Therapy adherence, safety and efficacy of rivaroxaban in prevention of venous thromboembolism in patients with hip or knee endoprosthesis.

PURPOSE: Rivaroxaban is a potent, selective direct inhibitor of factor Xa. The aim of this study was to evaluate the therapy adherence, safety and efficacy of rivaroxaban therapy in reducing the risk of venous thromboembolism in patients undergoing elective hip or knee replacement. METHODS: The prospective, post-marketing clinical trial was conducted on adult patients after knee or hip endoprosthesis. Data were collected at the baseline and three control visits (five days, a month and three months after the baseline). Morisky Medication Adherence Scale (MMAS-8) was used for evaluation of therapy adherence. RESULTS: The study included 60 patients who received rivaroxaban therapy in a dose of 10 mg once a day. A low adherence to the drug was observed in 15% patients. All patients had an average MMAS-8 score in the range of high adherence 0.65 ± 0.90. Symptomatic venous thromboembolism was observed in two patients with numerous risk factors. No major bleeding was recorded during entire follow-up period. During the five-day postoperative in-hospital follow-up, signs of wound complications were recorded in 8 (13.3%) patients, and 4 (6.7%) of them underwent surgical revision of the wound. CONCLUSION: Generally, there was high adherence to rivaroxaban therapy, but low adherence was present in 15% of patients. Rivaroxaban showed good safety and efficacy. However, high proportion of wound complications and patients needing surgical revision of the wound should be further evaluated through larger studies.

Non-interventional Pilot Study Evaluating the Efficacy and Safety of Lysozymebased Therapy in Patients with Non-infectious Sore Throat.

OBJECTIVE: This study aimed to evaluate the efficacy and safety of lysozyme-based oral antiseptic in the therapy of non-infectious sore throat in teachers. MATERIALS AND METHODS: A non-interventional, prospective, pilot study was conducted with two examinations. The first was performed as part of a general medical examination. If a non-infectious sore throat was confirmed by clinical checkup and all other inclusion and non-exclusion criteria confirmed, patients were offered to be enrolled in the study. After signing the informed consent form, patients were advised to use lysozyme-based lozenges, six times a day, for a period of five days. A telephone call follow-up examination was performed within 24 hours from the therapy completion. RESULTS: This was a pilot study involving 25 adult patients of both genders. Lysozyme-based lozenges showed positive effects in relieving the symptoms of non-infectious sore throat in teachers. At the same time, the lozenges showed excellent tolerability, and no side effects were reported during the study. 92% of patients confirmed they would take the same medicine again due to the same problem. CONCLUSION: The results of this "proof-of-concept" study indicated that lysozyme-based antiseptic could be effective and safe in the treatment of non-infectious sore throat in teachers and should be further evaluated as treatment option in this condition.

Nifuroxazide Has Better Efficacy Than Probiotic Treatment in Adult Patients with Acute Diarrheal Syndrome.

Background: Acute gastroenteritis remains an extremely common problem among the general population. In Western countries, an average person will probably face one or two episodes of gastrointestinal infections every year. Objective: The aim of this study was to compare the efficacy of nifuroxazide and probiotic preparation containing lactic acid bacteria in the treatment of acute diarrheal syndrome. Methods: The study was prospective, comparative study. Patients who suffered from acute infective diarrhoea for ≤72 hours and had ≥3 unformed stools per day, with no administration of antibiotics during 10 days before enrolment were divided into two groups: nifuroxazide group and the lactic acid probiotic group. All patients received therapies four times a day for three days. Data was collected at the baseline visit (before the initiation of the treatment) and two follow-up examinations on the third and seventh day from the treatment start. Results: The study included 61 patients, 36 in nifuroxazide group and 25 in probiotic group. Nifuroxazide group compared to probiotic group showed faster improvement of patients' condition with lower number of stools three and seven days after therapy start (p=0.001 and p<0.001 respectively) and faster stool consistency normalization. On the seventh day from therapy start medium mushy stool consistency was observed in the majority of patients in nifuroxazide group (n=31, 86%) and only in small number of patients in probiotic group (n=5, 20%). Patients were feeling better and there was a trend of reporting better therapy efficacy in nifuroxazide group. Subjective assessment of therapy tolerability was also better in nifuroxazide group. Compliance to therapy and recommended dietary regime was similar between groups and there were no significant differences between groups regarding age, gender, elevated body temperature, abdominal pain, cramps, nausea and vomiting. Conclusion: Although probiotics are sometimes used in the treatment of acute diarrheal syndrome, nifuroxazide has better efficacy and greater patients' satisfaction. Nifuroxazide can be recommended as the first choice empirical treatment in adult patients with the acute diarrheal syndrome.

