Biomedical subjects

L M Eri

Publications and source records attributed to L M Eri.

At least 37 records · Page 2Linked to original sources

PubMed1994

Safety, side effects and patient acceptance of the luteinizing hormone releasing hormone agonist leuprolide in treatment of benign prostatic hyperplasia.

The luteinizing hormone releasing hormone agonist leuprolide was investigated in a double-blind, randomized, placebo-controlled study comprising 50 evaluable patients with moderate to severe symptoms resulting from benign prostatic hyperplasia. Patients received 3.75 mg. leuprolide depot or placebo as an injection every 28 days for 24 weeks. Hemoglobin level decreased by 0.8 gm/100 ml. (p = 0.0052) for patients receiving leuprolide. Mean testicular volume decreased by 28.9% (p < 0.001) compared to placebo. Of 26 patients receiving leuprolide 5 had a weight gain of more than 3 kg. Almost all patients receiving leuprolide experienced hot flushes. Breast changes, and loss of energy and vigor were not more pronounced than for patients receiving placebo. Erectile function and sexual activity were lost during treatment. Libido also decreased but was still partially retained. Despite this, patients receiving leuprolide were generally contented with their sexual life during treatment. Side effects were bothersome for some patients but were reversible. Of the patients in our study 73% expressed that they could repeat or continue treatment if that had been possible. The high cost of these drugs will limit their use for a benign condition, such as benign prostatic hyperplasia.

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PubMed1994

Safety, side effects and patient acceptance of the antiandrogen Casodex in the treatment of benign prostatic hyperplasia.

Casodex, a new nonsteroidal antiandrogen, was investigated in this double-blind, randomized, placebo-controlled study comprising 28 evaluable patients with benign prostatic hyperplasia, who received Casodex at a dosage of 50 mg daily or a placebo for 24 weeks. The good safety profile of Casodex was confirmed. In common with other nonsteroidal antiandrogens, Casodex was associated with breast enlargement and/or tenderness, being reported by all patients upon direct questioning. A change in sexual function was assessed by two questionnaires, one of them revealing no statistically significant difference between the groups. However, using an alternative questionnaire, approximately half of the patients reported reduced erectile function (p = 0.002), mostly partial, and reduced sexual activity (p = 0.015), whereas libido was well maintained when compared to the placebo. Casodex was not associated with hot flushes. No other side effects of clinical significance were seen, and Casodex was well tolerated by the majority of the patients.

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PubMed1993

A prospective, placebo-controlled study of the antiandrogen Casodex as treatment for patients with benign prostatic hyperplasia.

Casodex, a new nonsteroidal antiandrogen, is presently being investigated in phase III studies as a new hormonal treatment for advanced prostatic cancer. The safety and efficacy of Casodex at a dosage of 50 mg. daily for 24 weeks in patients with benign prostatic hypertrophy were investigated in this double-blind placebo-controlled trial, initially planned for 60 patients. Inclusion was discontinued at 30 patients after report of liver toxicity when Casodex was given long-term at high doses to mice. Prostate volume was decreased by 26.4% at the end of therapy (3.7% in the placebo group). The differences between Casodex and placebo therapy for the changes in values from baseline to 24 weeks of treatment in maximum urinary flow rate at spontaneous micturition and after instillation of saline were 0.8 and 1.4 ml. per second (not statistically significant). Pressure-flow examinations and frequency-volume charts did not show any treatment effect. Casodex patients tended to obtain more improvement in symptom scores than placebo patients, reaching statistical significance for irritative symptoms at week 24. Even if all patients had side effects, mostly mild, Casodex was well tolerated and patient compliance was excellent.

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PubMed1993

A prospective, placebo-controlled study of the luteinizing hormone-releasing hormone agonist leuprolide as treatment for patients with benign prostatic hyperplasia.

Several physicians have used luteinizing hormone-releasing hormone agonists for small, selected groups of patients with benign prostatic hyperplasia but their clinical role in this indication is still not well defined. We investigated the effect of the luteinizing hormone-releasing hormone agonist leuprolide given as an injection every 28 days for 24 weeks in a double-blind, placebo-controlled trial with 50 evaluable patients along an extensive protocol with the main emphasis on objective parameters for outcome assessment. Prostate volume decreased by 34.5% (2.6% in the placebo group). Maximum flow rate at spontaneous micturition and after instillation of saline improved by 2.0 ml. per second (32%) and 3.0 ml. per second (54%) more than with placebo. Detrusor pressure during micturition decreased by approximately 24% for patients who received leuprolide compared to placebo and was accompanied by a 25% increase in flow rate, which indicated decreased bladder outlet resistance. Improvement in urodynamic parameters generally was of statistical significance. Symptom scores improved significantly for both groups throughout the study when compared to those before treatment. At between group comparison, the improvement for irritative symptoms in favor of leuprolide reached statistical significance at week 48. With few exceptions, leuprolide patients tolerated the treatment well even if they had side effects, such as flushing and decreased sexual function.

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PubMed1992

Patient recruitment to and cost of a prospective trial of medical treatment for benign prostatic hyperplasia.

409 consecutive patients, referred by general practitioners for assumed benign prostatic hyperplasia (BPH), were evaluated for inclusion into a hormone therapy trial for BPH. 97 patients were excluded initially. Upon examination of the 312 remaining patients, 221 were found to be ineligible for various reasons and 11 refused to participate. Other patients were excluded after a second, more extensive examination and 5 patients withdrew during the trial. We are now left with 66 patients (16.1% of the patients initially referred), of which approximately 33 are receiving placebo treatment. The financial costs for the hospital to carry out a drug trial with approximately 65 evaluable patients is estimated to exceed 40,000 pounds.

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PubMed1992

Measuring the quality of life of patients with benign prostatic hyperplasia. Assessment of the usefulness of a new quality of life questionnaire specially adapted to benign prostatic hyperplasia patients.

A questionnaire consisting of 36 questions based on a visual analogue scale for measuring the quality of life (QOL) of benign prostatic hyperplasia (BPH) patients is presented and assessed. The sensitivity of the questionnaire is demonstrated by its ability to register a statistically significant (p less than 0.01) improvement of QOL after prostate surgery (transurethral resection of the prostate). Its reliability is shown by its ability to give reproducible results in a nonoperated BPH patient group. Patient compliance has been excellent. It is discussed to what extent questions directly concerning symptoms from prostatism should be included in QOL questionnaires for BPH patients. Nonparametric statistics are applied. It is concluded that questionnaires like this are useful tools in the assessment of BPH patients, irrespective of the treatment modality. They will probably be of particular value in studies of drug therapy of BPH, complementing methods of assessment like symptom score and urodynamic parameters.

Humans↗

PubMed1988