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Stephen Padilla, 03 Aug 2018
It appears that the two-dose AS04-adjuvanted HPV-16/18 vaccine (AS04-HPV-16/18v) is the most cost-effective choice for lowering the burden of cervical cancer through universal mass vaccination for 12-year-old girls in Singapore from the perspective of the healthcare payer (MOH Singapore), according to a recent study.
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No increased ophthalmic risk with roxadustat treatment in DD CKD-related anaemia

Roshini Claire Anthony
28 Jun 2020

Roxadustat treatment for anaemia in patients with dialysis-dependent chronic kidney disease (DD CKD) does not come with an increased risk of ophthalmic abnormalities, according to a phase III trial conducted in Japan.

Adults (age 20 years) with CKD and anaemia who had been undergoing stable haemodialysis thrice weekly (TIW) for >12 weeks at 58 sites in Japan were randomized 1:1 to receive oral roxadustat TIW (n=150; mean age 64.6 years, 67.3 percent male) or intravenous injections of darbepoetin alfa once weekly (QW; n=152; mean age 64.9 years, 71.1 percent male) for up to 24 weeks. The doses of the medications were titrated to maintain haemoglobin levels of 10–12 g/dL.

Fifty-four percent of patients in each group had diabetes mellitus (DM). Ninety-two and 93.4 percent of roxadustat and darbepoetin alfa recipients, respectively, had a history of hypertension. Patients in the roxadustat and darbepoetin alfa groups were on haemodialysis for a mean 59.45 and 56.13 months, respectively, and had anaemia for a mean 68.37 and 58.71 months, respectively. Compared with those on darbepoetin alfa, patients in the roxadustat group had a non-significantly higher rate of previous or concurrent retinal vascular disorder* (41.3 percent vs 37.5 percent) and history of DM and retinal vascular disease (32.7 percent vs 27.6 percent).

Overall, new or worsening retinal haemorrhage occurred at a comparable rate between roxadustat and darbepoetin alfa recipients (32.4 percent vs 36.6 percent). This finding was consistent at week 12 (23.5 percent vs 25.7 percent), week 24 (26.5 percent vs 27.0 percent), and at treatment end (23.9 percent vs 29.0 percent). [ERA-EDTA 2020, abstract MO002]

“There was no clinically meaningful change in the number of retinal haemorrhages in either group [mean change from baseline to end of treatment, 0.2 and 0.3 in the roxadustat and darbepoetin alfa groups, respectively],” said Dr Yasir Sepah from the Nguyen Eye Lab, Stanford School of Medicine, Stanford, California, US, who presented the results at ERA-EDTA 2020.

During treatment, new or worsening retinal haemorrhages occurred in 19.1 and 25.0 percent of roxadustat and darbepoetin alfa recipients, respectively, who had no retinal haemorrhage at baseline, and in 58.3 and 59.2 percent, respectively, who had 1 retinal haemorrhage at baseline.

Among patients without DM at baseline, new or worsening retinal haemorrhages occurred in 21.1 and 29.5 percent of roxadustat and darbepoetin alfa recipients, respectively, during treatment, and in 13.3 and 23.2 percent at treatment end. Among patients with DM, new or worsening retinal haemorrhages occurred at a comparable rate between roxadustat and darbepoetin alfa recipients (51.9 percent vs 50.0 percent [during treatment] and 42.3 percent vs 40.0 percent [treatment end]). 

According to Sepah, non-clinical data has suggested that angiogenesis may be associated with an increased risk of certain retinal pathologies. “Angiogenesis may be mediated via vascular endothelial growth factor, which can be induced by HIF-1α,” he said.

“During the 24-week treatment period, these data suggest that DD CKD patients who were treated with [the HIF-PHI**] roxadustat were not at an increased risk of ophthalmic abnormalities, compared with patients treated with darbepoetin alfa,” he concluded.

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Most Read Articles
Stephen Padilla, 03 Aug 2018
It appears that the two-dose AS04-adjuvanted HPV-16/18 vaccine (AS04-HPV-16/18v) is the most cost-effective choice for lowering the burden of cervical cancer through universal mass vaccination for 12-year-old girls in Singapore from the perspective of the healthcare payer (MOH Singapore), according to a recent study.
25 Apr 2020
The human papillomavirus (HPV) DNA vaccine (GX-188E) is effective against HPV type 16/18–associated cervical intraepithelial neoplasia (CIN) 3, according to the results of a phase II trial.
Audrey Abella, 02 Jul 2020
The highly selective SGLT2 inhibitor bexagliflozin demonstrated significant efficacy and safety in controlling hyperglycaemia, weight, and blood pressure (BP) in patients with type 2 diabetes (T2D) who were at high risk of cardiovascular (CV) events, results of the BEST** trial have shown.
18 Jul 2019
In the treatment of patients with human papillomavirus-positive oropharyngeal squamous cell carcinoma (HPV+ OPSCC), de-escalating dose and volume of radiotherapy (RT) or chemoradiotherapy (CRT) based on response to induction chemotherapy appears to positively affect oncologic outcomes and reduce toxicity, according to data from the phase II OPTIMA trial.