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Exhibit B-Global AIIA iDetailer CARD

Published by pankaj.kumar, 2017-06-15 05:28:10

Description: Exhibit B-Global AIIA iDetailer CARD

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Information Patient ProfilePrescribing Information Indications and Select Safety Information

CozAAR™ (losartan)COZAAR™ Efficacy Studies SummaryFor patients with mild-to-moderate hypertension1COZAAR: Power Over 24 HoursIn a 6-week clinical trial vs valsartan,Mean hourly ambulatory blood pressure monitoring (ABPM) reduction at 6 weeks1 160 BP REDUCTION Systolic HOUR 150 140 130ABPM, mmHg 120 COZAAR 50 mg once daily (n=93) t C onsistent diastolic BP reduction throughout the full Valsartan 80 mg once daily (n=94) 24-hour ABPM period (primary end point)1 110 t Similar antihypertensive effects between losartan and 100 Diastolic valsartan therapies1 90 Study Design 80 70 13 14 15 16 17 18 19 20 21 22 23 1 2 3 4 5 6 7 8 9 10 0 10 11 Noon Midnight Time of day, hour Adapted from Monterroso et al,1 P=NS. with kind permission from Springer Science and Business Media. Prescribing Information Indications and Select Safety Information

CozAAR™ (losartan)Study DesignMonterroso et al.A 6-week, multicenter, double-blind, parallel-design trial in 187 patients with mild-to-moderate essential hypertension(SiDBP 95–115 mmHg). Patients received losartan 50 mg or valsartan 80 mg once daily. The primary end point was the changefrom baseline in 24-hour mean diastolic ABPM after 6 weeks of therapy.1Prescribing Information Indications and Select Safety Information

CozAAR™ (losartan)COZAAR Efficacy Studies SummaryCOZAAR: a leader in ARB clinical trial dataExperience power proven in 4 landmark studies2-5 LIFE: reduction in the risk of CV morbidity in hypertensive patients with LVH (n=9193)2,6,a,b HEAAL: reduction in the risk of mortality and hospitalization due to heart failure in patients with a history of NYHA Class II–IV heart failure who are intolerant of ACE inhibitors (n=3834)3,6 RENAAL: renal protection in type 2 diabetic patients with proteinuria (n=1513)4,6 ELITE II: reduction in the risk of overall mortality in patients with a history of NYHA Class II–IV heart failure, comparable to that of captopril (n=3152)5,6,a Study DesignaPatients showed similar reductions in BP in both groups.bT he benefits of COZAAR on CV morbidity and mortality do not apply to black patients with hypertension and LVH.2,6 Prescribing Information Indications and Select Safety Information

