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Table of Contents
REVIEW ARTICLE
Year : 2020  |  Volume : 10  |  Issue : 2  |  Page : 56-74

Twenty-four-hour blood pressure management in India: A position statement by Indian College of cardiology


1 Director and Senior Interventional Cardiologist, Lakshmi Hospital, Palakkad, India
2 Cardiology, Sri Jayadeva Institute of Cardiovascular Sciences and Research Hospital, Bangalore, India
3 Professor of Cardiology, Apollo Hospitals, Delhi, India
4 Senior Consultant cardiologist, Sir Ganga Ram Hospital, New Delhi, India
5 Department of Cardiology, Medical College, Kolkata, India
6 Senior Interventional Cardiologist at Woodlands Hospital and Sri Aurobindo Seva Kendra in Kolkata, Kolkata, India
7 Consultant Interventional Cardiologist and Electrophysiologist, Frontier Lifeline Hospital, Chennai, India
8 Director and Head, Non-invasive Cardiology, Fortis Escorts Heart Institute, New Delhi, Senior Consultant Cardiologist, India
9 Senior Consultant Cardiologist, Peerless Hospital and B K Roy Research Centre, Kolkata, India
10 Department of Medicine and Cardiology, Dr. D.Y Patil University, Navi Mumbai, India
11 Department of Cardiology, Apollo Hospitals, Chennai, India
12 Senior Consultant, Interventional Cardiologist, Apollo Hospitals, Bangalore, India
13 Senior Cardiologist, Interventional and Electrophysiology, Sir Ganga Ram Hospital, New Delhi, India
14 Non Interventional Cardiology, Fortis Escorts Heart Institute, New Delhi, India
15 Rtd. Professor and Head, Medical College, Kolkata, India

Date of Submission09-Apr-2020
Date of Decision22-May-2020
Date of Acceptance31-May-2020
Date of Web Publication25-Sep-2020

Correspondence Address:
Dr. P B Jayagopal
Lakshmi Hospital, Chittur Road, Palakkad, Kerala 678 013
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/JICC.JICC_18_20

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  Abstract 


Blood pressure (BP), even in healthy normotensive individuals, is dynamic, varies with a circadian periodicity, and is influenced by physiological and environmental factors. Abnormal 24-h BP patterns have been observed in many patients with hypertension (HTN), which may be overlooked if evaluations are based only on office BP measurements. Out of office BP measurements, such as Ambulatory Blood Pressure Monitoring and Home Blood Pressure Monitoring (ABPM and HBPM) is important for optimal BP management and are better predictors of adverse outcomes. However, HTN diagnosis and management are often based on relatively few clinic BP measurements, and there are no recommendations to guide clinicians managing patients with abnormal 24-h BP patterns in India. Thus, the present consensus statement aims to provide uniform evidence-based recommendations for the diagnosis and management of abnormal 24-h BP patterns. Strategies for screening for HTN based on the current prevalence trends in India have been suggested. Further, recommendations on the appropriate use of ABPM and HBPM in diagnosis and management of HTN are provided.

Keywords: Ambulatory blood pressure monitoring, blood pressure variability, home blood pressure monitoring, hypertension management, masked hypertension, morning surge, nocturnal hypertension, white-coat hypertension


How to cite this article:
Jayagopal P B, Srinivas B C, Raghu T R, Khanna N N, Srinivas K H, Manchanda S C, Guha S, Ray S, Thomas JM, Srivastava S, Roy DG, Shetty SR, Sathyamoorthy I, Ravindranath K S, Navasundi GB, Mantri R R, Jain P, Khan AK. Twenty-four-hour blood pressure management in India: A position statement by Indian College of cardiology. J Indian coll cardiol 2020;10:56-74

How to cite this URL:
Jayagopal P B, Srinivas B C, Raghu T R, Khanna N N, Srinivas K H, Manchanda S C, Guha S, Ray S, Thomas JM, Srivastava S, Roy DG, Shetty SR, Sathyamoorthy I, Ravindranath K S, Navasundi GB, Mantri R R, Jain P, Khan AK. Twenty-four-hour blood pressure management in India: A position statement by Indian College of cardiology. J Indian coll cardiol [serial online] 2020 [cited 2020 Oct 27];10:56-74. Available from: https://www.joicc.org/text.asp?2020/10/2/56/296119




  Introduction Top


In healthy individuals, many biological processes such as heart rate and blood pressure (BP) display an endogenously regulated 24-h pattern, known as a circadian rhythm. Although the rhythmic changes in BP represent a normal physiological phenomenon, several reports have demonstrated that cardiovascular (CV) and cerebrovascular events occur with a circadian periodicity and coincide with the periods of elevated BP.[1] Abnormal 24-h BP patterns are closely correlated with and have been shown to be an independent risk factor for mortality, CV events, and end-organ damage.[2],[3]

Normal circadian rhythm of blood pressure

The rise (during the daytime) and the fall (during night-time) in BP levels over the 24-h period are generally synchronized with the body's sleep-wake cycle and help an individual to adapt to higher activity levels during wakefulness.[4],[5] The circadian pattern of BP is regulated by intrinsic neurohormonal mechanisms, primarily the sympathetic activity, and influenced by extrinsic factors such as physical activity, stress, stimulant or other medication use, light/dark cycle, and temperature.[6] Other factors reported to regulate the 24-h BP pattern include the circadian rhythm-related hormones and regulatory mechanisms, pain modulators, and renal-hemodynamic effects.[6]

