STATISTICAL AND PHARMACOECONOMIC CHARACTERISTICS OF THE RESULTS OF CLINICAL RESEARCHES OF CHRONIC PROSTATITIS TREATMENT
DOI:
https://doi.org/10.11603/2312-0967.2019.2.10161Keywords:
chronic prostatitis, antibiotics, non-steroidal anti-inflammatory drugs, prostate protectors, clinical efficacy, equivalence, indicator “odds”, cost/efficiency ratioAbstract
The aim of the work. Statistical summary of clinical trials (CT) of drugs used in the treatment of chronic prostatitis (CP) as well as their pharmacoeconomic evaluation.
Materials and Methods. The materials of the study were: information of the Cochrane database on controlled trials and the Medline/PubMed website of the National Medical Library of the United States for 1995–2012 on the efficacy and safety of antibiotics (ABs), prostate protectors (PPs) and non-steroidal anti-inflammatory drugs (NSAIDs) in the treatment of CP; data from the Orange Book of the US Food and Drug Administration (OB); protocols of the Committee of Medicines for Humans of the European Medicines Agency (СНМР) and Rx index – Manual on the Equivalence of Medicines on the therapeutic equivalence and/or bioequivalence of medicines; information of the software complex “Pharmacy” dated January 2019 on the minimum purchase prices of drugs.
The methods of information search, analysis and synthesis, statistics and pharmacoeconomics, indicator “odds” as well as the index of CP of the US National Institute of Health (NIH-CPSI) were used for the evaluation of symptoms in CT.
Results and Ddiscussion. The results of published reviewed, randomized, placebo-controlled CT were arranged with the use of NIH-CPSI as a result of the ABs, PPs and NSAIDs application in the treatment of CP. The statistical generalization shows that the indicator “odds” (O) of ABs and PPs in the CT are more than 1 and range from 2.68 to 14.38 and from 1.27 to 3.29 respectively, which means that the clinical effect is more likely to observe. In the use of Rofecoxib (O = 3.76) also has the probability of clinical effect manifestation.
Information on the equivalence of ABs, PPs and NSAIDs registered in Ukraine for the treatment of CP was systematized. It was established that 3 trade names (TN) of Levofloxacin (one of them is in two doses) are present in the list of Rx index. However, it was found that Levofloxacin-Teva tab. 500 mg No. 10 (Actavis LTD, Malta) is present in two of the reviewed lists (OB and Rx index).
In addition, it was shown that the drugs from the subgroup of Silodosin are available only in the list of СНМР. In the Finasteride subgroup one drug Adenosteride-Zdorovye tab. 5 mg No.30 (Zdorovye, Ukraine) is present in the Rx index, but Proskar tab. 5 mg No. 28 (Merck Sharp and Dohme B.V., Nederlands) is present in two studied lists (OB and Rx index).
The cost/effectiveness ratio index for TN Levofloxacin, Ciprofloxacin, Tamsulosin, Serenoa repens, Finasteride, Silodosin and Rofecoxib was calculated. At the same time, the lowest rate of clinical efficacy was used for ABs, namely, for Levofloxacin – 92.0 %, Ciprofloxacin – 72.8 %, and in PPs – for TN, which showed clinical efficacy more than 70 %.
Conclusions. As a result of summarizing of clinical trials data on the use of drugs for the treatment of CP it was established that clinical efficacy of ABs is 92.0–93.5 % (Levofloxacin) and 72.8–76.8 % (Ciprofloxacin); of PPs is from 56.0 % (Silodosin) to 76.7 % (Serenoa repens); of NSAID Rofecoxib is 79.0 %. It was found that the probability of clinical effect manifestation is much greater in the treatment of CP with ABs (O = 2.68...14.38) and PPs (O = 1.27...3.29). At the same time, the best result is characteristic for AB Levofloxacin and it is noticeably better for such PPs as Serenoa repens, Finasteride and Tamsulosin. The cost/efficiency ratio shows that in January 2019 clinical and economic advantage of use of such drugs was obsedved: in the group of ABs among the Levofloxacin trade names for Levofloxacin tab. 500 mg No. 14 (Astrafarm, Ukraine) and among the Ciprofloxacin trade names for Ciprofloxacin tad. 250 mg No.10 (DZ GNCLS, Ukraine); in the group of PPs among the Tamsulosin trade names for Urimak caps. 0.4 mg No. 30 (Macleods Pharmaceuticals Ltd, India), among the Finasteride trade names for Adenosterid-Zdorovye tad. 5 mg No. 30 (Zdorovye, Ukraine) and among the trade names of herbal medicines for Prostamol® uno caps. 320 mg No. 30 (Berlin-Chemi AG, Germany).
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