CozAAR™ (losartan)Study DesignsLosartan Intervention For Endpoint reduction in hypertension (LIFE): A double-blind, randomized, parallel-group study in 9193patients aged 55–80 years with essential hypertension and electrocardiogram-documented LVH receiving losartan- or atenolol-basedtherapy for at least 4 years (mean, 4.8 years) and until ≥1040 patients experienced a first primary event (CV death, stroke, or MI). Theprimary end point was to evaluate the long-term effects of losartan- or atenolol-based therapy on the combined incidence of CV morbidityand mortality (defined as a composite of CV death, stroke, and MI). Patients received either losartan 50 mg or atenolol 50 mg. After 2months, HCTZ 12.5 mg was added to reach goal BP ≤140/90 mmHg, then after 4 months, patients were titrated up to losartan 100 mgplus HCTZ 12.5 mg or atenolol 100 mg plus HCTZ 12.5 mg as needed to reach goal BP ≤140/90 mmHg. At month 6, additional open-label antihypertensive medication, including upward titration of HCTZ, but excluding ACE inhibitors, angiotensin II receptor blockers, orbeta blockers, was added to reach goal BP. Further titration with other open-label therapy was mandatory if BP was ≥160/95 mmHg.2Heart failure Endpoint evaluation of the Angiotensin II Antagonist Losartan (HEAAL): An international, double-blind, randomized,multicenter, event-driven trial comparing the effect of 2 doses of losartan, 150 mg daily and 50 mg daily, in 3834 patients (analyzed) withsymptomatic heart failure (New York Heart Association Class II–IV); LVEF ≤40%, with stable CV medical therapy for at least 2 weeks; andknown intolerance to ACE inhibitors. The primary end point was a composite of death or admission for heart failure. Admission for heartfailure was defined as a minimum of 24-hour, in-patient admission to—or overnight stay at—any health care facility, with the primarycause being treatment of worsening heart failure and during which an additional diuretic drug, intravenous or oral nitrate, or intravenousinotropic agent, was given.3Evaluation of Losartan in the Elderly II (ELITE II): A randomized, double-blind, controlled trial comparing the effects of losartan vscaptopril on morbidity and mortality in 3152 patients with New York Heart Association Class II–IV heart failure and ejection fraction ≤40%.Patients were randomly assigned losartan 12.5 mg titrated to 50 mg once daily or captopril 12.5 mg titrated to 50 mg 3 times daily. Theprimary end point was all-cause mortality.5Reduction of Endpoints in NIDDM with the Angiotensin II Antagonist Losartan (RENAAL): A double-blind, placebo-controlled,multinational, randomized study in 1513 patients with type 2 diabetes and nephropathy to evaluate the renal protective effect oflosartan for a mean follow-up of 3.4 years. Patients were randomized to receive either losartan 50 mg or placebo once daily, along withconventional antihypertensive therapy (excluding other angiotensin II receptor blockers and ACE inhibitors). After week 4, the dose oflosartan was increased to 100 mg once daily if the sitting trough blood pressures were ≥140/90 mmHg. After an additional 8 weeks,antihypertensive agents (diuretics, calcium channel blockers, alpha- or beta blockers, and centrally acting agents excluding angiotensin IIreceptor blockers and ACE inhibitors) were added or their doses increased to achieve goal BP. The primary end point was a composite ofdoubling of baseline serum creatinine, ESRD (defined by the need for long-term dialysis or renal transplantation), or death.4 Prescribing Information Indications and Select Safety Information

COzaar™ and HYzAAR™ (losartan + HCTZ50/12.5)COZAAR/HYZAAR Efficacy Joint Study SummaryFor patients with hypertension and LVH2COZAAR/HYZAAR: Power to reduce the risk ofcardiovascular morbidity and mortalitya CV death, MI, or stroke In the LIFE study, 16 Proportion of patients with rst event, % Based on COZAAR/HYZAAR 13% t C OZAAR/HYZAAR reduced the primary composite 508 events (n=4,605) end point of CV death, MI, and stroke by 13% vs atenolol, 14 risk reduction vs atenolol with similar BP reductions (P=0.021)2 Atenolol-based regimen (P=0.021) 12 588 events (n=4,588) t S ignificantly greater stroke risk reduction by 25% Adapted from Dahlöf et al,1 vs atenolol (P=0.0010)2 10 Adjusted risk reduction: 13.0%, P=0.021. with permission from Elsevier. 8 Unadjusted risk reduction: 14.6%, P=0.009. t No significant difference in CV death or MI was seen vs atenolol2 6 6 12 18 24 30 36 42 48 54 60 66 Time, months 4 4,524 4,460 4,392 4,312 4,047 3,897 1,889 901 4,494 4,414 4,349 4,289 4,247 4,189 4,112 3,992 3,821 1,854 876 2 4,205 4,135 4,066 0 0Number at riskCOZAAR 4,605Atenolol 4,588 Study DesignaCV morbidity and mortality were defined as a composite of CV death, MI, and stroke.2 Prescribing Information Indications and Select Safety Information

