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Abstract

Adverse drug reactions (ADRs) pose significant challenges to the healthcare system and the quality of life of hypertensive patients. This prospective observational cohort study aims to evaluate the incidence, severity, and types of ADRs among hypertensive patients receiving anti-hypertensive therapy in a tertiary care hospital in Rajasthan. We recruited 222 hypertensive patients and monitored them at baseline, 24 hours, 7 days, and 30 days. The study found that 44% of participants experienced ADRs, with 7?ing severe, 25% moderate, and 68% mild. The most common ADRs were associated with ARBs (45%), followed by diuretics (25%) and CCBs (21%), with hyperkalemia and angioedema being the most frequently reported ADRs. These findings underscore the need for meticulous monitoring and patient education to mitigate ADRs in hypertensive patients.

Keywords

Hypertension, Adverse Drug Reaction, Drug Therapy Problem.

Introduction

Hypertension, a prevalent cardiovascular condition affecting over 1.13 billion people worldwide, significantly increases the risk of heart disease, stroke, and kidney failure (Schutte et al., 2022). Effective management of hypertension involves the use of various anti-hypertensive drugs, each with potential ADRs that can impact patient adherence and overall health outcomes (Passerela et al., 2018). Understanding and managing these ADRs is crucial for optimizing treatment and improving patient quality of life. The WHO-UMC system and the modified Hartwig and Siegel scale are pivotal in assessing and categorizing ADRs, thus ensuring standardized and reliable evaluations (Uppsala Monitoring Centre) (Cureus). Anti-hypertensive drugs, including angiotensin receptor blockers (ARBs), calcium channel blockers (CCBs), beta-blockers, and diuretics, are commonly prescribed to manage blood pressure. However, these medications can cause a range of ADRs, from mild to severe, affecting patient compliance and increasing healthcare costs (Liu et al., 2021). Recent studies highlight the need for vigilant monitoring of ADRs to balance the therapeutic benefits of anti-hypertensive drugs against their potential risks. Addressing these ADRs involves a systematic approach encompassing patient history reviews, clinical monitoring, collaborative efforts with healthcare providers, and robust documentation practices. This study aims to provide a comprehensive assessment of ADRs in hypertensive patients, examining the incidence, types, and severity of reactions, and to propose systematic approaches for managing these ADRs effectively.

Methods:

This prospective observational cohort study was conducted at Ananta Institute of Medical Science and Research Centre, Rajsamand, Rajasthan. All diagnosed hypertensive patients, both inpatient and outpatient, receiving treatment were included, except for pregnant women and patients below 18 years. Ethical clearance was obtained from the ethical committee of the institute. Data were analyzed using SPSS version 23 and Microsoft Office Excel 365, with categorical data presented as percentages and quantitative data described using mean and standard deviation.

Result


Table 1: Socio-demographic characteristics of the study participants

Variables

Frequency (N = 222)

Percent (%)

Age range

 

 

20 – 29

3

1.4

30 – 39

7

3.2

40 – 49

40

18.0

50 – 59

58

26.1

>60

114

51.4

Mean ± SD

59.5 ± 11.85

 

Sex

 

 

Male

122

55.0

Female

100

45.0

Occupation

 

 

Retired/Housewife

147

66.2

Famers

42

18.9

Laborer/Others

33

14.9

Marital status

 

 

Married

173

77.9

Unmarried/Others

49

22.1

BMI

 

 

Normal

153

68.9

Obese

69

31.1

Duration of Treatment

 

 

Newly Diagnosed

71

32.0

< 1>

84

37.8

1-5 years

67

30.2


A total of 222 patients participated in the study, with a mean age of 59.5 ± 11.85 years. The majority were over 60 years old (51.4%) and married (77.9%). Most participants were retired or housewives (66.2%), and 68.9% had a normal BMI. Newly diagnosed patients and those with less than one year of treatment comprised 69.8% of the cohort.


Table 2:  WHO causality assessment of ADRs (WHO, 2020).

Type of reaction

No. of Patients [98]

Percent (%)

Certain

24

24.5

Probable/likely

35

35.7

Possible

18

18.4

Unlikely

21

21.4

Conditional/Unclassifiable

-

-

Unassessable/Unclassifiable

-

-


Among the 222 participants, 98 patients (44%) reported experiencing ADRs. The WHO-UMC causality assessment categorized these reactions as certain (24.5%), probable/likely (35.7%), possible (18.4%), and unlikely (21.4%).


Table 3: Severity of reported ADRs by modified Hartwig and Siegel scale (Hartwig and Siegel, 1992).

Type of reaction

No. of Patients [98]

Percent (%)

Lethal

-

-

Severe

7

7.1

Moderate

24

24.5

Mild

67

68.4


Among the 98 patients with ADRs, 7.1% had severe reactions, 24.5% had moderate reactions, and 68.4% had mild reactions.


