<h2>Can Multiple Endpoints in Clinical Papers Create New Insights?</h2>
Featuring&nbsp;Dr. Nina Shah&nbsp;from the Multiple Myeloma Translational Initiative, University of California, San Francisco and&nbsp;Dr. Evangelos Terpos&nbsp;from the University of Athens School of Medicine.
Drs. Nina Shah and Evangelos Terpos believe both progression-free survival (PFS) and minimal residual disease (MRD) are relevant endpoints to be aware of in multiple myeloma clinical trials. Watch them discuss this and topics such as hazard ratio and population characteristics.

"You may need 4, 5 or even more years in order to see a median PFS. So, possibly for approvals the MRD may give us some hints because we do know that MRD definitely correlates with both PFS and overall survival, both in the front line setting and also in the relapsed/refractory."
Dr. Evangelos
Terpos University of Athens School of Medicine Athens, Greece

black

"I think the best place to measure MRD for those patients is right before maintenance therapy. So after the transplant, before you start something new, because that’s a very clean breakpoint that you can say, ‘Okay, how is this patient going to do?’ That is what has been done in a lot of the trials."
Dr. Nina Shah
Multiple Myeloma Translational Initiative of the University of California in San Francisco, San Francisco, CA, US

<h2>Experts opinion about Multiple Myeloma</h2>

MULTIPLE-MYELOMA

HEMATOLOGY

Experts Perspective

Reference

See aTTP†&nbsp;— Diagnosis determined through clinical assessment
Start&nbsp;CABLIVI*&nbsp;— Consider early administration of CABLIVI in combination with PEX and immunosuppressive therapy
Support with ADAMTS13&nbsp;— ADAMTS13 test results inform treatment decisions
<hr>

<h2>ISTH TTP Guidelines are the first evidence-based, international guidelines on the diagnosis, treatment, and management of aTTP1,2</h2>

Treatment recommendations have evolved to include PEX, immunosuppressive therapy,&nbsp;and CABLIVI

Initiation of CABLIVI is recommended for&nbsp;acute aTTP events(initial and relapsing)

Starting CABLIVI early&nbsp;is believed to have the greatest benefit in the early phase of acute aTTP events (initial or relapsing)

<h3>Who should not start CABLIVI?</h3>
<ul>
 <li>CABLIVI is contraindicated in patients with a previous severe hypersensitivity reaction to caplacizumab-yhdp or to any of its excipients</li>
 <li>Withhold CABLIVI treatment 7 days prior to elective surgery, dental procedures, or other invasive interventions</li>
</ul>
&nbsp;
*&nbsp;A conditional recommendation defined as desirable effects of the recommendation probably outweighing the undesirable effects. Assumes timely access to ADAMTS13 testing and clinical diagnosis based on high likelihood of aTTP. If ADAMTS13 testing is not available, do not add CABLIVI. †The ISTH TTP Guidelines refer to aTTP as iTTP.

<h3>Indications:</h3>
CABLIVI (caplacizumab-yhdp) is indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP),in combination with plasma exchange and immunosuppressive therapy.
<h3>Important safety information contraindications:</h3>
CABLIVI is contraindicated in patients with a previous severe hypersensitivity reaction to caplacizumab-yhdp or to any of its excipients. Hypersensitivity reactions have included urticaria.
aTTP=acquired thrombotic thrombocytopenic purpura; ISTH=International Society on Thrombosis and Haemostasis; iTTP=immune thrombotic thrombocytopenic purpura; PEX=plasma exchange; TTP=thrombotic thrombocytopenic purpura.

<h2>See aTTP—Diagnosis determined through clinical assessment1</h2>
aTTP is a life-threatening blood disorder with considerable morbidity and mortality in the acute phase

<h2>Diagnose aTTP through clinical assessment or risk assessment tools prior to ADAMTS13 testing</h2>

<h3>Clinical assessment†</h3>
<ul>
 <li>Thrombocytopenia (&lt;150 × 109/L)</li>
 <li>Evidence of microangiopathic hemolytic anemia 
 <ul>
 <li>Hb and hematocrit below reference range</li>
 <li>Low haptoglobin</li>
 <li>Presence of schistocytes in peripheral blood smear</li>
 </ul></li>
 <li>Relatively preserved renal function</li>
</ul>

<h3>Risk assessment tools†</h3>
Available risk assessment tools include:
<ul>
 <li>PLASMIC score</li>
 <li>French score</li>
</ul>
<hr>
The higher the risk assessment score the more likely patients have severe ADAMTS13 deficiency and aTTP

<h3>Identifying aTTP is crucial for initiation of an appropriate therapeutic strategy</h3>
*A conditional recommendation defined as desirable effects of the recommendation probably outweighing the undesirable effects. 
 Assumes timely access to ADAMTS13 testing and clinical diagnosis based on high likelihood of aTTP. If ADAMTS13 testing is not available, do not add CABLIVI. †List includes laboratory tests and results only; exclusive of physical symptoms, such as petechiae. ‡ISTH did not appraise the evidence of these 2 tools.

