E Stoner

Cornell University, Ithaca, New York, United States

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Publications (70)268.15 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: To evaluate familial aggregation and the mode of inheritance of bothersome benign prostatic hyperplasia (BPH). During an extension of the North American Finasteride Trial, 301 of 895 patients and 158 spousal controls completed a family history questionnaire. Segregation analysis was performed to examine the mode of inheritance in first-degree relatives of the 301 probands. The lifetime cumulative probability of bothersome BPH was similar in relatives of those with BPH (0.35; 95% confidence interval [CI] 0.28 to 0.44) and spousal controls (0.36; 95% CI 0.22 to 0.56), but the age of onset was significantly earlier in relatives of cases than controls (P = 0.001). Fathers of those with BPH had a significantly elevated risk of bothersome BPH (unadjusted odds ratio [OR] 2.1; 95% CI 1.2 to 3.8) and brothers had a significantly elevated risk of both bothersome BPH (OR 3.5; 95% CI 1.7 to 7.3) and transurethral resection of the prostate (OR 3.6; 95% CI 1.4 to 8.8). After adjusting for family size, the risk of bothersome BPH increased approximately twofold with each additional affected first-degree relative (0 relatives, OR 1.0; 1 relative, OR 1.7; 2 relatives, OR 4.7). Segregation analysis suggested a rare autosomal codominant allele (frequency 0.0004). These findings confirm previous findings that family history and early age of onset are associated with an increased risk of BPH and that the most likely mode of inheritance is autosomal dominant or codominant. Bothersome BPH appears to have a weaker genetic component than more restrictive definitions of hereditary BPH. Thus, linkage studies are more likely to be successful if they focus on stricter definitions of hereditary BPH (eg, early onset, large volume, strong family history) rather than symptomatic or clinical BPH.
    Urology 05/2003; 61(4):781-5. · 2.42 Impact Factor
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    ABSTRACT: To summarize the 6-year clinical trial data with finasteride. Benign prostatic hyperplasia is a chronic and progressive disease and therefore assessment of long-term safety and efficacy is important. The North American and International Phase III Finasteride trials enrolled symptomatic men with enlarged prostate glands. The initial 1-year placebo-controlled study was followed by a 5-year open-label extension. In total, 6-year finasteride data were available in 487 patients originally randomized to finasteride, and 5-year data were available on 238 patients originally randomized to placebo. After 6 years of treatment with finasteride 5 mg, the mean quasi-American Urological Association Symptom Score improved by 4.0 points, the median prostate volume decreased by 24%, and the mean maximal urinary flow rate increased by 2.9 mL/s (P <0.001 for all parameters). Long-term finasteride treatment was well tolerated, with a low incidence of drug-related sexual adverse events occurring during the first year and even fewer occurrences during the 5-year open extension. Treatment with finasteride leads to durable improvement in urinary tract symptoms, flow rate, and prostate volume, with no increase in the prevalence of drug-related adverse events over time.
    Urology 04/2003; 61(4):791-6. · 2.42 Impact Factor
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    ABSTRACT: To evaluate the effects of finasteride, a specific type II 5-alpha-reductase inhibitor, on symptoms of benign prostatic hyperplasia, prostate volume, and urinary flow during a 7 to 8-year period. A total of 190 men with symptomatic benign prostatic hyperplasia and enlarged prostates entered one of two Phase II double-blind 3 to 6-month studies. Of these, 156 patients continued taking open-label finasteride, and more than 70 patients completed 7 to 8 years of treatment. The symptoms were scored using a patient self-administered modified Boyarsky symptom questionnaire. Prostate volume was measured by magnetic resonance imaging or ultrasonography, and the maximal urinary flow rate was assessed noninvasively. Treatment with finasteride for 7 to 8 years led to sustained improvement in symptoms, reduction in prostate volume (28% from baseline), and increased urinary flow (median 2.5 mL/s from baseline). Decreases in dihydrotestosterone (86%) and prostate-specific antigen (54%) levels were also maintained. Long-term finasteride treatment was safe and generally well tolerated. Long-term treatment with finasteride was well tolerated and resulted in durable symptom relief and improvement in prostate volume and urinary flow.
