Novel basal insulins and fixed-ratio combinations of basal insulin and GLP-1RA are safer and more convenient options for uncontrolled type 2 diabetes.
<ul>
</ul>
<h2>Main Takeaway</h2>
<ul>
 <li>
 This review informs about new and advanced therapeutic options available for patients with type 2 diabetes (T2D) uncontrolled with oral antidiabetic drugs (OADs).</li>
 <li>
 Basal insulin (BI), with its advanced new formulations, is an important therapeutic option in patients with advancing T2D.</li>
 <li>
 If BI is insufficient in achieving the desired glycaemic goals, treatment intensification with prandial insulin, pre-mixed insulin or glucagon-like peptide-1 receptor agonist (GLP-1RA) should be considered.</li>
 <li>
 Recently, ‘fixed-ratio combinations’ (FRCs) of BI and GLP-1RA have been approved for use with safe and effective antihyperglycaemic profiles whilst reducing injection burden, thereby promoting adherence.</li>
</ul>
<h2>Key Highlights</h2>
<ul>
 <li>
 As T2D is a progressive disorder, most patients eventually require insulin therapy to obtain optimal glycaemic control.</li>
 <li>
 The American Diabetes Association (ADA), European Association for the Study of Diabetes and American Association of Clinical Endocrinologists recommend the early use of BI in the course of T2D treatment.</li>
 <li>
 Generally, BI therapy is initiated on non-achievement of glycaemic targets after receiving 2-3 OADs.</li>
 <li>
 Advances in BI formulations have led to flatter and longer action profiles, resulting in a significant reduction in hypoglycaemia.</li>
 <li>
 Recent BI analogues are easy to initiate as a once-daily injection.</li>
 <li>
 However, insulin dosing and subsequent titration are prescribed on the basis of insulin formulations and clinician and patient preferences.</li>
 <li>
 Recommended insulin initiation dosages vary with formulations, but are generally conservative to reduce the risk for hypoglycaemia.</li>
 <li>
 Post-initiation, BI should be appropriately titrated to achieve optimal fasting plasma glucose targets.</li>
 <li>
 If the daily BI dose is approximately &gt;0.5 U/kg and glycated haemoglobin (HbA1c) targets are unmet, initiation of combination injectable therapies should be considered, primarily to address postprandial hyperglycaemia.</li>
 <li>
 Three options of therapy intensification recommended by the ADA include the addition of rapid-acting insulin, switching to premixed insulin and addition of GLP-1RA.</li>
 <li>
 Insulin intensification increases the risk for hypoglycaemia and weight gain with the increased need for self-monitoring of blood glucose levels.</li>
 <li>Addition of GLP-1RA to existing BI therapy results in similar HbA1c reductions compared with basal-bolus insulin therapy, with a decreased risk for hypoglycaemia and weight gain. 
 <ul>
 <li>However, gastrointestinal side effects are common with GLP-1RA and its use should be contraindicated or cautionary in at-risk patient populations.</li>
 </ul></li>
 <li>
 Recently, FRCs of BI and GLP-1RA have been approved for T2D treatment.</li>
 <li>Studies indicate that in patients suboptimally controlled on OADs or BI, FRCs (vs individual components) have the following beneficial effects: 
 <ul>
 <li>significant improvement in glycaemic control with 55-75% of patients achieving HbA1c &lt;7.0%;</li>
 <li>mitigation of weight gain and no higher risk for hypoglycaemia vs BI alone; and</li>
 <li>reduced gastrointestinal side effects vs GLP-1RA alone.</li>
 </ul></li>
 <li>
 In patients not achieving glycaemic targets with less than 50-60 U BI, FRCs are a safe and effective option with convenient once-daily subcutaneous injectable dosing.</li>
</ul>

Reference

Basal Insulin and Beyond: Advanced Therapies for Type 2 Diabetes

TYPE-2-DIABETES

DIABETES

CHRONIC-OBSTRUCTIVE-PULMONARY-DISEASE-(COPD)

