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LLC Novartis Pharma, Moscow, Russian Federation Abstract. The problem of off-label use is still unsolved during the pharmacotherapy in children. In connection with the above, the need to stimulate the conduct of specially organized clinical studies, the purpose of which will be to evaluate the efficacy and safety of using drugs in children in different age groups, becomes evident. However the complexity of the organization of clinical studies in pediatrics is associated not only with regulatory aspects but also with lack of understanding of the importance of these studies by pediatricians and parents. The authors conducted a study aimed at finding out the frequency of off-label prescriptions in the Russian Federation in pediatric practice and doctors’ and parents’ attitude to this kind of use of medications. The study has shown the evidence that the off-label prescription practice is widely-used in healthcare in Russia and is routine for most respondents. The highest frequency of off-label prescriptions is observed in the group of children from 0 to 5 years. The majority of physicians and parents don’t consider themselves responsible for popularization of clinical trials which indicates that this problem should be widely discussed in the society. Parents trust physicians in terms of therapy choices or their recommendations regarding participation in clinical trials. A portrait of a typical “staunch opponent” of clinical trials among parents.

Studies have shown that exposure to organophosphates (OPs) is associated with increased frequency of gastrointestinal diseases. In order to evaluate the effect of dysfunction of detoxification system on the development of gastrointestinal pathology, we studied «esterase status» (activity of acetylcholinesterase, butyrylcholinesterase and paraoxonase 1 (PON1)) among workers at the plants providing storage and disposal of OPs. The enzymatic activity of PON1 was significantly increased in individuals who had prolonged direct contact with the OPs. It was shown that among all gastrointestinal diseases included in this study PON1 activity was increased in patients with chronic esophagitis and chronic gastritis as compared to workers without gastrointestinal diseases (p

Aim. To compare the dynamics of various parameters of circadian blood pressure profile (BP CP) and to assess the selection criteria for two combinations of the first-choice antihypertensive agents (AHA): angiotensin-converting enzyme (ACE) inhibitor plus thiazide diuretic (TD) or angiotensin II receptor antagonist (ARA) and calcium antagonist (CA) in patients with moderate to severe arterial hypertension (AH). Material and methods. This randomised study included 66 men aged 35-60 years with Stage 2-3 AH. Group I (n=37) received the combination of enalapril and hydrochlorothiazide (ENP + HCT; 20/12,5 mg/d), while Group II (n=29) was administered the combination of valsartan and S-amlodipine (VAL + S-AMD; 160/5 mg/d). All medications were taken daily, once a day. At baseline and after 12 weeks of the treatment, all participants underwent 24-hour blood pressure monitoring (BPM). The analysed parameters included: mean values and variability of systolic and diastolic BP (SBP, DBP), time index and pressure load index for SBP and DBP over 24 hours, dayand night-time, magnitude and velocity of SBP and DBP morning surge (MS), and diurnal/nocturnal BP ratio. Results. Twelve-week therapy with combinations significantly reduced mean SBP and DBP levels in patients with moderate to severe AH, regardless of the time of the day/night. It was also associated with reduced BP variability, mostly during the day-time. The ENP+HCT combination was more effective in terms of SBP MS reduction, while the VAL+S-AMD combination effect was more pronounced for DBP MS prevention. The VAL+S-AMD combination significantly improved diurnal/nocturnal BP ratio. Conclusion. The results obtained should be considered in the design of the antihypertensive combination therapy for Stage 2-3 AH patients with “non-dipper”, “night-peaker”, and “over-dipper” types of the two-phase BP CP.