A Polypill for primary prevention of cardiovascular disease: A feasibility study of the World Health Organization

<p>Abstract</p> <p>Background</p> <p>The feasibility of conducting a large-scale Polypill clinical trial in developing countries remains unclear. More information is needed regarding the efficacy in reducing the risk factors of cardiovascular disease (CVD), side effects, improvement in adherence and physician/patient "acceptability" of the Polypill.</p> <p>Methods</p> <p>We conducted an open-label, parallel-group, randomized clinical trial involving three sites in Sri Lanka that enrolled a total of 216 patients without established CVD. The trial compared a Polypill (75 mg aspirin, 20 mg simvastatin, 10 mg lisinopril and 12.5 mg hydrochlorothiazide) to Standard Practice. After randomization, patients were followed monthly for three months. Pre-specified primary outcomes included reduction in systolic blood pressure, total cholesterol and estimated 10-year CVD risk. We also evaluated the recruitment process and acceptability of the Polypill by both physicians and patients.</p> <p>Results</p> <p>Patients were recruited in a six-month period as planned. Two hundred three patients (94.0%) completed the treatment program and returned for their three-month follow-up visits. No safety concerns were reported. These findings suggest a high rate of patient acceptability, a finding that is bolstered by the majority of patients completing the trial (90%) indicating that they would take the Polypill "for life" if proven to be effective in reducing CVD risk. Approximately 86% of the physicians surveyed agreed with and supported use of the Polypill for primary prevention and 93% for secondary prevention of CVD. Both the Polypill and Standard Practice resulted in marked reductions in systolic blood pressure, total cholesterol and 10-year risk of CVD. However, the differences between the treatment groups were not statistically significant.</p> <p>Conclusions</p> <p>We successfully completed a Polypill feasibility trial in Sri Lanka. We were able to document high acceptability of the Polypill to patients and physicians. We were unable to estimate the risk factor reductions on the Polypill because the control group received similar treatment with individual drugs. The Polypill was however simpler and achieved comparable risk factor reductions, highlighting its potential usefulness in the prevention of CVD.</p> <p>Trial registration number</p> <p>ISRCTN: <a href="http://www.controlled-trials.com/NCT00567307">NCT00567307</a></p

The correlation between local weather and leptospirosis incidence in Kandy district, Sri Lanka from 2006 to 2015

Background: Leptospirosis is an important public health problem in Sri Lanka. Most people become infected by contact with leptospires in soil and in surface water. Survival of leptospires in the environment depends upon the moisture in soil, humidity, temperature and surface water. Leptospires are spread by flood water and waterways. Therefore, the weather of an area influences the leptospirosis incidence of that area. Objectives: To find out the correlations between the leptospirosis incidence in the district of Kandy, Sri Lanka, and local weather variables and then to explore the utility of the findings. Methods: We gathered data on reported leptospirosis cases in the Kandy district and mid-year population data and calculated weekly incidences for 2006 to 2015. Daily weather data from Katugastota weather station was obtained and converted into weekly data. We plotted time series graphs and observed the correlation between six aggregated weather parameters and leptospirosis incidence. Those weather parameters were rainfall, the count of wet days per week, days with rainfall >100 mm per week, minimum temperature, average temperature and average humidity. Then we looked for correlations between leptospirosis incidence and those weather parameters by performing the wavelet analysis. Results: Our wavelet analysis results show peaks of wet days per week, days with rainfall >100 mm per week, minimum temperature, average temperature and average humidity respectively after 2, 3, 13, 20 and 1 week lags were followed by peaks of leptospirosis incidence. Nadirs (troughs) of rainfall after a week were followed by nadirs of leptospirosis incidence. Conclusions: All weather parameters studied are correlated with local leptospirosis incidence and the climate in Kandy is conducive for leptospirosis transmission. Leptospirosis incidence in the Kandy district is high compared to the national and global incidence. Therefore, leptospirosis preventive work in Kandy deserves more attention, especially during months with favorable weather for leptospirosis transmission

The Sinhala version of the Pain Catastrophizing Scale: validation and establishment of the factor structure in pain patients and healthy adults

Objective: This study was conducted to translate the Pain Catastrophizing Scale into and adapt it to the Sinhala language and to examine its psychometric properties and factor structure in pain patients and healthy adults in Sri Lanka.\ud \ud Setting and Design: A cross-sectional study was conducted, recruiting pain patients from multiple clinics and healthy adults from the community as convenience samples.\ud \ud Methods: Cross-cultural adaptation of the Pain Catastrophizing Scale for Sinhala speakers was carried out using recommended methods. The adaptation's psychometric properties and factor structure were tested in 149 pain patients and 172 healthy adults. Temporal stability was tested in a sample of 104 young adults. Pain intensity of patients was assessed using a visual analog scale, and personality traits of all participants were assessed with the Eysenck Personality Questionnaire.\ud \ud Results: Factor analysis revealed that the three-factor structure of the original version of the Pain Catastrophizing Scale was the best fit to the data from participant samples. Cronbach's alpha values of the three components and total scores for patients and healthy adults ranged from 0.72 to 0.87. Pain catastrophizing exhibited moderate positive correlations with neuroticism in patients and healthy adults and with pain intensities in patients. A high intraclass correlation coefficient of agreement (0.81) revealed an acceptable temporal stability in young adults.\ud \ud Conclusions: The results suggest that the Sinhala version of the Pain Catastrophizing Scale retains the original three-factor structure. It is a stable, valid and sufficiently reliable tool to assess pain catastrophizing in Sinhala-speaking individuals in Sri Lanka

An Atypical Clinical Manifestation of a Hump-Nosed Pit Viper Envenomation

Envenomations by hump-nosed pit vipers (HNVs) are frequent in Sri Lanka and in South India. Until recently, HNV was considered a moderately venomous snake. Here, we report a case of a previously healthy female developing all the known serious complications, plus some previously unreported complications following a HNV envenomation. She had muscarinic symptoms like profuse sweating and salivation within a couple of minutes and a seizure several minutes after envenomation. Her acute kidney injury (AKI) was swift onset and progressed to end-stage renal failure at three months. She had mild parotid swelling, crepitations in her lungs, and edema of the bitten leg. She had evidence of microangiopathic hemolytic anemia and hemolytic uremic syndrome as well. She developed local tissue necrosis, a non-ST-elevation myocardial infarction (non-STEMI), and anterior ischemic optic neuropathy (AION) following the envenomation. We believe the best explanation for her swift onset complication is intravascular injection of venom. We believe ischemia due to thrombotic microangiopathy has contributed to local tissue necrosis. Those ischemia and kidney failure have contributed to non-STEMI and AION. We illustrate the issue of the sluggish progress made by medicine in understanding the complications of envenomation by using HNV as an example