Study says a steroid used to treat kidney ailments has adverse effects

New Delhi: A steroid used to treat a kidney disease, common in India, itself causes unacceptable levels of infections among patients, a new study has found and stressed the need to change the existing treatment guidelines.

The study conducted by the George Institute for Global Health found that treatment with pills of methylprednisolone is linked to a large increase in the risk of serious adverse effects such as infections, gastrointestinal and bone disorders among patients with IgA nephropathy and those having excess protein in their urine.

IgA nephropathy is a kidney disease that occurs when the antibody immunoglobulin A (IgA) gets deposited in the kidneys.

"Up to 30 per cent of all people with IgA nephropathy will eventually develop end-stage kidney disease. Decreased kidney function, persistent proteinuria, and hypertension are the strongest risk factors," said Vivekanand Jha, Executive Director -- GIGH India.

Jha is one of the authors associated with the study which was published in the Journal of the American Medical Association.

Methylprednisolone is also used to treat conditions like skin diseases, rheumatic disorders, allergies, asthma among others.

In the study, participants with IgA nephropathy and proteinuria (presence of excess proteins in urine) were randomly assigned to oral methylprednisolone for two months, with subsequent weaning over 4 to 6 months.

Recruitment was planned in several countries including China and India but after 2.1 years' median follow-up, it was discontinued because of an unexpectedly high rate of serious adverse effects, including infections, gastrointestinal and bone disorders, it said.

Serious events occurred in 20 participants (14.7 per cent) in the methylprednisolone group vs 4 (3.2 per cent) in the placebo group, mostly due to excess serious infections, including two deaths, the study said.

"Although the results were consistent with potential renal benefit, definitive conclusions about treatment benefit cannot be made, owing to early termination of the trial," says Vlado Perkovic of the George Institute for Global Health, Sydney, and a lead author of the study.

Professor Hong Zhang of Peking University First Hospital, Beijing, added that a limitation of the study was that the recruitment was stopped earlier than planned because of excess adverse events and so the power of the study was less than predicted, and both risks and benefits might be overestimated thus.

India is currently leading global recruitment in the follow up low-dose testing trial which will investigate how the benefit of treatment will be available to the patients without the risk. Eight Indian centres are participating.

"Our effort is to see that the treatment should produce benefit, but with no side effect or risk as was seen in the first phase.

"A series of steps are being taken to mitigate this risk in the second phase - this includes reducing the dose and giving it for slightly longer duration, and use of prophylaxis against the common infections like TB, and lung infections," said Jha.

The George Institute for Global Health works on a broad health landscape and conducts clinical, population and health system research aimed at changing health practice and policy worldwide.

The Institute has been ranked among the top 10 global institutes for impact for the last several years.