Displaying publications 61 - 80 of 111 in total

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  1. Takeuchi M, Okamoto K, Takagi T, Ishii H
    Diabetes Res Clin Pract, 2008 Sep;81(3):370-6.
    PMID: 18649967 DOI: 10.1016/j.diabres.2008.05.013
    To investigate ethnic difference by focusing on fasting serum insulin (FSI) in inter-East Asian patients with type 2 diabetes.
    Matched MeSH terms: Asian Continental Ancestry Group/statistics & numerical data
  2. Eng HS, Mohamed Z, Calne R, Lang CC, Mohd MA, Seet WT, et al.
    Kidney Int, 2006 May;69(10):1858-64.
    PMID: 16612333
    Cyclosporine is a substrate of cytochrome P-450 3A (CYP3A) subfamily of enzymes and characterized by a narrow therapeutic range with wide interindividual variation in pharmacokinetics. A few single-nucleotide polymorphisms detected in CYP3A genes have been shown to correlate significantly with the CYP3A protein expression and activity. We therefore postulated that these polymorphisms could be responsible for some of the interindividual variation in cyclosporine pharmacokinetics. The objective of our study is to determine correlation if any between single-nucleotide polymorphisms of CYP3A5 and CYP3AP1 on cyclosporine dose requirement and concentration-to-dose ratio in renal allograft recipients. Cyclosporine-dependent renal allograft recipients were genotyped for CYP3A5 A6986G and CYP3AP1 G-44A. The cyclosporine dosages prescribed and the corresponding cyclosporine trough levels for each patient were recorded so that cyclosporine dose per weight (mg/kg/day) and concentration-to-dose ratio (C(0)/D, whereby C(0) is trough level and D is daily dose per weight) could be calculated. A total of 67 patients were recruited for our study. The dose requirement for 1, 3, and 6 months post-transplantation ranged 2.3-11.4, 1.0-9.0, and 1.4-7.2 mg/kg/day, respectively. Patients with *1*1*1*1 (n=5) CYP3A5- and CYP3AP1-linked genotypes needed higher dose of cyclosporine compared to patients with *1*3*1*3 (n = 27) and *3*3*3*3 (n = 33) linked genotypes in months 3 and 6 post-transplantation (P < 0.016). The identification of patients with *1*1*1*1 by CYP3A5 and CYP3AP1 genotyping may have a clinically significant and positive impact on patient outcome with reduced rejection rate by providing pretransplant pharmacogenetic information for optimization of cyclosporine A dosing.
    Matched MeSH terms: Asian Continental Ancestry Group/statistics & numerical data
  3. Ng TP, Niti M, Chiam PC, Kua EH
    J Am Geriatr Soc, 2006 Jan;54(1):21-9.
    PMID: 16420194
    To make comparative estimates of prevalence of late-life functional disability, examine sociodemographic and health correlates, investigate sex and ethnic differences, and estimate population attributable risk of modifiable risk factors.
    Matched MeSH terms: Asian Continental Ancestry Group/statistics & numerical data*
  4. Chan EW, Chiang PP, Wong TY, Saw SM, Loon SC, Aung T, et al.
    Invest Ophthalmol Vis Sci, 2013 Feb;54(2):1169-75.
    PMID: 23341009 DOI: 10.1167/iovs.12-10258
    We determined the impact of glaucoma severity and laterality on vision-specific functioning (VF) in an Asian population.
    Matched MeSH terms: Asian Continental Ancestry Group/statistics & numerical data*
  5. Ang TL, Fock KM, Dhamodaran S, Teo EK, Tan J
    J Gastroenterol Hepatol, 2005 Oct;20(10):1603-9.
    PMID: 16174081
    In Singapore, the highest incidence of gastric cancer occurs in the Chinese (C), with lower rates among Malay (M) and Indian (I) subjects. The purpose of the present paper was to examine whether racial differences in the prevalence of Helicobacter pylori and serum pepsinogen (PG) could account for this difference.
    Matched MeSH terms: Asian Continental Ancestry Group/statistics & numerical data*
  6. Ng TP, Tan WC
    Sleep Med, 2005 Nov;6(6):523-9.
    PMID: 16271696
    BACKGROUND AND PURPOSE: To investigate the prevalence and determinants of daytime sleepiness in an Asian multi-ethnic population. Cross-sectional survey based on a questionnaire in multi-ethnic Asian adult population of Singapore (2.4 million).
    PATIENTS AND METHODS: Measured frequency of excessive daytime sleepiness (EDS), socio-demographic status, sleep duration, perceived sleep insufficiency, frequent awakenings, difficulty falling asleep, snoring, breathing pauses, GHQ-12, shift work, solvent exposure at work, substance use, medications, and chronic diseases in random sample of 2,298 adults, aged 20-74 years, representing Chinese, Malays and Indians.
