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2.
Psychiatry Res ; 335: 115882, 2024 May.
Article in English | MEDLINE | ID: mdl-38554495

ABSTRACT

We investigate the predictive factors of the mood recurrence in patients with early-onset major mood disorders from a prospective observational cohort study from July 2015 to December 2019. A total of 495 patients were classified into three groups according to recurrence during the cohort observation period: recurrence group with (hypo)manic or mixed features (MMR), recurrence group with only depressive features (ODR), and no recurrence group (NR). As a result, the baseline diagnosis of bipolar disorder type 1 (BDI) and bipolar disorder type 2 (BDII), along with a familial history of BD, are strong predictors of the MMR. The discrepancies in wake-up times between weekdays and weekends, along with disrupted circadian rhythms, are identified as a notable predictor of ODR. Our findings confirm that we need to be aware of different predictors for each form of mood recurrences in patients with early-onset mood disorders. In clinical practice, we expect that information obtained from the initial assessment of patients with mood disorders, such as mood disorder type, family history of BD, regularity of wake-up time, and disruption of circadian rhythms, can help predict the risk of recurrence for each patient, allowing for early detection and timely intervention.


Subject(s)
Bipolar Disorder , Depressive Disorder, Major , Humans , Mood Disorders/diagnosis , Prospective Studies , Depressive Disorder, Major/diagnosis , Bipolar Disorder/diagnosis , Circadian Rhythm , Recurrence
3.
Sci Rep ; 14(1): 4138, 2024 02 20.
Article in English | MEDLINE | ID: mdl-38374105

ABSTRACT

This cross-sectional study aimed to develop and validate population-based machine learning models for examining the association between breastfeeding and metabolic syndrome in women. The artificial neural network, the decision tree, logistic regression, the Naïve Bayes, the random forest and the support vector machine were developed and validated to predict metabolic syndrome in women. Data came from 30,204 women, who aged 20 years or more and participated in the Korean National Health and Nutrition Examination Surveys 2010-2019. The dependent variable was metabolic syndrome. The 86 independent variables included demographic/socioeconomic determinants, cardiovascular disease, breastfeeding duration and other medical/obstetric information. The random forest had the best performance in terms of the area under the receiver-operating-characteristic curve, e.g., 90.7%. According to random forest variable importance, the top predictors of metabolic syndrome included body mass index (0.1032), medication for hypertension (0.0552), hypertension (0.0499), cardiovascular disease (0.0453), age (0.0437) and breastfeeding duration (0.0191). Breastfeeding duration is a major predictor of metabolic syndrome for women together with body mass index, diagnosis and medication for hypertension, cardiovascular disease and age.


Subject(s)
Cardiovascular Diseases , Hypertension , Metabolic Syndrome , Humans , Female , Breast Feeding , Metabolic Syndrome/epidemiology , Cross-Sectional Studies , Bayes Theorem , Machine Learning
4.
Sci Rep ; 13(1): 16746, 2023 10 05.
Article in English | MEDLINE | ID: mdl-37798321

ABSTRACT

This retrospective cross-sectional study assessed older adults aged between 40 and 80 years, registered in the Korean National Health Insurance Service database from 2002 to 2019 to investigate the association between vestibular loss and the risk of dementia. The population was divided into three groups (general, vestibular loss, and hearing loss). The hazard ratios (HRs) of dementia in the vestibular and hearing loss groups were calculated using national population data. In total, 2,347,610 individuals were identified (general: 2,145,609, vestibular loss: 60,525, hearing loss: 141,476). Mean ages were 53.29 years, 58.26 years, and 58.52 years, respectively. Dementia occurred in 127,081 (IR = 4.91 per 1000 person-years), 7705 (IR = 10.79 per 1000 person-years), and 16,116 (IR = 9.63 per 1000 person-years) patients. The vestibular and hearing loss groups had hazard ratios for dementia of 1.084 (95% CI, 1.059-1.110) and 1.074 (95% CI, 1.056-1.092), respectively, compared with the general group. The results of the current study suggest that vestibular loss increases the risk of developing dementia. Therefore, similar to hearing loss, vestibular loss should be considered a risk factor for dementia, and treatments such as adequate vestibular rehabilitation may reduce this risk.


