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Celiprolol

An Evaluation of its Pharmacological Properties and Clinical Efficacy in the Management of Hypertension and Angina Pectoris

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Summary

Synopsis

Celiprolol is a β1-selective adrenoceptor antagonist (β-blocker) which acts as a weak agonist at β2-adrenoceptors. The drug demonstrates vasodilator properties and does not depress heart rate to the same extent as propranolol, atenolol or metoprolol.

Celiprolol has shown equivalent antihypertensive efficacy to other β-blockers, notably propranolol, atenolol, metoprolol and pindolol, in patients aged 18 to 75 years with mild to moderate essential hypertension. The drug has also shown similar antihypertensive efficacy to the angiotensin converting enzyme inhibitor enalapril and to combination diuretic therapy with hydrochlorothiazide and amiloride. Celiprolol was equally effective in adult patients of all ages, although no data are available for patients aged over 75 years.

Data from a small number of clinical trials indicate celiprolol to be as effective as both propranolol and atenolol in improving work capacity and reducing the frequency of anginal attacks in patients with stable effort angina. However, the drug has not yet been evaluated in postmyocardial infarction patients.

Celiprolol offers advantages over other β-blockers, including reduction of peripheral vascular resistance and maintenance of resting heart rate, cardiac output and renal perfusion. The drug is also associated with improvements in plasma lipid profiles and does not appear to adversely affect carbohydrate metabolism or lung function, although its use in patients with reversible obstructive pulmonary disease is not recommended.

Celiprolol is therefore a highly cardioselective β-blocker with ancillary characteristics which are potentially useful in patients with hypertension and angina complicated by other conditions commonly associated with advanced age. These include impaired glucose tolerance or diabetes mellitus, peripheral vascular disease and hyperlipidaemia. The drug may also be preferred to other β-blockers in patients in whom a reduction in heart rate would be particularly undesirable. Further long term (> 12 months) clinical trials and pharmacoeconomic data are now required to confirm the clinical relevance of the pharmacodynamic advantages of celiprolol therapy.

Overview of Pharmacodynamic Properties

Celiprolol is a β1-selective adrenoceptor antagonist (β-blocker) with weak β2-adrenoceptor agonist and vasodilator activity. The drug reduces standing and supine systolic (SBP) and diastolic (DBP) blood pressure and mean arterial pressure in healthy volunteers and patients with mild to moderate essential hypertension, but does not depress heart rate to the same extent as propranolol, atenolol or metoprolol.

Unlike some other β-blockers, celiprolol is not associated with increased peripheral resistance or depressed left ventricular function. Increased or unchanged cardiac output, cardiac index and left ventricular performance were reported in studies of healthy volunteers and patients with mild to moderate essential hypertension who received the drug. Reductions in left ventricular mass secondary to celiprolol therapy have also been observed in patients with hypertension. Improvements in work capacity (measured by bicycle ergometry) and beneficial effects on myocardial oxygen balance have been documented in patients with angina pectoris after treatment with celiprolol.

Celiprolol exerts favourable effects on plasma lipid profiles by reducing triglyceride and low density lipoprotein cholesterol levels and increasing high density lipoprotein cholesterol levels. No adverse effects on carbohydrate metabolism have been reported. In fact, insulin sensitivity and glucose disposal were improved in 25 patients with mild to moderate essential hypertension and dyslipidaemia after treatment with celiprolol 200 to 400 mg/day for 12 months.

Celiprolol did not adversely affect pulmonary function after doses of up to 600mg in the majority of studies of healthy volunteers and patients with mild asthma; neither did it interfere with the bronchodilating action of inhaled β2-agonists. However, a small but significant overall decrease in respiratory function was observed after celiprolol 100 mg/day for 10 weeks in 8 patients with chronic obstructive pulmonary disease.

Overview of Pharmacokinetic Properties

Celiprolol exhibits nonlinear pharmacokinetics in humans after oral administration, with increased bioavailability after higher doses. In a group of elderly volunteers (mean age 65.5 years), peak plasma concentrations occurred within 3.5 to 4.5 hours of administration and plasma elimination half-life was 5.00 to 7.91 hours. The pharmacokinetic profile of the drug in the elderly is similar to that in the general population. Pharmacodynamic activity is still evident at 24 hours; this allows once daily administration. Bioavailability of celiprolol after oral administration may be reduced by the presence of food.

