Are drugs for the treatment of benign prostatic hyperplasia safe?

In December 2015, the Journal of Urology published the results of a new study that examined the safety of new drugs for the treatment of benign prostatic hyperplasia (BPH): doxazosin, finasteride, and their combination. The six most common side effects with their use were: dizziness, orthostatic hypotension, weakness, impotence, decreased libido and impaired ejaculation.

The study randomized 3047 men with BPH aged 50 years or older to receive placebo, doxazosin (4-8 mg), finasteride (5 mg), or doxazosin + finasteride. The follow-up period for patients averaged 4.5 years. The incidence of side effects was compared with placebo.

results

Analysis of the first year of therapy showed that the risk of developing dizziness

was significantly higher with the use of doxazosin (2.2 times; p<0.001) and the combination of drugs (2.8 times; p<0.001). After a year of treatment, only patients who were prescribed the combination of drugs were significantly more likely to report dizziness (2.1 times; p<0.001).

The risk of developing orthostatic hypotension during the first year of treatment was significantly higher when using doxazosin (2.4 times; p<0.001), as well as the combination of doxazosin and finasteride (2.7 times; p<0.001). Whereas after a year of therapy, only in patients receiving doxazosin, the incidence of orthostatic hypotension was 1.5 times higher (p=0.023).

Weakness

occurred significantly more often in patients receiving combination therapy in the first year of treatment (3.1 times; p=0.002), but then the frequency of its development was the same in the groups.

The analysis demonstrated that the incidence of impotence

in the first year of therapy was significantly higher when using finasteride (1.9 times; p=0.006) and the combination of doxazosin and finasteride (2.4 times; p <0.001). But after a year of therapy, the incidence of impotence was the same as in the placebo group.

Decreased libido

occurred significantly more often in patients receiving finasteride (1.7 times; p=0.021) and combination therapy in the first year of treatment (2 times; p=0.001), but then the frequency of its development was comparable to that in the placebo group.

Ejaculation disorder

occurred significantly more often when finasteride was prescribed (2.5 times; p=0.002) and a combination of drugs (5.5 times; p<0.001) in the first year of therapy. When using the drugs for more than a year only against the background of doxazosin + finasteride, the frequency of ejaculation disorders was increased (1.8 times; p = 0.045).

Source:

Lorraine L. Janeczko. More Side Effects in First Year With BPH Drugs. Medscape.com

OMNIK (capsules)

Back in another part of the country, the clinic told us that there was a similar drug with a similar effect and name.
And it was better for us to buy the second one... But by that time we had almost completed the course; nothing could be changed. I am writing this review from the point of view of the owners who observe the effect of this drug. Alas, the animal cannot say what it feels and how, so I want to write about what we observed. I hope the information is useful to you.

It is not difficult to buy the drug, you can do it without a prescription, but it was not available in every pharmacy. The cost is approximately 140 UAH (about 330 rubles). The box looks like this:

There is no special information on the sides. Be sure to check the expiration date.

The instructions are very large. But I advise everyone to read it, since the side effects are strong, and you need to know what will happen to you (your family). You can read part of the instructions in the photo:

There are no particular difficulties in application. We tried to give 1 capsule after breakfast at approximately the same time. I had to be careful about swallowing the medicine, since the capsule cannot be split.

Externally, the capsules differ from others, and therefore it is difficult to confuse them. The blister with them looks like this:

And the flip side:

Our application. We began to give this medicine as prescribed by the doctor during the disease crisis. On the 2nd day, it was easier for the dog to go to the toilet, but his general condition began to deteriorate. The temperature rose and did not fall. The husband decided to stop the drug after 4 days and look at the body’s reaction. The problem returned - it was impossible to urinate again. They chose the lesser of two evils and resumed the course again. The doctors who prescribed the drug said that the general poor condition of the body, as well as many possible side effects, is inevitable. But they won't be able to help with other drugs or treatments until this underlying crisis passes.

I had to wait for the entire course, about a month. The general condition was really bad. Yes, the dog began to go to the toilet easier and endure less. This became the main advantage of the medicine. But the stream was still thin and jerky, so I had to stand for a long time. We had a fever most days; the only difference was how high it was. The pet was very lethargic, he didn’t get up, let alone go for a walk. It was difficult to move his paws, so we tried, soon after breakfast, we started to have loose stools, so we calculated the time to go for a walk with him before lunch. Sometimes he refused to eat. In order not to put extra stress on the stomach and liver, we changed the diet.

