Efficacy and Safety of Ferric Carboxymaltose in the Management of Iron Deficiency Anemia: A Multi-Center Real-World Study from India
Ayyavoo Charmila,1 Suma Natarajan,2 Thevoor Venkatesan Chitra,3 Nivedita Pawar,4 Sucheta Kinjawadekar,5 Yogini Firke,6 Umaiyal Murugesan,7 Poonam Yadav,8 Neelam Ohri,9 Vidhu Modgil,10 Ajinkya Rodge,11 Onkar C Swami11 1Obstetrics and Gynecology, Aditi Hospital, Tiruchirappalli, Tamil Nadu, India; 2Ob...
| Main Authors: | , , , , , , , , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
Dove Medical Press
2022-06-01
|
| Series: | Journal of Blood Medicine |
| Subjects: | |
| Online Access: | https://www.dovepress.com/efficacy-and-safety-of-ferric-carboxymaltose-in-the-management-of-iron-peer-reviewed-fulltext-article-JBM |
| _version_ | 1811244908058509312 |
|---|---|
| author | Charmila A Natarajan S Chitra TV Pawar N Kinjawadekar S Firke Y Murugesan U Yadav P Ohri N Modgil V Rodge A Swami OC |
| author_facet | Charmila A Natarajan S Chitra TV Pawar N Kinjawadekar S Firke Y Murugesan U Yadav P Ohri N Modgil V Rodge A Swami OC |
| author_sort | Charmila A |
| collection | DOAJ |
| description | Ayyavoo Charmila,1 Suma Natarajan,2 Thevoor Venkatesan Chitra,3 Nivedita Pawar,4 Sucheta Kinjawadekar,5 Yogini Firke,6 Umaiyal Murugesan,7 Poonam Yadav,8 Neelam Ohri,9 Vidhu Modgil,10 Ajinkya Rodge,11 Onkar C Swami11 1Obstetrics and Gynecology, Aditi Hospital, Tiruchirappalli, Tamil Nadu, India; 2Obstetrics and Gynecology, Ganga Medical Centre & Hospitals, Coimbatore, Tamil Nadu, India; 3Obstetrics and Gynecology, PSG Hospitals, Coimbatore, Tamil Nadu, India; 4Obstetrics and Gynecology, Nivedita Maternity Home, Nashik, Maharashtra, India; 5Obstetrics and Gynecology, Kamalesh Mother and Child Hospital, New Mumbai, Maharashtra, India; 6Obstetrics and Gynecology, Dhanvantari Hospital, Mumbai, Maharashtra, India; 7Obstetrics and Gynecology, Sri Kumaran A Speciality Hospital, Chennai, Tamil Nadu, India; 8Obstetrics and Gynecology, SDMH Hospital, Jaipur, Rajasthan, India; 9Obstetrics and Gynecology, New Life Hospital, Varanasi, Uttar Pradesh, India; 10Obstetrics and Gynecology, Suman Hospital, Ludhiana, Punjab, India; 11Medical Services, Emcure Pharmaceuticals Ltd., Pune, Maharashtra, IndiaCorrespondence: Onkar C Swami, Emcure Pharmaceuticals Ltd., Pune, Maharashtra, 411 057, India, Tel +91-93724 23101, Email onkar.swami@emcure.co.inBackground: Parenteral iron preparations, like ferric carboxymaltose (FCM), are commonly used to manage moderate-to-severe iron deficiency anemia (IDA). Real-world data on efficacy and safety of FCM is limited in India.Methods: A retrospective, observational and real-world study was conducted to assess the efficacy and safety of FCM in adolescents and adults with IDA across 269 centers in India. Data was retrieved from medical records of patients who received FCM for management of IDA. Physicians’ clinical assessment of efficacy and safety of FCM was also assessed. Data were analyzed for hematological parameters at baseline and at 4 ± 1 week for study population, and for severity of anemia.Results: In 1800 patients with IDA, intravenous FCM resulted in a significant increase in hemoglobin (Hb) of 2.76 g/dL, serum ferritin of 35.85 μg/L, red blood cell (RBC) count, hematocrit, mean corpuscular volume (MCV), and mean corpuscular hemoglobin (MCH) (P < 0.001 for all) at 4 ± 1 week as compared to baseline. In subjects with severe IDA, an increase in Hb was of 3.31 g/dL, serum ferritin increased of 35.84 μg/L, RBC count, hematocrit and MCH improved significantly (P < 0.001 for all). In subjects with moderate IDA, Hb (increase of 2.63 g/dL), serum ferritin (increase of 35.92 μg/L), RBC count, hematocrit, MCV, and MCH improved significantly (P < 0.001 for all). In subjects with mild IDA, only the mean Hb values at 4 weeks were significantly higher (P < 0.001; increased by 1.89 g/dL). Physicians rated efficacy of FCM as very good to good in 97.5% of patients. Similarly, safety of FCM was rated very good to good in 97.2% subjects.Conclusion: FCM efficiently, safely and quickly corrects moderate-to-severe anemia in Indian patients in a short span of 4 weeks. Physicians’ positive clinical impression of efficacy and safety supports clinical usage of FCM in real-world scenario.Keywords: ferric carboxymaltose, iron deficiency anemia, pregnancy, efficacy, safety, India |
