Polypharmacy and pattern of medication use among patients with gastroesophageal reflux disease: results from Pars Cohort study.

BACKGROUND: Gastroesophageal Reflux Disease (GERD) is a common chronic condition. Its chronic nature may affect the pattern of medication use. This study aimed to investigate the prevalence, associated factors, and patterns of polypharmacy and medication use among GERD patients in southwestern Iran. METHODS: We used data from the Pars Cohort Study. We classified drugs using the Anatomical Therapeutic Chemical classification system. The Lexicomp® database was used to assess potential drug-drug interactions. Multivariable Poisson regression was applied. Adjusted prevalence ratio (PR) and its 95% confidence interval (CI) were estimated. RESULTS: A total of 9262 participants were included. Among 2,325 patients with GERD, age-standardized prevalence of polypharmacy was 9.5% (95% CI: 7.5%, 11.6%) in males, and 19.3% (95% CI: 17.2%, 21.4%) in females. The PR of experiencing Polypharmacy by GERD patients compared to non-GERD patients was 1.82 (95% CI: 1.61, 2.05%). Multimorbidity (PR: 3.33; CI: 2.66, 4.15), gender (PR: 1.68; CI: 1.30, 2.18), and metabolic syndrome (PR: 1.77; CI: 1.45, 2.15) were associated with polypharmacy among GERD patients. Drugs for acid-related disorders were the most common used drugs among men, women and elders. We found that 13.9%, 4.2%, and 1.1% of GERD patients had type C, D and X drug interactions, respectively. CONCLUSION: GERD is correlated with a higher prevalence of polypharmacy. Among GERD patients, females, those with multi-morbidities, and those with metabolic syndrome may be affected more by polypharmacy. Considering the fairly high rate of interactions identified, a review of the medication list is essential when approaching GERD patients, and physicians must check for medications that may worsen GERD.

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.

Population-based pattern of medication use and prevalence of polypharmacy among patients with cardiovascular diseases: results of the Pars cohort study from Iran.

BACKGROUND: Polypharmacy in patients with cardiovascular diseases (CVDs) has been linked to several adverse outcomes. This study aimed to investigate the pattern of medication use and prevalence of polypharmacy among CVDs patients in Iran. METHOD: We used the baseline data of the Pars cohort study (PCS). The participants were asked to bring their medication bags; then, the medications were classified using the Anatomical Therapeutic Chemical classification. Polypharmacy was defined as using five or more medications concurrently. Poisson regression modeling was applied. The adjusted prevalence ratios (PR) and its 95% confidence interval (CI) were estimated. RESULTS: Totally, 9262 participants were enrolled in the PCS, of whom 961 had CVDs. The prevalence of polypharmacy in participants with and without CVDs was 38.9% and 7.1%, respectively. The highest prevalence of polypharmacy (51.5%) was among obese patients. Abnormal waist-hip ratio (PR: 2.79; 95% CI 1.57-4.94), high socioeconomic status (PR: 1.65; 95% CI 1.07-2.54), tobacco-smoking (PR: 1.35; 95% CI 1.00-1.81), patients with more than three co-morbidities (PR: 1.41; 95% CI 1.30-1.53), high physical activity (PR: 0.66; 95% CI 0.45-0.95), use of opiate ever (PR: 0.46; 95% CI 0.26-0.82), and healthy overweight subjects (PR: 0.22; 95% CI 0.12-0.39) were associated with polypharmacy. Cardiovascular drugs (76.1%), drugs acting on blood and blood-forming organs (50.4%), and alimentary tract and metabolism drugs (33.9%) were the most frequently used drugs. Agents acting on the renin-angiotensin system were the mostly used cardiovascular system drugs among men and those above 60 years old, while beta-blocking agents were mostly prevalent among cardiovascular system drugs in women with CVDs. CONCLUSION: Given the high prevalence of polypharmacy among CVDs patients, and subsequent complications, programs to educate both physicians and patients to prevent this issue is crucial.