The Efficacy and Tolerability of a Fixed Combination of Perindopril and Indapamide in the Treatment of Unregulated Essential Hypertension - a Postmarketing Study.

OBJECTIVE: The objective of this non-interventional post-marketing clinical trial was to analyze the antihypertensive effect and safety of a fixed combination of perindopril and indapamide in the treatment of unregulated essential hypertension. PATIENTS AND METHODS: The prospective clinical trial included patients aged 20 to 75 years with essential hypertension and blood pressure values ≥ 140/90 mmHg at baseline. On the basis of the investigator's decision, patients received 2 mg perindopril + 0.625 mg indapamide (group 2+0.625) or 4 mg perindopril + 1.25 mg indapamide (group 4+1.25). RESULTS: The study included 1173 patients (426 patients in group 2+0.625 and 747 patients in group 4+1.25) at 27 investigational centers in Bosnia and Herzegovina. Mean blood pressure values at baseline and visits after nine months were significantly higher in the 4+1.25 group compared to the 2+0.625 group. There was a significant drop in systolic and diastolic blood pressure in both groups. The target values of systolic and diastolic blood pressure, according to the European Society of Cardiology (2018), were reached after nine months of therapy by more than 80% of patients in the 2+0.625 group, and this number was significantly higher compared to the 4+1.25 group where more than 60% of patients reached target values. Newly diagnosed patients had a better response to therapy. The percentage of patients receiving additional antihypertensive therapy decreased by the end of the study. Age, gender and the existence of diabetes mellitus were identified as negative predictors of target blood pressure achievement. The therapy showed a good safety profile. CONCLUSION: A fixed combination of perindopril and indapamide was effective and safe in the treatment of unregulated essential hypertension.

Comparative Study of the Efficacy of the Lysozyme, Benzydamine and Chlorhexidine Oral Spray in the Treatment of Acute Tonsillopharyngitis - Results of a Pilot Study.

OBJECTIVE: Lysozyme is a natural antimicrobial and immunomodulatory enzyme, which is produced as a host response to infectious agents. The objective of this study was to compare the efficacy and safety of lysozyme-based versus benzydamine and chlorhexidinebased oral spray in patients with an acute tonsillopharyngitis associated with a common cold. PATIENTS AND METHODS: A prospective twoarm pilot study (lysozyme/cetylpyridinium/lidocaine spray versus: benzydamine spray-arm 1; chlorhexidine/lidocaine spray-arm 2) was conducted in the primary health care unit. Efficacy was evaluated by the patient's self-assessment of pain, difficulty in swallowing and the throat swelling, by using the visual analog scale (VAS) at baseline and three follow-up visits. Safety was evaluated by the assessment of the frequency and severity of adverse effects. RESULTS: Lysozyme-based spray reduced pain faster than benzydamine-based spray and slower than chlorhexidine-based spray. Lysozyme-based and chlorhexidinebased sprays similarly reduced difficulty in swallowing, but were faster than benzydamine-based spray. Similar effects on the reduction of throat swelling were seen in all treated groups. All tested products showed proper safety and were well tolerated, with no serious adverse events reported. CONCLUSIONS: The lysozyme-based oral spray was shown to be effective and safe in the reduction of pain, difficulty in swallowing and throat swelling in patients with acute tonsillopharyngitis associated with a common cold. Lysozyme-based oral spray (containing natural compound with advantages of influencing immune system and preventing recurrences) had similar activity to benzydamine and chlorhexidine-based oral antiseptic sprays.

Efficacy of carbocisteine in the treatment of chronic obstructive pulmonary disease and impact on the quality of life.

