Online First articles
Erratum to: Influence of Telmisartan on Insulin Response after Glucose Loading in Obese Patients with Hypertension: ARB Trial of Hypertension in Obese Patients with Hyperinsulinemia Assessed by Oral Glucose Tolerance Test (ATHLETE)
Yutaka Mori, Takaaki Tanaka, Kenichi Matsuura, Junichi Yokoyama, Kazunori Utsunomiya
DOI: 10.1007/s12325-011-0089-y
Adv Ther. 2012;29(2). In press.
Abstract | Full text
The authors of the above-mentioned paper noticed a few errors in the tables and figures, as reported. In Table 1, the ‘group treated with the current ARB’ BMI score should read 26.6±2.2, and not 26.6±1.9, as reported. Also, the BMI max-min scores for both groups should read 33.0-23.6 (telmisartan group) and 30.6-24.5 (ARB group), not 25.0-31.3 and 25.0-30.6, as reported. In Table 2, the baseline HbA1c result for the current ARB group should read 5.66±0.52, and not 5.56±0.52, and the 6 month LDL cholesterol result for the telmisartan group should read 109.6±30.0, not 109.6±30.3, as reported. In Figure 1A the P value should be P<0.05, not P=0.05. In Figures 1 and 2, the x axis values were slightly incorrect; the correct figures are shown below. The authors regret the errors, and thank Springer Healthcare for publishing the correction.
Amlodipine/Valsartan Single-Pill Combination: A Prospective, Observational Evaluation of the Real-Life Safety and Effectiveness in the Routine Treatment of Hypertension
Yuri Karpov, Neelesh Dongre, Alexey Vigdorchik, Krisada Sastravaha
DOI: 10.1007/s12325-011-0095-0
Adv Ther. 2012;29(2). In press.
Abstract | Full text
Introduction: As several international guidelines on hypertension have now recommended, single-pill/fixed-dose combination antihypertensive therapies may be particularly beneficial as first-line therapy in high-risk patients, in whom more rapid and pronounced blood pressure (BP) control is desired. Upon the single-pill combination of amlodipine and valsartan becoming available, the authors conducted this international, observational study to evaluate its efficacy and safety in a real-life practice setting. Methods: This prospective, open-label, postmarketing surveillance study enrolled adults with arterial hypertension (systolic BP >140 mmHg and/or diastolic BP >90 mmHg) who were prescribed antihypertensive therapy with single-pill combination amlodipine/valsartan 5/80, 5/160, or 10/160 mg once daily. Patients were observed over a 3-month period (12 weeks) with approximately monthly intervals between clinic visits. Results: A total of 8336 patients completed all study visits and were included in the efficacy analysis. Mean age was 54.7 years and 83.4% of patients had received prior antihypertensive therapy. BP reductions were dose related. Overall, mean BP was reduced from 165.0/99.3 mmHg at baseline to 128.7/80.4 mmHg at 12 weeks (−36.3/−18.9 mmHg; P<0.0001). The magnitude of BP reduction rose with increasing severity of baseline BP. Control of BP (<140/90 mmHg) was achieved in 77.7% of patients. Efficacy was consistent in subgroups of patients with comorbidities and regardless of whether patients were previously treated with monotherapy or combination therapy. Adverse events were reported in 5.3% of patients. The incidence of edema declined from 10.4% at baseline to 8.5% at study end. Conclusion: Single-pill combination amlodipine/valsartan safely and effectively reduced BP across all hypertension grades and allowed the vast majority of patients to achieve BP goals.
Lack of Pharmacokinetic Interactions Between Dapagliflozin and Simvastatin, Valsartan, Warfarin, or Digoxin
Sreeneeranj Kasichayanula, Ming Chang, Xiaoni Liu, Wen-Chyi Shyu, Steven C. Griffen, Frank P. LaCreta, David W. Boulton
DOI: 10.1007/s12325-011-0098-x
Adv Ther. 2012;29(2). In press.
Abstract | Full text
Introduction: Coronary heart disease, stroke, and peripheral vascular disease are the most common causes of mortality in patients with type 2 diabetes mellitus (T2DM). The aim of these studies was to assess the potential for pharmacokinetic interaction between dapagliflozin, a sodium glucose co-transporter-2 inhibitor being developed for the treatment of T2DM, and four medications commonly prescribed in patients with T2DM and cardiovascular disease: simvastatin, valsartan, warfarin, and digoxin. Methods: Potential pharmacokinetic interactions between 20 mg dapagliflozin, 40 mg simvastatin, or 320 mg valsartan were assessed in an open-label, randomized, five-period, five-treatment, unbalanced crossover study in 24 healthy subjects. In a second study, the effects of steady-state dapagliflozin on the pharmacokinetics of 25 mg warfarin or 0.25 mg digoxin were assessed in an open-label, randomized, two-period, two-treatment crossover study in 30 healthy subjects divided into two cohorts. The potential pharmacodynamic interaction between dapagliflozin and warfarin was also evaluated. Results: All treatments were well tolerated. Neither simvastatin nor valsartan had any clinically meaningful effect on the pharmacokinetics of dapagliflozin. Dapagliflozin increased the area under the curve for simvastatin, simvastatin acid, and valsartan by approximately 19%, 30%, and 6%, respectively, and decreased the maximum observed plasma concentration of valsartan by approximately 6%. These effects were not considered clinically meaningful. In addition, dapagliflozin had no effect on the pharmacokinetics of either digoxin or warfarin. The pharmacodynamics of warfarin were also unaffected by dapagliflozin. Conclusion: In these studies the co-administration of dapagliflozin and simvastatin, valsartan, warfarin, or digoxin was well tolerated without clinically meaningful drug-drug interaction.