Heart India

ORIGINAL ARTICLE
Year
: 2014  |  Volume : 2  |  Issue : 2  |  Page : 39--42

Hypertension on Target with TENORMIN (HOTT) Study-Evaluation of the Effectiveness and Safety of Atenolol in Indian Population


Qayum Mukaddam1, Manoj M Naik2, Abhijit Trailokya3,  
1 Medical Director, Medical Services, Abbott Healthcare, Mumbai, Maharashtra, India
2 Chief Manager, Medical Services, Abbott Healthcare, Mumbai, Maharashtra, India
3 Medical Advisor, Medical Services, Abbott Healthcare, Mumbai, Maharashtra, India

Correspondence Address:
Manoj M Naik
Chief Manager Medical Services Division, Abbott Healthcare Pvt. Ltd. 1st Floor, D Mart Building, Goregaon - Mulund Link Road, Mumbai - 400 080
India

Abstract

Background: Atenolol is a widely used anti-hypertensive drug worldwide. Despite well-studied from other population, due to the paucity of data from Indians, this study was conducted. Materials and Methods: This was a prospective cohort study conducted in 566 tertiary care hospitals in India. Adult male or female naïve patients with Stage I 1 or Stage II 2 (Seventh Report of the Joint National Committee) essential hypertension or patients uncontrolled on current monotherapy or other combination therapy. Demographic details, blood pressure and heart rate readings (weeks 2, 8, and 12) and drug-related details of the study participants were collected and analyzed. Results: A total of 2657 participants were evaluated. The mean (standard deviation [SD]) baseline systolic and diastolic blood pressure of the study participants were 161.73 (15.13) and 99.21 (11.37), respectively. Mean (SD) of the baseline heart rate was 84.39 (10.17) beats/min. Statistically significant reductions (P < 0.05) were noted in both the blood pressures and heart rate at all the follow-up visits in comparison to baseline. Of the total 632 patients with Stage I hypertension, 153 (24.21%) achieved a reduction in blood pressure <120/80 mmHg, while 245 (38.77%) had their blood pressure between 121 and 140 mmHg systolic and/or 81-90 mmHg diastolic at 12 weeks of therapy. Global assessment of the efficacy and tolerability were found to be at least satisfactory in the majority of the study participants. Conclusion: To conclude, atenolol as an anti-hypertensive agent seems to be promising both in terms of effectiveness and safety profile in the Indian population.



How to cite this article:
Mukaddam Q, Naik MM, Trailokya A. Hypertension on Target with TENORMIN (HOTT) Study-Evaluation of the Effectiveness and Safety of Atenolol in Indian Population.Heart India 2014;2:39-42


How to cite this URL:
Mukaddam Q, Naik MM, Trailokya A. Hypertension on Target with TENORMIN (HOTT) Study-Evaluation of the Effectiveness and Safety of Atenolol in Indian Population. Heart India [serial online] 2014 [cited 2019 Sep 23 ];2:39-42
Available from: http://www.heartindia.net/text.asp?2014/2/2/39/134577


Full Text

 Introduction



Hypertension (HTN) or high blood pressure, sometimes called arterial hypertension, is a chronic medical condition in which the blood pressure in the arteries is elevated. Blood pressure is summarised by two measurements, systolic and diastolic, which depend on whether the heart muscle is contracting (systole) or relaxed between beats (diastole). This equals the maximum and minimum pressure, respectively. Normal blood pressure at rest is within the range of 100-140 mmHg systolic and 60-90 mmHg diastolic. High blood pressure is said to be present if it is often at or above 140/90 mmHg. According to World Health Report 2002, cardiovascular diseases (CVDs) will be the largest cause of death and disability by 2020 in India. In 2020 AD, 2.6 million Indians are predicted to die due to coronary heart disease which constitutes 54.1% of all CVD deaths. Nearly half of these deaths are likely to occur in young and middle aged individuals (30-69 years). Atenolol, a water soluble cardio selective beta blocker was approved by United States Food and Drug Administration in 1981 for the treatment of essential hypertension. [1] Earlier evidence largely supported the use of atenolol as a first-line anti-hypertensive. [2] Although several large studies have been conducted with atenolol in different parts of the world, [3],[4] a detailed PubMed search revealed only few published clinical studies with atenolol in the Indian population. [5],[6],[7],[8] Hence, considering the paucity of the data, this study was conducted to assess the effectiveness and safety of atenolol when administered in its approved dose range in a large number of patients with essential hypertension and we present here the results of preliminary analysis of the study.

 Materials and Methods



Study participants and procedure

This was an observational, prospective, cohort study conducted at various centers in India where in physicians working in 566 tertiary care hospitals in the country were contacted for the study. Data from individuals aged more than 18 years, of either sex, drug naïve, diagnosed of having either Stage I or II essential hypertension as per Seventh Report of the Joint National Committee (JNC VII) guidelines [9] since the study was conducted in 2009. Adult, male, or female naïve patients with Stage I 1 or Stage II 2 (JNC VII) essential hypertension or patients uncontrolled on current monotherapy or other combination therapy. A structured data entry form was electronically created for each of the participating center. The extracted details include demographics (age and sex), stage of hypertension, concomitant illness, readings of blood pressure and heart rate, safety profile at every visit (weeks 2, 8 and 12) of the patient, drug related details (dose, frequency of atenolol, and concomitant medications). Global assessment of efficacy in patients was done by the treating physician and was classified into one of the following: Excellent, very good, good, satisfactory, and poor. In addition, global assessment of tolerability (categorized into either good, moderate, or poor) was performed both by the physician and patient.

