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Evaluating adherence, tolerability and safety of oral calcium citrate in elderly osteopenic subjects: a real-life non-interventional, prospective, multicenter study.
Rondanelli, M, Minisola, S, Barale, M, Barbaro, D, Mansueto, F, Battaglia, S, Bonaccorsi, G, Caliri, S, Cavioni, A, Colangelo, L, et al
Aging clinical and experimental research. 2024;36(1):38
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Plain language summary
The occurrence of fractures and osteoporosis are significant concerns in elderly adults, as ageing remains one of the primary risk factors for these conditions. While the incidence of fracture and risk may vary, the incidence of fragility fractures significantly increases with advancing age, particularly after the age of 50 years. This study's aim was to evaluate the adherence, tolerability, and safety of calcium citrate administration in an "outpatient" population in routine clinical practice. This study was a non-interventional, prospective, multicentre study. Two-hundred and sixty-eight individuals (comprised 245 females (91.4%) and 23 males (8.6%)) were enrolled. Results showed a high rate of adherence to calcium citrate supplementation over a one-year period in osteopenic elderly subjects. Additionally, the incidence of adverse reactions was low (3.9%), further emphasizing the tolerability of calcium citrate. Authors concluded that future studies designed to assess the long-term impact of calcium citrate supplementation on hard endpoints, such as bone density, fractures/falls, quality of life measures and adherence are needed.
Expert Review
Conflicts of interest:
None
Take Home Message:
- The occurrence of fractures and osteoporosis are significant concerns in older adults, as ageing remains one of the primary risk factors for this condition.
- Calcium supplementation, usually with vitamin D, is a recommended complement to other specific pharmacological treatments of osteoporosis.
- This non-interventional, prospective multicentre study suggests a 91% adherence to calcium citrate supplementation over one year in elderly osteopenic patients with generally good (80%) tolerability and 4% reporting gastrointestinal adverse effects.
Evidence Category:
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A: Meta-analyses, position-stands, randomized-controlled trials (RCTs)
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B: Systematic reviews including RCTs of limited number
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X
C: Non-randomized trials, observational studies, narrative reviews
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D: Case-reports, evidence-based clinical findings
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E: Opinion piece, other
Summary Review:
Introduction
A non-interventional, prospective multicentre study was conducted to evaluate the adherence, safety, and tolerability of calcium citrate supplementation in elderly osteopenic subjects.
Method:
A total of 231 Caucasian female (91%) and male (8%) participants with a median age of 70 received 500mg of calcium citrate supplementation daily for one year. Adherence was assessed based on tolerability, compliance, and persistence. Safety evaluations included monitoring of adverse reactions (ARs), physical examinations, and clinical laboratory evaluations.
Results
A total of 222 out of 231 participants (96%) completed the study. Nine subjects did not return for assessments or complete their diaries.
The primary and secondary findings of this study were as follows:
- An average adherence of 91% of oral calcium citrate supplementation was observed which was higher than the reported reference rate of 57% (p = 0.0179).
- Subjects with adherence <80% experienced a higher frequency of adverse events compared to those with adherence >80% (32/77; 42% vs 16/145%, (p = 0.0001).
- Gastrointestinal ARs were the most commonly reported, with constipation comprising 50% of all reported ARs.
- Reductions in systolic (130.7 ± 16.9 mmHg to 127.9 ± 14.5 mmHg) (p = 0.0102) and diastolic blood pressure 79.5 ± 8.7 mmHg to 77.4 ± 8.6 mmHg (baseline to V2) (p = 0.0116) were observed from baseline to the second visit.
- Positive changes were also noted in nutritional status (p = 0.0116), circulatory system disorders (p = 0.0001), and muscles/skeleton disorders (p = 0.0067) from baseline to post-baseline visit.
Conclusion:
This study revealed a 91% adherence to calcium citrate supplementation over one year in older adults with osteopenia, Additionally, the 4% incidents of ARs reported were related to gastrointestinal disorders.
Clinical practice applications:
- The prevalence of osteoporosis rises as individuals age, with approximately 10% of women at 60 years, 20% at 70 years, and 40% at 80 years.
