Article

Incidence of venous thromboembolism in users of strontium ranelate: an analysis of data from a prescription-event monitoring study in England.

Drug Safety Research Unit, Bursledon Hall, Southampton, UK.
Drug Safety (Impact Factor: 2.62). 07/2010; 33(7):579-91. DOI: 10.2165/11533770-000000000-00000
Source: PubMed

ABSTRACT Strontium ranelate is indicated for the treatment of postmenopausal osteoporosis. An association between strontium ranelate and venous thromboembolism (VTE) was identified in an analysis of phase III clinical trials.
To estimate the incidence of VTE in patients within the strontium ranelate (Protelos(R)) Prescription-Event Monitoring (PEM) study cohort during the first 12 months after starting treatment.
Patients in this analysis were identified from dispensed prescriptions that had been issued by general practitioners (GPs) in England for strontium ranelate between October 2004 and January 2008. For each individual patient, a Green Form questionnaire was sent to their GP 12 months after the date of the first prescription issued for strontium ranelate, requesting information about the patient including start and stop dates of treatment (if stopped), age, sex, indication, any history of VTE events, reasons for stopping and whether the patient had any events since starting the drug. VTE was defined as reports of deep vein thrombosis (DVT) or pulmonary embolism (PE). The crude incidence of VTE was calculated for events that occurred during the first 12 months after starting treatment (plus 30 days after stopping), with 95% Poisson exact CIs for the whole cohort, and subsets defined by age and past history of VTE.
The final analysis cohort consisted of 10 782 patients. Where specified, mean age was 73.3 years (SD 11.45) [n = 10 696]; 9833 (91.3%) were female and 934 (8.7%) were male. Where the history of VTE was specified, 233 patients (2.6%) had a history of VTE prior to starting. In the first 12-month period, there were 48 incident reports of VTE (DVT or PE) during treatment (or within 30 days of stopping) in the cohort, with 7696.89 years of exposure, giving a crude incidence rate of VTE of 6.24 cases (95% CI 4.60, 8.27) per 1000 patient-years exposed.
This analysis has provided an estimate of the incidence of VTE in patients treated with strontium ranelate in the general practice setting. The rate is similar to estimates in populations of similar age and corresponds to the incidence found in patients from phase III clinical studies and observational cohort studies of strontium ranelate on this topic. The crude annual incidence rate of VTE in the PEM cohort is higher than the background annual incidence rate found in the UK population, but is similar to estimates in populations of similar age and populations receiving treatment for postmenopausal osteoporosis. Also, we acknowledge the potential for underestimating the incidence in this population. Nevertheless, this analysis contributes to the ongoing postmarketing safety assessment of this product.

0 Followers
 · 
93 Views
  • [Show abstract] [Hide abstract]
    ABSTRACT: This paper deals with the phenomenon that a fairly large amount of speech sound is radiated from the outer surface of vocal organs. It is shown that the quantity of radiation from the wall is not always negligibly small but rather large especially in hyperbaric atmosphere as in the diver's speech, and that it is varied depending on the vocal tract configuration. It is also shown that the higher formant peaks in the "wallsound" are almost vanished in the air speech but still remain some extent in the helium speech. Those findings are obtained from a simulation of speech radiation, and evidenced by the experimental measurement of the sounds from lips and others of talkers in several atmospheric pressures from 1ATA to 31ATA of helium-oxygen gas mixture.
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Strontium ranelate is one of the first-line agents with proven anti-fracture activity used in the therapy of post-menopausal osteoporosis. Its mechanism of action makes it, however, different from other drugs, since it simultaneously stimulates two reverse processes: bone formation and bone resorption. The action of the agent depends on various mechanisms, including the activation of calcium receptors, localised on osteoblasts and osteoclasts, and on the influence on the OPG/RANKL system. The drug effectively prevents spinal, hip and extravertebral fractures. The agent's anti-fracture efficacy within the spine does not depend on the patient's age, or on base BMD values, or on the concentration of bone metabolism markers. As to the anti-fracture efficacy in the hip, it concerns women with an increased bone fracture risk. Strontium ranelate increases bone mineral density within the lumbar spine and the hip, decreases the concentrations of bone resorption markers, and increases the concentrations of bone formation markers. The drug is administered in a daily 2.0 g oral dose. This paper presents indications to therapy with strontium ranelate, specifying also its side effects and contraindications. We compare the anti-fracture efficacy of strontium ranelate to the efficacy of other agents of proven anti-fracture activity, based on published clinical studies.
    Endokrynologia Polska 01/2011; 62(1):65-72. · 1.21 Impact Factor
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: Alcohol is widely consumed across the world. It is consumed in both social and cultural settings. Until recently, two types of alcohol consumption were recognized: heavy chronic alcohol consumption or light consumption. Today, there is a new pattern of consumption among teenagers and young adults namely: binge drinking. Heavy alcohol consumption is detrimental to many organs and tissues, including bones, and is known to induce secondary osteoporosis. Some studies, however, have reported benefits from light alcohol consumption on bone parameters. To date, little is known regarding the effects of binge drinking on bone health. Here, we review the effects of three different means of alcohol consumption: light, heavy, and binge drinking. We also review the detailed literature on the different mechanisms by which alcohol intake may decrease bone mass and strength. The effects of alcohol on bone are thought to be both direct and indirect. The decrease in bone mass and strength following alcohol consumption is mainly due to a bone remodeling imbalance, with a predominant decrease in bone formation. Recent studies, however, have reported new mechanisms by which alcohol may act on bone remodeling, including osteocyte apoptosis, oxidative stress, and Wnt signalling pathway modulation. The roles of reduced total fat mass, increased lipid content in bone marrow, and a hypoleptinemia are also discussed.
    Osteoporosis International 09/2011; 23(1):1-16. DOI:10.1007/s00198-011-1787-7 · 4.17 Impact Factor