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NEBIVOLOL
Summary
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Nebivolol is a long-acting, cardioselective beta-blocker currently licensed for the treatment of hypertension. It has mild vasodilating properties attributed to its interaction with the L-arginine/nitric oxidepathway, a property not shared by other beta-blockers. To date this has been demonstrated in volunteers and small numbers of patients. If this mechanism is shown to result in improved clinical outcomes, nebivolol could be of value in managing hypertensive patients with endothelial dysfunction eg those with diabetes mellitus or hypercholesterolaemia and in patients with ischaemic heart disease. It isan effective antihypertensive agent. Short-term (up to 12 weeks), published clinical studies in patients with mild-to-moderate essential hypertension have shown that it lowers sitting systolic and diastolic blood pressure to a similar extent as standard therapies atenolol, metoprolol, enalapril, lisinopril, nifedipine and hydrochlorothiazide. One open, non-comparative study showed that asignificant reduction in BP is maintained over 1 year. It is well-tolerated; the frequency and severity of adverse events is similar to that reported for placebo, atenolol or enalapril in published studies. In the largest comparative study the numbers of patients complaining of fatigue was smaller for nebivolol compared with atenolol, although the numbers in both groups were too small for any meaningfulcomparisons to be made. In addition, in single comparative studies with nifedipine or metoprolol, the overall incidence of adverse events was smaller in the nebivolol groups. Although uncontrolled heart failure is listed as a contra-indication in the SPC, preliminary studies have shown that nebivolol has beneficial effects on left ventricular function in patients with hypertension and heart failure.Nebivolol is considerably more expensive than atenolol, but costs less than carvedilol or celiprolol.

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Date Published: August 1999

Monograph Number: 4/99/13

Marketed: April 1999

Region of Origin to whom queries should be directed: South and West (Bristol)

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The information contained herein will be superseded in due course.

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Not to be usedfor commercial purposes. Copyright DIPG 1999.

NEBIVOLOL
APPROVED NAME: BRAND NAME: PRESENTATION: Nebivolol Nebilet (A. Menarini Pharmaceuticals UK Ltd) Tablets containing nebivolol hydrochloride 5.45mg (equivalent to 5mg nebivolol) Beta blockers [BNF 2.4] Treatment of essential hypertension Adults : 5mg daily preferably at the same time of day For details of combinations with otherantihypertensive agents, dose in: patients with renal insufficiency, hepatic insufficiency, the elderly and children see SPC A new cardioselective beta blocker with vasodilatory properties due to enhancement of endothelial nitric oxide release. It provides an alternative to other vasodilatory beta blockers in hypertensive patients unable to tolerate atenolol Hospital [Y] £9.80 Community [Y]

THERAPEUTICCLASS: LICENSED INDICATIONS: DOSAGE & ADMINISTRATION:

THERAPEUTIC COMMENT:

SECTOR OF USE: COST (28 days): TREATMENT ALTERNATIVES:

Drug Atenolol Betaxolol Bisoprolol Carvedilol Celiprolol

Dosage 50mg daily 20mg daily 10mg daily 25mg daily 200mg daily

Cost for 28 days £1.22 £7.51 £9.61 £13.15 £18.00

MIMS May 1999 & Drug Tariff June 1999

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NEBIVOLOL
INTRODUCTIONPHARMACOKINETICS In Western societies, 15-20% of the adult population has hypertension [1]. According to the 1996 health survey, 23% of all adults in England had high blood pressure. Among those subjects who had hypertension, 59% were receiving antihypertensive medication [2]. Of the populations on antihypertensive medication 64% had their blood pressure under control, but the other 36% were inadequately...