W            0    I


     COREG CR has no adverse effects
     on HbA1c or total cholesterol
            Uncontrolleit Hypertens...
eft t

COREG CR has                                                                110
on triglycerides or weiig t

Low incidence of beta-blocker adverse
events that concern physicians

                     r e beta bloc e olerabirty co c...
G C provided i               ifi ant peak
                                           essure (BP) reducti ns1 ,3
According to the American Association of Clinical Endocrinolo ists

Comprehensive vasodilating SNS blockade

f3- ockade wit I p oved B 0                       Row

Selective Beta-1 Bl'ockade...

      Cardioprotective                                                                                    5
...Across the
cardiovascular continuum

    CR                                                                           e


Important Safety Information

Patients taking COREG CR or Coreg®            Worsening HF or fluid retention may occur
C · A once-a-day
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Dtp Coreg Cr Sales Aid


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Dtp Coreg Cr Sales Aid

  1. 1. AD W 0 I C CCl~rEG TI' CI ic da demon.r-+........+....-~ C~REG C controls hy e ensio (carvedHol phosphate) without affecting metabo ic arame e -. Extended-release Capsules I patie is with type II diabetes. ower pressure withou losing control Peas see Impo Safety nfonnation on ge 1
  2. 2. ONCE-A-DAY COREG CR has no adverse effects on HbA1c or total cholesterol Uncontrolleit Hypertension ~ 46 years old ~ One or more of the following comorbid conditions: ~CAD ~ Type 2 Diabetes ~ Dyslipidemia ~@D.COREG CR 20 mg OD In GEMINI*, patients taking Coreg® (carvedilol): p- 0.6~ 10 0.001 p~ I ~ .... 7.2 7.2 185.6 8 'quot; 186 .s ':l< e 185 ~ 6 (J (l) <quot; 184 iii Ql .0 quot;0 :I: 183 4 181.7 J:: c: U III 182 II> E :E ... :I 181 2 C1i. m ... 180 iii 0 {2 179 MONTH 5 t BASELINE 01 MONTH 51 BASELINE N=433 HbAl c did not c:hanl.1i'quot; IrlJrn baseline (mean [:80] cnangt:!: U.U2 iJ !±O.l)4%); 95% el, -0.00 b to O.10uhJ; P=O.65}. Metoprolol tartrate demonstrated Metoprolol tartrate demonstrated II>- no effect on total cholesterol (P=0.5)1.2 significant increase in HbA 1c (change from baseline 0.15%; P<0.001)1 The effects of carvedilol and metoprolol tartrate on clinical outcomes have not been compared in long-term clinical trials in patients with hypertension and type 2 diabetes. In the GEMINI study, metoprolol succinate-which is the generic name of Toprol-Xl' (a registered trademark of the AstraZeneca group of companies) extended-release tablets-was not studied. Please see Important Safety Information on page 11. 2:
  3. 3. eft t COREG CR has 110 on triglycerides or weiig t In GEMINI, patients taking COREGquot; No Change in Weight 1.2 p= 0.36 I I 98.2 I P=0?8 :J 21'1] 97.2 Ci 100 I ~ 200 ~ ... 95 I Cl 190 .s .c: 90 168.3 Cl 180 'iii 85 'quot; 159.4 ~ <II 170 ,., quot;0 80 '': 160 quot;0 ,., <II 75 0 0 150 cc 70 0> c 1~0 ro ~ 65 130 <II c :E 60 120 ro <II ~tJ 110 :E SC 100 ~ 01 BASELINE MONTH 5 f MONTH 51 BASELINE Wclgh1 did not a nge from baseline (mean Change: 0,' kg: P-O.J6). ... Metoprolol tartrate demonstrated ... Metoprolol tartrate demonstrated significant elevation in triglycerides significant weight gain from baseline (change from baseline 13.2%; (change from baseline 1.2 kg; P<O.0001)1.2 P<O.0001)1.2 COREG CR is indicated for the management of essential hypertension. COREG CR can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. 