Clinical characteristics and treatment patterns in patients with atherosclerotic cardiovascular disease with hypercholesterolemia: a retrospective analysis of a large US real-world database cohort.

OBJECTIVE: Guidelines developed by the American College of Cardiology/American Heart Association (ACC/AHA) recommend lipid-lowering therapies (LLTs) to reduce low-density lipoprotein cholesterol (LDL-C) and atherosclerotic cardiovascular disease (ASCVD) risk. This study described LLT utilization patterns and LDL-C goal achievement (to <70 mg/dL) among patients with ASCVD in the United States. METHODS: This retrospective study was conducted using Optum's de-identified Clinformatics Data Mart Database (CDM). Patients with their first ASCVD diagnosis (index date) in the CDM database between July 1, 2015, and December 31, 2018, were followed for ≥12 months to assess LLT utilization patterns and change in LDL-C. LLTs included were statins and non-statin LLTs (ezetimibe, fibrates, and proprotein convertase subtilisin/kexin type 9 inhibitors). Adherence was measured as the proportion of days covered (PDC), defined as the number of days with drug on-hand (or number of days exposed to drug) divided by the 12-month follow-up period. Patients with PDC ≥0.8 were considered adherent. RESULTS: Among the patients with ASCVD (N = 1,424,893) included in this study, only 621,978 (43.7%) had at least one LDL-C measurement at baseline (6 months prior to and 3 months after the index date). The mean age was 71.5 years, and almost half of the patients were female. Patients were followed for a mean (standard deviation [SD]) duration of 30.6 (11.4) months (median of 29.9 months). During the follow-up, about one-quarter of the patients did not receive any LLT. Among treated patients, 89.5% received statins and 10.5% received non-statin LLT. Less than half (47.6%) of the patients were adherent to the index treatment during the 12-month follow-up. Even in patients receiving combination therapy (statin + non-statin LLT), a sizable proportion (35.8%) showed an increase in LDL-C over the follow-up period. CONCLUSIONS: This retrospective study highlighted limited LDL-C monitoring in patients with ASCVD, and unmet need in terms of suboptimal utilization of non-stain LLTs, limited adherence to LLTs, and inadequate lipid control after treatment (among those with LDL-C measurements during the follow-up period) need to be addressed to improve outcomes in this patient cohort.

International societies of cardiologists recommend use of medications to lower the "bad" cholesterol, and its risk of cardiovascular diseases like stroke. We aimed to describe how those medications are being used and to what extent patients with cardiovascular diseases in the United States have their "bad" cholesterol under control. Results of this study indicate that cholesterol check-up among the patients was limited. Among recommended medications, statins were mostly used, whereas use of other recently approved medications was minimal. One-quarter of patients were not prescribed medications to control their cholesterol. Moreover, patients were not taking the medications as frequently as prescribed.

Destiffening effect of valsartan and atenolol: influence of heart rate and blood pressure.

OBJECTIVE: We investigated data in 373 patients from the EXPLOR trial to determine the influence of heart rate (HR) and blood pressure (BP) on aortic stiffness in response to beta-blockade or angiotensin 2 type 1 receptor antagonism, administered during 24 weeks. METHODS: Carotid-femoral pulse wave velocity (PWV) was measured with aplanation tonometry (Sphygmocor ) after 8 (W8) and 24 weeks (W24) of treatment by the single-pill combination valsartan-amlodipine (80/5  mg, then 160/10  mg) or an atenolol-amlodipine combination (50/5  mg, then 100/10  mg) in a prospective, randomized, parallel-groups multicenter trial with PROBE design. Drugs were up-titrated at W8. We analyzed the changes in PWV in relation with the changes in BP and HR, and major covariates, using mixed models in each treatment arm. RESULTS: The unadjusted reductions in mean BP and PWV were not significantly different between groups. HR was significantly reduced in the atenolol group, but not in the valsartan group. After adjustment on BP and HR, PWV significantly decreased with valsartan [-0.37  m/s (-0.70 to -0.08) at W8 and -0.43 (-0.76 to -0.10) m/s at W24], whereas no significant change was observed after atenolol [-0.16  m/s (-0.49 to 0.17) at W8 and -0.05 (-0.35 to 0.44) m/s at W24]. CONCLUSION: These findings suggest that the reduction in PWV observed after atenolol could be explained by changes in BP and HR, whereas in patients treated by valsartan, about half of the decrease in aortic stiffness was BP-independent.

