© Borgis - New Medicine 4/2003, s. 108-111
Barbara Gryglewska, Tomasz Grodzicki
Betaxolol in elderly patients in primary care
Department of Internal Medicine and Gerontology Collegium Medicum Jagiellonian University,
Head of Department: Tomasz Grodzicki MD, PhD
The object of the study was to evaluate the effectiveness and tolerance of betaxolol in elderly patients with hypertension (HT) and/or coronary heart disease (CHD) in primary care.
Material and methods: An open study was carried out in general practice. Treatment using betaxolol (Lokren, Sanofi-Synthelabo) was given in a dose of 10-40 mg daily to patients with CHD and HT, not taking b-blockers and without contraindications. The treatment was continued over 8 weeks. At the beginning and end of the study, measurements of blood pressure, heart rate, and weight were performed in addition to a questionnaire related to the history of HT and CHD, medicines, concomitant diseases and risk factors of CV diseases. Effectiveness and tolerance were assessed by the physician (using a 4-point scale) and the patient (3-point scale).
Results: A total of 2839 patients (42%M) aged between 60 – 93 years (mean 68±5.8) were enrolled. Blood pressure values at entry were 167.1±18.6/97.9±10.2 mmHg and heart rate was 83±10.5 beats/min. Almost all subjects (97%) suffered from hypertension, and 67% of them were diagnosed as having CHD (22% after myocardial infarction). Other complications of hypertension are retinopathy (49%) or left ventricular hypertrophy confirmed by electrocardiography or echocardiography (65%). Concomitant diabetes was diagnosed in 22% studied. Family history of hypertension was confirmed in 59% subjects. Betaxolol was mainly used at a dose of 20 mg (63%) or 10mg (36%) daily. The drug was most often added to antihypertensive (91%), lipid-lowering (50%), and anti-platelet (51%) treatment. Treatment led to a significant drop in blood pressure from 167.1±18.6/97.9±10.2 to 141.4±13.7/84±8.3 mmHg, accompanied by a reduction in heart rate from 83±10.5 beats/min. to 70.3±8.4ud/min. at good (59%) or very good (35%) tolerance and effectiveness (good – 57%; very good – 34 %). Only 3% of the studied patients did not reach normal values of systolic blood pressure, and 12% of diastolic blood pressure. Side effects occurred only in 7% of the patients (mainly bradycardia <50 beats/min – 1.5%, headaches and dizziness – 1.2%, weakness – 0.7%. Health condition improved in in the opinion of the majority of patient (74%). Treated subjects did not report any deterioration of sleep quality (no change – 62%, improvement – 35%), mood (no change – 64%, improvement – 34%), physical efficacy (no-change – 62%, improvement – 36%) or sexual performance (94%).
Conclusions: Betaxolol is a safe and effective medication in the treatment of elderly patients with hypertension and coronary heart disease in primary care.
Cardiovascular drugs are the most frequently-prescribed drugs for the elderly (1). But there is very little clinical data on the effects of medications in the elderly, due to a poor representation of the real geriatric population in clinical trials (1). Most drug prescription information for the elderly is extrapolated from younger patients, and there is evidence of underutilization of effective cardiovascular medications in the elderly patients. Moreover, optimal medication prescribing for older people is especially daunting, because they require complex regimens for multiple chronic conditions (2). Additionally, to minimise adverse drug reactions, practitioners must consider age-related changes in drug pharmacokinetics and pharmacodynamics, when selecting from the thousands of chemical entities available (3).
Beta-blockading is one of the most permissible forms of therapy for hypertension (HT) and preferred treatment in patients with coronary heart disease (CHD), (4, 5, 6). However, there are observed differences between guidelines in use beta- blockers among older patients with these diseases, the differences being said to have great prognostic importance in the elderly (1, 7). Although desensitisation, and a decrease in the number of beta-adrenergic receptors are observed and decreased responses to beta-blockers are seen with ageing, beta –blockers are effective to reduce mortality and morbidity either in younger or in older patients with CHD or HT (8, 9). A decreased response to beta blockade is seen predominantly in their action to the contractility, heart rate, and to a lesser extent on peripheral vasodilatation (9). The beta-blockers, especially non-selective beta-blockers, are contraindicated in patients with asthma or moderate-to severe bronchospastic disease (10). They may also affect the sleep pattern and worsen depression and sometimes, if left ventricular dysfunction is present, they can cause decompensation. So beta-blockers are not a good choice of therapy for some elderly patients suffering from chronic diseases.
Betaxolol is one of the newer cardioselective beta-adrenoreceptor antagonists with a long half-life, 16-22 hrs, making it suitable for once-a-day administration (11). It has been shown that betaxolol is effective in the treatment of hypertension and stable angina pectoris in comparison to other beta-blockers (10). Batoxolol is widely used in the treatment of glaucoma in the elderly, but its safety and efficiently in older patients with HT and CHD are limited (12, 13). The objective of the study was to evaluate the effectiveness of, and tolerance to betaxolol in therapy on patients over 59 years old with hypertension and/or coronary heart disease in primary care.
MATERIALS AND METHODS
This study is a part of wider research, which is in press. All patients agreed orally to participate to the study. The study was conducted at primary care. Patients over 59 years old not receiving a beta-blocker were enrolled in an open-label clinical trial. Treatment with betaxolol (Lokren, Sanofi-Synthelabo) was given at a dose of 10-40 mg daily to patients with CHD and/or HT without contraindications. Remaining antihypertensive or antianginal therapy was not modified during the study.
The treatment continued for 8 weeks. At the beginning and end of the study measurements of blood pressure and heart rate were made in twice addition to a questionnaire related to the history of HT and CHD, medication, and any concomitant diseases. The effectiveness of betaxolol was analysed by changes in systolic blood pressure and heart rate from baseline values, and by the physician´s assessment as very good, good, moderate or bad. Tolerance of the drug was also assessed by the physician (using a 4-point scale) and the patient (3-point scale). The subjective opinions of the patients related to their estimates of the quality of sleep, mood, and physical and sexual efficiency were gathered. All complaints related to side effects of the drug were noted.
All data are expressed as mean ±SD. Comparisons between data at the beginning and the end of the study were done by Student´s T-test for paired data. For all tests, p values?>?0.05 were considered statistically significant.
A total of 2839 patients (42%M) aged between 60-93 years (mean 68±5.8) were enrolled (Table 1). Almost all subjects (97%) suffered from hypertension, and 67% of them from CHD (22% after myocardial infarction). Other complications of hypertension were retinopathy (49%), and left ventricular hypertrophy confirmed by electrocardiography or echocardiography (65%). Concomitant diabetes was present in 22% of the subjects. A family history of hypertension was confirmed in 59%. Betaxolol was mainly used at a dose of 20 mg (63%) or 10 mg (36%) daily. The drug was most often added to antihypertensive (91%), lipid-lowering (50%), or anti-platelet (51%) treatment (Table 2).
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