Giada Crescioli | Università degli Studi di Firenze (University of Florence) (original) (raw)

Papers by Giada Crescioli

British Journal of Clinical Pharmacology, Jul 3, 2018

Clinical Pharmacology & Therapeutics, Feb 26, 2021

The prevention of fetal growth restriction (FGR) is challenging in clinical practice. To date, no... more The prevention of fetal growth restriction (FGR) is challenging in clinical practice. To date, no meta-analysis summarized evidence on the relative benefits and harms of pharmacological interventions for FGR prevention. We performed a systematic review and network meta-analysis (NetMA), searching PubMed, Embase, Cochrane Library, and ClinicalTrials. gov from inception until November 2019. We included clinical trials and observational studies on singleton gestating women evaluating antiplatelet, anticoagulant, or other treatments, compared between each other or with controls (placebo or no treatment), and considering the pregnancy outcome FGR (primary outcome of the NetMA). Secondary efficacy outcomes included preterm birth, placental abruption, and fetal or neonatal death. Safety outcomes included bleeding and thrombocytopenia. Network meta-analyses using a frequentist framework were conducted to derive odds ratios (ORs) and 95% confidence intervals (CIs). Of 18,780 citations, we included 30 studies on 4,326 patients. Low molecular weight heparin (LMWH), alone or associated with low-dose aspirin (LDA), appeared more efficacious than controls in preventing FGR (OR 2.00, 95% CI 1.27-3.16 and OR 2.67, 95% CI 1.21-5.89 for controls vs. LMWH and LDA + LMWH, respectively). No difference between active treatments emerged in terms of FGR prevention, but estimates for treatments other than LMWH +/-LDA were imprecise. Only the confidence in the evidence regarding LMWH vs. controls was judged as moderate, according to the Confidence in Network Meta-Analysis framework. No treatment was associated with an increased risk of bleeding, although estimates were precise enough only for LMWH. These results should inform clinicians on the benefits of active pharmacological prophylaxis for FGR prevention. Fetal growth restriction (FGR) is a relatively common pregnancy complication and is usually defined based on the discrepancy between actual and expected fetal ultrasound biometric measurements for a given gestational age. 1 Fetuses with FGR do not achieve the genetically predetermined growth potential as a result of maternal (e.g., undernutrition, exposure to toxins,

European Heart Journal, Nov 1, 2020

Journal of Clinical Medicine

The present study examined the role of the perception of risks and benefits for the mother and he... more The present study examined the role of the perception of risks and benefits for the mother and her babies in deciding about the COVID-19 vaccination. In this cross-sectional study, five hypotheses were tested using data from a convenience sample of Italian pregnant and/or breastfeeding women (N = 1104, July–September 2021). A logistic regression model estimated the influence of the predictors on the reported behavior, and a beta regression model was used to evaluate which factors influenced the willingness to become vaccinated among unvaccinated women. The COVID-19 vaccination overall risks/benefits tradeoff was highly predictive of both behavior and intention. Ceteris paribus, an increase in the perception of risks for the baby weighed more against vaccination than a similar increase in the perception of risks for the mother. Additionally, pregnant women resulted in being less likely (or willing) to be vaccinated in their status than breastfeeding women, but they were equally accep...

Pharmacoepidemiology and Drug Safety, 2021

Phytotherapy Research, Jul 18, 2023

The safety of Serenoa repens (SR)‐containing products was evaluated conducting a retrospective wo... more The safety of Serenoa repens (SR)‐containing products was evaluated conducting a retrospective worldwide analysis of pharmaco‐ and phytovigilance report forms of suspected adverse reactions (SARs) collected up to 31 January 2022. Multivariate logistic regression was performed to estimate the odds ratios (ORs) of serious SAR. A total of 1810 report forms were analysed; 92% of subjects were males, with a median age of 69 years; 44% of cases were defined as serious. Subjects exposed to dietary supplements had a higher risk of developing serious SARs (OR: 1.60 [95% CI: 1.20–2.15]), as subjects exposed to 2–5 (OR: 1. 83 [95% CI: 1.30–2.58]) or more than 5 (OR: 3.45 [95% CI: 2.36–5.06]) suspect/interacting products. The probability of experiencing serious SAR was higher for subjects exposed to concomitant products (OR: 1.55 [95% CI: 1.15–2.08]), to more than four active compounds (OR: 4.38 [95% CI: 3.21–5.99]) and to SR for more than 14 days (OR: 1.89 [95% CI: 1.10–3, 22]), and lower for subjects exposed to higher doses of SR (OR: of 0.34 [95% CI: 0.20–0.58]). This evidence improves awareness on safety of SR containing products, suggesting the need of a further update of periodic reviews by national and international regulatory agencies.

