Luca Cacciotti

Long-term effects of nutraceuticals (berberine, red yeast rice, policosanol) in elderly hypercholesterolemic patients

IntroductionStatins are at the forefront of strategies to manage dyslipidemia, although they are not always well tolerated. At 6–7 months after the drug was supplied, discontinuation rates averaged 30%. Alternate agents to statins have been studied. Some nutraceuticals demonstrated an efficacy in reducing cholesterol concentrations. However, there are no data regarding the use of nutraceuticals in elderly dyslipidemic patients. The purpose of this study was to examine the efficacy, safety, and tolerability of a nutraceutical-based protocol in elderly hypercholesterolemic patients previously intolerant to statins.MethodsThis study was performed as a randomized, prospective, parallel group, single-blind study. Patients were included in the study if they had high total cholesterolemia, high low-density lipoprotein cholesterol (LDL-C), >75 years of age, statin-intolerant, and were refusing other pharmaceutical treatments for hypercholesterolemia. At the baseline visit, eligible patients were randomized to either nutraceutical-combined pill (containing berberine 500 mg, policosanol 10 mg, red yeast rice 200 mg, folic acid 0.2 mg, coenzyme Q10 2.0 mg, and astaxanthin 0.5 mg) or placebo, and the first dose was dispensed. The efficacy, safety, and tolerability of the proposed treatment were fully assessed after 3, 6, and 12 months of treatment.ResultsOut of 106 consecutive patients screened, 80 eligible patients were randomized to receive either nutraceutical-combined pill (40 patients) or placebo (40 patients). No patients were lost and no deaths occurred during the follow-up. There was a statistically significant reduction in total cholesterolemia (−20%), LDL-C (−31%), and insulin resistance (−10%) with nutraceutical treatment. No significant changes were detected for plasma high-density lipoprotein cholesterol (HDL-C). Furthermore, no statistical differences were found between baseline and end-study safety parameters. Medication compliance and tolerability were high.ConclusionIn this study the authors have demonstrated that combined nutraceuticals significantly reduce cholesterolemia and achieved acceptable plasma LDL-C levels in elderly hypercholesterolemic patients who were previously statin-intolerant. Combined nutraceuticals is also safe and well tolerated in these patients.

Observational study on Takotsubo-like cardiomyopathy: clinical features, diagnosis, prognosis and follow-up

Objectives The present study attempts to identify appropriate elements that may contribute to clarify the broad clinical features (diagnosis, care, complication and prognosis) of Takotsubo-like cardiomyopathy for improving its management. Design study Observational study. Setting Primary level of care referred to the emergency department of Vannini Hospital, Rome, Italy. Participants The study population consisted of 75 patients, 72 of the them were women and 3 were men with a mean age of 71.9±9.6 years. Methods From February 2004 to November 2010, prospectively included 84 consecutive patients diagnosed for suspected Takotsubo-like cardiomyopathy. To be eligible, patients had to meet all the Mayo clinic criteria in the absence of neurological trauma or intracranial haemorrhage. Moreover, those patients that at follow-up still presented alteration of acute phase at ECG and echocardiogram were excluded. Thus, 75 patients comprised the study population. To follow-up 19 patients were lost. Results None of 75 patients died in acute phase. All patients were promptly discharged (8.4±4.4 days), since they recovered their normal functional status without symptoms. Follow-up information was available for 56 patients. At a mean follow-up time of 2.2±2 years (range, 0.1–6.8 years) two octogenarian patients (2.6%) died because of sudden cardiac death and pulmonary embolism, respectively. The Takotsubo-like cardiomyopathy recurred in one patient. Conclusions The results of this study support the previous reports about the good prognosis, also in critically ill patients, of Takotsubo-like cardiomyopathy. Further assessment will be needed to determine a careful and sustained follow-up for choosing the best care and foreseeing the recurrences of this emerging condition.

Comparison of Microlife BP A200 Plus and Omron M6 Blood Pressure Monitors to Detect Atrial Fibrillation in Hypertensive Patients

IntroductionSelf-monitoring home blood pressure (BP) devices are currently recommended for long-term follow-up of hypertension and its management. Some of these devices are integrated with algorithms aimed at detecting atrial fibrillation (AF), which is common essential hypertension. This study was designed to compare the diagnostic accuracy of two widely diffused home BP monitoring devices in detecting AF in an unselected population of outpatients referred to a hypertension clinic because of high BP.MethodsIn 503 consecutive patients the authors simultaneously compared the accuracy of the Microlife® BP A200 Plus (Microlife) and the OMRON® M6 (OMRON) home BP devices, in detecting AF.ResultsSystolic and diastolic BP as well as heart rate (HR) values detected by the two devices were not significantly different. Pulse irregularity was detected in 124 and 112 patients with the OMRON M6 and Microlife BP A200 Plus devices, respectively. Simultaneous electrocardiogram (ECG) recording revealed that pulse irregularity was due to AF in 101 patients. Pulse irregularity detected by the OMRON M6 device corresponded to AF in 101, to supraventricular premature beats in 18, and to frequent premature ventricular beat in five patients, respectively. Pulse irregularity detected by the Microlife BP A200 Plus device corresponded to AF in 93, to supraventricular premature beats in 14, and to ventricular premature beats in five patients. The sensitivity for detecting AF was 100%, the specificity was 92%, and diagnostic accuracy 95% for the OMRON M6 and 100%, 92%, and 95 for the Microlife BP A200 Plus, respectively. AF was newly diagnosed by ECG recordings in 47 patients, and was detected in all patients by the OMRON device, and in 42 patients by the Microlife device.ConclusionThese results indicate that OMRON M6 is more accurate than Microlife BP A200 Plus in detecting AF in patients with essential hypertension. Widespread use of these devices in hypertensive patients could be of clinical benefit for the early diagnosis and treatment of this arrhythmia and related consequences.