| first_indexed | 2024-04-12T14:32:49Z |
| format | Article |
| id | doaj.art-d812fde601e6496193f7a0ca67ccd91f |
| institution | Directory Open Access Journal |
| issn | 1179-2736 |
| language | English |
| last_indexed | 2024-04-12T14:32:49Z |
| publishDate | 2022-06-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Journal of Blood Medicine |
| spelling | doaj.art-d812fde601e6496193f7a0ca67ccd91f2022-12-22T03:29:14ZengDove Medical PressJournal of Blood Medicine1179-27362022-06-01Volume 1330331375818Efficacy and Safety of Ferric Carboxymaltose in the Management of Iron Deficiency Anemia: A Multi-Center Real-World Study from IndiaCharmila ANatarajan SChitra TVPawar NKinjawadekar SFirke YMurugesan UYadav POhri NModgil VRodge ASwami OCAyyavoo Charmila,1 Suma Natarajan,2 Thevoor Venkatesan Chitra,3 Nivedita Pawar,4 Sucheta Kinjawadekar,5 Yogini Firke,6 Umaiyal Murugesan,7 Poonam Yadav,8 Neelam Ohri,9 Vidhu Modgil,10 Ajinkya Rodge,11 Onkar C Swami11 1Obstetrics and Gynecology, Aditi Hospital, Tiruchirappalli, Tamil Nadu, India; 2Obstetrics and Gynecology, Ganga Medical Centre & Hospitals, Coimbatore, Tamil Nadu, India; 3Obstetrics and Gynecology, PSG Hospitals, Coimbatore, Tamil Nadu, India; 4Obstetrics and Gynecology, Nivedita Maternity Home, Nashik, Maharashtra, India; 5Obstetrics and Gynecology, Kamalesh Mother and Child Hospital, New Mumbai, Maharashtra, India; 6Obstetrics and Gynecology, Dhanvantari Hospital, Mumbai, Maharashtra, India; 7Obstetrics and Gynecology, Sri Kumaran A Speciality Hospital, Chennai, Tamil Nadu, India; 8Obstetrics and Gynecology, SDMH Hospital, Jaipur, Rajasthan, India; 9Obstetrics and Gynecology, New Life Hospital, Varanasi, Uttar Pradesh, India; 10Obstetrics and Gynecology, Suman Hospital, Ludhiana, Punjab, India; 11Medical Services, Emcure Pharmaceuticals Ltd., Pune, Maharashtra, IndiaCorrespondence: Onkar C Swami, Emcure Pharmaceuticals Ltd., Pune, Maharashtra, 411 057, India, Tel +91-93724 23101, Email onkar.swami@emcure.co.inBackground: Parenteral iron preparations, like ferric carboxymaltose (FCM), are commonly used to manage moderate-to-severe iron deficiency anemia (IDA). Real-world data on efficacy and safety of FCM is limited in India.Methods: A retrospective, observational and real-world study was conducted to assess the efficacy and safety of FCM in adolescents and adults with IDA across 269 centers in India. Data was retrieved from medical records of patients who received FCM for management of IDA. Physicians’ clinical assessment of efficacy and safety of FCM was also assessed. Data were analyzed for hematological parameters at baseline and at 4 ± 1 week for study population, and for severity of anemia.Results: In 1800 patients with IDA, intravenous FCM resulted in a significant increase in hemoglobin (Hb) of 2.76 g/dL, serum ferritin of 35.85 μg/L, red blood cell (RBC) count, hematocrit, mean corpuscular volume (MCV), and mean corpuscular hemoglobin (MCH) (P < 0.001 for all) at 4 ± 1 week as compared to baseline. In subjects with severe IDA, an increase in Hb was of 3.31 g/dL, serum ferritin increased of 35.84 μg/L, RBC count, hematocrit and MCH improved significantly (P < 0.001 for all). In subjects with moderate IDA, Hb (increase of 2.63 g/dL), serum ferritin (increase of 35.92 μg/L), RBC count, hematocrit, MCV, and MCH improved significantly (P < 0.001 for all). In subjects with mild IDA, only the mean Hb values at 4 weeks were significantly higher (P < 0.001; increased by 1.89 g/dL). Physicians rated efficacy of FCM as very good to good in 97.5% of patients. Similarly, safety of FCM was rated very good to good in 97.2% subjects.Conclusion: FCM efficiently, safely and quickly corrects moderate-to-severe anemia in Indian patients in a short span of 4 weeks. Physicians’ positive clinical impression of efficacy and safety supports clinical usage of FCM in real-world scenario.Keywords: ferric carboxymaltose, iron deficiency anemia, pregnancy, efficacy, safety, Indiahttps://www.dovepress.com/efficacy-and-safety-of-ferric-carboxymaltose-in-the-management-of-iron-peer-reviewed-fulltext-article-JBMferric carboxymaltoseiron deficiency anemiapregnancyefficacysafetyindia |
| spellingShingle | Charmila A Natarajan S Chitra TV Pawar N Kinjawadekar S Firke Y Murugesan U Yadav P Ohri N Modgil V Rodge A Swami OC Efficacy and Safety of Ferric Carboxymaltose in the Management of Iron Deficiency Anemia: A Multi-Center Real-World Study from India Journal of Blood Medicine ferric carboxymaltose iron deficiency anemia pregnancy efficacy safety india |
| title | Efficacy and Safety of Ferric Carboxymaltose in the Management of Iron Deficiency Anemia: A Multi-Center Real-World Study from India |
| title_full | Efficacy and Safety of Ferric Carboxymaltose in the Management of Iron Deficiency Anemia: A Multi-Center Real-World Study from India |
| title_fullStr | Efficacy and Safety of Ferric Carboxymaltose in the Management of Iron Deficiency Anemia: A Multi-Center Real-World Study from India |
| title_full_unstemmed | Efficacy and Safety of Ferric Carboxymaltose in the Management of Iron Deficiency Anemia: A Multi-Center Real-World Study from India |
| title_short | Efficacy and Safety of Ferric Carboxymaltose in the Management of Iron Deficiency Anemia: A Multi-Center Real-World Study from India |
| title_sort | efficacy and safety of ferric carboxymaltose in the management of iron deficiency anemia a multi center real world study from india |
| topic | ferric carboxymaltose iron deficiency anemia pregnancy efficacy safety india |
| url | https://www.dovepress.com/efficacy-and-safety-of-ferric-carboxymaltose-in-the-management-of-iron-peer-reviewed-fulltext-article-JBM |
| work_keys_str_mv | AT charmilaa efficacyandsafetyofferriccarboxymaltoseinthemanagementofirondeficiencyanemiaamulticenterrealworldstudyfromindia AT natarajans efficacyandsafetyofferriccarboxymaltoseinthemanagementofirondeficiencyanemiaamulticenterrealworldstudyfromindia AT chitratv efficacyandsafetyofferriccarboxymaltoseinthemanagementofirondeficiencyanemiaamulticenterrealworldstudyfromindia AT pawarn efficacyandsafetyofferriccarboxymaltoseinthemanagementofirondeficiencyanemiaamulticenterrealworldstudyfromindia AT kinjawadekars efficacyandsafetyofferriccarboxymaltoseinthemanagementofirondeficiencyanemiaamulticenterrealworldstudyfromindia AT firkey efficacyandsafetyofferriccarboxymaltoseinthemanagementofirondeficiencyanemiaamulticenterrealworldstudyfromindia AT murugesanu efficacyandsafetyofferriccarboxymaltoseinthemanagementofirondeficiencyanemiaamulticenterrealworldstudyfromindia AT yadavp efficacyandsafetyofferriccarboxymaltoseinthemanagementofirondeficiencyanemiaamulticenterrealworldstudyfromindia AT ohrin efficacyandsafetyofferriccarboxymaltoseinthemanagementofirondeficiencyanemiaamulticenterrealworldstudyfromindia AT modgilv efficacyandsafetyofferriccarboxymaltoseinthemanagementofirondeficiencyanemiaamulticenterrealworldstudyfromindia AT rodgea efficacyandsafetyofferriccarboxymaltoseinthemanagementofirondeficiencyanemiaamulticenterrealworldstudyfromindia AT swamioc efficacyandsafetyofferriccarboxymaltoseinthemanagementofirondeficiencyanemiaamulticenterrealworldstudyfromindia |