 ). All patients were at risk for all-cause mortality based on general population life tables, with an increased risk of mortality in individuals following a CV event. The conceptual model assumed that the pharmacist-prescribing intervention would reduce BP, with a resultant decreased risk of CV and kidney disease; the costs of implementing pharmacist-prescribing HTN management were thus compared with long-term cost offsets as well as health and mortality benefits resulting from this BP reduction.

The base case scenario was a third-party payer perspective, with a 30-year time horizon, 1-year model cycles, and costs and quality-adjusted life years (QALYs) discounted at 3% per annum. 12 Results are reported at both the individual level and scaled up to the US population based on the number of individuals with uncontrolled HTN.

The Alberta Clinical Trial in Optimizing Hypertension (R x ACTION) was conducted in Alberta, Canada from 2009 to 2013. 10 This analysis was conducted in 2023 and used a model base case based on the mean 6-month reduction in systolic BP (SBP) (−18.3 mm Hg) observed with the pharmacist intervention in the R x ACTION study, which involved pharmacist assessment and counseling of BP, antihypertensive medication review, and prescribing antihypertensives in a face-to-face encounter. Pharmacist follow-up occurred every 4 weeks until BP was at goal for 2 consecutive visits followed by 12-week intervals for the remainder of the 24-week study duration. In the model, it was assumed that this would correspond to 6 visits in the first year and quarterly visits thereafter. For the comparator group, we assumed that BP would remain at baseline levels. We did not use the control group from the R x ACTION trial because it was an active intervention. Baseline clinical and demographic characteristics were based on the trial population (eTable 1 in Supplement 1 ).

The risk of CVD over time for the control arm was calculated based on Framingham risk equations for myocardial infarction (MI), stroke, heart failure (HF), and angina given baseline BP levels. 13 - 15 The association between SBP reduction in the intervention group and reduced risk of CVD was estimated using results from the Blood Pressure Lowering Treatment Trialists’ Collaboration. 16 A regression analysis was conducted based on the reported values for SBP and risk reduction of major CV events, and the resulting slope was used to estimate the impact of a 1-unit reduction on the relative risk. The resulting estimated association was a 0.026 (SE, 0.004) decrease in relative risk of CVD per each mm Hg decrease in SBP.

The impact of BP on kidney disease was characterized by the risk of end-stage kidney disease (ESKD), which was based on a reported association between BP categories and ESKD incidence observed in a US historical cohort study and a 25-year follow-up study. 17 , 18 Rates per 100 000 person-years were reported by category (normal, pre-HTN, stage 1 HTN, and stage 2 HTN), and converted to annual probabilities. For the modeled population at baseline, the mean BP corresponded to stage 1 HTN, which corresponded to an ESKD rate of 19.5 per 100 000 person-years, or an annual risk of 0.000194 per person. This annual risk was retained for the control arm. For the treatment arm, regression analysis of risk by BP category was conducted to estimate a risk reduction of 0.77 associated with observed BP reduction, which was applied to result in an annual ESKD probability of 0.000150 for the pharmacist-prescribing intervention group. Mortality was based on US life tables, with a hazard ratio of 1.71 applied to account for the increased risk of mortality in a population with CVD. 19

In the base case of the model, all pharmacist assessments were assumed to incur a cost of $23.10, reflecting the 2019 reimbursement rate for Current Procedural Terminology (CPT) 99211 (level 1 patient encounters). 20 Visits were assumed to be monthly for the first 3 months (assumed time until HTN became controlled), followed by quarterly, with 6 pharmacist visits in the first year and 4 annually after that. Given that the clinical model included pharmacist prescribing of medications, we assumed that patients receiving the intervention would incur an incremental medication cost of $32.78/mo, based on the mean monthly medication cost for individuals with HTN in the US. This was chosen conservatively to maximize the cost of the pharmacist intervention; the true incremental medication cost is likely lower given that some usual care patients receive physician-prescribed HTN medications, and pharmacist-prescribing interventions often result in discontinuation of less appropriate or effective medications. 10 , 21 Annual background all-cause health care costs for all individuals were based on age-specific values reported by the Agency for Healthcare Research and Quality. 22

