70-year-old man with long-standing type 2 diabetes mellitus, paroxysmal atrial fibrillation and dyslipidemia presented to the emergency department with nausea, vomiting and generalized weakness. The patient had been on his current antidiabetes regimen for a few years, which included metformin, liraglutide, modified release gliclazide and empagliflozin. His most recent glycated hemoglobin (HbA1c) level was 7.8%, and he had no history of diabetic ketoacidosis. The patient had been discharged from hospital a few days earlier after having undergone coronary artery bypass surgery with no complications. He had been receiving insulin subcutaneously perioperatively while the antidiabetic agents he usually took were held one day preoperatively. Upon discharge, he resumed taking his usual medications. On initial evaluation in the emergency department, the patient was found to have left lower lobe pneumonia. Laboratory investigations showed a pH of 7.27 (normal 7.36-7.44), a bicarbonate level of 10 (normal 22-31) mmol/L, an anion gap of 31 (normal 7-15) mmol/L, a near-normal glucose level of 11.2 (normal 3.9-11.0) mmol/L and an elevated white blood cell count of 22 (normal 4-11) × 10 9 cells/L. The β-hydroxybutyric acid level was elevated, at more than 3.2 (normal < 0.3) mmol/L, but venous lactate was within the normal range. Urinalysis showed the presence of ketones. The patient was given fluids intravenously, insulin perfusion and antibiotics (ceftriaxone, intravenously). The anion gap decreased to 20 within five hours of therapy starting, and the patient was transitioned to insulin given subcutaneously. Within 48 hours, the anion gap had normalized, the insulin regimen was discontinued, and the patient was restarted on metformin, liraglutide and modified release gliclazide; the empagliflozin, however, was not restarted.
RATIONALE: Improving HAE patients' health-related quality of life (QoL) is a continuing goal. The objective was to investigate the long-term benefit of lanadelumab from the patient perspective. METHODS: Patients > _12 years old with HAE type 1/2 who continued from HELP (rollovers) received 300mg lanadelumab on day 0, then 300mg every 2 weeks (q2wks) after their first attack (regular dosing stage). Newly enrolled patients (nonrollovers) received 300mg q2wks from day 0. The planned treatment period was 132 weeks. QoL was assessed with the Angioedema QoL Questionnaire (AE-QoL [higher scores5poorer outcome]) at baseline and every 4-8 weeks, and the Treatment Satisfaction Questionnaire for Medication (TSQM-9; treatment effectiveness, convenience, and global-satisfaction domains [higher scores5greater satisfaction]) at days 364, 574, and end of study (EOS). All endpoints were summarized using descriptive statistics. RESULTS: 212 patients received treatment (n5109 rollovers; n5103 nonrollovers). Rollovers experienced improvement in AE-QoL total and domain scores from day 0 to EOS (respective mean change [SD]: in total score
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