'A randol].iled. double-blind, parallel-group trial (The Glycemic Effects in Diabetes Mellitus: Carvedilol-Metoprolol Companson in Hypertensives IGEMINIJ) compared the effects of carvedllol and metoprolol tartrate on glycemiC control. The 1235 participants (COREG n=498, 'Iletoprolol tartrate n=737) were aged 36 to 85 years with hypertension (> 130/80 mmNg) and type 2 diabetes mellitus (glycosylaled hemoglobin [HbAlcI, 6.5%-8.5%) and were receiving renin-angiotensin system (RAS) blockers. Patients were followed for up to 35 weeks. COR phosphate) 'Month 5 represents the maintenance penod after randomization, References: 1.8akns Gl. Fonseca V. Kalholi RE, GL ,lor loo Gfl'I'I~II~veslll;l ors. Mel<UJooliC errc<:ls 01 carvedllol vs et II ol(J' in patients with type 2 dlirlJ tes me Illrs 3JId 11'pSl1e'lsJ~n; a r I du:nizcd (carvedilol conlrOI.)C! tf,al .lAMA 200~;2922227-2236. 2. Data 011 file (/55), (ii 61. arn (1158), GiaxoSmlthKlire. Extended-release Capsules I o,wer pressure wi hou losing control
  4. 4. Low incidence of beta-blocker adverse events that concern physicians r e beta bloc e olerabirty co ce ns: atigue, erecti e io ',a d dquot;zzi as quot;' Incidence With COR EO CR in Hypertensiont1 ADVERSE EVENT PLACEBO CORE CR (N=84) 4% FATIGUE 0% ERECTILE DYSFUNCTION 1% 2% orZZINESS .. All dose strengths were generally well tolerated 1 ... Other adverse events occurring more frequently with COREG CR than with placebo (incidence>1%) included: nasopharyngitis (4%), nausea (2%), peripheral edema (2%)2 ne> (n (1), f3 Iy 'Survey of 287 physicians, Ilcluding cardioloqlsts (n=41), electrophysiologlsts (n=40), i'1terventional cardiologists (n=40), Internal practice/general practice (n. 74). and others (n=21). Physicians were asked to quot;Please Indicate the 3 most concerning lolerabliltllSSUeS OClaled WI! Il-blockers that have been ~xperienced by patients In yotJr practice.' tOouble-blind, randomized. parallel-group study that compared the BP 8ffects ot COREG CR and placebo In patients using ambulatory blOOd pressure monitoring (ABPM). The study included 338 patients with essential hypertension (Sitting diastoliC blood pressure [DBPj ~90 and ~109 mmHq) who were randomized to receive 20, 40, or 80 mg of CORf'iG CR or placebo for 6 weeks. Please see Important Safety Infonmation on page 11.
  5. 5. G C provided i ifi ant peak CO' essure (BP) reducti ns1 ,3 bl,o'Q,d I P<O.005, changes from baseline vs placebo. § Systolic blood pressure. 0 II Diastolic blood pressure. -2 c; JO -4 .. Maintains significant E .§. -6 BP reductions a. Cll .S throughout the -8 '<:quot; Cl entire 24 hours 3 -10 'quot; ..:= u <: -12 ''quot; quot; .., Provides BP control ~ -14 in a dose-dependent -15.3 t -16 manner3 Peak DBPquot; CORG C . BP reductions at trough 2 DOSE SBP DBP P<O.OOl, changes from baseline vs placebo 4 (mmHg) (mmHg) 20 mg -2.8 -5.2 40 mg -7.4~ -8.4~ 80 mg OOREG CR placebO-subtracted reductions from a double-blind. rar:1domlzed, parallel·group study that compared the BP effects of COREG OR and placebo in patients using ABPM. The study Included 338 patients with essential hypertension (sitting DBP ,,90 and ,,109 mmHg) who were randDmli:ed to receive 20, 40, or 80 mg 00 of COREG OR or placebo for 6 weeks. Mean sitting SBP and DBP al baseline were 150 mmHg and 99 mmHg, fespecNvely. The primary endpoint was change In mean 24-hotJr DBP by ABPM. Placebo· subtracted mean changes in mean 24-hour SBP/OBP measured by ABPM were -6.1/-4.0 mmHg, -9.4/·7.6 mmHg. and -11.8/-9.2 mmHg for 20 mg, 40 mg, and 80 mg, respectively. Peak and trough BP were measured as average of hours 3· 7 and 20·24, respectrvely.2 References: 1, Data on fite (#81), (#82), and (#77), GlaxoSl1lllhKI·ne. 2, Prescribing rquot;lormalion for COREG CR. GlaxoS rtIIKIJOO. j, Weber MA, Sica DA. Tarka EA, Iyergar M, Fleck R. Bakris til Controlled· re:p.asp. f.arvedilol ill he tr tmenl of esse'llial h 'petleflSilln Am J CardIa!. 2006,98(snppl):32 -38l 4. Wp.bec MA. Bakris Gl. Taf1<a EA, 'Iyengar M, FI'eck R, Sica lJ Efficacy Of a once· dally [armulatloll of carverlilol lor the treatment of hypel1ension J Clln Hypertens. 2006;8840.849 Lower pressure withou 10 ing cant I