Statistical analysis

Descriptive statistics were used for depicting the demographic characteristics of the study patients. Numerical variables were checked for normal distribution by Kolmogorov-Smirnov test. Change in blood pressure and heart rate from baseline at 2, 8, and 12 weeks were assessed using repeated measures ANOVA with post-hoc test. Further, patients were also categorized into those who had achieved a blood pressure of 120/80 or less and those with a blood pressure of 140/90 mmHg or less at the end of 12 weeks of treatment. Fisher's exact probability test was used for analyzing this categorical variable. Descriptive statistics were used for representing both the safety and tolerability profile of the patients. All the statistical analyses were performed using SPSS 16.0 (SPSS Inc., Chicago, Illinois, USA).

 RESULTS



Demographic details

A total of 3237 participant details were collected from all the centers. Of these, data from 580 participants were either lost to follow-up or their data was incomplete, leaving behind a final of 2657 evaluable patients. The demographic details of these patients were represented in [Table 1].{Table 1}

Efficacy

The mean (standard deviation [SD]) baseline systolic (SBP) and diastolic (DBP) blood pressure of the study participants were 161.73 (15.13) and 99.21 (11.37) respectively. Mean (SD) of the baseline heart rate was 84.39 (10.17) beats/min. Statistically significant reductions (P < 0.05) were noted in both the blood pressures and heart rate at all the follow-up visits in comparison to baseline [Table 2] and [Graph 1]. [SUPPORTING:1] Of the total 632 patients with Stage I hypertension, 153 (24.21%) achieved a reduction in blood pressure <120/80 mmHg, while 245 (38.77%) had their blood pressure between 121 and 140 mmHg systolic and/or 81-90 mmHg diastolic at 12 weeks of therapy. Similarly, of the total 2025 patients with Stage II hypertension, 600 (29.63%) achieved a blood pressure <120/80 mmHg, while 1619 (79.95%) had their blood pressure between 121 and 140 mmHg systolic and/or 81-90 mmHg diastolic at 12 weeks of therapy. Of the total 2657 patients, global efficacy assessment, by the physician was done for 2528 patients and were categorized as excellent (878 [34.73%]), very good (1056 [41.77%]), good (467 [18.47%]), satisfactory (113 [4.47%]), and poor (14 [0.55%]).{Table 2}

Safety and tolerability

Adverse events were reported in a total of 58 (21.8%) patients. Giddiness (13 [0.49%]), headache (12 [0.45%]), dryness of mouth (6 [0.23%]), reduced libido (5 [0.19%]), dizziness (4 [0.15%]) were majorly reported adverse events. All the events were mild to moderate in intensity and were self-limiting. Patients were classified into good (2146 [84.89%]), moderate (188 [7.44%]) and poor (33 [1.31%]) as per global tolerability assessment scale by the treating physician. Similarly, global tolerability assessment evaluation by the patient was available for a total of 2329 patients (good [2146 (84.9%)], moderate [152 (6%)] and poor [31 (1.23%)]).

Concomitant medications

The study participants were receiving one or more of the following classes of concomitant medications: Angiotensin converting enzyme inhibitors/angiotensin receptor blockers (745 [28%]), calcium channel blockers (585 [22.1%] [22.02%]), diuretic (220 [8.3%]), oral hypoglycemic agents (165 [6.2%]).

 DISCUSSION



This study was conducted to assess the effectiveness and safety of atenolol in a total of 2657 patients diagnosed as having essential hypertension. We found that atenolol, in its approved dose ranges was both effective and well-tolerated until 12 weeks of treatment. Furthermore, a majority of the patients were found to be satisfied with the treatment regime as assessed by both the treating physicians and patients themselves.

In India, atenolol has been approved by Drug Controller General of India for the treatment of hypertension angina pectoris and cardiac arrhythmias. Atenolol by antagonizing the peripheral sympathetic activity on the beta-adrenergic receptors reduces both the heart rate and force of contraction of the heart, thereby lowering the blood pressure. [10] Considering their effect from various controlled clinical trials, [11],[12] various international committees such as European Society of Hypertension (ESH)/European Society of Cardiology have recommended them as anti-hypertensive agents in the initiation and maintenance and also have shown long-term favorable effects on all-cause and cardiovascular morbidity and mortality. [13] In addition, atenolol has been shown to improve the arterial distensibility in hypertensive patients. [14] A recent pragmatic trial with polypill-based strategy, containing atenolol, had also established the beneficial cardiovascular effects in patients with hypertension. [15] However, in recent years, their role is questionable. [16],[ 17] Studies have established the protective role of atenolol only in patients with heart disease such as coronary artery disease or congestive cardiac failure. [3] Even, a large meta-analysis has not shown any protection against stroke in hypertensive patients on atenolol therapy. [18] However, the present study on 2657 patients albeit followed-up for just 12 weeks, had shown a significant reduction in both SBPs and DBPs irrespective of co-morbid cardiovascular diseases.

The study was limited by the fact that there was no control group, short duration of follow-up of the study participants, sub group analysis for patients with combination therapy and patients with co-morbid illnesses were not performed, lack of any measure of compliance to treatment as well as hard end point as an outcome measurement. However, the strength of the study lies in the fact that until date, this is the largest collection of data from the Indian population representing various ethnic regions of the country.

 CONCLUSION



The situation in India of hypertension has been alarming. It was reported that of a total of 9.4 million deaths in India in 1990, cardiovascular diseases caused 2.3 million deaths (25%). A total of 1.2 million deaths were due to coronary heart disease and 0.5 million due to stroke. It has been predicted that by 2020, there would be a 111% increase in cardiovascular deaths in India. The need for an effective anti-hypertensive agent is a requirement. To conclude, atenolol as an anti-hypertensive agent seems to be promising both in terms of effectiveness and safety profile in the Indian population.

 ACKNOWLEDGMENT



We would like to thank all the doctors for participating and providing with accurate data.

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