Subject(s)
Deafness , Dementia , Hearing Loss , Humans , Aged , Adult , Middle Aged , Aged, 80 and over , Retrospective Studies , Cross-Sectional Studies , Hearing Loss/epidemiology , Dementia/epidemiology , Dementia/etiology , Republic of Korea/epidemiology , Risk Factors
5.
Obes Res Clin Pract ; 17(5): 405-410, 2023.
Article in English | MEDLINE | ID: mdl-37739857

ABSTRACT

OBJECTIVE: We investigated the associations between obesity parameters and the risk of hyperuricemia among Korean adults by sex, age, and diabetes mellitus status. METHODS: This study analyzed data from 17,753 adults from the Korea National Health and Nutrition Examination Survey (KNHANES) 2016-2018. Multivariable logistic regression analyses were conducted to examine the associations of body mass index (BMI), waist circumference (WC), and general and abdominal obesity with the risk of hyperuricemia (serum uric acid ≥7.0 mg/dL in men and ≥6.0 mg/dL in women). RESULTS: Of all the participants, 12.7% (n = 2256) had hyperuricemia. The age-adjusted mean serum uric acid levels increased significantly with increasing BMI and WC (P for trend <0.001). The adjusted odds ratios (ORs) of hyperuricemia increased as BMI and WC increased in both sexes (P for trend <0.001). General (OR 1.98, 95% confidence interval [CI]: 1.69-2.32) and abdominal (OR 2.21, 95% CI: 1.89-2.58) obesity in men and general (OR 3.26, 95% CI: 2.60-4.09) and abdominal (OR 3.43, 95% CI: 2.69-4.37) obesity in women were associated with higher risks of hyperuricemia. These associations were prominent in women. The association between abdominal obesity and hyperuricemia persisted after additional adjustments for BMI in both sexes. Significant interactions were observed in younger adults and individuals without diabetes mellitus. CONCLUSION: Increased BMI and WC, and general and abdominal obesity, may be important risk factors for hyperuricemia in both sexes. Women, young adults, and individuals without diabetes mellitus require particular attention to prevent obesity and hyperuricemia.


Subject(s)
Diabetes Mellitus , Hyperuricemia , Male , Young Adult , Humans , Female , Uric Acid , Obesity, Abdominal/complications , Obesity, Abdominal/epidemiology , Hyperuricemia/complications , Hyperuricemia/epidemiology , Nutrition Surveys , Obesity/complications , Obesity/epidemiology , Risk Factors , Body Mass Index , Diabetes Mellitus/epidemiology , Diabetes Mellitus/etiology , Republic of Korea/epidemiology , Waist Circumference
6.
J Cachexia Sarcopenia Muscle ; 14(5): 2196-2203, 2023 Oct.
Article in English | MEDLINE | ID: mdl-37550773

ABSTRACT

BACKGROUND: Unhealthy body composition, including high fat mass, low muscle mass and low bone mass, is a critical health issue in adults. The weight-adjusted waist index (WWI) estimates fat and muscle mass and may have implications for bone health. We examined its association with body composition outcomes in a large Korean adult cohort. METHODS: This study used data from the Korean National Health and Nutrition Examination Survey (2008-2011). WWI was calculated as waist circumference (cm) divided by the square root of body weight (kg). Dual-energy X-ray absorptiometry was used to measure bone mineral density (BMD), appendicular lean mass (ALM) and total body fat percentage. Unhealthy body composition was defined as combined presence of high fat mass, low bone mass and low muscle mass. RESULTS: A total of 5983 individuals (3034 men [50.7%] and 2949 women [49.3%]; mean age: 63.5 ± 8.7 years) were included. WWI was positively correlated with total body fat percentage (r = 0.478, P < 0.001) and inversely with ALM/weight (r = -0.485, P < 0.001) and BMD at the lumbar spine (r = -0.187, P < 0.001), femoral neck (r = -0.269, P < 0.001) and total hip (r = -0.255, P < 0.001). Higher WWI quartiles correlated with lower BMD, T-scores and ALM/weight, along with increased total body fat, evident in both genders and more pronounced in women, even after adjusting for confounders. This trend remained statistically significant across WWI quartiles for all analyses (P < 0.001). Higher WWI quartiles were also significantly associated with higher odds of unhealthy body composition, with adjusted odds ratio in the highest WWI group of 18.08 (95% CI, 4.32-75.61) in men and 6.36 (95% CI, 3.65-11.07) in women. The optimal cutoff values of WWI for unhealthy body composition were 10.4 cm/√kg in men and 10.5 cm/√kg in women. CONCLUSIONS: In community-dwelling adults, high WWI values are associated with unfavourable body composition outcomes, indicating high fat mass, low muscle mass and low bone mass. WWI can potentially serve as an integrated index of body composition, underscoring the need for further research to validate its use in clinical settings.

