A group of academic and industry experts in the fields of nutrition, cardiology, epidemiology, food science, bone health, and integrative medicine examined the data on the relationship between calcium supplement use and risk of cardiovascular events, with an emphasis on 4 of the Bradford Hill criteria for causal inference: strength, consistency, dose-response, and biological plausibility. Results from 2 epidemiological studies and a meta-analysis of randomized, controlled clinical trials, including a subgroup analysis from the Women's Health Initiative, have prompted concern about a potential association between calcium supplement use and a small increase in the risk of adverse cardiovascular events. However, a number of issues with the studies, such as inadequate compliance with the intervention, use of nontrial calcium supplements, potential bias in event ascertainment, and lack of information on and adjustment for known cardiovascular risk determinants, suggest that bias and confounding cannot be excluded as explanations for the reported associations. Findings from other cohort studies also suggest no detrimental effect of calcium from diet or supplements, with or without vitamin D, on cardiovascular disease risk. In addition, little evidence exists for plausible biological mechanisms to link calcium supplement use with adverse cardiovascular outcomes. The authors do not believe that the evidence presented to date regarding the hypothesized relationship between calcium supplement use and increased cardiovascular disease risk is sufficient to warrant a change in the Institute of Medicine recommendations, which advocate use of supplements to promote optimal bone health in individuals who do not obtain recommended intakes of calcium through dietary sources.
"In addition, AE case reports in a case reporting system such as VAERS can be analysed statistically using methods such as filtering based on a case number cutoff, proportional reporting ratio (PRR)
, and Chi-square test, in order to screen for possible causal AEs
. To make more convincing causality assessment using a statistical method, randomized, well-controlled experimental design for evaluating a causality hypothesis is typically required
[34,35]. These statistical methods can be used to address any possible ‘causal adverse event hypothesis’. "
[Show abstract][Hide abstract] ABSTRACT: Background
A medical intervention is a medical procedure or application intended to relieve or prevent illness or injury. Examples of medical interventions include vaccination and drug administration. After a medical intervention, adverse events (AEs) may occur which lie outside the intended consequences of the intervention. The representation and analysis of AEs are critical to the improvement of public health.
The Ontology of Adverse Events (OAE), previously named Adverse Event Ontology (AEO), is a community-driven ontology developed to standardize and integrate data relating to AEs arising subsequent to medical interventions, as well as to support computer-assisted reasoning. OAE has over 3,000 terms with unique identifiers, including terms imported from existing ontologies and more than 1,800 OAE-specific terms. In OAE, the term ‘adverse event’ denotes a pathological bodily process in a patient that occurs after a medical intervention. Causal adverse events are defined by OAE as those events that are causal consequences of a medical intervention. OAE represents various adverse events based on patient anatomic regions and clinical outcomes, including symptoms, signs, and abnormal processes. OAE has been used in the analysis of several different sorts of vaccine and drug adverse event data. For example, using the data extracted from the Vaccine Adverse Event Reporting System (VAERS), OAE was used to analyse vaccine adverse events associated with the administrations of different types of influenza vaccines. OAE has also been used to represent and classify the vaccine adverse events cited in package inserts of FDA-licensed human vaccines in the USA.
OAE is a biomedical ontology that logically defines and classifies various adverse events occurring after medical interventions. OAE has successfully been applied in several adverse event studies. The OAE ontological framework provides a platform for systematic representation and analysis of adverse events and of the factors (e.g., vaccinee age) important for determining their clinical outcomes.
[Show abstract][Hide abstract] ABSTRACT: Calcium supplements have been widely used by older men and women. However, in little more than a decade, authoritative recommendations have changed from encouraging the widespread use of calcium supplements to stating that they should not be used for primary prevention of fractures. This substantial shift in recommendations has occurred as a result of accumulated evidence of marginal antifracture efficacy, and important adverse effects from large randomized controlled trials of calcium or coadministered calcium and vitamin D supplements. In this review, we discuss this evidence, with a particular focus on increased cardiovascular risk with calcium supplements, which we first described 5 years ago. Calcium supplements with or without vitamin D marginally reduce total fractures but do not prevent hip fractures in community-dwelling individuals. They also cause kidney stones, acute gastrointestinal events, and increase the risk of myocardial infarction and stroke. Any benefit of calcium supplements on preventing fracture is outweighed by increased cardiovascular events. While there is little evidence to suggest that dietary calcium intake is associated with cardiovascular risk, there is also little evidence that it is associated with fracture risk. Therefore, for the majority of people, dietary calcium intake does not require close scrutiny. Because of the unfavorable risk/benefit profile, widespread prescribing of calcium supplements to prevent fractures should be abandoned. Patients at high risk of fracture should be encouraged to take agents with proven efficacy in preventing vertebral and nonvertebral fractures.
Journal of bone and mineral research: the official journal of the American Society for Bone and Mineral Research 04/2011; 26(4):899; author reply 900-1. DOI:10.1002/jbmr.331 · 6.83 Impact Factor
[Show abstract][Hide abstract] ABSTRACT: The ADVICE (ADherence in VItamin-D and Calcium Embedded or not) survey was aimed to evaluate the effect of a patient-focused motivation strategy on the adherence to calcium and vitamin D supplementation. The survey also intended to identify possible factors being able to influence the compliance (i.e. the existence of individual preferences towards different dosages or regimens of supplementation).
We planned to involve consecutive patients visited between 2010 and 2011 at 35 centres specialized in diagnosis and treatment of osteoporosis in different Italian regions. Each patient has been requested to declare if he/she was already assuming any supplementation with calcium and vitamin D (naïve or not naïve). All patients underwent a first visit (T0) and two follow up visits at 6 and 12 months (T6 e T12). The assessment of the adherence was measured through the Morinsky Medication Adherence Scale, a score based on 8 different questions, specifically validated to determine therapeutical compliance (0-5: not acceptable; 6-7: acceptable; 8: ideal).
732 women (mean age: 66.9; average BMI: 25.3) and 30 men (mean age: 71.9; average BMI: 24.5) were enrolled; 34% of female patients (n=245) and 66% of males (n=20) reported previous fractures. Not naïve patients were 385 (54%). A total of 309 patients (43%) were concurrently assuming an antifracture drug; 229 subjects were osteoporotic (45%), while 224 were osteopenic (44%). The mean Morinsky score in not naïve patients was 5.72, 6.19 and 6.18 at T0, T6, and T12, respectively. Thus, no differences in the Morinsky score were observed between T6 and T12. Naïve patients showed an average Morinsky score of 5.78 at T6 and 6.39 at T12. Older age was not significantly associated with the observed changes in the scores. The onset of AEs related to the supplementation with calcium and vitamin D was able to negatively influence the adherence at the subsequent control point. Bone mineral density, previous fractures, and concurrent assumption of any antifracture drug did not significantly influence the adherence, as well as the differences in the dosages or regimens of calcium and vitamin D administration.
Activities aimed to strengthen motivation of the patients improved the adherence to calcium and vitamin D supplementations after only 6 months.
Clinical Cases in Mineral and Bone Metabolism 09/2012; 9(3):157-60.
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