Gender-related differences in the management of hypertension by cardiologists: the PARITE study.

BACKGROUND: Several studies have shown gender differences in the management of cardiovascular risk factors and diseases. Whether the management of hypertension by cardiologists in France differs according to patient gender has not been fully investigated. AIMS: The main objective of this cross-sectional, multicentre study was to examine the management according to gender of hypertensive patients by office-based cardiologists in France. METHODS: Cardiologists were asked to include consecutively two men and two women attending a routine consultation for essential hypertension. Therapeutic management was evaluated by comparing cardiovascular investigations in the preceding 6 months and hypertension control according to gender and the patients' global cardiovascular risk. RESULTS: Overall, data from 3440 adult patients (53% men) referred to 654 cardiologists were analysed. Hypertension was uncontrolled in 76% of both men and women and 69% were at high global cardiovascular risk (75% of men, 62% of women; P<0.001). Significantly fewer cardiovascular investigations had been performed in the preceding 6 months in women (22.6% vs 44.2% in men; P<0.001). The treatment regimen was changed by the cardiologist in approximately 50% of patients regardless of gender or global cardiovascular risk. CONCLUSIONS: The PARITE study shows that in French office-based cardiology practice, the antihypertensive regimen is adjusted as often in female as in male patients. However, the results suggest that there is room for improvement in the investigation of cardiovascular disease in women. Healthcare providers could be encouraged to implement established guidelines on the prevention of cardiovascular disease in women.

Efficacy of morning and evening dosing of amlodipine/valsartan combination in hypertensive patients uncontrolled by 5 mg of amlodipine.

OBJECTIVES: This study compared the effects of morning and evening dosing of amlodipine/valsartan combination on 24-h blood pressure (BP) in patients uncontrolled by amlodipine (5 mg). METHODS: This was a multicenter study that used a prospective, randomized, open-label, blinded endpoint design. Patients with essential hypertension, who's ambulatory BP was uncontrolled after 4 weeks on amlodipine (5 mg) were randomized to receive amlodipine/valsartan (5/160 mg) for 8 weeks in the morning or evening (n=231, 232, respectively), with optional uptitration up to 10/160 mg after 4 weeks if the office BP was uncontrolled. A 30-h ambulatory BP measurement was taken at randomization and at the end of the study. RESULTS: Morning and evening dosing with amlodipine/valsartan had equivalent effects on systolic BP (mean 24 h, daytime, night-time, and 24-30 h) and diastolic BP (mean 24 h, daytime, night-time, and 24-30 h). There was a small difference in the night-time diastolic BP (-4.92 vs.-6.20 mmHg; P=0.02) and a slight but nonsignificant trend for higher BP reduction during daytime for morning intake and during night-time for evening intake. BP control rates based on 24-h ambulatory BP measurement values (<120/80 mmHg) were similar between morning and evening dosing (47 vs. 45%). CONCLUSION: These results indicate that, in patients with BP uncontrolled by amlodipine (5 mg), morning and evening treatment with amlodipine/valsartan combination have similar effects on circadian BP, especially when 24-h mean values are considered.

Amlodipine-valsartan combination decreases central systolic blood pressure more effectively than the amlodipine-atenolol combination: the EXPLOR study.