It is well known that in normal healthy individuals, arterial BP is lower by ~10%–20% during sleep (at night-time), commonly referred as night-time BP dipping.[7] The BP increases steadily during preawakening hours (typically between 3:00 am and 6:00 am) with a sudden and rapid elevation of up to 45 mmHg, upon awakening, a phenomenon known as the morning BP surge [Figure 1].[4] The timing of nocturnal BP dipping and morning surge may, however, vary depending on the individual's sleep-wake cycle. For example, in night-shift workers, the timing of “nocturnal” dipping and “morning” surge was shifted to synchronize with the sleep-wake cycle on the 1st day of the night shift.[1],[8]
Figure 1: Normal circadian rhythm of blood pressure. Figure represents the normal circadian pattern of blood pressure, i.e., changes in blood pressure observed in normotensive individuals over a 24-h period. The normal circadian pattern is characterized by a ~10%–20% dip in blood pressure at night-time (nocturnal dipping) followed by a sharp rise in blood pressure in the early morning hours (morning blood pressure surge), which typically coincides with the individual's time of awakening

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Adverse CV events that have been shown to coincide with the early morning surge, even among normotensive individuals, include sudden cardiac death, myocardial infarctions, angina pectoris, myocardial ischemia, and ischemic stroke.[9],[10],[11] Meta-analyses, including >10,000 patients from studies that evaluated the timing of CV events, showed that the risk of sudden cardiac death, myocardial infarction, and stroke events occurring in the morning (between 6:00 am to noon) was increased by 29%, 40%, and 49%, respectively, compared to the rest of the day.[9],[12],[13] Night-time BP values are now recognized as an important aspect of the BP profile, and abnormal nocturnal dipping patterns are associated with increased risk of mortality and target organ damage.[14],[15] Further, BP is a dynamic variable that reflects the changes occurring in the body in response to internal (including physical, emotional, sleep, and neurohumoral) and environmental stimuli over seconds to years. These fluctuations in normal BP are referred to as BP variability (BPV), which is known to be an independent predictor of hypertensive target organ damage and CV events.[16],[17]

Rationale and objectives

Currently, there is an established linear relationship between higher mean values of BP measured in office/clinical setting (office BP [OBP]) and worsening CV and renal outcomes; however, there is a growing body of evidence that suggests that out-of-office BP measurements (OOBPMs), using home BP monitoring (HBPM) and Ambulatory Blood Pressure Monitoring (ABPM) may be better predictors of morbidity and mortality associated with hypertension (HTN), compared to isolated OBPMs.[18],[19] Moreover, compared to normal ambulatory BP, elevated ambulatory 24-h BP values are reported to be more closely correlated with higher risk of new-onset HTN, diabetes, and CV events and an unfavorable metabolic profile.[20] Abnormal BP patterns such as Exaggerated Morning Blood Pressure Surge (EMBPS) and lack of a normal nocturnal BP dip have been shown to be associated with increased incidence of stroke, heart failure, and other CV events.[21] Further, BPV is also an independent source of prognostic information in hypertensive patients.[18] The need for assessing BP variance becomes even more evident when analyzed in light of the fact that in some high-risk hypertensive patients, CV outcomes may not improve substantially even when mean BP values are maintained within physiological limits, using BP-lowering therapy.[22] In addition, BPV may contribute to worsening end-organ damage and increased vascular events.[23],[24],[25] Therefore, the management of BP should aim at controlling average 24-h BP levels, restoring a normal circadian rhythm with appropriate nocturnal dipping and morning BP surge, and decreasing variation of BP levels over time. There is also a need to assess population-specific BP variance as differences have been observed in the patterns of BP variance between Caucasians and non-Caucasians. Compared to Westerners, Asians show a greater surge in morning BP and a steeper slope, which could be a plausible risk factor for the higher number of strokes observed in this population.[26]

Despite the current evidence indicating the importance of 24-h BP control for optimal management of HTN, diagnosis and treatment decisions are often based on relatively few OBPMs. Further, currently, in India, there is no specific recommendation/guidance to aid clinicians in managing patients with abnormal 24-h BP patterns. Thus, the present consensus statement aims to provide uniform evidence-based recommendations for the diagnosis and management of abnormal 24-h BP patterns. Strategies for screening for HTN based on the current prevalence trends in India have been suggested. Further, recommendations on the appropriate use of ABPM and HBPM in diagnosis and management of HTN are provided.


  Methodology Top


The guidelines included in this consensus statement were developed based on the published evidence, current national and international guidelines, and experiential learning of the expert panel. Available evidence from randomized trials, observational studies, meta-analyses, and critical reviews was reviewed, and the current Indian Hypertension Guidelines (IHG)-IV,[27] the European Society of Cardiology (ESC) and European Society of Hypertension (ESH) Guidelines for the management of arterial hypertension (ESC-ESH 2018),[28] and the American College of Cardiology (ACC)/American Heart Association (AHA) Clinical Practice Guidelines (ACC/AHA 2018)[29] were also referred. A National Consensus Steering Committee that included 18 key experts and thought leaders met twice in Hyderabad, India, between June 2019 and August 2019 and corresponded frequently over e-mails and conference calls, to discuss the available evidence and get a consensus for the guidelines. In addition, five regional meetings were organized to get inputs from 30 experts, from various Indian states, who comprised the National Development Committee. Recommendations passed with unanimous consensus from the National Consensus Steering Committee were included.

An electronic literature search was conducted in the databases of MEDLINE and Cochrane Library. The search strategy was developed by combining Medical Subject Headings and free-text keywords using Boolean operators (“OR” and “AND”): (HTN OR hypertension OR blood pressure) AND (variation OR variability) AND (24*hour OR 24*h). Articles from all clinical studies, reviews, systematic reviews, and meta-analysis were collected through June 2019, and no additional filters were used. The search was further intensified by performing a manual search of references from the relevant articles retrieved. As the primary goal is to provide evidence-based recommendations for the management of Indian patients, clinical data from studies conducted in the Indian population were given the highest priority. However, in case direct evidence from Indian studies were lacking, studies in the Asian populations were preferred as these may be relevant to Indian patients. Data from pertinent global studies were also included where appropriate.

