No Increased Risk of Cardiac Events in Diabetes Patients Treated with AFREZZA(R)

Treatment of type 1 or type 2 diabetes patients with the investigational ultra rapid acting mealtime insulin AFREZZA(R) (insulin human [rDNA origin]) Inhalation Powder does not result in excess cardiovascular events according to the results of two different recent studies.

The results of the studies also show that inhaled AFREZZA did not produce clinically significant effects on heart rate, PR and QRS interval duration, or cardiac morphology.

Two phase 3, clinical trials are currently underway AFREZZA(R), a novel, ultra rapid-acting mealtime insulin therapy in late stage clinical investigation for the treatment of adult patients with type 1 and type 2 diabetes mellitus for the control of hyperglycemia. Trials are seeking to evaluate the efficacy and safety of AFREZZA using MannKind Corporation’s next generation inhalation device.

Researchers reviewed cardiovascular adverse events from nine phase 2/3 clinical trials (of 4,467 patients treated for periods from three months to two years) to determine if excess cardiovascular events occurred in patients treated with AFREZZA versus current antidiabetic therapies.

In controlled trials, the incidence of cardiovascular events did not show increased risk with AFREZZA use in type 1 (31 vs. 35, 0.85 relative risk), type 2 (167 vs. 136, 1.02 relative risk) or the combined type 1 plus type 2 (198 vs. 171, 1.01 relative risk) diabetes populations. The number of patients with ischemic events was low and similar between treatment groups. Cerebrovascular events and other cardiovascular events, such as coronary artery disease, and arrhythmic events were also similar between treatment groups.

For further detail:

Echo-Contrast Agent Does Not Alter Pulmonary Pressure: Study

A new safety study showed that injecting a diagnostic echo-contrast agent in patients undergoing right heart catheterization did not alter baseline pulmonary pressures.

Thirty patients, including 19 with pulmonary hypertension, participated in the crossover, placebo-controlled study.  Study results show that the administration of perflutren protein-type A microspheres injectable suspension did not lead to a rise in pulmonary arterial systolic pressure (PASP) or pulmonary vascular resistance (PVR).

The study, which was jointly designed by the United States Food and Drug Administration and GE Healthcare, indicated that there is no significant safety issue related to the general physical blockage of pulmonary vasculature.

For additional reading:

Personalized Treatments Offer Opportunities for Cancer Patients

According to new studies, more researchers are focusing on the use of genetic information to match drugs to the drivers of tumors in specific patients, creating personalized treatments with increased effectiveness that can be delivered more quickly to market.

The studies, which were released recently at the American Society of Clinical Oncology’s annual meeting, indicate that personalized medicine is becoming an increasingly important tool in the battle against cancer.

Researchers are matching genetic information about a tumor to new treatments to improve results, and they believe that by targeting mutations fewer patients will be needed to prove the efficacy of new drugs.  This could increase the speed with which those treatments can be delivered to other patients.

The researchers are using “biomarkers,” or specific genetic traits in tumors, in the development of treatments.  However, many tumors are fueled by multiple pathways that can help the tumors to develop resistance when a single pathway is disrupted. Researchers and drug companies are already testing combinations of targeted treatments, which both complicates the risks of treatment and the process necessary to achieving approval.

Targeted drugs are also expensive and do not necessarily offer a cure, but the increased response by patients is remarkable.