    RESULTS: Among the respondents, 10.8% reported usually feeling sleepy in the daytime, and 9.0% were classified as having EDS. Marked ethnic difference was observed, with higher rates of EDS in Malays and Chinese, compared to Indians. Increased risk of EDS was associated with perceived sleep insufficiency; snoring and breathing pauses; shift work and solvent exposure at work; psychiatric morbidity and chronic diseases, particularly chronic rhinitis; and medications with sedating effects.
    CONCLUSIONS: Daytime sleepiness is associated with a multiplicity of highly prevalent risk factors in the community, including sleep behavior, breathing-, work- and medically related factors. Significant ethnic differences, which were not explained by these factors, were observed between Chinese, Malays and Indians.
    Matched MeSH terms: Asian Continental Ancestry Group/statistics & numerical data*
  7. Ohn Mar S, Malhi F, Syed Rahim SH, Chua CT, Sidhu SS, Sandheep S
    Asia Pac J Public Health, 2015 Nov;27(8 Suppl):19S-25S.
    PMID: 25972428 DOI: 10.1177/1010539515586457
    This cross-sectional study investigated the use of alternative medications to alleviate menopause-related symptoms among Malay, Chinese, and Indian women of Ipoh city. The prevalence, types, effectiveness, and associated factors were determined. The prevalence of alternative medication use was 41.4%. Evening primrose oil (EPO) was the most popular medication used (18.1%), followed by soy-based products (12.3%), green tea (6.8%), and gingko (5.8%). The medication was reported to be highly effective by 58.3% of soya bean diet users and 41.1% of EPO users. Significant variables associated with the use were Chinese or Indian ethnicity (P < .001), age between 50 and 54 years (P < .01), lower self-health rating (P < .05), education level of diploma or professional degree (P < .05), employment as professionals or entrepreneurs (P < .05), and the use of hormone replacement therapy (P < .05). Regression analysis showed that Chinese and Indians had significantly higher odds for the use than Malays (Chinese: odds ratio [OR] = 4.33, 95% confidence interval [CI] = 2.392-7.837; Indians: OR = 3.248, 95% CI = 1.586-6.654).
    Matched MeSH terms: Asian Continental Ancestry Group/statistics & numerical data*
  8. Teoh MK, Ramasamy D, Wong KP
    Aust N Z J Surg, 1992 Nov;62(11):862-5.
    PMID: 20169704
    Ultrasound examination of the abdominal aorta was performed on 100 patients with cardiovascular disease and a control group of 100 subjects. The objectives were to define the normal aortic size of Malaysians, to screen for aneurysms and to compare the aorta size of the different population groups. In the study group the mean anteroposterior (AP) diameter of the non-aneurysmal aortas at the level of the renal arteries was 1.82 cm (range 0.9-2.6 cm) in men and 1.83 cm (range 1.5-2.3 cm) in women. This compares with 1.61 cm (range 1.1-2.2 cm) in men and 1.50 cm (range 0.8-2.4 cm) in women in the control group. The dimensions of the infrarenal aorta show a similar relationship between the two groups. These AP diameters were significantly smaller than the published figures from studies done on Western populations and are consistent with the smaller stature of Malaysians. Five aneurysms and one ectasia were found (mean size 5 cm, range 3.5-6.0 cm), all in men aged 50-75 years in the study group, and none in the control group. All the aneurysms were easily palpable in these patients who were thinner than the average Caucasian. Given the lower incidence of aortic aneurysms in Malaysians there is no role for routine ultrasound screening of the population. High risk groups can be adequately screened by clinical examination alone.
    Matched MeSH terms: Asian Continental Ancestry Group/statistics & numerical data*
  9. Abubakar M, Sung H, Bcr D, Guida J, Tang TS, Pfeiffer RM, et al.
    Breast Cancer Res, 2018 09 18;20(1):114.
    PMID: 30227867 DOI: 10.1186/s13058-018-1033-8
    BACKGROUND: Limited evidence, mostly from studies in Western populations, suggests that the prognostic effects of lifestyle-related risk factors may be molecular subtype-dependent. Here, we examined whether pre-diagnostic lifestyle-related risk factors for breast cancer are associated with clinical outcomes by molecular subtype among patients from an understudied Asian population.

