Magazin
2006-07-18
Basingstoke, England (ots/PRNewswire) -
- New Data Show FOSRENOL Is an Effective Monotherapy - Leading toImproved Phosphate Reduction in Dialysis Patients PreviouslyReceiving Alternative Phosphate Binder Therapies
New data show calcium-free FOSRENOL (lanthanum carbonate) furtherreduces phosphate levels in dialysis patients previously receivingother monotherapies or combined phosphate binders, including calciumcarbonate and sevelamer hydrochloride[1]. The data, presented todayat the XLIII ERA-EDTA Congress in Glasgow, also showed that FOSRENOLsignificantly increased the number of patients achieving KidneyDisease Outcome Quality Initiative (K/DOQI) targets compared to thosewho were previously treated with other monotherapies.
Dr Alastair Hutchison from the Manchester Institute of Nephrology& Transplantation and one of the trial's lead investigators said,"These study results add further weight to the extensive data packagewhich demonstrates FOSRENOL is an effective phosphate binder.FOSRENOL offers patients with hyperphosphataemia an effectivetreatment option which could simplify their management by reducingtablet burden to as little as one tablet taken during each meal."
A total of 359 dialysis patients were treated with FOSRENOL asmonotherapy and were available for analysis from this multicentre,open label study, following a switch from their previous bindertherapy. Over 40% of patients were previously on combinationphosphate binder therapy (2 or more binders). The study found that at12 weeks of FOSRENOL monotherapy, patients' mean serum phosphatelevels were 1.84 mmol/L compared with 1.99 mmol/L on other previouslyreceived phosphate binding therapies*. In addition, there was anincreased percentage of patients who reached KDOQI targets. The studyalso demonstrated that FOSRENOL was well-tolerated throughout.
(* For patients assessed at Week 12, the mean change fromscreening to Week 12 was -0.13 (P < 0.05).)
Further data presented at the ERA-EDTA Congress showed thattreatment with FOSRENOL was associated with a high level of patientand physician satisfaction, based on a number of assessments andlinked to a reduction in tablet burden[2]. The majority of patientsand physicians expressed a preference for FOSRENOL over previousphosphate binders.
"Poor patient adherence is a problem often found in patients withhyperphosphataemia," says Dr Rajnish Mehrotra from the Harbor-UCLAMedical Center, California and one of the lead investigators of thetrial. "These findings show that FOSRENOL may help to tackle thisproblem."
Other data presented at the meeting also extended FOSRENOL'sexisting body of evidence. Data from 93 patients, 17 of whom werefollowed for up to 6 years in an open-label extension study, showedthat FOSRENOL effectively maintained reductions in mean serumphosphate levels whilst remaining tolerated[3].
These studies are promising news for the nearly one million peopleon dialysis worldwide who are at risk from the serious consequencesof hyperphosphataemia, shown to be associated with long-termmorbidity and mortality[4]. Up to 70 percent of CKD patients willdevelop hyperphosphataemia[5] which, if not managed successfully, maycause serious long-term health risks leading to renal osteodystrophy(resulting in bone pain, brittle bones and skeletal deformities), andpotentially contribute to cardiovascular disease, which accounts foralmost half of all deaths among dialysis patients.[6] As a result,patients with hyperphosphataemia are often already taking as many aseight or nine different medications[7]. As FOSRENOL is associatedwith a lower tablet burden than existing phosphate binders, it mayoffer simplified dosing for these patients.
Dr Raymond Pratt, Vice President Shire Global Medical Affairs,said, "Shire welcomes the presentation of these data which furtheradd to the robust evidence supporting the effectiveness andtolerability of FOSRENOL in patients with hyperphosphataemia, as wellas showing a high-level of patient and physician satisfaction. Shireis very proud to be able to offer a calcium-free alternative withproven efficacy and tolerability for patients in need of an effectiveand well-tolerated phosphate binder, which may also help to simplifythe management of their condition."
FOSRENOL has been available in the US for 18 months with over44,000 patients receiving Fosrenol since launch and will continue tobe launched across Europe in the remainder of 2006 and into 2007.
Notes to Editors:
Managing Hyperphosphataemia
Phosphorus, an element found in nearly all foods, is absorbed fromthe gastrointestinal tract into the blood stream. When the kidneysfail, they no longer effectively filter out phosphates, even with thehelp of blood-cleansing dialysis machines. While the normal adultrange for phosphorus is 2.5 (0.8mmol/L) to 4.5 mg/dL (1.4mmol/L), theblood phosphorus levels of many patients on dialysis exceed 6.5 mg/dL(2.1mmol/L). Such levels have been linked to a significantly higherillness and death risk for patients who have undergone at least oneyear of dialysis. Most dialysis patients develop hyperphosphataemia.