RESPIRATORY

A deeper look at the inflammation behind exacerbations in COPD

Role of type 2 inflammation in type 2 COPD

<h2>Each Copd Exacerbation May Increase the Risk of Another, Putting Patients’ Lives at Greater Risk</h2>
<h3>Exacerbation risk accelerates after each exacerbation1</h3>

Based on data from a large population-based cohort of 73,106 Canadian patients who were hospitalized for the first time because of a severe exacerbation of COPD (1990-2005, followed until death or March 31, 2007) with a median follow-up of 3.6 years (range 1 day to 17 years). The mean age of patients in this retrospective study was 75 years old.1
aAdjusted for age, sex, calendar time, and the modified Chronic Disease Score.1
<h3>Exacerbations have been shown to accelerate lung function decline2</h3>
Significant lung function decline may occur even after a single COPD exacerbation2
<ul>
 <li>The annual decline in postbronchodilator FEV1&nbsp;nearly doubled after 1 moderate-to-severe exacerbation (pre-exacerbation 39.1 mL/year vs 76.5 mL/year postexacerbation [P=0.003])2,b</li>
</ul>
bBased on data from a retrospective analysis of 586 patients with moderate-to-severe (postbronchodilator FEV1&nbsp;70% of the predicted normal and FEV1&nbsp;70% of FVC) COPD participating in the 4-year, randomized, double-blind, placebo-controlled, parallel-group UPLIFT trial.
<h2>Exacerbations may increase morbidity risk3-6</h2>
Patients with exacerbations leading to hospitalization are at an increased risk for hospital readmissions
<ul>
 <li>Up to 35% of patients were readmitted within 90 days following an exacerbation3-5,c</li>
</ul>
COPD exacerbations are associated with a worsening of symptoms that can seriously impact quality of life
Patients typically experience:

Limited activity levels and exercise capacity6

Sleep-related disturbances8,9

Anxiety and depression8

cBased on data from an investigation that examined outcomes (in-hospital and 90-day postdischarge mortality and 90-day readmission) in patients with a severe COPD exacerbation (n=15,191) seen within the European COPD Audit.3
<h3>Exacerbations may increase mortality risk1</h3>

<h3>~2x&nbsp;</h3>
higher riske

After second exacerbationd

black

<h3>~3x&nbsp;</h3>
higher riske

After fifth exacerbationd

<h4>Noteworthy</h4>
<h3>All-cause mortality data showf:&nbsp;&nbsp;50%&nbsp;&nbsp;of patients died less than 4 years after their first COPD-related hospitalization1,d</h3>
dBased on data from a large population-based cohort of 73,106 Canadian patients who were hospitalized for the first time because of a severe exacerbation of COPD (1990-2005, followed until death or March 31, 2007) with a median follow-up of 3.6 years (range 1 day to 17 years). The mean age of patients in this retrospective study was 75 years old. eRelative risk of mortality compared to the first exacerbation (adjusted hazard ratio). fThe median survival was 3.6 years.

<h2>Chronic Underlying Inflammation Drives the Downward Spiral of Copd Progression10-18</h2>
Different types of chronic inflammation have an important role in COPD pathophysiology
Many cell types and cytokines are involved in these processes, including:

<h4>Noteworthy</h4>
<h3>Up to&nbsp;&nbsp;37%&nbsp;&nbsp;of COPD patients without an asthma comorbidity had evidence of type 2 inflammation25-29,g</h3>
gBased on findings from 5 studies in COPD patients without asthma. Eosinophil levels used to define type 2 inflammation ranged from ≥300 cells/μL to ≥340 cells/μL (blood), ≥2% (blood and sputum), or &gt;3% nonsquamous cells (sputum). Percentages of patients with type 2 inflammation ranged from 12.3% to 37%.25-29
<h2>Type 2 inflammation may drive poor outcomes in COPD9,30,31</h2>
Type 2 inflammation encompasses both type 2 effector cells (eg, Th2, ILC2, eosinophils, and mast cells) and key cytokines (eg, IL-4, IL-13, and IL-5)16,19,20,32-41