For individuals experiencing health events, the cost of the event was stratified into the first-year postevent and subsequent years. Costs for CV events (ie, stroke, heart failure, angina, and MI) were based on reported values from a US microsimulation model of HTN screening strategies, which used Medical Expenditure Panel Survey data. The cost for ESKD was based on US Renal Data System data (eTable 2 in Supplement 1 ). 23 All costs were inflated to 2021 US dollar based on the US Consumer Price Index-Medical Care. 24

Health state utilities were taken from a published catalog of EQ-5D utility values in the US. Baseline utilities were 0.867 for patients without ESKD or CVD and age-adjusted using a utility decrement of 0.00029 per year after age 70 years. 25 The utility values included in the model were 0.694 for stroke, 0.725 for MI, 0.636 for HF, 0.709 for angina, and 0.708 for ESKD. Disease-specific utilities were assumed to be chronic and continued to apply years after the event.

One-way sensitivity analyses were used to examine the impact of variation in key inputs, including (1) increased costs per pharmacist visit, reflecting reimbursement values aligned with a greater likelihood of dissemination and sustainability—$100 for an initial visit and $50 per follow-up; (2) reduced time horizon to 5 years; (3) alternative assumptions regarding SBP decrease, ranging from −5 to −27 mm Hg; (4) examining each type of health benefit (ie, reductions in stroke, MI, angina, HF, and ESKD) in isolation; (5) assuming that the HTN benefit is only sustained for 10 years, after which point there is no benefit to the intervention; and (6) a conservative scenario in which the BP decrease is assumed to be −10 mm Hg, losing 50% of benefit at 5 years, and 100% of benefit at 10 years. The range of BP values explored in sensitivity analysis reflects existing literature on the effect of pharmacist interventions on BP. A meta-analysis 7 reported that pharmacist interventions decreased mean SBP by an additional −7.6 mm Hg compared with usual care, but the types of pharmacist interventions in the included studies were heterogeneous and did not include prescriptive authority. Alternatively, the cluster-randomized trial of a pharmacist-prescribing intervention in black barbershops reported a mean reduction in SBP of −27 mm Hg in the intervention group; thus our use of −18.3 mm Hg from the R x ACTION is reasonable.

In addition to the 1-way sensitivity analyses, a 1000-iteration probabilistic sensitivity analysis was conducted to reflect the impact of stochastic parameter uncertainty on results. This included probabilistic variability of cost, clinical, and health-related quality of life parameters, including the SBP reduction and the relationship between SBP and clinical event risk.

Base case cost-effectiveness results were expanded to the US population to estimate cumulative cost and health impacts over 30 years. Individual-level results output by the model were multiplied year-over-year by the estimated number of incidents and prevalent patients with uncontrolled HTN assumed to be accessing the intervention. This time horizon was chosen to capture the lifetime of the model cohort. The prevalence of uncontrolled HTN was estimated to be 92.1 million 26 ; it was assumed that 50% of eligible individuals would access the intervention. Over a 30-year time horizon, incident cases of HTN were added each year based on a US cohort study. 27 It was assumed that the 50% rate of intervention use would persist among incident cases. Clinical and cost outcomes were assessed over the time horizon.

Briefly, the R x ACTION trial enrolled 248 participants (mean [SD] age, 64 [12.5] years; 121 [49%] male; 41 [15%] currently smoked; and 109 [48%] had diabetes). The mean (SD) baseline BP was 150/84 (13.9/11.5) mm Hg with a mean (SD) of 1.7 (1.2) antihypertensives per participant. The pharmacist intervention achieved a significant reduction in SBP at 6 months compared with the active control group (−18.3 mm Hg vs −11.8 mm Hg, respectively; P  < .001).