7.
Nutrients ; 15(4)2023 Feb 05.
Article in English | MEDLINE | ID: mdl-36839180

ABSTRACT

Despite the enormous global market of dietary supplements, the impact of dietary supplements on kidney disease is still unclear. Based on the National Health and Nutrition Examination Survey from 2015 to 2017, this study evaluated the association between dietary supplement and chronic kidney disease (CKD) in 13,271 Korean adults. Among the dietary supplements, vitamin and mineral intake was the highest at 61.41%, followed by omega-3 fatty acids at 11.85%, and ginseng at 7.99%. The prevalence of CKD was significantly higher in those who consumed amino acids and proteins, ginseng and red ginseng, and herbal medicine (plant extract)-berries than in those who did not. Conversely, patients who consumed probiotic supplements had a significantly lower prevalence of CKD than those who did not. In the population without CKD risk factors or history of CKD, the prevalence of CKD was high in the group consuming ginseng and red ginseng. After adjusting for covariates, the herbal medicine (plant extract)-berry group showed an independent association with CKD incidence. In conclusion, it is suggested that dietary supplements may affect kidney function. Further large-scale cohort studies are required to elucidate the exact effects of each dietary supplement on CKD.


Subject(s)
Dietary Supplements , Renal Insufficiency, Chronic , Adult , Humans , Nutrition Surveys , Dietary Supplements/adverse effects , Renal Insufficiency, Chronic/epidemiology , Plant Extracts , Republic of Korea/epidemiology
8.
Epidemiol Health ; 44: e2022096, 2022.
Article in English | MEDLINE | ID: mdl-36317400

ABSTRACT

OBJECTIVES: The Korea National Health and Nutrition Examination Survey (KNHANES) is a public health survey that assesses individuals' health and nutritional status and monitors the prevalence of major chronic diseases. In general, sampling weights are adjusted for unit non-responses and imputation is conducted for item non-responses. In this study, we proposed strategies for imputing item non-responses in the KNHANES in order to improve the usefulness of data, minimize bias, and increase statistical power. METHODS: After applying logical imputation, we adopted 2 separate imputation methods for each variable type: unweighted sequential hot-deck imputation for categorical variables and sequential regression imputation for continuous variables. For variance estimation, multiple imputations were applied to the continuous variables. To evaluate the performance of the proposed strategies, we compared the marginal distributions of imputed variables and the results of multivariable regression analysis for the complete-case data and the expanded data with imputed values, respectively. RESULTS: When comparing the marginal distributions, most non-responses were imputed. The multivariable regression coefficients presented similar estimates; however, the standard errors decreased, resulting in statistically significant p-values. The proposed imputation strategies may cope with the loss of precision due to missing data, thus enhancing statistical power in analyses of the KNHANES by providing expanded data with imputed values. CONCLUSIONS: The proposed imputation strategy may enhance the utility of data by increasing the number of complete cases and reducing the bias in the analysis, thus laying a foundation to cope with the occurrence of item non-responses in further surveys.