Persistent symptoms (dyspnea, chronic cough, sputum)9

Progressive lung function decline9

Exacerbations9

Select cytokines play important roles in type 2 inflammation

IL-4 and IL-13 promote the activation and trafficking of type 2 inflammatory cells, including eosinophils, to the lungs, which may contribute to airway remodeling and parenchymal destruction in COPD32,34,42-48

IL-4 and IL-13 drive inflammatory cell activity

IL-13 plays a role in emphysema, fibrosis, and goblet cell hyperplasia and increases expression of MUC5AC, a major constituent of airway mucus17,33,34,48-51

The critical role of IL-13 in airflow limitation

IL-33 initiates and amplifies the broad inflammatory cascades in COPD, inclusive of type 2 inflammation and beyond22,23

The role of IL-33

IL-5 is required for the growth and differentiation, recruitment, activation, and survival of eosinophils, which may be biomarkers of a broader type 2 inflammatory response32

The role of IL-5

<h2>Look for Elevated Blood Eosinophils (≥300 Cells/μl)—a Biomarker of Type 2 Inflammation in Copd9,31</h2>
<h3>Identifying COPD patients with type 2 inflammation may help determine those at increased risk of exacerbations</h3>

Blood eosinophils
<h3>≥300</h3>
cells/μL

<h3>32%</h3>
increased risk of 
 COPD exacerbations30,h,i

hResults from an observational analysis of 1553 patients with GOLD spirometry grade 2-4 COPD evaluating the relationship between blood eosinophil counts and COPD exacerbation risk.30
iStratified analysis confirmed that increased exacerbation risk was driven by subjects with a history of frequent exacerbations, defined as ≥2 exacerbations per year.
<h3>Elevated eosinophils and a history of frequent exacerbations help identify patients and guide treatment options9,52</h3>
According to GOLD 2023 recommendations, patients with frequent exacerbations (GOLD Group E) and blood eosinophils ≥300 cells/μL may receive an ICS in combination with LABA + LAMA9
<h4>Noteworthy</h4>
Even when treatment is optimized with inhaled triple therapy, many patients with COPD may continue to experience exacerbations52

Understanding type 2 inflammation in COPD may help shed light on why some patients continue to experience exacerbations

Abbreviations

References

A deeper look at the inflammation behind exacerbations can IGNITE NEW THINKING IN COPD

This randomized clinical trial demonstrated that preoperative administration of low-molecular-weight-heparin (LMWH) is safe and feasible for lung cancer patients preparing to receive minimally invasive surgery.

<h2>Key Takeaway</h2>
<ul>
 <li>Preoperative administration of LMWH resulted in no significant effects on coagulationrelated events compared with postoperative start of LMWH for minimally invasive lung , cancer surgery patients.</li>
 <li>This method was found to be safe and feasible with minimal invasive surgery.</li>
 <li>There were no venous thromboembolisms (VTEs) or blood transfusion or other major complications between preoperative LMWH-administration group (PRL) and the postoperative LMWH-administration group (POL) with no significant differences between two groups.</li>
 <li>The operation duration was significantly longer in the PRL vs POL group.</li>
</ul>

<h2>Why This Matters</h2>
<ul>
 <li>There is a strong relationship between lung cancer and VTE, indicated by significant evidence showing that VTE incidence in lung cancer patients increased 22 times more than non-cancer patients, while the risk in lung cancer patients was still sevenfold higher than that in other malignancies.</li>
 <li>American Society of Clinical Oncology Clinical Practice Guideline recommends thromboprophylaxis before surgery and continuing for at least 7–10 days for cancer patients undergoing major surgery.</li>
 <li>There are no clear guidelines, no academic organization’s definite instructions, and no dependable clinical experiments for conducting preoperative anticoagulation.</li>
 <li>This study was innovatively designed to testify whether preoperative administration of LMWH in lung cancer patients was safe and feasible.</li>
</ul>

