scholarly journals Corrigendum to “Efficacy and Tolerability of Intravenous Ferric Carboxymaltose in Patients with Iron Deficiency at a Hospital Outpatient Clinic: A Retrospective Cohort Study of Real-World Clinical Practice”

Anemia ◽  
2019 ◽  
Vol 2019 ◽  
pp. 1-4
Author(s):  
António Robalo Nunes ◽  
Ana Palricas Costa ◽  
Sara Lemos Rocha ◽  
Ana Garcia de Oliveira
Keyword(s):  
Cohort Study ◽  
Clinical Practice ◽  
Iron Deficiency ◽  
Real World ◽  
Outpatient Clinic ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Ferric Carboxymaltose ◽  
Hospital Outpatient ◽  
Hospital Outpatient Clinic

scholarly journals Efficacy and Tolerability of Intravenous Ferric Carboxymaltose in Patients with Iron Deficiency at a Hospital Outpatient Clinic: A Retrospective Cohort Study of Real-World Clinical Practice

Anemia ◽  
2017 ◽  
Vol 2017 ◽  
pp. 1-7 ◽  
Author(s):  
António Robalo Nunes ◽  
Ana Palricas Costa ◽  
Sara Lemos Rocha ◽  
Ana Garcia de Oliveira
Keyword(s):  
Clinical Practice ◽  
Iron Deficiency ◽  
Real World ◽  
Outpatient Clinic ◽  
Transferrin Saturation ◽  
Intravenous Iron ◽  
Ferric Carboxymaltose ◽  
Hospital Outpatient ◽  
Hospital Outpatient Clinic ◽  
Real World Evidence

Ferric carboxymaltose (FCM) is an intravenous iron formulation to correct iron deficiency. Although its use has been extensively studied in clinical trials, real-world evidence regarding FCM treatment is scarce. Our aim was to evaluate the efficacy and tolerability of FCM treatment in patients with iron deficiency, with or without anemia, at a hospital outpatient clinic. Data was collected retrospectively from medical records. During this 2-year study, 459 patients were included. Mean age was 58.6 ± 17.5 years and most patients received cumulative FCM doses of 501–1000 mg (63.2%). Six weeks after administration of FCM, efficacy endpoints hemoglobin increase ≥2 g/dL, hemoglobin increase ≥3 g/dL, and transferrin saturation > 20% were attained by 41%, 20%, and 63% of patients, respectively. Patients who received higher FCM doses showed significant reduced odds of not achieving hemoglobin increase ≥2 g/dL (501–1000 mg, adjusted odds ratio [OR]: 0.34, 95% confidence interval [CI] 0.18–0.62; 1001–3000 mg, OR: 0.19, 95% CI 0.07–0.49), compared to 500 mg doses. Treatment-emergent adverse events were documented in <4% of patients. In conclusion, FCM treatment was effective and well-tolerated by outpatients with iron deficiency at a hospital clinic, and its dosage should be adjusted to improve iron deficiency management in clinical practice.

Real-world effectiveness and tolerability of erenumab: A retrospective cohort study

Cephalalgia ◽  
2020 ◽  
Vol 40 (13) ◽  
pp. 1511-1522 ◽  
Author(s):  
Saad Kanaan ◽  
Gabrielle Hettie ◽  
Elizabeth Loder ◽  
Rebecca Burch
Keyword(s):  
Clinical Trials ◽  
Cohort Study ◽  
Clinical Practice ◽  
Adverse Events ◽  
Real World ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Injection Site Reaction ◽  
Clinical Interview ◽  
Headache Center