    Urology 01/2003; 60(6):1040-4. · 2.42 Impact Factor
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    ABSTRACT: Background. Benign prostatic hyperplasia is a progressive, androgen-dependent disease resulting in enlargement of the prostate gland and urinary obstruction. Preventing the conversion of testosterone to its tissue-active form, dihydrotestosterone, by inhibiting the enzyme 5α-reductase could decrease the action of androgens in their target tissues; in the prostate the result might be a decrease in prostatic hyperplasia and therefore in symptoms of urinary obstruction.Methods. In a double-blind study, we evaluated the effect of two doses offinasteride (1 mg and 5 mg) and placebo, each given once daily for 12 months, in 895 men with prostatic hyperplasia. Urinary symptoms, urinary flow, prostatic volume, and serum concentrations of dihydrotestosterone and prostate-specific antigen were determined periodically during the treatment period.Results. As compared with the men in the placebo group, the men treated with 5 mg of finasteride per day had a significant decrease in total urinary-symptom scores (P <0.001), an increase of 1.6 ml per second (22 percent, P <0.001) in the maximal urinary-flow rate, and a 19 percent decrease in prostatic volume (P <0.001). The men treated with 1 mg of finasteride per day did not have a significant decrease in total urinary-symptom scores, but had an increase of 1.4 ml per second (23 percent) in the maximal urinary-flow rate, and an 18 percent decrease in prostatic volume. The men given placebo had no changes in total urinary-symptom scores, an increase of 0.2 ml per second (8 percent) in the maximal urinary-flow rate, and a 3 percent decrease in prostatic volume. The frequency of adverse effects in the three groups was similar, except for a higher incidence of decreased libido, impotence, and ejaculatory disorders in the finasteride-treated groups.Conclusions. The treatment of benign prostatic hyperplasia with 5 mg of finasteride per day results in a significant decrease in symptoms of obstruction, an increase in urinary flow, and a decrease in prostatic volume, but at a slightly increased risk of sexual dysfunction.
    The Journal of Urology 03/2002; 167(2 Pt 2):1102-7; discussion 1108. · 3.70 Impact Factor
  • John D. McConnell, Elizabeth Stoner
    Advances in Protein Chemistry - ADVAN PROT CHEM. 01/2001; 56:143-180.
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    ABSTRACT: We evaluated prostate volume and prostate-specific antigen (PSA) as predictors of acute urinary retention (AUR) in men with benign prostatic enlargement (BPE). Data were pooled from 3 identical 2-year, multinational, multicenter, non-US, placebo-controlled finasteride trials in 4,222 men with BPE and no evidence of prostate cancer. The 2-year incidence of spontaneous AUR was higher in placebo patients with enlarged prostates (4.2% in men with prostate volume > or =40 ml vs. 1.6% in the <40 ml group) and higher PSA levels (3.9% in men with PSA > or =1.4 ng/ml vs. 0.5% in the <1.4 ng/ml group) at baseline. Finasteride reduced AUR incidence by 61% in men with larger prostates, by 63% in men with higher PSA levels, and by 47% in men with smaller prostates, compared with placebo. BPE patients with larger prostate volumes, higher PSA levels and no evidence of prostate cancer have an increased risk of developing AUR and therefore derive the greatest benefit from the risk reduction seen with finasteride therapy.
    European Urology 12/2000; 38(5):563-8. · 10.48 Impact Factor
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    ABSTRACT: Objectives: We evaluated prostate volume and prostate–specific antigen (PSA) as predictors of acute urinary retention (AUR) in men with benign prostatic enlargement (BPE).Methods: Data were pooled from 3 identical 2–year, multinational, multicenter, non–US, placebo–controlled finasteride trials in 4,222 men with BPE and no evidence of prostate cancer.Results: The 2–year incidence of spontaneous AUR was higher in placebo patients with enlarged prostates (4.2&percnt; in men with prostate volume ≥40 ml vs 1.6&percnt; in the
    European Urology - EUR UROL. 01/2000; 38(5):563-568.