  6. 6. According to the American Association of Clinical Endocrinolo ists • n Guidelines for treat' nt of hyperte in patients with diabetes1 Because the major adverse effects of {3-blockers may be mediated by peripheral vasoconstriction.. drugs that block both a- and {3-receptors (such as carvedi/o/) may prove to be particularly beneficial .. 1 11 -AACE Hypertension Task Force Level of Grade' Evidence· --­ A 1 ACE Inhibitor or ARB as first- or second-line agent Thiazide diuretic as first- or second-line agent (in low A 1 dosage with adequate potassium replacement or sparing) ~-blocker (preferably drugs that block both a- and A 1 13-receptors) as second- or third-line agent CCB (preferably nondihydropyridine) as secondo, third-, or A 1 fourth-line agent 'Level of evidence and grade are determined by the Amencan Association of Clinical Endocnnologists, wtlich reviews and grades Clinical !l'iden~ in iIOCordance with established criteria. (See: The American Association of Cllnlca ndocrinologists protocol for standardized production of clinical, guidelines. Endocr Pracl. 2004;10:353-361.) I~nad I $Ulmelll or Reference: 1. AACE Hypel1cnslon Task Force. American IIssoclation of 'Clinical EndocTinologists Medical GUidelines ,tOI GI It<II Pradlc:e lor lire diag hypenension Endocr Pract. 2006:12:193-222. 2. Egan BM, Basiie J. Gillilan RJ. Cohen jD Cardioprotecllofl'l e I I beta blocker th fO,DY J elm Hyper!lHIs 2005;7 09-416 6
  7. 7. Comprehensive vasodilating SNS blockade f3- ockade wit I p oved B 0 Row Selective Beta-1 Bl'ockade Comprehensive Vasodilating Blockade1 ~ Beta-1 blockade reduces heart rate BP= Blood Pressuro tThe basis (mecl'.a sm of action) for the be cial effects of Re~isl£lnce TPR= Total Peripheral Beta blockade in hyperte as CO=. Cardiac Outpul not been established.
  8. 8. ONCE-A-DAY Cardioprotective 5 Coreg® (carve i 0) red ce all...cau e mortali y I CA 1r. by 23% (95°/0 C ,2 % '040 0 pa quot;e /or,2 Post-MI LV All-cause mortality was 15% in Fatal or Nonfatal Reinfarction U the placebo group and 12% in the COREG group1 % Added cardioprotection on top II> of current standard therapies in Post-MI LVDt PATIENT TYPE STARTING DOSE POST-MI LVD Please see Indications Statements and Important Safety Information on pages 10 and 11. 'Carvedtlol Post-Infarct Survival Control in LV Dysfunction (CAPRICORN) was a double-blind study comparing COREG and placebo in 1959 plUl nls with a recent MI (within 21 days) and left ventricular ejection fraction (LVEF) .-;40%, with (47%) or without (53%) symptoms of HF. Patients given COREG rec.1 d 6.25 mg BID, titrated as tolerated to 25 I11g BID. Entry cnteria inclUded a systolic BP >90 mmHg. a sitting heart rate >60 beats/minute. and no contraindlcations 0 Il-blocker use. , Support for the use of COREG CR for the treatment of mild-to-severe HF and Post-MI LVD is based on the equivalence of pharmacok,netlc and pharmacodynamic UJ,-blockadej parameters between COREG CR and COREG. 'ACE inhibitors or angiotensin II receptor blockers (97%). aspirin (85%). dluret1cs (34%), lipid-lowering agents (23%). and anticoagulants (20%); 47% were revascularized. 'Starling dose: 20 m9 00. Uptitrate to 40 m9 00 after 3-10 days as tolerated The maximum/target dose is 80 mg 00. If clinically indicated. start at 10 m9 00 and/or uptitrate more slowly. Patients should be malntalOed on lower doses If higher doses are not tolerated. No dosing alteration needed when slarted after IV or oral iI-blocker MI treatment. 8
