ObjectiveTo investigate whether a fixed-dose combination (FDC) of 0.5 mg dutasteride and 0.4 mg tamsulosin is more effective than watchful waiting with protocol-defined initiation of tamsulosin therapy if symptoms did not improve (WW-All) in treatment-naïve men with moderately symptomatic benign prostatic hyperplasia (BPH) at risk of progression. Patients and MethodsThis was a multicentre, randomised, open-label, parallel-group study (NCT01294592) in 742 men with an International Prostate Symptom Score (IPSS) of 8-19, prostate volume ≥30 mL and total serum PSA level of ≥1.5 ng/mL. Patients were randomised to FDC (369 patients) or WW-All (373) and followed for 24 months. All patients were given lifestyle advice. The primary endpoint was symptomatic improvement from baseline to 24 months, measured by the IPSS. Secondary outcomes included BPH clinical progression, impact on quality of life (QoL), and safety. ResultsThe change in IPSS at 24 months was significantly greater for FDC than WW-All (-5.4 vs −3.6 points, P < 0.001). With FDC, the risk of BPH progression was reduced by 43.1% (P < 0.001); 29% and 18% of men in the WW-All and FDC groups had clinical progression, respectively, comprising symptomatic progression in most patients. Improvements in QoL (BPH Impact Index and question 8 of the IPSS) were seen in both groups but were significantly greater with FDC (P < 0.001). The safety profile of FDC was consistent with established profiles of dutasteride and tamsulosin. ConclusionFDC therapy with dutasteride and tamsulosin, plus lifestyle advice, resulted in rapid and sustained improvements in men with moderate BPH symptoms at risk of progression with significantly greater symptom and QoL improvements and a significantly reduced risk of BPH progression compared with WW plus initiation of tamsulosin as per protocol.Keywords benign prostatic hyperplasia, dutasteride, fixed-dose combination, lower urinary tract symptoms, tamsulosin, watchful waiting [Correction added on 13 February 2015 after first online publication: The trademark symbol for 'Duodart' has been changed to a registered symbol]

BackgroundIn the Commonwealth of Independent States (CIS) countries the epidemiology of chronic obstructive pulmonary disease (COPD) is poorly characterized. The objective of this analysis is to present the prevalence, burden and risk factors associated with COPD in three CIS countries as part of the CORE study (Chronic Obstructive Respiratory Diseases), the rationale and design of which have been described elsewhere.MethodsA total of 2842 adults (≥18 years) were recruited (964 in Ukraine, Kiev, 945 in Kazakhstan, Almaty and 933 in Azerbaijan, Baku) between 2013 and 2015 during household visits. Two-step cluster randomization was used for the sampling strategy. All respondents were interviewed about respiratory symptoms, smoking status and medical history, and underwent spirometry with bronchodilator. COPD was defined as (i) “previously diagnosed” when the respondent reported that he/she had previously been diagnosed with COPD by a doctor, (ii) “diagnosed by spirometry” using the GOLD criteria (2011) based on spirometry conducted during the study (FEV1/FVC <  0.70), and (iii) “firstly diagnosed by spirometry”, when the patient had received the COPD diagnosis for the first time based on the spirometry results obtained in this study.ResultsThe prevalence of “previously diagnosed” COPD was 10.4, 13.8 and 4.3 per 1000, and the prevalence of COPD “diagnosed by spirometry” was 31.9, 66.7 and 37.5 per 1000 in Ukraine, Kazakhstan, and Azerbaijan, respectively. Almost all respondents with COPD were diagnosed for the first time during this study. A statistically significant relationship was shown between smoking and COPD in Kazakhstan (odds ratio, OR: 3.75) and Azerbaijan (OR: 2.80); BMI in Ukraine (OR: 2.10); tuberculosis in Ukraine (OR: 32.3); and dusty work in Kazakhstan (OR: 2.30). Co-morbidities like cardiovascular diseases and a history of pneumonia occurred significantly (p <  0.05) more frequently in the COPD population compared to the non-COPD population across all participating countries. For hypertension, this was the case in Ukraine and Azerbaijan.ConclusionIn CIS countries (Ukraine, Kazakhstan and Azerbaijan), the prevalence of COPD “diagnosed by spirometry” was significantly higher than the prevalence of previously diagnosed COPD. Compared to many other countries, the prevalence of COPD seems to be relatively low in CIS countries. Factors such as limited funding from the government; lack of COPD knowledge and the attitude within the population, and of primary care physicians; as well as low access to high-quality spirometry may play a role in this under-diagnosis of COPD. The information provided in this paper will be helpful for healthcare policy makers in CIS countries to instruct COPD management and prevention strategies and to allocate healthcare resources accordingly.

