[Randomized study of tolerability, safety and efficacy of Pletax in intermittent claudication]. / Randomizirovannoe issledovanie perenosimosti, bezopasnosti i éffektivnosti preparata Pletaks pri peremezhaiushcheisia khromote.

AIM: This study was aimed at assessing tolerability, safety and therapeutic efficacy of Pletax® (cilostazol) compared with Trental® (pentoxifylline) in patients with moderate-to-severe intermittent claudication. PATIENTS AND METHODS: The study included a total of one hundred 40-to-65-year-old patients presenting with confirmed diagnosis of moderate-to-severe intermittent claudication. Depending on the therapeutic regimen, the patients were divided into two groups. Group 1: 50 patients orally took Pletax® (cilostazol) at a dose of 100 mg twice daily 30 minutes before meals or 2 hours after meals together with conventional therapy. Group 2: 50 patients took oral Trental® (pentoxifylline) in a dose of 400 mg 3 times daily 30 minutes before meals or 2 hours after meals along with conventional therapy. The duration of the follow up period amounted to 24 weeks for both groups. The treadmill test was carried out at room temperature, with the running track tilt angle of 0° at a speed of 3 km/h. The primary parameters of efficacy were as follows: the dynamics of the minimal walking distance (a distance walked by the patient until the appearance of pain in the extremity) and dynamics of the maximal walking distance (a distance walked by the patients until full stop due to pain in the extremity). RESULTS: Analysing efficacy demonstrated higher results of Pletax® compared with Trental®. The obtained findings suggested that Pletax® showed a significant clinical effect as soon as at 2 weeks, followed by advantage during the whole period of follow up. Analysing the parameters of the minimal and maximal walking distances in the group of patients taking Pletax® demonstrated clear superiority over the Trental® group as soon as by week 2 of administration, which preserved during the whole follow-up period. The minimal pain-free walking distance in the Pletax group at baseline amounted to 92.9±83.4 m (Trental group - 92.3±78.4; p=0.3), followed by an increase at week 8 to 126±115 m (Trental group - 116±96.3; p=0.51), at week 16 to 136±116 m (Trental group - 118±95.5; p=0.04), at week 24 to 149±126 b (Trental group - 127±98.9; p=0.01). At the same time, the effect of Pletax® and Trental® on the secondary parameter of efficacy, i.e., the ankle-brachial index was comparable: at baseline - 0.472 and 0.482 (p=0.28), at 2 weeks - 0.48 and 0.483 (p=031), at 8 weeks - 0.49 and 0.485 (p=0.74), at 16 weeks - 0.494 and 0.492 (p=0.2), at 24 weeks - 0.501 and 0.496 (p=0.45). CONCLUSION: The obtained findings demonstrated advantages of Pletax® over Trental®, manifesting themselves in the achievement of the highest parameters by such criteria as the minimal and maximal walking distance. High safety and efficacy of Pletax® were confirmed by low frequency of unfavourable events during therapy.

[Analysis of the state-of-the-art of consulting medical care to patients with glucocorticoid-induced osteoporosis or its risk according to the data of a questionnaire survey (GLUCOST study)].

AIM: To analyze the state-of-the-art of consulting medical care to Russian patients with glucocorticoid-induced osteoporosis (GCOP) or its risk. SUBJECTS AND METHODS: This GLUCOST study was organized and conducted by the Russian Association of Osteoporosis. A total of 1129 patients with chronic inflammatory diseases, who had been taking oral glucocorticosteroids (OGCSs) a long time (3 months or more), were examined. The patients filled out an anonymous questionnaire on their own. Whether the measures taken to diagnose, prevent, and treat GCOP complied with the main points of Russian clinical guidelines was assessed. RESULTS: 61.8% of the patients knew that the long-term treatment of GCOP might cause osteoporosis. 48.1% of the respondents confirmed the results of bone densitometry; 78.1% of the patients reported that they had been prescribed calcium and vitamin D supplements by their physician, but their regular intake was confirmed by only 43.4%; 25.4% of the patients had sustained one low-energy fracture or more. Treatment for GCOP was prescribed for 50.8% of the patients at high risk for fractures, but was actually received by 40.2%. Therapeutic and diagnostic measures were implemented in men less frequently than in women. When the patient was aware of GCOP, the probability that he/she would take calcium and vitamin D supplements rose 2.7-fold (95% Cl; 2.1 to 3.5; p = 0.001) and that he/she would follow treatment recommendations did 3.5-fold (95% Cl; 2.3 to 5.3; p = 0.001). Bone densitometry increased the prescription rate for antiosteoporotic medication and patient compliance. CONCLUSION: According to the data of Russia's large-scale GLUCOST survey, every four patients with chronic inflammatory disease who are on long-term OGCS therapy have one low-energy fracture or more. Due to inadequate counseling, the patients are little aware of their health and do not get the care required to prevent the disease. Less than 50% of patients who have GCOP and a high risk for fractures undergo examination and necessary treatment aimed at preventing fractures.

[Preliminary results of an open-label observational study evaluating the efficacy and safety of Prolia used in women with postmenopausal osteoporosis].

