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Correction to Lepor et al., N Engl J Med 335(8):533-540 August 22, 1996.

Correspondence
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Volume 336:293-294 January 23, 1997 Number 4
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Terazosin, Finasteride, or Both in Benign Prostatic Hyperplasia

 

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To the Editor: The study by Lepor et al. (Aug. 22 issue)1 confirms the efficacy of {alpha}1-adrenergic antagonists in the management of benign prostatic hyperplasia. It also underscores the importance of focusing on the patients' symptoms, rather than relying on proxy physiologic measurements that correlate variably with the symptoms.2,3 However, although the American Urological Association Symptom Index includes both "irritative" symptoms (frequency, urgency, and nocturia) and "obstructive" symptoms (weak stream and hesitancy), only the total scores were reported.1 It would be useful to know the score for each category of symptoms, because the degree of relief of the two types of symptoms may differ.3 For example, irritative symptoms may not improve to the same degree as obstructive symptoms after prostatectomy. This observation is of even greater concern in elderly men, who are more likely to be bothered by irritative symptoms than are younger men.3

In addition, low doses of {alpha}1-adrenergic antagonists may relieve irritative symptoms in many elderly men. In an earlier study of terazosin by the same group, relief of obstructive symptoms occurred only at the highest dose (10 mg), whereas irritative symptoms were relieved at lower doses (5 mg and possibly 2 mg).4 Although the new study was not designed to address this question, an analysis comparing the degree of relief of irritative and obstructive symptoms according to age would be of interest.1,4


George A. Kuchel, M.D.
Montreal General Hospital
Montreal, QC H3G 1A4, Canada


Catherine E. DuBeau, M.D.
Neil M. Resnick, M.D.
Brigham and Women's Hospital
Boston, MA 02115

References

  1. Lepor H, Williford WO, Barry MJ, et al. The efficacy of terazosin, finasteride, or both in benign prostatic hyperplasia. N Engl J Med 1996;335:533-539. [Free Full Text]
  2. Gormley GJ, Stoner E, Bruskewitz RC, et al. The effect of finasteride in men with benign prostatic hyperplasia. N Engl J Med 1992;327:1185-1191. [Abstract]
  3. DuBeau CE, Yalla SV, Resnick NM. Implications of the most bothersome prostatism symptom for clinical care and outcomes research. J Am Geriatr Soc 1995;43:985-992. [Medline]
  4. Lepor H, Auerbach S, Puras-Baez A, et al. A randomized, placebo-controlled multicenter study of the efficacy and safety of terazosin in the treatment of benign prostatic hyperplasia. J Urol 1992;148:1467-1474. [Medline]

 
To the Editor: Treatment with {alpha}1-adrenergic antagonists such as terazosin is known to cause orthostatic hypotension, the ultimate consequence of which is syncope. Lepor et al. excluded patients who had taken "any antihypertensive drug except a diuretic or an angiotensin-converting–enzyme inhibitor within two weeks before the lead-in period." Does this statement mean that only these two types of antihypertensive drug were used during the study?

It is unfortunate that the authors do not provide data on blood pressure measured in the supine and upright positions, especially in view of the fact that the frequency of dizziness, asthenia, and postural hypotension was significantly increased in the terazosin and combination-therapy groups. Although the number of men with syncope was similar in the four groups, the degree of the fall in blood pressure and the severity of symptoms may have varied. We think the discussion of the side effects in this well-designed study is a little too brief.


Theo Thien, M.D.
Jacques W.M. Lenders, M.D.
University Hospital Nijmegen
6500 HB Nijmegen, the Netherlands


 
Dr. Lepor replies:

To the Editor: Kuchel et al. ask about the effects of the different treatments on the symptoms of benign prostatic hyperplasia. Using the American Urological Association Symptom Index, which assesses seven symptoms characteristic of the disease, we found that terazosin and combination therapy resulted in a statistically significant and clinically important improvement in symptoms, but an analysis of individual symptoms was not done.

Thien and Lenders request clarification of an exclusion criterion. One of the many exclusion criteria was therapy with any antihypertensive drug other than a diuretic or an angiotensin-converting–enzyme inhibitor within two weeks before the beginning of the lead-in period. With respect to the relation between blood pressure and adverse events, orthostatic hypotension was defined as a fall of more than 20 mm Hg in the systolic blood pressure when the patient changed from the supine to the upright position. The percentages of men who had at least one episode of orthostatic hypotension during the study in the placebo, finasteride, terazosin, and combination groups were 30, 26, 45, and 39 percent, respectively, and syncopal episodes occurred in only 0, 1.0, 1.0, and 2.3 percent of the men.

In the article, in the right-hand column of page 537, the mean changes from base line in the serum prostate-specific antigen concentration at 52 weeks are stated incorrectly. The correct values are as follows: an increase of 0.1 ng per milliliter in the placebo group, a decrease of 0.9 ng per milliliter in the finasteride group, an increase of 0.4 ng per milliliter in the terazosin group, and a decrease of 0.9 ng per milliliter in the combination-therapy group.


Herbert Lepor, M.D.
New York University Medical Center
New York, NY 10016


 


 

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