    METHODS: In this population-based case series, we evaluated breast cancer risk factors in relation to 10-year all-cause mortality (ACM) and 5-year recurrence by molecular subtype among 3012 women with invasive breast cancer in Sarawak, Malaysia. A total of 579 deaths and 314 recurrence events occurred during a median follow-up period of ~ 24 months. Subtypes (luminal A-like, luminal B-like, HER2-enriched, triple-negative) were defined using immunohistochemical markers for hormone receptors and human epidermal growth factor receptor 2 (HER2) in conjunction with histologic grade. Hazard ratios (HRs) and 95% confidence intervals (CIs) for the associations between risk factors and ACM/recurrence were estimated in subtype-specific Cox regression models.

    RESULTS: We observed heterogeneity in the relationships between parity/breastfeeding, age at first full-term pregnancy (FFP), family history, body mass index (BMI), and tumor subtype (p value  30 vs data in Western populations. Further prospective studies will be needed to clarify the role of lifestyle modification, especially changes in BMI, in improving clinical outcomes for women with luminal A-like breast cancer.

    Matched MeSH terms: Asian Continental Ancestry Group/statistics & numerical data*
  10. Choo CC, Chew PKH, Ho RC
    PMID: 29621197 DOI: 10.3390/ijerph15040691
    An important risk factor for suicide assessment is the suicide precipitant. This study explores suicide attempt precipitants across the lifespan. Three years of medical records related to suicide attempters who were admitted to the emergency department of a large teaching hospital in Singapore were subjected to analysis. These cases were divided into three age groups: Adolescence, Early Adulthood, and Middle Adulthood. A total of 540 cases were examined (70.9% females; 63.7% Chinese, 13.7% Malays, 15.9% Indians), whose ages ranged from 12 to 62. There were eight cases above the age of 65 years which were excluded from the analysis. Significant differences were found in precipitants for suicide attempts across the lifespan. Middle adults had relatively fewer relationship problems, and adolescents had comparatively fewer financial and medical problems. The models to predict medically severe attempts across the age groups using suicide precipitants were not significant. The findings were discussed in regards to implications in suicide assessment and primary prevention in Singapore, as well as limitations and recommendations for future research.
    Matched MeSH terms: Asian Continental Ancestry Group/statistics & numerical data*
  11. Tan CH, Hilal S, Xu X, Vrooman H, Cheng CY, Wong TY, et al.
    J Alzheimers Dis, 2020;73(4):1501-1509.
    PMID: 31958085 DOI: 10.3233/JAD-190866
    There is a need to elucidate the combined influence of neurodegeneration and cerebrovascular disease (CeVD) on cognitive impairment, especially in diverse populations. Here, we evaluated 840 multiethnic individuals (mean age = 70.18) across the disease spectrum from the Epidemiology of Dementia in Singapore study. First, we determined whether a validated quantitative MRI score of mixed pathology is associated with clinical diagnosis and whether the score differed between ethnicities (Chinese, Malays, and Indians). We then evaluated whether the score was associated with multidomain cognitive impairment and if additional measures of CeVD were further associated with cognitive impairment. We found that lower quantitative MRI scores were associated with