- Calcium supplementation, usually with vitamin D, is a recommended complement to other specific pharmacological treatments of osteoporosis.
- The safety of calcium supplements remains controversial regarding an increased risk of cardiovascular events. Therefore, it is essential to investigate the safety profile of calcium in these populations.
- This study reported adherence, tolerability, and safety of calcium citrate supplementation in osteopenic elderly patients with 4% of patients reporting gastrointestinal adverse effects.
Considerations for future research:
- This study was conducted on 91% Caucasian females and 8% males with a mean age of 70 years therefore, there is a need to include more male and Asian participants from various age groups in further research.
- Future studies are needed to assess the long-term impact of calcium citrate supplementation on bone density, fractures, and quality of life.
Abstract
BACKGROUND Osteoporosis is a common concern in the elderly that leads to fragile bones. Calcium supplementation plays a crucial role in improving bone health, reducing fracture risk, and supporting overall skeletal strength in this vulnerable population. However, there is conflicting evidence on the safety of calcium supplements in elderly individuals. AIM: The aim of this study was to evaluate the adherence, safety and tolerability of calcium citrate supplementation in elderly osteopenic subjects. METHODS In this non-interventional, prospective, multicenter study, subjects received daily 500 mg calcium citrate supplementation for up to one year. Adherence was calculated based on compliance and persistence. Safety was assessed through adverse reactions (ARs), deaths, and clinical laboratory evaluations. RESULTS A total of 268 Caucasian subjects (91.4% female, mean age 70 ± 4.5 years) participated in the study. Mean adherence to treatment was 76.6 ± 29.5% and half of subjects had an adherence of 91% and ~ 33% of participants achieved complete (100%) adherence. ARs were reported by nine (3.9%) subjects, primarily gastrointestinal disorders, with no serious ARs. The frequency of all adverse events (including ARs) was significantly higher in subjects with adherence of < 80% (41.6%; 32/77) vs. those with adherence ≥ 80% (11%; 16/145, p < 0.0001). Both systolic and diastolic blood pressure decreased from baseline to follow-up visit (change of -2.8 ± 13.9 mmHg, p = 0.0102 and -2.1 ± 10.4 mmHg, p = 0.0116, respectively). CONCLUSION This study demonstrated favorable adherence to calcium citrate supplementation in elderly osteopenic subjects. The occurrence of ARs, though generally mild, were associated with lower adherence to calcium supplementation.
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How to position sodium-glucose co-transporter 2 inhibitors in the management of diabetes in acromegaly patients.
Zaina, A, Prencipe, N, Golden, E, Berton, AM, Arad, E, Abid, A, Shehadeh, J, Kassem, S, Ghigo, E
Endocrine. 2023;(3):491-499
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Dysgeusia in Patients with Breast Cancer Treated with Chemotherapy-A Narrative Review.
Pellegrini, M, Merlo, FD, Agnello, E, Monge, T, Devecchi, A, Casalone, V, Montemurro, F, Ghigo, E, Sapino, A, Bo, S
Nutrients. 2023;(1)
Abstract
Breast cancer (BC) is the most common cancer worldwide. Chemotherapy (CT) is essential for the treatment of BC, but is often accompanied by several side effects, including taste alterations, due to different mechanisms. Although dysgeusia is usually underestimated by clinicians, it is considered very worrying and disturbing by cancer patients undergoing CT, because it induces changes in dietary choices and social habits, affecting their physical and psychological health, with a profound impact on their quality of life. Several strategies and therapies have been proposed to prevent or alleviate CT-induced dysgeusia. This review aimed to evaluate the available evidence on prevalence, pathophysiological mechanisms, clinical consequences, and strategies for managing dysgeusia in BC patients receiving CT. We queried the National Library of Medicine, the Cochrane Library, Excerpta Medica dataBASE, and the Cumulative Index to Nursing and Allied Health Literature database, performing a search strategy using database-specific keywords. We found that the literature on this topic is scarce, methodologically limited, and highly heterogeneous in terms of study design and criteria for patient inclusion, making it difficult to obtain definitive results and make recommendations for clinical practice.
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Efficacy of Teduglutide for Parenteral Support Reduction in Patients with Short Bowel Syndrome: A Systematic Review and Meta-Analysis.