<h3>Important safety information (cont’d) warnings and precautions:</h3>
<ul>
 <li>CABLIVI increases the risk of bleeding. Cases of major bleeding, including life-threatening and fatal bleeding have been reported in patients receiving CABLIVI, mainly in those using concomitant anti-platelet agents or anticoagulants. The risk of bleeding is increased in patients with underlying coagulopathies and concomitant use of CABLIVI with drugs affecting hemostasis.</li>
 <li>In clinical studies, severe bleeding adverse reactions of epistaxis, gingival bleeding, upper gastrointestinal hemorrhage, and metrorrhagia were each reported in 1% of subjects. Overall, bleeding events occurred in approximately 58% of patients on CABLIVI versus 43% of patients on placebo.</li>
 <li>If clinically significant bleeding occurs, interrupt use of CABLIVI. Von Willebrand factor concentrate may be administered to rapidly correct hemostasis. If CABLIVI is restarted, monitor closely for signs of bleeding.</li>
 <li>Withhold CABLIVI for 7 days prior to elective surgery, dental procedures or other invasive interventions. If emergency surgery is needed, the use of von Willebrand factor concentrate may be considered to correct hemostasis. After the risk of surgical bleeding has resolved, and CABLIVI is resumed, monitor closely for signs of bleeding.</li>
</ul>
Hb=hemoglobin; LDH=lactate dehydrogenase.

<h2>Start CABLIVI*—Consider early administration of CABLIVI in combination with PEX and immunosuppressive therapy1</h2>
Recommended diagnostic and management strategy for acute events with access to ADAMTS13 results within 7 days

<h3>Treatment of relapses for a patient previously diagnosed with aTTP could be started safely based on clinical grounds without the need for a confirmatory ADAMTS13 test</h3>
&nbsp;
<h3>Who should not start CABLIVI?</h3>
<ul>
 <li>CABLIVI is contraindicated in patients with a previous severe hypersensitivity reaction to caplacizumab-yhdp or to any of its excipients</li>
 <li>Withhold CABLIVI treatment 7 days prior to elective surgery, dental procedures, or other invasive interventions</li>
</ul>
*&nbsp;A conditional recommendation defined as desirable effects of the recommendation probably outweighing the undesirable effects. Assumes timely access to ADAMTS13 testing and clinical diagnosis based on high likelihood of aTTP. If ADAMTS13 testing is not available, do not add CABLIVI.

<h3>Important safety information (cont’d) adverse reactions:</h3>
The most common adverse reactions (&gt;15% of patients) were epistaxis (29%), headache (21%) and gingival bleeding (16%).
<h3>Concomitant use of anticoagulants:</h3>
Concomitant use of CABLIVI with any anticoagulant may increase the risk of bleeding. Assess and monitor closely for bleeding with concomitant use.

<h2>Support with ADAMTS13—ADAMTS13 test results inform treatment decisions1</h2>
Timely access to ADAMTS13 results is key to providing optimal care for patients with aTTP
<h4>Select US labs testing ADAMTS13 activity, inhibitors, and antibodies</h4>
<div>
 <table cellpadding="5" cellspacing="5">
 <tbody>
 <tr>
 <td>
 ARUP Labs</td>
 <td>
 800-522-2787</td>
 </tr>
 <tr>
 <td>
 LabCorp</td>
 <td>
 800-334-5161</td>
 </tr>
 <tr>
 <td>
 Machaon Diagnostics</td>
 <td>
 800-566-3462</td>
 </tr>
 <tr>
 <td>
 Mayo Clinic Laboratories</td>
 <td>
 800-533-1710</td>
 </tr>
 <tr>
 <td>
 Quest Diagnostics</td>
 <td>
 866-697-8378</td>
 </tr>
 <tr>
 <td>
 Versiti</td>
 <td>
 800-245-3117 x6250</td>
 </tr>
 </tbody>
 </table>
</div>
 
 These listings do not constitute an endorsement by Sanofi Genzyme and are not included in the ISTH Guidelines. The following is a selection of national laboratories offering ADAMTS13 tests activity, inhibitor, and antibody testing. This is not an exhaustive list of labs that offer one or more of these tests or an endorsement of any lab. Other testing options may be available, including at local or regional laboratories. Content is current as of July 2020, and tests may not be available in all states. Please call laboratory to confirm test availability, sample shipping information, and all other logistics.

