Prevalence and Incidence of Metabolic Syndrome and Its Components Among Waterpipe Users.

Objectives: To determine the associations between waterpipe use, duration, and intensity of use with prevalence and incidence of metabolic syndrome and its components (increased waist circumference, triglycerides, fasting glucose, blood pressure and decreased high-density lipoprotein cholesterol). Methods: We conducted cross-sectional and prospective analyses using data from the Pars Cohort Study in southern Iran, encompassing 9,264 participants at the baseline, and 5,002 randomly selected in a repeated follow-up. We used multivariate logistic regression models adjusted for age, sex, education, wealth score, physical activity and cigarette pack-years to report odds ratios (OR) and 95% confidence intervals (CI). Results: Among 9,264 participants, 3,119 (33.7%) had metabolic syndrome, and 3,482 (37.6%) had ever smoked waterpipe, with both more common in women than in men. In adjusted models, former waterpipe use was significantly associated with prevalence (OR = 1.43, 95% CI: 1.23-1.68) and incidence (OR = 1.57, 95% CI: 1.19-2.06) of the metabolic syndrome while current waterpipe use was not. Past use was associated with increased risk in all components of metabolic syndrome; current use was associated with increases in all except high blood glucose and hypertension. Past waterpipe users had higher waterpipe use intensity (before quitting) in comparison with current users (2.3 vs. 2.0 waterpipes per day, p < 0.01) and had started waterpipe smoking at a younger age (27.2 vs. 30.1 years, p < 0.01). Conclusion: Waterpipe use was associated with metabolic syndrome and its components, especially among former users potentially due to higher intensity and earlier initiation of use.

Effectiveness of polypill for primary and secondary prevention of cardiovascular disease: a pragmatic cluster-randomised controlled trial (PolyPars).

BACKGROUND: We aimed to investigate the effectiveness of fixed-dose combination therapy (polypill) for primary and secondary prevention of major cardiovascular diseases in a typical rural setting. METHODS: The PolyPars Study is a two-arm pragmatic cluster-randomised trial nested within the PARS cohort study, including all residents aged over 50 years in the entire district in southern Iran. The 91 villages underwent random allocation into two arms: the control arm, encompassing 45 clusters, was subjected to non-pharmacological intervention (educational training on healthy lifestyle), whereas the intervention arm, comprising 46 clusters, received the non-pharmacological interventions in conjunction with a once-daily polypill tablet. This tablet comprised two antihypertensive agents, a statin and aspirin. The primary outcome was the first occurrence of major cardiovascular events defined as a composite of hospitalisation for acute coronary syndrome (non-fatal myocardial infarction and unstable angina), fatal myocardial infarction, non-fatal and fatal stroke, sudden death and heart failure. The Cox regression model, with shared frailty, was used to account for clustering effect. RESULTS: During December 2015-December 2016, a total of 4415 participants aged 50-75 years were recruited (2200 participants in the intervention arm and 2215 participants in the control arm). The overall median of follow-up duration was 4.6 years (interquartile interval 4.4-4.9). The achieved adherence rate to polypill in intervention arm was 86%. In the control group, 176 (8.0%) of 2215 participants developed primary outcome, compared with 88 (4.0%) of 2200 participants in the polypill group. We found substantial reduction in risk of primary outcome both in relative and absolute scales (HR 0.50, 95% CI 0.38 to 0.65; absolute risk reduction 4.0%, 95% CI 2.5% to 5.3%). No difference in serious adverse events was observed between the two groups. CONCLUSIONS: The fixed-dose combination therapy using polypill can safely halve the risk of major cardiovascular diseases at the population level. TRIAL REGISTRATION NUMBER: NCT03459560.

Prevalence of metabolically healthy obesity and healthy overweight and the associated factors in southern Iran: A population-based cross-sectional study.

Background and Aims: Obesity is considered a major growing threat to public health which could negatively affect the quality of life. The current cross-sectional study was conducted to investigate the population-based prevalence of metabolically healthy obesity (MHO) and healthy overweight (MHOW) and associated factors in southern Iran. Methods: Baseline data from the Pars Cohort Study was analyzed. Metabolically healthy participants were identified based on the definition of the American Heart Association for the metabolic syndrome. The prevalence of MHOW and MHO and their 95% confidence intervals were estimated. Poisson regression was applied for the calculation of prevalence ratios (PRs). Results: Gender- and age-standardized prevalences of MHOW and MHO were 6.3% (6.0%-6.6%) and 2.3% (2.1%-2.5%), respectively. The following factors were associated with being MHOW compared with those with normal weight: Being younger, female gender (1.31, 1.20-1.43), higher socioeconomic status, being noncurrent cigarette smoker (1.27, 1.11-1.45), low level of physical activity (1.14, 1.03-1.25), having normal overweight during adolescence, and overweight (1.35, 1.24-1.48) or obesity (1.68, 1.53-1.86) during young adulthood. We also found strong associations between MHO and younger age groups, female gender (2.87, 2.40-3.42), being married (1.57, 1.08-2.27), Fars ethnicity (1.25, 1.10-1.43), higher socioeconomic status, ever use of tobacco (1.14, 1.00-1.30), never use of opium (1.85, 1.19-2.86), lower physical activity (1.45, 1.20-1.72), being normal weight in 15-year body pictogram and being overweight (1.87, 1.59-2.20) or obese (3.20, 2.74-3.72) in 30-year body pictogram when considering those with normal weight or MHO. Conclusion: Potentially modifiable factors including physical activity should be more emphasized. Furthermore, our study issued that it would be more reasonable that the prevention of unhealthy obesity be initiated before the development of MHO, where there are more protective factors and they could be more effective.

