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Roshini Claire Anthony, 16 Dec 2016

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Jackey Suen, 21 Dec 2016

Adding everolimus to fulvestrant in second-line treatment of hormone receptor (HR)-positive, HER2-negative advanced breast cancer improves progression-free survival (PFS) by 40 percent, the phase II PrECOG 0102 study has shown. [SABCS 2016, abstract S1-02]

Ceritinib ups hyperglycaemia risk

14 Nov 2019
One million deaths in China occur each year as a result of diabetic complications.

Ceritinib use appears to carry a significant risk of developing hyperglycaemia, a new Japan study has found.

Accessing the Japan Adverse Drug Even Report (JADER) database, researchers identified signals of hyperglycaemia and related events. They identified 7,837 such cases out of 887,636 adverse drug reactions reported in the databases. Reported odds ratios (ROR) were calculated using a two-by-two contingency table.

Of the three anaplastic lymphoma kinase inhibitors (ALKIs), only ceritinib resulted in significant RORs. There were 429 database entries that initiated ceritinib use before September 2017; four of them developed hyperglycaemia, indicating an insignificant risk (ROR, 1.06, 95 percent confidence intervals [CI], 0.39–2.83).

On the other hand, seven of 132 patients who started ceritinib medication after September 2017 showed hyperglycaemia and related events. The resulting risk estimate was significant (ROR, 6.29, 95 percent CI, 2.94–13.5).

“The insignificant ROR before September 2017 might be biased due to the limited case application and/or possible prior use of crizotinib or alectinib,” researchers explained.

A similar pattern of effect was reported when JADER datapoints with use of antidiabetes agents were excluded. Of the 545 remaining users of ceritinib, eight developed hyperglycaemia events (ROR, 2.54, 95 percent CI, 1.27–5.12).

In any of the analyses performed above, crizotinib and alectinib, both ALKIs, did not result in a significantly higher likelihood of developing hyperglycaemia.

“Clinicians including diabetologists and oncologists should emphasize vigilance for ceritinib-associated hyperglycaemia,” the researchers said.

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Most Read Articles
29 Nov 2019
Metformin Extended Release 500 mg,750 mg, and 1000 mg
30 Nov 2018
New drug applications approved by US FDA as of 16 - 30 November 2018 which includes New Molecular Entities (NMEs) and new biologics. It does not include Tentative Approvals. Supplemental approvals may have occurred since the original approval date.
Roshini Claire Anthony, 16 Dec 2016

Five years of extended therapy with the aromatase inhibitor (AI) letrozole did not improve survival in postmenopausal breast cancer patients, according to findings of the NRG Oncology/NSABP B-42 trial presented at the San Antonio Breast Cancer Symposium (SABCS 2016) held in Texas, US. 

Jackey Suen, 21 Dec 2016

Adding everolimus to fulvestrant in second-line treatment of hormone receptor (HR)-positive, HER2-negative advanced breast cancer improves progression-free survival (PFS) by 40 percent, the phase II PrECOG 0102 study has shown. [SABCS 2016, abstract S1-02]