severity of clinical diagnosis and Chinese individuals had the highest quantitative MRI scores, followed by Indians and Malays. Lower quantitative MRI scores were also associated with lower performance in attention, language, visuoconstruction, visuomotor, visual, and verbal memory domains. Lastly, the presence of intracranial stenosis and cortical cerebral microinfarcts, but not cerebral microbleeds, were associated with memory performance beyond quantitative MRI scores. Taken together, our results demonstrate the utility of using multiple MRI markers of neurodegeneration and CeVD for identifying multiethnic Asians with the greatest cognitive impairment due to mixed pathology.
    Matched MeSH terms: Asian Continental Ancestry Group/statistics & numerical data*
  12. Golder V, Kandane-Rathnayake R, Hoi AY, Huq M, Louthrenoo W, An Y, et al.
    Arthritis Res Ther, 2017 03 20;19(1):62.
    PMID: 28320433 DOI: 10.1186/s13075-017-1256-6
    BACKGROUND: Systemic lupus erythematosus (SLE) is associated with significant impairment of health-related quality of life (HR-QoL). Recently, meeting a definition of a lupus low disease activity state (LLDAS), analogous to low disease activity in rheumatoid arthritis, was preliminarily validated as associated with protection from damage accrual. The LLDAS definition has not been previously evaluated for association with patient-reported outcomes. The objective of this study was to determine whether LLDAS is associated with better HR-QoL, and examine predictors of HR-QoL, in a large multiethnic, multinational cohort of patients with SLE.
    METHODS: HR-QoL was measured using the Medical Outcomes Study 36-item short form health survey (SF-36v2) in a prospective study of 1422 patients. Disease status was measured using the SLE disease activity index (SLEDAI-2 K), physician global assessment (PGA) and LLDAS.
    RESULTS: Significant differences in SF-36 domain scores were found between patients stratified by ethnic group, education level and damage score, and with the presence of active musculoskeletal or cutaneous manifestations. In multiple linear regression analysis, Asian ethnicity (p 
    Matched MeSH terms: Asian Continental Ancestry Group/statistics & numerical data
  13. Yeo KK, Tai BC, Heng D, Lee JM, Ma S, Hughes K, et al.
    Diabetologia, 2006 Dec;49(12):2866-73.
    PMID: 17021918 DOI: 10.1007/s00125-006-0469-z
    AIMS/HYPOTHESIS: The aim of the study was to determine whether the risk of ischaemic heart disease (IHD) associated with diabetes mellitus differs between ethnic groups.

    METHODS: Registry linkage was used to identify IHD events in 5707 Chinese, Malay and Asian Indian participants from three cross-sectional studies conducted in Singapore between the years 1984 and 1995. The study provided a median of 10.2 years of follow-up with 240 IHD events experienced. We assessed the interaction between diabetes mellitus and ethnicity in relation to the risk of IHD events using Cox proportional hazards regression.

    RESULTS: Diabetes mellitus was more common in Asian Indians. Furthermore, diabetes mellitus was associated with a greater risk of IHD in Asian Indians. The hazard ratio when comparing diabetes mellitus with non-diabetes mellitus was 6.41 (95% CI 5.77-7.12) in Asian Indians and 3.07 (95% CI 1.86-5.06) in Chinese (p = 0.009 for interaction). Differences in the levels of established IHD risk factors among diabetics from the three ethnic groups did not appear to explain the differences in IHD risk.