Prevalence and Correlates of Polypharmacy, and Drug Utilization Pattern in a Semi-urban Population: Results from the Pars Cohort Study.

BACKGROUND: Although polypharmacy is considered a major predictor of irrational use of drugs, little is known about polypharmacy in developing regions. We aimed to indicate the prevalence and correlates of polypharmacy and to determine the medication profile at the population level in southern Iran. METHODS: In this cross-sectional study, we analyzed data from participants of the Pars Cohort Study (PCS) (aged above 40 years, N=9269). Polypharmacy was defined as using five or more medications concurrently. A Poisson multivariable model was applied to estimate the adjusted prevalence ratios (APRs) of various risk factors. The Anatomical Therapeutic Chemical (ATC) classification system was used for classifying medications. RESULTS: Prevalence of polypharmacy was 10.4%, (95% CI: 9.75; 11.08) and it was higher among females (15.0%), older adults (age≥65 years) (16.0%), and individuals with more than two chronic conditions (31%). Being female, educated, married, and not having a low socio-economic class were independently associated with a higher likelihood of polypharmacy. The most prevalent medications among female participants were sex hormones and modulators of the genital system (58.4%), drugs for acid-related disorders (14.6%), and anti-anemic preparations (13.6%,). On the other hand, males were using acid-related disorders (14.6%), anti-inflammatory and anti-rheumatic products (7.8%), and beta-blocking agents (6.3%). CONCLUSION: The prevalence of polypharmacy in our sample was relatively low, especially among males. Cardiovascular drugs, acid suppressants, hormonal contraceptives, and anti-anemic preparations are drug classes with the highest contribution to polypharmacy.

Estimation of 10-Year Risk of Cardiovascular Diseases Using WHO Risk Prediction Charts: A Population-Based Study in Southern Iran.

Background: An effective strategy for primary prevention of Cardiovascular Disease (CVD) is accurate diagnosis and the subsequent evidence-based treatment for high-risk people. This study aimed to estimate the 10-year risk of CVD and its related factors. Methods: The baseline data of 8138 participants of the Pars cohort study (PCS) in southern Iran were used. Risk scores were calculated using the updated 2019 WHO CVD risk prediction charts. The scores were determined based on age, gender, current smoking status, systolic blood pressure (SBP), diabetes status, and total serum cholesterol. Demographic and socioeconomic variables, physical activity, and anthropometric indices were measured and analyzed. Multivariable logistic regression was applied to estimate the adjusted odds ratio (aOR) and 95% confidence intervals (CI). Results: The mean (SD) age of the participants was 51.65 (9.06) years, and 53.44% were female. The 10-year CVD risk for 23.89% of participants was ≥10%. The prevalence of hypertension, diabetes, hypercholesterolemia, and smoking was 12.79%, 8.38%, 12.80%, and 14.41%, respectively. Having abdominal obesity, having low or moderate physical activity, being illiterate or having diplomas or lower degrees, and being in the third quartile of the wealth score group were associated with a higher 10-year risk of CVD. Conclusion: About one-fourth of the participants had moderate risk and higher. Due to the relatively high prevalence of CVD risk factors in the middle-aged population, the modifiable risk factors are recommended to be adjusted. Additionally, individual- and community-based educational policies are essential to create a healthy lifestyle.

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, classifies individuals almost identically to the laboratory-based model. Therefore, in countries with limited resources, these two models can be used interchangeably.

The pattern of medication use, and determinants of the prevalence of polypharmacy among patients with a recent history of depressive disorder: results from the pars cohort study.

