PARIS—Sexual dysfunction is highly prevalent in sexually active women with end-stage renal disease requiring hemodialysis (HD), according to data presented at the 49^th Congress of the European Renal Association-European Dialysis and Transplant Association (ERA-EDTA).

Suetonia Palmer, MD, senior lecturer at the University of Otago in Christchurch, New Zealand, and colleagues elsewhere used the widely validated Female Sexual Function Index (FSFI) to screen for any form of sexual dysfunction in women with ESRD on HD. The women included in the study were recruited from 27 dialysis clinics in Europe and South America.

Compared with increasing awareness of sexual dysfunction in men

on HD, sexual dysfunction in women with chronic kidney disease has not been rigorously investigated and is therefore less well understood, Dr. Palmer said.  Also, descriptive data for sexual dysfunction in women on HD are limited by suboptimal study design.

Of 1,472 women who were contacted, 659 completed the FSFI questionnaire.  More than half of them lived with a partner, and slightly more than a third described themselves as sexually active. Overall, 555 respondents, or 84%, had FSFI scores consistent with sexual dysfunction.

When the analysis was restricted to the subgroup of HD patients who were sexually active, the prevalence of sexual dysfunction was 55%. Other studies have found a prevalence rate for sexual dysfunction of about 30% for women in the general population.

The study also found that single women who are were not waitlisted for a transplant had the highest risk for sexual dysfunction.

Given the potentially high prevalence of sexual dysfunction in women on dialysis, more studies are needed to examine the relevance of sexual dysfunction on symptom burden and quality of life in these women, Dr. Palmer said.

Finally, she cautioned that the study had a response rate of only 45%. Additionally, the analysis did not include data for race or ethnicity, which has been shown to correlate with sexual function in other populations.

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Ft. Lauderdale, FL (written by Johanna Jainchill/USA Today) -- An advocate for travelers with disabilities said that the recent mishap between Carnival Cruise Lines and a passenger's dialysis machine is a lesson that travelers should always keep medical equipment on their person.

As several Florida news outlets reported this week, a South Florida family was escorted off a Carnival ship last Saturday after the cruise line was not able locate one of the family members' dialysis machine.

According to a report on Local10.com, Lillian Hensley, her disabled daughter, her son and son's wife were all supposed to be on a five-day Carnival cruise from Miami this week, but instead were asked to disembark before it departed because the daughter's dialysis equipment was not located.

Hensley's daughter requires nightly dialysis, the report said, and Hensley received clearance from Carnival to bring a portable dialysis machine on board. Hensley said she she checked the equipment with the rest of her luggage and boarded the ship.

Carnival said that Hensley had advised the line that she would be bringing medical supplies, but that she would hand-carry them onto the ship, "per Carnival's standard procedures in these cases."

Carnival said Hensley turned over her dialysis supplies to a porter at the cruise terminal, and that there was "some question as to whether the supplies actually made it on board as the shipboard staff was not able to locate them." Carnival then decided it was better for Hensley not to sail, "Given that it is imperative that Ms. Hensley have her dialysis supplies."

Hensley told the news channel that she informed Carnival that she did not want to disembark without the machine, which her daughter needs to survive, and that Carnival "did not offer an apology or explanation, but told her to take her daughter to the emergency room."

Roberta Schwartz, owner of Imagine Your Vacations and the former Director of Education for the Society for Accessible Travel & Hospitality, an advocate group for travelers with disabilities, said that travelers should always carry their medical equipment with them.

"It's ultimately up to the passenger to be responsible for any valuables, whether it's travel papers, passports, jewelry, medicines, and medical equipment," Schwartz said. "When bringing your own equipment, it shouldn't be out of your sight."

Schwartz added that valuables like medical equipment should never be checked in.

"While most of the time everything shows up, there are times when things go missing," she said. "I think we've all experienced lost baggage somewhere in our travels."

Schwartz said that without knowing the size of the passenger's machine, it's not clear why she chose to give it to a porter. However, she said shoreside staff, including the porters who are not cruise line employees, need more training on how to handle medical equipment. She also suggested that the cruise line have a special tagging system that could have flagged the machine as critical to be delivered.

"Then again, she never should have checked it in the first place," Schwartz said.

Carnival said that once the ship was at sea on Saturday, the supplies were located, and that they will be delivered to Hensley's residence when the Carnival Destiny returns to port today.

In the Local10 report, Hensley said that Carnival's apology and offer of full refund of her family's cruise fare along with a credit for a future five-day cruise was not enough, and that she is considering a lawsuit.

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PARIS--(EON: Enhanced Online News)--Baxter International Inc. (NYSE: BAX) today announced results from two large, international multicenter trials demonstrating that a low glucose peritoneal dialysis (PD) regimen favorably impacted metabolic measures important for end-stage renal disease (ESRD) patients with diabetes, including blood glucose (sugar) control and selected lipids (fats and cholesterol). The combined results were presented as a late-breaking presentation at the 49^th Annual European Renal Association - European Dialysis and Transplant Association (ERA-EDTA) congress in Paris.