The recommendations form a general guide to achieve 24-h BP control, especially in the Indian population. While treating an individual patient, the benefit–risk potential must be analyzed and the line of therapy should be administered based on involved decision-making with the patient.


  Screening for Hypertension and Hypertension-Related Complications Top


According to the Global Burden of Disease study, the high prevalence of HTN and HTN-related morbidity and mortality is a cause for concern globally.[30],[31] The prevalence of HTN (including high morning BP surge and nocturnal HTN) and HTN-related CV diseases (CVDs) is higher in Asian populations than in Western populations.[32] A systematic review of epidemiological studies in India has shown that the burden of HTN has been on the rise since the 1990s, with prevalence rates ranging from 25% to 42% in urban areas and 10% to 20% in rural areas.[33],[34],[35],[36] Reports suggest an increase in the incidence of CVDs in India, which is primarily attributed to uncontrolled HTN.[27],[37] Further, an incremental trend in HTN prevalence has been observed among younger adults and in rural areas,[34],[38] primarily attributed to rapid urbanization and the consequent lifestyle changes (e.g., sedentary lifestyle, high dietary salt intake, and consumption of high-sugar and high-fat diet) and increase in prevalence of obesity.[27],[36],[39] A cause for greater concern is the fact that many patients with HTN remain uncontrolled despite treatment or are unaware of their condition.[40]

The recent IHG-IV recognizes that HTN in India is characterized by few special features, such as an earlier onset, clustering of multiple CV risk factors, rising average BP in general population, significant seasonal variations, and low rates of awareness, treatment, and control.[27] Therefore, HTN screening and treatment strategies should be designed considering these characteristics of HTN in India [Box 1].



HTN is an important risk factor for developing CVDs including coronary disease, left ventricular hypertrophy (LVH), valvular heart diseases, cardiac arrhythmias, stroke, and renal failure.[41] In 2015, HTN led to 1.6 million deaths (>100% increase since 1990) and 33.9 million disability-adjusted life years in India.[42],[43] Early detection of CV complications could help prevent or delay adverse outcomes in patients with HTN. Patients with HTN and comorbid kidney disease often experience further progression of kidney disease; conversely, patients with chronic kidney disease (CKD) develop HTN and hence adverse outcomes at an earlier stage.[44],[45] It is recommended to screen for and initiate the management of renal complications early during the course of the disease in patients with HTN.[46]

Early diagnosis is crucial for the management of BP, and timely intervention can help prevent or delay adverse outcomes. However, in addition to the growing burden of HTN, clinicians face several challenges in diagnosis and management of hypertensive patients in India:

  • Lack of understanding/awareness regarding the condition among patients and caregivers
  • Contemporary diagnostic techniques such as ABPM are not widely available or utilized
  • There is a paucity of studies evaluating the prevalence and impact of various abnormal ambulatory BP patterns.



  Assessment of 24-H Blood Pressure Top


Office blood pressure measurement

Rational management of HTN can be performed by accurate measurement of BP. In office setting, validated and standardized auscultatory or oscillometric semiautomatic or automatic sphygmomanometers are the preferred options for the measurement of BP.[47] Use of mercury sphygmomanometers is not recommended due toxic effect of mercury on patients as well as the environment.[27] The recommendations for appropriate measurement of BP in the clinic are summarized in [Figure 2].
Figure 2: Recommendations for office BP measurement. To obtain accurate BP measurements in office, patients should be asked to remain seated for at least 5–10 min before measurement of BP with a validated semiautomatic/automatic, auscultatory, or oscillometric sphygmomanometers. While taking the reading, patients should be seated with their back erect and supported, feet placed flat on the ground, and arms supported at heart level. An appropriate-sized cuff should be secured above the patient's elbow. The BP should be measured by a nurse, physician assistant, or other trained personnel. Take average of at least two readings measured 1–2 min apart. BP: Blood pressure

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Out-of-office blood pressure measurement

Although OBPM is a widely used and reliable method, it provides a single assessment under conditions that can influence the assessed parameter.[15] Several international guidelines recommend the use of OOBPM, majorly advocating the complementary use of HBPM and ABPM.[15],[28],[29],[48] The recommendations for BP measurement across Indian and international guidelines are summarized in [Table 1]. The current European and American guidelines as well as the IHG-IV recommend the use of OOBPM for diagnostic purposes.[27],[28],[29] The use of HBPM, and ABPM if necessary, for diagnosing HTN, allows differentiation between patients with white-coat HTN (WCH), masked HTN (MH), or sustained HTN.[15],[28] The results from the recently concluded India ABPM Study showed that a large number of patients were unaware of their condition or had been misdiagnosed;[49] these observations support the use of OOBPM in the diagnosis and management of HTN in India.
Table 1: Blood pressure measurement-related recommendations across international guidelines

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Ambulatory blood pressure monitoring

Ambulatory BP monitors allow the measurement of BP at regular intervals (~15–30 min) for a period of 24–48 h, providing accurate estimation of daytime and night-time BP. Few studies have also demonstrated 24-h ABPM to be more accurate than OBPMs in predicting CV morbidity and mortality.[50],[51],[52] Further, elevation in the mean ambulatory 24-h BP is strongly associated with CV and stroke events. Owing to the greater number of readings, elimination of digit preference, and observer bias, ABPM offers a valuable tool for evaluating efficacy and response to drug treatment.[53] Thus, ABPM serves as one of the best clinical tools to diagnose HTN and also predict organ damage.