CozAAR™ (losartan)Study DesignDahlöf et al.A double-blind, randomized, parallel-group study in 9193 patients aged 55–80 years with essential hypertensionand electrocardiogram-documented LVH receiving losartan- or atenolol-based therapy for at least 4 years (mean, 4.8 years) anduntil ≥1,040 patients experienced a first primary event (CV death, stroke, or MI). The primary end point was to evaluate thelong-term effects of losartan- or atenolol-based therapy on the combined incidence of CV morbidity and mortality (defined as acomposite of CV death, stroke, and MI). Patients received either losartan 50 mg or atenolol 50 mg. After 2 months, HCTZ 12.5 mgwas added to reach goal BP ≤140/90 mmHg, then after 4 months, patients were titrated up to losartan 100 mg plus HCTZ 12.5 mgor atenolol 100 mg plus HCTZ 12.5 mg as needed to reach goal BP ≤140/90 mmHg. At month 6, additional open-labelantihypertensive medication, including upward titration of HCTZ, but excluding ACE inhibitors, angiotensin II receptor blockers, orbeta blockers, was added to reach goal BP. Further titration with other open-label therapy was mandatory if BP was ≥160/95 mmHg.2Prescribing Information Indications and Select Safety Information

HYzAAR™ (losartan + HCTZ50/12.5)HYZAAR Efficacy Joint Study SummaryHYZAAR: Powerful combination forthe hypertension treatment.7,8The JOINT study: scientific evidence of efficacy of HYZAAR.7 Better BP reduction with HYZAAR HYZAAR improves BP in uncontrolled* patients t S witching uncontrolled patients to HYZAAR, who were treated Better BP reductions Better BP reductions Better BP reductions for patients on ARB for patients on CCB for patients on ARB+CCB with ARBs, CCBs in monotherapy or in combination, showed better BP reduction7–160 –160 –160 t Hyzaar better BP reductions than ARB7 t Hyzaar better BP reductions than CCB7–140 145 –140 147 –140 140 t Hyzaar better BP reductions than ARB+CCB7–120 –120 –120–100 134 –100 134 –100 131 Study DesignmmHg mmHg mmHg–80 80 –80 80 –80 82 88 87 87–60 –60 –60–40 Baseline 6 Months –40 6 Months –40 Baseline 6 Months Baseline ARB→ CCB→ →ARB + CCB Losartan/HCTZ Losartan/HCTZ Losartan/HCTZ p=< 0.001 by ANOVA SBP DBP* uncontrolled = outpatients whose BP was more than 130/80 mm Hg despite antihypertensive agents being prescribed for more than 3 months prior to study entry. Prescribing Information Indications and Select Safety Information

HYzAAR™ (losartan + HCTZ50/12.5)Study DesignJoint StudyThe JOINT (Jekei Optimal Antihypertensive Treatment) study was a a multicenter, prospective, observational, self-controlled studyin 228 Japanese outpatients whose blood pressure had been treated previously with one or more antihypertensive for more than3 months without achieving BP goal (130/80 mmHg). This study was conducted at 28 centers and clinics of Tokyo, Japan.7Eligible patients were men and women between 20 and 75 years of age with essential hypertension and those with CKDwith hypertension. All the patients in the study were given one tablet of losartan 50mg/hydrochlorothiazide12.5 mg (LOS / HCTZ) once daily in the morning.7If the patient was treated with an ARB or a CCB alone or in combination, the combination LOS / HCTZ was substituted for eitherdrug or the combination. If the patient was being treated with 3 drugs including an inhibitor of the renin angiotensin system (RAS),the RAS inhibitor was changed to LOS / HCTZ.7The primary end point was the change in clinical SBP and DBP after 6 months of treatment.7Prescribing Information Indications and Select Safety Information

CozAAR XQ™ (amlodipine camsylate + losartan potassium)COZAAR XQ Information MOA Efficacy Indications & Dosage SummaryMore than two-thirds of hypertensive patients cannot becontrolled with one drug and will require two or moreagents from different drug classes9 t T he use of fixed-dose combinations may be more convenient and simplify the treatment regimen, and may cost less than the individual components prescribed separately9 Prescribing Information Indications and Select Safety Information