Bioletto, F, D'Eusebio, C, Merlo, FD, Aimasso, U, Ossola, M, Pellegrini, M, Ponzo, V, Chiarotto, A, De Francesco, A, Ghigo, E, et al
Nutrients. 2022;(4)
Abstract
Teduglutide has been described as an effective treatment for parenteral support (PS) reduction in patients with short bowel syndrome (SBS). However, a quantitative summary of the available evidence is still lacking. PubMed/Medline, EMBASE, Cochrane library, OVID, and CINAHL databases were systematically searched up to July 2021 for studies reporting the rate of response (defined as a ≥20% reduction in PS) to teduglutide among PS-dependent adult patients. The rate of weaning (defined as the achievement of PS independence) was also evaluated as a secondary end-point. Ten studies were finally considered in the meta-analysis. Pooled data show a response rate of 64% at 6 months, 77% at 1 year and, 82% at ≥2 years; on the other hand, the weaning rate could be estimated as 11% at 6 months, 17% at 1 year, and 21% at ≥2 years. The presence of colon in continuity reduced the response rate (-17%, 95%CI: (-31%, -3%)), but was associated with a higher weaning rate (+16%, 95%CI: (+6%, +25%)). SBS etiology, on the contrary, was not found to be a significant predictor of these outcomes, although a nonsignificant trend towards both higher response rates (+9%, 95%CI: (-8%, +27%)) and higher weaning rates (+7%, 95%CI: (-14%, +28%)) could be observed in patients with Crohn's disease. This was the first meta-analysis that specifically assessed the efficacy of teduglutide in adult patients with SBS. Our results provide pooled estimates of response and weaning rates over time and identify intestinal anatomy as a significant predictor of these outcomes.
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Primary Aldosteronism and Resistant Hypertension: A Pathophysiological Insight.
Bioletto, F, Bollati, M, Lopez, C, Arata, S, Procopio, M, Ponzetto, F, Ghigo, E, Maccario, M, Parasiliti-Caprino, M
International journal of molecular sciences. 2022;(9)
Abstract
Primary aldosteronism (PA) is a pathological condition characterized by an excessive aldosterone secretion; once thought to be rare, PA is now recognized as the most common cause of secondary hypertension. Its prevalence increases with the severity of hypertension, reaching up to 29.1% in patients with resistant hypertension (RH). Both PA and RH are "high-risk phenotypes", associated with increased cardiovascular morbidity and mortality compared to non-PA and non-RH patients. Aldosterone excess, as occurs in PA, can contribute to the development of a RH phenotype through several mechanisms. First, inappropriate aldosterone levels with respect to the hydro-electrolytic status of the individual can cause salt retention and volume expansion by inducing sodium and water reabsorption in the kidney. Moreover, a growing body of evidence has highlighted the detrimental consequences of "non-classical" effects of aldosterone in several target tissues. Aldosterone-induced vascular remodeling, sympathetic overactivity, insulin resistance, and adipose tissue dysfunction can further contribute to the worsening of arterial hypertension and to the development of drug-resistance. In addition, the pro-oxidative, pro-fibrotic, and pro-inflammatory effects of aldosterone may aggravate end-organ damage, thereby perpetuating a vicious cycle that eventually leads to a more severe hypertensive phenotype. Finally, neither the pathophysiological mechanisms mediating aldosterone-driven blood pressure rise, nor those mediating aldosterone-driven end-organ damage, are specifically blocked by standard first-line anti-hypertensive drugs, which might further account for the drug-resistant phenotype that frequently characterizes PA patients.
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Development and validation of a scoring system for pre-surgical and early post-surgical prediction of bariatric surgery unsuccess at 2 years.