<h3>Prescribe CABLIVI—the first and only FDA-approved, guideline-recommended therapy for aTTP in combination with PEX and immunosuppressive therapy</h3>
*&nbsp;A conditional recommendation defined as desirable effects of the recommendation probably outweighing the undesirable effects. Assumes timely access to ADAMTS13 testing and clinical diagnosis based on high likelihood of aTTP. If ADAMTS13 testing is not available, do not add CABLIVI.
<h3>Important safety information (cont’d) pregnancy:</h3>
<ul>
 <li>Pregnancy:&nbsp;There are no data on the use of caplacizumab in pregnant women. Studies in guinea pigs showed no effect of caplacizumab on the dams or foetuses. As a precautionary measure, it is preferable to avoid the use of Cablivi during pregnancy.</li>
 <li>Breastfeeding:&nbsp;There are no data on the use of caplacizumab in breastfeeding women. It is unknown whether caplacizumab is excreted in human milk. A risk to the child cannot be excluded. A decision must be made whether to discontinue breastfeeding or to abstain/discontinue from therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.</li>
</ul>

References

ISTH Guidelines

<h2>MRD: Lingering Posttreatment Malignant Cells That May Eventually Cause Relapse</h2>
<ul>
 <li>MRD describes the low level of malignant cells that persist in the bone marrow after treatment but cannot be detected with conventional outcome measures and which eventually lead to relapse1,2</li>
 <li>A patient who is MRD negative has achieved clinical remission with the absence of aberrant clonal cells by NGF or NGS per at least 100,000 nucleated cells2</li>
 <li>Even patients in CR may remain MRD+, if residual malignant cells are detected on a test sample. Studies have shown that patients in CR with persistent MRD have outcomes on par with patients in PR3-6</li>
 <li>Current IMWG criteria for MRD- defines the threshold as a minimum sensitivity of 10-5, although as testing has improved it has become increasingly common to establish MRD- at a threshold of 10-6 2,7</li>
</ul>

<h2>Defining MRD per IMWG response criteria2</h2>
Highest&nbsp; ←&nbsp;Detectable tumour burden in blood and bone marrow&nbsp;→&nbsp;Lowest

SD:&nbsp;Stable disease/no change

Not meeting criteria for CR, VGPR, PR, minimal response, or progressive disease

PR: Partial Response

<ul>
 <li>
 A&nbsp;≥ 50% reduction of serum M-protein and reduction in 24h urinary M-protein by&nbsp;≥ 90% or to &lt;200 mg/24 h</li>
 <li>
 If serum and urine M-protein are unmeasurable, a&nbsp;≥ 50% decrease in the difference between involved and uninvolved FLC levels is required in place of the M-protein criteria</li>
 <li>
 If serum and urine M-protein and serum-free light assay are unmeasurable, a&nbsp;≥ 50% reduction in plasma cells is required in place of M-protein, provided baseline bone marrow plasma cell percentage was&nbsp;≥ %30&nbsp;</li>
 <li>
 In addition to the above listed criteria, if present at baseline, a&nbsp;≥ 50% reduction in the size of soft tissue plasmacytomas is also required</li>
</ul>

VGPR: Very Good Partial Response

Serum and urine M-protein detectable by immunoflixation but not on electrophoresis or ≥ 90% reduction in serum M-protein plus urine M-protein level &lt; 100 mg/24 h

CR: Complete Response

Negative immunofixation on the serum and urine, disappearance of any soft tissue plasmacytomas, and &lt; 5% plasma cells in bone marrow aspirates

sCR: Stringent Complete Response

CR plus normal FLC ratio and absence of clonal cells in bone marrow biopsy by immunohistochemistry

MRD-a: Minimal Residual Disease Negativity

<ul>
 <li>
 Flow MRD-negative: Absence of phenotypically aberrant clonal plasma cells by NGF on bone marrow aspirates using the EuroFlow standard operation procedure for MRD detection in multiple myeloma (or validated equivalent method) with a minimum sensitivity of 1 in 105&nbsp;nucleated cells or higher</li>
 <li>
 Sequencing MRD-negative: Absence of clonal plasma cells by NGS on bone marrow aspirate in which presence of a clone is defined as &lt;2 identical sequencing reads obtained after DNA sequencing of bone marrow aspirates using the LymphoSIGHT platform (or validated equivalent method) with a minimum sensitivity of 1 in 105&nbsp;nucleated cells or higher</li>
 <li>
 Imaging plus MRD-negative: MRD negativity as defined by NGF or NGS plus disappearance of every area of increased tracer uptake found at baseline or a preceding PET/CT or decrease to less mediastinal blood pool SUV or decrease to less than that of surrounding normal tissue</li>
</ul>

Sustained MRD-b: Sustained Minimal Residual Disease Negativity

MRD negativity in the marrow (NGF or NGS, of both) and by imaging as defined on the previous slide, confirmed minimum of 1 year apart. Subsequent evaluations can be used to further specify the duration of negativity (eg, MRD-negative at 5 years)

aRequires a CR.
bSustained MRD negativity when reported should also annotate the method used (eg, sustained flow MRD-negative, sustained sequencing MRD-negative).

