ObjectivesThe number of elderly patients diagnosed with hepatocellular carcinoma (HCC) is expected to increase. We compared the presenting features and outcome of HCC in elderly (≥70 years) and ...younger patients (<70 years).DesignMulticentre retrospective cohort study and nested case–control study.Patients614 elderly and 1104 younger patients from the ITA.LI.CA database, including 1834 HCC cases consecutively diagnosed from January 1987 to December 2004. Both groups were stratified according to treatment: hepatic resection, percutaneous procedures, transarterial chemoembolisation (TACE). Survival was assessed in the whole population and in each treatment subgroup. Age, sex, aetiology, cirrhosis, comorbidities and cancer stage (CLIP score) were tested as predictors of survival. In each subgroup, differences in patient survival were also assessed after adjustment and matching by propensity score.ResultsAgeing was associated with a higher prevalence of comorbidities, better liver function and CLIP score. Regardless of age, two-thirds of patients underwent radical treatments or TACE. Elderly patients underwent more ablative procedures and fewer resections or TACE sessions. The survival of elderly and younger patients was comparable in each treatment subset, and was predicted by CLIP score. This result was confirmed by the propensity analysis.ConclusionsThe overall applicability of radical or effective HCC treatments was unaffected by old age. However, treatment distribution differed, elderly individuals being more frequently treated with percutaneous procedures and less frequently with resection or TACE. Survival was unaffected by age and primarily predicted by cancer stage, assessed by the CLIP system, both in the overall population and in treatment subgroups.
A case of liver injury during lipid‐lowering therapy Agnoletti, Davide; Fogacci, Federica; Di Micoli, Antonio ...
Phytotherapy research,
November 2022, 2022-11-00, 20221101, Letnik:
36, Številka:
11
Journal Article
We investigated sex and racial inequalities in clinical trials testing serum uric acid (SUA) lowering drugs and analyzed the temporal trends of participation among the pre-specified demographic ...groups.
Data were collected from publications of clinical trials testing SUA-lowering drugs. Linear regression analysis was performed to assess the relation between drug approval year and proportion of women and minorities enrolled in clinical studies.
The mean percentage enrollment of women in clinical trials significantly decreased over the time (r = −0.43, P-value = 0.02). Moreover, there was a statistically significant difference in mean percentage enrollment of women among trials testing different SUA-lowering drugs, with the highest representation in rasburicase (71.1%) and the lowest representation of women in dotinurad (0.8%). Over the time, also the mean percentage enrollment of racial minorities decreased, passing from 8.7% to 2.2% in a 10-year period.
Women were proportionally underrepresented compared with their share of the population with asymptomatic hyperuricemia, overall (participation-to-prevalence ratio (PPR) = 0.34), in trials testing xanthine oxiase inhibitors (PPR = 0.38) and uricosurics (PPR = 0.29), and in trials with febuxostat, allopurinol, pegloticase, halofenate/arhalofenate, verinurad, lesinurad and dotinurad. Women were proportionally underreppresented also compared with their share of the population with gout, overall (PPR = 0.69) and in trials testing XOIs (PPR = 0.69), uricosurics (PPR = 0.68), and all SUA-lowering drugs excepted for rasburicase, pegloticase and topiroxostat.
Our analysis shows that women and racial and ethnical minorities are underrepresented in controlled clinical trials testing SUA-lowering drugs, with similar pattern across drug classes.
•Women and racial/ethnical minorities are underrepresented in clinical trials testing urate lowering drugs.•Sex and ethnic inequalities sharpened over time in clinical research regarding urate lowering drugs.•Further efforts are needed to ensure complete information about management of hyperuricemia and gout.
Our aim was to evaluate if a nutritional intervention with a dietary supplement (Diuripres®) containing magnesium, standardized extract of orthosiphon, hawthorn, and hibiscus could positively affect ...blood pressure (BP), vascular health, and metabolic parameters in 60 individuals with high-normal BP or stage I hypertension. Participants followed a low-fat low-sodium Mediterranean diet for 4 weeks before being randomly allocated to 8-week treatment with two pills each day of either Diuripres® or placebo. Diuripres® significantly decreased systolic BP compared to placebo after 4 weeks (3.1 ± 0.8 mmHg; p < 0.05) and more consistently after 8 weeks (3.4 ± 0.9 mmHg; p < 0.05). At 8-week follow-up, after correction for multiple testing, dietary supplementation with Diuripres® was associated with significant improvements in diastolic BP (-3.1 ± 0.6 mmHg; p < 0.05), aortic BP (-4.3 ± 0.4 mmHg; p < 0.05), and high-sensitivity C-reactive protein (hs-CRP; 0.04 ± 0.01 mg/dL; p < 0.05) in comparison with baseline. The reductions in diastolic BP (--3.8 ± 0.7 mmHg; p < 0.05), aortic BP (-5.2 ± 1.0 mmHg; p < 0.05), and hs-CRP (-0.03 ± 0.01 mg/dL; p < 0.05) were also significant compared to placebo. Therefore, our study shows that dietary supplementation with Diuripres® may be useful in individuals with high-normal BP or stage I hypertension.
