Friday, February 25, 2005

FDA PANEL SAYS ATACAND CAN BE USED WITH ACE INHIBITORS

The Food and Drug Administration's Cardiovascular & Renal Drugs Advisory Committee said that AstraZeneca Plc should be permitted to market Atacand (candesartan cilexetil), an angiotensin receptor blocker, to patients with congestive heart failure who are taking ACE inhibitors, Reuters reported Thursday.

On Tuesday, the FDA approved the hypertension drug to treat heart failure, but a News Alert from FDAAdvisoryCommittee.com on Thursday said the findings of one of the studies the approval was based on "have drawn particular attention because they appear to contradict the findings of previous large-scale studies of concomitant use of [angiotensin receptor blockers] and ACE inhibitors."

The FDA advisors initially ruled that the study failed to show benefits other than those achieved with ACE inhibitors but later decided the drug does offer patients "a chance for improvement," Reuters said.

Panel chairman Steven Nissen, medical director for Ohio's Cleveland Clinic, told Reuters that although the committee did "pick apart" the study, AstraZeneca did a good job in trying to demonstrate its data, adding that the drug does "add to the opportunity for patients to benefit."

Monday, February 21, 2005

STUDY SHOWS DUAL BLOCKADE WITH ATACAND, LISINOPRIL NO MORE EFFECTIVE THAN LISINOPRIL ALONE IN REDUCING SYSTOLIC BLOOD PRESSURE IN DIABETES

Combining AstraZeneca Plc's Atacand (candesartan cilexetil) with lisinopril may be no different than lisinopril alone or additional lisinopril in reducing systolic blood pressure in hypertensive patients, according to a new study published in the February edition of Diabetes Care.

Investigators conducted the Candesartan and Lisinopril Microalbuminuria (CALM) II study in 75 hypertensive patients (age range, 35-74 years) with type 1 or type 2 diabetes. For at least one month prior to randomization, all had seated office systolic blood pressure of between 120 mm Hg and 160 mm Hg during treatment with lisinopril 20 mg/day. Participants were assigned to receive additional treatment with lisinopril 20 mg/d (resulting in a total lisinopril dose of 40 mg/d) or Atacand 16 mg/d (dual-blockade) for 12 months.

Results showed dual-blockade treatment tended to be more effective than lisinopril 40 mg/d in reducing daytime, 24-hour and nighttime systolic BP. However, the trend was not significant. Mean differences between treatment groups at follow-up were as follows: daytime, 5.6 mm Hg; 24-hour, 3.9 mm Hg; and nighttime, 2.2 mm Hg. Between-group reductions in seated systolic BP were also not significantly different (mean difference at follow-up, 0.1 mm Hg).

Urinary albumin excretion levels remained stable throughout follow-up with both regimens, and the authors observed no significant between-group differences in urinary albumin excretion rate.

In general, both treatments were well tolerated. Two patients in the dual-blockade group and one in the lisinopril group were taken off study medication because of increases in potassium. Overall, serum potassium levels were not significantly different between groups, nor did HbA1c change significantly over time. One patient in each group discontinued treatment after experiencing dizziness and fatigue.

"In conclusion, there was no statistically significant difference between lisinopril 40 mg once daily and lisinopril 20 mg in combination with [Atacand] 16 mg once daily in reducing systolic blood pressure in hypertensive patients with diabetes," the authors concluded.

Friday, July 2, 2004

ASTRAZENECA SUBMITS SNDA FOR ATACAND CHRONIC HEART FAILURE THERAPY

AstraZeneca Plc submitted a supplemental New Drug Application to the Food and Drug Administration for Atacand (candesartan cilexetil) as a potential therapy for chronic heart failure.

The sNDA submission included data from the clinical trial program known as CHARM (Candesartan in Heart failure Assessment of Reduction in Mortality and morbidity), which involved 7,601 patients with classic symptoms of chronic heart failure.

CHARM comprised three placebo-controlled studies of ATACAND, which included patients who had left ventricular systolic dysfunction (LVEF less than or equal to 40 percent) and were using standard therapy that included an ACE inhibitor; patients with LVEF less than or equal to 40 percent who were intolerant of ACE inhibitors; and patients with preserved left ventricular systolic function (LVEF greater than 40 percent).

Results of the trials "showed the effects of Atacand on cardiovascular deaths and hospital admissions for heart failure when compared with placebo among a broad spectrum of patients with symptomatic heart failure," AstraZeneca said in a press release.

Initial results from the studies were presented at the 2003 European Society of Cardiology Congress and were published in four articles in the Sept. 6, 2003, issue of The Lancet.

Atacand, an angiotensin receptor blocker, is currently approved for the treatment of hypertension.