Another property of the drug became no less serious. Despite the fact that it is considered an antibiotic and should kill all sorts of nasty things in the body, we had a slightly different effect. Yes, sometimes various bees, wasps, and insects tried to bite the dog; on a walk, sometimes he caught ostyuki (from a plant like a sharp grain). But often we found inflammation if it appeared and it went away quickly. And then what happened is unknown, but a lump began to form on our neck. It was getting bigger. Since at this time we often visited veterinarians, we were under supervision. The cause of the inflammation could not be determined. We were told that there was no point in opening it while we were using this drug. And at the end, “the inflammation will go away naturally.” So it actually happened that after finishing the course, on the 2nd day, an abscess opened in that place and additional treatment of the resulting wound was required. It’s hard for me to call it a coincidence, but I can’t explain the relationship either.

View the side effects indicated by the manufacturer in the table:

Bottom line. The effect after taking it lasted for a week. Then the problem returned, maybe just not with such force. I had to go to different veterinary hospitals in another city. I won’t say that the reception was in vain, but we are very glad that we no longer give it to our pet. You can read about a different drug prescribed in another review (“Prostatilen”).

Treatment of chronic pelvic pain in men. Chronic prostatitis

Some cases of acute prostatitis progress to chronic prostatitis. The existence of chronic bacterial (infectious) prostatitis is not in doubt. But if we take all cases of chronic prostatitis as 100%, then chronic bacterial prostatitis, which is most often caused by a group of Escherichia coli bacteria (E. coli), accounts for no more than 10-15% of cases. The remaining cases are not associated with infections in any way. Those. Most cases of diseases that cause pelvic pain in men can hardly be called chronic bacterial lesions of the prostate gland.

Multidisciplinary approach

The problem of chronic prostatitis is very complex, multifactorial, and has not been fully resolved by medical science. At the Ilyinskaya Hospital, a multidisciplinary team of experts deals with the treatment of chronic pelvic pain in men - urologists, proctologists, radiologists, neurologists, psychotherapists, pain treatment specialists, etc. Close interaction between doctors of different specialties, their deep clinical knowledge and analytical abilities allow for complex differential diagnosis , identify and eliminate the cause of pelvic pain.

Three-glass urine sample

This diagnostic test was developed in the 60s of the 20th century by two American urologist professors E. Meares and T. Stamey and made it possible to separate urinary tract infections (pyelonephritis, cystitis, inflammation of the kidneys and bladder) and inflammation that is located directly in the prostate gland . In this test, the patient is asked to urinate the very first portion of urine (10 ml) into the first tube. If there are a lot of leukocytes in this portion of urine, this clearly indicates urethritis, provided that there are no leukocytes in the remaining portions of urine. The patient should then release 50-100 ml of urine. Thus, he flushes the urethra, preventing material from the urethra from entering the next portion of urine. After this, the second 10 ml is collected - the second portion of urine. If there are no leukocytes in the second portion of urine, but there are in the first, then this is definitely urethritis. If there are leukocytes in both the first and second portions of urine, then this is inflammation of the higher parts of the genitourinary system - prostatitis, cystitis or pyelonephritis. After the second portion is collected, the patient undergoes a prostate massage. Its juice or secretion is squeezed out - in case of inflammation, leukocytes will get into it. It happens that the prostate secretion is not released. In any case, a third portion of urine is collected, another 10 ml, it washes away the prostate secretion, which was released into the urethra, but did not come out. If there are no leukocytes in the first and second portions of urine, but only in the third portion after prostate massage, then this is prostatitis. If there are leukocytes in all three portions, then the situation is complex - it could be prostatitis, cystitis, or pyelonephritis.

A three-glass urine sample allows you to establish the fact of inflammation in the prostate gland, i.e. the presence of leukocytes either in the secretion of the prostate or in a portion of urine that is released after a massage. The presence of white blood cells indicates that there is inflammation in the prostate gland. And if bacteria are sown from the post-massage portion, this is the same chronic bacterial prostatitis. But in the vast majority of cases, bacteria cannot be found.

In recent years, a three-glass urine sample has been simplified to a two-glass urine sample, in which the second portion of urine is not collected before the prostate massage, and the collected portion of urine after it from the 3rd becomes the 2nd. This is completely acceptable, does not affect diagnostic accuracy in any way and saves time.