  9. 9. ...Across the cardiovascular continuum ortality in sy p oma'c HF quot;: COR G reduc,ed ------­ • 17% 19% 67% RISK REDUCTION RISK REDUCTION RISK REDUCTION o qql in e COREG group 0 ~G n ttl. 34% In t . CO group 14S'~ 17. t 8 melopr I tar rme roup 2.5 In m Jopr I ...0% It the. .e1oprc I Irtml quot; Ollp u 18 95 95 u Ct, gc,;, to 32.' CI, 38 ~ lJ H~,fl 9quot;' p= 11006 :::.0 Extrapolation from the survival curves suggested that COREG extended median survival by 1.4 years 4 20% cardiovascular death risk reduction (29% in the COREG group, 35% in the metoprolol tartrate group; 95% CI, 10% to 30%; P=0.0004)5 In a separate, crossover study of patients with HF or Post-MI LVD receiving COREG CR, the most common adverse events were dizziness (3%) and headache (2%)~3 Carvedilol Metoprolol European Trial (COMET) was a dou 'ind, ~ bllllZed, roup loal comparing COREG with metoprolol tartr;;lte In 3029 pallents with chronic HF (NYHA Class II-IV) followed for 'PATIENT TYPE STARTING DOSE approxim 5 years. COMET compared carvedilol (target dose: 25 m9 BID) to metoprolol tartrate H ART FAILURE' (targel dose: 50 Ing BID). It is not known whether this formulation of metoprolol at any dose or this low dose of metoprololln any formulalton has any effect on survival or hospitalization In patients wllll HF. Metoprolol tartrate is not Indicated in the Uniled Stales for HF. COMET did not compare carvedilol to metoprolol succlnale (Toprol-XL-). The efficacy of carvedildl versus metoprolol succinate in HF has not been established In a head-to­ ilead outcomes study. The target dose of metoprolol succinate in HF IS 200 ~ 00.quot; Thus. thiS tnill extends the time over which carvediloJ manilests benafi g SI) 'n HF, but It IS not evidenoe that carvedilollmproves outcrnne CtL'et' the formlJlatj~ of metoprolol ( oprol-XL ) with benefits in HF. ·Nonrandomlz.ed, crossover study of 174 patients with mild-to-!ilevere HF or aSYlllptolquot;latlc Post-MI LV lilat compared tho pllarrT1flLquot;Oknnic profil~ 01 COREG and CORt::G CR. Patients received COREG (3.125, 6.25,12.5, or 25 mg twice dally) for 2 weeks and then the eqUivalent dose of COREG CR (10. 20, 40. or 00 mg CIlcedaily) for 2 weeks. 'Start ng dose: 10 mg 00 for 2 weeks. Uptltration to 20, 40, and 80 mg 00 should occur over successive intervals of at least 2 weeks, based on olera ,I. The maximum/target dose is 80 mg 00. Patients should be 'I11all'llarned on lower doses If higher doses are not tolerated. References: 1,1re CAPRICORN I ve 'galors E eel of carwllllol on olJleome aIle. ,quot;'{O(;iIroi Ir1 a'ction II) PJtle!1ts wi h 3ft-ven rleli f dysflll'C!lon: UN! CAPRICORN I. L'J'quot;,el 200Ul57J385-1390. 2. F'reseriiJlnli Inlonn~li n lor r~n~omised COREG Cll GI~xoS ~ lin 3. [lara 011 file (g66) and (#78), GIsxOSl1llIRKlil18 4. Pnoll7­ '/1I50n PA. Swenberg K_ Icli!nd JG~, et al. lor tile COMET IIIvb'!;[llfalors. Comparison of cllrtk~J oulcolnes 'II p~1iefll~ v!itluh~nir. rt a I Te I~ tile c.lIF'o'edliol af)U m loprol r..edllal r Metoprolal European Trial (COMET!' randCnUsed conlnllled triol Lancet. 2003;362:7-13 5_ Tor·)·Pl!der en C. Poo - san PA, Swedberg K, at ai, forlhe COMET In~llSlJjJalllt'$. ~fi1ecl~ or metoprolol an aquot;Mllllol on cami,e-speci!lc morJa'lty and Lower p ess ra wi hoo 10 ing Il'lDrbi~ll,!, In palienls vquot;llh I;l']rome hem f Illre-OOMET Am Hem J. 2005:149:370-376. COil r 6. Toprol-XL· Pr ~rRiI11l111In·mallon. Wlm ngm ,Oe Asl neca LP: 2007
  10. 10. ONCE-A-DAY CR e Indications Hypertension COREG CR is indicated for the management of essential hypertension. COREG CR can be used alone or in combination with other antihypertensive agents, especially thiazide-type diuretics. Post-M I Left entric lar Dysfunction (l:.VD) COREG CR is indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of an MI and have a left ventricular ejection fraction (LVEF) -:;40% (with or without symptomatic heart failure [HF]). Mila-to-Severe F COREG CR is indicated for the treatment of mild-to-severe HF of ischemic or cardiomyopathic origin, usually in addition to diuretics, angiotensin-converting enzyme (ACE) inhibitor, and digitalis, to increase survival and, also, to reduce the risk of hospitalization. Please see Important Safety Information on page 11. o
