Reduction of late stillbirth with the introduction of fetal movement information and guidelines – a clinical quality improvement

We have performed a full cross-validation of this clinical Femina data collection against the routinely collected data of the Medical Birth Registry of Norway to validate the estimates of reduced mortality in the total population. The original estimate of fewer deaths during the intervention with OR 0.7 remains virtually unchanged for the original data collection

24-Hour ambulatory blood pressure control with triple-therapy amlodipine, valsartan and hydrochlorothiazide in patients with moderate to severe hypertension

To determine the effectiveness and safety of once-daily combination therapy with amlodipine, valsartan and hydrochlorothiazide for reducing ambulatory blood pressure (ABP) in patients with moderate to severe hypertension, a multicenter, double-blind study was performed (N=2271) that included ABP monitoring in a 283-patient subset. After a single-blind, placebo run-in period, patients were randomized to receive amlodipine/valsartan/hydrochlorothiazide (10/320/25 mg), valsartan/hydrochlorothiazide (320/25 mg), amlodipine/valsartan (10/320 mg) or amlodipine/hydrochlorothiazide (10/25 mg) each morning for 8 weeks. Efficacy assessments included change from baseline in 24-h, daytime and night time mean ambulatory systolic BP (SBP) and diastolic BP (DBP). Statistically significant and clinically relevant reductions from baseline in all these parameters occurred in all treatment groups (P<0.0001, all comparisons versus baseline). At week 8, least squares mean reductions from baseline in 24-h, daytime and night time mean ambulatory SBP/DBP were 30.3/19.7, 31.2/20.5 and 28.0/17.8 mm Hg, respectively, with amlodipine/valsartan/hydrochlorothiazide; corresponding reductions with dual therapies ranged from 18.8–24.1/11.7–15.5, 19.0–25.1/12.0–16.0 and 18.3–22.6/11.1–14.3 mm Hg (P⩽0.01, all comparisons of triple versus dual therapy). Treatment with amlodipine/valsartan/hydrochlorothiazide maintained full 24-h effectiveness, including during the morning hours; all hourly mean ambulatory SBP and mean ambulatory DBP measurements were ⩽130/85 mm Hg at end point. Amlodipine/valsartan/hydrochlorothiazide combination therapy was well tolerated. Once-daily treatment with amlodipine/valsartan/hydrochlorothiazide (10/320/25 mg) reduces ABP to a significantly greater extent than component-based dual therapy and maintains its effectiveness over the entire 24-h dosing period

Switching patients with uncontrolled hypertension on amlodipine 10 mg to single-pill combinations of telmisartan and amlodipine: results of the TEAMSTA-10 study

OBJECTIVE: To evaluate the efficacy and safety of two different strengths of single-pill combinations of the angiotensin II receptor blocker telmisartan 40 or 80 mg (T40 or T80) and the calcium channel blocker amlodipine 10 mg (A10) compared with that of A10 monotherapy in a hypertensive patient population whose blood pressure was not controlled by A10. RESEARCH DESIGN AND METHODS: An 8-week, randomized, double-blind, controlled study to compare the efficacy and safety of single-pill combinations of T40/A10 or T80/A10 versus A10 monotherapy in 947 patients with uncontrolled hypertension (diastolic blood pressure [DBP] ≥90 mmHg after 6 weeks' A10). MAIN OUTCOME MEASURES: The primary end point was change from baseline in seated in-clinic trough cuff DBP after 8 weeks. Secondary efficacy end points included change from baseline in seated in-clinic trough cuff systolic blood pressure (SBP), and the proportion of patients achieving SBP/DBP response (<140/90 mmHg or ≥10/15 mmHg reduction) and SBP/DBP goal (<140/90 mmHg) after 8 weeks' treatment. Adverse events were recorded throughout. RESULTS: In a patient population who had failed to achieve DBP goal with A10, T40/A10 and T80/A10 resulted in significantly greater (P < 0.0001) reductions in seated trough SBP/DBP versus A10 (-3.7/-2.8 mmHg; -3.9/-2.8 mmHg), significantly higher SBP/DBP goal rates versus A10 (58.8/63.7% and 60.3/66.5% vs. 50.2/51.1%), and significantly higher SBP/DBP response rates with T40-80/A10 versus A10 (64.7/66.0% and 65.8/68.7% vs. 54.1/53.4%). T40-80/A10 were well tolerated. Rates of peripheral edema adverse events were low (6.7-8.5%) and not significantly different between the treatment groups; however, patients were pre-screened for intolerance to A10. CONCLUSIONS: Switching patients who fail to achieve blood pressure goal with A10 to a single-pill combination of T40/A10 or T80/A10 results in superior SBP/DBP reductions, and SBP/DBP goal and response rates