The beta-blocker atenolol is less effective than angiotensin-receptor blockers and calcium-channel blockers for reducing central blood pressure (BP). The trial was designed to determine whether the advantages of angiotensin-receptor blockers over atenolol remained significant when both were combined with the calcium-channel blocker amlodipine. A prospective, randomized, blinded endpoint (PROBE design) parallel group, multicenter trial including 393 patients with essential hypertension resistant to 4 weeks of 5 mg of amlodipine was set out. Central systolic BP, augmentation index (AIx; either rough or adjusted on heart rate), and carotid-to-femoral pulse wave velocity were measured with applanation tonometry (SphygmoCor) at inclusion and after 8 and 24 weeks of active treatment with an amlodipine-valsartan combination (5/80 mg and then 10/160 mg) or an amlodipine-atenolol combination (5/50 mg and then 10/100 mg). From baseline to week 24, central systolic BP decreased significantly more in the amlodipine-valsartan group (-13.70+/-1.15 mm Hg; P<0.0001) than in the amlodipine-atenolol group (-9.70+/-1.10 mm Hg; P<0.0001; difference: -4.00 mm Hg [95% CI: -7.10 to -0.90]; P=0.013), despite similar changes in brachial systolic BP. The difference in rough AIx reduction was -6.5% (95% CI: -8.3 to -4.7; P<0.0001) in favor of amlodipine-valsartan. AIx adjusted on heart rate was significantly reduced in favor of amlodipine-valsartan (-2.8% [95% CI: -4.92 to -0.68]; P<0.01). Heart rate decreased significantly more with amlodipine-atenolol (difference: -11 bpm [95% CI: -14 to -8 bpm]; P<0.001). Pulse wave velocity decreased by 0.95 m/s in both groups with no significant difference. Differences in central systolic BP and rough AIx remained significant after adjustment to the changes in heart rate. The amlodipine-valsartan combination decreased central (systolic and pulse) pressure and AIx more than the amlodipine-atenolol combination.

A specific training on hypertension guidelines improves blood pressure control by more than 10% in hypertensive patients: the VALNORM study.

VALNORM was designed to assess the impact on blood pressure (BP) control of a specific training in new European Society of Hypertension-International Society of Hypertension (ESH-ISH) guidelines for hypertension management. It was an 8-week prospective, randomized, open, blinded end points design study. General practitioners (GPs) located in France were randomized in two groups: group 1 (G1) without training to the guidelines and free attitude for the prescription whereas group 2 (G2) received a specific training in ESH guidelines. The primary efficacy criteria was strict BP control at week 8 (systolic BP/diastolic BP [SBP/DBP] <140/90 mm Hg and/or SBP/DBP <130/80 mm Hg if diabetes or renal insufficiency). All physicians used the same treatment (valsartan 80 or 160 mg once daily alone or in fixed combination with hydrochlorothiazide 12.5 or 25 mg once daily). BP was measured in the GPs' office with an electronic device. The groups GPs included 4,436 patients with essential uncontrolled hypertension (G1: 595 physicians, 2,308 patients; G2: 502 physicians, 2,128 patients). Patients' main characteristics were: age = 61 +/- 13 years, 52% female, BP = 160 +/- 13/92 +/- 9 mm Hg. No difference was observed between the two groups. The primary efficacy criteria showed in G2: 47.8% of BP control vs. G1: 44.7%, P = .005. Subgroup analysis according to age, body mass index (BMI), previous diabetes, and antihypertensive treatment showed that higher efficacy in G2 was more significant in these high-risk subgroups: age >60 years (G1: n = 1,150, G2: n = 1,035), BMI >/=25 kg/m(2) (G1: n = 1540, G2: n = 1430), diabetes (G1: n = 267, G2: n = 290), no previous antihypertensive treatment (G1: n = 1,111, G2: n = 1,005). The percentage of patients with controlled BP in each subgroup was: diabetes: G1 11.2% vs. G2 17.9% (P = .001), age >60 years: G1 40.3% vs. G2 43.7% (P = .022), BMI >/=25 kg/m(2): G1 43.2% vs. G2 45% (P = .165), untreated: G1 48.2% vs. G2 52.4% (P = .005). Specific training on the guidelines showed a positive impact on BP control, highly significant in patients at high cardiovascular risk such as diabetic hypertensive patients.