Daprodustat Treatment for Renal Anemia associated with ischemic stroke: Insights from Three Patient Cases

Japan: In a recent report published in Cureus Journal, three cases of ischemic stroke occurring in patients undergoing daprodustat therapy for renal anemia have raised significant concerns among healthcare professionals.

Daprodustat, a medication FDA-approved for treating anemia in chronic kidney disease (CKD) patients, is known for stimulating erythropoiesis by inhibiting the hypoxia-inducible factor prolyl hydroxylase enzyme. While generally considered safe, these cases highlight potential neurological risks associated with the therapy.

Therefore, the researchers suggest discontinuing daprodustat to reduce the risk of recurrent ischemic strokes.

Hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitors are being increasingly utilized for treating renal anemia. While ischemic stroke is a rare but serious adverse event associated with HIF-PH inhibitor therapy, its clinical characteristics have not yet been documented.

In the study, Naohiro Uchio, Department of Neurology, Mitsui Memorial Hospital, Tokyo, Japan, and colleagues present three patients who experienced ischemic strokes while undergoing daprodustat therapy.

In two cases, hemoglobin levels surpassed the target of 13 g/dL for renal anemia (Cases 1 and 2). Notably, two patients suffered strokes within two months of starting daprodustat (Cases 2 and 3). One patient, despite being on dual antiplatelet therapy, also experienced an ischemic stroke (Case 3). Fortunately, none of the patients had a recurrence, likely due to the cessation of daprodustat treatment. This leads to the suggestion that daprodustat therapy may significantly contribute to the risk of developing ischemic strokes.

Commenting on the mechanism behind these occurrences, the authors noted that the exact causes of thromboembolism associated with HIF-PH inhibitor therapy remain unclear. However, it is believed that HIF-PH inhibitors have multiple effects, particularly their role in promoting erythropoiesis.

“These inhibitors stimulate the transcription of the erythropoietin gene, which can trigger hypoxia-induced responses leading to increased red blood cell production. Consequently, the erythropoietic effects of HIF-PH inhibitor therapy are thought to contribute to thromboembolism. Currently, only a limited number of risk factors have been identified, including excessive or rapid increases in hemoglobin levels and iron deficiency,” the researchers wrote.

The findings revealed that the occurrence of ischemic stroke poses a significant challenge in managing patients on daprodustat therapy for renal anemia, as highlighted by the authors.

“Such strokes may arise during periods of excessive hemoglobin elevation exceeding 13 g/dL or within the first two months following daprodustat initiation, likely due to heightened erythropoietic stimulation. Therefore, upon the onset of an ischemic stroke, it is crucial to discontinue daprodustat to prevent recurrence and prioritize patient safety,” the authors concluded.

Reference:

Uchio N, Komaki S, Hao, et al. (April 10, 2024) Ischemic Stroke During Daprodustat Therapy for Renal Anemia: A Report of Three Cases. Cureus 16(4): e57990. doi:10.7759/cureus.57990

Powered by WPeMatico

Lactobites bar may act as galactagogue to increase human milk volume in lactating women, suggests research

Difficulty in lactation or breastfeeding may be due to
cesarean delivery, poor nutrition have been linked to lactation difficulties. Breastmilk
production can be increased through galactagogues, kangaroo mothering and
relaxation techniques. Instead of pharmaceutical products, various
complementary and alternative techniques can be employed as galactagogue. The
Galactagogues are synthetic or plant molecules of milk production-inducing,
-maintaining, and -increasing molecules that operate as mediators of intricate
physiological and physical processes. These include herbal medicines and
techniques such as herbal compression, herbal supplements, herbal bars, and
herbal teas that contain ginger, stinging nettle, fenugreek, orturmeric that
promote breast milk production without causing adverse effects. Lactobite bar
is a natural lactation supplement containing Fennel, Moringa Leaves, Shatavari,
Halim Seeds, and Berries that are rich in antioxidants and are known to
naturally assist lactation. The objective of this study was to evaluate the
effect of Lactobites bar as a galactagogue to increase the production of milk
in lactating women and the metabolism-boosting effect, which can contribute to
weight loss and fat burn

In this current real-world evidence study, 53 lactating
women were enrolled. During the study, they received lactobites bar for 28
days. The intestinal health of the baby, incidences of formula feeding, the
volume of breast milk, baby’s anthropometric measures: such as changes in
height, changes in the quality of hair and skin of the mother were evaluated.
The feeling of wellness in the mother and haemoglobin levels were also assessed
during the study.

The haemoglobin levels were significantly increased in
mothers who were given lactobites bar. A significant increase was observed in
hours of night and day sleep, stool frequency per day, vol. of breast milk [p<0.05],
no. of diapers per day, height [p<0.05], changes in quality of hair and skin
of mother, and the feeling of wellness in mother [p<0.05]. A significant
reduction was observed in formula feeding incidence (p<0.001). No side
effects were reported.

The current Real World Evidence study showed that
consumption of Lactobites bar as a natural galactagogue supplement increased
the breastmilk production in lactating women. There was a significant increase
in hours of the night and day sleep, stool frequency per day, number of diapers
per day, baby’s height. In the mothers, lactobite bar improved hair and skin
health, increased feeling of wellness, volume of breast milk and increased
haemoglobin levels. There was a significant reduction observed in formula
feeding incidence. There were no serious side effects observed, and it is safe
for both the mother and the baby.

Based on the above results, authors inferred that the
lactobites bar are safe for mothers as they don’t cause any serious side
effects and also, they are safe for baby as it can be observed from the stool
frequency. The lactobites bar are also filling for the baby as the change in
number of diapers is quite frequent compared to baseline.

