European Journal of Cardiovascular Medicine

Hypertension is a significant public health concern and a leading risk factor for cardiovascular diseases, including coronary artery disease, stroke, and heart failure¹. In India, the prevalence of hypertension is increasing, with urban populations being more affected than rural populations². Stage-1 Hypertension, defined as systolic blood pressure (SBP) between 130–139 mmHg or diastolic blood pressure (DBP) between 80–89 mmHg, requires effective pharmacological management to prevent complications and improve patient outcomes³.

Beta-blockers are widely used antihypertensive agents that exert their effects by reducing cardiac output and sympathetic activity⁴. Among beta-blockers, Bisoprolol and Metoprolol are commonly prescribed due to their efficacy in controlling blood pressure and favorable safety profiles⁵. Bisoprolol, a highly selective beta-1 receptor blocker, is known for its longer half-life and reduced incidence of side effects. In contrast, Metoprolol, also a beta-1 selective blocker, is frequently used due to its established efficacy and availability in clinical practice^6,7.

While both drugs are effective in managing hypertension, comparative studies assessing their efficacy and tolerability in the Indian population are limited. This observational study aims to compare the effectiveness of Bisoprolol and Metoprolol in reducing blood pressure, achieving target blood pressure levels, and their safety profiles in patients with Stage-1 Hypertension. The findings of this study are intended to guide clinicians in selecting the most appropriate beta-blocker for managing hypertension in the Indian context.

Study Design

This was an observational, prospective study conducted at DVVPF's Medical College and Hospital, Ahilyanagar, Maharashtra, from January 2024 to December 2024. The study compared the efficacy and tolerability of Bisoprolol and Metoprolol in patients diagnosed with Stage-1 Hypertension.

Study Population

A total of 100 patients with Stage-1 Hypertension, aged 18–65 years, were enrolled in the study. Patients were included based on the following criteria:

Inclusion Criteria: Newly diagnosed Stage-1 Hypertension (SBP 130–139 mmHg and/or DBP 80–89 mmHg) and willingness to provide informed consent.

Exclusion Criteria: Patients with secondary hypertension, significant cardiac or renal dysfunction, history of beta-blocker intolerance, or those on other antihypertensive medications.

Sample Size and Group Allocation

Participants were randomly allocated into two groups (n=50 each):

Group 1: Treated with Bisoprolol (5 mg/day).

Group 2: Treated with Metoprolol (50 mg/day).

Study Procedure

Baseline evaluations, including medical history, physical examination, and measurement of SBP, DBP, and heart rate (HR), were conducted for all participants.

Patients were followed up monthly for 12 weeks. Blood pressure and HR were recorded at each visit.

The primary outcomes were the reduction in SBP and DBP from baseline. Secondary outcomes included HR reduction, achievement of target BP (<130/80 mmHg), patient satisfaction, and incidence of adverse events.

Adverse events were monitored through patient-reported symptoms and clinical assessments.

Data Collection and Statistical Analysis

Data were collected using a structured case record form. Statistical analysis was performed using SPSS version 26.0.

Continuous variables (e.g., SBP, DBP, HR) were expressed as mean ± standard deviation and compared using independent t-tests.

Categorical variables (e.g., adverse events, achievement of target BP) were analyzed using chi-square tests.

A p-value of <0.05 was considered statistically significant.

Ethical Considerations

The study was approved by the Institutional Ethics Committee of DVVPF's Medical College and Hospital. Written informed consent was obtained from all participants prior to enrollment. Confidentiality and anonymity were maintained throughout the study.

Demographic and Baseline Characteristics

The demographic and baseline characteristics of the study groups are summarized in Table 1.

Table 1: Demographic and Baseline Characteristics of Study Groups

Figure No:1. Demographic and Baseline Characteristics of Study Groups

The mean age of patients in the Bisoprolol group was 45.8 ± 8.7 years, while the Metoprolol group had a mean age of 46.4 ± 9.2 years, with no significant difference (p = 0.63). The gender distribution was identical in both groups (Male:Female ratio, 54%:46%; p = 0.72). Baseline systolic blood pressure (SBP) and diastolic blood pressure (DBP) were comparable between the two groups (SBP: 142.6 ± 4.2 mmHg vs. 143.1 ± 3.9 mmHg, p = 0.45; DBP: 91.4 ± 3.5 mmHg vs. 91.7 ± 3.3 mmHg, p = 0.57).

Blood Pressure Reduction

After 12 weeks of treatment, patients in the Bisoprolol group showed a greater reduction in SBP and DBP compared to the Metoprolol group (Table 2).

Table 2: Blood Pressure Reduction After 12 Weeks

Figure No:2. Blood Pressure Reduction After 12 Weeks

The mean SBP reduction was -19.3 ± 3.7 mmHg in the Bisoprolol group and -16.8 ± 4.1 mmHg in the Metoprolol group, with a statistically significant difference (p = 0.01). Similarly, the mean DBP reduction was significantly greater in the Bisoprolol group (-10.8 ± 2.6 mmHg) compared to the Metoprolol group (-8.9 ± 2.9 mmHg, p = 0.02).