Excretion of the drug occurs via the faecal and urinary routes after minimal or no systemic metabolism. Reduced urinary excretion of celiprolol has been reported in patients with renal failure; dosage reduction is therefore recommended in moderate to severe renal impairment.

Therapeutic Use

Noncomparative and placebo-controlled studies have shown oral celiprolol 200 to 600 mg/day to be effective in lowering SBP and DBP in patients with mild to moderate essential hypertension, with normalisation of blood pressure generally occurring in approximately 70% of patients overall.

In comparative studies in patients aged 18 to 75 years with mild to moderate essential hypertension, the antihypertensive efficacy of celiprolol was reported to be equivalent to that of the β-blockers atenolol, metoprolol, propranolol and pindolol, the angiotensin converting enzyme inhibitor enalapril or combination therapy with hydrochlorothiazide and amiloride. Mean reductions in supine or sitting SBP of 8.6 to 28mm Hg and DBP of 6.3 to 19.3mm Hg were observed with celiprolol over the dosage range 200 to 600 mg/day. 22 to 93% of patients responded to celiprolol therapy, on the basis of achieving resting DBP ≤90mm Hg or a reduction in DBP of ≥10mm Hg. Patients aged over 60 years achieved similar response rates to younger patients, although no study enrolled patients aged over 75 years.

In patients with stable angina pectoris, celiprolol significantly reduced the frequency of anginal attacks, nitroglycerin consumption and double product (heart rate × SBP) and increased time to ST segment depression. Dosages of 200 to 600 mg/day were of equivalent efficacy to propranolol 80 to 320 mg/day and atenolol 50 to 100 mg/day in alleviating anginal symptoms and increasing exercise capacity.

Tolerability

Pooled data from 18 double-blind trials have shown celiprolol to have a tolerability profile comparable to that of placebo. Celiprolol 200 to 600 mg/day was associated with a significantly lower incidence of adverse effects than either propranolol 40 to 80 mg/day or atenolol 50 to 100 mg/day in 991 patients with mild to moderate essential hypertension, 32% of whom were aged over 60 years. Furthermore, celiprolol did not cause bradycardia (< 50 beats/minute) and only 2.15% of patients withdrew because of suspected adverse effects in a postmarketing study of 2694 patients with mild to severe hypertension.

Celiprolol does not appear to exert adverse effects on plasma lipid profiles, carbohydrate metabolism or pulmonary function. Nevertheless, as with other β-blockers, current recommendations state that celiprolol should not be administered to patients with reversible obstructive pulmonary disease.

Dosage and Administration

A single daily oral dose of celiprolol 200mg, increased to 400mg if necessary, is recommended for the initial treatment of mild to moderate essential hypertension. It is suggested that each dose should be taken 30 to 60 minutes before or 2 hours after a meal.

For the long term management of angina pectoris, celiprolol may be administered at an initial dosage of 200 mg/day, which may be increased to 400 or 600 mg/day after intervals of 2 to 4 weeks if required.

A 50% reduction in celiprolol dosage is advised in patients with a creatinine clearance of 15 to 40 ml/min. The drug is not recommended for patients with creatinine clearance <15 ml/min and should be used with caution in patients with congestive heart failure. There are no specific dosage recommendations for the use of celiprolol in the elderly.

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  1. Adis International Limited, 41 Centorian Drive, Private Bag 65901, Mairangi Bay, Auckland 10, New Zealand

    Christopher J. Dunn & Caroline M. Spencer

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  1. Christopher J. Dunn
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Various sections of the manuscript reviewed by: T.J.M. Cleophas, Department of Medicine, Merwede Hospital Sliedrecht-Dordrecht, Sliedrecht, The Netherlands; J. De Crée, Clinical Research Unit, St. Bartholomeus v.z.w, Jan Palfijn Ziekenhuis, Merksem, Belgium; S.A. Doggrell, Department of Pharmacology, School of Medicine, University of Auckland, Auckland, New Zealand; S. Ghiringhelli, Division of Cardiology, Ospedale Civile di Breno, Breno, Italy; M.J. Kendall, Department of Medicine, Queen Elizabeth Hospital, Edgbaston, Birmingham, England; S.H. Taylor, Department of Medical Cardiology, The General Infirmary, Leeds, England.

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Dunn, C.J., Spencer, C.M. Celiprolol. Drugs & Aging 7, 394–411 (1995). https://doi.org/10.2165/00002512-199507050-00006

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