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The increase in prescriptions of bisphosphonates and the incidence proportion of osteonecrosis of the jaw after risk communication activities in Japan: a hospital-based cohort study.

Sumi E, Yamazaki T, Tanaka S, Yamamoto K, Nakayama T, Bessho K, Yokode M - Pharmacoepidemiol Drug Saf (2014)

Bottom Line: Twenty times more cases of ONJ have been reported to regulatory authority since 2007, compared with the period before 2007.In our cohort, the incidence proportion of ONJ during and after 2009 was four times greater than before 2009.However, there was no surveillance for ONJ before the revision.

View Article: PubMed Central - PubMed

Affiliation: Department of Clinical Innovative Medicine, Institute for Advancement of Clinical and Translational Science, Kyoto University, Kyoto, Japan.

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(a). The incidence proportion of confirmed cases of ONJ in the cohort. Legend: The incidence proportions of the confirmed ONJ cases in 100 BP-group patients in 2000–2002, 2003–2004, 2005–2006, 2007–2008 and 2009–2010 are indicated by a dark gray line of diamonds. The incidence proportions of confirmed ONJ cases per 100 non-BP-group patients in each 2- to 3-year period are indicated by a light gray line of squares. The number of patients in the BP group, the number of confirmed ONJ cases in the BP group, the number of patients in the non-BP group and the number of confirmed ONJ cases in the non-BP group are shown below the graph. (b). The proportions of recorded ONJ cases in the cohort. Legend: The proportions of recorded cases of inflammatory conditions of the jaw in 100 BP-group patients in 2000–2002, 2003–2004, 2005–2006, 2007–2008 and 2009–2010 are indicated by a dark gray line of diamonds. The proportions of recorded cases of inflammatory conditions of the jaw in 100 non-BP-group patients in each 2- to 3-year period are indicated by a light gray line of squares. The number of patients in the BP group, the number of recorded cases of inflammatory conditions of the jaw in the BP group, the number of patients in the non-BP group and the number of recorded cases of inflammatory conditions of the jaw in the non-BP group are shown below the graph
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fig03: (a). The incidence proportion of confirmed cases of ONJ in the cohort. Legend: The incidence proportions of the confirmed ONJ cases in 100 BP-group patients in 2000–2002, 2003–2004, 2005–2006, 2007–2008 and 2009–2010 are indicated by a dark gray line of diamonds. The incidence proportions of confirmed ONJ cases per 100 non-BP-group patients in each 2- to 3-year period are indicated by a light gray line of squares. The number of patients in the BP group, the number of confirmed ONJ cases in the BP group, the number of patients in the non-BP group and the number of confirmed ONJ cases in the non-BP group are shown below the graph. (b). The proportions of recorded ONJ cases in the cohort. Legend: The proportions of recorded cases of inflammatory conditions of the jaw in 100 BP-group patients in 2000–2002, 2003–2004, 2005–2006, 2007–2008 and 2009–2010 are indicated by a dark gray line of diamonds. The proportions of recorded cases of inflammatory conditions of the jaw in 100 non-BP-group patients in each 2- to 3-year period are indicated by a light gray line of squares. The number of patients in the BP group, the number of recorded cases of inflammatory conditions of the jaw in the BP group, the number of patients in the non-BP group and the number of recorded cases of inflammatory conditions of the jaw in the non-BP group are shown below the graph

Mentions: The incidence proportion of confirmed ONJ in the BP group increased approximately four-fold in 2009 and 2010, compared with the pre-2009 level. The incidence proportion of confirmed ONJ in the non-BP group remained low (Figure 3a). Both of the incidence proportion of confirmed ONJ cases and that of inflammatory conditions of the jaw increased after 2009; however, the increase in inflammatory conditions of the jaw was not as high as that of confirmed cases (Figure 3b). This measure was therefore not a good surrogate for confirmed ONJ in this study.