Bioletto, F, Pellegrini, M, D'Eusebio, C, Boschetti, S, Rahimi, F, De Francesco, A, Arolfo, S, Toppino, M, Morino, M, Ghigo, E, et al
Scientific reports. 2021;(1):21067
Abstract
Bariatric surgery (BS) is an effective treatment for morbid obesity. However, a simple and easy-to-use tool for the prediction of BS unsuccess is still lacking. Baseline and follow-up data from 300 consecutive patients who underwent BS were retrospectively collected. Supervised regression and machine-learning techniques were used for model development, in which BS unsuccess at 2 years was defined as a percentage of excess-weight-loss (%EWL) < 50%. Model performances were also assessed considering the percentage of total-weight-loss (%TWL) as the reference parameter. Two scoring systems (NAG-score and ENAG-score) were developed. NAG-score, comprising only pre-surgical data, was structured on a 4.5-point-scale (2 points for neck circumference ≥ 44 cm, 1.5 for age ≥ 50 years, and 1 for fasting glucose ≥ 118 mg/dL). ENAG-score, including also early post-operative data, was structured on a 7-point-scale (3 points for %EWL at 6 months ≤ 45%, 1.5 for neck circumference ≥ 44 cm, 1 for age ≥ 50 years, and 1.5 for fasting glucose ≥ 118 mg/dL). A 3-class-clustering was proposed for clinical application. In conclusion, our study proposed two scoring systems for pre-surgical and early post-surgical prediction of 2-year BS weight-loss, which may be useful to guide the pre-operative assessment, the appropriate balance of patients' expectations, and the post-operative care.
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Mediterranean Diet and SARS-COV-2 Infection: Is There Any Association? A Proof-of-Concept Study.
Ponzo, V, Pellegrini, M, D'Eusebio, C, Bioletto, F, Goitre, I, Buscemi, S, Frea, S, Ghigo, E, Bo, S
Nutrients. 2021;(5)
Abstract
The aim of this observational study was investigating the possible correlation between adherence to the Mediterranean diet (MeD) and SARS-COV-2 infection rates and severity among healthcare professionals (HCPs). An online self-administrated questionnaire (evaluating both MeD adherence and dietary habits) was filled out by HCPs working in Piedmont (Northern Italy) from 15 January to 28 February 2021. Out of the 1206 questionnaires collected, 900 were considered reliable and analyzed. Individuals who reported the SARS-COV-2 infection (n = 148) showed a significantly lower MeD score, with a lower adherence in fruit, vegetables, cereals, and olive oil consumption. In a logistic regression model, the risk of infection was inversely associated with the MeD score (OR = 0.88; 95% CI 0.81-0.97) and the consumption of cereals (OR = 0.64; 0.45-0.90). Asymptomatic individuals with SARS-COV-2 infection reported a lower intake of saturated fats than symptomatic; individuals requiring hospitalization were significantly older and reported worse dietary habits than both asymptomatic and symptomatic individuals. After combining all symptomatic individuals together, age (OR = 1.05; 1.01-1.09) and saturated fats intake (OR = 1.09; 1.01-1.17) were associated with the infection severity. HCPs who reported a SARS-COV-2 infection showed a significantly lower MeD score and cereal consumption. The infection severity was directly associated with higher age and saturated fat intake.
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Strategies for Reducing Salt and Sugar Intakes in Individuals at Increased Cardiometabolic Risk.
Ponzo, V, Pellegrini, M, Costelli, P, Vázquez-Araújo, L, Gayoso, L, D'Eusebio, C, Ghigo, E, Bo, S
Nutrients. 2021;(1)
Abstract
Non-communicable diseases (NCDs) are the first causes of death worldwide. Reduction in the dietary intake of salt and sugars is important lifestyle advice that is useful for NCD prevention. However, the simple recommendations of reducing salt and sugars by healthcare professionals are often ineffective; innovative strategies are therefore necessary. This review aimed at describing the current knowledge about the strategies to reduce dietary salt and sugar intake, including both strategies for the food industry to reduce the salt or sugar of its products and recommendations for health professionals in a clinical context, such as the replacement with substitutes in foods, the gradual reduction to allow a progressive consumer adaptation towards less intense taste, and the different spatial distribution of tastants within the food matrix with taste intensity enhancement. In addition, the cross-modal interaction between two or more different sensory modalities as an innovative strategy for enhancing sweetness and saltiness perception was described. Finally, the dietary tips for salt and sugar reduction were summarized in order to create a comprehensive guide of dietary advices for healthcare professionals for optimizing the management of patients at increased cardiometabolic risk.