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    ABSTRACT: The purpose of this open-label study extension was to assess the long-term safety and efficacy of finasteride in the treatment of men with benign prostatic hyperplasia (BPH). A Phase III North American BPH trial originally enrolled 895 men, 297 of whom were randomized to receive finasteride 5 mg. An enlarged prostate gland by digital rectal examination, symptoms of urinary obstruction, and a maximal urinary flow rate of less than 15 mL/s were required for entry. Patients who completed the initial 12-month, double-blind, placebo-controlled study were invited to participate in an open-label extension for 4 additional years. Of the 297 patients initially randomized to receive finasteride 5 mg, 259 completed 12 months in the double-blind period and 186 completed 48 months of open-label therapy. Prostate volume reached a nadir of -24.6% at month 24, and the effect was maintained through month 60. Compared with baseline values, month 60 prostate volume was decreased by 22.7% (P<0.001), the quasi-American Urological Association symptom score was decreased by 4.3 points, and maximal urinary flow was increased by 2.3 mL/s (P<0.001) on average. Finasteride was well tolerated, with no significant increase in the prevalence of sexual adverse events over time. Patients treated with finasteride 5 mg maintained an initial decrease in prostate volume and improvement in symptom score and maximal urinary flow rate over 5 years.
    Urology 04/1999; 53(4):690-5. · 2.42 Impact Factor
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    ABSTRACT: To determine the long-term effects of finasteride treatment on prostate tissue composition; to relate these effects to clinical outcomes; and to test the hypothesis that finasteride exerts a selective or preferential action on the transition zone. Nineteen men with symptomatic benign prostatic hyperplasia (BPH) who completed a 6-month double-blind trial of finasteride were enrolled in a 24-month open-label extension study of drug responders. Magnetic resonance imaging and prostate biopsy for morphometric analysis were performed together 70 times: at baseline (n = 19), after treatment periods of intermediate duration (6 to 18 months, n = 32), and after long-term drug treatment (24 to 30 months, n = 19). At baseline, prostate volume averaged 51 cc, of which 57% was transition zone. Decreases in symptom score, dihydrotestosterone and prostate-specific antigen levels, and prostate volume occurred at 6 months (P <0.01), stabilized, and were maintained without further long-term decreases. Prostate epithelium contracted progressively from baseline (19.2% tissue composition; 6.0-cc volume; 3.2 stroma/epithelial ratio) to intermediate (12.5%, 3.3 cc, and 5.6, respectively) to long-term treatment (6.4%, 2.0 cc, and 17.4, respectively, P <0.01 for all). Percent epithelial contraction was similar in the peripheral and transition zones (P = NS). The transition zone remained a relatively constant proportion (53% to 58%) of whole-prostate volume from baseline to long-term observation. Long-term finasteride treatment (24 to 30 months) results in a marked involution of the prostate epithelium, which continues to progress for many months after clinical effects stabilize. The effect on the epithelium is similar in the peripheral and transition zones for both morphometric and volumetric changes. Progressive contraction of the prostate epithelium appears to constitute the underlying mechanism for sustained action of finasteride.
    Urology 04/1999; 53(3):574-80. · 2.42 Impact Factor
  • Urology 01/1999; 53(4). · 2.42 Impact Factor
  • Urology 01/1999; 53(3). · 2.42 Impact Factor
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    ABSTRACT: BACKGROUND The Early Intervention Study, a placebo-controlled clinical trial, enrolled approximately 200 patients between age 45–65 years who had mild symptoms associated with early benign hyperplasia (BPH). Prostate volume was measured by magnetic resonance imaging (MRI) and read by the local radiologist, who was blinded to the treatment group but not to the sequence of MRI scans. In order to ascertain whether knowledge of the sequence of the MRI scans by the local radiologist was introducing bias in prostate volume changes, a single radiologist was selected to reread all MRI scans at the end of the study.METHODS Each film was masked as to patient identity, study drug, and date. A new randomization schedule was prepared to blind the single reader to both sequence and treatment. The two sets of readings were compared.RESULTSAccuracy was dramatically improved when defined as percentage of patients with a 20% or more decrease in prostate volume, from 14% to 0% in placebo patients, and from 38% to 29% in finasteride patients. The variability was significantly reduced (by 50%) when read by a single observer [1].CONCLUSIONSA single reader, blinded to time sequence as well as to therapy, improves the accuracy and precision of the measurements when compared to multiple readers, blinded only to drug therapy. Prostate 31:98–102, 1997. © 1997 Wiley-Liss, Inc.
