12 NEWS
AMG4138 _ Repatha _ Streamlined Authority _ AusDoc _ A4 _ 210x273mmH _ OctNov _ R0.2 _ FA . indd 1 26 / 8 / 2024 6:17 PM
12 NEWS
8 NOVEMBER 2024 ausdoc . com . au
| THE | DIABETES ISSUE
Stem cell therapy reverses T1DM
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Carmel Sparke A 25-YEAR-old woman with hard-tocontrol type 1 diabetes began producing her own insulin just months after an autologous transplant of reprogrammed stem cells , report doctors in China .
She was the first person to undergo an autologous transplantation of chemically induced pluripotent stem cell – derived ( CiPSC ) islets , they wrote in the journal Cell .
In June last year , the equivalent of almost 1.5 million islet cells
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were injected beneath the woman ’ s abdominal anterior rectus sheath in the first-in-human phase I clinical trial .
Within two weeks of the transplantation , the patient ’ s daily exogenous insulin dose requirements began to reduce from a baseline of 54 units a day .
By day 75 , the patient had achieved complete insulin independence , which continued for the follow-up period of one year , the authors wrote .
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And four months post-transplantation , the woman ’ s time-in-target glycaemic range increased from a baseline of 43 % to 96 %.
“ Promising results from this patient suggest that further clinical studies assessing CiPSC-islet transplantation in type 1 diabetes are warranted ,” said the authors , led by researchers from Peking University in Beijing .
Before the transplant , the patient had undergone two liver transplants as a result of cryptogenic cirrhosis ,
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in 2014 and 2016 , and was on immunosuppressant therapy .
She had also undergone a pancreas transplant in 2017 , which had to be removed a year later owing to thrombotic complications .
The patient was not a good candidate for an allogeneic or islet transplant because of the high risk of rejection , “ making the opportunity for an autologous transplant for this patient a valuable treatment option ”.
Cell 2024 ; 25 Sep .
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* Repatha ® is indicated for the prevention of CV events ( MI , stroke and coronary revascularisation ) in adults with established CVD in combination with an optimally dosed statin and / or other lipid-lowering therapies , as an adjunct to diet and exercise . 1 ‘ Power ’: 15 % relative risk reduction with Repatha ® vs placebo in the composite of the primary endpoint beyond optimised statin ± ezetimibe ( HR : 0.85 ; 95 % CI : 0.79 – 0.92 , p < 0.001 ). 2
PBS Information : Authority required ( STREAMLINED ). Non-familial and familial hypercholesterolaemia . Criteria apply . Refer to PBS Schedule for full authority information .
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For more information on Repatha ® or to report an adverse event or product complaint involving Repatha ® , please contact Amgen Medical Information on 1800 803 638 or visit www . amgenmedinfo . com . au .
Precautions : Hypersensitivity reactions . Concomitant lipid-lowering therapies – check all relevant prescribing information . Immunogenic potential . Pregnancy Category : B1 . Caution – breastfeeding . Adverse Reactions : Common – nasopharyngitis , upper respiratory tract infection , influenza , back pain , arthralgia , nausea , rash , and injection site reactions ( including injection site pain , erythema , bruising , swelling or haemorrhage ).
Abbreviations : CI , confidence interval ; CV , cardiovascular ; CVD , cardiovascular disease ; HR , hazard ratio ; LDL-C , low-density lipoprotein cholesterol ; MI , myocardial infarction ; PBS , Pharmaceutical Benefits Scheme .
References : 1 . Repatha ® ( evolocumab ) Approved Product Information . 2 . Sabatine MS , et al . N Engl J Med . 2017 ; 376 ( 18 ): 1713 – 1722 . 3 . Pharmaceutical Benefits Scheme . Evolocumab . Available at : https :// www . pbs . gov . au / medicine / item / 10958R [ Accessed June 2024 ].
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Diabetes drug gets green light
Rachel Fieldhouse THE TGA has approved empagliflozin for type 2 diabetes in children as young as 10 — either combined with metformin or as monotherapy if metformin is not tolerated .
The updated product information flags a starting dose of 10mg , which can be increased up to 25mg daily for patients needing further glycaemic control .
Dr Gary Deed , chair of the RACGP Specific Interests Diabetes group , said it was a “ wonderful addition to the toolkit ”, which had been limited to insulin and metformin for children .
“ We have limited options for treatment because the trials do not exist ,” the Queensland GP said .
“ The other oral add-on therapies we use for adults with type 2 diabetes do not have indications for these younger age groups .”
The TGA decision followed the phase III DINAMO trial , which showed that empagliflozin reduced children ’ s HbA1c by 9.2mmol / mol after 26 weeks compared with placebo .
The trial — funded by drug maker Boehringer Ingelheim — involved 158 children aged 10-17 ( mean age 14 ), previously treated with insulin or metformin , who were randomised to receive empagliflozin , the DPP-4 inhibitor linagliptin or placebo .
Participants taking empagliflozin lost close to 1kg on average and also had lower systolic blood pressure compared with placebo , while weight , blood pressure and HbA1c changes seen with linagliptin were not significant .
Adverse event rates were comparable to studies of adults , the authors reported . Dr Deed has previously received speaker fees and advisory or consultancy fees from both Boehringer Ingelheim and Eli Lilly .
Lancet Diabetes Endocrinol 2023 ; 1 Feb .