Subject(s)
Research Design , Humans , Nutrition Surveys , Surveys and Questionnaires , Regression Analysis , Republic of Korea/epidemiology
9.
J Affect Disord ; 316: 10-16, 2022 11 01.
Article in English | MEDLINE | ID: mdl-35940376

ABSTRACT

BACKGROUND: The clinical importance of morningness-eveningness, especially in mood disorders, is prevailing. The differential relation of chronotype with diagnoses of early-onset mood disorders, mood symptoms, anxiety, and quality of life was evaluated. METHODS: Early-onset mood disorder patients [n = 419; 146 major depressive disorder (MDD); 123 bipolar I disorder (BDI); 150 bipolar II disorder (BDII)] from the Mood Disorder Cohort Research Consortium were assessed for chronotype using the composite scale for morningness (CSM) and its association with clinical variables obtained during the clinician-verified euthymic state. RESULTS: The mean total CSM of BDI was significantly higher than MDD and BDII (p < 0.001). In all types of mood disorders, higher total CSM was associated with lower Quick inventory of depressive symptomatology (p < 0.005) and higher WHO quality of life (p < 0.005). Such negative correlations between the total CSM and Montgomery-Asberg depression rating were significant in MDD and BDI (p < 0.05) and marginally significant in BDII (p = 0.077). CSM was a significant contributor to quality of life in BDI (p < 0.001) and BDII (p = 0.011), but it was not for MDD. LIMITATIONS: The defined 'euthymic state' that may not fully reflect the remission of episode; limited generalizability due to clinical characteristic of early-onset mood disorder; the disparity between diurnal preference measured by the CSM and chronotype; possible effects of the last mood episode polarity and medication; and, lack of control group. CONCLUSION: Less eveningness was associated with less severe depressive symptoms and better quality of life. This suggests that morningness may reduce residual depressive symptoms and recover function of patients.


Subject(s)
Depressive Disorder, Major , Quality of Life , Circadian Rhythm , Cyclothymic Disorder , Humans , Prospective Studies , Surveys and Questionnaires
10.
Obstet Gynecol Sci ; 65(5): 468-476, 2022 Sep.
Article in English | MEDLINE | ID: mdl-35908650

ABSTRACT

OBJECTIVE: To evaluate menopause-related changes in body fat distribution and their relationship with insulin resistance in middleaged Korean women. METHODS: We analyzed women aged 40-60 years using data from the National Health and Nutrition Examination Survey conducted from 2008 to 2011. Body fat was measured using dual-energy X-ray absorptiometry. Insulin resistance was assessed using the homeostasis model assessment of insulin resistance (HOMA-IR). RESULTS: Among 3,468 participants, menopausal women (n=1,489) had a higher body mass index (BMI) and higher trunk, arm, and head fat percentages than premenopausal women (n=1,979). However, no significant difference was found in the leg fat percentage according to menopausal status. Multivariable regression analysis for HOMA-IR showed that trunk fat percentage, BMI, and waist circumference positively correlated with insulin resistance and leg fat percentage negatively correlated after adjusting for several confounding factors, whereas menopausal status was not associated with HOMAIR. CONCLUSION: Middle-aged women not only have different body weights and BMI but also have different body fat distributions according to menopausal status. Each fat percentage change in the trunk and leg is differently associated with metabolic health, particularly insulin resistance. To evaluate the metabolic health of middle-aged women, BMI is generally noted; however, body fat distribution, which can be easily assessed using dual-energy X-ray absorptiometry, should also be considered.

11.
Article in English | MEDLINE | ID: mdl-35565131

ABSTRACT

Disturbances in circadian rhythms cause several health problems, such as psychosis, metabolic syndrome, and cancer; however, their effect on kidney disease remains unclear. This study aimed to evaluate the association between chronic kidney disease (CKD) and sleep disturbance in a Korean adult population. A total of 17,408 participants who completed the National Health and Nutrition Examination Survey from 2016 to 2018 were assessed for their sleep patterns and renal function. CKD was defined as an estimated glomerular filtration rate ≤ 60 mL/min/1.73 m² or a positive dipstick urinalysis. Sleep onset time and sleep duration showed significant differences between the control and CKD groups (p < 0.001). After adjusting for the covariates, sleep onset time rather than sleep duration was independently associated with incidence of CKD, and this association was more significant in people who were older, in women, and in those with low body mass index and no comorbidities. When comparing the prevalence of newly diagnosed CKD according to sleep onset time in a population with no CKD risk factors or no history of CKD, the early bedtime group showed an independent association with incidence of new CKD (odds ratio (OR), 1.535; 95% confidence interval (CI), 1.011−2.330) even after adjusting for covariates. Impaired circadian rhythm along with sleep disturbance could be associated with CKD development; therefore, sleep disturbance might be an important therapeutic target for CKD.