CozAAR XQ™ (amlodipine camsylate + losartan potassium)COZAAR XQ Information MOA Efficacy Indications & Dosage SummaryTwo proven mechanisms of action combined for powerful efficacy10,11ARBs and CCBs work together in twodifferent ways to improve BP reduction11 ARB CCB 1 O ne of the main functions of ARBs is to decrease the vasoconstrictive effects of angiotensin II, a major BLOCKS RAAS BLOCKS Ca2+ channel contributor to the pathophysiology of hypertension10 Increased arterialBlocks vasoconstriction vasodilation 2 CCBs increase arterial vasodilation by reducing Decreased Adapted peripheral vascular resistance10 from Oparil Help to improve patient adherence and persistence aldosterone secretion et al.11 with an ARB/CCB single-pill combination12,a-c Decreased Study Designcatecholamine release Complementary actions Powerful BP-lowering efficacyaCOZAAR XQ was not specifically studied.b Adherence and persistence of patients using single-pill combinations of ARBs and CCBs were compared with the adherence and persistence of patients using free-combination therapy with ARBs and CCBs. Adherence was measured by using Proportion of Days Covered (PDC) for ARB/CCB because it allowed researchers to pinpoint the dates when a patient did not have possession of both ARBs and CCBs. Full adherence was defined as PDC ≥0.8.12c Persistence was measured by days to discontinuation where discontinuation was defined as a 30-day or more gap in the ARB/CCB treatment.12 Prescribing Information Indications and Select Safety Information

CozAAR XQ™ (amlodipine camsylate + losartan potassium)Study DesignZeng et al.A 13-month, retrospective analysis of pharmacy claims data from a national pharmacy benefit management company in 4525patients newly initiating treatment with either valsartan/amlodipine or amlodipine/olmesartan medoxomil single-pill combinationtherapy or an ARB plus dihydropyridine CCB free-combination therapy. Patients included in the study were divided into 2 groups:patients starting with valsartan/amlodipine or amlodipine/olmesartan medoxomil; patients in theARB/CCB free-combination group. Data analysis included the outcome variables of adherence and persistence.12Prescribing Information Indications and Select Safety Information

