Evaluation of the Efficacy and Safety of the Lercanidipine/Valsartan Combination in Korean Patients With Essential Hypertension Not Adequately Controlled With Lercanidipine Monotherapy: A Randomized, Multicenter, Parallel Design, Phase III Clinical Trial.

PURPOSE: The objective of this study was to evaluate the efficacy and safety of the lercanidipine/valsartan combination compared with lercanidipine monotherapy in patients with hypertension. METHODS: Part 1 of this study was the randomized, multicenter, double-blind, parallel group, Phase III, 8-week clinical trial to compare superiority of lercanidipine 10 mg/valsartan 80 mg (L10/V80) and lercanidipine 10 mg/valsartan 160 mg (L10/V160) combinations with lercanidipine 10 mg (L10) monotherapy. At screening, hypertensive patients, whose diastolic blood pressure (DBP) was >90 mm Hg after 4 weeks with L10, were randomized to 3 groups of L10, L10/V80, and L10/V160. The primary end point was the change in the mean sitting DBP from baseline (week 0) after 8 weeks of therapy. Patients who were randomly assigned to L10/V160 and whose mean DBP was still ≥ 90 mm Hg in part 1 were enrolled to the up-titration extension study with lercanidipine 20 mg/valsartan 160 mg (L20/V160) (part 2). FINDINGS: Of 772 patients screened, 497 were randomized to 3 groups (166 in the L10 group, 168 in the L10/V80 group, and 163 in the L10/V160 group). Mean (SD) age was 55 (9.9) years, and male patients comprised 69%. The mean (SD) baseline systolic blood pressure (SBP)/DBP were 148.4 (15.1)/94.3 (9.5) mm Hg. No significant differences were found between groups in baseline characteristics except the percentages of previous history of antihypertensive medication. The primary end points, the changes of mean (SD) DBP at week 8 from the baseline were -2.0 (8.8) mm Hg in the L10 group, -6.7 (8.5) mm Hg in L10/V80 group, and -8.1 (8.4) mm Hg in L10/V160 group. The adjusted mean difference between the combination groups and the L10 monotherapy group was -4.6 mm Hg (95% CI, -6.5 to -2.6; P < 0.001) in the L10/V80 group and -5.9 mm Hg (95% CI, -7.9 to -4.0, P < 0.001) in the L10/V160 group, which had significantly greater efficacy in BP lowering. A total of 74 patients were enrolled in the part 2 extension study. Changes of mean (SD) DBP and SBP from week 8 to week 12 and week 16 were -5.6 (7.9)/-8.0 (12.0) mm Hg and -5.5 (7.0)/-8.5 (11.3) mm Hg, respectively. For evaluation of the safety profile, the frequencies of adverse events between groups were also not significantly different. The most frequently reported adverse events were headache (6 cases, 20.7%) in the L10 group, dizziness (8 cases, 16.3%) in L10/V80 group, and nasopharyngitis (3 cases, 9.4%) in L10/V160 group, and the incidences of adverse events were not different between groups. IMPLICATIONS: Treatment of L10/V80 or L10/V160 combination therapy resulted in significantly greater BP lowering compared with L10 monotherapy. Moreover, the L20/V160 high dose combination had additional BP lowering effect compared with nonresponders with the L10/V160 combination. ClinicalTrials.gov: NCT01928628.

A case of cryptogenic stroke associated with patent foramen ovale coexisting with pulmonary embolisms, deep vein thromboses, and renal artery infarctions.

A paradoxical embolism is defined as a systemic arterial embolism requiring the passage of a venous thrombus into the arterial circulatory system through a right-to-left shunt, and is commonly related to patent foramen ovale (PFO). However, coexisting pulmonary embolisms, deep vein thromboses (DVT), and multipe systemic arterial embolisms, associated with PFO, are rare. Here, we report a patient who had a cryptogenic ischemic stroke, associated with PFO, which is complicated with a massive pulmonary thromboembolism, DVT, and renal infarctions, and subsequently, the patient was treated using a thrombolytic therapy.

A rare case of unruptured sinus of valsalva aneurysm obstructing the right ventricular outflow tract.

An unruptured sinus of Valsalva aneurysm is rare and is usually asymptomatic until a symptom associated with its complication develops. Hence, an unruptured sinus of Valsalva aneurysm is not infrequently missed unless echocardiogram is performed with other indications. An unruptured sinus of Valsalva aneurysm rarely protrudes into the right ventricular outflow tract, causing the right ventricular outflow tract obstruction. In this report, I describe a rare case of unruptured sinus of Valsalva aneurysm producing the right ventricular outflow tract obstruction, which was incidentally detected by echocardiography.

Congenital anomaly of the true double-lumen right coronary artery: An extremely rare case.

Double right coronary artery is a rare anomaly which is mostly identified by two separate pathways with a common ostium (one-two way). We report herein an extremely rare case of congenital true double-lumen right coronary artery, an anomaly, where a common pathway from the ostium to the proximal segment diverged into two separate pathways from the proximal to the mid-segment and then converged into one pathway (one-two-one way).

Very late stent thrombosis associated with multiple stent fractures and peri-stent aneurysm formation after sirolimus-eluting stent implantation.

Previous randomized trials have shown that drug-eluting stents (DES) are superior to bare-metal stents in reducing the need for target lesion revascularization, but safety issues with DES have recently been raised. We report a rare case of very late stent thrombosis 35 months after sirolimus-eluting stent implantation associated with delayed 5-segment stent fractures and peri-stent aneurysm formation.