The calcium scare—what would Austin Bradford Hill have thought?

Nordin, B. E. C.; Lewis, Joshua R.; Daly, Robin M.; Horowitz, J. D.; Metcalfe, Andrew; Lange, Kylie; Prince, Richard

doi:10.1007/s00198-011-1680-4

Cited by 46 publications

(36 citation statements)

References 17 publications

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“…An MI in a patient taking supplements for five to ten years would normally not be attributed to the long-term use of these bone-protecting pills, and therefore the association cannot be detected by SRSs. Our point is not whether or not calcium supplements really cause myocardial infarction [4], but even if this was the case, existing drug surveillance would probably miss detecting it by SRS. On the other hand, epidemiological studies not prospectively designed to detect specific ADRs (here, MIs as a function of calcium supplement intake) can always be criticized and their results judged to be inconclusive.…”

Section: Out Of Sight -Out Of Mind! Practical Examplesmentioning

confidence: 94%

The out-of-focus bias in drug surveillance

Gnädinger

Mellinghoff²

2012

Eur J Clin Pharmacol

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PURPOSE: Existing drug safety systems with phase II and III studies and post-marketing surveillance by principle do not allow for the recognition of an important class of adverse drug reactions (ADRs). ADRs that are resistant to being detected reliably may a) appear as if they are age-related chronic diseases, which also manifest themselves in a high degree without drug treatment, b) arise in "old" drugs, c) arise during long-term application, and d) arise with the administration to frail and aged populations. CONCLUSIONS: "Silent" and multi-factorial health problems evolving from long-term drug treatment must therefore be addressed with a systematic search strategy, as a third track along with the phase II and III studies and spontaneous reporting systems which still exist. SummaryExisting drug safety systems with phase II and III studies and post-marketing surveillance do not allow recognizing an important class of adverse drug reactions (ADRs) by principle. ADRs which are resistant to being detected reliably may a) be appearing like and age-related chronic diseases which also manifest themselves in a high degree without drug treatment, b) arriving in "old" drugs, c) during long-term application, and d) with the administration to frail and aged populations. "Silent" and multi-factorial health problems evolving from long-term drug treatment must therefore be addressed with a systematic search strategy, as a third track along with the phase II and III studies and spontaneous reporting systems which still exist. Existing pharmacovigilance system and its limitations

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Section: Out Of Sight -Out Of Mind! Practical Examplesmentioning

confidence: 94%

The out-of-focus bias in drug surveillance

Gnädinger

Mellinghoff²

2012

Eur J Clin Pharmacol

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“…Due to the controversial results of the studies regarding the association between calcium supplementation and the risk of coronary heart disease [72][73][74][75][76][77][78][79] , further research is needed [80][81][82] .…”

Section: Other Preventive Aspectsmentioning

confidence: 99%

New Reference Values for Calcium

Nil¹

2013

Ann Nutr Metab

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The nutrition societies of Germany, Austria and Switzerland are the joint editors of the ‘reference values for nutrient intake'. They have revised the reference values for the intake of calcium and published them in June 2013. The reference values for the calcium intake for infants are derived from the calcium content of breast milk. For infants from 4 to <12 months of age, the calcium intake from solid foods is included in addition to the calcium intake from breast milk. Thus, the reference values for infants are estimated values; they are 220 mg/day for infants to <4 months and 330 mg/day for infants from 4 to <12 months of age. As a parameter for determining the calcium requirement in children and adolescents, calcium retention is taken into account. The average requirement is calculated by the factorial method. A balanced calcium metabolism is calculated based upon calcium balance studies and used as a parameter for the determination of the calcium requirement in adults. On the basis of the average requirement, recommended calcium intake levels for children, adolescents and adults are derived. Depending on age, the recommended calcium intake ranges between 600 mg/day for children aged 1 to <4 years and 1,200 mg/day for adolescents aged 13 to <19 years; for adults, it is 1,000 mg/day.

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“…59 This study raised a storm of controversy and was followed by a slew of studies, editorials and commentaries both corroborating with as well as negating the findings. [60][61][62][63][64][65] However, it has to be noted that though a recent meta-analysis of 11 randomized controlled trials 61 demonstrated that the risk of incident myocardial infarction in those patients who were allocated to calcium did increase by 31%, the Vitamin D Vitamin D deficiency by leading to secondary hyperparathyroidism and increased bone turnover is presumed to be a major contributor to osteoporosis as it leads to secondary hyperparathyroidism and increased bone turnover. 68 Controversy in literature has recently erupted following the US Institute of Medicine (IOM) recommendations that the cut-point for serum vitamin D adequacy be 50 nmol/litre rather than the opinion of some experts that it should be 75 nmol/l.…”

Section: Secondary Osteoporosismentioning

confidence: 99%

A Review of the 2008 Singapore Ministry of Health Clinical Practice Guidelines on Osteoporosis and an Update

Tan

Bee

Chandran

2012

JAFES

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Osteoporosis is a major public health problem worldwide and it is of particular significance in a rapidly aging society such as Singapore. In order to prevent the devastating sequelae of osteoporosis, it is important, to diagnose the condition early, to identify its associated risk factors and to initiate pharmacotherapy promptly when required. In addition, it is important to increase awareness of this condition amongst both health care professionals and the public. The Singapore Ministry of Health (MOH) Clinical Practice Guidelines published in 2008 was an update of a previously published version in 2002. It aimed at providing the best evidence-based recommendations for diagnosis, classification, evaluation and multidisciplinary management of osteoporosis and osteoporotic fractures in Singapore. This article summarizes the guidelines, discusses their applicability and utilization in Singapore and briefly outlines updates in management since the publication of the CPG.

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The calcium scare—what would Austin Bradford Hill have thought?

Abstract: Present evidence that calcium supplementation increases heart attacks is too weak to justify a change in prescribing habits.

Cited by 46 publications

References 17 publications

The out-of-focus bias in drug surveillance

The out-of-focus bias in drug surveillance

New Reference Values for Calcium

A Review of the 2008 Singapore Ministry of Health Clinical Practice Guidelines on Osteoporosis and an Update

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