Effectiveness of polypill for primary and secondary prevention of cardiovascular diseases (PolyIran): a pragmatic, cluster-randomised trial.

BACKGROUND: A fixed-dose combination therapy (polypill strategy) has been proposed as an approach to reduce the burden of cardiovascular disease, especially in low-income and middle-income countries (LMICs). The PolyIran study aimed to assess the effectiveness and safety of a four-component polypill including aspirin, atorvastatin, hydrochlorothiazide, and either enalapril or valsartan for primary and secondary prevention of cardiovascular disease. METHODS: The PolyIran study was a two-group, pragmatic, cluster-randomised trial nested within the Golestan Cohort Study (GCS), a cohort study with 50 045 participants aged 40-75 years from the Golestan province in Iran. Clusters (villages) were randomly allocated (1:1) to either a package of non-pharmacological preventive interventions alone (minimal care group) or together with a once-daily polypill tablet (polypill group). Randomisation was stratified by three districts (Gonbad, Aq-Qala, and Kalaleh), with the village as the unit of randomisation. We used a balanced randomisation algorithm, considering block sizes of 20 and balancing for cluster size or natural log of the cluster size (depending on the skewness within strata). Randomisation was done at a fixed point in time (Jan 18, 2011) by statisticians at the University of Birmingham (Birmingham, UK), independent of the local study team. The non-pharmacological preventive interventions (including educational training about healthy lifestyle-eg, healthy diet with low salt, sugar, and fat content, exercise, weight control, and abstinence from smoking and opium) were delivered by the PolyIran field visit team at months 3 and 6, and then every 6 months thereafter. Two formulations of polypill tablet were used in this study. Participants were first prescribed polypill one (hydrochlorothiazide 12·5 mg, aspirin 81 mg, atorvastatin 20 mg, and enalapril 5 mg). Participants who developed cough during follow-up were switched by a trained study physician to polypill two, which included valsartan 40 mg instead of enalapril 5 mg. Participants were followed up for 60 months. The primary outcome-occurrence of major cardiovascular events (including hospitalisation for acute coronary syndrome, fatal myocardial infarction, sudden death, heart failure, coronary artery revascularisation procedures, and non-fatal and fatal stroke)-was centrally assessed by the GCS follow-up team, who were masked to allocation status. We did intention-to-treat analyses by including all participants who met eligibility criteria in the two study groups. The trial was registered with ClinicalTrials.gov, number NCT01271985. FINDINGS: Between Feb 22, 2011, and April 15, 2013, we enrolled 6838 individuals into the study-3417 (in 116 clusters) in the minimal care group and 3421 (in 120 clusters) in the polypill group. 1761 (51·5%) of 3421 participants in the polypill group were women, as were 1679 (49·1%) of 3417 participants in the minimal care group. Median adherence to polypill tablets was 80·5% (IQR 48·5-92·2). During follow-up, 301 (8·8%) of 3417 participants in the minimal care group had major cardiovascular events compared with 202 (5·9%) of 3421 participants in the polypill group (adjusted hazard ratio [HR] 0·66, 95% CI 0·55-0·80). We found no statistically significant interaction with the presence (HR 0·61, 95% CI 0·49-0·75) or absence of pre-existing cardiovascular disease (0·80; 0·51-1·12; pinteraction=0·19). When restricted to participants in the polypill group with high adherence, the reduction in the risk of major cardiovascular events was even greater compared with the minimal care group (adjusted HR 0·43, 95% CI 0·33-0·55). The frequency of adverse events was similar between the two study groups. 21 intracranial haemorrhages were reported during the 5 years of follow-up-ten participants in the polypill group and 11 participants in the minimal care group. There were 13 physician-confirmed diagnoses of upper gastrointestinal bleeding in the polypill group and nine in the minimal care group. INTERPRETATION: Use of polypill was effective in preventing major cardiovascular events. Medication adherence was high and adverse event numbers were low. The polypill strategy could be considered as an additional effective component in controlling cardiovascular diseases, especially in LMICs. FUNDING: Tehran University of Medical Sciences, Barakat Foundation, and Alborz Darou.

