Dataset Information

Risk of cardiac valvulopathy with use of bisphosphonates: a population-based, multi-country case-control study.

ABSTRACT:

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Analyses of healthcare data from 30 million individuals in three countries showed that current use of bisphosphonates may be associated with a small increased risk of cardiac valvulopathy (vs. those not exposed within the previous year), although confounding cannot be entirely ruled out. The observed tendency for decreased valvulopathy risk with cumulative duration of bisphosphonate use >6 months may even indicate a protective effect with prolonged use. Further studies are still needed to evaluate whether bisphosphonates increase or decrease the risk of valvulopathy.

Introduction

A signal of cardiac valve disorders with use of bisphosphonates was identified in the literature and EudraVigilance database, which contains reports of suspected adverse drug reactions from worldwide sources. The aim of this study was to evaluate the association using population-based healthcare data.

Methods

This was a case-control study among users of bisphosphonates and other drugs for osteoporosis in six healthcare databases covering over 30 million individuals in Italy, Netherlands and the UK from 1996 to 2012. Prescriptions/dispensations were used to assess drug exposure. Newly diagnosed cases of cardiac valvulopathy were identified via disease codes/free-text search. Controls were matched to each case by age, sex, database and index date. Adjusted odds ratios (ORs) were estimated using conditional logistic regression for the pooled data and meta-analysis of individual database risk estimates.

Results

A small but statistically significant association was found between exposure to bisphosphonates as a class and risk of valvulopathy. Overall risk was 18 % higher (95 % CI 12-23 %) in those currently exposed to any bisphosphonate (mainly alendronate and risedronate) vs. those not exposed within the previous year. Risk of valve regurgitation was 14 % higher (95 % CI 7-22 %). Decreased valvulopathy risk was observed with longer cumulative duration of bisphosphonate use, compared to use of less than 6 months. Meta-analyses of database-specific estimates confirmed results from pooled analyses.

Conclusions

The observed increased risks of cardiac valvulopathy with bisphosphonate use, although statistically significant, were quite small and unlikely to be clinically significant. Further studies are still needed to evaluate whether bisphosphonates increase or decrease the risk of valvulopathy and to investigate possible mechanisms for the association.

SUBMITTER: Coloma PM

PROVIDER: S-EPMC4839043 | biostudies-literature | 2016 May

REPOSITORIES: biostudies-literature

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Publications

Risk of cardiac valvulopathy with use of bisphosphonates: a population-based, multi-country case-control study.

Coloma P M PM de Ridder M M Bezemer I I Herings R M C RM Gini R R Pecchioli S S Scotti L L Rijnbeek P P Mosseveld M M van der Lei J J Trifirò G G Sturkenboom M M

Osteoporosis international : a journal established as result of cooperation between the European Foundation for Osteoporosis and the National Osteoporosis Foundation of the USA 20151222 5

<h4>Unlabelled</h4>Analyses of healthcare data from 30 million individuals in three countries showed that current use of bisphosphonates may be associated with a small increased risk of cardiac valvulopathy (vs. those not exposed within the previous year), although confounding cannot be entirely ruled out. The observed tendency for decreased valvulopathy risk with cumulative duration of bisphosphonate use >6 months may even indicate a protective effect with prolonged use. Further studies are sti ...[more]

PMID: 26694594

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Project description:ObjectiveTo evaluate the association between the risk of ectopic pregnancy (EP) and the use of common contraceptives during the previous and current conception/menstrual cycle.MethodsA multi-center case-control study was conducted in Shanghai. Women diagnosed with EP were recruited as the case group (n?=?2,411). Women with intrauterine pregnancy (IUP) (n?=?2,416) and non-pregnant women (n?=?2,419) were matched as controls at a ratio of 1?1. Information regarding the previous and current use of contraceptives was collected. Multivariate logistic regression analyses were performed to calculate odds ratios (ORs) and the corresponding 95% confidential intervals (CIs).ResultsPrevious use of intrauterine devices (IUDs) was associated with a slight risk of ectopic pregnancy (AOR1?=?1.87 [95% CI: 1.48-2.37]; AOR2?=?1.84 [1.49-2.27]), and the risk increased with the duration of previous use (P1 for trend <10-4, P2 for trend <10-4). The current use of most contraceptives reduced the risk of both unwanted IUP (condom: AOR?=?0.04 [0.03-0.05]; withdrawal method: AOR?=?0.10 [0.07-0.13]; calendar rhythm method: AOR?=?0.54 [0.40-0.73]; oral contraceptive pills [OCPs]: AOR?=?0.03 [0.02-0.08]; levonorgestrel emergency contraception [LNG-EC]: AOR?=?0.22 [0.16-0.30]; IUDs: AOR?=?0.01 [0.005-0.012]; tubal sterilization: AOR?=?0.01 [0.001-0.022]) and unwanted EP (condom: AOR1?=?0.05 [0.04-0.06]; withdrawal method: AOR1?=?0.13 [0.09-0.19]; calendar rhythm method: AOR1?=?0.66 [0.48-0.91]; OCPs: AOR1?=?0.14 [0.07-0.26]; IUDs: AOR1?=?0.17 [0.13-0.22]; tubal sterilization: AOR1?=?0.04 [0.02-0.08]). However, when contraception failed and pregnancy occurred, current use of OCPs (AOR2?=?4.06 [1.64-10.07]), LNG-EC (AOR2?=?4.87 [3.88-6.10]), IUDs (AOR2?=?21.08 [13.44-33.07]), and tubal sterilization (AOR2?=?7.68 [1.69-34.80]) increased the risk of EP compared with the non-use of contraceptives.ConclusionCurrent use of most contraceptives reduce the risk of both IUP and EP. However, if the contraceptive method fails, the proportions of EP may be higher than those of non-users. In the case of contraceptive failure in the current cycle, EP cases should be differentiated according to current use of OCPs, LNG-EC, IUDs, and tubal sterilization. In addition, attention should be paid to women with previous long-term use of IUDs.

Dataset Information

Risk of cardiac valvulopathy with use of bisphosphonates: a population-based, multi-country case-control study.

Unlabelled

Introduction

Methods

Results

Conclusions

Publications

Risk of cardiac valvulopathy with use of bisphosphonates: a population-based, multi-country case-control study.

Similar Datasets

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