The use of ABPM in the Indian population has been limited. ABPM was successfully performed in Indian children with CKD (n = 46).[54] Similar to the published literature, there was a high prevalence of Ambulatory Hypertension, in 90% children on dialysis. Nocturnal Hypertension was especially prevalent in this study. Of note, although 74% of the study subjects were known to be hypertensive, ABPM revealed that almost half of them had inadequate BP control. The diagnosis of HTN was missed in seven out of 13 children with LVH when clinic BP alone was used to diagnose HTN, and HTN could be detected with ABPM.[54] This study demonstrated that ABPM is feasible in the Indian setting and also contributes significantly to improve diagnosis and management of HTN. Recently, the India ABPM Study compared HTN diagnosis using OBPM and ABPM in 27,472 patients visiting primary care physicians.[49] The results revealed that >30% of the participants had WCH or MH and were misdiagnosed if only OBPM was to be used.[49] The evidence strongly supports the use of OOBPM for accurate HTN diagnosis in Indian patients [Box 2]/[Box 3]. The IHG-IV recommends the use of ABPM as it is a better predictor of CV events, although its application in routine practice may be limited due to the high cost.[27]



Validated Ambulatory Blood Pressure Monitoring devices are generally safe to use. Occasionally, petechiae of the upper arm or bruising under the inflating cuff may occur, and there may be sleep disturbances also. The parameters for assessing validity and limitations of ABPM are summarized in [Table 2].
Table 2: Ambulatory blood pressure monitoring: Indications, parameters for assessing validity, limitations

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Home blood pressure monitoring

The current Indian and international guidelines recommend the use of HBPM to measure BP at home to obtain reliable BP values.[27],[28],[29],[48] It is a useful and dependable measure of BP, which can be used as an adjunct to the more common and standardized methods, such as OBPM and ABPM. The HBPM is also a useful and convenient tool for predicting target organ damage and CV mortality and events.[56],[57] Given that HBPM offers more accurate BP measurements over multiple days at relatively low cost, a recent consensus document developed by experts in HTN across India recommends HBPM for routine management of HTN.[58] Further, the IHG-IV recommends using HBPM as a complimentary tool to clinic BP reading for diagnosis of HTN and follow-up.[27] The limitations of HBPM are listed in [Table 3].
Table 3: Home BP monitoring: Indications and limitations

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  Abnormal 24-H Blood Pressure Patterns Top


Monitoring 24-h BP patterns helps identify specific forms of HTN, which may be broadly classified as daytime and night-time HTN.[60] Isolated systolic, isolated diastolic, and systolic and diastolic HTN are the most commonly observed forms of daytime HTN. Other abnormal daytime BP patterns include WCH (characterized by elevated OBP/clinic systolic BP [SBP] ≥140 mmHg and/or ≥90 mmHg diastolic BP [DBP] with normal BP outside the clinic) and siesta dipping/postprandial hypotension.[60] The clinical importance of night-time BP measurements (during sleep) is also well recognized.

Exaggerated morning blood pressure surge

Morning hours of the day is critical since most changes in the physiological system occur during this time, and major CV events, such as myocardial infarction, sudden death, or stroke, are more likely to occur during the early hours of the day, making monitoring of morning BP patterns extremely critical [Box 4].[61] An EMBPS is an indication of increased CV risk and target organ damage.[10],[32] Despite the surge in morning BP not being linearly associated to mean BP values, it is significantly related to an increase in the incidence of stroke.[5] Further, the EMBPS is potentiated by synergistic resonance of different components of BPV, which are also considered responsible for the increased risk of CV events.[26] Morning BP values monitored at 06:00 am have shown that variation in BP during the morning is associated with target organ damage and has a statistically significant correlation with left ventricular mass index, brachial–ankle pulse wave velocity, and carotid intima-media thickness (P < 0.001 for all), in addition to impact on N-terminal pro-B-type natriuretic peptide urinary albumin: creatinine ratio (P < 0.01 for both).[62]



In Japanese patients with HTN, sleep-trough morning BP surge (STMS) (≥55 mmHg) was associated with a 2.7 times increased incidence of stroke.[63],[64] In addition, patients with STMS (≥40 mmHg) were at a higher risk of all-cause mortality, and composite of CV death, nonfatal myocardial infarction, nonfatal stroke, and heart failure.[64] Hypertensive patients with an STMS rate ≥11.3 mmHg/h were at a significantly high risk of all-cause mortality and CV mortality as compared with patients with an STMS rate of <11 mmHg/h (all-cause mortality: Heart Rate, 1.666; 95% confidence interval [CI], 1.185–2.341; P = 0.0033; CV mortality: HR, 2.608; 95% CI, 1.554–4.375; P = 0.0003).[65]

In addition to CV events, EMBPS is associated with complications among patients with diabetes. An Asian study evaluating the impact of EMBPS on diabetic patients from Iran showed that increased STMS was associated with neuropathy (0.023).[66] Poor glycemic control and insulin resistance among diabetic patients are associated with EMBPS. A study including 122 patients with diabetes showed that 88.5% of the patients had EMBPS. The study further showed a negative correlation of EMBPS with flow-mediated dilation to a significant extent (P = 0.03).[67]

Nocturnal dipping patterns: Extreme dipping, nondipping, and rising/reverse dipping

Nocturnal dipping phenomenon, defined as a decrease in night-time SBP of 10%–20% from daytime BP, represents a normal physiologic change. However, extreme dipping, nondipping, and rising or reverse dipping represent abnormal nocturnal BP patterns, which are associated with higher risk of stroke and CV events.[60],[69] The IHG-IV recommends OOBPM for evaluating abnormal nocturnal dipping BP patterns.[27] The ratio of day-time and night-time BP that is used to define various nocturnal dipping patterns is described in [Table 4]. Abnormal nocturnal dipping patterns are also known to be associated with end-organ damage.[70] Further, nondipping and sleep-related rising BP patterns are reported to be associated with increased all-cause mortality.[71] An important finding from the India ABPM Study was that many patients (~12%) had isolated night-time HTN and most of these patients had normal 24-h ABPM values.[49] Therefore, nocturnal BP should be evaluated and taken into considerations when managing Indian patients with HTN [Box 5].
Table 4: Estimation of dipping pattern on the basis of daytime and night-time blood pressure values