Abbreviations

About MRD

<h2>Pretreatment with P2Y12 inhibitors in patients with nonST-segment elevation acute coronary syndrome: A meta-analysis.</h2>

In this meta-analysis, clopidogrel pretreatment was associated with significantly lower risk of mortality, major adverse cardiovascular events (MACE), myocardial infarction (MI), death, and revascularization without increase in risk of major bleeding in nonST-segment elevation acute coronary syndrome (NSTE-ACS) patients. However, prasugrel or ticagrelor pretreatment lacked ischemic protection and caused major bleeding events.

<h2>Key Takeaway</h2>
<ul>
 <li>This meta-analysis comparing pretreatment with P2Y12 inhibitors with no pretreatment in patients with NSTE-ACS from nine studies demonstrated that: 
 <ul>
 <li>P2Y12 inhibitor pretreatment was associated with lower death from any cause without increasing the risk of major bleeding with no distinction in MI, revascularization and MACE</li>
 <li>Clopidogrel pretreatment subgroup was significantly associated with lower incidence of mortality, MACE, MI, and revascularization without increasing major bleeding</li>
 <li>Prasugrel or ticagrelor pretreatment subgroup was associated with no significant difference in mortality, MACE, MI or revascularization, whereas major bleeding events were significantly increased</li>
 <li>Lower mortality and ischemic protection were observed in non- randomized controlled trials (RCTs) vs RCTs</li>
 </ul></li>
</ul>

<h2>Why This Matters</h2>
<ul>
 <li>P2Y12 receptor inhibitor loading (300 mg clopidogrel) before percutaneous coronary intervention (PCI) is found to reduce MACE but slightly increase bleeding events 
 <ul>
 <li>However, large-scale RCTs of clopidogrel pretreatment are lacking</li>
 </ul></li>
 <li>Current RCTs for prasugrel and ticagrelor do not recommend pretreatment, as they do not reduce ischemic events but increase the risk of major bleeding.</li>
 <li>In the era of prasugrel and ticagrelor, the optimal timing of P2Y12 receptor inhibitor administration remains controversial.</li>
 <li>This meta-analysis compared pretreatment with P2Y12 inhibitors with no pretreatment in patients with NSTE-ACS.</li>
</ul>

<h2>Study Design</h2>
<ul>
 <li>This meta-analysis included trials meeting following criteria: Studies with &gt;50% of patients with NSTE-ACS; studies comparing pretreatment with P2Y12 inhibitor with no pretreatment; observational or randomized studies; studies with data on loading dose and timing of P2Y12 inhibitors were available; data reporting any data of interest, including at least any cause mortality, major bleeding</li>
 <li>Excluded trials: Ongoing and no control group studies and duplicate reports</li>
 <li>Primary efficacy and safety endpoint: Death from any cause and major bleeding</li>
 <li>Secondary endpoint: MACEs, MI and revascularization</li>
</ul>

<h2>Key Results</h2>
Characteristics of the included studies
<ul>
 <li>This meta-analysis included nine studies (2 RCTs, 2 post hoc analyses of RCTs and 5 non-RCTs).</li>
 <li>Pretreatment with prasugrel or ticagrelor was included in 2 studies, pretreatment with 3 P2Y12 inhibitors (clopidogrel, prasugrel, and ticagrelor) in one study, and pretreatment with clopidogrel in 6 studies.</li>
 <li>Of the 94,506 NSTE-ACS patients enrolled, 80,272 patients were pretreated with P2Y12 inhibitor.</li>
 <li>In total 51,922 patients (55.6%) were treated with clopidogrel, and 41,389 (44.4%) patients were treated with prasugrel or ticagrelor.</li>
</ul>

Impact on primary outcomes
<ul>
 <li>Pretreatment before coronary angiography (CAG) in NSTE-ACS patients was associated with 
 <ul>
 <li>Significant lower incidence of mortality (odds ratio [OR] = 0.62, 95% confidence interval, [CI]: 0.53–0.72, P &lt;0.00001)</li>
 <li>No significant difference in the incidence of major bleeding (OR = 1.02, 95% CI: 0.80–1.30, P = 0.89)</li>
 </ul></li>
</ul>

