Latest news from AHA meeting on AstraZeneca’s Crestor; Merck & Co’s Cozaar and anacetrapib; and Roche’s dalcetrapib

Article | 18 November 2009

A new analysis of 6,801 women in the JUPITER study, presented at the American Heart Association Annual Scientific Sessions in Orlando, Florida, showed that Anglo-Swedish drug major AstraZenca’s Crestor (rosuvastatin) 20mg significantly reduced cardiovascular (CV) events (defined as the combined risk of myocardial infarction, stroke, arterial revascularization, hospitalization for unstable angina, or death from CV causes) by nearly half (46%; p=0.002 versus placebo) in women without cardiovascular disease (CVD), but at increased risk of a cardiovascular event as identified by age and elevated high-sensitivity C-reactive protein (hsCRP). This analysis also showed a 42% reduction in CV events for men (p<0.001 vs placebo). >

“Nearly twice as many women die of heart attacks, strokes and other cardiovascular diseases as from all forms of cancer, including breast cancer,” said Alex Gold, executive director, clinical development, Crestor, at AstraZeneca US. “Women have been an under-represented population in primary prevention statin outcome trials, and there has been limited evidence that women can benefit from statin therapy. JUPITER, which used Crestor 20mg, is the first statin study to have shown a significant reduction in the risk of cardiovascular events in women without established cardiovascular disease,” Dr Gold noted.

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Also presented at the  AHA yesterday were two additional analyses of JUPITER data:
• Patients who achieved very low LDL-C (<50 mg/dl), with crestor 20mg experienced a significant 63% reduction in cv events (p><0.0001 vs placebo) and a 5%1 greater reduction in cv events than patients not achieving such a low ldl-c (p="0.0003)." current treatment guidelines recommend aggressive ldl-c goals for appropriate patients, based on results from outcome trials; however, there has been uncertainty about the possible side effects that could be linked with achieving very low ldl-c levels. in this analysis of 4,100 patients, the safety profile of rosuvastatin 20 mg was similar among patients who achieved ldl-c ><50 mg/dl and those who did not. >
• An analysis of 5,466 patients with impaired fasting glucose (IFG) at baseline demonstrated that Crestor 20mg significantly reduced the risk of CV events by 32% (p=0.028 vs. placebo).

Crestor generated $3.6 billion in annual sales in 2008, a 29% gain from the previous year, which analysts attributed to as a result from positive clinical data reported on the drug.

More presentations

US drug major Merck & Co presented the results of an investigational study named HEAAL at the ongoing 2009 AHA Scientific Sessions concluding that Cozaar (losartan) 150mg significantly reduced the risk of all-cause death or hospitalization due to heart failure compared to a lower 50 mg once daily dose of Cozaar.

Also at the AHA yesterday, Merck announced positive results from a Phase IIb study (N=589) that showed persistent lipid effects eight weeks after stopping active therapy with its investigational CETP inhibitor anacetrapib, either as monotherapy or in combination with Atorvastatin in patients with primary hypercholesterolemia or mixed hyperlipidemia. Relative to placebo, anacetrapib 10mg, 40mg, 150mg and 300mg arms showed a LDL-C reduction of 0%, - 1.2%, -9.3% and -15.3% and a HDL-C increase of 3.7%, 18.6%, 40.5% and 43.4% respectively. When compared with the atorvastatin, the anacetrapib arms showed a LDL-C change of +1.7%, -3.9%, -11.2% and -11.9% and a HDL-C increase of 2.6%, 13.1%, 40.7% and 41.8% respectively.

Additionally, new preclinical data on Swiss major Roche’s cholesteryl ester transfer protein inhibitor (CETPi) dalcetrapib were revealed. The company also announced the start of a new Phase III trial named dal-PLAQUE2 (n=900) in collaboration with Canadian Atherosclerosis Imaging Network and Montreal Heart Institute to further evaluate the effects of dalcetrapib on atherosclerotic disease progression.