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Obstructive sleep apnea and hypertension

Obstructive sleep apnea (OSA) is characterized by recurrent periods of complete or partial collapse of the upper airway during sleep, which leads to sleep disturbances.[72] Elderly women, prehypertensive subjects, primary care patients, patients with a history of spinal cord injury and stroke are at a higher risk of experiencing concurrent OSA and HTN.[73] The incidence of OSA is common among HTN patients, with prevalence rates of up to 14% reported in Indian patients with HTN.[74] A questionnaire-based study conducted in the southern part of India reported that hypertensive patients were at a significantly high risk of experiencing OSA (odds ratio: 11, 95% CI: 4.3, 28.2).[75]

In the presence of OSA, a rise in BP occurs due to sympathetic overactivity, systemic inflammation, oxidative stress, endogenous vasoactive factors, and endothelial dysfunction. Exaggerated sympathetic activity among patients with OSA causes vasoconstriction, leading to HTN.[76],[77],[78] Further, the presence of OSA among hypertensive patients is associated with CV events such as congestive heart failure, ischemic heart disease, and arrhythmias.[79]

Improvement in OSA outcomes such as breathing pause, tiredness after sleeping, wake time tiredness, snoring frequency, and snoring loudness has been reported in hypertensive patients with OSA treated with continuous positive airway pressure; however, the study did not evaluate the effect on BP.[80] Considering that the management of HTN is challenging in patients with OSA, antihypertensive treatment is often not sufficient to control HTN among OSA patients [Box 6]. The use of continuous positive airway pressure ventilation has shown a positive impact and is recommended for the management of patients with OSA.[81],[82]




  Blood Pressure Variability Top


BPV is defined as the standard deviation (SD) or coefficient of variation of beat-to-beat BP obtained by intra-arterial monitoring for 24 h or noninvasive ABPM/HBPM achieved over a period.[83],[84] The BPV is associated with increased risks for CVD and target organ damage. Studies have shown that increased short-term (24-h BPV) and long-term BPV presents higher risk of CV events and target organ damage in hypertensive patients.[85],[86] Therefore, reduction of BPV offers a novel strategy for optimal HTN management and may prevent or delay progression of target organ damage [Figure 3] [Box 7].
Figure 3: Therefore, reduction of BPV offers a novel strategy for optimal HTN management and may prevent or delay progression of target organ damage (Figure 3). ABPM: Ambulatory blood pressure monitoring, Arterial hypertension (AHT), BP: Blood pressure, BPV: Blood pressure variability, eGFR: Estimated glomerular filtration rate, ESRD: End-stage renal disease, HBPM: Home blood pressure monitoring

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Very short-term blood pressure variability

A beat-to-beat variability in BP is referred to as very short-term BPV. The primary mechanisms contributing to this are baroreceptor reflex and humoral response. The assessment of very short-term BPV requires continuous BP monitoring generally using a noninvasive finger cuff device equipped with an infrared photoplethysmograph.[24] Although newer noninvasive devices are being developed that may facilitate measurement of beat-to-beat BPV in ambulatory patients, currently, this parameter is generally measured in laboratory setting only.

Short-term or 24-h blood pressure variability

The variations in BP that occur over 24 h in response to physical and emotional stimuli and sleep are termed as short-term BPV. Several mechanisms including neural, humoral, vascular, rheological, environmental, behavioral, and emotional contribute to 24-h BPV. Continuous monitoring by ABPM is used for assessing short-term BP fluctuations within a day (24 h).[24]

Mid-term blood pressure variability

Mid-term BPV refers to day-to-day variations in BP, which was identified during HBPM studies and found to be associated with increased prevalence and severity of target organ damage and risk of fatal and nonfatal CV events.[87],[88],[89] The results from the Ohasama Study and the Finn-Home Study suggest that day-to-day BPV has prognostic value and increased variability is associated with higher risk of CV events and mortality in patients with HTN.[88],[89] Day-to-day variations in BP can be assessed using HBPM, wherein BP is recorded over 5–7 days, or ABPM performed over 48 h.[24]

Long-term blood pressure variability

BP fluctuations occurring over a longer period such as over months, from visit to visit, and seasonally are termed as long-term BPV. In addition to biological factors, long-term BPV is also influenced by behavioral factors as differences in fluctuations in BP are observed during weekdays and weekends. In addition, factors such as poor treatment compliance by the patient or improper dosing/titration of the antihypertensive medication by the physician might also influence long-term BPV. Errors in BP measurement may also contribute to visit-to-visit variability. Seasonal variations, summer versus winter, may be influenced by differences in temperature and daylight hours.[90] Arterial stiffness, lower arterial elasticity, and reduced aortic dispensability may also contribute to long-term BPV. The HBPM can be used efficiently to measure day-to-day BPV. Visit-to-visit BPV assessment can be performed with repeated ABPM or HBPM.