    The Prostate 12/1998; 31(2):98 - 102. · 3.84 Impact Factor
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    ABSTRACT: Finasteride therapy for benign prostatic hyperplasia (BPH) results in a marked lowering of serum prostate specific antigen (PSA) levels. However, little is known about the effect of finasteride on unbound or free serum levels of PSA. Such information would be important since percent free PSA may substantially improve the cancer specificity of PSA testing. Thus, we prospectively studied the effect of finasteride therapy on total and free serum PSA levels. In a randomized, placebo controlled, double-blind trial 40 men with histologically confirmed BPH (age range 52 to 78 years) were treated with either 5 mg. finasteride daily (26 patients) for 9 months or placebo (14) for 6 months. Prostate volume was assessed by transrectal ultrasound. Serum levels of free and total PSA were measured from archived serum samples stored at -70C at baseline and for as long as 9 months of treatment. In the finasteride group mean total PSA levels declined from 3.0 ng./ml. at baseline to 1.5 ng./ml. after 6 months of treatment (50% decrease, p <0.01). In the placebo group, with similar baseline levels, no significant change was observed. PSA density declined significantly in finasteride treated men (p <0.01) but not in men receiving placebo. The mean percent free PSA (13 to 17% at baseline) was not altered significantly by finasteride or placebo. Total PSA serum levels decreased by an average of 50% during finasteride therapy but percent free PSA did not change significantly. This information is potentially useful in the interpretation of PSA data used for early detection of prostate cancer in men receiving finasteride. However, further studies are required to demonstrate the use of percent free PSA to detect the development of cancer.
    The Journal of Urology 02/1998; 159(2):449-53. · 3.70 Impact Factor
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    ABSTRACT: We sought to quantify prostate tissue changes induced by finasteride and to identify a predictor of finasteride response in men with symptomatic benign prostatic hyperplasia (BPH) via a randomized, placebo controlled, double-blind clinical trial. Men with symptomatic BPH (52 to 78 years old) were randomly assigned to 6 months of treatment with finasteride (26) or placebo (15). Outcome measures were clinical (urinary symptom score and flow rate), chemical (serum prostate specific antigen and dihydrotestosterone levels), volumetric (transrectal ultrasound, and magnetic resonance imaging for whole and zonal prostate volumes) and histological (morphometry of prostate sextant biopsies, separated into inner and outer gland segments, to measure the percent epithelium, stroma and glandular lumen). In the finasteride group we found a suggestion of decreasing symptom scores and increasing flow rates (not significant) with significant decreases (p < 0.01) in prostate specific antigen (48%), dihydrotestosterone (74%) and prostate volume (21%). Finasteride treatment induced a 55% decrease in inner gland epithelium (p < 0.01) with little effect on stroma or lumina. We also found a linear correlation between pretreatment inner gland epithelial content and prostate volume decrease induced by the drug (tau = 0.58, p = 0.01). Finasteride treatment results in a major suppression of prostate epithelium, which is most pronounced in the inner gland. Moreover, a finasteride induced prostate volume decrease was predictable by quantification of epithelial tissues of the inner gland. These data lend additional support to the emerging concept of transition zone primacy in symptomatic BPH.
    The Journal of Urology 07/1997; 157(6):2171-8. · 3.70 Impact Factor
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    ABSTRACT: The Early Intervention Study, a placebo-controlled clinical trial, enrolled approximately 200 patients between age 45-65 years who had mild symptoms associated with early benign hyperplasia (BPH). Prostate volume was measured by magnetic resonance imaging (MRI) and read by the local radiologist, who was blinded to the treatment group but not to the sequence of MRI scans. In order to ascertain whether knowledge of the sequence of the MRI scans by the local radiologist was introducing bias in prostate volume changes, a single radiologist was selected to reread all MRI scans at the end of the study. Each film was masked as to patient identity, study drug, and date. A new randomization schedule was prepared to blind the single reader to both sequence and treatment. The two sets of readings were compared. Accuracy was dramatically improved when defined as percentage of patients with a 20% or more decrease in prostate volume, from 14% to 0% in placebo patients, and from 38% to 29% in finasteride patients. The variability was significantly reduced (by 50%) when read by a single observer [1]. A single reader, blinded to time sequence as well as to therapy, improves the accuracy and precision of the measurements when compared to multiple readers, blinded only to drug therapy.