AIM: To evaluate the efficacy and safety of Denosumab (Prolia), a first-line osteoporosis (OP) medication that is a fully human monoclonal antibody to the receptor activator of nuclear factor xB ligand (RANKL), within an open-label observational study. SUBJECTS AND METHODS: Patients aged 50 years or older with postmenopausal OP, who were treated with Prolia in clinical practice, were examined. The concentrations of the bone resorption (BR) marker of C-terminal telopeptide and other laboratory indicators (total serum calcium, total alkaline phosphatase, and creatinine) were measured following 3 months. Adverse drug reactions were recorded. RESULTS: Three months after initiation of the investigation, there was a significant decrease in the BR marker C-terminal telopeptide (by 89%; p<0.0001). There were rare adverse reactions: hypocalcemia in 3 (5.9%) patients, arthralgias in 2 (3.9%), and eczema in 1 (1.9%). There were neither serious adverse events nor study withdrawal cases. CONCLUSION: The preliminary results of the open-label study of Prolia in postmenopausal OP suggest that the significantly lower BR activity determines the efficacy of this drug and its high safety.

[Incidence rates of articular pain in urban and rural population of Russia (preliminary data)].

AIM: Screening of the population sample for articular pain and swelling. MATERIAL AND METHODS: A screening questionnaire for detection of arthritides and arthralgias was filled in for each adult rural and urban citizen aged over 18 years from 15 RF regions. Rural population was covered with a complete examination, urban one was examined by formation of a representative sample from general population. The screening covered a total of 31424 persons, mean age of whom was 47.6 +/- 17.6 years. Among them 14001 lived in the cities and 17423 in the villages. 61% respondents were women. RESULTS: Prevalence of arthralgias in the population reaches 46%. While the symptoms alleviated with time in 8%, they became chronic in the rest. The articular complaints rate in the population is sex-related and depends on the age. In persons under 20 years arthralgia occurs in 9%. Urban citizens have articular pains more frequently than rural population--43 and 33%, respectively. CONCLUSION: Pilot results of the screening program demonstrate prevalence of arthralgias in Russia and the importance of joint pathology problem in Russia.

[The x-ray morphometric characteristics of the spine in persons 50 and older]. / Rentgenomorfometrichskaia kharakteristika pozvonochnika u lits 50 let i starshe.

To specify shape of the vertebra in relation to age and sex, the authors studied roentgenomorphometric evidence upon examination of the thoracic and lumbar spine in 600 patients over 50. Vertebral deformities were found in 45.1 and 44.5% of the examined males and females, respectively. Changes corresponding to vertebral body fracture were recorded in 12.3% of the males and 15.3% of the females. Age-related trends in the frequency of various defects have been analyzed. The frequency differed in males and females.

[The epidemiology of osteoporotic fractures in the population of the city of Yaroslavl]. / Epidemiologiia osteoporoticheskikh perelomov v populiatsii goroda Iaroslavlia.

Prevalence and types of hip and spinal fractures were studied in Yaroslavl citizens aged > 50 years. In 1985 prevalence of hip fractures was 36.41 per 100000, in 1993-145, 84 per 100000. Maximal number of the fractures occurred in patients aged over 70 years. Fractures of the thoracic and lumbar spine were registered in 15.00 per 100000 with an increase in 1994. Osteoporotic hip fractures in the population sample occurred less frequently than fractures of the non-typical sites.

[Epidemiology of hip fractures in age groups at high risk for osteoporosis]. / Epidemiologiia perelomov bedra v vozrastnykh gruppakh povyshennogo riska po osteoporozu.

In accordance with the program on osteoporosis epidemiology in subjects over 50, a retrospective study of hip fracture incidence in populations of two Russian towns (Elektrostal and Yaroslavl) was performed. The total population of Elektrostal and Yaroslavl is above 100000 and 600000, respectively. The analysis of medical records of the traumatological departments of the central city hospitals where patients with hip fractures have been admitted and files from outpatient traumatological stations was performed for 1986-1991 and 1982-1991. The towns' administration provided statistical data on relevant population number and age distribution. Hip fracture has been defined as a fracture of the femoral neck or intertrochanteric region fracture (ICD 9 code 820.0 and 820.2). The incidence of hip fracture for the examined period for the town of Elektrostal made up 61/100000 person-years (32 males and 77 females) and for the town of Yaroslavl 61/100000 person-years (45 males and 70 females). Male/female ratio was 1:2 and 1:15, respectively. The occurrence of hip fractures was maximal in subjects over 75 years old. More recent data showed no significant differences in the incidence of hip fractures in the two towns, except a significant rise in hip fracture incidence in female residents of Yaroslavl. Compared to European countries, the incidence of hip fractures in the above towns was significantly lower. The reasons of these differences are unclear and need further investigation.

[The prevalence of and risk factors for osteoarthrosis in workers in tire manufacture]. / Rasprostranennost' i faktory riska osteoartroza u rabochikh shinnogo proizvodstva.

The data of epidemiological studies of rheumatic diseases, carried out at the Yaroslavl tire factory among 2508 workers are provided. Overall 845 subjects afflicted with different rheumatic diseases were identified. The prevalence of osteoarthrosis of the peripheral joints was 12.68 +/- 0.66%. The main industrial risk factors of osteoarthrosis were distinguished: occupational hazard (physical overloads), work record in the main specialty over 5 years, functional and static-dynamic loads of the bones and joints, elevated temperature and air humidity in industrial premises. As to the other factors, age, defects of the skeleton, hereditary load, foci of chronic infection, primary education, female sex, and the character of feeding turned out significant for the development of osteoarthrosis. The authors have worked out the tables of risk for osteoarthrosis of the peripheral joints, the use of which allows predicting the morbidity of every worker and distinguishing risk groups with a purpose of carrying out early treatment and prophylactic measures.