m News Capsules
`
`WHAT'S NEW IN DRUG RESEARCH
`AND MANAGED CARE PHARMACY
`
`New agent reduces PTH levels in hemodialysis
`patients with secondary hyperparathyroidism
`
`PHILADm.PHJA, P A- T he first agent in an
`investigational class of compounds
`known as the calcimimetics can control
`parathyroid hormone (PTH) levels in
`patients with end-stage renal disease
`who have secondary hyperparathy(cid:173)
`roidism, which occurs as a complica(cid:173)
`tion in half or more of all patients with
`chronic kidney disease.
`The agent, cinacalcet (NPS P harma(cid:173)
`ceuticals), rapidly reduces PTH secre(cid:173)
`tion by increasing the sensitivity of the
`calcium-sensing receptor to extracellular
`calcium. Data were presented in
`Philadelphia at the 35tb annual meeting
`of the American Society ofNephrology.
`"Cinacalcet is a completely novel
`compound that modulates the sensitivity
`of the calcium-sensing receptor and al(cid:173)
`lows us to manage hyperparathyroidism
`and control calcium-phosphorous prod(cid:173)
`uct (Ca x P ) in a way that we never could
`before," said Geoffrey A. Block, .MD.
`Cinacalcet was studied in a multicen(cid:173)
`ter, double-blind trial of82 patients on
`maintenance hemodialysis who had pre(cid:173)
`study PTH levels of 300 pg/ml. or
`greater despite standard therapies. Pa(cid:173)
`tients were randomized to cinacalcet (up
`to 180 rng/d) or placebo for 12 weeks.
`At the study's conclusion, 54% of
`cinacalcet-treated patients had plasma
`
`PTH reduced to the target level (g5o
`pg/ml..), compared with only 5% of
`placebo recipients (P< .001), according
`to Dr Block, who is director of clinical re(cid:173)
`search at Denver Nephrologists. Cinacal(cid:173)
`cet reduced PTH levels by the first week
`of dose titration, and PTI-1 levels re(cid:173)
`mained significantly lower compared
`with placebo throughout the study.
`"This agent allows us to control
`PTH without exacer-
`bating Ca x P," Dr
`Block said. "In fact,
`we're able to give Jess
`binder because we're
`not driving phosphorus
`absorption from the GI
`tract with cinacalcet."
`Ca x P declined by
`13.1% in cinacalcet(cid:173)
`u-eated patients
`(P=.003) compared
`witl1 only 5.6% in tile
`placebo group (P=.08) .
`The rate of adverse events was simi(cid:173)
`lar between the two groups, with tran(cid:173)
`sient GI symptoms being most
`conunon. No sym ptomatic hypocal(cid:173)
`cemia events occurred during the
`study and no patient had to be with(cid:173)
`drawn from the study because oflow
`serum calciu m concentrations.
`
`• Tueagent,
`cinacalcet, rapidly
`reducesPTH
`secretion by
`increasing the
`sensitivity of the
`calcium-sensing
`receptor.
`
`Data from two 1-year studies sup(cid:173)
`port the benefit of long-term cinacalcet
`therapy in addition to standard therapy
`in reducing PTH levels. In these stud(cid:173)
`ies, cinacalcet 25 to 100 mg/d was
`compared with placebo in a total of
`149 hemodialysis patients with PTH
`levels of 300 pg/mL or greater.
`F ifty percent of patients in the
`cinacalcec grou p and 12% in the place-
`bo group h ad a 30% or
`greater reduction in
`their PTH levels from
`baseline, according to
`lead investigator
`Sharon Moe, .MD, as(cid:173)
`sociate professor of
`medicine and assistant
`dean for research, Indi(cid:173)
`ana University, Indi(cid:173)
`anapolis, Ind.
`Forty-nine patients
`from these studies have
`completed a 1-year open-label exten(cid:173)
`sion study of cinacalcet. " For 2 years,
`we were able to maintain suppression
`of PTH using 30 to 180 mg/d of
`cinacalcet," Dr Moe said.
`NPS Phrumaceuticals' licensee,
`Amgen Inc, has announced that it in(cid:173)
`tends to file an NDA for cinacalcet dur(cid:173)
`ing the second half of2003.
`
`Omalizumab appears effective in patients
`with poorly controlled allergic asthma
`said t11at in the yearlong open-label
`D ENVER, CoLo-Patients whose asthma
`study, patients receiving add-on omal(cid:173)
`was poorly controlled with convention(cid:173)
`al treaunents and who received the in(cid:173)
`izurnab had an annualized race of 4.92
`vestigational anti-immunog!obulin-E
`events per patient year, com pared with
`drug omalizumab experienced about
`9. 76 per patient year for patients who
`continued to receive baseline treaonent
`half the number of asthma deteriora(cid:173)
`tion-related incidents as patients who
`for their asthma (P<.001).
`In his presentation at the 60th an(cid:173)
`did not receive the add-on medication.
`Rob Niven, .MD, a respiratory con(cid:173)
`niversary meeting of the Amer ican
`Academy of Allergy, Asthma an d Im(cid:173)
`sultant at the North West Lung Research
`Centre, Manchester, United Kingdom,
`munology, Dr Niven defined asthma
`
`deterioration-related incidents as those
`events in which patients needed to take
`a course of oral steroids or antibiotics,
`in which they missed school or work
`anendance du e to illness, in which they
`required an unscheduled physician
`visit, or in which they had to go to the
`emergency room or were h ospitalized.
`Dr Niven said the need for antibiotics
`for lung infections was a surrogate
`marker for lung function.
`The researchers enrolled 206 patients
`into the trial to receive omalizumab, a
`See Omallzumab on page 203
`
`April 2003 I Vol. 38
`
`Formulary
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`197
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`1
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`EX 1017
`IPR of U.S. Pat. No. 7,829,595
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`Copyright© 2003 EBSCO Publishing
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