Impact on MACE, MI, and revascularization
<ul>
 <li>No difference was noticed between the pretreatment group and no pretreatment group 
 <ul>
 <li>MACE: OR = 0.83, 95% CI: 0.68–1.01, P = 0.07</li>
 <li>MI: OR = 0.74, 95% CI: 0.54–1.00, P = 0.05</li>
 <li>Revascularization: OR = 0.82, 95% CI: 0.67–1.00, P = 0.05</li>
 </ul></li>
</ul>

Subgroup analyses:&nbsp;Prasugrel or ticagrelor vs clopidogrel
<ul>
 <li>Prasugrel or ticagrelor pretreatment was associated with: 
 <ul>
 <li>No striking differences in mortality (OR = 0.70, 95% CI: 0.31–1.59, P = 0.40), MACE, MI, and revascularization</li>
 <li>Significantly increased major bleeding events (OR = 1.67, 95% CI: 1.10–2.54, P = 0.02)</li>
 </ul></li>
 <li>Clopidogrel pretreatment was associated with lower incidence of mortality (OR = 0.61, 95% CI: 0.52–0.72, P &lt;0.0001), MACE, MI, and revascularization without increasing major bleeding.</li>
</ul>

Sensitivity analysis and reporting bias
<ul>
 <li>Results remained unchanged post excluding study with largest number of patients.</li>
 <li>No obvious heterogeneity in research results of different era* was observed.</li>
</ul>

<h2>Limitations</h2>
<ul>
 <li>Most included studies were non RCTs with inherent biases and confusions</li>
 <li>Obvious heterogeneity in MI and MACE was observed</li>
 <li>Pretreatment definition as well as the time from P2Y12 inhibitor load to PCI differed in various studies.</li>
 <li>The analysis of the potency of P2Y12 was limited due to a lack of data</li>
</ul>
*The relevant research results before (before 2011) and after the change (after 2011) For additional details, please refer to the source publication,&nbsp;<a href="https://pmc.ncbi.nlm.nih.gov/articles/PMC9259160/" target="_blank">Yan L et al.</a>

Ticagrelor vs Clopidogrel in high bleeding risk patients with ACS

OTHER-CARDIOLOGY-TOPICS

CARDIOLOGY

Hypertension is one of the most important modifiable risk factor in preventing cerebrovascular, cardiovascular, and renal morbidity and mortality worldwide.1

The overall prevalence of hypertension in the Middle East is about 29.5%2

Various modifiable factors affect the prevalence of hypertension in this region such as excessively high rates of smoking, obesity, a sedentary lifestyle, some gender gap, and a suboptimal healthcare system; socio-economic factors and disparities in education, literacy and urbanization play a significant role.2

Less than 50% of adults with hypertension receive antihypertensive medications and that around 10% only achieve control.2

<h2 style="text-align: center;">Irbesartan provides more BP lowering power than Losartan &amp; Valsartan6,7</h2>
<h3 style="text-align: center;">Irbesartan provides early &amp; late stage renal protection</h3>
<h4 style="text-align: center;">Patient population: Hypertensive patients with type-2 diabetes and Microalbuminuria</h4>
Irbesartan Significantly reduces the incidence &amp; delays progression to overt proteinuria3

Normalisation of Urinary Albumin Excretion in 1/3 of patients AT 24 Months

Irbesartan 300&nbsp;mg provides&nbsp;70%&nbsp;risk reduction in the progression from microalbuminuria to overt proteinuria3 34%&nbsp;of patient experienced significant regression to normoalbuminuria (&lt;30 mg/day) with&nbsp;Irbesartan&nbsp;300 mg3

<h3 style="text-align: center;">Irbesartan is the only ARB demonstrating powerful BP control with early and late stage renal protection in hypertensive patients with type 2 diabetics.3,4,5</h3>
IDNT Study: Irbesartan Reduces the Progression of Diabetic Nephropathy4

Efficacy of Irbesartan vs. Losartan6

<ul>
 <li>Irbesartan demonstrates up to&nbsp;45%&nbsp;greater BP-lowering power compared to Losartan in monotherapy6</li>
 <li>Irbesartan monotherapy gets&nbsp;48%&nbsp;of patients to BP goal after 1 week vs. 31% with Losartan6</li>
</ul>

Irbesartan vs. Valsartan monotherapy at week8

<ul>
 <li>Significantly greater BP-lowering power than valsartan in&nbsp;monotherapy7; as well as in&nbsp;combination therapy7</li>
 <li>Irbesartan superior efficacy&nbsp;was even more pronounced in morning (at&nbsp;trough) due to&nbsp;longer duration&nbsp;of action8</li>
</ul>

