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Re: rosemountbomber post# 129

Saturday, 03/09/2024 11:58:39 AM

Saturday, March 09, 2024 11:58:39 AM

Post# of 196
RMB. not sure as I haven't seen a detailed description on the trial design like we saw with AMRN's MITIGATE .
Some key pts .
This final trial is not about efficacy . The FDA has already accepted that OLC is the bioequivelant of Fosrenol . Fosrenol is powder or large chewable pills. OLC is a smaller " condensed " version.
The final trial ...with dialysis patients only about tolerability.
The earlier trial showed that while the side effects were the same for Fosrenol and OLC ...there were more of them reported for those trying OLC .

So in the real world ....does this make a difference in patient compliance .
On Fosrenol they have to chew the pills ( or mix the powder with applesauce ) with each meal . Patients hate chewing the pills .
On OLC they can swallow 1 small pill per meal ......but may experience more side effects ( will attach what those are later ) . So will the patients put up with more side effects ...which may diminish over time ...if they can swallow the smaller pills instead of chewing the larger pills.

So they are enrolling 90 . Some will drop out or miss the occasional pill. Hopefully at least 60 will take all the pills as directed ......except for those that stop because they are experiencing side effects they don't want to try and tolerate.

The perfect outcome is for at least 60 to take all the pills as directed for the entire time of the trial...with no dropouts due to side effects

In an open-label, long-term 2-year extension study in 93 patients who had transitioned from other studies, resulting in a total of up to 6 years treatment, mean baseline values and changes in transaminases were similar to those observed in the earlier comparative studies, with little change during treatment.
The safety of FOSRENOL was studied in two long-term, open-label clinical trials, which included 1,215 patients treated with FOSRENOL and 944 with alternative therapy. Fourteen percent (14%) of patients treated with FOSRENOL discontinued treatment due to adverse events. Gastrointestinal adverse reactions, such as nausea, diarrhea, and vomiting were the most common types of event leading to discontinuation.
In pooled active comparator controlled clinical trials, hypocalcemia was noted with an incidence of approximately 5% in both lanthanum and active comparator groups. A nonclinical study and a phase 1 study have shown reduced absorption of calcium in the intestine with lanthanum carbonate treatment.
In a crossover study in 72 healthy individuals comparing FOSRENOL Chewable Tablets to FOSRENOL Oral Powder, gastrointestinal adverse reactions such as nausea, diarrhea, and vomiting were more common for the oral powder formulation (18%) than for the chewable tablets (7%).

Its an open label trial

Primary Outcome Measures :
Incidence of treatment-related AEs leading to discontinuation [ Time Frame: 4 weeks ]
Tolerability as assessed by incidence of treatment-related AEs leading to discontinuation

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