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.

Polypharmacy and medication usage patterns in hypertensive patients: Findings from the Pars Cohort Study.

Polypharmacy, defined here as the concomitant use of five or more medications, is a significant health issue, particularly affecting individuals with chronic diseases like hypertension (HTN). To compare individuals with and without HTN in term of polypharmacy, and to investigate correlates of polypharmacy and medication use patterns in individuals with HTN in southwest Iran. This cross-sectional study used the baseline data of 9270 participants of the Pars Cohort Study (PCS) with a mean age of 52.6 ± 9.7 years. Poisson multivariable modeling was applied to identify correlates of polypharmacy, and Lexicomp® was used to assess drug-drug interactions. Anatomical Therapeutic Chemical classification was used to describe the pattern of medication use. The prevalence of polypharmacy in individuals without hypertension was 4.7 % (4.2%-5.2 %) vs. 23.7 % (22.1%-25.3 %) in individuals with hypertension (P < 0.001). Individuals with hypertension from middle-high socioeconomic status (SES) had a 1.51-fold higher prevalence of polypharmacy than vs. low SES. Those with more than three comorbidities had a 5.18 times higher prevalence of polypharmacy than those with isolated hypertension. Calcium channel blockers were the most common antihypertensives (20.9 %). In terms of drug-drug interactions, type C interactions were most prevalent among participants with hypertension and polypharmacy (76.0 %). Our findings imply a fairly high prevalence of polypharmacy and drug-drug interactions among individuals with hypertension; to tackle this issue, we recommend a national pharmacovigilance system, training programs for primary care physicians, public education and awareness campaigns, drug-checking campaigns, targeted screenings to alter modifiable risk factors, and the use of safe combination pills.

How Similar Are Drug Data and Disease Self-report? Estimating the Prevalence of Chronic Diseases in Less Developed Settings.

BACKGROUND: Drug data has been used to estimate the prevalence of chronic diseases. Disease registries and annual surveys are lacking, especially in less-developed regions. At the same time, insurance drug data and self-reports of medications are easily accessible and inexpensive. We aim to investigate the similarity of prevalence estimation between self-report data of some chronic diseases and drug data in a less developed setting in southwestern Iran. METHODS: Baseline data from the Pars Cohort Study (PCS) was re-analyzed. The use of disease-related drugs were compared against self-report of each disease (hypertension [HTN], diabetes mellitus [DM], heart disease, stroke, chronic obstructive pulmonary disease [COPD], sleep disorder, anxiety, depression, gastroesophageal reflux disease [GERD], irritable bowel syndrome [IBS], and functional constipation [FC]). We used sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and the Jaccard similarity index. RESULTS: The top five similarities were observed in DM (54%), HTN (53%), heart disease (32%), COPD (30%), and GERD (15%). The similarity between drug use and self-report was found to be low in IBS (2%), stroke (5%), depression (9%), sleep disorders (10%), and anxiety disorders (11%). CONCLUSION: Self-reports of diseases and the drug data show a different picture of most diseases' prevalence in our setting. It seems that drug data alone cannot estimate the prevalence of diseases in settings similar to ours. We recommend using drug data in combination with self-report data for epidemiological investigation in the less-developed setting.

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.

The association between anthropometric indices and ischemic heart disease: a large-scale cross-sectional study on the Iranian population.