Subject(s)
Renal Insufficiency, Chronic , Sleep Wake Disorders , Adult , Circadian Rhythm , Cross-Sectional Studies , Female , Glomerular Filtration Rate , Humans , Nutrition Surveys , Prevalence , Renal Insufficiency, Chronic/complications , Republic of Korea/epidemiology , Risk Factors , Sleep Wake Disorders/complications , Sleep Wake Disorders/epidemiology
12.
J Cancer Surviv ; 16(4): 741-750, 2022 08.
Article in English | MEDLINE | ID: mdl-34132983

ABSTRACT

PURPOSE: Although successful smoking cessation after cancer diagnosis is important, research on e-cigarette use and smoking behavior among cancer survivors (CS) is limited. This study compared cigarette and e-cigarette use among CS and non-cancer populations in Korea. METHODS: This study analyzed the 2013-2018 National Health and Nutrition Survey data to investigate e-cigarette use and smoking behavior among Korean CS. The data were categorized into 1260 CS and 5040 non-cancer populations using the propensity score matching method. A multiple logistic regression was conducted among CS who previously used cigarettes or e-cigarettes to evaluate factors influencing successful cessation. RESULTS: Regarding conventional smoking, the proportion of ex-smokers was higher (25.2% versus 19.9%) than current smokers (6.7% versus 10.6%) in the CS group than in the propensity matched non-cancer population (PMNCP) (p < 0.001). However, ever use of e-cigarettes did not differ between them (2.4% versus 2.7%, p = 0.529). Successful cessation, defined as not using either cigarettes or e-cigarettes, correlated with problem drinking (OR 0.442, 95% CI 0.207-0.940), depression (OR 0.276, 95% CI 0.087-0.872), and cancer sites. CS of stomach, liver, colorectal, and lung cancer maintained higher successful smoking cessation rates than PMNCP. CONCLUSIONS: Korean CS had a higher cessation rate than PMNCP regarding conventional smoking; however, there was no difference in e-cigarette use. IMPLICATIONS FOR CANCER SURVIVORS: In Korea, some CS continue to use e-cigarettes, and physicians should focus on helping them quit. Individualized and timely interventions should be provided for both cigarette and e-cigarette users, considering factors influencing successful cessation.


Subject(s)
Cancer Survivors , Electronic Nicotine Delivery Systems , Neoplasms , Tobacco Products , Case-Control Studies , Humans , Neoplasms/epidemiology , Republic of Korea/epidemiology
13.
Article in English | MEDLINE | ID: mdl-33808963

ABSTRACT

An association between fiber intake and allergic diseases in children has been reported; however, many studies have not been conducted to assess this association in adults. We aimed to evaluate the association between dietary fiber intake and allergic diseases (asthma, allergic rhinitis, and atopic dermatitis) among 10,479 adults using data from the Korean National Health and Nutrition Examination Survey (2010-2011). As dietary fiber intake increased, the prevalence of asthma (Q4 adjusted odds ratio (OR): 0.656; 95% confidence interval (CI): 0.48-0.91, p for trend < 0.0001) and atopic dermatitis (Q3 crude OR: 0.746; 95% CI: 0.57-0.98; Q4 adjusted OR: 0.712; 95% CI: 0.50-1.01, p for trend < 0.0001) decreased. The prevalence of allergic rhinitis (Q2 adjusted OR: 0.840; 95% CI: 0.70-1.00, p for trend < 0.0001) tended to decrease, especially in males. Subgroup analysis revealed that fiber intake reduced allergic rhinitis symptoms, including watery rhinorrhea (Q3 adjusted OR: 0.734; 95% CI: 0.55-0.97; Q4 adjusted OR: 0.722; 95% CI: 0.54-0.97) and dog allergen sensitization (Q3 adjusted OR: 0.319; 95% CI: 0.13-0.82; Q4 adjusted OR: 0.338; 95% CI: 0.13-0.86), exclusively in males. Thus, dietary fiber intake influences allergic diseases in adults, especially males.