    CONCLUSIONS/INTERPRETATION: Asian Indians are more susceptible to the development of diabetes mellitus than Chinese and Malays. When Asian Indians do develop diabetes mellitus, the risk of IHD is higher than for Chinese and Malays. Consequently, the prevention of diabetes mellitus amongst this ethnic group is particularly important for the prevention of IHD in Asia, especially given the size of the population at risk. Elucidation of the reasons for these ethnic differences may help us understand the pathogenesis of IHD in those with diabetes mellitus.
    Matched MeSH terms: Asian Continental Ancestry Group/statistics & numerical data
  14. Lee YY, Waid A, Tan HJ, Chua AS, Whitehead WE
    World J Gastroenterol, 2012 Nov 28;18(44):6475-80; discussion p. 6479.
    PMID: 23197894 DOI: 10.3748/wjg.v18.i44.6475
    To survey irritable bowel syndrome (IBS) using Rome III criteria among Malays from the north-eastern region of Peninsular Malaysia.
    Matched MeSH terms: Asian Continental Ancestry Group/statistics & numerical data*
  15. Xiang YT, Ungvari GS, Correll CU, Chiu HF, Lai KY, Wang CY, et al.
    Psychiatry Clin Neurosci, 2015 Aug;69(8):489-96.
    PMID: 25708964 DOI: 10.1111/pcn.12283
    Little is known about electroconvulsive therapy (ECT) use in Asian inpatients with schizophrenia. This study examined trends of ECT use for schizophrenia patients in Asia between 2001 and 2009 and its independent demographic and clinical correlates.
    Matched MeSH terms: Asian Continental Ancestry Group/statistics & numerical data*
  16. Viswanathan S, Wah LM
    Mult Scler, 2019 10;25(11):1452-1461.
    PMID: 30113245 DOI: 10.1177/1352458518792430
    OBJECTIVES: This study looked at observed crude prevalence/incidence of multiple sclerosis (MS) and neuromyelitis optica spectrum disorder (NMOSD) in Malaysia and identified any inter-ethnic differences for MS/NMOSD.

    METHODS: This was a nationwide tertiary hospital-based retrospective cross-sectional study using the capture-recapture method. It looked at the estimated crude prevalence of confirmed MS and NMOSD and annual incidence on 29 December 2017. Recapture of data was done between February and March 2018 on 1 March 2018. Public and referring private institutions were accessed.

    RESULTS: The survey identified 767 MS and 545 NMOSD subjects, with crude prevalence rates of 2.73 per 100,000 (95% confidence interval (CI): 2.53; 2.92 per 100,000 population) and 1.94 per 100,000 (95% CI: 1.77; 2.10 per 100,000 population) with observed crude annual incidence of 0.55 (95% CI: 0.43; 0.58) for MS and 0.39 per 100,000 (95% CI: 0.35; 0.47) for NMOSD. The MS:NMOSD ratios were 1.4:1.0. The capture-recapture method revealed 913 MS (95% CI: 910; 915.9) and 580 (95% CI: 578.8; 581.2) NMOSD with prevalence per 100,000 of 3.26 (95% CI: 3.05; 3.47) and 2.07 (95% CI: 1.90; 2.24), respectively. In the MS group, 59.4% were Malay, 16.6% Chinese, 20.5% Indian, and 3.5% were from indigenous groups. In the NMOSD group, 47.3% were Malay, 46.9% Chinese, 3.5% Indian, and 2.3% were from other indigenous groups. The ratio of NMOSD to MS among the Chinese was 2:1, but the ratio of MS to NMOSD among the Malays was 1.8:1, and that in Indians was 8.3:1.

    CONCLUSION: There is a modest increase in the prevalence of MS and NMOSD in Malaysia with inter-ethnic differences for MS/NMOSD.