Symptoms

There is no increase in body temperature with chronic prostatitis; the main symptom is chronic pain in the perineum. Sometimes patients compare this pain to a nail or pin. The pain can be quite intense, but it can also be moderate and dull. It can be constant, or it can occur in connection with sexual intercourse, physical activity or long walking. The pain may intensify at certain times of the day, often in the evening. The intensity of the pain may fluctuate, but the pain itself is almost constant. The second main symptom of chronic prostatitis is urination disorders - frequent, less often painful urination. Possible weakening of the urine stream, as with prostate adenoma. Sometimes with chronic prostatitis, libido decreases and erection weakens, which is most likely a consequence of prolonged pain in the perineum.

All patients who have pain require treatment. But there is another group of patients in whom the level of leukocytes in the prostate secretion is increased, but there is no pain. Previously, this form was called “prostatitis without prostatitis.” According to modern standards, such patients do not need to be treated. It has been proven that there is no correlation between the level of leukocytes and the intensity of pain. There may be many white blood cells, but the pain may be mild. Conversely, there may be no leukocytes at all, and the pain is simply unbearable. From the above it follows that the term “chronic prostatitis” itself is unfair. This condition should be called "chronic pelvic pain syndrome in men."

Forms of chronic pelvic pain syndrome in men (CPPS)

Chronic pelvic pain includes 4 forms. The first form, up to 15% of cases, is chronic bacterial prostatitis. With it there is pain, there is an increase in leukocytes in the prostate secretion and there are bacteria. The second form is chronic inflammatory non-bacterial prostatitis - there is an increase in the content of leukocytes, there is pain, but there is no infection. The third form is chronic non-inflammatory non-bacterial prostatitis - there are no leukocytes or bacteria, but there is pain. And the fourth form is asymptomatic non-bacterial chronic prostatitis, when there are leukocytes in the prostate secretion, but there are no symptoms - no pain, no urination disorders. Since the fourth form has no patient complaints, it is not treated. And those patients who complain of pain need treatment.

Difficulties in diagnosis

Even at the dawn of studying the problem of chronic prostatitis in the late 60s and early 70s, the co-author of the three-glass test, Edwin E. Meares, called chronic prostatitis “the trash can of clinical ignorance,” since chronic prostatitis is often called other diseases that are completely prostatitis. are not, but cause pain in the perineum in men. Therefore, if the patient has pain and other characteristic symptoms such as weakening of the urine stream, the urologist must exclude all diseases of the pelvic organs that can lead to the development of pain in the perineum. In other words, today's tactics for treating chronic pelvic pain syndrome in men is that chronic prostatitis itself is a diagnosis of exclusion. Those. it is placed last, when all other diagnoses have been excluded.

First of all, the patient is given a three- or two-glass urine sample to understand whether there is inflammation in the prostate gland or not, whether it is associated with infection or not. Then exclusion of urolithiasis is required. To do this, ultrasound or CT examinations are performed, which inform the doctor about the absence of stones in the bladder and in the lower third of the ureter - such stones can cause similar pain. The next step is to check the quality of urination - uroflowmetry. It shows how freely the bladder empties. The completeness of bladder emptying and the volume of residual urine are also determined. Prostate adenoma is excluded. If the urine stream is significantly weakened, urethral stricture should be excluded. An MRI and consultation with a proctologist are prescribed. Based on MRI data, proctologists can detect non-urological diseases - chronic hemorrhoids, rectal fissure, rectal fistula, inflammation of the pelvic muscles, neoplasms of the pelvic organs, and other diseases that can cause similar pain. Those. examination for suspected chronic prostatitis can be quite broad to exclude all possible causes of pelvic pain. And if such a reason is found, it must be eliminated.

Treatment of bacterial chronic prostatitis

If the bacterial nature of chronic prostatitis is confirmed, treatment consists of the use of antibiotics. Antibiotics are used that penetrate well into the prostate gland and are active against the so-called. gram-negative bacteria - primarily Escherichia coli, which most often causes bacterial prostatitis. The antibiotic, dose and duration of treatment must be prescribed by a doctor. As a rule, the duration of treatment of chronic bacterial prostatitis with an antibiotic is from 4 to 8 weeks.