The increase in prescriptions of bisphosphonates and the incidence proportion of osteonecrosis of the jaw after risk communication activities in Japan: a hospital-based cohort study.

Sumi E, Yamazaki T, Tanaka S, Yamamoto K, Nakayama T, Bessho K, Yokode M - Pharmacoepidemiol Drug Saf (2014)

(a). The incidence proportion of confirmed cases of ONJ in the cohort. Legend: The incidence proportions of the confirmed ONJ cases in 100 BP-group patients in 2000–2002, 2003–2004, 2005–2006, 2007–2008 and 2009–2010 are indicated by a dark gray line of diamonds. The incidence proportions of confirmed ONJ cases per 100 non-BP-group patients in each 2- to 3-year period are indicated by a light gray line of squares. The number of patients in the BP group, the number of confirmed ONJ cases in the BP group, the number of patients in the non-BP group and the number of confirmed ONJ cases in the non-BP group are shown below the graph. (b). The proportions of recorded ONJ cases in the cohort. Legend: The proportions of recorded cases of inflammatory conditions of the jaw in 100 BP-group patients in 2000–2002, 2003–2004, 2005–2006, 2007–2008 and 2009–2010 are indicated by a dark gray line of diamonds. The proportions of recorded cases of inflammatory conditions of the jaw in 100 non-BP-group patients in each 2- to 3-year period are indicated by a light gray line of squares. The number of patients in the BP group, the number of recorded cases of inflammatory conditions of the jaw in the BP group, the number of patients in the non-BP group and the number of recorded cases of inflammatory conditions of the jaw in the non-BP group are shown below the graph
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4230466&req=5

fig03: (a). The incidence proportion of confirmed cases of ONJ in the cohort. Legend: The incidence proportions of the confirmed ONJ cases in 100 BP-group patients in 2000–2002, 2003–2004, 2005–2006, 2007–2008 and 2009–2010 are indicated by a dark gray line of diamonds. The incidence proportions of confirmed ONJ cases per 100 non-BP-group patients in each 2- to 3-year period are indicated by a light gray line of squares. The number of patients in the BP group, the number of confirmed ONJ cases in the BP group, the number of patients in the non-BP group and the number of confirmed ONJ cases in the non-BP group are shown below the graph. (b). The proportions of recorded ONJ cases in the cohort. Legend: The proportions of recorded cases of inflammatory conditions of the jaw in 100 BP-group patients in 2000–2002, 2003–2004, 2005–2006, 2007–2008 and 2009–2010 are indicated by a dark gray line of diamonds. The proportions of recorded cases of inflammatory conditions of the jaw in 100 non-BP-group patients in each 2- to 3-year period are indicated by a light gray line of squares. The number of patients in the BP group, the number of recorded cases of inflammatory conditions of the jaw in the BP group, the number of patients in the non-BP group and the number of recorded cases of inflammatory conditions of the jaw in the non-BP group are shown below the graph
Mentions: The incidence proportion of confirmed ONJ in the BP group increased approximately four-fold in 2009 and 2010, compared with the pre-2009 level. The incidence proportion of confirmed ONJ in the non-BP group remained low (Figure 3a). Both of the incidence proportion of confirmed ONJ cases and that of inflammatory conditions of the jaw increased after 2009; however, the increase in inflammatory conditions of the jaw was not as high as that of confirmed cases (Figure 3b). This measure was therefore not a good surrogate for confirmed ONJ in this study.

Bottom Line: Twenty times more cases of ONJ have been reported to regulatory authority since 2007, compared with the period before 2007.In our cohort, the incidence proportion of ONJ during and after 2009 was four times greater than before 2009.However, there was no surveillance for ONJ before the revision.

View Article: PubMed Central - PubMed

Affiliation: Department of Clinical Innovative Medicine, Institute for Advancement of Clinical and Translational Science, Kyoto University, Kyoto, Japan.

Show MeSH
Related in: MedlinePlus