    Matched MeSH terms: Asian Continental Ancestry Group/statistics & numerical data
  17. Fournier T, Tibère L, Laporte C, Mognard E, Ismail MN, Sharif SP, et al.
    Appetite, 2016 12 01;107:362-371.
    PMID: 27521166 DOI: 10.1016/j.appet.2016.08.009
    The Malaysian society is experiencing and coping with a fast modernization process, which is characterized by a rapid urbanization and rural exodus, an important reduction of the size of households, and the emergence of a new middle class. The Malaysian Food Barometer launched in 2013 has provided better understanding how these macro issues have affected the lifestyles and especially the food habits of the Malaysians. The country has indeed undergone a transition period from under-nutrition to over-nutrition in a few decades, with the prevalence of overweight and obesity having markedly and rapidly increased. A quantitative survey (n = 2000), elaborated from a qualitative preliminary phase, was carried out with the aim of analyzing the transformation of food habits at the national level. The present article focuses on the BMI issue in Malaysia, and investigates its relationships with the socio-demographic variables of the population, as well as their eating patterns. The mean BMI is 23.64 kg/m2, with 9.5% of the sample being obese, and 22% overweight. Strong statistical associations have been identified between BMI and independent variables such as size of the living area, ethnicity, level of education, gender, and age. Contrary to general believe, overweight and obesity were neither associated with the number of food intakes taken per day (including snacks) nor with the frequency of eating out. Nonetheless, obesity is over-represented in people who have dissonant eating behaviors, i.e. who declare having fewer food intakes a day (food norms) than they do actually (food practices). This process testifies that the Malaysians are experiencing a "food transition", which is linked with socio-economic development.
    Matched MeSH terms: Asian Continental Ancestry Group/statistics & numerical data*
  18. Endarti D, Riewpaiboon A, Thavorncharoensap M, Praditsitthikorn N, Hutubessy R, Kristina SA
    Value Health Reg Issues, 2018 May;15:50-55.
    PMID: 29474178 DOI: 10.1016/j.vhri.2017.07.008
    OBJECTIVES: To gain insight into the most suitable foreign value set among Malaysian, Singaporean, Thai, and UK value sets for calculating the EuroQol five-dimensional questionnaire index score (utility) among patients with cervical cancer in Indonesia.

    METHODS: Data from 87 patients with cervical cancer recruited from a referral hospital in Yogyakarta province, Indonesia, from an earlier study of health-related quality of life were used in this study. The differences among the utility scores derived from the four value sets were determined using the Friedman test. Performance of the psychometric properties of the four value sets versus visual analogue scale (VAS) was assessed. Intraclass correlation coefficients and Bland-Altman plots were used to test the agreement among the utility scores. Spearman ρ correlation coefficients were used to assess convergent validity between utility scores and patients' sociodemographic and clinical characteristics. With respect to known-group validity, the Kruskal-Wallis test was used to examine the differences in utility according to the stages of cancer.

    RESULTS: There was significant difference among utility scores derived from the four value sets, among which the Malaysian value set yielded higher utility than the other three value sets. Utility obtained from the Malaysian value set had more agreements with VAS than the other value sets versus VAS (intraclass correlation coefficients and Bland-Altman plot tests results). As for the validity, the four value sets showed equivalent psychometric properties as those that resulted from convergent and known-group validity tests.

    CONCLUSIONS: In the absence of an Indonesian value set, the Malaysian value set was more preferable to be used compared with the other value sets. Further studies on the development of an Indonesian value set need to be conducted.

    Matched MeSH terms: Asian Continental Ancestry Group/statistics & numerical data*
  19. Alex D, Khor HM, Chin AV, Hairi NN, Othman S, Khoo SPK, et al.
    BMJ Open, 2018 07 17;8(7):e019579.
    PMID: 30018093 DOI: 10.1136/bmjopen-2017-019579
    OBJECTIVES: Falls represent major health issues within the older population. In low/middle-income Asian countries, falls in older adults remain an area which has yet to be studied in detail. Using data from the Malaysian Elders Longitudinal Research (MELoR), we have estimated the prevalence of falls among older persons in an urban population, and performed ethnic comparisons in the prevalence of falls.

    DESIGN: Cross-sectional analysis was carried out using the first wave data from MELoR which is a longitudinal study.

    SETTING: Urban community dwellers in a middle-income South East Asian country.

    PARTICIPANTS: 1565 participants aged ≥55 years were selected by simple random sampling from the electoral rolls of three parliamentary constituencies.