Hyperphosphataemia disrupts the delicate interplay between thebody's levels of calcium, parathyroid hormone (PTH) and vitamin D.Over time, hyperphosphataemia can ultimately lead to calcification ofthe heart, lung and some arteries. Accumulating evidence shows thathyperphosphataemia contributes to cardiovascular disease, whichaccounts for almost half of all deaths among dialysis patients. Infact, studies have shown that cardiovascular mortality in dialysispatients aged 25-34 years is more than 5 times greater than that inpeople aged 65-74 in the general population.[8]
Since dialysis and diet restrictions alone generally cannotcontrol phosphate levels, patients traditionally managehyperphosphataemia by taking phosphate binding agents with every mealand snack. Such binders "soak up" phosphate in the gastrointestinaltract, before it can be absorbed into the blood. Although theseagents can be effective, some can cause potentially serious sideeffects including hypercalcaemia, bone toxicity and tolerabilityproblems.
Lanthanum carbonate (FOSRENOL(R))
FOSRENOL(R) works by binding to dietary phosphate in the GI tract;once bound, the FOSRENOL(R)/phosphate complex cannot pass through theintestinal lining into the blood stream and is eliminated from thebody. As a consequence, overall phosphate absorption from the diet isdecreased significantly. Shire has conducted an extensive clinicalresearch programme for FOSRENOL(R) involving over 5500 patients, someof whom have been treated for up to 6 years. This programme hasdemonstrated that FOSRENOL(R) is an effective phosphate binder with atolerability profile for long-term use. FOSRENOL(R) was approved bythe FDA in October 2004 and is now available for prescription in theUS. In March 2005 regulatory authorities in the EU granted marketingauthorization for FOSRENOL(R) in sixteen member states, thuscompleting the first step in securing marketing approval throughoutEurope. Fosrenol has since been launched in Ireland, Sweden, Finland,Denmark and Austria. The final step in the European process wasrecently completed resulting in recommendation for approval in theremaining 11 member states. Further roll-outs are underway across therest of Europe and other countries around the world. The company hasout-licensed the rights to develop, market and sell FOSRENOL(R) inJapan to Bayer Yakuhin Ltd.
Patients with renal insufficiency may develop hypocalcaemia. Serumcalcium levels should therefore be monitored at regular timeintervals for this patient population and appropriate supplementsgiven.
No data are available in patients with severe hepatic impairment.Caution should, therefore, be exercised in these patients, aselimination of absorbed lanthanum may be reduced.
Fosrenol should not be used during pregnancy.
It is unknown whether lanthanum is excreted in human breast milk.The excretion of lanthanum in milk has not been studied in animals.Breast feeding is not recommended when the mother is treated withFosrenol.
Tissue deposition of lanthanum has been shown with Fosrenol inanimal studies. In 105 bone biopsies from patients treated withFosrenol for up to 4.5 years, rising levels of lanthanum were notedover time . No clinical data are available on deposition of lanthanumin other tissues. Safety data exceeding 24 months are currentlylimited. The risk/benefit from longer-term administration should becarefully considered.
Patients with acute peptic ulcer, ulcerative colitis, Crohn'sdisease or bowel obstruction were not included in clinical studieswith Fosrenol.
Approximately 24% of all ESRF patients who participated inregistration clinical studies, reported a drug related adversereaction, as determined by the investigator. No individual ADR wasreported at a frequency greater than 10%. The most commonly reportedADRs (>1/100, 1/10) are gastrointestinal reactions such as abdominalpain, constipation, diarrhoea, dyspepsia, flatulence, nausea andvomiting. These are minimized by taking Fosrenol with food andgenerally abated with time with continued dosing. Hypocalcaemia wasthe only other commonly reported adverse reaction.
Shire
Shire is a global specialty pharmaceutical company with astrategic focus on meeting the needs of the specialist physician andcurrently focuses on developing and marketing products in the areasof attention deficit and hyperactivity disorder (ADHD),gastrointestinal (GI), renal diseases and human genetic therapies.Shire has operations in the world's key pharmaceutical markets (US,Canada, UK, France, Italy, Spain and Germany) as well as a specialistdrug delivery unit in the US.
