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Study: Sensipar (Cinacalcet) Doesn’t Significantly Lower Risk of Major Heart Problems in Dialysis Patients

Risk of death or major cardiovascular events was reduced by only 7% in 5-year study (Nov. 3)

A study led by an international team of researchers has found that Sensipar (cinacalcet, Amgen) — a drug commonly prescribed to patients with kidney failure and secondary hyperparathyroidism — does not significantly reduce the risk of death or major cardiovascular events.

The results of the EVOLVE trial, which enrolled about 4,000 kidney patients from several continents and was conducted over 5 years, were mixed, the researchers said.

“The results of the EVOLVE trial suggest that cinacalcet favorably alters bone and mineral metabolism, and could result in improved health and longevity for patients with end-stage renal disease,” said lead author Glenn Chertow, MD, of the Stanford University School of Medicine. “But the trial was not definitive in determining cardiovascular benefits because so many patients discontinued taking the study drug.”

Researchers did say the trial results showed possible cardiovascular benefits when certain factors were taken into account, such as an imbalance in age between study participants who were treated with cinacalcet and those who received placebo. Participants who received the drug were on average a year older; age is a major risk factor for cardiovascular disease.

The study was published online in the November 3 issue of the New England Journal of Medicine.

Patients on kidney dialysis are among the most frail and chronically ill, with high mortality and hospitalization rates. This makes recruitment and retention of such patients in clinical trials particularly challenging, the study stated.

Earlier studies suggested that cinacalcet, one of several drugs used to treat secondary hyperparathyroidism, may also help to prevent or ameliorate cardiovascular disease. Cinacalcet is manufactured by Amgen Inc., which sponsored the EVOLVE trial.

Because secondary hyperparathyroidism and associated disorders are linked with death, fractures, and cardiovascular disease, physicians have prescribed the drug in the hopes of preventing cardiovascular events in patients undergoing dialysis. Its side effects include nausea and gastrointestinal (GI) distress.

Determining the appropriate treatment course for patients with advanced chronic kidney disease, particularly those on dialysis, can be challenging. Patients with kidney failure require either kidney transplantation or dialysis; the latter typically requires 3- to 4-hour sessions of blood cleansing three times per week. In addition, patients on hemodialysis take about 19 prescription tablets daily and often experience GI disturbances and other side effects.

“The burden of hemodialysis treatment is considerable, and most patients take several prescription medications, often several times per day,” Chertow said. “Cinacalcet is not a perfect drug. It has been shown to be safe, and the gastrointestinal side effects are not prohibitive, but when someone is taking 20 pills a day, it is difficult to justify the 21st unless it makes an important difference.”

The EVOLVE trial, which was originally designed to last 4 years, was extended to nearly 5½ years in an attempt to reach the required number of endpoints. Between August 22, 2006, and January 31, 2008, researchers recruited 3,883 patients on hemodialysis with secondary hyperparathyroidism from the U.S., Canada, Europe, Latin America, Russia, and Australia. The patients were randomly assigned to receive a treatment course with either cinacalcet or placebo and were followed for up to 64 months.

The trial’s primary analysis showed that the relative risk of death or a major cardiovascular event was reduced by 7% in patients treated with cinacalcet — a statistically non-significant result. Adjusting for age, or a combination of age and other clinical features of the study population (such as diabetes or a history of heart disease), the risk reduction was 12% and was nominally statistically significant, the study said.

Source: Stanford University School of Medicine; November 3, 2012.

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