This study aimed to evaluate the superiority of anthropometric indices compared to others for predicting ischemic heart disease (IHD) or cardiometabolic risk factors. This study was a cross-sectional analysis of the Pars Cohort Study data. In total, 9229 Valashahr inhabitants aged 40-75 were included in the analysis. The area under the receiver operating characteristic curve (AUC) analyses was used to compare the predictive accuracy of four anthropometric measures, including body mass index, waist to height ratio (WHtR), waist to hip ratio (WHR), and waist circumference (WC). IHD prevalence was 10.4% in our sample. The prevalence of diabetes mellitus (DM), hypertension, dyslipidemia, and metabolic syndrome was 12.7%, 29.2%, 58.4%, and 22.3%, respectively. All anthropometric indices had poor to good accuracy in predicting IHD risk factors, with AUCs ranging between 0.580 and 0.818. WHR was the most accurate measure for predicting IHD in both genders. All indexes had a better accuracy for predicting DM, dyslipidemia, and metabolic syndrome (MetS) in males than in females. To conclude, anthropometric measures, especially WC and WHtR, are recommended for predicting metabolic syndrome in primary prevention settings. These simple indices could help physicians find those who need further evaluation for MetS.

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.

Liver fibrosis in pars cohort study: A large-scale study on the prevalence and correlated factors.

BACKGROUNDS AND STUDY AIMS: The fibrosis-4 (FIB-4) is a non-invasive scoring system for estimating liver fibrosis severity as a biomarker of chronic liver disease. We aimed to estimate the prevalence and severity of chronic liver disease at the community level using FIB-4. PATIENTS AND METHODS: This cross-sectional study was conducted using the Pars Cohort database collected in Valashar, Fars province, Iran. Participants were divided into three groups based on their FIB-4 scores: low risk of liver fibrosis (FIB < 1.45), intermediate cases (1.45 ≤ FIB-4 ≤ 3.25), and high risk of liver fibrosis (FIB-4 > 3.25). RESULTS: In total, 9269 individuals with a mean age of 52.65 years were enrolled in the study, of which 4278 (46.2 %) were male. Among all participants, 7853 (84.7 %) were in the low-risk, and 65 (0.7 %) were in the high-risk groups. In the final ordinal regression model, male gender, being a farmer or rancher, living in rural areas, history of opioid use, history of jaundice, no history of diabetes, history of depression, and positive HBs Ag were independently associated with higher FIB-4 scores. CONCLUSION: Our study revealed that males, individuals residing in rural areas, and those engaged in farming and ranching occupations face a heightened risk of liver fibrosis. These findings emphasize the need for future programs for early detection and effective management of liver fibrosis in these at-risk populations.

Validity of Body Image Pictogram to Determine Overweight/Obesity in Adults from Less Developed Populations: Results From Pars Cohort Study.

BACKGROUND: Despite the evidence for validity of body image pictogram (BIP) to discriminate overweight, obese, and normal individuals, there is little evidence on the probable effect of socio-demographic variables on its validity. To investigate the effects of socioeconomic status (SES), age, ethnicity, and educational level on the validity of BIP to discriminate normal weight, overweight, and obese people. METHODS: We used the Pars Cohort Study (PCS) data. Stunkard's BIP score was used as test measure. Participants were classified as normal (body mass index [BMI]<25), overweight (BMI=25 to 29.9), and obese (BMI≥29.9) based on their BMI (kg/m2 ). Area under curve (AUC) and its 95% CI were estimated and compared. Optimal cutoff points and their sensitivity, specificity, and likelihood ratio were reported. RESULTS: A total of 9232 participants with a female/male ratio of 1.03 were included. The prevalence of overweight and obesity was 37.4% and 18.2%, respectively. Regardless of socio-demographic levels, the optimal cut-points to discriminate normal BMI from overweight, and overweight from obese participants were BIP score of four and five, respectively. Estimated AUC correlated with ethnicity (P<0.001) for both genders, and with SES for females (P<0.05). CONCLUSION: Although BIP may be a valid measure to categorize the general adult population into normal, overweight and obese, its validity depends on SES and ethnicity. BIP may be available as a proxy measure for BMI categories in socio-demographically homogeneous populations but not in heterogeneous populations.

Pictogram Is a Valid Instrument to Classify At-Risk Adult Population Based on Abdominal Obesity: Results from Pars Cohort Study.