For further information on Shire, please visit the Company'swebsite: www.shire.com.
[1]. Hutchison A et al. Efficacy of Lanthanum CarbonateMonotherapy in Dialysis Patients Previously Receiving AlternativePhosphate Binder Therapy. Presented at the XLIII ERA-EDTA Congress,Glasgow, UK, 15-18 July, 2006.
[2]. Mehrotra R et al. A New Formulation of Lanthanum Carbonate isPreferred by Patients and Physicians. Presented at the XLIII ERA-EDTACongress, Glasgow, UK, 15-18 July, 2006.
[3]. Hutchison A et al. Sustained Safety, Tolerability andEfficacy of Lanthanum Carbonate: Results from up to Six Years ofTreatment. Presented at the XLIII ERA-EDTA Congress, Glasgow, UK,15-18 July, 2006.
[4]. Block G et al. Mineral Metabolism, Mortality, and Morbidityin Maintenance Hemodialysis. Am Soc Nephrol 2004; 15: 2208-18.
[5]. Lederer E et al. Hyperphosphataemia.www.emedicine.com/med/topic1097.html. Accessed 23-Mar-06.
[6]. Block G et al. Re-evaluation of risks associated withhyperphosphataemia and hyperparathyroidism in dialysis patients:recommendations for a change in management. Am J Kidney Dis 2000; 35(6): 1226 - 1237
[7]. United States Renal Data System. Medication Use AmongDialysis Patients in the DMMS. American Journal of Kidney Disease1998; 32 (2) Suppl 1 (August): S60-68
[8]. Foley R et al. Clinical Epidemiology of CardiovascularDisease in Chronic Renal Disease. American Journal of Kidney Disease1998; 32 (5) Suppl 3:112-119
ots Originaltext: Shire Pharmaceuticals Group PlcIm Internet recherchierbar: http://www.presseportal.de
Contact:For Further Information, please contact: SHIRE, Media, Jessica Mann, +44-1256-894-280, Investor Relations, Cléa Rosenfeld, +44-1256-894-160, Resolute Communications, Tara Breen, +44-2070-151-350, Eleanor Heightman, +44-2073-977-078
Fosrenol(R) Demonstrates Effective Phosphate Control With as Few as Three Tablets a Day
- New Data Show FOSRENOL Is an Effective Monotherapy - Leading toImproved Phosphate Reduction in Dialysis Patients PreviouslyReceiving Alternative Phosphate Binder Therapies
New data show calcium-free FOSRENOL (lanthanum carbonate) furtherreduces phosphate levels in dialysis patients previously receivingother monotherapies or combined phosphate binders, including calciumcarbonate and sevelamer hydrochloride[1]. The data, presented todayat the XLIII ERA-EDTA Congress in Glasgow, also showed that FOSRENOLsignificantly increased the number of patients achieving KidneyDisease Outcome Quality Initiative (K/DOQI) targets compared to thosewho were previously treated with other monotherapies.
Dr Alastair Hutchison from the Manchester Institute of Nephrology& Transplantation and one of the trial's lead investigators said,"These study results add further weight to the extensive data packagewhich demonstrates FOSRENOL is an effective phosphate binder.FOSRENOL offers patients with hyperphosphataemia an effectivetreatment option which could simplify their management by reducingtablet burden to as little as one tablet taken during each meal."
A total of 359 dialysis patients were treated with FOSRENOL asmonotherapy and were available for analysis from this multicentre,open label study, following a switch from their previous bindertherapy. Over 40% of patients were previously on combinationphosphate binder therapy (2 or more binders). The study found that at12 weeks of FOSRENOL monotherapy, patients' mean serum phosphatelevels were 1.84 mmol/L compared with 1.99 mmol/L on other previouslyreceived phosphate binding therapies*. In addition, there was anincreased percentage of patients who reached KDOQI targets. The studyalso demonstrated that FOSRENOL was well-tolerated throughout.
(* For patients assessed at Week 12, the mean change fromscreening to Week 12 was -0.13 (P < 0.05).)
Further data presented at the ERA-EDTA Congress showed thattreatment with FOSRENOL was associated with a high level of patientand physician satisfaction, based on a number of assessments andlinked to a reduction in tablet burden[2]. The majority of patientsand physicians expressed a preference for FOSRENOL over previousphosphate binders.
