Does Praluent data point to problems for PCSK9 class?

Praluent reduced the need for apheresis by 75% in HeFH. That is an invasive and expensive procedure so it is impressive that it was significantly reduced. What gets me concerned is the safety profile. Yet another study says that there are no safety concerns because the event rate is comparable to placebo(aka statin by itself). If this additional 50% reduction in LDL is so great why isn't it showing more heart attacks and events in the placebo arm? Why is it comparable? Managed care is not looking for surrogate markers like LDL reductions. They want hard evidence showing outcomes. We can say the study was not powered to prove event reductions but why aren't we even seeing a difference? Not good for the class so far.

 

the chinks in the PCSK9 amour start to unravel. Clark Jordan with his MBA and lack of medical knowledge will soon respond that researchers from UCSF do not know shit. UCSF is in SF and SF is full of gays. Gays cannot be trusted. Amgen will spin the BS.

 

This study wasn't long enough to show a difference. Our outcomes trial is much longer. Hopefully the additional time will show reductions in events but who the hell knows

 

Will the benefit be enough to justify the price Amgen wants and the access reps, doctors, and patients find acceptable?

I doubt it.

 

Amgen Repatha reps, how many of your doctors see HeFH patients and of those how many will undergo lipoprotein apheresis?

This may add another $20M to Repatha! Now it only needs another $930M to be a billion dollar drug!


ROME, ITALY — Alirocumab (Praluent, Sanofi/ Regeneron), when prescribed for patients with heterozygous familial hypercholesterolemia (HeFH), who normally undergo lipoprotein apheresis, may help them avoid or become less dependent on that treatment, according to new research presented at the European Society of Cardiology (ESC) 2016 Congressheartwire from Medscape in an interview at the ESC congress on August 29, 2016.

Apheresis, which is done weekly or biweekly, costs $50,000 to $75,000 per year. The reason is the machines that are used; the kits are throwaways. "The supplies are costly. It's also time-consuming for nursing," he said.

"With this drug we have an opportunity now to eradicate apheresis totally for some of these patients and to reduce the amount of therapy from once a week to every 2 weeks. . . . By lowering that you're going to have a significant effect on cost and on patients' convenience," he continued, adding that the costs of the drug for his study were $7000 to $10,000 per year.

Moriarty and colleagues conducted the phase 3 ODYSSEY-ESCAPE trial involving 62 HeFH patients at 14 centers in the US and Germany who underwent apheresis either weekly or every 2 weeks.

The results were published simultaneously with the ESC congress presentation in the European Heart Journal.

In the study, researchers randomized the patients to receive alirocumab or placebo by subcutaneous injection (150 mg, n=41) or placebo (n=21) every 2 weeks for 18 weeks while still continuing regular lipid medications.

They administered apheresis treatment over 2 study phases: for 6 weeks according to the patient's established schedule, then adjusted for weeks 7 to 18 based on individual needs.

"After 6 weeks we evaluated who would need the apheresis further during that time period, compared with the placebo group," Moriarty said during his presentation. "If alirocumab could lower LDL at least 30%, then we don't need to treat with apheresis.

"Over 63% of patients did not need treatment with apheresis, because their LDL reductions were more than 30% compared with apheresis without the drug. Over 90% of patients had a more than 50% reduction of apheresis therapy over this 18-week period," he said.


In all, 92.7% of patients in the alirocumab group avoided at least half of apheresis treatments, compared with 14.3% of the placebo group.

The drug was generally safe and well tolerated.

 

Amgen's Ray Jordan will come up with a great lie and Amgen will be forcing patients to take Repatha who aren't even eligible for apheresis. We will make TRILLIONS of DOLLARS for Banker Bob to roll in.

 

These studies are only 12 weeks in duration, & it would be exceedingly unlikely to see a difference in events to be meaningful. Second they report events in these studies, not time to events, such as in outcome studies. For example if 3 died on placebo in the study by week 12, they could have died on day 3, 4 and 5. The median number would have died on day 4. Also 3 could have died on treatment but they all passed away on day 79, 80, & 81 with median events at day 80. The true value of that data would be patients lived longer by 76 days on treatment, but that time data would not be captured. The only thing reported would be the number of events which look similar. This is an over simplification but you usually need large datasets to see small differences in outcomes and all the statistics that you evaluate need to be prespecified before the study begins for it to have the most validity.

 

This study wasn't powered to show outcomes. What it shows, like the recent Repatha data revealed, is LDL reduction. It is just more garbage to keep the wolves at bay a little longer. The outcome trials won't be very impressive, and word is that they will be out later than originally planned. In the meantime we can talk about the LDL reductions that doctors do not care about.

 

When the trials are complete we will here that there is a separation in the lines that shows a 6-10% drop in events. Once LDL is optimized with a statin the pcsk9 will not have a tremendous benefit. They will be pigeonholed to HeFH, HoFH, and statin intolerant patients(fully documented) that are very high risk. The benefit of pcsk9 will be greater with low dose statin on board. However, doctors are going to be required to maximize the dose of generic statins before prescribing a $14000 LDL lowering product.

 

#TRUTH

#REPATHA on its way to being a nice drug

#MillionDollarDrugNotBILLION

#BANKERBOBTOSELLAMGEN