<h2 style="text-align: center;">Irbesartan comes with the power to get majority of patients to BP goal9</h2>
Proportion of Patients Normalised (DBP less than 90 mmHg) up to 24 months9

<h2 style="text-align: center;">Irbesartan in the management of hypertension</h2>
<h3 style="text-align: center;">Role of Irbesartan&nbsp;in Renal protection</h3>
Microalbuminuria&nbsp;is frequently seen in patients with established essential hypertension, and is a predictor of a higher risk for cardiovascular and probably renal dysfunction.1&nbsp;Mortality from coronary heart disease is&nbsp;10x&nbsp;higher in patients who have microalbuminuria2

<h2 style="text-align: center;">Role of Irbesartan in mild-moderate &amp; recently diagnosed hypertension</h2>
<h3 style="text-align: center;">Powerful SBP &amp; DBP reduction1</h3>
Greater BP Reductions Observed in Monotherapy with Irbesartan 150mg or Valsartan 80 mg*1

<h2 style="text-align: center;">Power to get majority of patients to BP goal2</h2>
Additional Goal Attainment Associated with Irbesartan/HCTZ 300 mg/25mg

<table border="1" cellpadding="1" cellspacing="1" style="width:500px;">
 <tbody>
 <tr>
 <td>Irbesartan provide powerful BP-lowering that gets over 80% of patients to DBP goal at 12 months and maintains them at 24 months.2</td>
 </tr>
 </tbody>
</table>

<ul>
 <li>
 At 12 months, of the patients treated to target (&lt;140/90 mmHg),&nbsp;an additional 7.3% were able to reach goals with Irbesartan/HCTZ 300 mg/25 mg</li>
 <li>
 In patients achieving target,&nbsp;only 14% required&nbsp;another drug on top of Irbesartan/ Irbesartan/HCTZ or a therapy with other medications</li>
</ul>

<h2 style="text-align: center;">Superior persistence rate compared to other hypertensives including IRBs3</h2>
ICE: Persistence with initial antihypertensive monotherapy after 12 months3

<h2 style="text-align: center;">Role of Irbesartan in uncontrolled or severe hypertensives</h2>
Proven rapid efficacy to lower SBP/DBP by -43/-27 mmHg only after 7 weeks1
BP reduction with Irbesartan 300mg/25mg in patients with severe hypertension at Week 71

<ul>
 <li>
 In higher risk hypertensives, BP goal should be achieved more rapidly- favours combination therapy and quicker dose adjustment.</li>
 <li>
 Fixed combination of two drugs can simplify treatment and favour adherence.1</li>
</ul>

<h2 style="text-align: center;">Greater BP lowering power than Valsartan/HCTZ</h2>

Irbesartan vs. valsartan combination therapy at week 82

Percent of Patients Normalised* with Combination Therapy at Week 82

<h2 style="text-align: center;">8/10 not on goal patients reach their BP target at stay at BP goal over 24 months3</h2>
<h6 style="text-align: center;">Long-term therapeutic response with irbesartan &amp; irbesartan/HCTC-based reimens3</h6>

<h2 style="text-align: center;">Role of Irbesartan in hypertensives with multiple risk factors (CVD, dyslipidemia, Obesity, Diabetes)</h2>
<h3 style="text-align: center;">In patients with severe hypertension</h3>
Irbesartan is rapidly effective and recommended as initial therapy in patients with severe hypertension1

BP Reduction with Irbesartan 300mg/25mg in Patients with Severe Hypertension at week&nbsp;7

RAPiHD Severe: Conclusions1
<ul>
 <li>
 Irbesartan/HCTC 300/25mg enables a greater proportion of subjects with severe hypertension to achieve the target BP of&lt;140/90 mmHg compared with irbesartan monotherapy</li>
 <li>
 Combination therapy achieves more rapid BP reducctions compared with monotherapy</li>
 <li>
 Combination therapy has a similar safety profile to monotherapy, with no increase in electroyte disturbances</li>
</ul>

<h2 style="text-align: center;">In patients with severe hypertension with CV risk factors &amp; Microlbuminuria</h2>
<h3 style="text-align: center;">BP Goal Achievement*&nbsp;at Week 18</h3>

<h2 style="text-align: center;">Irbesartan Significantly reduces the incidence &amp; delays progression to overt proteinuria2</h2>

<h2 style="text-align: center;">IDNT Study: Irbesartan Reduces the Progression of Diabetic Nephropathy3</h2>

<h2 style="text-align: center;">Irbesartan has the power to reduce CV disease progression in LVH patients</h2>
Irbesartan&nbsp;is more effective than amlodipine at regressing left ventricular hypertrophy (LVH).
<h3 style="text-align: center;">Irbesartan vs amlodipine change in LVMI4,5</h3>