"Poor patient adherence is a problem often found in patients withhyperphosphataemia," says Dr Rajnish Mehrotra from the Harbor-UCLAMedical Center, California and one of the lead investigators of thetrial. "These findings show that FOSRENOL may help to tackle thisproblem."
Other data presented at the meeting also extended FOSRENOL'sexisting body of evidence. Data from 93 patients, 17 of whom werefollowed for up to 6 years in an open-label extension study, showedthat FOSRENOL effectively maintained reductions in mean serumphosphate levels whilst remaining tolerated[3].
These studies are promising news for the nearly one million peopleon dialysis worldwide who are at risk from the serious consequencesof hyperphosphataemia, shown to be associated with long-termmorbidity and mortality[4]. Up to 70 percent of CKD patients willdevelop hyperphosphataemia[5] which, if not managed successfully, maycause serious long-term health risks leading to renal osteodystrophy(resulting in bone pain, brittle bones and skeletal deformities), andpotentially contribute to cardiovascular disease, which accounts foralmost half of all deaths among dialysis patients.[6] As a result,patients with hyperphosphataemia are often already taking as many aseight or nine different medications[7]. As FOSRENOL is associatedwith a lower tablet burden than existing phosphate binders, it mayoffer simplified dosing for these patients.
Dr Raymond Pratt, Vice President Shire Global Medical Affairs,said, "Shire welcomes the presentation of these data which furtheradd to the robust evidence supporting the effectiveness andtolerability of FOSRENOL in patients with hyperphosphataemia, as wellas showing a high-level of patient and physician satisfaction. Shireis very proud to be able to offer a calcium-free alternative withproven efficacy and tolerability for patients in need of an effectiveand well-tolerated phosphate binder, which may also help to simplifythe management of their condition."
FOSRENOL has been available in the US for 18 months with over44,000 patients receiving Fosrenol since launch and will continue tobe launched across Europe in the remainder of 2006 and into 2007.
Notes to Editors:
Managing Hyperphosphataemia
Phosphorus, an element found in nearly all foods, is absorbed fromthe gastrointestinal tract into the blood stream. When the kidneysfail, they no longer effectively filter out phosphates, even with thehelp of blood-cleansing dialysis machines. While the normal adultrange for phosphorus is 2.5 (0.8mmol/L) to 4.5 mg/dL (1.4mmol/L), theblood phosphorus levels of many patients on dialysis exceed 6.5 mg/dL(2.1mmol/L). Such levels have been linked to a significantly higherillness and death risk for patients who have undergone at least oneyear of dialysis. Most dialysis patients develop hyperphosphataemia.
Hyperphosphataemia disrupts the delicate interplay between thebody's levels of calcium, parathyroid hormone (PTH) and vitamin D.Over time, hyperphosphataemia can ultimately lead to calcification ofthe heart, lung and some arteries. Accumulating evidence shows thathyperphosphataemia contributes to cardiovascular disease, whichaccounts for almost half of all deaths among dialysis patients. Infact, studies have shown that cardiovascular mortality in dialysispatients aged 25-34 years is more than 5 times greater than that inpeople aged 65-74 in the general population.[8]
Since dialysis and diet restrictions alone generally cannotcontrol phosphate levels, patients traditionally managehyperphosphataemia by taking phosphate binding agents with every mealand snack. Such binders "soak up" phosphate in the gastrointestinaltract, before it can be absorbed into the blood. Although theseagents can be effective, some can cause potentially serious sideeffects including hypercalcaemia, bone toxicity and tolerabilityproblems.
Lanthanum carbonate (FOSRENOL(R))
FOSRENOL(R) works by binding to dietary phosphate in the GI tract;once bound, the FOSRENOL(R)/phosphate complex cannot pass through theintestinal lining into the blood stream and is eliminated from thebody. As a consequence, overall phosphate absorption from the diet isdecreased significantly. Shire has conducted an extensive clinicalresearch programme for FOSRENOL(R) involving over 5500 patients, someof whom have been treated for up to 6 years. This programme hasdemonstrated that FOSRENOL(R) is an effective phosphate binder with atolerability profile for long-term use. FOSRENOL(R) was approved bythe FDA in October 2004 and is now available for prescription in theUS. In March 2005 regulatory authorities in the EU granted marketingauthorization for FOSRENOL(R) in sixteen member states, thuscompleting the first step in securing marketing approval throughoutEurope. Fosrenol has since been launched in Ireland, Sweden, Finland,Denmark and Austria. The final step in the European process wasrecently completed resulting in recommendation for approval in theremaining 11 member states. Further roll-outs are underway across therest of Europe and other countries around the world. The company hasout-licensed the rights to develop, market and sell FOSRENOL(R) inJapan to Bayer Yakuhin Ltd.
