Upper Normal Limit of Serum Alanine Aminotransferase and Its Association with Metabolic Risk Factors in Pars Cohort Study


Faeze Sehatpour 1Alireza Salehi 2Hossein Molavi Vardanjani 1Hossein Poustchi 3Abdullah Gandomkar 4Reza Malekzadeh 3 4



BACKGROUND The range of serum alanine aminotransferase (ALT) varies in different sub-populations or countries. Its population-specific cut-off points may provide a more effective screening tool for non-alcoholic fatty liver disease (NAFLD). Objectives To investigate the upper normal level (UNL) of ALT and its association with metabolic syndrome (MS) in a semi-urban population in southern Iran. METHODS The baseline data of Pars Cohort Study was used. A total of 9264 subjects aged 40-75 years were enrolled. UNL of ALT was estimated based on 95 percentile of ALT in participants who had body mass index (BMI) < 25. Multivariable logistic regression was applied and adjusted odds ratio (OR) and its 95% confidence interval (CI) were estimated. RESULTS 95 percentile of ALT was 41.71 U/L and 32.9 U/L in men and women, respectively. Abnormal waist circumference (OR: 1.72, 95%CI: 1.34, 2.21), triglyceride (OR: 1.63, 95%CI: 1.25, 2.13), fasting blood sugar (OR: 1.69, 95%CI: 1.32, 2.16), cholesterol level (OR: 1.06, 95%CI: 1.03, 1.09) and systolic blood pressure (OR: 1.08, 95%CI: 1.01, 1.16) were independently associated with ALT. CONCLUSION UNL of ALT in southern Iranian women is lower than the current recommended level, while these are almost the same for men. MS components are highly common in southern Iran and are associated with elevated serum ALT. Further studies are recommended to estimate the UNL of serum ALT among the Iranian population with NAFLD.

Effectiveness of Polypill for Prevention of Cardiovascular Disease (PolyPars): Protocol of a Randomized Controlled Trial


Fatemeh Malekzadeh 1 2 3Abdullah Gandomkar 2Zinab Malekzadeh 1Hossein Poustchi 1 4Mohsen Moghadami 2Mohammad Reza Fattahi 5Maryam Moini 5Amir Anushiravani 1 2Roozbeh Mortazavi 6Shahrokh Sadeghi Boogar 6Vahid Mohammadkarimi 6Firoozeh Abtahi 7Shahin Merat 1 8Sadaf G Sepanlou 1Reza Malekzadeh 1 2 4 8


Background: Cardiovascular diseases (CVDs) are the leading cause of death in Iran. A fixed-dose combination therapy (polypill) was proposed as a cost-effective strategy for CVD prevention, especially in lower-resource settings. We conducted the PolyPars trial to assess the effectiveness and safety of polypill for prevention of CVD.

Methods: The PolyPars trial is a pragmatic cluster randomized controlled trial nested within the Pars Cohort Study. Participants were randomized to an intervention arm and a control arm. Participants in the control arm received minimal non-pharmacological care, while those in the intervention arm received polypill in addition to minimal care. The polypill comprises hydrochlorothiazide 12.5 mg, aspirin 81 mg, atorvastatin 20 mg, and either enalapril 5 mg or valsartan 40 mg. The primary outcome of the study is defined as the first occurrence of acute coronary syndrome (non-fatal myocardial infarction and unstable angina), fatal myocardial infarction, sudden cardiac death, new-onset heart failure, coronary artery revascularization procedures, transient ischemic attack, cerebrovascular accidents (fatal or non-fatal), and hospitalization due to any of the mentioned conditions. The secondary outcomes of the study include adverse events, compliance, non-cardiovascular mortality, changes in blood pressure, fasting blood sugar, and lipids after five years of follow-up.

Results: From December 2014 to December 2015, 4415 participants (91 clusters) were recruited. Of those, 2200 were in the polypill arm and 2215 in the minimal care arm. The study is ongoing. This trial was registered with ClinicalTrials.gov number NCT03459560.

Conclusion: Polypill may be effective for primary prevention of CVDs in developing countries.

Epidemiology of Adult Diabetes Mellitus and its Correlates in Pars Cohort Study in Southern Iran


Background: The burden of diabetes mellitus (DM) is increasing worldwide, especially in countries such as Iran. Modifiable correlates of the DM may be different across regions. We aimed to estimate the population-based prevalence of DM and its correlates among adults in southern Iran.

Methods: Baseline data of the Pars Cohort Study (PCS) was analyzed. Demographic and socio-economic characteristics, alcohol consumption, opium and tobacco abuse and cigarette smoking, laboratory findings, anthropometric measurements and perceived body shape at 15 and 30 years of age using pictogram were measured and analyzed. The age-standardized prevalence of DM was estimated. Robust Poisson regression was applied to estimate adjusted prevalence ratio (aPR) and 95% robust confidence intervals (CI). A P value <0.05 was considered statistically significant.