CozAAR XQ™ (amlodipine camsylate + losartan potassium) 0 Mean baseline DBP: 101.5 Mean baseline DBP: 100.8 Mean baseline DBP: 101.9 Mean baseline DBP: 101.1 Mean baseline DBP: 100.8 Mean baseline DBP: 101.7 Losartan 50 mgCOZAAR XQ Information MOA Mean change, mmHg –5 Efficacy Am5lomdigpiInne dicati–o7ns & Dosage Am–5l1oSmd1ig.pu7inme maLr–1oy01s0a0rmt.a5gn COZAAR XQ –10 5/50 mg –11.7 P<0.0001a COZAAR XQ 5/100 mg –15.6In a controlled clinical trial, –16.1 P<0.0001a P<0.0001a P<0.0001a –15COZAAR XQ: more powerful than P<0.0001a P<0.0001a P=0.0390b P<0.0001b P=0.0143b P=0.0027bamlodipine or losartan alone10,13In an 8-week clinical trial vs amlodipine monotherapy and losartan monotherapy,Greater reductions in DBP with COZAAR XQ10,13 Greater reductions in SBP with COZAAR XQ10,13 Reductions in mean DBP after 8 weeks of therapy (n=197) (primary end point)10,13 Reductions in mean SBP after 8 weeks of therapy (n=197)10,13 0 Mean baseline DBP: 101.5 Mean baseline DBP: 100.8 Mean baseline DBP: 101.9 Mean baseline DBP: 101.1 Mean baseline DBP: 100.8 Mean baseline DBP: 101.7 0 Mean baseline SBP: 158.4 Mean baseline SBP: 151.1 Mean baseline SBP: 152.3 Mean baseline SBP: 154.2 Mean baseline SBP: 151.1 Mean baseline SBP: 157.8 Losartan Losartan 50 mg 50 mgMean change, mmHg Amlodipine Amlodipine Losartan –5 –7 –5 COZAAR XQ 5 mg –7 5 mg 100 mg –10 5/50 mg COZAAR XQ Mean change, mmHg Amlodipine P<0.0001a Amlodipine Losartan –11.7 P<0.0001a 5/100 mg –11.7 –10.5 5 mg 100 mg –15.6 –16.1 P<0.0001a P<0.0001a –10 5 mg –15.5 –16 –15.5 P<0.0001a P<0.0001a P<0.0001a –15 –15 COZAAR XQ 5/100 mg P<0.0001a P<0.0001a COZAAR XQ P<0.0001a P=0.0143b –24 P=0.0390b P=0.0027b –20 5/50 mg P<0.0001b –25.7 –25 P<0.0001a P=0.0092b P<0.0001a P=0.0229b P=0.0035b P<0.0001b Study DesignResponse ratesd achieved with COZAAR XQ vs monotherapies10,13(CnO=3Z8A)ARRXeQduc5t/i5on0smingmea8n6S.8B%P aftePr 8vwaelueeks COZAAR XQ 5/100 mg 86.8% P value aP value for treatment arm from baseline to 8 weeks.1 the(rna=py41(n)=197)10,13 bP value between COZAAR XQ and individual components.1 ofAmlodipine 5 mg (n=40)Mean baseline SBP: 158.4 77.5% P=0.3794b Amlodipine 5 mg (n=40) 77.5% P=0.0667Mean baseline SBP: 154.2 Mean baseline SBP: 151.1 b 0 Mean baseline SBP: 151.1 Mean baseline SBP: 152.3 Mean baseline SBP: 157.8Losartan 50 mg (n=38) Losartan Losartan 100 mg (n=40) 72.5% P=0.0201b –5 50% P=0.0500–1m71bgMean change, mmHgu rIne–1p0coorntetrdolpleedripclhineircaaAlm–le5l1todmrd5iieg.pa5imnlse ,al1essP<0t.0h00a1an 1% of patients takAinm–g5l1omd5Cig.p5inOe ZAALR1o–0s0a1Xrm6taQgn –15 COZAAR XQ COZAAR XQ P<0.0001a 5/100 mg P<0.0001a P<0.0001a –20 5/50 mg –24 Prescribing Information –25.7 P<0.0001a Indications and Select Safety Information –25 P<0.0001a bb

CozAAR XQ™ (amlodipine camsylate + losartan potassium)Study DesignPark et al.An 8-week, multicenter, randomized, double-blind trial in 320 patients with mild-to-moderate essential hypertension. Patientsreceived losartan (50 mg or 100 mg), amlodipine (5 mg or 10 mg), or COZAAR XQ (5/50 mg, 5/100 mg, 10/50 mg, or 10/100 mg),once daily. The primary end point was the mean change from baseline in sitting DBP after 8 weeks of therapy.10,13Prescribing Information Indications and Select Safety Information

CozAAR XQ™ (amlodipine camsylate + losartan potassium)COZAAR XQ™ Patient Profile Patient Losartan Patient Amlodipine Indications & Dosage SummaryRespond to the rising prevalence of blood pressure that is not adequately controlled withAdditional power for patients switchedto COZAAR XQ10,14Additional BP reductions with COZAAR XQ for patients not adequately controlled with losartan 100 mg for 4 weeks10,14 Additional mean reductions in DBP and SBP after 8 weeks of therapy (n=142) 10,14 Lucya DBP SBP t N ot adequately controlled with losartan Mean baseline DBP: 97.5 Mean baseline DBP: 96.6 Mean baseline SBP: 141.9 Mean baseline SBP: 141.1 100 mg alone 0 t E ssential hypertension; BP: 142/97 mmHgMean change, mmHg –3 Stayed on Stayed on losartan 100 mg losartan 100 mg t 5 0 years old –6 Switched to Switched to t B ody mass index: –9 monotherapy monotherapy COZAAR XQ COZAAR XQ 26 kg/m2 –3.2 –3.4 5/100 mg 5/100 mg Study Design –11.7 –13.4 –12 P<0.0001 P<0.0001aHypothetical patient. Prescribing Information Indications and Select Safety Information