Results from the combined IMPENDIA/EDEN trials showed that a low-glucose PD regimen led to clinically and statistically significant reductions in serum levels of HbA1c (the standard marker for assessing blood glucose control) in adult PD patients with diabetes. In the studies, significant reductions also were seen with certain lipid parameters including serum triglycerides (type of lipid or fat found in the blood), VLDL-cholesterol and apolipoprotein B (a protein that helps form LDL, or bad cholesterol, in blood) following a low-glucose PD regimen.

“A low-glucose prescription should be considered when managing diabetic patients on peritoneal dialysis,” said Joanne Bargman, MD, University Health Network and professor of Medicine at the University of Toronto and presenting study investigator. “The data demonstrate low glucose PD regimens may be beneficial in aiding the management of glucose and lipid levels in diabetic PD patients.”

Diabetes accounts for 25 to 50 percent of all new cases of ESRD in the majority of developed countries.^{1, 2,3} As ESRD patients are at increased risk for cardiovascular disease, reducing the risk is an important focus, particularly in the treatment of patients with diabetes. As part of their standard dialysis therapy, PD patients are exposed to high levels of glucose.

About the Studies

The IMPENDIA and EDEN trials are randomized controlled studies involving 251 PD patients from 55 sites across 11 countries and four continents designed to evaluate the effects of a low glucose PD regimen on metabolic control over a six-month period. Combining both studies, the IMPENDIA/EDEN trials randomized 124 patients to a low glucose PD regimen containing either PHYSIONEAL (glucose), EXTRANEAL (icodextrin 7.5%), and NUTRINEAL (PD4 1.1% amino acids) in combination or a DIANEAL (PD4 glucose solution), EXTRANEAL and NUTRINEAL combination regimen versus a control group of 127 patients receiving DIANEAL-only. The primary endpoint was change in baseline of HbA1c levels between the intervention group and the control group. Secondary endpoints included evaluations of changes in serum lipids. The study protocol called for a combined analysis of the two studies.

Results showed a statistically significant reduction in the primary endpoint, as the mean HbA1c decreased by 0.5 percent in the intervention group but remained unchanged in the control group. For serum triglycerides, the difference between the low glucose and control groups represented a decrease of 0.7mmol/L. The difference for VLDL-cholesterol favoring the low glucose group was a decrease of 0.3mmol/L. These results also were statistically significant (p<0.05 level).

While an increased number of serious adverse events were observed in the intervention group, this difference was driven by two out of 17 study sites within the EDEN trial. Further analysis revealed that in the IMPENDIA trial, adverse event rates were similar between the control and intervention study arms. No overall differences between treatment groups were seen across the other 15 EDEN sites. Additional analyses are being conducted to further understand these differences.

Peritoneal Dialysis and Diabetes

ESRD is on the rise, in part due to the increasing rates of diabetes worldwide.⁴ HbA1c is a widely used marker of blood glucose control in diabetes management and higher levels in patients with diabetes indicate inadequate control of blood glucose levels, which can lead to cardiovascular disease,⁵ the leading cause of death in patients with ESRD.⁶

Peritoneal dialysis is a self-administered therapy that can be managed by patients at home and can offer a number of clinical benefits. In PD, dialysis solution is administered into the peritoneal (abdominal) cavity through a catheter in the patient’s abdomen.

However, large amounts of glucose can be absorbed from conventional dialysis regimens further challenging glucose control and achievement of target blood glucose levels in PD patients with diabetes.

Together with other risk factors, such as adverse changes in blood lipids and increased incidence of metabolic syndrome (the clustering of metabolic risk factors), overall cardiovascular risk can increase in these patients. Low glucose therapy is designed to help patients reduce glucose load and exposure to decrease the risk of developing co-morbidities associated with elevated glucose, like cardiovascular disease and diabetic complications.

“These data add to the growing body of clinical evidence for Baxter’s PD solutions and are an example of our ongoing efforts to seek innovative therapeutic solutions that can help improve patient outcomes,” said Sarah Prichard, MD, vice president and therapeutic area lead for Baxter’s Renal franchise.

About Baxter’s PD Solutions

These limited summaries of product characteristics are intended for international use. Refer to country-specific Summary of Product Characteristics or package insert.

PHYSIONEAL and NUTRINEAL are not commercially available in the United States.

About Baxter

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

Baxter, Dianeal, Extraneal, Nutrineal and Physioneal are trademarks of Baxter International Inc.

¹ USRDS Annual Data Report 2011

² ANZDATA Registry: ANZDATA Annual Report 2010

³ ERA-EDTA Registry: ERA-EDTA Registry Annual Report 2009

⁴Diabetes in America. 2nd edition. National Diabetes Data Group. Bethesda, MD, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, (NIH publ. No. 95–468; 1995:349-400)

⁵ Larsen ML, Horder M, Mogensen EF (1990). "Effect of long-term monitoring of glycosylated hemoglobin levels in insulin-dependent diabetes mellitus". N. Engl. J. Med. 323 (15): 1021–5.

⁶ McCullough PA. Coronary artery disease. Clin J Am Soc Nephrol. 2007 May 2(3):611-6. Epub 2007 Mar 21.

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