Based on a meta-analysis,[91] the preferred indices might include SD for the clinic, visit-to-visit and home BPV, and average real variability, or SD (the “weighted” SD) for 24-h BPV. Although the SD method is one of the most reliable one, monitoring the nocturnal and day-time BP for the mean BP should be done cautiously owing to the greater fall of BP during night. Further, indices unaffected by day-to-night changes, such as ARV or weighted 24-h SD, may be preferred for CV risk estimation.[92]


  Masked and White-Coat Hypertension Top


Masked hypertension

MH, defined as normal OBP readings (<140/90 mmHg) and consistently elevated average out-of-office readings (average daytime ambulatory BP ≥135/85 mmHg),[94] remains under-treated if diagnosis is based only on OBP.[95],[96] There is a paucity of studies evaluating MH in India. Recently, the results from the large India ABPM Study were reported. In this study, OBPM and ABPM data were collected from >27,000 individuals visiting primary care physicians and nearly 20% of the participants were found to have MH.[49] Similar prevalence rates for MH (19%) were observed in different regions in the India ABPM Study.[49]

In treated patients, MH is referred to as masked uncontrolled HTN (MUCH). A prevalence of 32.1% MUCH was observed among treated HTN patients with well-controlled OBP.[97] There is a lack of data on MUCH in India. In the Asia BP@Home Study, among 1443 treated patients with HTN, 9% were reported to have MUCH.[98] The risk of target organ damage, CVD, CV-related mortality, stroke, and all-cause mortality in persons with MH or MUCH was shown to be equivalent to those with sustained HTN and greater than that in normotensive individuals and in those with WCH.[95],[99],[100],[101],[102],[103],[104] A higher prevalence of MUCH in men and patients with smoking history, diabetes, obesity, and long duration of HTN has been observed. Furthermore, nocturnal high BP versus elevated daytime BP was most often attributable to the presence of MUCH.[97]

An association between target organ damage leading to LVH, increased carotid intima media thickness and pulse wave velocity, and MH has been reported in the Finn-Home Study.[105] High prevalence of MH (30%–60%), changes in 24-h BP profile, and impaired night dipping are reported in CKD patients.[94] A prospective cross-sectional study conducted in children with stage 3 and 4 CKD (N = 46) in South India included ABPM assessment in addition to the casual BP. In this study, prevalence of confirmed HTN was 21.7%, MH was 19.6%, and LVH was 32.2%. An association between abnormal ABPM indices and the proportion of children with CKD with LVH was observed.[54] In another study from India, when potential kidney donors were evaluated by ABPM, 11.2% were detected with MH (awake ABPM: >130/90 mmHg, nocturnal BP: >120/80 mmHg, and OBP: <140/90 mmHg).[106]

Considering the high risk of CV, CKD, and target organ damage in these patients, decision regarding treatment regimens should be linked to the assessment of these diseases in individual patients. In addition, HBPM and ABPM should be utilized for early identification and diagnosis of MH [Box 8]. Although, the Finn-Home study suggested the superiority of HBPM to Clinic BP in predicting CVD risk, owing to the lack of night-time measurement, some MH patients could be misdiagnosed as normotensives.[107] Viera et al. demonstrated a prevalence of 51% (95% CI = 39%–62%) for MH in individuals with office SBP of 110–119 mmHg and that of 80% for persons with office SBP of 120–129 mmHg and 130–139 mmHg; a similar trend was observed for DBP >80 mmHg.[108] Although the cut-off of clinic SBP of 120 mmHg (and DBP 82 mmHg) was associated with the highest likelihood ratio of detecting MH, the false-positive rate (42%) was also high at this level. Hence, the decision to perform ABPM for patients with normal OBP should take into consideration the OBP level and other influencing factors.[108]



Both the ACC-AHA 2017 and ESC-ESH 2018 guidelines recommend diagnosis of MH with HBPM that should be further confirmed by ABPM.[28],[29] However, conducting ABPM/HBPM in all patients with normal OBP for confirmation of risk of MH is not feasible; hence, a threshold level (SBP/DBP >120/80 mmHg) is desirable. In addition to the OBP level, the presence or risk of CV, renal complications, and target organ damage should be taken into consideration to determine the need for evaluating MH using OOBPM.

White-coat hypertension

An elevated OBP measurement (OBPM, SBP ≥140/90 mmHg) in untreated individuals that is normal when measured by HBPM and ABPM is referred to as WCH.[95],[100],[109] The same phenomenon in patients being treated with antihypertensives is referred to as white-coat effect. In the large population-based study in India, WCH was observed in 12% of the patients evaluated using clinic and OOBPM.[49] In Western populations, a higher prevalence of WCH is reported among patients with high OBP (30%–40%) and among older people (>50%).[95],[101],[110] The prevalence of WCH is higher with increasing age, female sex, nonsmokers, and in the presence of a clinician.[29],[111] In patients with white-coat effect, an OBP 10 mmHg above goal should be followed-up with screening for white-coat effect with HBPM or ABPM.

A conversion from WCH to sustained HTN by ABPM and HBPM is observed in 1%–5% individuals per year.[109],[112] Further, another study has suggested that WCH leads to increased risk of developing sustained HTN.[113] A meta-analysis revealed that WCH was associated with a slight risk for CVD morbidity and mortality than normotensive persons, and this incidence of risk was lower than that observed in persons with sustained HTN.[114] While some consider WCH to be a benign condition, a study demonstrated that persistent WCH seen in the clinic was associated with higher CV and all-cause mortality risk than normotensive individuals.[115] Furthermore, an association of WCH for greater risk of developing conditions such as new-onset diabetes, clinic and ambulatory HTN, and LVH that increase CV risk has been observed.[104],[116] An increased incidence of dysmetabolic risk and subclinical organ damage has also been associated with WCH as compared with normotensive persons.[117] Increased BPV has also been noted in patients with WCH.[118],[119] A prevalence of 30% white-coat effect has been observed in CKD patients.[120] In a prospective, observational study conducted in patients with CKD attending nephrology clinic at a tertiary care center in India, a prevalence of 56.7% white-coat effect was observed when BP was measured by automated BP recorder.[121]

Misdiagnosis and mistreatment of WCH can lead to chronic treatment with antihypertensives, which have considerable side effects and add to the costs. Therefore, confirmation of WCH and white coat effect with HBPM and/or ABPM is essential [Box 9]. Lifestyle changes and regular follow-ups with OOBPMs are recommended in individuals with WCH.[28] Antihypertensive treatment (AHT) can be considered for WCH patients with greater CV risk, target organ damage, and abnormal OOBPMs or in those with persistent elevated BP.



