For US Health Care Professionals

Heart Failure Patient Profiles

To help you evaluate heart failure treatment with Atacand, two hypothetical cases of heart failure are presented with potential real-life outcomes.

Patient Profile #1

Profile #1: 75-year-old female presenting to the ER with chest pain and fatigue

Name:
Betty Bartlett, retired school teacher living in Hartford, Connecticut, who enjoys gardening and spending time with her grandchildren.
Age:
75
Height:
5'6"
Weight:
149
Medical history:
Dyslipidemia, hypertension
CV exam results:
NYHA class: II
LVEF:
28%
Heart rate:
73 bpm and irregular
Blood pressure:
144/98 mm Hg
Medications:
ACE inhibitor, Statin, Diuretic

Betty presented at the emergency room and complained of chest pain and increased fatigue.

Atacand provides significant reduction in the risk of CV death or hospitalization for HF when added to conventional HF therapy...*

With an ACE Inhibitor lowered 15%

Relative risk reduction† of CV death or HF hospitalization‡ (P=.011)9

Placebo + HF therapy including ACEI (n=538/1272) and ATACAND + HF therapy including ACEI (n=483/1276).

CHARM-Added was a double-blind, placebo-controlled study of 2548 subjects with NYHA Class II-IV HF and LVEF ≤40%, who were randomized to placebo or Atacand (initially 4 or 8 mg once daily, titrated as tolerated to 32 mg once daily) on top of ACE inhibitors and other conventional therapies. Median follow-up was 41 months.9

  1. * Conventional HF therapies could include ACEIs, beta-blockers, spironolactone, diuretics, and digitalis
  2. † Unadjusted hazard ratio 0.85 (95% CI 0.75-0.96)
  3. ‡ Primary end point

Patient Profile #2

Profile #2: 58-year-old male with no signs of fluid overload presenting with fatigue and frequent coughing

Name:
Gerald Washington, retired from a 23-year-long career with the US Army, lives in Baltimore, Maryland. He enjoys attending football games and working on his collection of classic American cars.
Age:
58
Height:
5'11"
Weight:
202
Medical history:
Diabetes, hypertension, prior myocardial infarction
CV exam results:
NYHA class: III
LVEF:
29%
Heart rate:
77 bpm and irregular
Blood pressure:
128/78 mm Hg
Medications:
Aspirin, β-blocker, Diuretic, Glimepiride, ACE inhibitor intolerant; reason: Refractory cough

Gerald visited his doctor recently and was euvolemic, and complained of fatigue and frequent coughing.

Atacand provides significant reduction in the risk of CV death or hospitalization for HF when added to conventional HF therapy...*

Without an ACE Inhibitor lowered 23%

Relative risk reduction† of CV death or HF hospitalization‡ (P=.0004)10

Placebo + HF therapy without ACEI (n=406/1015) and ATACAND + HF therapy without ACEI (n=334/1013).

CHARM-Alternative was a double-blind, placebo-controlled study of 2028 subjects with NYHA Class II-IV HF, LVEF ≤40%, not receiving an ACEI due to intolerance, who were randomized to placebo or Atacand(initially 4 or 8 mg once daily, titrated as tolerated to 32 mg once daily) on top of other conventional therapies. Median follow-up was 34 months.10

  1. * Conventional HF therapies could include include beta-blockers, spironolactone, diuretics, and digitalis
  2. † Unadjusted hazard ratio 0.77 (95% CI 0.67-0.89)
  3. ‡ Primary end point

Important Safety Information for Atacand & Atacand HCT

Use in pregnancy: When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, Atacand and Atacand HCT should be discontinued as soon as possible. See full Prescribing Information warnings and precautions, Fetal/Neonatal Morbidity and Mortality.