Journal of Clinical Medicine

Vitamin D (VitD) is largely used in Italy, often inappropriately; thus, an evaluation of its safe... more Vitamin D (VitD) is largely used in Italy, often inappropriately; thus, an evaluation of its safety is a crucial issue. This study analyses the adverse reactions (ARs) associated with the use of products containing VitD (VitDps) reported to the Italian National Pharmacovigilance and Phytovigilance networks. From March 2002 to August 2022, a total of 643 and 127 reports concerning 903 and 215 ARs were retrieved from Pharmacovigilance and Phytovigilance networks, respectively. Overall, 332 (29.6%) ARs were classified as serious, and the most described ones were hypercalcaemia, renal failure and tachycardia. Serious AR risk was significantly higher for subjects using more than four concomitant products (OR 2.44 [95% CI 1.30–4.60]) and VitD doses higher than 1000 IU/day (OR 2.70 [95% CI 1.30–5.64]). In Italy, there was a modest decrease in AR reporting, despite the slightly increased use of VitD during the COVID-19 pandemic. To the best of our knowledge, this is the first study describi...

Pharmacoepidemiology and Drug Safety

Frontiers in Pharmacology

Current medical research and opinion, Jan 25, 2018

Objective According to American clinical guidelines, allopurinol and febuxostat may be prescribed... more Objective According to American clinical guidelines, allopurinol and febuxostat may be prescribed as first-line therapy to treat hyperuricemia. However, the Italian Medicines Agency directive, called Nota 91, allows the reimbursement of second-line febuxostat in case of failure and/or intolerance of a previous allopurinol therapy, so partially embracing European League Against Rheumatism recommendations and the British Society for Rheumatology Guideline. Such inconsistency might lead to heterogeneity among General Practitioners (GPs) in treatment of hyperuricemia. This study therefore aimed to evaluate the prescribing behavior of GPs in terms of compliance with Nota 91 and/or official guidelines. Methods Using the Health Search Database, a retrospective cohort study was conducted to evaluate the patterns of use of allopurinol and febuxostat between 2011 and 2016. Results 44,257 and 5,837 patients were prescribed with allopurinol and febuxostat, respectively. Among febuxostat users, ...

Evidence-Based Complementary and Alternative Medicine

Introduction. Complementary and alternative medicines (CAMs) are commonly used among lactating wo... more Introduction. Complementary and alternative medicines (CAMs) are commonly used among lactating women, despite the poor knowledge of these products and of their safety. Perception of pregnancy- and breastfeeding-related difficulties and consequent use of CAMs may differ in bereaved women, by force of the distress related to previous loss, although no literature evidence is available. This Herbal supplements in Breastfeeding InvesTigation (HaBIT) post hoc analysis explored the impact of previous pregnancy loss on lactating behaviors and on use of CAMs during breastfeeding. Methods. A web-based survey was conducted among lactating women with no previous alive child, resident in Tuscany (Italy). Data on lactating behavior and on CAMs use were collected and evaluated among women with previous pregnancy loss as compared to control women. Results. Out of 476 women answering the questionnaire, 233 lactating women with one child were considered. Of them, 80 had history of pregnancy loss. Ces...

Internal and emergency medicine, Jan 25, 2018

Herbal weight-loss supplements are sold as self-medication products, and are often used under the... more Herbal weight-loss supplements are sold as self-medication products, and are often used under the misconception that their natural origin guarantees their safety. Food supplements are not required to provide any benefit/risk profile evaluation before marketing; however, possible risks associated with use of herbal extracts in food supplements are becoming more and more documented in the literature. Some herbs are listed as the leading cause of herb-induced liver injury, with a severe or potentially lethal clinical course, and unpredictable herb-drug interactions. Garcinia cambogia (GC) extract and GC-containing products are some of the most popular dietary supplements currently marketed for weight loss. Here, we present four cases of acute liver failure in women taking GC extract for weight loss, and a literature review of clinical evidences about hepatic toxicity in patients taking dietary supplements containing GC extract.

Clinical drug investigation, Jan 24, 2018

First-line treatment of chronic phase (CP) chronic myeloid leukemia (CML) is based on the first-g... more First-line treatment of chronic phase (CP) chronic myeloid leukemia (CML) is based on the first-generation tyrosine kinase inhibitor (TKI) imatinib or the second-generation TKIs dasatinib or nilotinib. Thanks to the efficacy of TKIs, CML has switched from a fatal to a 'chronic' pathology, and data from clinical trials have become insufficient to drive physicians' prescription choices and address long-term treatment outcomes. On the brink of commercialization of generic imatinib, this study aims to evaluate the therapeutic pattern of CP-CML and the occurrence of adverse events (AEs) over a decade of local real clinical practice. A retrospective cohort study was performed on CP-CML patients followed up in the Local Health Unit of Treviso (Veneto Region, Italy) during the period 2005-2015. Data were captured from both administrative databases and physicians' patient diaries. Of 81 CP-CML patients, 73 were treated with first-line imatinib; among the second-generation TKI...