BACKGROUND: Abdominal obesity is associated with increased risk of myocardial infarction and death events. Thus, obtaining data on the status of abdominal obesity is important in risk factor assessment and prevention of non-communicable diseases. This study aimed to evaluate the validity of using pictograms to classify abdominal obesity indices (waist circumference [WC], waist-hip ratio [WHR], and waist-height ratio [WHtR]) into normal and at-risk categories and determine the effects of demographic characteristics on this validity. METHODS: This cross-sectional study used data from Pars Cohort Study (PCS). Participants chose the most similar pictogram scores to their body size at 15, 30 years, and current age. Optimal normal/at-risk cut-off values for pictograms were calculated using sensitivity/specificity plots. Receiver operating characteristic curves were used to evaluate the validity of pictograms. Validity measures were analyzed across different subgroups of demographic characteristics. RESULTS: A total of 9263 participants (46% males) were included in the study. The estimated area under the curves were 84% for WC, 77% for WHR, and 89% for WHtR in males, and 84% for WC, 73% for WHR, and 90% for WHtR in females. Optimal pictogram cutoffs to classify central obesity for WC, WHR, and WHtR were 4, 4, and 5 in males and 4, 4, and 6 in females, respectively. The majority of demographic characteristics were not associated with the validity of pictograms. CONCLUSION: Using pictograms to determine normal and at-risk categories of abdominal obesity indices is valid among adult population with a wide range of demographic characteristics. However, the results need to be interpreted with caution in those with a positive history of weight fluctuation.

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.

Prevalence of Hepatitis B and C Infections and Associated Risk Factors in Pars Cohort Study, Southern Iran.

BACKGROUND Hepatitis B and C virus (HBV and HCV) infections rank among the most frequent infectious diseases with a rising worldwide burden. However, their epidemiology and risk factors are understudied in many regions, including Iran. METHODS This study was conducted as part of the Pars Cohort Study (PCS) in Valashahr district, Fars province (2012-2014). Participants received venipuncture for HBsAg and HCV antibody, followed by Polymerase Chain Reaction (PCR) testing. All infected people and their comparison groups completed a risk assessment questionnaire. RESULTS Overall, 9,269 people participated in the study; the majority were women and of Fars ethnicity. Prevalence of HBsAg and HCV antibody was 2.3% (n = 215) and 0.3% (n = 26), from whom 23% (n = 47) and 13% (n = 3) had indications for treatment, respectively. During follow-up, among HBsAg-positive individuals who were not on treatment, 62% tested negative for HBsAg, and in 2% HBV DNA had risen to treatment levels. Risk factors for HBV infection were illiteracy [OR = 3.43, 95% CI = 1.1, 10.3], and Turk ethnicity compared to Fars [OR = 1.58, 95% CI = 1.1, 2.3]. History of blood transfusion [OR = 2.00, 95% CI = 1.1, 3.5] and history of drug use [OR = 2.85, 95% CI = 1.1, 7.4] were associated with HCV infection, after adjustment. CONCLUSION Further epidemiological studies are needed to identify at-risk populations in different regions. Preventive interventions, including educational programs and transfusion safety strategies, are crucial for reducing the hepatitis burden.

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.

Three common CARD15 mutations are not responsible for the pathogenesis of Crohn's disease in Iranians.

BACKGROUND/AIMS: Crohn's disease frequency has increased in recent years in Iran. Genetic and environmental factors predispose people to this disease. Mutation in Caspase Recruitment Domain 15 (CARD15) gene is the most well known genetic predisposing factor to this disease. Frequency of three common CARD15 mutations has been studied in different ethnic groups. We aimed to study the frequency of these mutations in Iranian patients affected with Crohn's Disease. METHODOLOGY: One hundred fifteen proved cases of Crohn Disease and 115 age and sex matched normal controls were recruited in this study. Lf1007fs, R702W and G908R mutations were studied by Polymerase Chain Reaction-Restriction Fragment Length Polymorphims (PCR-RFLP) followed by sequencing the positive cases. RESULTS: Lf1007fs and G908R mutations were not found in either patients or age-sex matched controls. Just in two patients, R702W mutation was proved by Polymerase Chain Reaction-Restriction Fragment Length Polymorphism (PCR-RFLP) and sequencing. None of these patients had illeal or fibrostenotic type of disease while 14.7% of total patients had stricturing type of disease. No complication was seen in these two patients while 50.4% of patients had acquired complications during the course of disease. CONCLUSION: The three mutations described are not responsible for the pathogenesis of Crohn's Disease in Iranians. The results are in accordance with other Asian nations' studies on IBD Patients.