Results: Out of 9264 individuals, 919 (9.9%; 95% CI: 9.3-10.6) had DM. The prevalence of DM among the males and females was 7.6% (95% CI: 6.8-8.5) and 11.9% (95% CI: 10.9-12.9), respectively. Higher age, female gender, high socioeconomic status and using antihypertensive medication were associated with higher DM prevalence. Also, triglyceride level, physical inactivity, higher body mass index (BMI), pictogram score at 15, and its change from 15 to 30 years of age were significantly associated with DM.

Conclusion: Higher prevalence of modifiable factors such as physical inactivity and obesity among DM patients in the study population highlights the necessity of more effective preventive interventions in such settings, especially in younger ages.

A Comprehensive Look at Irritable Bowel Syndrome and its Associated Factors Considering the Rome IV Criteria: A Penalized Smoothly Clipped Absolute Deviation Regression Approach in the Pars Cohort Study


Peyman Arasteh 1Najmeh Maharlouei 2Seyed Sajjad Eghbali 3Mitra Amini 4Kamran B Lankarani 2Reza Malekzadeh 5


BACKGROUND After the introduction of the Rome IV criteria for the diagnosis of irritable bowel syndrome (IBS), studies on the clinical significance of the new criteria in the settings of a large study has been scarce. Objective: Herein we used the infrastructures provided by one the largest cohort studies in Iran to evaluate the epidemiological features related to IBS. METHODS A total of 9264 participants, were enrolled in the initial registry. Diagnosis of IBS was done using the Rome IV criteria. Individuals with IBS were compared with a control group. Since the study included a large sample size of patients, we used the penalized smoothly clipped absolute deviation (SCAD) regression analysis to construct a model for the evaluation of factors associated with IBS. RESULTS Overall, data of 9163 participants entered the final analysis. In total, 1067 (11.6%) individuals were diagnosed with IBS, among which 57 (5.3%) were diarrhea dominant (IBS-D), 380 (35.6%) were constipation dominant (IBS-C), and 630 (59%) did not mention having any of the two (IBS-U). In the regression model, back pain/arthralgia (OR: 1.98, 95% CI: 1.65 – 2.40), insomnia (OR: 1.65, 95% CI: 1.40 – 1.93), depression (OR: 1.64, 95% CI: 1.38 – 1.95), female sex (OR: 1.58, 95% CI: 1.27 – 1.96), anxiety (OR: 1.43, 95% CI: 1.21 – 1.69), and being married (OR: 1.23, 95% CI: 1.03 – 1.48), were associated with higher rates of IBS. We found that IBS prevalence displays a peak at the age of 41 years for both men and women. CONCLUSION The present study provides a background for follow-up studies to be conducted in order to evaluate causality between IBS and some major diseases such as liver disease. We also found that opium use, although not statistically significant, in addition to sex, education, back/joint pain, depression, insomnia, anxiety, and marital status might be a contributing factor in IBS.

Comparison of laboratory-based and non-laboratory-based WHO cardiovascular disease risk charts: a population-based study

Background: Determining the risk of Cardiovascular Disease (CVD) is a necessity for timely preventive interventions
in high-risk groups. However, laboratory testing may be impractical in countries with limited resources. This study
aimed at comparison and assessment of the agreement between laboratory-based and non-laboratory-based WHO
risk charts models.
Methods: This study was performed using the baseline data of 8138 participants in the pars cohort study who had
no history of CVD and stroke. The updated 2019 WHO model was used to determine the 10-year fatal and non-fatal
CVD risks. In general, there are two types of new WHO risk prediction models for CVD. The scores were determined
based on age, sex, smoking status, diabetes, Systolic Blood Pressure (SBP), and total cholesterol for the laboratory-
based model and age, sex, smoking status, SBP, and Body Mass Index (BMI) for the non-laboratory-based model. The
agreement of these two models was determined via kappa statistics for the classified risk (low: < 10%, moderate:
10–< 20%, high: 20%). Correlation coefficients (r) and scatter plots was used for correlation between scores.

Results: The results revealed very strong correlation coefficients for all sex and age groups (r = 0.84 for
males < 60 years old, 0.93 for males 60 years old, 0.85 for females < 60 years old, and 0.88 for females 60 years old).
In the laboratory-based model, low, moderate, and high risks were 76.10%, 18.17%, and 5.73%, respectively. These
measures were respectively obtained as 77.00%, 18.08%, and 4.92% in the non-laboratory-based model. Based on risk
classification, the agreement was substantial for males < 60 years old and for both males and females aged 60 years
(kappa values: 0.79 for males < 60 years old, 0.65 for males 60 years old, and 0.66 for females 60 years old) and
moderate for females < 60 years old (kappa = 0.46).
Conclusions: The non-laboratory-based risk prediction model, which is simple, inexpensive, and non-invasive, classi-
fies individuals almost identically to the laboratory-based model. Therefore, in countries with limited resources, these
two models can be used interchangeably.