In addition to antibiotics, alpha-blockers are prescribed. These drugs improve the quality of urination and the outflow of prostate secretions and relax the smooth muscles of the prostate. The duration of taking alpha-blockers is the same as the duration of taking antibiotics. Sometimes, especially in the presence of concomitant prostate adenoma, long-term or constant use of these drugs is required. To relieve pain, patients are prescribed anti-inflammatory drugs, usually containing ibuprofen or other non-steroidal anti-inflammatory drugs. They reduce swelling, reduce pain, and reduce inflammation activity. The duration of their use is usually no more than 2 weeks, since these drugs can cause adverse reactions from the gastrointestinal tract.

If many courses of antibiotic therapy have been carried out, but a stable result has not been achieved, another treatment method is used - direct injection of antibiotics into the prostate under ultrasound guidance. In some cases, just one injection of an antibiotic into the prostate gland leads to complete disappearance of pain.

Treatment of non-bacterial chronic prostatitis

In more than half of patients with chronic pelvic pain, no obvious cause of pelvic pain is found. In this case, urologists provide symptomatic treatment. First of all, a course of antibiotic therapy is prescribed for 2 weeks. And if during these two weeks the pain decreases, then another course of antibiotics is prescribed - from 2 to 4 weeks. Along with antibiotics, patients with chronic pelvic pain syndrome are prescribed alpha-blockers and non-steroidal anti-inflammatory drugs.

The urologists of the Ilyinskaya Hospital have at their disposal the most modern devices and apparatus for conducting physiotherapy. Methods of training the pelvic floor muscles with biofeedback and various shock wave effects are used. Physiotherapy can help reduce pain, but, unfortunately, it does not guarantee complete relief from pain in the perineum.

The classic method of treatment for non-bacterial chronic prostatitis is direct massage of the prostate gland. Massage improves drainage of the prostate gland and the outflow of secretions, and has a psychotherapeutic effect.

Sexually transmitted diseases (STDs) and chronic pelvic pain syndrome

Previously it was believed that prostatitis could be caused by gonorrhea and chlamydia. But the role of STDs in the development of chronic prostatitis has not been proven to date. These microorganisms live in the urethra in men, but they do not multiply in the prostate gland; this is not a suitable environment for them. However, if there is long-term chronic inflammation in the urethra, then the local resistance of the mucosa is reduced, and a favorable environment is formed for the proliferation of E. coli, which can enter the prostate gland and cause its inflammation. A number of scientific works have confirmed that antibiotic therapy aimed not at E. coli, but at chlamydia, gives a positive result in chronic prostatitis.

Pain management

Even if the causes of chronic pelvic pain cannot be found, the pain syndrome can be eliminated. At the Ilyinskaya Hospital, this is done by a unique group of algol specialists (from the Greek Algos - pain), using pain management technologies. Patients undergo therapeutic blockades - under X-ray or ultrasound control, a needle is brought to the nerve responsible for conducting pain impulses. An anesthetic is injected into the area of the nerve. The positive effect occurs quickly and lasts up to 6 months. If the therapeutic blockade is not enough, radiofrequency ablation is performed - destruction of the nerve with a high-frequency electric field. The conduction of pain impulses is blocked; the analgesic effect of this procedure can be very long-lasting.

A common cause of chronic pelvic pain is phantom pain. The source of pain has been eliminated, but a persistent focus of increased pain arousal has formed in the brain, and the patient continues to feel pain. This condition is called “central sensitization phenomenon” or neuropathic pain. To relieve it, specialists at the Ilyinskaya Hospital use drug regimens using a new generation of antidepressants and anticonvulsants. To learn more.

Psychotherapeutic support

Chronic pain has a serious negative impact on the patient's psyche. Neuroses, depression, and anxiety disorders may develop. “Tunnel vision” occurs - a condition when the patient does not notice anything except his pain, his perception of the world narrows. Psychotherapists at the Ilyinskaya Hospital will help the patient correct the perception of pain, restore social activity, support family relationships, and give a feeling of health and well-being. If necessary, maintenance drug therapy is prescribed.