In the base case analysis over a 30-year time horizon, the pharmacist intervention was associated with 2100 fewer cases of CVD and 8 fewer cases of kidney disease per 10 000 patients. Per patient, the intervention was associated with 0.34 additional life years (discounted) and 0.62 additional QALYs (discounted) ( Table 1 ). The intervention also resulted in overall cost savings of $10 162 per person, as the cost reduction associated with fewer CV events more than offset the cost of pharmacist visits and medication adjustments ( Table 1 ). When comparing health care costs only (ie, excluding the costs of the intervention itself) mean costs were $189 648 in the control group and $172 167 in the intervention group, for a savings of $17 481. As the pharmacist-prescribing intervention was associated with both better health outcomes and lower costs, it was found to be dominant (discounted and undiscounted). Results were robust in the probabilistic sensitivity analysis, because 100% of probabilistic iterations were in the economically dominant quadrant of the cost-utility plane ( Figure 2 ).

In 1-way sensitivity analyses, results remained dominant when pharmacist costs were increased from the CPT level 1 reimbursement rate of $23.10 to $100 for an initial visit and $50 per follow-up visit, indicating that further incentivizing the pharmacist intervention would not jeopardize the resulting value of the service and would offset the pharmacist labor costs ( Table 2 ). The intervention also continued to dominate usual care when benefits were only accrued for 10 years, at which point the intervention was assumed to be equivalent to usual care. Although in this scenario, cost savings were reduced to $5744 and QALY benefits were reduced to 0.08 per patient. This was further reduced to cost savings of $521 in a scenario where the SBP reduction was reduced to −10 mm Hg, with 50% efficacy loss at 5 years and 100% efficacy at 10 years. However, economic dominance was still retained. In a series of more conservative analyses (ie, reduced effectiveness of a less-intensive intervention, considering each respective health outcome in isolation), the intervention continued to result in health benefits, but with an increase in costs; incremental cost-effectiveness ratios ranged from $2093 to $24 076, well within standard thresholds for cost-effectiveness ( Table 2 ). Reducing the time horizon to 5 years yielded an incremental cost-effectiveness ratio of $16 987.

In a more comprehensive 1-way assessment of the association between incremental costs and QALYs across a range of SBP values, the pharmacist intervention was associated with increased QALYs and was associated with reduced costs for SBP reduction of −9 mm Hg or greater (eFigure 1 in Supplement 1 ). For a hypothetical SBP reduction between −5 and −9 mm Hg, although costs were greater for the pharmacist intervention, incremental cost-effectiveness ratios remained at cost-effective levels, ranging from $500 to $16 000. When the model with base case settings was expanded to the population level, it was estimated that with a 50% access rate, the pharmacist intervention would lead to $1.137 trillion in cost savings and save 30.2 million life years over 30 years ( Figure 3 ).

Pharmacist interventions significantly improve BP control, 7 but the economic impact of widespread adoption of such interventions has been unclear. Our study demonstrates that a pharmacist prescribing intervention would save $10 162 per person over a 30-year time horizon with and at the population level, a cumulative savings of $1.13 trillion dollars. These savings were largely attributable to a reduction in CV events due to improved BP control with the intervention. These findings mirror those from a similar analysis evaluating the implementation of this model in Canada. 11 The cost savings in that study were less at $6364 per person, translating to a population benefit of 15.7 billion over 30 years, likely due to the lower overall health care costs in Canada compared with the US.

There is a critical need for innovative approaches, such as pharmacist-led interventions, to improve BP control. Between 2010 and 2019, there was a 23.1% increase in HTN-related mortality in the US. 28 In 2019, the rate of HTN-related death among Black individuals aged 35 to 64 years was 96.3 events per 100 000—the highest of any race or ethnicity. Importantly, pharmacist-led interventions have been shown to significantly improve BP control among Black individuals and individuals of racial and ethnic minoritized groups. 8 , 29 - 31 There is also a sense of urgency for broader implementation of pharmacist interventions to improve BP control given the worsening shortage of primary care clinicians, which could reach between 17 800 and 48 000 by the year 2034. 32 Given that 95% of individuals in the US live within 5 miles of a pharmacy, pharmacists are a possible solution to improve care access. 33