Both the ACC 2017 and ESC 2018 have recommended that occurrence of MH and WCH should be investigated in patients with HTN and ABPM/HBPM should form the basis of therapeutic strategy decisions.[28],[29]


  Pharmacotherapeutic Treatment of 24-H Blood Pressure Top


Based on the current ESC/ESH and ACC/AHA guidelines [28],[29] and the subsequent report by Wander and Ram,[122] the present panel recommends initiating pharmacotherapy at 140/90 mmHg and at a lower threshold of 130/80 mmHg in high-risk patients. The recommended target BP is <130/80 mmHg for patients below 60 years and 130–140/80–90 mmHg in older patient (>60 years) [Box 10].[27]



A chronotherapeutic approach is recommended to achieve optimal 24-h BP control.[123] Key components of this approach include:

  1. Strategies to achieve sustained BP lowering over the 24-h period
  2. Maintain normal circadian BP pattern – appropriate morning BP surge and nocturnal dipping
  3. Strategies to decrease BPV
  4. Improving patient compliance.


Strategies for sustained blood pressure lowering over 24 h

Long-acting antihypertensive treatments

Agents with a longer half-life have a gradual onset and slower offset of action, resulting in an overall longer duration of action, which provides a greater therapeutic coverage.[124] Thus, long-acting antihypertensive agents provide sustained BP lowering, even at the end of the dosing interval. The sustained activity over longer duration allows for once daily dosing and may offset loss of BP control in case of a missed dose.[125],[126] Further, once-daily dosing regimen is associated with increased adherence, which results in improved efficacy and long-term clinical outcomes.[126] A comparison of the half-lives of available antihypertensive agents is presented in [Table 5]. Perindopril, telmisartan, amlodipine, bisoprolol, nebivolol, and chlorthalidone have the longest biological half-lives and hence may be preferred for achieving better 24-h BP control.
Table 5: Comparison of half-lives and trough/peak ratio of different antihypertensive agents[162]

Click here to view


Trough-to-peak ratio

The trough-to-peak (T/P) ratio is an index of how well the antihypertensive effect is sustained over the dosing interval.[127]



Antihypertensive agents with a T/P ratio closer to 100% show more uniform BP-lowering effect over the 24-h period.[126] The T/P ratios for commonly available antihypertensive agents are presented in [Table 5]. Candesartan, telmisartan, perindopril, amlodipine, and nebivolol have the highest T/P ratios and hence may be preferred for achieving better 24-h BP control.

Maintaining normal circadian rhythm

There is a paucity of Indian studies evaluating EMBPS and nocturnal HTN; hence, the recommendations are based on studies in Asian populations, where available, or global studies.

Choosing an antihypertensive agent to control exaggerated morning blood pressure surge

Although the routine OBP appears to be controlled with conventional AHT, morning BP remains uncontrolled in many patients.[128] Further, intensive therapy with a calcium channel blocker (CCB) or diuretic administered in the morning or an angiotensin receptor blocker (ARB) administered in the evening effectively reduced morning BP.[128] Thus, for achieving 24-h BP control, it is important to evaluate and manage EMBPS. One of the strategies to control EMBPS is using long-acting agents with high T/P ratio that provide 24-h coverage and hence lower the morning surge.[32] Studies show that different long-acting agents may have varying effect on 24-h BP. Amlodipine and telmisartan have been shown to better control EMBPS when compared to valsartan.[129],[130] An alternative approach is to use chronotherapeutic regimens with extended-release formulations and/or night-time dosing to effectively lower EMBPS.[131] Further, the renin-angiotensin-aldosterone-system (RAAS) has a physiologic influence on morning BP surge; hence, RAAS blockers may be effective in controlling EMBPS.[132],[133] Finally, in some cases, EMBPS may be attributed to treatment noncompliance; therefore, agents with a once-daily dosing regimen, which are associated with improved treatment compliance, should be preferred.

Strategies to address nocturnal hypertension

Kario reviewed the current evidence for management of 24-h BP and suggested that lowering nocturnal BP is critical for achieving good BP control over 24 h.[134] Patients should be evaluated for identifying uncontrolled nocturnal HTN (night-time BP >110/85 mmHg) after achieving morning home BP <130/80 mmHg. Dietary salt restriction and treatment with diuretics or mineralocorticoid receptor antagonists effectively reduce BP in patients with increased circulating volume.[134] On the other hand, CCBs, either as monotherapy or in combinations with RAAS blockers, are beneficial for patients with advanced vascular disease.[134] Further, timing of drug dosing may also play an important role in controlling nocturnal BP.