Background We aimed to systematically assess the effectiveness and tolerability of erenumab in a clinical setting, specifically a tertiary headache center. Methods This was a retrospective cohort study at the John Graham Headache Center of Brigham and Women’s Hospital. All patients who received erenumab from a headache specialist at the Center from 17 May 2018 to 31 January 2019 were included. Patients were contacted and underwent a structured clinical interview including information about erenumab use, perceived benefit, adverse events (AEs), and a global assessment of benefit versus drawbacks. Chart review was performed for patients who could not be contacted. Results Four hundred and forty-four patients were initially identified and 418 were eligible. Two hundred and ninety-five participants completed the structured clinical interview portion of the study (response rate 70.6%). Seventy-four patient charts were additionally reviewed. Two hundred and forty-one participants had used erenumab. One hundred and sixty nine (70%) of participants experienced at least one adverse event, with constipation (43%), injection site reaction (24%), fatigue (15%), worsening headache (12%), and dizziness (11%) the five most commonly reported AEs. One hundred and sixty-eight participants (69.7%) felt that the benefits of erenumab outweighed any drawbacks. One hundred and fifty-one participants (62.7%) planned to continue using erenumab. Cost of treatment was cited by 12% of participants as a reason for either not starting or for stopping erenumab. Of patients who had an increase in dose due to lack of or partial efficacy, 46.5% felt that the dose increase was helpful. We identified one case of unintended pregnancy in our study population. Conclusions This large “real-world” study validates the findings of benefit of erenumab observed in clinical trials. Although adverse events were far more common in this population than in clinical trials, the planned continuation rate was relatively high. The substantial discrepancy between adverse events seen in clinical practice compared with clinical trials suggests systematic differences between clinical trial participants and patients who receive the treatment in clinical practice, or may indicate suboptimal ascertainment of adverse events in the trials. Clinicians should continue to be vigilant for adverse events in clinical practice.

scholarly journals LDL-cholesterol change and goal attainment following statin intensity titration among Asians in primary care: a retrospective cohort study

2021 ◽  
Vol 20 (1) ◽  
Author(s):  
Hao Sen Andrew Fang ◽  
Qiao Gao ◽  
Mong Li Lee ◽  
Wynne Hsu ◽  
Ngiap Chuan Tan
Keyword(s):  
Primary Care ◽  
Clinical Trials ◽  
Cohort Study ◽  
Real World ◽  
Retrospective Cohort Study ◽  
Retrospective Cohort ◽  
Goal Attainment ◽  
Real World Data ◽  
World Data ◽  
Asian Patients

Abstract Background Clinical trials have demonstrated that either initiating or up-titrating a statin dose substantially reduce Low-Density Lipoprotein-Cholesterol (LDL-C) levels. However, statin adherence in actual practice tends to be suboptimal, leading to diminished effectiveness. This study aims to use real-world data to determine the effect on LDL-C levels and LDL-C goal attainment rates, when selected statins are titrated in Asian patients. Methods A retrospective cohort study over a 5-year period, from April 2014 to March 2019 was conducted on a cohort of multi-ethnic adult Asian patients with clinical diagnosis of Dyslipidaemia in a primary care clinic in Singapore. The statins were classified into low-intensity (LI), moderate-intensity (MI) and high-intensity (HI) groups according to the 2018 American College of Cardiology and American Heart Association (ACC/AHA) Blood Cholesterol Guidelines. Patients were grouped into “No statin”, “Non-titrators” and “Titrators” cohorts based on prescribing patterns. For the “Titrators” cohort, the mean percentage change in LDL-C and absolute change in LDL-C goal attainment rates were computed for each permutation of statin intensity titration. Results Among the cohort of 11,499 patients, with a total of 266,762 visits, there were 1962 pairs of LDL-C values associated with a statin titration. Initiation of LI, MI and HI statin resulted in a lowering of LDL-C by 21.6% (95%CI = 18.9–24.3%), 28.9% (95%CI = 25.0–32.7%) and 25.2% (95%CI = 12.8–37.7%) respectively. These were comparatively lower than results from clinical trials (30 to 63%). The change of LDL-C levels due to up-titration, down-titration, and discontinuation were − 12.4% to − 28.9%, + 13.2% to + 24.6%, and + 18.1% to + 32.1% respectively. The improvement in LDL-C goal attainment ranged from 26.5% to 47.1% when statin intensity was up-titrated. Conclusion In this study based on real-world data of Asian patients in primary care, it was shown that although statin titration substantially affected LDL-C levels and LDL-C goal attainment rates, the magnitude was lower than results reported from clinical trials. These results should be taken into consideration and provide further insight to clinicians when making statin adjustment recommendations in order to achieve LDL-C targets in clinical practice, particularly for Asian populations.

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