| Katherine, a mother of two from the suburbs | | | | The change worked for Katherine. Instead of |
| of Orlando, Florida, was diagnosed with type | | | | the 12 tablets she was taking per day on a |
| 2 diabetes shortly after her 30th birthday. | | | | previous phosphate binder, Katherine now |
| Two decades later, her diabetes led to kidney | | | | takes fewer than five tablets a day. |
| failure. Unfortunately, this scenario is not | | | | |
| uncommon, as diabetes is the leading cause of | | | | The new medication has enabled Katherine to |
| kidney failure in the United States, | | | | consistently maintain her phosphorus levels |
| accounting for nearly half of the people who | | | | within the recommended guidelines. |
| begin treatment each year. | | | | Katherine's new binder also is a chewable |
| | | | tablet, which she prefers, because like all |
| When the kidneys stop working normally, it is | | | | dialysis patients, she needs to restrict the |
| called chronic kidney disease (CKD). In | | | | amount of water she drinks each day. While |
| Katherine's case, the disease advanced to its | | | | Katherine has not experienced any side |
| most severe form, CKD Stage 5, which occurs | | | | effects related to FOSRENOL(R), her doctor |
| when an individual has lost at least 85 | | | | did advise her that individuals taking the |
| percent of his or her kidney function and | | | | medication may experience nausea or vomiting, |
| begins dialysis. Of the 20 million Americans | | | | which generally lessen over time as patients |
| who have some form of kidney disease, more | | | | continue with their treatment. |
| than 530,000 are on dialysis. Dialysis | | | | |
| performs tasks that healthy kidneys do, such | | | | Thanks to dialysis, diet and her newly |
| as remove wastes, control excess salt and | | | | prescribed phosphate binder therapy, |
| water balance, and maintain blood pressure. | | | | Katherine is successfully managing her health |
| | | | and staying active. On most days, she can be |
| The overall management of kidney disease is | | | | found in her swimming pool with her children |
| challenging and can lead to a variety of | | | | and grandchildren. |
| additional problems. In Katherine's case, she | | | | |
| developed hyperphosphatemia | | | | This patient account reflects one person's |
| (hi-per-FOS-fuh-TE-me-uh)-high levels of | | | | experience with hyperphosphatemia, CKD Stage |
| phosphorus in the blood-which can lead to | | | | 5 and her treatment with FOSRENOL(R). This |
| serious long-term health problems over time, | | | | information is not intended as a substitute |
| such as mineral deposits in the heart and | | | | for medical advice. |
| blood vessels, bone disease and even death. | | | | |
| | | | Note to Editors: Important Safety |
| Fortunately, there are treatments available | | | | Information: During clinical trials, the most |
| to help patients control their kidney disease | | | | common side effects of FOSRENOL(R) were |
| and limit the impact of hyperphosphatemia. | | | | gastrointestinal, and included nausea, |
| Through a combination of dialysis, diet and | | | | vomiting, and diarrhea. Nausea and vomiting |
| phosphate binder therapy, patients can manage | | | | generally lessened over time as patients |
| their phosphorus levels. In addition to going | | | | continued with their treatment. Patients who |
| to dialysis three times a week, Katherine | | | | stopped treatment usually reported |
| follows a diet that limits foods high in | | | | gastrointestinal side effects as the reason |
| phosphorus, such as dairy products and dark | | | | for stopping. Other side effects reported in |
| soda. But phosphorus is found in most foods, | | | | trials included dialysis graft complications, |
| so patients often cannot reach target blood | | | | headache, abdominal pain, and low blood |
| phosphorus levels through dietary restriction | | | | pressure. Although studies were not designed |
| and dialysis alone. Many patients, including | | | | to detect differences in risk of bone |
| Katherine, need to take phosphate binders at | | | | fracture and mortality, there were no |
| meals and snacks to help further control | | | | differences demonstrated in patients treated |
| their phosphorus levels. Phosphate binders | | | | with FOSRENOL(R) compared to alternative |
| are prescription medications which "soak up" | | | | therapy for up to 3 years. The duration of |
| phosphorus in the gastrointestinal tract | | | | treatment exposure and time of observation in |
| before it can be absorbed into the blood, | | | | the clinical program were too short to |
| thereby helping patients maintain target | | | | conclude that FOSRENOL(R) does not affect the |
| blood phosphorus levels. | | | | risk of bone fracture or mortality beyond 3 |
| | | | years. While lanthanum has been shown to |
| Because phosphate binders need to be taken | | | | accumulate in the GI tract, liver, and bone |
| with each meal, finding an effective binder | | | | in animals, the clinical significance in |
| that fits each individual patient's needs can | | | | humans is unknown. If you suffer from acute |
| be challenging. In April 2005, a member of | | | | stomach ulcer, colon inflammation and colon |
| Katherine's health care team recommended that | | | | ulcers, Crohn's disease, or bowel |
| she change her phosphate binder to | | | | obstruction, it is important to know that |
| FOSRENOL(R) because it could reduce the | | | | patients with these conditions were not |
| number of tablets she had to take each day. | | | | included in FOSRENOL(R) clinical |
| | | | studies-please discuss with your doctor. |