    OUTCOME MEASURES: Consenting participants from the MELoR study were asked the question 'Have you fallen down in the past 12 months?' during their computer-assisted home-based interviews. Logistic regression analyses were conducted to compare the prevalence of falls among various ethnic groups.

    RESULTS: The overall estimated prevalence of falls for individuals aged 55 years and over adjusted to the population of Kuala Lumpur was 18.9%. The estimated prevalence of falls for the three ethnic populations of Malays, Chinese and Indian aged 55 years and over was 16.2%, 19.4% and 23.8%, respectively. Following adjustment for ethnic discrepancies in age, gender, marital status and education attainment, the Indian ethnicity remained an independent predictor of falls in our population (relative risk=1.45, 95% CI 1.08 to 1.85).

    CONCLUSION: The prevalence of falls in this study is comparable to other previous Asian studies, but appears lower than Western studies. The predisposition of the Indian ethnic group to falls has not been previously reported. Further studies may be needed to elucidate the causes for the ethnic differences in fall prevalence.

    Matched MeSH terms: Asian Continental Ancestry Group/statistics & numerical data*
  20. Techatraisak K, Hestiantoro A, Ruey S, Banal-Silao MJ, Kim MR, Seong SJ, et al.
    BMC Womens Health, 2019 05 16;19(1):68.
    PMID: 31096979 DOI: 10.1186/s12905-019-0758-6
    BACKGROUND: Dienogest has been shown to substantially improve endometriosis-associated symptoms such as debilitating chronic pelvic pain, and in turn, health-related quality of life (HRQoL). To date, there is no data on patient-reported outcomes reflecting the real-world practice in Asia where endometriosis is a relevant health, social and economic burden. This non-interventional, multi-center, prospective study aims to investigate the influence of dienogest on HRQoL.

    METHODS: Asian women received dienogest (2 mg/daily) and were followed for 24 months. The effectiveness of dienogest to improve HRQoL and endometriosis-associated pelvic pain (EAPP) was assessed by patient-reported outcomes. HRQoL, especially the "pain" domain as primary endpoint, was evaluated with the Endometriosis Health Profile-30 (EHP-30) questionnaire. The numeric rating scale served to determine changes in the severity of EAPP. Within the presented interim analysis (data cut-off: 2017-11-27), the mean changes in EHP-30 and EAPP scores from baseline to 6 months upon availability of the data were evaluated. Treatment-emergent adverse events (TEAEs) and bleeding profiles were documented.

    RESULTS: Dienogest therapy decreased EHP-30 scores in all assessed domains (score 0-100, lower scores indicate better HRQoL). Primarily, the "pain" domain was improved in 78.4% of patients. EAPP was reduced (score 0-10, lower scores reflect less pain), highlighted by a mean reduction of the pain score by - 4.5 points. Patients with a higher EAPP score at baseline had an increased response to dienogest (- 6.2 points mean change) compared to patients with low baseline EAPP severity (- 1.4 points mean change). Both surgically and clinically diagnosed patients described comparable pain reduction, as well as women with or without prior treatment. Drug-related TEAEs were documented for 31.5% of patients, with amenorrhoea (5.9%) and metrorrhagia (5.1%) being the most common events. The bleeding pattern was changed upon dienogest, characterized by decreased normal bleeding (84.2 to 28.8%) and increased amenorrhea (3.2 to 42.9%) at 6 months.

    CONCLUSION: The data indicate an amelioration of HRQoL and EAPP upon dienogest therapy. No new safety signals were observed. Therefore, its use as first-line therapy for long-term management of debilitating and chronic endometriosis-associated pain represents an interesting option that remains to be further investigated.

    TRIAL REGISTRATION: Name of registry: Clinical Trials Clinicaltrials.gov registration number: NCT02425462 Registration date: 2015-04-24. Registration timing: prospective.

    Matched MeSH terms: Asian Continental Ancestry Group/statistics & numerical data
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