British journal of clinical pharmacology, Jan 16, 2018

Use of complementary and alternative medicines (CAMs) during breastfeeding is commonly increasing... more Use of complementary and alternative medicines (CAMs) during breastfeeding is commonly increasing, mainly due to their presumed higher safety compared to conventional medications. Indeed, CAMs can cause serious adverse effects, and high-quality evidence supporting their use during lactation is limited. In Italy, specific investigations on the attitude of lactating women towards CAMs are lacking. The Herbal supplements in Breastfeeding InvesTigation (HaBIT) aimed to explore the attitudes and knowledge on CAMs among lactating women. A web-based survey was conducted over a six-year period among lactating women resident in Tuscany (Italy). Data on lactating behavior, CAMs use during pregnancy or breastfeeding, and women knowledge about CAMs' efficacy and safety were collected. 388 lactating women answered the questionnaire; the majority of them were primiparae with high education level. Two-hundred and four women declared to have been CAMs users during breastfeeding. Moreover, the 6...

BMC cancer, Jan 18, 2018

Inter-patient variability in response to opioids is well known but a comprehensive definition of ... more Inter-patient variability in response to opioids is well known but a comprehensive definition of its pathophysiological mechanism is still lacking and, more importantly, no studies have focused on children. The STOP Pain project aimed to evaluate the risk factors that contribute to clinical response and adverse drug reactions to opioids by means of a systematic review and a clinical investigation on paediatric oncological patients. We conducted a systematic literature search in EMBASE and PubMed up to the 24th of November 2016 following Cochrane Handbook and PRISMA guidelines. Two independent reviewers screened titles and abstracts along with full-text papers; disagreements were resolved by discussion with two other independent reviewers. We used a data extraction form to provide details of the included studies, and conducted quality assessment using the Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies. Young age, lung or gastrointestinal cancer, neuropat...

British Journal of Clinical Pharmacology, Jul 3, 2018

Clinical Pharmacology & Therapeutics, Feb 26, 2021

The prevention of fetal growth restriction (FGR) is challenging in clinical practice. To date, no... more The prevention of fetal growth restriction (FGR) is challenging in clinical practice. To date, no meta-analysis summarized evidence on the relative benefits and harms of pharmacological interventions for FGR prevention. We performed a systematic review and network meta-analysis (NetMA), searching PubMed, Embase, Cochrane Library, and ClinicalTrials. gov from inception until November 2019. We included clinical trials and observational studies on singleton gestating women evaluating antiplatelet, anticoagulant, or other treatments, compared between each other or with controls (placebo or no treatment), and considering the pregnancy outcome FGR (primary outcome of the NetMA). Secondary efficacy outcomes included preterm birth, placental abruption, and fetal or neonatal death. Safety outcomes included bleeding and thrombocytopenia. Network meta-analyses using a frequentist framework were conducted to derive odds ratios (ORs) and 95% confidence intervals (CIs). Of 18,780 citations, we included 30 studies on 4,326 patients. Low molecular weight heparin (LMWH), alone or associated with low-dose aspirin (LDA), appeared more efficacious than controls in preventing FGR (OR 2.00, 95% CI 1.27-3.16 and OR 2.67, 95% CI 1.21-5.89 for controls vs. LMWH and LDA + LMWH, respectively). No difference between active treatments emerged in terms of FGR prevention, but estimates for treatments other than LMWH +/-LDA were imprecise. Only the confidence in the evidence regarding LMWH vs. controls was judged as moderate, according to the Confidence in Network Meta-Analysis framework. No treatment was associated with an increased risk of bleeding, although estimates were precise enough only for LMWH. These results should inform clinicians on the benefits of active pharmacological prophylaxis for FGR prevention. Fetal growth restriction (FGR) is a relatively common pregnancy complication and is usually defined based on the discrepancy between actual and expected fetal ultrasound biometric measurements for a given gestational age. 1 Fetuses with FGR do not achieve the genetically predetermined growth potential as a result of maternal (e.g., undernutrition, exposure to toxins,