Aim To investigate the effects of carbocisteine treatment in the reduction of frequency of productive cough episodes, preventing disease progression and improving the quality of life as well as the tolerability of the administered treatment and patient compliance during the study. Methods This observational, non-interventional, multicenter, cohort study included 501 patients with chronic obstructive pulmonary disease (COPD) who were administrated carbocisteine capsules 375 mg and followed up during the next 15 days. The patients were observed at 3 points, baseline and two additional assessments. General clinical condition of patients, along with the spirometry testing at all three points were examined. Thr quality of life was assessed on the 1st and 3rd observation with Leicester Cough Questionnaire. Tolerability and patient compliance were measured throughout the study. Results There was a significant change of forced expiratory volume in 1 second (FEV1) status between the second and third observation (p=0.002). Examination of general symptoms showed a statistically significant reduction in cough by 74.9%, in sputum production by 48.5%, in dyspnea by 29% and in fatigue by 50%. After the administration of carbocisteine the median value of overall quality of life was 3.79 (3.63 - 3.89). Conclusion 375mg carbocisteine capsules were found to be effective and well-tolerated in the treatment of COPD, with a small percentage of reported mild adverse reactions and with a significant improvement of quality of life.

Open Clinical Trial on Using Nifuroxazide Compared to Probiotics in Treating Acute Diarrhoeas in Adults.

BACKGROUND: Nifuroxazide is well known and often used anti-diarrhoeal medicine which has been pushed back from routine practice in recent years and often replaced with probiotics. Even probiotics are accepted and placed in some therapeutic guidelines for diarrhoea treatment, there are no enough evidence for its effectiveness and no comparative efficacy data with nifuroxazide in treatment of acute diarrhea. PATIENTS AND METHODS: In open, prospective observational study, the efficacy and safety of nifuroxazide were compared with a probiotic containing lactic acid bacteria in the treatment of acute diarrhoea. A total number of 169 adult patients were included in this study, who administered nifuroxazide in the dose of 200 mg/4 times a day, while they took preparation containing lactic acid bacteria (1,2 x 107 live lyophilised lactic-acid bacteria) three times a day for three days. RESULTS: Mean time to last unformed stool (TLUS) in a group which was treated with nifuroxazide was two days, while it took five days for the stool normalisation in the group using probiotic (p=0.0001). CONCLUSIONS: Orally administered nifuroxazide has demonstrated better efficiency as compared to probiotic in treating acute diarrhoea, and both medicines have shown the same safety and tolerance in this study.

Efficacy and Safety of Oral Spray Containing Lysozyme and Cetylpyridinium: Subjective Determination of Patients with Tonsillopharyngitis.

INTRODUCTION: Tonsillopharyngitis (sore throat) is a common disease mainly related to the seasonal common cold. To relieve unpleasant symptoms and discomfort of acute tonsillopharyngitis associated with common cold, patients usually take some non-prescription drugs. THE AIM: The primary aim of this study was to assess subjective determinations of the efficacy and the safety/tolerability of an oral spray comprising a combination of lysozyme chloride and cetylpyridinium chloride in those patients. MATERIAL AND METHODS: The study involved 1727 patients with tonsillopharyngitis associated with common cold and treated with the studied drug, in the period from December 2014 through March 2015. RESULTS: In total, 95% of patients rated the studied drug to be well, very well and excellently effective. In 32% of patients, the symptoms were relieved 10 minutes after the application of the spray. Significant correlations were found between the two subjective assessments of the drug efficiency with the total of 74.11% (95% CI: 73.41, 77.47%) of patients who said that the feeling of pain in the throat completely disappeared after the drug administration, evaluated the impact/effect of the drug was very good or good (Pearson Chi Square=391.401, p<0.001). The effectiveness was significantly better in patients with up to two episodes of common cold a year (Pearson Chi Square=6.101; p=0.014). The studied drug was rated to be well, very well and excellently tolerated by 97% of patients. CONCLUSION: According to patients' subjective assessment, the combination of lysozyme chloride and cetylpyridinium chloride in a formulation of spray can quickly, efficiently and safely resolve the symptoms of acute tonsillopharyngitis associated with common cold.