BACKGROUND: Inappropriate medication use among individuals with depressive disorders (DD) is a rising public health challenge. We aimed to investigate the polypharmacy and its determinants among individuals with DD in a less developed region, and evaluate the pattern of medication use in this population. METHODS: Data was extracted from Pars Cohort Study (PCS) between 2016 and 2019. Participants were asked to bring all the medication they were using regularly, and history of DD during the last 12 months prior to study was obtained. The Anatomical Therapeutic Chemical classification was applied and polypharmacy was defined as concurrent use of five or more medications. Logistic regression models were developed to estimate the associations between polypharmacy and DD, adjusted for relevant covariates. The prevalence of consumption of each drug class was estimated among males, females, and elders. Logistic regression was applied and the adjusted odds ratio (OR) and its 95% confidence interval (CI) were estimated. RESULTS: A total of 9264 participants with a mean age of 52.6 (SD: 9.7) were enrolled. The prevalence of polypharmacy was 22.6% [95% CI (20.7-24.6)]. The most common drug classes were genitourinary system (55.4%) and nervous system (29.1%) medication, respectively. Recent history of DD was reported among 19.4% (n = 1795) participants, the majority of whom were females. Factors associated with polypharmacy include female gender (OR: 1.51), Fars ethnicity (OR: 1.52), lower physical activity (OR: 1.74), and higher socioeconomic status (OR: 1.40). The prevalence of antidepressant use among males was higher than females (P < 0.001). CONCLUSION: The prevalence of polypharmacy is high among patients with a recent history of depressive disorder. Females, individuals with higher socioeconomic status and lower physical activity, and those who use tobacco are more likely to be polymedicated. Surveillance measures need to be established to monitor the patterns of medication use among individuals with depressive disorders.

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

The Framingham 10-year cardiovascular disease risk is measured by laboratory-based and non-laboratory-based models. This study aimed to determine the agreement between these two models in a large population in Southern Iran. In this study, the baseline data of 8138 individuals participated in the Pars cohort study were used. The participants had no history of cardiovascular disease or stroke. For the laboratory-based risk model, scores were determined based on age, sex, current smoking, diabetes, systolic blood pressure (SBP) and treatment status, total cholesterol, and High-Density Lipoprotein. For the non-laboratory-based risk model, scores were determined based on age, sex, current smoking, diabetes, SBP and treatment status, and Body Mass Index. The agreement between these two models was determined by Bland Altman plots for agreement between the scores and kappa statistic for agreement across the risk groups. Bland Altman plots showed that the limits of agreement were reasonable for females < 60 years old (95% CI: -2.27-4.61%), but of concern for those ≥ 60 years old (95% CI: -3.45-9.67%), males < 60 years old (95% CI: -2.05-8.91%), and males ≥ 60 years old (95% CI: -3.01-15.23%). The limits of agreement were wider for males ≥ 60 years old in comparison to other age groups. According to the risk groups, the agreement was better in females than in males, which was moderate for females < 60 years old (kappa = 0.57) and those ≥ 60 years old (kappa = 0.51). The agreement was fair for the males < 60 years old (kappa = 0.39) and slight for those ≥ 60 years old (Kappa = 0.14). The results showed that in overall participants, the agreement between the two risk scores was moderate according to risk grouping. Therefore, our results suggest that the non-laboratory-based risk model can be used in resource-limited settings where individuals cannot afford laboratory tests and extensive laboratories are not available.

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

This corrects the article "Effectiveness of polypill for prevention of cardiovascular disease (PolyPars): protocol of a randomized controlled trial" published on 2020: Volume 23, Issue 08, Pages 548-556. Correction to: Arch Iran Med. 2020;23(8):548-556. doi: 10.34172/aim.2020.58. In the original version of this article, the recruitment period was wrongly reported to last from December 2014 to December 2015 in abstract and methods sections of the article. This is corrected into "from December 2015 to December 2016" in the PDF and HTML versions of the article. Also the "PolyIran" is changed to "PolyPars" in the last paragraph of the discussion section in the PDF and HTML versions of the article.

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

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.

The association between waterpipe smoking and gastroesophageal reflux disease.

Background: Unlike cigarettes, there is little information about the association between other tobacco products and the risk of gastroesophageal reflux disease (GERD) and esophageal adenocarcinoma. Methods: We used the baseline data from the Pars Cohort Study conducted in southern Iran. In 2012, 9264 local residents between 40 and 75 years old were enrolled, with detailed information about lifestyle, including duration and frequency of tobacco use. GERD was defined based on questions assessing heartburn and regurgitation in the past 12 months, frequency and severity. Associations were calculated by logistic regression models adjusted for age, sex, education, cigarettes and body mass index. Results: In the study, 25.4% of the participants had severe GERD (interfering with participants' routines), 25.1% had frequent GERD (at least once a week) and 11.2% had both severe and frequent GERD, all more common among women (p < 0.001); 45.6% of women and 28.3% of men smoked waterpipes. Among people not using medications against reflux symptoms, there was an association between waterpipe smoking and severe [odds ratio (OR) = 1.18; 95% confidence interval (CI):1.04-1.35], frequent (OR = 1.16; 95% CI: 1.02-1.32) and severe and frequent reflux (OR = 1.30; 95% CI: 1.08-1.56). The associations increased with the duration of use, intensity and cumulative waterpipe-years, reaching an OR of 1.44 (95% CI: 1.12-1.86) for severe and frequent reflux in those who had smoked more than 48 waterpipe-years. There was effect modification by sex, and all the associations were only seen among women. Conclusion: The increasing trend in the association between cumulative waterpipe use and reflux disease among women is particularly important given the growing waterpipe tobacco epidemic in many populations.

