FINASTERIDA: TEN YEARS OF CLINICAL USE. SYSTEMATIC REVIEW OF THE LITERATURE

The fundamental objective of treating patients with benign prostatic hyperplasia (BPH) is to improve their symptoms and quality of life.

The symptoms can be produced by an increase in prostate size and / or an increase in alpha-adrenergic activity, with obstruction of the lower urinary tract.

Epidemiological and natural history studies of patients with lower urinary tract symptoms secondary to BPH indicate that age, symptom level, prostate volume and maximum urinary flow value are indicators of the risk that the patient has of needing surgery or suffering from acute urinary retention (AUR). Those patients with more than one risk factor will have a higher probability of AUR 

Available treatments must meet the following criteria to be considered an acceptable option:

– Efficacy and Safety Studies in randomized, placebo-controlled clinical trials with a minimum follow-up of 1 year.

– That they are drugs that improve the patient’s symptoms and / or prevent complications.

– That they have minimal morbidity and mortality, compared with standard treatment or with transurethral resection of the prostate (TUR) and that they do not interfere with the quality of life of the patient, and finally.

– That they have long-term studies maintaining the demonstration of efficacy and safety, that it is compared with existing treatments and that cost-effectiveness studies are carried out with new and existing treatments.

Among the treatment options are considered first line by the latest international consensus of the World Health Organization: antagonists of alpha adrenergic receptors whose most important molecules are alfuzosin, doxazosin, terazosin and tamsulosin and inhibitors of 5- alpha-reductase whose most important molecules are finasteride and dutasteride.

The other treatment options such as “wait and see” should be used in patients with mild symptoms and little impact on quality of life. Surgical treatment is the last and most aggressive option, with morbidity (hematuria, urethral stricture, urinary infection, epididymo-orchitis, etc.) that is between 15-20%. It is an option to propose to patients with moderate and severe symptoms and significant impairment of the quality of life, who do not accept or do not respond to drug treatment.

A final factor to consider is the existence of comorbidity associated with BPH, with the association between ischemic heart disease, arterial hypertension and BPH being quite frequent.

A decade has passed since the clinical introduction of Finasteride in the treatment of BPH. For this reason, we propose to review the literature, with the criteria mentioned above, to assess the current status of the drug.

MATERIAL AND METHOD

Inclusion criteria are established that must be met by those works that are finally going to be reviewed. The analysis is carried out on studies whose design corresponds to controlled and randomized clinical trials, meta-analyzes, mixed follow-up studies with intervention (open extensions of clinical trials), health-related quality of life studies, and drug studies. -economic.

The studies analyzed include patients aged between 50 and 85 years with lower urinary tract symptoms suggestive of BPH, measurements of maximum urinary flow (LMF) between 5 ml and 15 ml / s, whose detrusor (bladder muscle) pressure a maximum flow was greater than 50 cm of water, presenting residual urine volumes greater than 150 ml and prostate enlargement verified by digital palpation (DRE), ultrasound, Computerized Axial Tomography or Magnetic Nuclear Resonance. The type of intervention consists of treatment with finasteride compared with placebo or finasteride compared with alpha-blockers or plant extracts alone or in combination.

Those studies whose patients included subjects with evidence of active urinary tract infection, chronic prostatitis, neurogenic bladder, or prostatic carcinoma were excluded.

The following results were analyzed:

– Lower urinary tract symptoms evaluated by questionnaires such as the International Prostatic Symptom Score (IPSS), American Urological Association Symptom Index (AUASI) and Boyarski.

– Quality of life with questionnaires such as the BPH Impact Index (BII).

– Measurement of prostate volume (PV).

– Maximum urinary flow (LUM).

– Influence on the natural history of the disease:

?? Incidence of acute urinary retention (AUR).

?? Incidence of surgical treatment.

– Adverse Effects (AE) related to the drug: dysfunction in the sexual sphere.

– Cost-effectiveness evaluation.

The strategy for locating scientific papers focuses on the use of computer databases available in Medline, Embase, Healthstar and the Cochrane Library from 1990 to June 2002. For the location of published papers, terms in controlled language were used with the different Mesh: “finasteride”, “benign prostatic hyperplasia”, “prostate” and the different subheadings: cost, economics, quality, adverse events; combined and related through the different Boléan operators. The use of methodological filters in the search strategy improved the location of those studies with an optimal level of evidence: meta-analysis, systematic reviews and clinical trials. They are therefore collected,

Two independent reviewers selected the studies for inclusion, assessing the quality level of each one, the differences were resolved after discussion. The articles are analyzed and classified according to the classification scale of the level of scientific evidence, in order to establish hierarchically different levels of evidence based on the scientific rigor of the study design. In our analysis we start from the criteria of the AATM (Agéncia d ??

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