    The Prostate 06/1997; 31(2):98-102. · 3.84 Impact Factor
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    ABSTRACT: We attempted to determine the clinical and biological characteristics of familial benign prostatic hyperplasia (BPH). Urinary flow rate, prostate size, symptom score, serum prostate specific antigen, testosterone and dihydrotestosterone were measured in subjects who participated in the nationwide Merck phase III finasteride clinical trial. Findings in the 69 men with familial BPH (3 or more family members with BPH, including the proband) were compared to those in the 345 with no family history of BPH. Logistic regression was used to detect relationships between familial BPH, and these variables before and after 5 alpha-reductase inhibition with finasteride. Familial BPH was characterized by large prostate size. Mean prostate volume in men with familial and sporadic BPH was 82.7 and 55.5 ml., respectively (p < 0.001). Other clinical findings, including serum androgen levels and response to finasteride, were similar in familial and sporadic BPH. The frequency of familial BPH in patients with prostate size in the largest and smallest deciles was 46 and 13%, respectively. Familial BPH in this group of patients was associated with large prostate size, normal serum androgen levels and normal response to 5 alpha-reductase inhibition. A genetic factor responsible for familial BPH may exert its influence through androgen independent control of prostatic growth.
    The Journal of Urology 04/1997; 157(3):876-9. · 3.70 Impact Factor
  • Journal of Urology - J UROL. 01/1997; 158(6).
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    ABSTRACT: The effects of urinary symptoms on health-related quality of life (HRQL) are important in therapeutic decision making. Few have evaluated the treatment effects on HRQL in men with benign prostatic hyperplasia (BPH), even though increased urinary symptoms are associated with greater worry, bother, and interference with living activities. We report on patient assessments of such disease-specific measures as well as general HRQL measures from two placebo-controlled clinical trials of finasteride in the treatment of symptomatic BPH. Patients treated with finasteride appeared to have greater improvement than placebo-treated patients in disease-specific measures and in patient global assessment. The treated group appeared to have a greater mean increase in sexual domain scores. As expected, general measures (health rating, life satisfaction, ladder of life) changed little. Thus, treatment with finasteride appears to reduce bother, worry, and activity interference due to symptoms but in a small percentage of men may lead to slightly reduced sexual function.
    The Prostate 09/1996; 29(2):83-90. · 3.84 Impact Factor
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    ABSTRACT: We reviewed the available data on the effect of finasteride on serum levels of prostate specific antigen (PSA), PSA velocity and PSA density in men with benign prostatic hyperplasia (BPH) and prostate cancer. To our knowledge all previously published analyses of PSA data from clinical trials of finasteride therapy for BPH and prostate cancer are reviewed. The normal reference range of serum PSA levels in men with BPH and no evidence of prostate cancer who were treated with finasteride for 6 months or longer is half that in untreated men with BPH. The percent by which serum levels of PSA are suppressed after 6 months of treatment for prostate cancer does not tend to be greater than that for BPH. To interpret serum PSA levels in men with BPH treated with finasteride for 6 months or longer, the serum PSA level should be multiplied by 2 and compared to either age-independent or age-specific upper limits of normal for serum PSA in untreated men with BPH. On the basis of limited data the sensitivity and specificity of this approach appear to be similar to those of the corresponding PSA limits in untreated men with BPH.
    The Journal of Urology 02/1996; 155(1):3-9. · 3.70 Impact Factor
  • Elizabeth Stoner
    Prostate. 01/1996; 29:82-87.

Publication Stats

2k Citations
268.15 Total Impact Points

Institutions

  • 1990–2003
    • Cornell University
      Ithaca, New York, United States
  • 2000
    • University of Vienna
      Wien, Vienna, Austria
  • 1999
    • Tampa Bay Research Institute
      St. Petersburg, Florida, United States
    • University of California, Los Angeles
      • Department of Urology
      Los Angeles, CA, United States
  • 1994
    • Dalhousie University
      Halifax, Nova Scotia, Canada
  • 1992
    • University of Texas Southwestern Medical Center
      • Department of Internal Medicine
      Dallas, TX, United States
  • 1991
    • KU Leuven
      • Centre for Clinical Pharmacology
      Leuven, VLG, Belgium
  • 1989
    • Ghent University
      • Endocrinology
      Gent, VLG, Belgium