Subject(s)
Dermatitis, Atopic , Rhinitis, Allergic , Animals , Cross-Sectional Studies , Dermatitis, Atopic/epidemiology , Dietary Fiber , Dogs , Nutrition Surveys , Prevalence , Republic of Korea/epidemiology , Rhinitis, Allergic/epidemiology
14.
Depress Anxiety ; 38(6): 661-670, 2021 06.
Article in English | MEDLINE | ID: mdl-33818866

ABSTRACT

BACKGROUND: Many mood disorder patients experience seasonal changes in varying degrees. Studies on seasonality have shown that bipolar disorder has a higher prevalence rate in such patients; however, there is limited research on seasonality in early-onset mood disorder patients. This study estimated the prevalence of seasonality in early-onset mood disorder patients, and examined the association between seasonality and mood disorders. METHODS: Early-onset mood disorder patients (n = 378; 138 major depressive disorder; 101 bipolar I disorder; 139 bipolar II disorder) of the Mood Disorder Cohort Research Consortium and healthy control subjects (n = 235) were assessed for seasonality with Seasonality Pattern Assessment Questionnaire (SPAQ). RESULTS: A higher global seasonality score, an overall seasonal impairment score, and the prevalence of seasonal affective disorder (SAD) and subsyndromal SAD showed that mood disorder subjects had higher seasonality than the healthy subjects. The former subject group had a significantly higher mean overall seasonal impairment score than the healthy subjects (p < .001); in particular, bipolar II disorder subjects had the highest prevalence of SAD, and the diagnosis of bipolar II disorder had significantly higher odds ratios for SAD when compared to major depression and bipolar I disorder (p < .05). CONCLUSIONS: Early-onset mood disorders, especially bipolar II disorder, were associated with high seasonality. A thorough assessment of seasonality in early-onset mood disorders may be warranted for more personalized treatment and proactive prevention of mood episodes.


Subject(s)
Bipolar Disorder , Depressive Disorder, Major , Seasonal Affective Disorder , Bipolar Disorder/epidemiology , Cohort Studies , Depressive Disorder, Major/epidemiology , Humans , Mood Disorders , Prevalence , Prospective Studies , Seasonal Affective Disorder/epidemiology , Seasons
15.
JMIR Ment Health ; 7(8): e21283, 2020 Aug 05.
Article in English | MEDLINE | ID: mdl-32755884

ABSTRACT

BACKGROUND: Smartphones and wearable devices can be used to obtain diverse daily log data related to circadian rhythms. For patients with mood disorders, giving feedback via a smartphone app with appropriate behavioral correction guides could play an important therapeutic role in the real world. OBJECTIVE: We aimed to evaluate the effectiveness of a smartphone app named Circadian Rhythm for Mood (CRM), which was developed to prevent mood episodes based on a machine learning algorithm that uses passive digital phenotype data of circadian rhythm behaviors obtained with a wearable activity tracker. The feedback intervention for the CRM app consisted of a trend report of mood prediction, H-score feedback with behavioral guidance, and an alert system triggered when trending toward a high-risk state. METHODS: In total, 73 patients with a major mood disorder were recruited and allocated in a nonrandomized fashion into 2 groups: the CRM group (14 patients) and the non-CRM group (59 patients). After the data qualification process, 10 subjects in the CRM group and 33 subjects in the non-CRM group were evaluated over 12 months. Both groups were treated in a similar manner. Patients took their usual medications, wore a wrist-worn activity tracker, and checked their eMoodChart daily. Patients in the CRM group were provided with daily feedback on their mood prediction and health scores based on the algorithm. For the CRM group, warning alerts were given when irregular life patterns were observed. However, these alerts were not given to patients in the non-CRM group. Every 3 months, mood episodes that had occurred in the previous 3 months were assessed based on the completed daily eMoodChart for both groups. The clinical course and prognosis, including mood episodes, were evaluated via face-to-face interviews based on the completed daily eMoodChart. For a 1-year prospective period, the number and duration of mood episodes were compared between the CRM and non-CRM groups using a generalized linear model. RESULTS: The CRM group had 96.7% fewer total depressive episodes (n/year; exp ß=0.033, P=.03), 99.5% shorter depressive episodes (total; exp ß=0.005, P<.001), 96.1% shorter manic or hypomanic episodes (exp ß=0.039, P<.001), 97.4% fewer total mood episodes (exp ß=0.026, P=.008), and 98.9% shorter mood episodes (total; exp ß=0.011, P<.001) than the non-CRM group. Positive changes in health behaviors due to the alerts and in wearable device adherence rates were observed in the CRM group. CONCLUSIONS: The CRM app with a wearable activity tracker was found to be effective in preventing and reducing the recurrence of mood disorders, improving prognosis, and promoting better health behaviors. Patients appeared to develop a regular habit of using the CRM app. TRIAL REGISTRATION: ClinicalTrials.gov NCT03088657; https://clinicaltrials.gov/ct2/show/NCT03088657.