Results from the MAPEC trial showed that patients taking antihypertensive medication at bed-time have lower mean night-time BP, despite similar 24-h ambulatory BP, compared with those on morning dosing.[135],[136] Further, chronotherapeutic regimes are associated with reduced risk of adverse CV events and target organ damage, including in patients with renal dysfunction and diabetes and elderly patients.[137] Several studies and a systematic review that evaluated the effect of time of administration of antihypertensive drug (morning vs. evening) suggest that CCBs and diuretics should be administered in the morning, while evening dosing may be preferred for RAAS blockers and beta-blockers.[138],[139],[140]

Management of patients with blood pressure variability

In the Syst-Eur study, treatment with the CCB, nitrendipine, resulted in a modest but significant reduction in SD of both day-time (−1.5 mmHg) and night-time average SBP (1.1 mmHg).[141] Nitrendipine did not affect the coefficient of variation. In the landmark ASCOT-BPLA study, Visit to Visit Variability (VVV) was significantly lower and also decreased over time, with amlodipine treatment versus atenolol.[142] Further, this lower inter-individual VVV with amlodipine treatment was associated with a reduced risk of stroke and vascular events.[142] The beneficial effect of amlodipine treatment on BPV has been reported in randomized trials, including the large ALLHAT study involving 24,004 hypertensive patients.[143],[144] A retrospective study that compared BPV among hypertensive patients treated with amlodipine versus other CCBs in China showed that the patients in amlodipine group had better BPV control (diff [95% CI]: 0.86 [−1.26 to − 0.47], P < 0.05) as compared with other CCBs.[145] A study, comparing the effect of amlodipine versus valsartan on 24-h ambulatory BPV in treatment-naïve HTN patients in Japan, reported superior 24-h BPV control with amlodipine (including reduced maximum values of daytime and night-time SBP and DBP).[146]

In the X-CELLENT study, antihypertensive therapy with the long-acting diuretic, indapamide sustained release, was shown to significantly reduce VVV in SBP when compared to placebo or candesartan.[144] In the ALLHAT study, treatment with chlorthalidone showed similar reduction in VVV as observed with amlodipine over a period of 28 months.[144]

In a randomized trial that evaluated the effect of four beta-blockers on BPV, treatment with beta-blockers significantly reduced ambulatory day-time BP but increased coefficient of BP variation.[141],[147] A systematic review of the effect of various AHTs on BPV showed that while CCBs and diuretics reduced BPV, treatment with beta-blockers increased BPV in a dose-dependent manner.[148]

Choosing antihypertensive treatment based on available evidence

Efficacy and safety of most currently available antihypertensive agents have been evaluated in randomized controlled clinical studies. The benefits of different classes of antihypertensive agents with regard to 24-h BP control are summarized in [Table 6]. A summary of landmark trials by antihypertensive drug class is presented in [Table 7].
Table 6: Benefits of different classes of antihypertensive therapies

Click here to view
Table 7: Landmark trials for different classes of antihypertensive drugs

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Combination therapy for 24-h blood pressure management

Most patients with HTN require combination therapy with ≥2 agents to achieve sustained BP control. Current guidelines recommend initiating antihypertensive therapy with a combination of two drugs, either two separate pills or a fixed-dose single-pill combination, in patients with stage ≥2 or resistant HTN.[27],[28],[29] Combination therapy with a single-pill combination may improve speed, efficiency, and predictability of BP control. Further, initial low-dose combination therapy may be more effective and preferred over high-dose monotherapy.[28],[149]

It is reported that combination therapy with a CCB and an ARB or diuretic is significantly more effective in reducing BPV than other antihypertensive combinations.[150] Further, the combination of long-acting drugs, such as telmisartan-amlodipine, seems useful to buffer excessive BP fluctuations over a 24 h period, with their administration being characterized by the highest rating in the smoothness index.[151],[152],[153] Further, CCBs, as monotherapy or in combination with ARB, are more effective for daytime BP control while diuretics, both as monotherapy and in combination with ARB, are effective for reducing nocturnal BP.[26],[154] Thus, the preferred two-drug combinations include a RAAS blocker and CCB or diuretic.[27],[28] The combination of two RAAS blockers (e.g., telmisartan and ramipril) is not recommended as this is associated with increased adverse events without an increase in benefit as observed in the ONTARGET study.[155] A beta-blocker may be considered in a two-drug combination therapy regimen when there is a specific indication for beta-blocker use (e.g., angina, postmyocardial infarction, heart failure, or increased heart rate).

In nearly one-third of patients, BP remains uncontrolled despite treatment with two-drug combination therapy, and further, uptitration of treatment is required. In such patients, preferred three-drug combination comprises a RAAS blocker, a CCB, and diuretic.[27],[28] Spironolactone may be added to other antihypertensive agents in patients with resistant HTN, if not contraindicated.[28][174]

Acknowledgments

The authors thank members of the National Development Committee for their invaluable inputs

National Development Committee

Dr. Kajal Ganguly, Dr. Kartik Vasudevan, Dr. P. S. Mohanamurugan, Dr. P. Harikrishnan, Dr. Madanmohan, Dr. Manokar, Dr. T. R. Muralidharan, Dr. Krishna Moorthy, Dr. K. P. Pramod Kumar, Dr. Bhaskar Shah, Dr. Mukesh Parikh, Dr. Hetan Shah, Dr. Vidya Suratkal, Dr. Harish Bajaj, Dr. Akshay Mehta, Dr. Nirmal Jain, Dr. V. T. Shah, Dr. Ashok Punjabi, Dr. M. Vishwanathan, Dr. Dhiren Shah, Dr. Kaushal Chatrapati, Dr. Ripen K. Gupta, Dr. Amar Singhal, Dr. V. K. Chopra, Dr. Aseem Dhall, Dr. Sibananda Dutta.

Writing assistance was provided by Jyothi Ramanathan, PhD, and additional editorial support was provided by Sangita Patil, PhD, CMPP (both SIRO Clinpharm Pvt. Ltd., Thane, India). We thank Dr. Mohammed Yunus Khan Hukkeri (Dr. Reddy's Laboratories) for providing valuable inputs additional guidance and editorial support during the development of this manuscript.

Financial support and sponsorship

Funding for this position statement was provided by Dr. Reddy's Laboratories.

Conflicts of interest

There are no conflicts of interest.



 
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