Widespread implementation of pharmacist-prescribing interventions targeting uncontrolled HTN is feasible but will require continued advancement in pharmacist scope of practice legislation and eligibility for reimbursement through the Centers for Medicare & Medicaid Services. Today, 49 states and the District of Columbia have legislative provisions allowing pharmacist prescriptive authority through collaborative practice agreements, standing orders, or statewide protocols. 34 Such collaborative models often occur between pharmacists and physicians and permit prescriptive authority to pharmacists to initiate, adjust, or discontinue medications for specific medical conditions per an agreed-upon protocol or current clinical practice guidelines. 35 This approach is also evidence-based as it has been used in randomized trials demonstrating the effectiveness of physician-pharmacist collaborative models for HTN. 8 , 30 Expansion of prescriptive authority for pharmacists could increase access for those with limited or no source of primary care, which disproportionately affects males, underrepresented minorities, the uninsured, and those living in the southern US. 36

While pharmacists may participate in collaborative models, pharmacists are infrequently recognized by payers because they are not recognized clinicians under the Social Security Act. Pharmacists can bill for services incident to those provided by a physician or advanced practice clinician; however, this is limited to Level 1, which is only $23.10 for 5 minutes of clinical services and insufficient for the level of service provided. 37 Our analysis showed that a pharmacist-prescribing intervention would remain cost-effective if pharmacists received a hypothetical reimbursement of $100 for the initial visit and $50 for each follow-up. While some states have recently passed clinician status legislation, much work remains to ensure pharmacists are adequately compensated for the clinical services they provide.

This study had limitations. The cost savings assume a 50% uptake of the intervention, and the savings magnitude depends on uptake. However, if pharmacists are appropriately incentivized through adequate reimbursement for providing the service, this level of uptake is likely an underestimate. Another assumption is that BP control did not change in the comparator group, and a proportion of patients in the comparator group may have improved BP control with usual care. Further, the proportion of patients with uncontrolled HTN continues to rise and has only worsened because of the COVID-19 pandemic. These findings cannot be generalized to other populations with HTN (eg, pregnancy), and we were unable to determine how alternative delivery methods (eg, telehealth) would impact the cost-effectiveness of this model.

This economic analysis suggests that pharmacist-prescribing interventions are cost-effective, result in significant estimated savings for the health care system, and are economically dominant. Assuming a 50% adoption rate, pharmacist-prescribing interventions would save an estimated $10 162 per person over a 30-year time horizon with cumulative population-level savings of more than a trillion dollars. The necessary tools (eg, collaborative practice, treatment algorithms) and resources (eg, patient access to community pharmacies) are readily available to implement pharmacist-prescribing interventions across the US; however, reimbursement limitations remain a barrier.

Accepted for Publication: September 24, 2023.

Published: November 3, 2023. doi:10.1001/jamanetworkopen.2023.41408

Open Access: This is an open access article distributed under the terms of the CC-BY License . © 2023 Dixon DL et al. JAMA Network Open .

Corresponding Author: Dave L. Dixon, PharmD, Department of Pharmacotherapy and Outcomes Science, Center for Pharmacy Practice Innovation, Virginia Commonwealth University School of Pharmacy, 410 N 12th St, Box 980533, Richmond, VA 23298-0533 ( [email protected] ).

Author Contributions: Drs Dixon and Johnston had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis.

Concept and design: Dixon, Johnston, Marra, Tsuyuki.

Acquisition, analysis, or interpretation of data: Dixon, Johnston, Patterson, Tsuyuki.

Drafting of the manuscript: Dixon, Johnston.

Critical review of the manuscript for important intellectual content: Dixon, Patterson, Marra, Tsuyuki.

Statistical analysis: Johnston.

Administrative, technical, or material support: Dixon, Marra.

Supervision: Dixon, Tsuyuki.