Magazine archive /
2017 /

The effectiveness of the use of drugs Omnic and Omnic Ocas in patients with lower urinary tract symptoms due to benign prostatic hyperplasia (multicenter observational program)

DOI: https://dx.doi.org/10.18565/urology.2017.5.42-47

BOO. Shalekenov, E.A. Kuandykov, S.B. Shalekenov
JSC "Kazakh Medical University of Continuing Education", Department of Urology and Andrology, Almaty, Kazakhstan

The purpose of this study was to examine the effectiveness and safety of 6-month use of Omnic and Omnic Ocas in patients with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) in routine urological practice in Kazakhstan. Design. The design of the project was a multicenter prospective observational program that involved the collection of data from patients with symptoms of urinary dysfunction due to BPH who received Omnic Ocas or Omnic as primary therapy. Materials and methods. The program included 1513 patients with a verified diagnosis of LUTS/BPH who were treated with Omnic Ocas or Omnik (tamsulosin) by urological specialists in medical institutions in the Republic of Kazakhstan. Study According to the protocol, 1381 patients completed the study. The average age of the patients was 63 years. The study program included three control visits: visit 1 (initial), during which the patient filled out the I-PSS questionnaire on symptoms and quality of life, determined the maximum urine flow rate (Qmax) according to uroflowmetry and prostate volume according to digital rectal study, the level of PSA in the blood plasma was assessed. Visit 2 and Visit 3 were carried out on average 3 and 6 months, respectively, after Visit 1 and reflected the assessment of the outcomes of the prescribed therapy during the observation period of the patient. Results. During the 6-month treatment, an improvement in clinical symptoms was noted on the I-PSS scale for patients of different age groups. The drug therapy used was more effective for patients with urine flow Discussion. The results of a significant improvement in urinary function in all patients with lower urinary tract symptoms and benign prostatic hyperplasia who took part in the study according to the protocol and received therapy with Omnic Ocas or Omnic (tamsulosin) (n=1381) indicate the following: in age groups “under 55 years”, “55–65 years” and “over 65 years” a decrease in symptoms was observed (the total score on the I-PSS scale after 6 months of therapy decreased by 41.6%), the feeling of incomplete emptying of the bladder after urination was reduced, the need to urinate more often than 2 hours after urination is reduced, and a decrease in the intermittency of the stream is noted. The therapy was well tolerated: adverse events were reported in 1.6% of patients. Thus, we can conclude that the drugs Omnik and Omnik Okas are highly effective in all age groups of patients with LUTS/BPH and the favorable safety profile of these drugs in routine clinical practice. Conclusion. The data obtained allow us to conclude that the drugs Omnik and Omnik Okas are highly effective in all age groups of patients with LUTS/BPH and the favorable safety profile of these drugs.

Key words: symptoms of urinary dysfunction, benign prostatic hyperplasia, tamsulosin, controlled absorption system for oral administration, α1-adrenergic receptors

Read the article in the Doctor's Library

Literature

1. McVary KT, Roehrborn CG, Avins AL, Barry MJ, Bruskewitz RC, Donnell RF, Foster HE Jr, Gonzalez CM, Kaplan SA, Penson DF, Ulchaker JC, Wei JT Update on AUA guideline on the management of benign prostatic hyperplasia. J Urol. 2011;185(5):1793–803.

2. Singh I., Agarwal V., Garg G. Tamsulosin and Darifenacin Versus Tamsulosin Monotherapy for BPH with Accompanying Overactive Bladder. J. Clin Diagnosis Res. 2015;9(6):PC08–11.

3. Yuan JQ, Mao C., Wong SY, Yang ZY, Fu XH, Dai XY, Tang JL Comparative Effectiveness and Safety of Monodrug Therapies for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: A Network Meta-analysis. Medicine (Baltimore). 2015;94(27):e974.

4. Bishr M., Boehm K., Trudeau V., Tian Z., Dell'Oglio P., Schiffmann J., Jeldres C., Sun M., Shariat SF, Graefen M., Saad F., Karakiewicz PI Medical management of benign prostatic hyperplasia: Results from a population-based study. Can Urol Assoc J 2016;10(1-2):55–59.

5. Carnevale FC, Antunes AA, da Motta Leal Filho JM et al. Prostatic artery embolization as a primary treatment for benign prostatic hyperplasia: preliminary results in two patients. Cardiovasc Intervent Radiol. 2010;33(2):355–361.

6. Michel MC et al. Cardiovascular Safety of the Oral Controlled Absorption System (OCAS) Formulation of Tamsulosin Compared to the Modified Release (MR) Formulation. Eur Urol. 2005;4(2 Suppl):53–60.

About the authors / For correspondence

AUTHORIZATION: B. U Shalekenov – Doctor of Medical Sciences, Professor, Head. Department of Urology and Andrology JSC “Kazakh Medical University of Continuing Education” Almaty, Kazakhstan; e-mail