<h3 style="text-align: center;">Meta-analysis of randomized, controlled trials of LV Hypertrophy regression in essential hypertension6</h3>

<h2 style="text-align: center;">SILVHIA: Irbesartan provides greater regression of left ventricular Hypertrophy (LVH) than Atenolol7</h2>
<h3 style="text-align: center;">Left ventricular mass index (LVMI) reduction</h3>

Irbesartan

HYPERTENSION

<ul>
 <li>A host of awareness programs targeting children to be held in the French Pavilion, from 4 to 7 March</li>
 <li>An event full of entertainment to be held in conjunction with the 100th anniversary of insulin's discovery</li>
 <li>Since its launch in 2016, KiDS program trained 57,284 students in 183 schools, 4,117 teachers, 3,045 parents and 188 school nurses across the country</li>
</ul>

The Ministry of Health and Prevention (MohAP) will organize at the French Pavilion, Expo 2020 Dubai several activities and events as part of the Kids and Diabetes in Schools (KiDS) program, in cooperation with the Ministry of Education and Sanofi, an innovative global healthcare company.
Running from 4-7 March, the activities are coinciding with the 100th anniversary of insulin discovery, the medicine which made a huge difference in the daily living of patients.
Since its launch in 2016, the KiDS program has covered 183 schools with 57,284 students and has trained 4,117 teachers, 3,045 parents and 188 school nurses across the UAE, in addition to handing out 60,000 booklets to children, schools and families.

<h2>Fostering preventive patterns&nbsp;&amp; behaviors</h2>
"Organizing such activities of the KiDS program is part of the ministry' awareness initiatives aimed at fostering preventive behaviors among children, upbringing healthy generations and securing their psychological and physical safety and improving healthcare standards as per the best international practices," said HE Dr. Hussain Abdul Rahman Al Rand, Assistant Undersecretary for the Public Health Sector at the Ministry of Health and Prevention.
"We are glad to organize the KiDS program with students. The program highlights the importance of creating a positive environment helping children with diabetes manage their condition using the best and most effective protocols," added Al Rand.
He stated that organizing the activities at such a global event, Expo 2020 Dubai, would help expand the positive impact of the program on children and society, as well as stimulate international dialogue for better progress and cooperation in the global fight against diabetes.

<h2>Top priority</h2>
Al Rand underscored that the ministry pays top priority to the planning and implementation of diabetes-related health awareness paths, especially for students, in coordination with health and educational bodies, highlighting the importance of cooperation with the International Diabetes Federation and Sanofi carry out the KiDS program, which is part of the ministry's strategy to establish a sustainable health environment according to locally and internationally effective partnerships and programs.
Kids and Diabetes in Schools (KiDS) was launched in 2013 by the International Diabetes Federation (IDF), the International Society for Pediatric and Adolescent Diabetes (ISPAD), and Sanofi
In 2016, the UAE has adopted the KiDS program to prevent diabetes type 2, address the symptoms of diabetes type 1, and spread healthy habits among students across the country.

<h2>Healthy future for Children</h2>
"We are pleased to continue this collaboration with the IDF and ISPAD during the years of implementing the KiDS project on a global scale," said Niven Al-Khoury, General Manager General Medicines at Sanofi KSA and Gulf Countries. "On the local level, working with the UAE's Ministries of Health and Education to implement the program across the UAE demonstrates our firm commitment to implementing our vision for a healthy future for all children in the country.
The activities include an entertaining game, with the official "Tanton" character for the KiDS program, which welcomes children and helps them throughout the journey. Also, giant screens are also available displaying interesting information about diabetes, including ways of prevention and living with it. Once visitors to the booth complete all the necessary stickers and seals, they will be rewarded bags containing a sketch booklet on diabetes prevention, and eco-friendly notebooks "made of recycled paper".