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.

Prevalence, Awareness, Treatment, Control, and Correlates of Hypertension in the Pars Cohort Study.

BACKGROUND: High blood pressure is an important risk factor for all-cause mortality and cardiovascular mortality and morbidity among Iranians. We aimed to estimate its prevalence, correlates, and its rate of awareness, treatment, and control in South of Iran. METHODS: The Pars Cohort Study (PCS) was launched in a district of Fars province. All residents between 40 and 75 years old in the district were recruited from 2012 to 2014. Hypertension was defined as either systolic/diastolic blood pressure ≥ 140/90 mm Hg or taking medications. Logistic regression was used to identify the correlates of hypertension and awareness and its treatment and control. A total of 9264 participants were recruited. Of the total participants, 46.2% were men. The mean age was 52.6 years (SD: 9.7). RESULTS: Prevalence of hypertension was 26.9%. Of the total 2489 hypertensives, 49.6% were aware and 55.7% were under treatment. Blood pressure was controlled in 69.2% of treated hypertensives. In the adjusted model, female sex and history of cardiovascular disease (CVD) were positively associated with having hypertension, higher awareness, and better treatment and control. Older age, being overweight or obese, and having a history of diabetes were also positively associated with having hypertension and higher awareness and treatment; however, being overweight or obese was associated with poorer hypertension control. Older age and having a history of diabetes did not show a statistically significant association with control. CONCLUSION: Being underweight and higher physical activity were inversely associated with having hypertension but were not associated with awareness, treatment, or control. Prevalence of hypertension is high but the rates of awareness, treatment, and control are not adequate.

Reliability Analysis of a Newly Developed Questionnaire for Quality Control of Follow-up Visits in PolyIran Study.

BACKGROUND: The PolyIran study is a large-scale pragmatic cluster randomized controlled trial of fixed-dose combination therapy (Polypill) for prevention of cardiovascular diseases (CVD) in Iran. The PolyIran Quality Control Program (PIQCP) including a new questionnaire was developed to assess the quality of data collection during follow-up visits. The aim of this study was to assess the inter-rater reliability of PIQCP questionnaire. METHODS: The study was conducted in 26 (11%) randomly selected clusters (from a total of 236 PolyIran clusters). All participants within these 26 clusters were enrolled. The quality scores were measured according to the PIQCP guidelines by two independent raters. The intraclass correlation coefficients (ICC) were measured. In addition, the quality scores were categorized into good (70%) and poor (<70%). The kappa coefficient was used to assess inter-rater agreement for this categorical quality scores. RESULTS: A total number of 945 PolyIran participants were enrolled of which, 501 (53%) were from intervention arm. In 934 participants (98.8%), the quality score could be successfully identified by both raters. The ICC (95%CI) of the overall quality scores was 0.985 (0.983-0.987). It was 0.976 (0.972-0.980) and 0.988 (0.986-0.990) in intervention and control arms, respectively. We found excellent agreement between the two raters in identifying participants with good and poor quality scores (kappa = 0.988, P < 0.001). The kappa values were 0.972 (P < 0.001) and 1.000 (P < 0.001) in intervention and control arms, respectively. DISCUSSION: Our results suggested that the PIQCP questionnaire is a reliable tool for assessing quality of data collection in PolyIran follow-up visits. Using this measure will help us in efficient monitoring of the PolyIran follow-ups and may ensure high quality data.