Prevalence and Correlates of Gastroesophageal Reflux Disease in Southern Iran: Pars Cohort Study.

BACKGROUND Prevalence of gastroesophageal reflux disease (GERD) is increasing worldwide. We aimed to estimate the prevalence of GERD in Pars Cohort Study (PCS) and to find its correlates. METHODS We used the baseline data from PCS. PCS was conducted in the district of Valashahr in Fars province in southern Iran from 2012 to 2014. 9264 inhabitants who were 40-75 years old, and agreed to participate were enrolled. Data were collected by a structured questionnaire and simple physical examination of all participants. RESULTS Generally, 58.50% (95% CI 57.49 - 59.51) of the participants had GERD and 25.10% (95% CI 24.22 - 25.99) experienced it at least weekly. Approximately, 32.0%, 52.0%, and 24.4% of the participants reported heart burn sensation, regurgitation, and both symptoms, respectively. Being female (OR: 1.45, 95% CI 1.27 - 1.65), being older (OR: 1.20, 95% CI 1.06 - 1.36), being divorced/ widowed/separated (OR: 1.38, 95% CI 1.01 - 1.91), and lower education (OR: 1.43, 95% CI 1.02 - 2.03) were associated with frequent GERD. CONCLUSION GERD is common in PCS and its prevalence is close to that in western countries. Being female, higher age, being divorced/widowed/separated, lower education, history of hypertension, anxiety, insomnia, and non-cigarette tobacco smoking were associated with frequent GERD. We are going to investigate the causal relationship between these risk factors and GERD in the next stages of PCS.

Epidemiologic Study of Opium Use in Pars Cohort Study: A Study of 9000 Adults in a Rural Southern Area of Iran.

BACKGROUND: Opium is one of the most common substances used worldwide with variable epidemiologic features in different regions. This study was performed in southern Iran, to find the epidemiology of opium use and its association with different factors and diseases. METHODS: This cross-sectional study was performed on baseline data extracted from Pars Cohort Study performed in Valashahr, a rural area in southern Iran. For any subject, information was collected about demographic factors, some common diseases including heart disease, stroke and hypertension and the state of using opium, other substances and cigarettes. RESULTS: There were 4276 males and 4988 females, with a mean age of 52.6 ± 9.7 years of whom 8.4% reported opium use (17.3% of males and 0.7% of females). In men, the history of stroke and heart disease were significantly more common in opium users (12.6% vs. 8.8%, P = 0.001 and 2.8% vs. 1.5%, P = 0.01, respectively) while the history of hypertension was significantly more common in non-opium users (7.8% vs. 10.3%, P = 0.04). Younger age, male gender, being non-married and positive history of joint pain, cigarette smoking and alcohol consumption were the factors associated with opium use. CONCLUSION: Opium use is common in non-married men who have a positive history of cigarette smoking and alcohol consumption in the rural population of southern Iran. It is associated with increased risk of heart disease and stroke and decreased risk of hypertension in males. Global interventional and preventive measures are required to control this complicated social problem.

Pars cohort study of non-communicable diseases in Iran: protocol and preliminary results.

OBJECTIVES: The pars cohort study (PCS) is a 10-year cohort study aiming to investigate the burden and the major risk factors of non-communicable diseases, and to establish a setting to launch interventions for prevention of these diseases and controlling their risk factors. METHODS: All inhabitants of Valashahr district in South of Iran, aged 40-75 years, were invited to undergo interviews and physical examination, and to provide biological samples. A total of 9264 invitees accepted to participate in the study (95 % participation rate) and were recruited from 2012 to 2014. Active follow-up was also carried out after 12 months. RESULTS: About 46 % of participants were male and 54 % were female. About 14.0 % of the participants were current smokers and 8.4 % were ever opium users. The prevalence of overweight and obesity were 37.3 and 18.2 %, respectively. The prevalence of hypertension was 26.9 %. A total of 49 participants died during a median follow-up of one year. CONCLUSIONS: PCS with its large scale and wealth of socio-economic and medical data can be a unique platform for studying the etiology of non-communicable diseases and effective interventions in Iran.