European Heart Journal, Nov 1, 2020

Journal of Clinical Medicine

The present study examined the role of the perception of risks and benefits for the mother and he... more The present study examined the role of the perception of risks and benefits for the mother and her babies in deciding about the COVID-19 vaccination. In this cross-sectional study, five hypotheses were tested using data from a convenience sample of Italian pregnant and/or breastfeeding women (N = 1104, July–September 2021). A logistic regression model estimated the influence of the predictors on the reported behavior, and a beta regression model was used to evaluate which factors influenced the willingness to become vaccinated among unvaccinated women. The COVID-19 vaccination overall risks/benefits tradeoff was highly predictive of both behavior and intention. Ceteris paribus, an increase in the perception of risks for the baby weighed more against vaccination than a similar increase in the perception of risks for the mother. Additionally, pregnant women resulted in being less likely (or willing) to be vaccinated in their status than breastfeeding women, but they were equally accep...

Pharmacoepidemiology and Drug Safety, 2021

Phytotherapy Research, Jul 18, 2023

The safety of Serenoa repens (SR)‐containing products was evaluated conducting a retrospective wo... more The safety of Serenoa repens (SR)‐containing products was evaluated conducting a retrospective worldwide analysis of pharmaco‐ and phytovigilance report forms of suspected adverse reactions (SARs) collected up to 31 January 2022. Multivariate logistic regression was performed to estimate the odds ratios (ORs) of serious SAR. A total of 1810 report forms were analysed; 92% of subjects were males, with a median age of 69 years; 44% of cases were defined as serious. Subjects exposed to dietary supplements had a higher risk of developing serious SARs (OR: 1.60 [95% CI: 1.20–2.15]), as subjects exposed to 2–5 (OR: 1. 83 [95% CI: 1.30–2.58]) or more than 5 (OR: 3.45 [95% CI: 2.36–5.06]) suspect/interacting products. The probability of experiencing serious SAR was higher for subjects exposed to concomitant products (OR: 1.55 [95% CI: 1.15–2.08]), to more than four active compounds (OR: 4.38 [95% CI: 3.21–5.99]) and to SR for more than 14 days (OR: 1.89 [95% CI: 1.10–3, 22]), and lower for subjects exposed to higher doses of SR (OR: of 0.34 [95% CI: 0.20–0.58]). This evidence improves awareness on safety of SR containing products, suggesting the need of a further update of periodic reviews by national and international regulatory agencies.

Journal of Clinical Medicine

Vitamin D (VitD) is largely used in Italy, often inappropriately; thus, an evaluation of its safe... more Vitamin D (VitD) is largely used in Italy, often inappropriately; thus, an evaluation of its safety is a crucial issue. This study analyses the adverse reactions (ARs) associated with the use of products containing VitD (VitDps) reported to the Italian National Pharmacovigilance and Phytovigilance networks. From March 2002 to August 2022, a total of 643 and 127 reports concerning 903 and 215 ARs were retrieved from Pharmacovigilance and Phytovigilance networks, respectively. Overall, 332 (29.6%) ARs were classified as serious, and the most described ones were hypercalcaemia, renal failure and tachycardia. Serious AR risk was significantly higher for subjects using more than four concomitant products (OR 2.44 [95% CI 1.30–4.60]) and VitD doses higher than 1000 IU/day (OR 2.70 [95% CI 1.30–5.64]). In Italy, there was a modest decrease in AR reporting, despite the slightly increased use of VitD during the COVID-19 pandemic. To the best of our knowledge, this is the first study describi...

Pharmacoepidemiology and Drug Safety

Frontiers in Pharmacology

Current medical research and opinion, Jan 25, 2018

Objective According to American clinical guidelines, allopurinol and febuxostat may be prescribed... more Objective According to American clinical guidelines, allopurinol and febuxostat may be prescribed as first-line therapy to treat hyperuricemia. However, the Italian Medicines Agency directive, called Nota 91, allows the reimbursement of second-line febuxostat in case of failure and/or intolerance of a previous allopurinol therapy, so partially embracing European League Against Rheumatism recommendations and the British Society for Rheumatology Guideline. Such inconsistency might lead to heterogeneity among General Practitioners (GPs) in treatment of hyperuricemia. This study therefore aimed to evaluate the prescribing behavior of GPs in terms of compliance with Nota 91 and/or official guidelines. Methods Using the Health Search Database, a retrospective cohort study was conducted to evaluate the patterns of use of allopurinol and febuxostat between 2011 and 2016. Results 44,257 and 5,837 patients were prescribed with allopurinol and febuxostat, respectively. Among febuxostat users, ...

