Drugmaker Novartis announced that it is ending a study of a drug to treat high blood pressure after the independent data monitoring committee said it could increase risk to patients with a high risk of heart or kidney problems.

In the trial arm in which Rasilez/Tekturna was added to the standard of care there was an increased incidence after 18-24 months of non-fatal stroke, renal complications, hyperkalemia and hypotension in this high-risk study population. The committee said the ALTITUDE study showed high-risk patients were unlikely to benefit from treatment with the drug in combination with standard blood pressure treatments.

In the study, Rasilez/Tekturna was given to patients with type 2 diabetes and renal impairment in addition to optimal cardiovascular treatment including an angiotensin converting enzyme inhibitor or angiotensin receptor blocker.

Novartis is recommending that ALTITUDE investigators remove Rasilez/Tekturna-based products from their patients' treatment regimen and review their high blood pressure medication. Novartis is also reviewing the findings with DMCs of other clinical studies involving Rasilez/Tekturna-based products and combination therapies.

The company said sales of the drug are likely to be negatively impacted. Rasilez/Tekturna brought in $449 million in sales in the first nine months of 2011.