16.
Cardiovasc Diabetol ; 18(1): 162, 2019 11 21.
Article in English | MEDLINE | ID: mdl-31752850

ABSTRACT

BACKGROUND: Statin therapy reduces the risk of cardiovascular events across a broad spectrum of patients; however, it increases the risk of new-onset diabetes (NOD). Although the highest dose pitavastatin is considered to not be associated with NOD, there are limited data regarding the impact of long-term highest dose pitavastatin use on the development of NOD in patients at high risk of developing diabetes. Therefore, we prospectively compared the differences in the development of NOD between the lowest and the highest dose of pitavastatin in patients at high risk of developing diabetes during a 3-year follow-up. METHODS: This post hoc analysis of a prospective, single-blinded, randomized study compared the risk of NOD between the highest dose of pitavastatin (4 mg) and the lowest dose of pitavastatin (1 mg) over a 3-year follow-up in patients with acute coronary syndrome. Among 1044 patients of the original study, 667 patients at high risk of developing type 2 diabetes mellitus were in the subgroup analysis. The primary endpoint was a comparison of the differences in the cumulative incidence of NOD in the pitavastatin 1 mg and 4 mg groups during a 3-year follow-up. RESULTS: With propensity score matching, there were no significant differences in baseline demographic characteristics between the 2 groups. Incidence of NOD was similar between the pitavastatin 1 mg and 4 mg groups [12 of 289 patients (4.2%) and 8 of 289 patients (2.8%), respectively; p = 0.36]. In a prespecified analysis, there were no significant differences in NOD events according to sex, age, diagnosis, body mass index, glucose intolerance, or dyslipidemia. CONCLUSIONS: Administration of highest-dose pitavastatin did not increase the risk of NOD in patients at high risk of developing diabetes during the 3-year follow-up. Moreover, various risk factors for NOD such as metabolic syndrome components, glucose intolerance, dyslipidemia, obesity, or hypertension did not affect the development of NOD during pitavastatin administration. Thus, the highest dose pitavastatin can be safely used in patients with metabolic syndrome who are at high risk of developing diabetes. Trial registration Clinical Trial registration information. URL: https://clinicaltrials.gov/ct2/show/NCT02545231. Unique identifier: NCT02545231.


Subject(s)
Blood Glucose/drug effects , Diabetes Mellitus, Type 2/chemically induced , Dyslipidemias/drug therapy , Hydroxymethylglutaryl-CoA Reductase Inhibitors/adverse effects , Lipids/blood , Quinolines/adverse effects , Adult , Aged , Biomarkers/blood , Blood Glucose/metabolism , Diabetes Mellitus, Type 2/blood , Diabetes Mellitus, Type 2/diagnosis , Diabetes Mellitus, Type 2/epidemiology , Dyslipidemias/blood , Dyslipidemias/diagnosis , Dyslipidemias/epidemiology , Female , Follow-Up Studies , Humans , Hydroxymethylglutaryl-CoA Reductase Inhibitors/administration & dosage , Incidence , Male , Middle Aged , Prospective Studies , Quinolines/administration & dosage , Randomized Controlled Trials as Topic , Risk Assessment , Risk Factors , Time Factors , Treatment Outcome
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