  11. 11. Important Safety Information Patients taking COREG CR or Coreg® Worsening HF or fluid retention may occur during uptitration of COREG CR or COREG. (carvedilol) should avoid abrupt cessation of therapy. Following abrupt cessation of The most common side effects reported therapy with certain ~-blocking agents, in the controlled trials in HF (reported exacerbation of angina pectoris and, in in ~1 0% of patients [both the mild-to­ some cases, MI and ventricular moderate and the severe populations arrhythmias have occurred. The dosage studied] and more frequently on COREG) should be reduced gradually over a 1- to were dizziness, fatigue, weight increase, 2-week period and the patient should be hypotension, and bradycardia. Worsening carefully monitored. HF symptoms were also reported, but with equal or greater frequency in COREG CR and COREG are placebo-treated patients. contraindicated in patients with bronchial asth ma or related bronchospastic The most common side effects reported conditions, second- or third-degree with COREG in the CAPRICORN trial were AV block, sick sinus syndrome, or severe consistent with the profile of the drug in bradycardia (unless a permanent the US HF trials and the COPERNICUS pacemaker is in place), in patients with trial, as well as the health status of cardiogenic shock or decompensated patients. The only additional adverse heart failure (HF) requiring the use of events reported in >3% of patients and intravenous inotropic therapy (such more frequently on COREG in CAPRICORN patients should first be weaned from were dyspnea, lung edema, and anemia. intravenous therapy before initiating COREG CR or COREG), in patients with The most common side effects in clinically manifest hepatic impairment, hypenension trials with carvedilol were and in patients who are hypersensitive nasopharyngitis (COREG CR) and to any component of this product. dizziness and fatigue (COREG) and were generally mild. Like other I)-blockers, COREG CR and COREG should be used with caution in patients with peripheral vascular disease, thyrotoxicosis or who are undergoing major surgery. Caution should also be used in diabetic patients as I)-blockers may mask some of the manifestations of hypoglycemia, particularly tachycardia. Lower press ure wrthout losing control 11
  12. 12. C · A once-a-day e beta-blocker wit out aU I No adverse effect on metabolic profile: HbA 1 c' total cholesterol, triglycerides, HDL and weight 1 Low incidence of adverse events that most cone to physicians: fatigue, erectile dysfunction, and dizziness 2 Significant BP reductions throughout the entire 24 hours3 PATIENTS WITH HIYPERTENSION* STARTI G DOSE UPT TRATION DOS MAX MUM TARGET DOSE o~ tiered commercial managed care plans t4 COREG CR is covered on 89% 'Starting dose: 20 mg 00. Uptilrale to 40 rng 00 after 1 10 2 weeks. as needed for BP control. The ma~nnum/largel doso 80 rng QO, if required. IS hier 2 coverago = 54%, Tier 3 coverage = 35% Relerences: 1. Data on hie (#~5), (#56), allD (#58), GlaxoSmithKlll1e 2 Oata all file (#81). (#S2.), !l1ld ('77). GlaroSnllU Xlln bilr M; SI 011, T I;a E! 1'fEl1'III r M, 1llCl: R, 3. Bakns GL. Controlled-release carvedllol in the Ireilquot;lme!1! of essenllalllypenensloll. Am J Cardio/. 2005,98(s'JIIPI).32L-38L. 4. MI!(1IlJ1~dl, US~, orJ'lllI f'j CempllS£, NI:J~ be' 2007, Employer. HMO, HMO-Medicaid, HMO-Medicare. flSurer. MedJcal GrOl,r, PllM. POS. PPO, S1[t M!lIJic:aid Of anllatioll .IDes. N (1,840) COREG CR should be taken as a whole capsule in the morning with food. It should. not be crushed, chewed, or taken in divided doses. Please see complete Prescribing Information provided. COREG (carvedilol phosphate) Extended-release Capsules COHc~;GILquot;'o GtaxoSmtthKline Lower pressl.J re wirthoullosing control