CozAAR XQ™ (amlodipine camsylate + losartan potassium)Study DesignHong et al.An 8-week, multicenter, randomized, double-blind study of 142 patients with essential hypertension not adequately controlled onlosartan 100 mg monotherapy for 4 weeks. Patients were randomized to receive either COZAAR XQ 5/100 mg or losartan 100 mgmonotherapy once daily. The primary end point was the mean change from baseline in sitting DBP after 8 weeks of therapy.14Prescribing Information Indications and Select Safety Information

CozAAR XQ™ (amlodipine camsylate + losartan potassium)COZAAR XQ™ Patient Profile Patient Losartan Patient Amlodipine Indications & Dosage SummaryIn patients inadequately controlled with amlodipine 5 mg,Additional BP reductions with the startingdose of COZAAR XQ 5/50 mg10,15COZAAR XQ 5/50 mg achieved additional BP reductions comparable to amlodipine 10 mg10,15 Additional mean reductions in DBP and SBP after 8 weeks of therapy (n=184)10,15,a DONb DBP SBP t Not adequately controlled with Mean baseline DBP: 96.8 Mean baseline DBP: 97.2 Mean baseline SBP: 143.3 Mean baseline SBP: 145.2 amlodipine 5 mg 0 t BP: 144/97 mmHg t 54 years oldMean change, mmHg Switched to Titrated to t Weight: 72 kg –3 COZAAR XQ 5/50 mg amlodipine 10 mg Switched to –6 –8.9 monotherapy COZAAR XQ Titrated to amlodipine 10 mg –9.4 5/50 mg monotherapy –9 –12.2 –13.4 P=NS –12 P=NS Study DesignaP atients who did not reach a DBP <90 mmHg after an initial 4 weeks of treatment with amlodipine 5 mg received 8 weeks of further treatment with either COZAAR XQ 5/50 mg or amlodipine 10 mg.10,15bHypothetical patient. Prescribing Information Indications and Select Safety Information

CozAAR XQ™ (amlodipine camsylate + losartan potassium)Study DesignKang et al.An 8-week, multicenter, randomized, double-blind study of 142 patients with essential hypertension not adequately controlledon losartan 100 mg monotherapy. Patients were randomized to receive either COZAAR XQ 5/100 mg or losartan 100 mgmonotherapy once daily. The primary end point was the mean change from baseline in sitting DBP after 8 weeks of therapy.15Prescribing Information Indications and Select Safety Information

CozAAR XQ™ (amlodipine camsylate + losartan potassium)COZAAR XQ™ Information Patient Profile Indications & Dosage SummaryRespond to the rising prevalence of uncontrolled hypertension with16COZAAR XQ: the world’s leading ARB anda CCB in one powerful antihypertensive10,17Losartan, the world’s leading ARB:17 Indications:10t M ore than 15 years of BP-lowering experience18 t F or the treatment of essential hypertension t In patients where blood pressure is not adequatelyt Included in more than 900 clinical publications19,a controlled with either amlodipine or losartan monotherapyt O ver 120 million prescriptions worldwide since 199518,bAmlodipine, a CCB:20 Once-daily dosing in 2 convenient doses10t T he administration of amlodipine camsylate as a single 5/50 mg 5-mg dose was shown to be bioequivalent to amlodipine besylate 5 mg in a randomized, single-blind, crossover, comparative study in 18 healthy subjects10t C ontains the same active substance (amlodipine) as 5/100 mg amlodipine besylate, the world’s leading ARB and a medication available for nearly 20 years, but formed with a different salt (camsylate)10,20aBased on the results of a PubMed search of the word “losartan” and limited to “Clinical Trial Articles”; performed on July 13, 2011. Search results may capture publications that include losartan in combination with other classes ofmedications.19bBased on IMS Health, NPA™ Monthly TRxs, May 1995–August 2011.17 Prescribing Information Indications and Select Safety Information