<h2>See this article in media</h2>
<ul>
 <li><a href="https://protect-de.mimecast.com/s/p3xNCQkoEgs6Y4yYytxJHF4?domain=bodhi-production-assets.s3.amazonaws.com)" target="_blank">Dubai 93 FM Radio</a></li>
 <li><a href="https://www.youtube.com/watch?v=XZ1g7AwJJZM)" target="_blank">Al Ain TV</a></li>
 <li><a href="https://www.youtube.com/watch?v=589-nFf-UHs" target="_blank">Video</a></li>
</ul>
Online:
<ul>
 <li><a href="https://www.albayan.ae/expo/news/2022-03-04-1.4383899" target="_blank">Al Bayan Newspaper</a></li>
 <li><a href="https://wam.ae/ar/details/1395303026753" target="_blank">Emirates News Agency (WAM)</a></li>
 <li><a href="https://www.zawya.com/en/press-release/events-and-conferences/ministry-of-health-organizes-kids-program-at-expo-2020-dubai-to-promote-diabetes-awareness-at-schools-mh6flggp" target="_blank">Zawya - English</a></li>
 <li><a href="https://al-ain.com/article/expo-2020-dubai-kids-diabetes" target="_blank">Al Ain TV online</a></li>
 <li><a href="https://nabd.com/s/101035634-40d2b3/%D8%A5%D9%83%D8%B3%D8%A8%D9%88-2020-%D8%AF%D8%A8%D9%8A..-%D9%83%D9%8A%D8%AF%D8%B2-%D9%8A%D8%B9%D8%B2%D8%B2-%D9%88%D8%B9%D9%8A-%D8%B7%D9%84%D8%A7%D8%A8-%D8%A7%D9%84%D9%85%D8%AF%D8%A7%D8%B1%D8%B3-%D8%A8%D9%85%D8%B1%D8%B6-%D8%A7%D9%84%D8%B3%D9%83%D8%B1%D9%8A" target="_blank">NABD</a></li>
 <li><a href="https://alwatan.ae/?p=932642" target="_blank">Al Watan Newspaper</a></li>
</ul>

Ministry of Health organizes "KiDS" program at Expo 2020 Dubai to promote diabetes awareness at schools

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OUT-OF-TAXONOMY

<ul>
 <li>Agreement aims to provide more advanced and effective treatments and revitalised research and development (R&amp;D) in the field of diabetes in Saudi Arabia</li>
 <li>Strategic deal covers the rollout of training courses and workshops for medical doctors and diabetes educators with specific criteria and performance indicators</li>
</ul>

The Saudi Health Council, represented by the National Diabetes Centre, signed a memorandum of understanding (MoU) with Sanofi, to collaborate on various initiatives in research and development in the field of diabetes in the kingdom.
In the presence of Dr Nahar bin Mazki Al-Azmi, Secretary-General of the Saudi Health Council, and Dr Moatazbellah bin Muhammad Alruwaithi, Assistant Secretary-General, Dr Suleiman bin Nasser Alshehri, Director General of Saudi Diabetes Centre, Tarja Stenvall, Senior Vice President, General Medicines Key Markets, Sanofi and Niven Al- Khoury, General Manager General Medicines KSA &amp; Gulf MCO at Sanofi, the event has been held at the headquarters of the General Secretariat of the Council.
“This collaboration will serve as a great impetus in offering efficient healthcare initiatives to develop the ecosystem of diabetes management in the country. Sanofi and SHC will collaborate in building the nucleus of scientific research and generating disease local data supported by establishing a comprehensive diabetes research network. In addition, the agreement includes launching a digital tool that aim to improve the efficiency of diabetes management among people living with diabetes in the country. This MoU will include collaboration in the development and implementation of tailored training courses and workshops for physicians and diabetes educators with specific criteria and performance indicators.” Dr. Al-Shehri said.
Dr. Al-Shehri acknowledges Sanofi’s effort in supporting scientific research, enhancing disease management capabilities, and patients awareness programs. He also conveyed his desire for continued effective and successful cooperation in the future between the two entities, in order to further improve the country’s healthcare sector.
Meanwhile, Tarja Stenvall, Senior Vice President, General Medicines Key Markets, Sanofi, welcomed the collaboration and highlighted its substantial role in facilitating comprehensive, high-quality healthcare to people living with diabetes.
“Drawing on our unrivalled experience in the fight against diabetes, we are implementing a series of strategic projects in the healthcare sector of Saudi Arabia. We’re grateful to the Saudi Health Council for its sustained efforts in coordination with various authorities to prevent and control diabetes as part of its commitment to bolster the country’s public health.” Tarja Stenvall, said

<h2>Read this article in media</h2>
<a href="https://www.arabianbusiness.com/abnews/saudi-health-council-sanofi-partner-to-boost-diabetes-studies-and-research" target="_blank">Arab Business</a>
<a href="https://www.zawya.com/mena/en/press-releases/story/Saudi_Health_Council_Sanofi_partner_to_boost_diabetes_studies_and_research_in_the_kingdom-ZAWYA20220118133557/" target="_blank">Zawaya</a>
<a href="https://saudigazette.com.sa/article/616014" target="_blank">Saudi Gazette</a>
<a href="https://worldakkam.com/shc-sanofi-partners-support-diabetes-research-and-kingdom-research/657032/" target="_blank">World Akkam</a>
<a href="https://sawahpress.com/en/business/shc-sanofi-partner-to-boost-diabetes-studies-and-research-in-kingdom/" target="_blank">Sawah Press</a>

Saudi Health Council, Sanofi partner to boost diabetes studies and research in the kingdom

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