COMPARISON OF CABERGOLINE VERSUS RALOXIFENE ADD-ON THERAPY TO LONG-ACTING SOMATOSTATIN ANALOGUE IN PATIENTS WITH INADEQUATELY CONTROLLED ACROMEGALY: A RANDOMIZED OPEN LABEL CLINICAL TRIAL.

OBJECTIVE: The present study aimed to evaluate the efficacy of add-on therapy of cabergoline versus raloxifene to long-acting somatostatin analogues (SAs) in patients with inadequately controlled acromegaly. METHODS: This was a prospective, randomized open label clinical trial. Forty-four patients (22 per group) completed the study; where participants received either cabergoline (3 mg/week) or raloxifene (60 mg twice daily) add-on therapy for 12 weeks in a parallel manner. The primary outcome was the rate of reduction in serum insulin-like growth factor 1 (IGF-1) from baseline. Secondary outcomes comprised normalization of serum IGF-1 for age and sex. RESULTS: Serum IGF-1 was significantly decreased in both the cabergoline (40.3 ± 25.6%, P<.001) and raloxifene (31.5 ± 24.6%, P<.001) groups, with no significant difference between arms ( P>.05). Normalization in serum IGF-1 values occurred in 40.9% of patients who were on cabergoline compared to 45.5% of those receiving raloxifene ( P = .76). The subsequent logistic regression analysis highlighted baseline IGF-1 as a significant predictor of IGF-1 normalization (odds ratio, 0.995; 95% confidence interval, 0.990-0.999; P = .02). Using the receiver operating characteristic (ROC) curve analysis for the entire group, the baseline IGF-1 value of 1.47 the upper limit of normal (ULN) was the best cut-off point to identify patients with normal IGF-1 at the end of the study (sensitivity: 52.6%, specificity: 84.0%, Yoden's index: 0.366). Full biochemical control of acromegaly was achieved in 22.7% of patients in the cabergoline group compared to 13.6% of those in the raloxifene group ( P = .43). CONCLUSION: Cabergoline and raloxifene add-on therapy could effectively decrease serum IGF-1 level in patients with inadequately controlled acromegaly. The efficacy profiles of both drugs are comparable. ABBREVIATIONS: DA = dopamine agonist; FBG = fasting blood glucose; GH = growth hormone; IGF1 = insulin-like growth factor-1; IQR = interquartile range; OR = odds ratio; ROC = receiver operating characteristic; SA = somatostatin analogue; SERM = selective estrogen modulator receptor; ULN = upper limit of normal.

Improving the Practice of Nutrition Therapy in the NRITLD Critically Ill Patients: An International Quality Improvement Project.

BACKGROUND: In previous decades several studies have been performed demonstrating that providing appropriate nutritional support to intensive care unit patients affects complications, time of mechanical ventilation, length of ICU stay, and risk of death. In this study we provided a report of nutrition statuses in Masih Daneshvari's ICU as compared to 156 ICUs from 20 countries that participated in an international nutrition survey. MATERIALS AND METHODS: All patients admitted to an intensive care unit during a specified one-month period who required artificial nutrition were included in this study. Characteristics of patients, performance of nutrition practices, and ICU outcomes were registered for all patients and compared with data from 156 other intensive care units from various countries around the world. RESULTS: Twenty patients, of which 11(55%) were males and 9(45%) were females, were included in this study. The median age was 50.5 yrs (IQR: 40.5-56.0). Seventeen (85%) of them had EN nutrition only, 2(10%) had PN nutrition only, and 1(5%) had both EN and PN nutrition during their stay in the ICU. The adequacy of calorie intake was 67.6% (vs. 61.1% in all 157 ICUs) and the adequacy of protein intake was 84.9% (vs. 56.7% in 157 ICUs). CONCLUSION: In our ICU, enteral feeding was superior to parenteral feeding. Also we considered early initiation of enteral feeding within 48 hours following ICU admission. We just used polymeric formula during this study. As a result of formula variation limits, we overestimated calories and protein needs. Glutamine and Selenium supplementations have not been used yet for patient in our ICU, regardless of their proven benefits in oxidative stress conditions like pulmonary diseases. Therefore, limited use of supplementations like selenium is inevitably among the disadvantages of Masih Daneshvari Hospital's ICU, which is a tertiary-care center for chronic pulmonary diseases.