<h2>Study Design</h2>
<ul>
 <li>This trial was a prospective study in West China Hospital from July 2017 to June 2018 (ChiCTR2000040547) where patients prepared to undergo lung cancer surgery were randomly divided into PRL and POL groups with 4000 IU per day dosage. All patients received thromboprophylaxis until discharge.</li>
 <li>Inclusion criteria: Patients aged 18–75 years without any preoperative VTEs (both VTE history and current screening); intended for video-assisted thoracoscopic major thoracic surgery (including lobectomy and sub lobar resection); diagnosed pathologically with primary lung cancer</li>
 <li>Exclusion criteria: Coagulation disorders (preoperative international normalized ratio [INR] &gt;1.5, or blood platelet count &lt;50 × 109/L); receiving any therapeutic anticoagulation preoperatively; undergoing preoperative planned or intraoperative converted open thoracic surgery; severe renal or liver dysfunction; suffered intraoperative bleeding (&gt;500 ml owing to vessels rupture); rejected to continue the study at any point of the study; on menstruation perioperatively</li>
 <li>Endpoints: Postoperative coagulation function parameters; postoperative drainage data; hematologic data; intraoperative bleeding volume; reoperation rates; surgical time</li>
</ul>

<h2>Key Results</h2>
<ul>
 <li>A total of 246 patients were recruited from July 2017 to June 2018 in this study; patients were randomly allocated (N = 230) to PRL (n = 108) and POL (n = 122) groups. 
 <ul>
 <li>Finally, 212 participants were included in the analysis (PRL group: n = 101; mean age, 55.88 ± 10.11 years; POL group: n = 111; mean age, 58.17 ± 9.99 years).</li>
 <li>146/212 cases were analyzed on postoperative day 3 for coagulation profile (POL [n = 85] and PRL [n = 61]).</li>
 </ul></li>
 <li>No significant differences were found in coagulation parameters between the POL and PRL groups on first postoperative day: Prothrombin time (PT) (P = 0.158); activated partial thromboplastin time (APTT) (P = 0.339); thrombin time (TT) (P = 0.402); fibrinogen (FIB) (P = 0.806); INR (P = 0.190)</li>
 <li>Drainage data were comparable between the groups: Drainage duration (P = 0.165); mean drainage volume (P = 0.795); total drainage volume (P = 0.445)</li>
 <li>No difference was noted on postoperative day 1 between the two groups regarding intraoperative bleeding volumes (P = 0.195), postoperative hemoglobin value (P = 0.735), and platelet count (P = 0.472).</li>
 <li>The reoperation rate was comparable between the two groups (P = 0.606).</li>
 <li>Surgical time/operation duration in the PRL group was significantly longer than that in the POL group (117.15 ± 41.63 vs 104.13 ± 29.07 minutes, P = 0.008).</li>
 <li>Coagulation function parameters on postoperative day 3 were not significantly different between POL vs PRL groups: PT (P = 0.173); APPT (P = 0.712); TT (P = 0.951); FIB (P = 0.633); INR (P = 0.492); PLT (P = 0.141); HGB (P = 0.247)</li>
</ul>

<h2>Key limitations</h2>
<ul>
 <li>Sample size was relatively small, thus minimizing evidence grade of results.</li>
 <li>Postoperative blood examination was conducted in the morning (around 7 o’clock) but not at a specific point after LMWH administration.</li>
 <li>Lack of VTE occurrence in both groups was less convincing for preoperative start of LMWH providing sufficient thromboprophylaxis.</li>
 <li>Participants included were assessed at the early stage of lung cancer.</li>
 <li>Result could not be expanded to cover other races as only Chinese patients were included.</li>
</ul>

Safety profile of preoperative administration of low-molecular-weight heparin for Lung Cancer population

THROMBOSIS

CARDIOLOGY

<h2>More invasive surgery is associated with a higher rate of VTE.</h2>
In the GAPS non-inferiority randomized controlled trial (RCT) in elective surgical inpatients at moderate or high risk of venous thromboembolism (VTE), administration of pharmacological thromboprophylaxis alone was non-inferior to a combination of pharmacological thromboprophylaxis plus graduated compression stockings (GCS).