In conclusion, this real-world evidence study demonstrated a
significant increase in the volume of breast milk, baby’s weight and height,
babies hours of night and day sleep, stool frequency per day, and no. of
diapers per day. It showed a significant reduction in formula feeding
incidence. It showed the overall wellness of mothers by supporting increase in
haemoglobin and overall recovery during the postpartum period.

Source: Malhotra et al. / Indian Journal of Obstetrics and
Gynecology Research 2024;11(1):7–12

Powered by WPeMatico

Indian branded pharma Sector sees a decline in growth: Report

New Delhi: The Indian pharmaceutical sector is set for a mixed quarter, with slow growth expected in the branded formulations, according to the Systematix Institutional Equities report.

Analysts predict a median year-on-year (YoY) revenue growth of 12 per cent and quarter-on-quarter (QoQ) growth of 5 per cent for the coverage universe.

However, companies such as Dr Reddy’s Laboratories (DRRD), Zydus Lifesciences (ZYDUSLIF), Lupin (LPC), and Mankind Pharma (MANKIND) expected to outperform on a YoY basis.

But the YoY growth is expected to decline for the Indian Pharmaceutical Market (IPM), projected at approximately 8 per cent, largely due to minimal drug price inflation linked to the Wholesale Price Index (WPI), which is close to 0 per cent compared to 12 per cent last year.

Sun Pharma’s domestic business is anticipated to post mid-single-digit growth, while its U.S. segment is likely to benefit from an expanded market share of generic Revlimid (gRevlimid). The company’s revenue, EBITDA, and PAT are expected to grow at 7 per cent, 15 per cent, and 16 per cent QoQ respectively, and a robust 12 per cent, 31 per cent, and 38 per cent YoY.

The growth in the Contract Research and Manufacturing Services (CRAMS) division is set to outpace generics, driven by a ramp-up in contrast media. Despite a relatively flat quarter, YoY figures are promising, with expectations of 10 per cent revenue growth and a 23 per cent increase in both EBITDA and PAT.

Cipla’s India business is projected to grow at a high single-digit rate, supported by a ramp-up of the generic Lanreotide launched last quarter. The US business is expected to remain stable, with YoY revenue, EBITDA, and PAT growth projected at 5 per cent, 5 per cent, and 11 per cent, respectively.

Dr. Reddy’s is anticipated to show double-digit growth in its India business due to a distribution agreement with Sanofi Healthcare for its vaccine portfolio. However, its U.S. business is expected to see flat QoQ growth. Revenue is projected to grow by 2 per cent QoQ and 13 per cent YoY, with EBITDA and PAT increasing by 6 per cent and 9 per cent QoQ.

While Zydus is expected to achieve mid-single-digit domestic branded formulations growth, its U.S. sales may contract sequentially. The company’s wellness business is projected to grow modestly but decline QoQ due to seasonality. Despite this, YoY figures for revenue, EBITDA, and PAT are expected to grow by 20 per cent, 79 per cent, and 107 per cent.

Lupin’s domestic business should see mid- to high-single-digit growth, supported by a steady contribution from generic Spiriva and new launches like gProlensa and gOracea in the US YoY, revenue is expected to grow by 12 per cent, EBITDA by 38 per cent, and PAT by 64 per cent.

Mankind’s domestic branded formulation sales are anticipated to grow in the low double digits, with the consumer business showing signs of recovery. Exports are expected to ramp up, with YoY revenue, EBITDA, and PAT growing by 14 per cent, 17 per cent, and 21 per cent.

Powered by WPeMatico

Caffeine intake linked to better vascular health in study

Consuming more caffeine may improve heart health, according to a study published in the Rheumatology journal.

Powered by WPeMatico

4+ hour emergency care wait linked to heightened risks of death and longer hospital stay for hip fracture patients

Waiting more than 4 hours in emergency care for treatment is linked to heightened risks of death and a longer hospital stay for hip fracture patients, reveals a single center study, published online in Emergency Medicine Journal.

Powered by WPeMatico

Policy change may be helping to drive rise in treatment-resistant vaginal thrush, study reveals

A change in policy may be helping to drive a rise in treatment-resistant vaginal thrush, amid significant yearly increases in the prevalence of fungal infections caused by fungal Candida species, suggests the first study of its kind, published online in the journal Sexually Transmitted Infections.

Powered by WPeMatico

Significant worldwide disparities seen in availability and timeliness of new cancer drugs

Despite considerable progress in the discovery and development of new cancer drugs, there are significant disparities in both the availability and timeliness of these medicines worldwide, with poorer countries missing out, suggests a global analysis of new drug launches between 1990 and 2022, published in the open access journal BMJ Global Health.

Powered by WPeMatico

Heat stress impacts infant growth rates up to age of 2, new analysis suggests

Exposure to high levels of heat may both impact the growth of fetuses during pregnancy and infants up to the age of 2, a new analysis suggests.

Powered by WPeMatico

Study finds common breast cancer treatments may speed aging process

A new study led by investigators at the UCLA Health Jonsson Comprehensive Cancer Center has revealed that common breast cancer treatments, including chemotherapy, radiation, and surgery, may accelerate the biological aging process in breast cancer survivors.

Powered by WPeMatico

Ultra-powered MRI scans show damage to brain’s ‘control center’ is behind long-lasting COVID-19 symptoms

Damage to the brainstem—the brain’s ‘control center’—is behind long-lasting physical and psychiatric effects of severe COVID-19 infection, a study suggests.

Powered by WPeMatico