Conflict of Interest Disclosures: Dr Dixon reported receiving personal fees from Mercatus Center during the conduct of the study and receiving grants from Boehringer Ingelheim outside the submitted work. Dr Johnston reported receiving funding from the Canadian Pharmacists association outside the submitted work. Dr Patterson reported receiving honoraria from Mercatus Center during the conduct of the study and working at the National Pharmaceutical Council outside the submitted work. Dr Tsuyuki reported receiving grants from Merck, Sanofi, AstraZeneca, and Pfizer and being the President of Hypertension Canada and the editor-in-chief of the Canadian Pharmacists Journal outside the submitted work. No other disclosures were reported.

Funding/Support: The Mercatus Center at George Mason University commissioned this work with authors D.L.D. and J.P.

Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Data Sharing Statement: See Supplement 2 .

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• Published: 30 March 2000

A systematic review of patient information leaflets for hypertension

• DA Fitzmaurice 1 &
• JL Adams 1  

Journal of Human Hypertension volume  14 ,  pages 259–262 ( 2000 ) Cite this article

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Metrics details

Objective : To review patient information leaflets on hypertension to determine the quality of information currently available to patients.

Design and setting : A standardised systematic rating of patient information leaflets for hypertension in the UK.

Main outcome measure : A quality score per leaflet based on a pre-determined rating scale. using recognised criteria with marks allocated for content, writing style, readability and design.

Results : Sixty-one leaflets were received, 42 from the Internet and 19 from other sources. Leaflets could achieve a maximum of 84 points. Scores ranged from 30 to 70 for non-Internet leaflets and 28 to 67 for Internet leaflets. Leaflets produced by Boeringer Ingelheim for the British Hypertension Society and Greenlines Publishing (with a medical education grant from Knoll Ltd) scored highest overall. A detailed analysis of the non-Internet leaflets showed that few leaflets contained the full range of information considered important though most should be readable by the majority of the adult population and are written using appropriate language and typeface.

Conclusion : High quality information is available for patients, though some leaflets fall below an adequate standard. Professionals providing advice to patients should have some knowledge of what constitutes good quality information and be critical of the resources they use. Ideally surgeries and clinics should stock a range of the best information available so that patients can chose the leaflet most appropriate to their needs.

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Department of General Practice, Division of Primary Care, Public and Occupational Health, University of Birmingham, Edgbaston, Birmingham, B15 2TT, UK

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Fitzmaurice, D., Adams, J. A systematic review of patient information leaflets for hypertension. J Hum Hypertens 14 , 259–262 (2000). https://doi.org/10.1038/sj.jhh.1001003

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Received : 22 July 1999

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Published : 30 March 2000

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DOI : https://doi.org/10.1038/sj.jhh.1001003

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• Published: 06 November 2023

Constipation as a cause of lumboperitoneal shunt dysfunction in a patient with idiopathic intracranial hypertension

• Nida Kalyal 1 ,
• Anca-Mihaela Vasilica   ORCID: orcid.org/0000-0002-4031-8684 2 ,
• Harutomo Hasegawa 1 ,
• Florence Rose Hogg 1 ,
• Mohamed Mahdi-Rogers 3 ,
• Eoin O’Sullivan 4 &
• Bassel Zebian 1  

Acta Neurologica Belgica ( 2023 ) Cite this article

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Department of Neurosurgery, King’s College Hospital, London, UK

Nida Kalyal, Harutomo Hasegawa, Florence Rose Hogg & Bassel Zebian

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Anca-Mihaela Vasilica

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Eoin O’Sullivan

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The study was conceptualised by NK and BZ. Material preparation and data and image collection were performed by NK, HH, FHR, MMR, EO, AMV, and BZ. The first draft of the manuscript was written by NK, and all authors reviewed and edited the final version of the manuscript prior to submission.

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Kalyal, N., Vasilica, AM., Hasegawa, H. et al. Constipation as a cause of lumboperitoneal shunt dysfunction in a patient with idiopathic intracranial hypertension. Acta Neurol Belg (2023). https://doi.org/10.1007/s13760-023-02410-y

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Received : 25 July 2023

Accepted : 16 October 2023

Published : 06 November 2023

DOI : https://doi.org/10.1007/s13760-023-02410-y

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