We assessed the prevalence and incidence of Systemic Lupus Erythematosus (SLE) in 2010 in adults from four cities in Russia, Kazakhstan and Ukraine. Individuals with SLE were identified retrospectively from the medical records of specialized centers. Prevalent SLE patients were nondeceased city residents, diagnosed prior to December 31, 2010; incident patients were residents newly diagnosed between January 1 and December 31, 2010. Population size was obtained from official census data. The observed prevalence rates (per 100,000, 95% CI) were 9.0 (7.1-11.2) in Kursk and Yaroslavl, Russian Federation; Kazakhstan; in Vinnitsa, Ukraine. The cumulative incidence rates (per 100,000, 95% CI) were 1.4 (0.7-2.4); 1.6 (0.4-4.1) and 0.3 (0.0-1.8), correspondingly. All rates were higher among females compared to males, and incidence peaked in the population aged 25-44. These rates appear slightly lower than those reported from Western Europe and the USA. This could be because of study design (case-ascertainment), local health care practices or true differences in disease risk. Case age and sex distribution was similar to the known epidemiology of SLE. The rates were highest in Kazakhstan, likely because of a predominantly ethnic Asian population. Lupus (2014) 23, 213-219.

BackgroundIn the Commonwealth of Independent States (CIS) countries epidemiology of Bronchial Asthma (BA) is poorly characterized. The objective of this analysis is to present the prevalence, burden and risk factors associated with BA in the CIS countries as part of the CORE study (Chronic Obstructive REspiratory diseases).MethodsA total of 2842 adults (≥18 years) were recruited (964 in Kiev, Ukraine, 945 in Almaty, Kazakhstan, and 933 in Baku, Azerbaijan) in 2013–2015 during household visits. A two-step cluster random sampling strategy was used. All respondents were interviewed about respiratory symptoms, smoking, medical history. Two definitions were used: (i) “doctor diagnosed asthma” when the respondent reported that he/she had ever been diagnosed with BA by a doctor, (ii) “wheezing symptoms” (when the respondent reported wheezing at the ATS Respiratory Symptoms Questionnaire during the study) using GINA (2012) recommendations. Chi-square tests were used to assess differences in proportions. Binary logistic regression was used to estimate odds ratios (OR) and 95% CI for association between risk factors and BA.ResultsPrevalence of “doctor diagnosed asthma” was 12.5, 19.0 and 26.8 per 1000 persons, and prevalence of “wheezing symptoms” was 74.4, 254.8 and 123.4 per 1000 in Ukraine, Kazakhstan, and Azerbaijan, respectively. Statistically significant relationship with “wheezing symptoms” was shown for smoking (OR 1.99 (CI 1.22–3.27) in Ukraine, 2.08 (CI 1.54–2.81) in Kazakhstan, 8.01 (CI 5.24–12.24) in Azerbaijan); overweight/obesity (OR: 1.66 (CI 1.02–2.72); 1.94 (CI 1.44–2.62); 1.77 (CI 1.18–2.68), respectively) and dusty work (OR: 3.29 (CI 1.57–6.89); 1.68 (CI 1.18–2.39); 2.36 (CI 1.56–3.59), respectively), and for tuberculosis in Azerbaijan (OR: 10.11 (CI 3.44–29.69)). Co-morbidities like hypertension, cardiovascular diseases, abnormal blood lipids and a history of pneumonia occurred significantly (p < 0.05) more frequently in respondents with BA compared to those without BA across all participating countries.ConclusionIn CIS countries (Ukraine, Kazakhstan and Azerbaijan) the prevalence of doctor diagnosed asthma was significantly lower compared to prevalence of wheezing symptoms underlining that BA is likely to be underreported in these countries. The information provided in this paper will be helpful for healthcare policy makers in CIS countries to instruct BA management strategies and to allocate healthcare resources accordingly.

BackgroundMain treatable Chronic Respiratory Diseases (CRDs) like Chronic Obstructive Pulmonary Disease (COPD), Bronchial Asthma (BA) and Allergic Rhinitis (AR) are underdiagnosed and undertreated worldwide. CORE study was aimed to assess the point prevalence of COPD, BA and AR in the adult population of major cities of Commonwealth of Independent States (CIS) countries – Azerbaijan, Kazakhstan, and Ukraine based on study questionnaires and/or spirometry, and to document risk factors, characterize the COPD, BA and AR population to provide a clearer “epidemiological data”.MethodsA descriptive, cross-sectional, population-based epidemiological study conducted from 2013 to 2015 with two-stage cluster geographical randomization. Interviewers conducted face-to-face visits at respondent’s household after informed consent and eligibility assessment including interviews, anthropometry, spirometry (with bronchodilator test) and completion of disease-specific questionnaires.ResultsTwo thousand eight hundred forty-two respondents (Ukraine: 964 from Ukraine; 945 from Kazakhstan; 933 Azerbaijan) were enrolled. Mean age was 40–42 years and males were 37%–42% across three countries. In Kazakhstan 62.8% were Asians, but in Ukraine and in Azerbaijan 99.7% and 100.0%, respectively, were Caucasians. Manual labourers constituted 40.5% in Ukraine, 22.8% in Kazakhstan and 22.0% in Azerbaijan, while office workers were 16.1%, 31.6% and 36.8% respectively. 51.3% respondents in Ukraine, 64.9% in Kazakhstan and 69.7% in Azerbaijan were married.ConclusionCORE study collected information that can be supportive for health policy decision makers in allocating healthcare resources in order to improve diagnosis and management of CRDs. The detailed findings will be described in future publications.Trial registrationStudy Protocol Summary is disclosed at GlaxoSmithKline Clinical Study Register on Jun 06, 2013, study ID 116757.Electronic supplementary materialThe online version of this article (10.1186/s12890-017-0471-x) contains supplementary material, which is available to authorized users.