<h2>Main Takeaway</h2>
<ul>
 <li>The risk for venous thromboembolism (VTE) is significantly higher with emergency general surgery than elective surgery.</li>
 <li>Emergency surgery and procedures with increased invasiveness are associated with significant risk for VTE.</li>
</ul>

<h2>Why This Matters&nbsp;</h2>
<ul>
 <li>This is the first study to compare the rate of VTE in the emergency surgery compared with the same operations performed electively.</li>
 <li>Surgeons and hospitals should promote research and quality improvement processes aimed at patients undergoing elective surgery to prevent and mitigate VTE.</li>
 <li>A more aggressive VTE chemoprophylaxis regimen may be considered for emergency and more invasive surgery.&nbsp;</li>
</ul>

<h2>Study Design</h2>
<ul>
 <li>A retrospective cohort study of 604,537 patients from the American College of Surgeons National Surgical Quality Improvement Program database.</li>
 <li>Patients underwent cholecystectomies (n=285,847), ventral hernia repairs (VHRs; n=158,500) and partial colectomies (PCs; 160,190) during 2005-2016.</li>
 <li>Primary outcome was VTE at 30 days</li>
 <li>Funding: None disclosed.</li>
</ul>

<h2>Key Results</h2>
<ul>
 <li>Mean age was 55.3 years.</li>
 <li>Of the procedures, 57.3% were performed laparoscopically.</li>
 <li>Overall rate of VTE within 30 days was 1.1% (deep vein thrombosis [DVT], 0.8% and pulmonary embolism [PE], 0.4%).</li>
 <li>The rate of VTE within 30 days was 1.9% for emergency surgery and 0.8% for elective surgery (P&lt;0.001).</li>
 <li>At 30 days, emergency vs. elective showed significantly higher rate of: 
 <ul>
 <li>DVT: 1.4% vs. 0.5% (P&lt;0.001)</li>
 <li>PE: 0.6% vs. 0.3% (P&lt;0.001).</li>
 </ul></li>
 <li>The rate of VTE was 0.4% for laparoscopic surgery and 2.0% for open surgery.</li>
 <li>The rate of VTE increased with increasing invasiveness of surgery (0.5% for cholecystectomy, 0.8% for VHR and 2.4% for PC; P&lt;0.001).</li>
 <li>The 30-day mortality rate was 9 times higher in patients undergoing emergency vs. elective surgery (3.6% vs. 0.4%; P&lt;0.001).</li>
 <li>On multivariable analysis, independent risk factors for VTE were: 
 <ul>
 <li>Emergency general surgery (OR, 1.70; 95% CI, 1.61-1.79; P&lt;0.001);</li>
 <li>Open surgery (OR, 3.38; 95% CI, 3.15-3.63; P&lt;0.001); and</li>
 <li>PC (OR, 1.86; 95% CI, 1.73-1.99; P&lt;0.001).</li>
 </ul></li>
</ul>

<h2>Limitations</h2>
<ul>
 <li>Retrospective design.</li>
 <li>The database represents only a sample of procedures performed and therefore, the findings may not be generalisable.</li>
 <li>VTE chemoprophylaxis adherence, dosing or the type of anticoagulants used were not known.</li>
 <li>Information on specific practice locations or facility types was not available</li>
</ul>

Risk for VTE is higher in emergency surgery than elective procedures

The authors concluded that among patients who had undergone gynecological laparoscopic surgery, the incidence of postoperative deep vein thrombosis (DVT) was high, and that this incidence can be reduced by targeting high-risk factors.

<h2>Key Takeaway</h2>
<ul>
 <li>After gynecological laparoscopic surgery: 
 <ul>
 <li>Incidence of DVT among patients was 11.55%.</li>
 <li>Independent risk factors of DVT: Age &gt;50 years, hypertension, D-dimer &gt;0.5 mg/L, duration of surgery≥60 min, intraoperative pneumoperitoneum pressure≥15 mm Hg, and duration of days in bed &gt;3 days.</li>
 </ul></li>
 <li>Clinical management of these high-risk factors should be strengthened to reduce DVT incidence.</li>
</ul>

<h2>Why This Matters</h2>
<ul>
 <li>DVT of the lower extremities continues to be one of the common complications of gynecological surgery.</li>
 <li>Therefore, it is essential to understand the risk factors of DVT after gynecological laparoscopic surgery, to guide early prevention and treatment of DVT in clinical settings, and to reduce DVT occurrence after surgery.</li>
 <li>This study analyzed relevant clinical data of patients who had undergone gynecological laparoscopic surgery and explored the related factors of postoperative DVT.</li>
</ul>

