Lilly, BI diabetes drug shows greater A1C reduction in African-American adults than placebo, study shows
RIDGEFIELD, Conn. — A drug used to treat Type 2 diabetes produced significant reduction in blood sugar in African-American patients, according to results of a late-stage clinical trial.
Boehringer Ingelheim Pharmaceuticals and Eli Lilly announced Thursday results of a phase-3 trial of Tradjenta (linagliptin) in which 226 patients with Type 2 diabetes received 5 mg of the drug once per day or placebo.
Patients in the treatment group showed a reduction of HbA1C of 0.88%, compared with 0.24% among those receiving placebo. The drug makers noted that African Americans and other ethnic minority groups "significantly" are underrepresented in clinical trials, and this was the first published trial of a DPP-4 inhibitor — the drug class to which Tradjenta belongs — specifically conducted in African-American adult patients. Diabetes disproportionately affects African-Americans, with non-Hispanic African-American adults having a risk of developing the disease 77% greater than non-Hispanic white adults, according to the Centers for Disease Control and Prevention.
CVS study: Targeted interventions versus broad adherence education proves more effective
WOONSOCKET, R.I. — Adherence interventions targeted to nonadherent patients proved more effective in improving medication adherence when compared with broad interventions that cast a wide net to encompass all medication takers, according to new research sponsored by CVS Caremark.
According to the study, entitled "Targeting Cardiovascular Medication Adherence Interventions,” more than one-third of adherence interventions targeted to nonadherent patients resulted in improved medication adherence, compared with 18% of broad interventions.
The study was conducted by researchers at Harvard University, Brigham and Women’s Hospital and CVS Caremark and was published in the May/June issue of the Journal of the American Pharmacists Association.
“While medication nonadherence is widely recognized as a major public health issue that impacts patient health and contributes to rising healthcare costs, there has not been a clear consensus about how best to influence patient behavior and support appropriate medication use," said Sarah Cutrona, a former research associate at Brigham and Women’s Hospital. "These results suggest that broad interventions, which aim to prevent nonadherence by educating and motivating all patients, were the least effective. Without the benefit of identifying patients and their specific barriers to adherence, these types of interventions may be too general to motivate individual patients to change their medication taking behavior."
The researchers reviewed nearly 60 peer-reviewed articles about randomized controlled trials for three types of interventions to improve medication adherence for cardiovascular disease or diabetes. These interventions included: broad interventions targeting all patients, focused interventions targeting nonadherent patients and dynamic interventions initially administered to all patients but then targeted to nonadherent patients based on real-time adherence information. Results found that dynamic interventions (32%) and focused interventions (25%) were more likely to show impact on adherence as compared with broad interventions (18%).
"This study is part of our ongoing research collaboration with Harvard and Brigham and Women’s Hospital to better understand the factors that impact mediation adherence," said Troyen Brennan, EVP and chief medical officer of CVS Caremark, who heads the research initiative that conducted the study. "As a pharmacy innovation company, we believe these results can be useful in helping to develop and better target adherence interventions so they are relevant for the patient and enable them to make better choices about their medications and achieve positive health outcomes."
The researchers concluded that targeting patients who are nonadherent to their cardiovascular medications may lead to better adherence, but more research is needed to determine how best to identify and intervene with nonadherent patients. The accuracy, cost and reproducibility of methods for identifying target populations should be a central consideration in future studies, especially in an environment where resources are limited and healthcare professionals and payers need to identify the most cost-effective and impactful ways to intervene and affect positive behavior change.
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Patients with ulcerative colitis respond to Simponi, study finds
SAN DIEGO — Findings from a new study indicate that more than half of the patients with ulcerative colitis who received subcutaneous injections of a drug used to treat autoimmune disorders responded to the treatment.
Johnson & Johnson subsidiary Janssen Research and Development announced results of a phase-3 trial of Simponi (golimumab) in ulcerative colitis patients whose condition had previously failed to improve with or who were intolerant to conventional drugs.
In one treatment group, patients received 200 mg of the drug subcutaneously at week zero and 100 mg at week two, while in another they received 400 mg at week zero and 200 mg at week two. A third group received placebo. Results indicated that 51.8% of patients in the first group responded to treatment after six weeks, compared with 55% in the second group and 29.7% in the placebo group.
"Therapeutic options for patients living with moderate to severe forms of ulcerative colitis who have failed or become intolerant to conventional treatments are quite limited today, which is particularly challenging in managing a disease that primarily affects a younger, active patient population," study investigator and University of California San Diego School of Medicine professor William Sandborn said.