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2 0 0 3 B J U I N T E R N A T I O N A L | 9 2 , 1 0 4 4 – 1 0 4 8 | doi:10.1046/j.1464-410X.2003.04537.x
LETTERS
1 Roehrborn CG, Van Kerrebroeck P,
Nordling J. Safety and efficacy of
alfuzosin 10mg once-daily in the
treatment of lower urinary tract
symptoms and clinical benign prostatic
hyperplasia: a pooled analysis of three
double-blind, placebo-controlled studies.
BJU Int 2003; 92: 257–61
2 Kirby RS. Doxazosin in benign prostatic
hyperplasia. effects on blood pressure and
urinary flow in normotensive and
hypertensive men. Urology 1995; 46:
182–6
3 Kirby RS. Terazosin in benign prostatic
hyperplasia. effects on blood pressure in
normotensive and hypertensive men. Br J
Urol 1998; 82: 373–9
4 The Seventh Report of the Joint
National Committee on Prevention,
Detection, Evaluation and Treatment
of High Blood Pressure. NIH Publication
03–5233: NIH, May 2003
5 di Priolo L, Priore P, Gocco C et al.
Dose-titration study of alfuzosin, a new
alpha1-adrenoceptor blocker, in essential
hypertension. Eur J Clin Pharmacol 1988;
35: 25–30
6 Sega R, Marazzi ME, Bombelli M et al.
Comparison of the new alpha1-blocker,
alfuzosin with propranolol as first-line
therapy in hypertension. Pharmacol Res
1991; 24: 41–52
Reply
Dr Wyllie made the following two points: (i)
the blood pressure was relatively low in the
hypertensive group; and (ii) the absence of a
decrease in blood pressure under alfuzosin in
the hypertensive group may be explained by
the relatively low baseline blood pressure in
this group, because alfuzosin has previously
been shown to have a significant effect on
blood pressure in other studies of
hypertensive patients.
The responses, provided in the same order as
the comments, are:
(i) Patients included in the analysis of
hypertensive patients in Table 3 of the
paper were those reporting a history of
hypertension at baseline and also include
those with controlled hypertension (i.e.
normal blood pressure) on antihypertensive
medications. This would explain the mean
values in the Table, which are lower than
expected for the definition of hypertension.
(ii) Dr Wyllie also mentions that alfuzosin had
been shown to lower blood pressure in two
early studies of hypertension [1,2]; in these
studies, older formulations (not once daily)
were used, at relatively higher doses (5 mg
twice daily to 20 mg four times daily [1];
2.5 mg up to 10 mg twice daily [2]); moreover,
the results showed a significant difference in
favour of propranolol at 4 weeks and there
was no equivalence of alfuzosin vs
propranolol [2], as mentioned.
The clinical uroselectivity of an a-blocker
(clearly shown with alfuzosin) is related to
many factors that contribute at different
levels to the final benefit/risk ratio, e.g.
pharmacological selectivity, absence of
passage through the blood–brain barrier,
preferential distribution in prostatic tissue,
dose, and formulation (C
max
, T
max
). Affinity
studies on human-cloned a1-receptor
subtypes showed that alfuzosin, like terazosin
and doxazosin, is devoid of significant
receptor subtype selectivity [3,4], but in
isolated human tissues, alfuzosin had the
highest selectivity ratio for the prostate over
vascular tissue (ratio 144) compared with
tamsulosin (90), doxazosin (51) and terazosin
(19) [5]. In addition, in a conscious-rat model,
it was shown that the primary effect of
alfuzosin is as a urethral relaxant and not an
antihypertensive effect [6]. Alfuzosin also
penetrates the brain poorly, which may
contribute to a lower incidence of CNS-
related adverse events, e.g. dizziness and
somnolence [7]. A preferential distribution in
prostatic tissue has also been reported [8].
While it is possible that high doses of other
SAFETY AND EFFICACY OF ALFUZOSIN
10 MG ONCE-DAILY IN THE TREATMENT
OF LOWER URINARY TRACT SYMPTOMS
AND CLINICAL BENIGN PROSTATIC
HYPERPLASIA: A POOLED ANALYSIS OF
THREE DOUBLE-BLIND, PLACEBO-
CONTROLLED STUDIES
Sir,
I read with interest the clinical summary of
the once-daily formulation of alfuzosin [1]
which confirms the utility of a-adrenoceptor
antagonists for treating LUTS associated with
BPH. As would be expected from any study
involving Prof Roehrborn, I particularly
appreciate the attention to detail. In this
context I wonder whether, in the same way
that BPH symptoms are stratified as mild,
moderate or severe, if patients with BPH who
were ‘hypertensive’ should be stratified
similarly. In the present study the
hypertensive patients were entered with a
mean blood pressure of ª 147/88 mmHg,
whereas in the comparable studies involving
doxazosin [2] and terazosin [3] the mean point
for the ‘hypertensive’ groups was anywhere
up to 162/99 mmHg. Although the patients in
the alfuzosin report met the definition of the
7th Joint National Committee (JNC-7) on
Hypertension as being hypertensive (i.e. a
systolic pressure of 140–159 or a diastolic of
90–99 mmHg) [4], many of the group judged
by the same criteria would be considered to be
normotensive. Intriguingly, in two early
studies alfuzosin lowered blood pressure in
essential hypertension, producing equivalent
reductions to propranolol [5,6]. On this basis,
although not affecting the interpretation of
the data, the reader might want to consider
Prof Roehrborn’s hypertensive patients as
having what was known as ‘borderline’
hypertension. However, after JNC-7 most of
the group would probably be best described as
having ‘pre-hypertension’ or Stage 1
hypertension [4].
M.G. WYLLIE, PhD, Urodoc Ltd, Herne Bay,
Kent, UK
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