Despite the fact that patients in hospice were in the terminal phase of disease, 30% of patients had no diagnosis awareness, and an even higher percentage of patients (62%) who had no prognosis awareness.
ACROSTUDY is a world-wide non-interventional, post marketing surveillance study performed to monitor the safety and outcomes of pegvisomant (PEG) in clinical practice. We report data from acromegaly patients who have been included in the Italian ACROSTUDY registry. The data of 341 acromegaly patients (171 males) were available for analysis using data freeze (12/9/2012). Patients were enrolled in 25 Italian endocrine centres. Before and during PEG treatment IGF-I, liver enzymes, metabolic parameters, and pituitary MRI were assessed. Before PEG, 54.3% patients had been treated with medical therapy and surgery, 22.9% medical therapy only, and 15.8% medical plus radiation and surgical therapy. 199 adverse events were reported in 98 patients (28.7%). Serious adverse events were documented in 29 patients (8.5%). 71.1% of patients had no significant change in tumor volume. Central MRI reading was performed in 34 patients; in 7 patients, an increase in tumor volume was found. Hormonal efficacy progressively increased since the start of PEG. After 6 years, normal IGF-I levels were found in 70.9% of patients (mean daily dose 18.1 mg). 87.1% of patients were treated with daily PEG although in 8.8% of patients, it was administered 2-6 times per week and in 3.8% with weekly injections. 74.8% received a PEG dose 10-15 mg/daily. PEG is a drug with a favorable safety profile which is efficacious also considering that in Italy it is currently available as third-line therapy.
This study describes the results of a semi-structured interview to assess the illness awareness of cancer patients in Hospice. The results of this study are based on the interviews made in Rimini and Savignano sul Rubicone Hospices (n = 51). Psychologists evaluated illness awareness of the participants interviewed independently from the code system that is provided for the interview. According to the psychologists, 18 patients (35%) were aware, 11 patients (22%) were unaware, and 22 patients (43%) were aware with defense mechanisms. According to the code system of the interview, the results were the following: 18 patients (35%) were aware, 2 patients (4%) were unaware, and 29 patients (57%) were aware with defense mechanisms. Two participants had to be reassessed because of inconsistency in some factors. In conclusion, the data analysis underlined that the congruence of the 2 assessment methods was found in 33 of the 51 patients examined (65%) and that the degree of concordance was rather low (kappa = .46; 95% CI = 0.24-0.68).
Early palliative care improves the main outcomes of the assistance in patients with advanced oncologic and non-oncologic chronic diseases. The available data are probably enough to consider early palliative cares a novel standard of care in these groups of patients.
On the basis of this original study approach, we could speculate that in the centers in which more patients are treated with pegvisomant, less adverse events are reported, but the long-term effectiveness is lower than in centers with less cases, perhaps because of an inadequate patient's selection.
Objectives: To assess the efficacy and the safety of our rapid detoxification protocol in preventing signs and symptoms of withdrawal and pain severity.Design: Prospective, open-label case series study.Settings: Public primary care at the Pain and Palliative Care Unit of the Infermi Hospital of Rimini, Italy.Patients: The authors studied 10 consecutive patients suffering from chronic noncancer pain who were refractory to intrathecal (IT) morphine, and hence indicated for ziconotide therapy.Interventions: IT pump was refilled with saline solution, and each patient received endovenous morphine, oral clonidine, ketoprofen, and lorazepam for the first 3 days, and slow-release tramadol, oral clonidine, and ketoprofen for 10 days. Ziconotide therapy was started at the end of the 2-week detoxification treatment.Main outcome measures: The observer-rated opioid withdrawal scale (OOWS) was used for the assessment of withdrawal signs, visual analogue scale was used for pain intensity assessment, and also adverse events were recorded.Results: Withdrawal symptoms were experienced by 3 patients (30 percent). Their average OOWS decreased significantly (p 0.05) from 4.3 ± 2.5 to 1.7 ± 0.6 at days 3 and 14 of protocol, respectively, with no increment of pain intensity. Withdrawal symptoms were resolved in 4 days on average without the need of adjuvant medications. One patient with high morphine dosage (20 mg/d), interestingly, did not show any withdrawal symptoms.Conclusions: The detoxification protocol was effective in preventing withdrawal signs without increasing pain severity, allowing to rapidly convert IT morphine to ziconotide monotherapy in patients who are refractory to morphine.
Two monophasic oral contraceptives containing gestodene (GTD, 75 micrograms) and ethinylestradiol (EE, 30 micrograms) or norgestimate (NGS, 250 micrograms) and EE (35 micrograms) were compared during the first six cycles of use. The subjects were randomly assigned to receive either type: 97 received GTD/EE and 92 NGS/EE. Six women in the GTD/EE group and nine in the NGS/EE group withdrew from the study; three (3%) and two (2%), respectively, withdrew because of adverse reactions. A total of 562 cycles for GTD/EE and 523 for NGS/EE were available. No woman became pregnant during the study. Overall, 94.4% of cycles in the GTD/EE group and 92.8% in the NGS/EE group were normal. A similar incidence of breakthrough bleeding (0.2% of cycles for GTD and 1.6% for NGS) and spotting (5.4% vs. 5.6%) was observed. Amenorrhea was never reported. Duration of withdrawal bleeding tended to be slightly longer in the NGS/EE group, significantly so for cycles 2 (0.5 days, p = 0.016), 4 (0.5 days, p = 0.031) and 5 (0.4 days, p = 0.045). Cycle 2 was significantly longer in the GTD/EE group (0.3 days, p = 0.027). Side-effects were reported by 12 (12%) women in the GTD/EE group and 13 (14%) in the NGS/EE group. The most common side-effects were headache (five cases (5%) in the GTD/EE group and two (2%) in the NGS/EE group) and breast pain (three (3%) and eight (9%) cases respectively). There were no statistically significant differences between the two groups with respect to change in body weight or changes in blood pressure and in laboratory data.(ABSTRACT TRUNCATED AT 250 WORDS)
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