SUMMARYSummaryDifferent Patients. Different Needs.Discover which agent might be right for the appropriate patientt R enal protection in type 2 diabetics with proteinuriat Treatment for hypertensiont Heart failure when treatment with an ACE inhibitor is no longer appropriatet Reduction of CV morbidity and mortality in hypertensive patients with LVHat H ypertension t Essential hypertensiont H TN where combination therapy is appropriate t B lood pressure not adequately controlled on amlodipinet R eduction in risk of CV morbidity and mortality in hypertensive patients with LVHa t B lood pressure not adequately controlled on losartant F or HTN when initial treatment with losartan or HCTZ alone is inadequate to control BPt Initial treatment of severe hypertension (SiDBP ≥110 mmHg).aT he benefits of COZAAR on CV morbidity and mortality do not apply to black patients with hypertension and LVH.6 Indications and Select Safety Information Prescribing Information

ABBREVIATIONS Indications and Select Safety InformationAbbreviationsABPM = ambulatory blood pressure monitoringACE = angiotensin-converting enzymeARB = angiotensin II receptor blockerBP = blood pressureCa = calciumCCB = calcium channel blockerCV = cardiovascularDBP = diastolic blood pressureELITE II = Evaluation of Losartan in the Elderly II (ELITE II)ESRD = end-stage renal diseaseHCTZ = hydrochlorothiazideHEAAL = H eart failure Endpoint evaluation of the Angiotensin II Antagonist LosartanHTN = hypertensionLIFE = Losartan Intervention For Endpoint reduction in hypertensionLVEF = left-ventricular ejection fractionLVH = left ventricular hypertrophyMI = myocardial infarctionNYHA = New York Heart AssociationRAAS = renin-angiotensin-aldosterone systemRENAAL = R eduction of Endpoints in NIDDM with the Angiotensin II Antagonist LosartanSBP = systolic blood pressureSiDBP = sitting diastolic blood pressure Prescribing Information

selected safety informationSelected Safety InformationSelected Safety InformationNote to countries: Please insert the local SSI here.Approved Selected Safety Information can be found on the following URL:http://editorial.merck.comCountries are responsible for ensuring that the Selected Safety Information (or alternatively abridged SmPC) included inpromotional materials is consistent with the Worldwide Review Guidelines, the appropriate product circular, and local laws,regulations, and customs. In those instances where this guidance runs contrary to local laws, regulations, or customs, the localrules take precedence.WPC/EUSPC SSI should be used as the template for the creation of the local SSI. It is the local country’s responsibility toensure that the most current local product circular is used in the development of local SSI.Prescribing Information Indications and Select Safety Information