Usefulness of Nutraceuticals (Armolipid Plus) Versus Ezetimibe and Combination in Statin-Intolerant Patients With Dyslipidemia With Coronary Heart Disease

Statins are extensively used to treat dyslipidemia, but, because of their low tolerability profile, they are discontinued in a significant proportion of patients. Ezetimibe and nutraceuticals have been introduced as alternative therapies and have proved to be effective and well tolerated. A single-blind, single-center, randomized, prospective, and parallel group trial comparing a combination of nutraceuticals (red yeast rice, policosanol, berberine, folic acid, coenzyme Q10 and astaxanthin), called Armolipid Plus, and ezetimibe for 3 months in terms of efficacy and tolerability. Patients who did not achieve their therapeutic target (low-density lipoprotein cholesterol <100 mg/dl) could add the alternative treatment on top of randomized treatment for another 12 months: 100 patients who are dyslipidemic with ischemic heart disease treated with percutaneous coronary intervention were enrolled (ezetimibe n = 50, nutraceutical n = 50). Efficacy (lipid profile) and tolerability (adverse events, transaminases, and creatine kinase) were assessed after 3 and 12 months. After 3 months, 14 patients in the nutraceutical group achieved their therapeutic target, whereas none of the patients in the ezetimibe group did. At 1-year follow-up, 58 patients (72.5%) of the combined therapy group (n = 86) and 14 (100%) of the nutraceutical group reached the therapeutic goal. No patients experienced important undesirable effects. In conclusion, nutraceuticals alone or in combination with ezetimibe are well tolerated and improve the lipid profile in statin-intolerant patients with coronary heart disease. Further studies are needed to assess long-term effects of nutraceuticals on mortality.

Stress cardiomyopathy: transient basal ballooning.

Stress cardiomyopathy is a reversible left ventricular dysfunction triggered by emotional stress. We describe a variant of transient left ventricular ballooning in a patient in which basal and midventricular segments are affected. This confirms that there is not just one ventricular dysfunction pattern in Takotsubo cardiomyopathy. The involvement of only the basal and midventricle segments is an intriguing observation with no clear explanation; furthermore, there are no predictive factors for the differently sited wall motion abnormalities.

Effectiveness of nebivolol and hydrochlorothiazide association on blood pressure, glucose, and lipid metabolism in hypertensive patients

IntroductionOnly 50% of hypertensive patients receive an appropriate treatment to normalize blood pressure (BP). Although monotherapy is often adequate in normalizing BP, it is sometimes necessary to start with combination therapy. The aim of the study was to evaluate the efficacy of nebivolol alone and in association with hydrochlorothiazide (HCT) in reducing BP in hypertensive patients with new-onset, mild-to-moderate hypertension, and to assess the effect of combination therapy on glucose and lipid metabolism.MethodsAt enrollment, patients underwent a full cardiovascular and metabolic evaluation. Patients were then prescribed nebivolol (5 mg/day). After 1 month, in those patients whose BP was not normalized, HCT 12.5 mg was added and increased further to 25 mg after 1 month in those whose BP still was not normalized. All patients were assessed at monthly intervals for a further 5 months.ResultsWe enrolled 233 treatment-naive patients. After the first month of treatment with nebivolol, 70% of patients had normalized BP. The addition of HCT increased responder rates to 94%. An improvement in glucose metabolism was noted with nebivolol alone (at 1 month, the reduction in Homeostasis Model Assessment of Insulin Resistance [HOMA-IR] was 26% and remained stable at 6 months); the adjunct of HCT blunted the reduction in HOMA-IR. No significant changes on lipid profile were noted with nebivolol, either alone or in combination therapy.ConclusionNebivolol is effective in mild-to-moderate hypertension and associated with favorable metabolic effects. The addition of HCT optimizes BP control in a high number of patients resistant to monotherapy without a negative impact on patients’ glucose and lipid profile.

Late enhancement detected by cardiac magnetic resonance imaging in acute myocarditis mimicking acute myocardial infarction: location patterns and lack of correlation with systolic function.

