Publication updates: 8 to 16 Aug 2023

1. Effect of Sotagliflozin on Early Mortality and Heart Failure-Related Events: A Post Hoc Analysis of SOLOIST-WHF

This was a post hoc analysis of the SOLOIST-WHF (Effect of #Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes Post-worsening #heartfailure (WHF)) study to evaluate the efficacy of sotagliflozin versus placebo in decreasing the mortality and HF-related events. Patients were initiated on study drug on or before discharge from their index hospitalization. The main endpoint was cardiovascular death or HF-related event (HF hospitalization or urgent care visit) within 90 and 30 days after discharge for the index WHF hospitalization.? Sotagliflozin decreased the relative risk of a composite of?cardiovascular mortality?and HF-related hospitalizations and urgent visits for HF by >40% within 90 days and within 30?days of discharge from the index WHF hospitalization and also significantly decreased total mortality at 90?days after discharge.

2. Empagliflozin improves insulin sensitivity in patients with recent acute coronary syndrome and newly detected dysglycemia

This study investigated the effects of #empagliflozin on insulin resistance, insulin sensitivity and β-cell function indexes in patients with a recent acute coronary event and newly detected dysglycemia, i.e., impaired glucose tolerance (IGT) or #T2DM . The sample size was small- 42 patients with a recent myocardial infarction (n = 36) or unstable angina (n = 6) and newly detected dysglycemia were randomized to either empagliflozin 25?mg daily or placebo. After 7 months, #empagliflozin significantly decreased glucose and insulin values during the OGTT, whereas C-peptide, mannose and HbA1c did not differ. Empagliflozin significantly improved insulin sensitivity indexes but did not impact insulin resistance and β-cell function. After cessation of the drug, all indexes returned to initial levels. Insulin sensitivity indexes were inversely correlated with left ventricular mass at baseline.

3. Prophylactic Doxycycline Does Not Reduce Exacerbations in Moderate COPD

In this study, 22 patients with moderate to very severe #COPD and an exacerbation history were randomized to 12-months #doxycycline 100mg once daily or placebo. The primary study outcome was exacerbation rate per person year. 81% were already prescribed inhaled corticosteroids at baseline. COPD exacerbation rate did not differ between the groups – doxycycline/placebo rate ratio 0.86 (0.67, 1.10); p=0.23.?However, doxycycline reduced the exacerbation rate among people with severe COPD and in those with an eosinophil count <300 cells/μL.

4. Relief with 10?kHz spinal cord stimulation for the treatment of painful diabetic neuropathy

This was a prospective, multicenter, randomized controlled trial that compared conventional medical management (CMM) alone with 10?kHz SCS plus CMM (10?kHz SCS+CMM) in 216 patients with refractory painful #diabeticneuropathy ?(PDN). At 24?months, 10?kHz SCS reduced pain by a mean of 79.9% compared to baseline, with 90.1% of participants experiencing ≥50% pain relief. Participants had significantly improved HRQoL and sleep, and 65.7% demonstrated clinically meaningful neurological improvement.?

5. Aflibercept 8 mg Approved by FDA for wet #AMD , #diabeticMacularEdema , and #DiabeticRetinopathy

The US Food and Drug Administration (FDA) has approved aflibercept 8 mg for the treatment of wet #ageRelatedMacularDegeneration (#AMD ), #diabeticMacularEdema , and #diabeticRetinopathy , making it the first and only treatment approved for wet AMD and DME for immediate dosing at 8- week and up to 16-week intervals following 3 initial monthly doses.

The approval is based on on data from the #PULSAR and #PHOTON trials, which included patient populations with wet AMD and DME, respectively. Both were double-masked, active-controlled trials, which randomized patients in 3 treatment groups - aflibercept 8 mg every 12 weeks, aflibercept 8 mg every 16 weeks, or aflibercept 2 mg every 8 weeks. The 48-week results from the trials suggested aflibercept 8mg demonstrated noninferiority and clinically equivalent vision gains at 48 weeks with both 12- and 16-week dosing regimens after only 3 initial monthly doses when compared to an aflibercept 2 mg with 8-week dosing regimen after initial monthly doses.

6. #Canagliflozin controls the increase in cardiorenal stress #biomarkers in patients with type 2 diabetes and albuminuria at a high risk for cardiac and renal events

In this study, (#CREDENCE trial - Canagliflozin and Renal Events in Diabetes With Established Nephropathy Clinical Evaluation), concentrations of NT-proBNP, high-sensitivity cardiac troponin T, growth differentiation factor-15, and IGFBP7 (insulin-like growth factor binding protein 7) were measured. The effect of canagliflozin on biomarker concentrations was evaluated. Baseline concentrations of each biomarker were strongly predictive of cardiac and renal outcomes.?At 1 year, the biomarkers all rose by 6% to 29% in the placebo arm but only by 3% to 10% in the canagliflozin arm (all?P<0.01).

-----------------------------------------------------------------------------------------------------------

#medicalaffairs ?#medicalwriting ?#medicalwriter ?#medicalcontent ??

#medicalcommunications ?#healthcarecommunications ?#scientificwriting ?

#freelancemedicalwriter ?#scicomms #medcomms