Heart Rate Reduction

The mean reduction in heart rate (HR) after 12 weeks of treatment was -12.5 ± 3.4 bpm in the Bisoprolol group and -11.2 ± 3.7 bpm in the Metoprolol group. However, this difference was not statistically significant (p = 0.13) (Table 3).

Table 3: Heart Rate Reduction After 12 Weeks

Figure No:3 Heart Rate Reduction after 12 Weeks

Adverse Events and Tolerability

Adverse events occurred in 18% of patients in the Bisoprolol group and 22% of patients in the Metoprolol group (Table 4).

Table 4: Adverse Events and Discontinuation Rates

Figure No:4. Adverse Events and Discontinuation Rates

The most frequently reported adverse events were fatigue (8% vs. 10%, p = 0.71), dizziness (6% vs. 8%, p = 0.59), and mild bradycardia (4% vs. 6%, p = 0.69). The discontinuation rate due to adverse events was slightly lower in the Bisoprolol group (4%) compared to the Metoprolol group (6%), but the difference was not statistically significant (p = 0.69).

Achievement of Target Blood Pressure and Patient Satisfaction

A higher proportion of patients achieved target blood pressure (<130/80 mmHg) in the Bisoprolol group (76%) compared to the Metoprolol group (64%), with a statistically significant difference (p = 0.04) (Table 5).

Table 5: Achievement of Target Blood Pressure and Patient Satisfaction

Figure No:5. Achievement of Target Blood Pressure and Patient Satisfaction

Additionally, patient-reported satisfaction scores were significantly higher in the Bisoprolol group (8.4 ± 1.1) than in the Metoprolol group (7.9 ± 1.3; p = 0.03).

This study compared the efficacy and tolerability of Bisoprolol and Metoprolol in patients with Stage-1 Hypertension treated at DVVPF's Medical College and Hospital, Ahilyanagar, Maharashtra, over a one-year period. The findings provide valuable insights into the management of hypertension in an Indian clinical setting.

Key Findings

The results of this study demonstrated that Bisoprolol was significantly more effective in reducing both systolic blood pressure (SBP) and diastolic blood pressure (DBP) compared to Metoprolol. Patients in the Bisoprolol group achieved a mean SBP reduction of -19.3 ± 3.7 mmHg compared to -16.8 ± 4.1 mmHg in the Metoprolol group (p = 0.01). Similarly, the reduction in DBP was greater with Bisoprolol (-10.8 ± 2.6 mmHg vs. -8.9 ± 2.9 mmHg, p = 0.02). These findings are consistent with previous research that highlights the superior antihypertensive efficacy of Bisoprolol due to its higher beta-1 receptor selectivity and longer half-life (Channaraya et al¹¹., 2012; Wander et al¹⁰., 2024).

The proportion of patients achieving target BP (<130/80 mmHg) was significantly higher in the Bisoprolol group (76%) compared to the Metoprolol group (64%, p = 0.04). Similar results were reported in a recent meta-analysis by Guo et al¹⁴. (2023), which demonstrated the efficacy of beta-blockers, particularly Bisoprolol, in achieving better blood pressure control when used as monotherapy or in combination.

Tolerability and Safety

Both drugs demonstrated comparable safety profiles, with adverse event rates of 18% and 22% for Bisoprolol and Metoprolol, respectively (p = 0.61). The most common adverse events included fatigue, dizziness, and mild bradycardia, consistent with previous studies (Weiss et al⁹., 2007; Channaraya et al¹¹., 2012). The slightly lower discontinuation rate in the Bisoprolol group (4% vs. 6%) further underscores its favorable tolerability. Similarly, Roghani et al¹⁴. (2024) noted that Bisoprolol had a more favorable safety profile in patients with cardiovascular conditions, which supports its role as a tolerable beta-blocker in hypertensive patients.

Clinical Implications

The findings of this study have significant clinical implications for the management of Stage-1 Hypertension in India. With its superior efficacy and comparable tolerability, Bisoprolol emerges as a preferred option for patients requiring beta-blocker therapy. Previous studies, including those by Wander et al⁹ (2024) and Pasternak et al¹². (2015), have highlighted the long-term cardiovascular benefits of Bisoprolol in both hypertensive and heart failure patients. Furthermore, the higher patient satisfaction scores observed with Bisoprolol in this study highlight its acceptability among patients, which may improve adherence to treatment—a critical factor for long-term hypertension management.

Study Strengths and Limitations

The strength of this study lies in its prospective design and real-world setting, which enhance the generalizability of the findings. However, some limitations should be acknowledged. The study's sample size was relatively small, and the follow-up period was limited to 12 weeks, which may not fully capture the long-term outcomes of treatment. Additionally, the study did not account for variations in patient comorbidities or lifestyle factors that could influence treatment outcomes.

This study highlights that Bisoprolol is more effective than Metoprolol in managing Stage-1 Hypertension, achieving significantly greater reductions in systolic and diastolic blood pressure and a higher proportion of patients reaching target BP levels (<130/80 mmHg). Despite its superior efficacy, Bisoprolol demonstrated a comparable safety and tolerability profile, with similar rates of adverse events and discontinuations as Metoprolol. The higher patient satisfaction scores with Bisoprolol further emphasize its acceptability and potential to improve treatment adherence. These findings suggest that Bisoprolol is a better option for Stage-1 Hypertension in the Indian population.

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