Patients with renal insufficiency may develop hypocalcaemia. Serumcalcium levels should therefore be monitored at regular timeintervals for this patient population and appropriate supplementsgiven.
No data are available in patients with severe hepatic impairment.Caution should, therefore, be exercised in these patients, aselimination of absorbed lanthanum may be reduced.
Fosrenol should not be used during pregnancy.
It is unknown whether lanthanum is excreted in human breast milk.The excretion of lanthanum in milk has not been studied in animals.Breast feeding is not recommended when the mother is treated withFosrenol.
Tissue deposition of lanthanum has been shown with Fosrenol inanimal studies. In 105 bone biopsies from patients treated withFosrenol for up to 4.5 years, rising levels of lanthanum were notedover time . No clinical data are available on deposition of lanthanumin other tissues. Safety data exceeding 24 months are currentlylimited. The risk/benefit from longer-term administration should becarefully considered.
Patients with acute peptic ulcer, ulcerative colitis, Crohn'sdisease or bowel obstruction were not included in clinical studieswith Fosrenol.
Approximately 24% of all ESRF patients who participated inregistration clinical studies, reported a drug related adversereaction, as determined by the investigator. No individual ADR wasreported at a frequency greater than 10%. The most commonly reportedADRs (>1/100, 1/10) are gastrointestinal reactions such as abdominalpain, constipation, diarrhoea, dyspepsia, flatulence, nausea andvomiting. These are minimized by taking Fosrenol with food andgenerally abated with time with continued dosing. Hypocalcaemia wasthe only other commonly reported adverse reaction.
Shire
Shire is a global specialty pharmaceutical company with astrategic focus on meeting the needs of the specialist physician andcurrently focuses on developing and marketing products in the areasof attention deficit and hyperactivity disorder (ADHD),gastrointestinal (GI), renal diseases and human genetic therapies.Shire has operations in the world's key pharmaceutical markets (US,Canada, UK, France, Italy, Spain and Germany) as well as a specialistdrug delivery unit in the US.
For further information on Shire, please visit the Company'swebsite: www.shire.com.
[1]. Hutchison A et al. Efficacy of Lanthanum CarbonateMonotherapy in Dialysis Patients Previously Receiving AlternativePhosphate Binder Therapy. Presented at the XLIII ERA-EDTA Congress,Glasgow, UK, 15-18 July, 2006.
[2]. Mehrotra R et al. A New Formulation of Lanthanum Carbonate isPreferred by Patients and Physicians. Presented at the XLIII ERA-EDTACongress, Glasgow, UK, 15-18 July, 2006.
[3]. Hutchison A et al. Sustained Safety, Tolerability andEfficacy of Lanthanum Carbonate: Results from up to Six Years ofTreatment. Presented at the XLIII ERA-EDTA Congress, Glasgow, UK,15-18 July, 2006.
[4]. Block G et al. Mineral Metabolism, Mortality, and Morbidityin Maintenance Hemodialysis. Am Soc Nephrol 2004; 15: 2208-18.
[5]. Lederer E et al. Hyperphosphataemia.www.emedicine.com/med/topic1097.html. Accessed 23-Mar-06.
[6]. Block G et al. Re-evaluation of risks associated withhyperphosphataemia and hyperparathyroidism in dialysis patients:recommendations for a change in management. Am J Kidney Dis 2000; 35(6): 1226 - 1237
[7]. United States Renal Data System. Medication Use AmongDialysis Patients in the DMMS. American Journal of Kidney Disease1998; 32 (2) Suppl 1 (August): S60-68
[8]. Foley R et al. Clinical Epidemiology of CardiovascularDisease in Chronic Renal Disease. American Journal of Kidney Disease1998; 32 (5) Suppl 3:112-119
ots Originaltext: Shire Pharmaceuticals Group PlcIm Internet recherchierbar: http://www.presseportal.de
Contact:For Further Information, please contact: SHIRE, Media, Jessica Mann, +44-1256-894-280, Investor Relations, Cléa Rosenfeld, +44-1256-894-160, Resolute Communications, Tara Breen, +44-2070-151-350, Eleanor Heightman, +44-2073-977-078
Shire Pharmaceuticals Group Plc
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