<h2>Study Design</h2>
<ul>
 <li>The study enrolled patients who underwent gynecological laparoscopic surgery from January 1, 2018, to May 31, 2020.</li>
 <li>Inclusion criteria: Patients who (1) underwent gynecological laparoscopic surgery for the first time; (2) underwent venous color ultrasound to detect DVT pre- and post-operatively; (3) were not using contraceptives or other hormonal drugs, or drugs possibly affecting blood clotting function before surgery; and (4) were well informed and agreed to participate in the study</li>
 <li>Exclusion criteria: Patients who (1) underwent traditional gynecological open surgery; (2) were receiving drugs for anticoagulation before surgery; (3) had diseases involving abnormal blood coagulation function, such as hemophilia and leukemia; and (4) were not willing to participate in the study</li>
 <li>The criteria for diagnosing DVT were as follows: 
 <ul>
 <li>Clinical characteristics: Postoperative pain, numbness, swelling, and limited mobility of the affected side of the lower limb</li>
 <li>Signs: Larger circumference of the lower limb of the affected side than that of the healthy side, as well as a positive Homans sign</li>
 <li>Auxiliary examination: Substantial echo in the venous cavity as observed using color Doppler ultrasound venous examination of the lower extremities</li>
 </ul></li>
</ul>

<h2>Key Results</h2>
<ul>
 <li>In total, 355 patients who underwent gynecological laparoscopic surgery were included. Of these, 41 patients developed DVT (DVT group, incidence: 11.55%); 314 patients were included in the non-DVT group.</li>
 <li>Patient characteristics: 
 <ul>
 <li>The DVT and non-DVT groups demonstrated significant differences with regard to age, hypertension, D-dimer, duration of surgery, intraoperative pneumoperitoneum pressure, duration of days in bed (all P &lt;0.05).</li>
 <li>In contrast, the two groups did not differ significantly with regard to body mass index, diabetes, hyperlipidemia, American Association of Anesthesiologists classification, and intraoperative blood transfusion (all P &gt;0.05).</li>
 </ul></li>
 <li>Independent risk factors of DVT in patients who had undergone gynecological laparoscopic surgery: 
 <ul>
 <li>Age &gt;50 years: Odds ratio [OR] = 4.246, 95% confidence interval [CI]: 1.234–7.114; P = 0.012</li>
 <li>Hypertension: OR = 2.219, 95% CI: 1.153–4.591; P = 0.028</li>
 <li>D-dimer &gt;0.5 mg/L: OR = 3.914, 95% CI: 1.083–5.229; P = 0.008</li>
 <li>Duration of surgery 60 min: OR = 2.542, 95% CI: 1.101–4.723; P = 0.031</li>
 <li>Intraoperative pneumoperitoneum pressure 15 mmHg: OR = 3.845, 95% CI: 1.119–5.218; P = 0.022</li>
 <li>Duration of days in bed &gt;3 days: OR = 1.566, 95% CI: 1.182–1.994; P = 0.037</li>
 </ul></li>
</ul>

<h2>Limitations</h2>
<ul>
 <li>The sample size of cases selected in this study was small.</li>
 <li>This was a single-center study.</li>
</ul>

Risk factors of lower extremity DVT in patients undergone gynecological laparoscopic surgery

What is the Thrombotic Risk vs Hemorrhagic Risk in Surgical Patients?

Watch Prof. Juan I. Arcelus, MD. PHD Department of Surgery, University of Granada, Spain: Discussing VTE management in general surgical patients.

Advancing Therapy with iGlarLixi: Differentiation from complex insulin regimens

An educational video outlining key data from indirect comparisons of iGlarLixi versus IDegAsp.

Thrombosis VTE SZ 2022 Summary Video

Watch the short video summary of the VTE SZ 2022 program, with a little teaser for 2023 at the end and stay tuned for our upcoming communications to join world-renowned experts in VTE management.

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