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Objective To assess whether there is an association between statin use and the occurrence of polymyalgia rheumatic (PMR) in the spontaneous reporting database of the World Health Organisation (WHO). Methods We conducted a case/non-case study based on individual case safety reports (ICSR) in the WHO global ICSR database (VigiBase). Case reports containing the adverse event term polymyalgia rheumatica (WHOART or MedDRA Preferred Term) were defined as cases. Non-cases were all case reports containing other adverse event terms. Each case was matched to five non-cases by age, gender, and time of reporting. Case reports regarding a statin as suspected or concomitant drug were identified using the Anatomical Therapeutic Chemical (ATC) classification. Multivariate logistic regression was used to calculate reporting odds ratios (RORs) with 95% confidence intervals (CI). Results We identified 327 reports of PMR as cases and 1635 reports of other ADRs as non-cases. Among cases, statins were more frequently reported as suspected agent (29.4%) compared to non-cases (2.9%). After adjustment for several covariates, statins were significantly associated with reports of PMR (ROR 14.21; 95% CI 9.89–20.85). Conclusion The results of this study lends support to previous anecdotal case reports in the literature suggesting that the use of a statin may be associated with the occurrence of PMR. Further studies are needed to study the strength of the association in more detail and to elucidate the underlying mechanism.

BackgroundA growing body of evidence shows the short-term benefits of breastfeeding, which include protection against infections, allergies, and lung diseases. However, evidence on the long-term benefits of breastfeeding is scarce and often conflicting. The BReastfeeding Attitude and Volume Optimization (BRAVO) trial is designed to study the effect of breastfeeding on early signs of later chronic diseases, particularly cardiovascular, respiratory, and metabolic risks later in life. In addition, the effectiveness of breastfeeding empowerment in promoting breastfeeding will also be evaluated.Methods/designThis study is an ongoing randomized trial in Jakarta, Indonesia, that began in July 2012. Pregnant women are being screened for their breastfeeding plan in the third trimester, and those with low intention to breastfeed are randomly allocated to either receiving an add-on breastfeeding-optimization program or usual care. Primary outcomes include breastfeeding rate, lung function, and blood pressure during the first year of life and vascular/cardiac characteristics, which will be measured at the age of 4 to 5 years. Child growth and infection/illness episodes are measured, whereas cognitive testing is planned for the children at 5 years of age.DiscussionTo date, 784 women (80 %) have been randomized of the 1,000 planned, with satisfactory completeness of the 1-year follow up (90.1 %). Included mothers are of lower socioeconomic status and more often have blue-collar jobs, similar to what was observed in the pilot study.Trial registrationClinicalTrials.gov, NCT01566812. Registered on 27 March 2012.Electronic supplementary materialThe online version of this article (doi:10.1186/s13063-016-1397-y) contains supplementary material, which is available to authorized users.

The Hajj is an annual pilgrimage to Mecca and one of the largest gathering of people in the world. Most Indonesian pilgrims are senior adults and elderly adults, who are more prone to acquire infections during the Hajj ritual. The aims of this study are to investigate the dynamics of Streptococcus pneumoniae colonization and to investigate antibiotic susceptibility of pneumococcal strains in Indonesian pilgrims. This was a prospective multi-site longitudinal study in Indonesian hajj pilgrims aged >18 years old in the year 2015. Nasopharyngeal swabs were collected from the same subject before departure and upon arrival at the airport. S. pneumoniae was identified using conventional and molecular approach, while antibiotic susceptibility was determined using a disk diffusion method. Among 813 Hajj pilgrims who were enrolled from five sites in this study, the prevalence of S. pneumoniae carriage rates before- and after-the Hajj were 8.6% (95% CI 6.7–10.5%) and 8.2% (95% CI 6.4–10.1%), (p value: 0.844) respectively. Serotype 16F, 6A/6B, 3, 18, and 23F were the five most prevalent serotypes before Hajj, whereas serotypes 3, 34, 13, 4, and 23F were the most prevalent serotypes after Hajj. Serotype 3 was identified as most acquired serotype during Hajj in Indonesian pilgrim. There was an increase in the percentage of isolates susceptible to co-trimoxazole after Hajj (42.9% versus 57.4%). The study provided an overview of the change of dynamics of S. pneumoniae serotype acquisition in Indonesian Hajj Pilgrims. Along with data of vaccination serotypes coverage and antimicrobial susceptibility, these findings may contribute to recommendation of vaccination and treatment policies in the future.