RefErencesReferences1. M onterroso VH, Rodriguez Chavez V, Carbajal ET, et al. Use of ambulatory blood pressure monitoring to compare antihypertensive efficacy and safety of two angiotensin II receptor antagonists, losartan and valsartan. Adv Ther. 2000;17(2):117–131.2. D ahlöf B, Devereux RB, Kjeldsen SE, et al. Cardiovascular morbidity and mortality in the Losartan Intervention For Endpoint reduction in hypertension study (LIFE): a randomised trial against atenolol. Lancet. 2002;359(9311):995–1003.3. K onstam MA, Neaton JD, Dickstein K, et al. Effects of high-dose versus low-dose losartan on clinical outcomes in patients with heart failure (HEAAL study): a randomised, double-blind trial. Lancet. 2009;374(9704):1840–1848.4. Brenner BM, Cooper ME, de Zeeuw D, et al. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med. 2001;345:861–869.5. P itt B, Poole-Wilson PA, Segal R, et al. Effect of losartan compared with captopril on mortality in patients with symptomatic heart failure: randomised trial—the Losartan Heart Failure Survival Study ELITE II. Lancet. 2000;355(9215):1582–1587.6. COZAARTM (losartan) WPC-MK0954-T-112012.7. H osoya T, Kuriyama S, Ohno I, et al. Antihypertensive effect of a fixed-dose combination of losartan / hydrochlorothiazide in patients with uncontrolled hypertension: a multicenter study. Clin Exp Nephrol. doi 10.1007/s10157-011-0564-4.8. HYZAARTM (losartan + HCTZ) WPC-MK0954A-T-112012.9. T he Seventh Report of the Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure. National High Blood Pressure Education Program. http:// www.nhlbi.nih.gov/guidelines/hypertension/. Accessed March 11th, 2013.10. COZAAR XQTM (amlodipine camsylate + losartan potassium) WPC-MK0954F-T-112012.11. Oparil S, Weber M. Angiotensin receptor blocker and dihydropyridine calcium channel blocker combinations: an emerging strategy in hypertension therapy. Postgrad Med. 2009;121(2):25–39.12. Z eng F, Patel BV, Andrews L, et al. Adherence and persistence of single-pill ARB/CCB combination therapy compared to multiple-pill ARB/CCB regimens. Curr Med Res Opin. 2010;26(12):2877–2887.13. P ark CG, Youn HJ, Chae SCl, Yang JY, Kim MH, Hong TJ, et al. Evaluation of the Dose-Response Relationship of Amlodipine and Losartan Combination in Patients with Essential Hypertension: An 8-Week, Randomized, Double-Blind, Factorial, Phase II, Multicenter Study. Am J Cardiovasc Drugs, 2012;12(1):35-47.14. H ong B-K, Park CG, Kim, KS, et al. Comparison of the Efficacy and Safety of Fixed-Dose Amlodipine/Losartan and Losartan in Hypertensive Patients Inadequately Controlled with Losartan: A Randomized, Double-Blind, Multicenter Study. doi:10.2165/115975410.000000000.00000 1175-3277/12/0000-0000.15. K ang S-M, Youn J-C, Chae SC, et al. Comparative efficacy and safety profile of amlodipine 5 mg/losartan 50 mg fixed-dose combination and amlodipine 10 mg monotherapy in hypertensive patients who respond poorly to amlodipine 5 mg monotherapy: an 8-week, multicenter, randomized, double-blind phase III noninferiority study. Clin Ther. 2011;33(12):1953– 1963.16. Raised blood pressure. Global Health Observatory (GHO). World Health Organization Web site. http://www.who.int/gho/ncd/risk_factors/blood_pressure_prevalence_text/en/. Accessed May 16, 2013.17. Data on file, MSD.18. COZAAR. Drugs FDA Web site. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseac. Accessed May 2, 2011.19. Losartan. PubMed Web site. http://www.ncbi.nlm.nih.gov/pubmed. Accessed May 13, 2013.20. NORVASC. Drugs FDA Web site. http://www.accessdata.fda.gov/scripts/cder/drugsatfda/index.cfm?fuseac. Accessed May 2, 2013.Prescribing Information Indications and Select Safety Information

PRESCRIBING informationPrescribing InformationPrescribing InformationNote to countries: Please insert the local Prescribing Information here.Countries are responsible for ensuring that the Prescribing Information included in promotional materials is consistent with theWorldwide Review Guidelines, the appropriate product circular, and local laws, regulations, and customs. In those instanceswhere this guidance runs contrary to local laws, regulations, or customs, the local rules take precedence.Prescribing Information Indications and Select Safety Information

Please consult the Prescribing Information before prescribing.Copyright © 2013 MSD International GmbH. All rights reserved.CARD-1073100-0000 06/13Prescribing Information Indications and Select Safety Information


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