Evidence-Based Complementary and Alternative Medicine

Introduction. Complementary and alternative medicines (CAMs) are commonly used among lactating wo... more Introduction. Complementary and alternative medicines (CAMs) are commonly used among lactating women, despite the poor knowledge of these products and of their safety. Perception of pregnancy- and breastfeeding-related difficulties and consequent use of CAMs may differ in bereaved women, by force of the distress related to previous loss, although no literature evidence is available. This Herbal supplements in Breastfeeding InvesTigation (HaBIT) post hoc analysis explored the impact of previous pregnancy loss on lactating behaviors and on use of CAMs during breastfeeding. Methods. A web-based survey was conducted among lactating women with no previous alive child, resident in Tuscany (Italy). Data on lactating behavior and on CAMs use were collected and evaluated among women with previous pregnancy loss as compared to control women. Results. Out of 476 women answering the questionnaire, 233 lactating women with one child were considered. Of them, 80 had history of pregnancy loss. Ces...

Internal and emergency medicine, Jan 25, 2018

Herbal weight-loss supplements are sold as self-medication products, and are often used under the... more Herbal weight-loss supplements are sold as self-medication products, and are often used under the misconception that their natural origin guarantees their safety. Food supplements are not required to provide any benefit/risk profile evaluation before marketing; however, possible risks associated with use of herbal extracts in food supplements are becoming more and more documented in the literature. Some herbs are listed as the leading cause of herb-induced liver injury, with a severe or potentially lethal clinical course, and unpredictable herb-drug interactions. Garcinia cambogia (GC) extract and GC-containing products are some of the most popular dietary supplements currently marketed for weight loss. Here, we present four cases of acute liver failure in women taking GC extract for weight loss, and a literature review of clinical evidences about hepatic toxicity in patients taking dietary supplements containing GC extract.

Clinical drug investigation, Jan 24, 2018

First-line treatment of chronic phase (CP) chronic myeloid leukemia (CML) is based on the first-g... more First-line treatment of chronic phase (CP) chronic myeloid leukemia (CML) is based on the first-generation tyrosine kinase inhibitor (TKI) imatinib or the second-generation TKIs dasatinib or nilotinib. Thanks to the efficacy of TKIs, CML has switched from a fatal to a 'chronic' pathology, and data from clinical trials have become insufficient to drive physicians' prescription choices and address long-term treatment outcomes. On the brink of commercialization of generic imatinib, this study aims to evaluate the therapeutic pattern of CP-CML and the occurrence of adverse events (AEs) over a decade of local real clinical practice. A retrospective cohort study was performed on CP-CML patients followed up in the Local Health Unit of Treviso (Veneto Region, Italy) during the period 2005-2015. Data were captured from both administrative databases and physicians' patient diaries. Of 81 CP-CML patients, 73 were treated with first-line imatinib; among the second-generation TKI...

British journal of clinical pharmacology, Jan 16, 2018

Use of complementary and alternative medicines (CAMs) during breastfeeding is commonly increasing... more Use of complementary and alternative medicines (CAMs) during breastfeeding is commonly increasing, mainly due to their presumed higher safety compared to conventional medications. Indeed, CAMs can cause serious adverse effects, and high-quality evidence supporting their use during lactation is limited. In Italy, specific investigations on the attitude of lactating women towards CAMs are lacking. The Herbal supplements in Breastfeeding InvesTigation (HaBIT) aimed to explore the attitudes and knowledge on CAMs among lactating women. A web-based survey was conducted over a six-year period among lactating women resident in Tuscany (Italy). Data on lactating behavior, CAMs use during pregnancy or breastfeeding, and women knowledge about CAMs' efficacy and safety were collected. 388 lactating women answered the questionnaire; the majority of them were primiparae with high education level. Two-hundred and four women declared to have been CAMs users during breastfeeding. Moreover, the 6...

BMC cancer, Jan 18, 2018

Inter-patient variability in response to opioids is well known but a comprehensive definition of ... more Inter-patient variability in response to opioids is well known but a comprehensive definition of its pathophysiological mechanism is still lacking and, more importantly, no studies have focused on children. The STOP Pain project aimed to evaluate the risk factors that contribute to clinical response and adverse drug reactions to opioids by means of a systematic review and a clinical investigation on paediatric oncological patients. We conducted a systematic literature search in EMBASE and PubMed up to the 24th of November 2016 following Cochrane Handbook and PRISMA guidelines. Two independent reviewers screened titles and abstracts along with full-text papers; disagreements were resolved by discussion with two other independent reviewers. We used a data extraction form to provide details of the included studies, and conducted quality assessment using the Quality Assessment Tool for Observational Cohort and Cross-Sectional Studies. Young age, lung or gastrointestinal cancer, neuropat...