INTRODUCTION Knowledge of prognostic factors in end-stage renal disease patients has improved dialysis management and methods for reducing morbidity and mortality, underlining the importance of identification, prevention and control of these factors.

OBJECTIVE Identify factors affecting prognosis (survival or death) in hemodialysis patients at the Medical-Surgical Research Center in Havana over a ten-year period.

METHODS Descriptive, prospective study of 81 end-stage renal disease patients who received hemodialysis at the Medical-Surgical Research Center from 1995 to 2004. Prognostic factors were identified at initiation of and during dialysis treatment, using chi square, t test, McNemar test, Kaplan Meier analysis, log-rank test and Cox regression model, with significance threshold set at p <0.05.

RESULTS Hypertension and diabetes were the leading causes of end-stage renal disease. Six patients were referred late. Mean survival was 4.4 years; with survival of 86.6%, 54.7% and 26.6% at one, three and five years respectively. Factors predictive of decreased survival that were most frequent at initiation of hemodialysis were hypertension and chronic anemia (both present in 95.9% of cases); malnutrition, hypoalbuminemia, cardiovascular disease and chronic liver disease increased during treatment while hypertension decreased. In multivariate analysis, prognostic factors that significantly predicted decreased survival were hypertension, inadequate vascular access and diabetes. Patients aged ≥60 years and those with malnutrition, hypoalbuminemia, anemia, cardiovascular disease or liver disease had lower survival figures at the end of the study period. Leading causes of death were infections (45.2%) and cardiovascular disease (41.9%); the latter was present in 93.5% of deaths, independent of underlying cause of death.

CONCLUSIONS Survival of hemodialysis patients diminished at five years. Some negative predictive factors are present at initiation of hemodialysis, such as diabetes, hypertension and chronic anemia; others increased later, including malnutrition, hypoalbuminemia, cardiovascular disease and liver disease.

KEYWORDS Hemodialysis, prognostic factors, survival, chronic kidney disease, end-stage renal disease, Cuba

Diabetic foot ulcer is a principal diabetic complication. It has been shown that diabetic patients have decreased growth factor concentrations in their tissues, particularly epidermal growth factor. Growth factor shortage impairs wound healing, which leads to chronic nonhealing wounds and sometimes eventual amputation. Ischemic diabetic foot ulcer is the most difficult to treat and confers the highest amputation risk.

Injecting epidermal growth factor deep into the wound bottom and contours encourages a more effective pharmacodynamic response in terms of granulation tissue growth and wound closure. Epidermal growth factor injected into the ulcer matrix may also result in association with extracellular matrix proteins, thus enhancing cell proliferation and migration.

Heberprot-P is an innovative Cuban product containing recombinant human epidermal growth factor for peri- and intra-lesional infiltration; evidence reveals it accelerates healing of deep and complex ulcers, both ischemic and neuropathic, and reduces diabetes-related amputations.
Clinical trials of Heberprot-P in patients with diabetic foot ulcers have shown that repeated local infiltration of this product can enhance healing of chronic wounds safely and efficaciously. As a result, Heberprot-P was registered in Cuba in 2006, and in 2007 was included in the National Basic Medications List and approved for marketing. It has been registered in 15 other countries, enabling treatment of more than 100,000 patients.

Heberprot-P is a unique therapy for the most complicated and recalcitrant chronic wounds usually associated with high amputation risk. Local injection in complex diabetic wounds has demonstrated a favorable risk–benefit ratio by speeding healing, reducing recurrences and attenuating amputation risk. Further testing and deployment worldwide of Heberprot-P would provide an opportunity to assess the product’s potential to address an important unmet medical need.

KEYWORDS Diabetic foot ulcer, Heberprot-P, amputation, healing, unmet medical need, rhEGF, Cuba