Objective Clinical recognition of acute myocarditis is difficult. Late enhancement (LE) detected by magnetic resonance imaging appears to be a valuable tool for evaluating and monitoring inflammatory myocardial diseases. However, patterns of myocardial enhancement and its correlation with systolic function are not yet well defined. The aim of this study was to assess the extent and location of LE during the acute phase of active myocarditis mimicking acute myocardial infarction and at follow-up, in order to correlate LE with systolic function and to monitor disease progression. Methods Magnetic resonance imaging was performed in 13 patients with clinical symptoms and signs of acute myocarditis. Results All patients showed LE, which was located in the lateral free wall in 11 (85%) patients, at the basal level in eight (61%), at the mid level in nine (69%), and at the distal level in 10 (77%). Moreover, six (46%) patients showed LE in the posterior and inferior wall (P = 0.099 versus lateral wall), four (31%) patients in the septum and inferior wall (P = 0.017 versus lateral wall) and three (23%) patients in the anterior wall (P = 0.006 versus lateral wall). Left ventricular ejection fraction was 0.50 ± 10 and it was severely reduced only in one patient (0.20). Conversely, in the remaining patients, left ventricular ejection fraction was preserved (≥0.45) (P < 0.001). Multifocal LE was detected in eight (61%) patients, whereas pericardial effusion was observed only in two (15%) patients (P = 0.002). Twelve patients showed ST-segment elevation and chest pain, as it occurs in acute myocardial infarction, whereas one patient showed non-ST-segment elevation with dyspnoea, as it occurs in non-ST-elevation myocardial infarction. The mean follow-up duration was 4 ± 12 months, and follow-up was complete for all but one patient who died. LE extent decreased in 11 (92%) patients, whereas new areas of LE were detected in one (8%) patient (P < 0.001). Conclusions Contrast enhancement is a frequent finding in the clinical setting of suspected myocarditis and is associated with active and/or persistent myocardial inflammation. Myocarditis detected by magnetic resonance imaging predominantly occurs in the lateral free wall and very rarely affects systolic function.

Stress cardiomyopathy with apical thrombosis promptly diagnosed with cardiovascular MRI.

Dear Sir, A 64-year-old woman was admitted to the coronary care unit because of severe chest pain after emotional stress. The ECG in leads V 1 –V 3 showed minimal ST elevation. Echocardiography revealed systolic dysfunction with apical akinesia, moderate mitral insuffi ciency and a high echogenic mass in the apex. Coronary angiography revealed the absence of obstructive coronary lesions. The creatinine kinase MB and troponin I were mildly elevated. After coronary angiography, cine-MRI ( fi g. 1 ) confi rmed apical akinesia and ballooning with basal hypercontraction, moderate mitral insuffi ciency and apical thrombus of 13 ! 8 mm. Delayed enhancement imaging with the inversion recovery technique ( fi g. 2 ) was performed in the acute phase in order to demonstrate reversibility of the apical damage. Since no hyperenhancement was detected, presumptive diagnosis of ‘stress carReceived: September 26, 2005 Accepted: October 11, 2005 Published online: December 12, 2005

The Echocardiography Laboratory in the informatic era

This article overviews the latest progress in echocardiography in this informatic era. We will present new, different techniques available in clinical settings for qualitative and quantitative evaluation of global and regional left ventricular function, showing their helpfulness in clinical work. We will also report our personal experiences with 3-dimensional (3-D) echocardiography in quantification of left ventricular total mass and left-ventricular dysfunctional mass, and in evaluation of left-ventricular parietal stress. Finally, we will show how the organization of a modern echocardiography laboratory is changing after informatic progress: we will report our personal experiences about transmission of echocardiography data between 2 work stations, located in different places; in this way we can realize an informatic web, which can go out from the single echocardiography laboratories and move toward intradepartment and interdepartment services.

Comparison of Low-Dose Statin Versus Low-Dose Statin + Armolipid Plus in High-Intensity Statin-Intolerant Patients With a Previous Coronary Event and Percutaneous Coronary Intervention (ADHERENCE Trial)

Low-density lipoprotein cholesterol (LDL-C) reduction is associated with a significant decrease in mortality, and statins represent the most effective drugs to achieve this. However, side effects of statins are very common and may lead to treatment discontinuation. Nutraceuticals are a combination of natural components that have shown efficacy in lowering LDL-C concentration when used alone or in association with other agents in patients who are intolerant to high-dose statins. Our aim was to compare the efficacy and tolerability of low-dose statin (LDS) therapy versus combined therapy of LDS plus a nutraceutical combination containing red yeast rice, policosanol, berberine, folic acid, coenzyme Q10 and astaxanthin (Armolipid Plus) in high-risk patients. We performed a randomized (1:1), prospective, parallel group, single-blind trial in which participants had coronary artery disease (n = 100), had undergone percutaneous coronary intervention in the preceding 12 months, were high-dose statin intolerant, and did not achieve ≥50% reduction in LDL-C with LDS treatment alone. After 3 months, patients in the LDS + Armolipid Plus (n = 50) group presented with a significantly greater reduction of LDL-C and total cholesterol (p <0.0001), and 70% of patients in this group achieved the therapeutic target (LDL-C <70 mg/dl), whereas patients in the LDS group did not. Six patients (3 from each group) dropped out due to myalgia. In conclusion, in patients with coronary artery disease and high-dose statin intolerance, the combination of LDS and nutraceuticals represents a valuable therapeutic option.