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What predicts the unsuccess of bariatric surgery? An observational retrospective study.
D'Eusebio, C, Boschetti, S, Rahimi, F, Fanni, G, De Francesco, A, Toppino, M, Morino, M, Ghigo, E, Bo, S
Journal of endocrinological investigation. 2021;(5):1021-1029
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Abstract
PURPOSE Bariatric surgery (BS) has been recognized as an effective treatment for most patients with morbid obesity, but a variable range of patients failed to achieve a successful weight-loss. Controversial data are available about predictors of unsuccess. We aimed to retrospectively assess whether clinical baseline characteristics of patients submitted to sleeve gastrectomy (SL) or gastric bypass (GBP) were associated with unsuccessful weight-loss after 12 and 24-month follow-up. METHODS Three hundred patients who underwent BS from the 1st January 2016, with at least 24-months follow-up, were enrolled. Patients were divided according to their percentage of excess weight-loss (%EWL) either < 50% or ≥ 50% after 12 and 24-month follow-up. RESULTS None of the patients was lost at follow-up; 56 (18.7%) patients showed a %EWL < 50% at 24 months. Age, neck circumference, obstructive sleep apnea (OSA) were significantly higher, while total cholesterol and %EWL 6-months lower in those with %EWL < 50% at 12-months. Age, neck circumference, male and OSA rates were increased, while %EWL at 6-months lower in patients with %EWL < 50% at 24-months. In a multiple regression model, age (OR = 1.076; 95% CI 1.029-1.125; p = 0.001; OR = 1.066; 1.027-1.107; p < 0.001) and %EWL at 6-months (OR = 0.876; 0.840-0.913; p < 0.001; OR = 0.950; 0.928-0.972; p < 0.001) were associated with %EWL < 50% both at 12- and 24-months, respectively, and neck circumference (OR = 1.142; 1.011-1.289; p = 0.032) with %EWL < 50% at 24-months. CONCLUSION Older age, larger neck circumference, and %EWL at 6-months were significantly associated with BS unsuccess, showing almost 90% of those patients an unsuccessful weight-loss early after surgery. Further larger studies with longer follow-up are needed to confirm these results.
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The incidence of the refeeding syndrome. A systematic review and meta-analyses of literature.
Cioffi, I, Ponzo, V, Pellegrini, M, Evangelista, A, Bioletto, F, Ciccone, G, Pasanisi, F, Ghigo, E, Bo, S
Clinical nutrition (Edinburgh, Scotland). 2021;(6):3688-3701
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Abstract
BACKGROUND & AIMS The refeeding syndrome (RFS) has been recognized as a potentially life-threatening metabolic complication of re-nutrition, but the definition widely varies and, its incidence is unknown. The aim of this systematic review and meta-analyses was to estimate the incidence of RFS in adults by considering the definition used by the authors as well as the recent criteria proposed by the American Society of Parenteral and Enteral Nutrition (ASPEN) consensus. Furthermore, the incidence of refeeding hypophosphatemia (RH) was also assessed. METHODS Four databases were systematically searched until September 2020 for retrieving trials and observational studies. The incidences of RFS and RH were expressed as percentage and reported with 95% confidence intervals (CI). RESULTS Thirty-five observational studies were included in the analysis. The risk of bias was serious in 16 studies and moderate in the remaining 19. The incidence of RFS varied from 0% to 62% across the studies. No substantial change in the originally reported incidence of RFS was found by applying the ASPEN criteria. Similarly, the incidence of RH ranged between 7% and 62%. In the subgroup analyses, inpatients from Intensive Care Units (ICUs) and those initially fed with >20 kcal/kg/day seemed to have a higher incidence of both RFS (pooled incidence = 44%; 95% CI 36%-52%) and RH (pooled incidence = 27%; 95% CI 21%-34%). However, due to the high heterogeneity of data, summary incidence measures are meaningless. CONCLUSION The incidence rate of both RFS and RH greatly varied according to the definition used and the population analyzed, being higher in ICU inpatients and in those with increased initial caloric supply. Therefore, a universally accepted definition for RFS, taking different clinical contexts and groups of patients into account, is still needed to better characterize the syndrome and its approach.