Association between Nontraditional Risk Factors and Calculated 10-Year Risk of Atherosclerotic Cardiovascular Disease in a Large General Population: Based on the Pars Cohort Study


Pooran Mohsenzadeh, Ali Ardekani, Hossein Poustchi, Zahra Mohammadi, Seyed Reza Abdipour Mehrian, Hamed Bazrafshan Drissi, Zahra Rahimian, Erfan Taherifard, Ali Nabavizadeh, Alireza kamalipour, Bita Mesgarpour, Fatemeh Malekzadeh & Hossein Molavi Vardanjani


Background: While the traditional risk factors of atherosclerotic cardiovascular disease (ASCVD) have been well-established, the evolving role of nontraditional risk factors is not apparent. This study aimed to evaluate the association between nontraditional risk factors and the calculated 10-year ASCVD risk in a general population.

Methods: This cross-sectional study was conducted using the Pars Cohort Study data. All inhabitants of the Valashahr district in southern Iran, aged 40–75 years, were invited (2012-2014). Patients with a history of cardiovascular disease (CVD) were excluded. The demographic and lifestyle data were collected using a validated questionnaire. Multinomial logistic regression analysis was used to evaluate the association between the calculated 10-year ASCVD risk and the nontraditional risk factors of CVD, including marital status, ethnicity, educational level, tobacco and opiate consumption, physical inactivity, and psychiatric disorders.

Results: Of 9264 participants (mean age =52.2±9.0 y; 45.8% male), 7152 patients met the inclusion criteria. In total, 20.2%, 7.6%, 36.3%, 56.4%, and 46.2% of the population were cigarette smokers, opiate consumers, tobacco consumers, ethnically Fars, and illiterate, respectively. The prevalence rates of low, borderline, and intermediate-to-high 10-year ASCVD risks were 74.3%, 9.8%, and 16.2%, respectively. In multinomial regression, anxiety (adjusted odds ratio [aOR], 0.58; P<0.001) was significantly associated with a lower ASCVD risk, whereas opiate consumption (aOR, 2.94; P<0.001) and illiteracy (aOR, 2.48; P<0.001) were significantly associated with a higher ASCVD risk.

Conclusion: Nontraditional risk factors are associated with the 10-year ASCVD risk and, thus, might be considered besides traditional ones for ASCVD in preventive medicine and health policies.

Scientifc Reports

Agreement between laboratory‑based and non‑laboratory‑based Framingham risk score in Southern Iran


Fatemeh Rezaei1 , Mozhgan Seif2 , AbdullahGandomkar3 , Mohammad Reza Fattahi4 & Jafar Hasanzadeh5


Introduction: Estimation of the risk of cardiovascular diseases (CVD), may lead to prophylactic therapies. This study aims to compare and evaluate the agreement between CVD prediction of Iran Package of Essential Non-communicable Disease (IraPEN) and Framingham risk score (FRS).

Methods: All 40-79 years old participants in the Yazd Health Study who did not have a history of CVD were included. The 10-years risk of CVD was estimated by the laboratory (IraPEN), non-laboratory WHO-EMR B and FRS. The risk was classified into low, moderate and high-risk groups. Cohen’s weighted kappa statistics were used to assess agreement between tools. To assess discrepancies McNemar’s χ2 test for paired data was used. P values < 0.05 were considered statistically significant.

Results: In total, 2103 participant was included and the risk scores were calculated. Of them, 26.5% were stratified as high risk by FRS, compared with 6.1% by IraPEN. A slight agreement (37.9%) was observed (kappa 0.17, P < 0.0001), in other words. This discrepancy between IraPEN vs. FRS was seen in both sexes (P < 0.0001), although in women the agreement ratio was higher (52.1% vs. 21.3%). The discrepancy between FRS and IraPEN in categorizing people at risk of CVD was 55.5%, (P < 0.0001) but this was not significant between IraPEN and non-laboratory WHO-EMR-B (World Health Organization – Eastern Mediterranean Regional-B group countries) score (P < 0.523; discrepancies, 5.8%).

Conclusion: Our study shows a slight agreement between various CVD risk scores. Thus, reviewing the IraPEN and using alternative tools for the low-risk group should be considered by decision-makers. It is important to use a more reliable score for nation-wide risk assessment.

The pattern of medication use, and determinants of the prevalenceof polypharmacy among patients with a recenthistory of depressive disorder: resultsfrom the pars cohort study

Prevalence and determinants of anemia among Iranian population aged ≥35 years: A PERSIAN cohort–based cross-sectional study