  • Atacand HCT is contraindicated in patients who are hypersensitive to any component of this product. Because of the hydrochlorothiazide component, this product is contraindicated in patients with anuria or hypersensitivity to other sulfonamide derived drugs
  • In heart failure patients receiving Atacand, hypotension, increases in serum creatinine, and hyperkalemia have occurred. Caution should be observed for hypotension when initiating therapy. Evaluation of patients with heart failure should always include assessment of renal function and volume status. Monitoring of blood pressure, serum creatinine, and serum potassium is recommended during drug dose escalation and periodically thereafter
  • In hypertension, volume and/or salt depletion should be corrected in adult and children patients prior to administering Atacand or Atacand HCT or symptomatic hypotension may occur
  • In patients with a history of sulfonamide or penicillin allergy, hydrochlorothiazide can cause acute transient myopia and acute angle-closure glaucoma, leading to permanent vision loss if left untreated. Atacand HCT should be discontinued
  • During concomitant use of Atacand and lithium, careful monitoring of serum lithium levels is recommended. Atacand HCT generally should not be given with lithium
  • Due to the thiazide component, patients should be observed for clinical signs of fluid or electrolyte imbalance and for metabolic alterations
  • Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus, and hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma
  • Atacand HCT is not recommended in patients with severe renal impairment and should be used with caution in patients with hepatic impairment
  • Greater sensitivity of some older individuals (eg, >75 years) with heart failure must be considered when taking Atacand
  • The adverse-event profile of Atacand in heart failure patients was consistent with the pharmacology of the drug and the health status of the patients. In the CHARM program, comparing Atacand in total daily doses up to 32 mg once daily (n=3803) with placebo (n=3796), 21.0% of patients discontinued Atacand for adverse events vs 16.1% of placebo patients
  • In hypertension, the AEs that occurred more frequently (>1% and greater than placebo) with Atacand were upper respiratory tract infection (URI) (6% vs 4%), dizziness (4% vs 3%), back pain (3% vs 2%), pharyngitis (2% vs 1%), and rhinitis (2% vs 1%)
  • While overall incidence of adverse events was similar to placebo in controlled clinical trials, some adverse events that occurred in at least 2% of patients treated with Atacand HCT were higher than placebo, including upper respiratory infection (URI) (3.6% vs 3.0%), back pain (3.3% vs 2.4%), dizziness (2.9% vs 1.2%), and flu-like symptoms (2.5% vs 1.9%)
  • The recommended initial dose for treating heart failure for Atacand is 4 mg once daily. The target dose for Atacand is 32 mg once daily, which is achieved by doubling the dose at approximately 2-week intervals, as tolerated by the patient
  • In adults with hypertension, the usual recommended starting dose for Atacand is 16 mg once daily as monotherapy in patients who are not volume depleted. Administration can be once or twice daily with total daily doses ranging from 8 to 32 mg for Atacand. Blood pressure response is dose related over the range of 2-32 mg for Atacand
  • In pediatric patients between 1 and <6 years of age with hypertension, the usual starting dose for Atacand is 0.20 mg/kg once daily with a daily dose range of 0.05-0.4 mg/kg once or twice daily. In pediatric patients between 6 and <17 years of age, the dosing is based on weight. Please see full Prescribing Information for dosage and administration
  • In adults with hypertension, start candesartan cilexetil 16 mg, titrate to 32 mg, move to Atacand HCT 32-12.5. Atacand HCT 16-12.5 is also available for patients uncontrolled on 25 mg of HCT

Indications for Atacand & Atacand HCT

Atacand is indicated for the treatment of heart failure (NYHA Class II-IV) in patients with left-ventricular systolic dysfunction (ejection fraction ≤40%) to reduce cardiovascular death and to reduce heart failure hospitalizations. Atacand also has an added effect on these outcomes when used with an ACE inhibitor.

Atacand is indicated for the treatment of hypertension in adults and children 1 to <17 years of age. It may be used alone or in combination with other antihypertensive agents. This fixed dose combination is not indicated for initial therapy.

Atacand HCT is indicated for the treatment of hypertension. This fixed dose combination is not indicated for initial therapy.

If you would like additional information regarding AstraZeneca products, please contact the Information Center at AstraZeneca in the US at 1-800-236-9933, Monday through Friday 8 AM – 7 PM ET, excluding holidays.

Please see full Prescribing Information for Atacand and Atacand HCT, including Boxed Warning regarding use in pregnancy.