Table 4: Adverse Drug Reaction Reported

Class of Drug

Adverse events experienced

No. of Patient (98)

%

? Blockers

Bronchospasm

9

9.2

 

CCBs

Flushing

7

7.1

Palpitation

14

14.3

Ankle swelling

4

4.1

 

ARBs

Dizziness

4

4.1

Hyperkalemia

18

18.4

Angioedema

18

18.4

 

 

Diuretics

Hypercalcemia

4

4.1

Hyperuricemia

14

14.3

Hypokalemia

4

4.1

Hyperkalemia

2

2.0


Hyperkalemia and angioedema were the most frequent ADRs, each affecting 18.4% of patients on ARBs. Reported from the data collected from patients' files.


Table 5: Cumulative of ADR reported.

Class of Drug

No. of Patients [98]

Percent (%)

ARBs

44

44.9

CCBs

21

21.4

?Bs

9

9.2

Diuretics

24

24.5


ADRs were most common among patients on ARBs (44.9%), followed by diuretics (24.5%) and CCBs (21.4%).


Table 6: Co-morbidities among hypertensive patients

Co-morbidities

No. of Patients [102]

Percent (%)

Diabetes Mellitus

29

28.4

COPD

13

12.7

Acute Ischemic Stroke

7

6.9

Coronary Artery Disease

4

3.9

Chronic Kidney Disease

11

10.8

Osteoarthritis

9

8.8

Benign Prostate Hyperplasia

7

6.9

Others

22

21.6


Diabetes mellitus was the most prevalent comorbidity (28.4%) among the 102 patients with comorbidities.

DISCUSSION

This study highlights the significant incidence of ADRs among hypertensive patients receiving treatment, with 44% experiencing ADRs. The majority of these were mild, but a notable proportion were moderate or severe, underscoring the need for careful monitoring and management. ARBs were the most common drug class associated with ADRs, particularly hyperkalemia and angioedema.

The findings emphasize the importance of regular monitoring, patient education, and effective communication between healthcare providers and patients. By proactively managing ADRs, healthcare professionals can improve patient adherence to antihypertensive therapy and overall treatment outcomes.

CONCLUSION:

Assessing ADRs in hypertensive patients is crucial for optimizing treatment and ensuring patient safety. A comprehensive approach involving patient history reviews, monitoring, education, and documentation can significantly reduce the risks associated with ADRs. Collaboration among healthcare providers is essential to tailor treatment plans and improve patient outcomes. Ongoing follow-up and participation in adverse event reporting systems are vital to maintaining high standards of care in hypertensive management.

REFERENCES

  1. WHO. (2020). The use of the WHO-UMC system for standardized case causality assessment. Retrieved from WHO-UMC system
  2. Hartwig, S.C., Siegel, J., & Schneider, P.J. (1992). Preventability and severity assessment in reporting adverse drug reactions. American Journal of Hospital Pharmacy, 49(9), 2229-2232.
  3. Schutte, A.E., et al. (2022). Addressing global disparities in blood pressure control: Perspectives of the International Society of Hypertension.
  4. Umemura, S., et al. (2019). The Japanese Society of Hypertension guideline for the management of hypertension.
  5. Liu, et al. (2021). Identifying drug-related attributes to personalize antihypertensive agents: The outcome report of patients receiving Metoprolol therapy.
  6. Passerela, et al. (2018). Hypertension Management in Diabetes.
  7. International Journal of Environmental Research and Public Health. (2022). Prognostic factors of new-onset hypertension in new and traditional hypertension definition in a large Taiwanese population follow-up study.

Reference

  1. WHO. (2020). The use of the WHO-UMC system for standardized case causality assessment. Retrieved from WHO-UMC system
  2. Hartwig, S.C., Siegel, J., & Schneider, P.J. (1992). Preventability and severity assessment in reporting adverse drug reactions. American Journal of Hospital Pharmacy, 49(9), 2229-2232.
  3. Schutte, A.E., et al. (2022). Addressing global disparities in blood pressure control: Perspectives of the International Society of Hypertension.
  4. Umemura, S., et al. (2019). The Japanese Society of Hypertension guideline for the management of hypertension.
  5. Liu, et al. (2021). Identifying drug-related attributes to personalize antihypertensive agents: The outcome report of patients receiving Metoprolol therapy.
  6. Passerela, et al. (2018). Hypertension Management in Diabetes.
  7. International Journal of Environmental Research and Public Health. (2022). Prognostic factors of new-onset hypertension in new and traditional hypertension definition in a large Taiwanese population follow-up study.

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Attahir Sa’ad Ayuba
Corresponding author

: Faculty of Pharmacy, Bhupal Noble’s University, Udaipur, Rajasthan, India.

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Dr. Ado Shehu
Co-author

KHADIJA UNIVERSITY, MAJIA

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Nikhil Nama
Co-author

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Monica Lal
Co-author

Photo
Indrakshi Tiwari
Co-author

Photo
Dr Amit Bhargav
Co-author

Photo
Dr. Ritika Bansal
Co-author

Attahir Sa’ad Ayuba, Dr. Ado Shehu, Nikhil Nama, Monica Lal, Indrakshi Tiwari, Dr. Amit Bhargav, Dr. Ritika Bansal, Assessment Of Adverse Drug Reactions Among Hypertensive Patients Receiving Treatment in Tertiary Care in Rajasthan, Int. J. of Pharm. Sci., 2024, Vol 2, Issue 12, 807-811. https://doi.org/10.5281/zenodo.14306834

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