The aim of this study was to assess whether dietary supplementation with a nutraceutical blend comprising extracts of bergamot and artichoke—both standardized in their characteristic polyphenolic ...fractions—could positively affect serum lipid concentration and insulin sensitivity, high-sensitivity C-reactive protein (hs-CRP), and indexes of non-alcoholic fatty liver disease (NAFLD) in 90 healthy individuals with suboptimal cholesterol levels. Participants were randomly allocated to treatment with a pill of either active treatment or placebo. After 6 weeks, the active-treated group experienced significant improvements in levels of triglycerides (TG), apolipoprotein B-100 (Apo B-100), and apolipoprotein AI (Apo AI) versus baseline. Total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C), non-high density lipoprotein cholesterol (Non-HDL-C), and hs-CRP also significantly decreased in the active-treated group compared to both baseline and placebo. At the 12-week follow-up, individuals allocated to the combined nutraceutical experienced a significant improvement in TC, LDL-C, Non-HDL-C, TG, Apo B-100, Apo AI, glucose, alanine transaminase (ALT), gamma-glutamyl transferase (gGT), hs-CRP, several indexes of NAFLD, and brachial pulse volume (PV) in comparison with baseline. Improvements in TC, LDL-C, Non-HDL-C, TG, fatty liver index (FLI), hs-CRP, and endothelial reactivity were also detected compared to placebo (p < 0.05 for all). Overall, these findings support the use of the tested dietary supplement containing dry extracts of bergamot and artichoke as a safe and effective approach for the prevention and management of a broad spectrum of cardiometabolic disorders.
Is the First Cut Always the Deepest? Borghi, Claudio; Di Micoli, Antonio; Fiorini, Giulia
Hypertension,
06/2023, Letnik:
80, Številka:
6
Journal Article
A 78-year-old man came to our attention after undergoing coronary computed tomography angiography documenting multivessel coronary artery disease. He was started on treatment with the proprotein ...convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab 140 mg subcutaneously every 2 weeks. Treatment-emergent changes in lipids and lipoproteins were long-lasting, and the medication was well tolerated by the patient in the long-term. Unexpectedly, after 2 years of continuous treatment with evolocumab, serum lipids increased, apparently without any reasonable explanation. During the follow-up visit, the patient was found to have habitually injected evolocumab into his right thumb instead of into the appropriate injection sites (i.e., abdomen, thighs or upper arms) after turning the injector upside down.
A 78-year-old man came to our attention after undergoing coronary computed tomography angiography documenting multivessel coronary artery disease. He was started on treatment with the proprotein ...convertase subtilisin/kexin type 9 (PCSK9) inhibitor evolocumab 140 mg subcutaneously every 2 weeks. Treatment-emergent changes in lipids and lipoproteins were long-lasting, and the medication was well tolerated by the patient in the long-term. Unexpectedly, after 2 years of continuous treatment with evolocumab, serum lipids increased, apparently without any reasonable explanation. During the follow-up visit, the patient was found to have habitually injected evolocumab into his right thumb instead of into the appropriate injection sites (i.e., abdomen, thighs or upper arms) after turning the injector upside down.
Emerging research and epidemiological studies established the health benefits of the Mediterranean diet, whose hallmark is the high consumption of olives and olive oil as the primary source of ...dietary fatty acids and major sources of antioxidants. The aim of this study was to evaluate the effect of daily dietary supplementation with highly standardized polyphenols—mainly hydroxytyrosol—which are derived from olive oil production by-products of an Italian olive variety (Coratina Olive) on the plasma cholesterol of a sample of hypercholesterolemic individuals. This single-arm, non-controlled, non-randomized, prospective pilot clinical study involved a sample of 30 volunteers with polygenic hypercholesterolemia. The study design included a 2-week run-in and a 4-week intervention period. Patients were evaluated for their clinical status and by the execution of a physical examination and laboratory analyses before and after the treatment. The intervention effect was assessed using Levene’s test followed by the independent Student’s t test after the log-transformation of the non-normally distributed continuous variables. Dietary supplementation with highly standardized polyphenols that are derived from Coratina Olive (namely SelectSIEVE® OptiChol) was associated with a significant improvement in systolic blood pressure, pulse pressure, total cholesterol, high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol, non-HDL-C, fasting plasma glucose, and uric acid compared to baseline values. Furthermore, SelectSIEVE® OptiChol was well tolerated by volunteers. We acknowledge that the study has some limitations, namely the small patient sample, the short follow-up, and the lack of randomization and control procedures. However, these results are consistent with previous literature that referred to extracts from different olive varieties. Definitely, our observations lay further foundations for the use of polyphenolic-rich olive extract from Coratina Olive in the prevention and treatment of first-stage metabolic syndrome.
Recently released position papers by the European Society of Hypertension (ESH) and the Italian Society of Hypertension (SIIA) provide therapeutic recommendations for the use of nutraceuticals in the ...management of high blood pressure (BP) and hypertension, opening up new perspectives in the field. This not-randomized diet-controlled clinical study aimed to evaluate if daily dietary supplementation with black garlic and pomegranate (namely SelectSIEVE® SlowBeat) could advantageously affect BP in individuals with high-normal BP or stage I hypertension. Enrolled subjects were adhering to a Mediterranean DASH (Dietary Approaches to Stop Hypertension) diet for two weeks before deciding whether to continue following Mediterranean DASH diet alone or in association with SelectSIEVE® SlowBeat. At the end of the study, dietary supplementation with SelectSIEVE® SlowBeat was associated with significant improvement in systolic blood pressure (SBP) and diastolic blood pressure (DBP) compared to baseline (Pre-treatment: SBP = 134.3 ± 4.2 and DBP = 88.2 ± 3.4; 4-Week Follow-up: SBP = 130.1 ± 2.8 and DBP= 83.7 ± 2.6). SBP improved also in comparison with control. In conclusion, the study shows that dietary supplementation with extracts from black garlic and pomegranate safely exert significant improvements in BP in healthy individuals adhering to a Mediterranean DASH diet.
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