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A meteor shower is a luminous phenomenon that takes place by the entry into the Earth's atmosphere of a cascade of particles coming from a stream intersected by our planet [...]

Abstract Banana is the second largest export crop in Colombia. To meet the demand of international markets, high amounts of chemical fertilizers are required, which represent high costs and can be hazardous to the environment. Plant growth promoting rhizobacteria (PGPR) can, at least partially, replace chemical fertilizers. In this paper, we evaluated the effect of nine PGPR of the genera Bacillus and Pseudomonas on banana growth. Banana seedlings were produced through tissue culture and acclimatized in the greenhouse core. Plants were inoculated with the rhizobacteria and growth parameters (plant height, leaf number, leaf area, pseudostem thickness, root and shoot fresh weight, root and shoot dry weight) were assessed after 55 days. The two best performing PGPR, Bs006 and Ps006 previously identified as Bacillus amyloliquefaciens and Pseudomonas fluorescens , respectively, promoted banana growth similarly or even slightly superior to 100% chemical fertilization, and were selected for further characterization of root colonization by both eletron microscopy and confocal microscopy of fluorescence in situ hybridization (FISH)–stained root tissues. Both P. fluorescens Ps006 and B. amyloquifaciens Bs006 showed ability to colonize banana roots, but Bs006 appeared faster than Ps006 in the colonization dynamics. This work demonstrated that inoculation of rhizobacteria Bacillus amyloliquefaciens Bs006 and Pseudomonas fluorescens Ps006 could partially replace the chemical fertilization of tissue cultured banana plants, and therefore could be used for the formulation of a new biofertilizer. [ABSTRACT FROM AUTHOR]

Antiplatelet therapy, including aspirin, is recommended to lower the vascular risk in patients with intermittent claudication. Policosanol has increased walking distances in these patients, probably because of its antiplatelet effects, but the effect of shorter treatment has not been studied. This double-blind study compared the effects of policosanol 10 mg/d and aspirin 100 mg/d for 10 weeks on walking distances in claudicants. Thirty-nine patients were randomized to policosanol or aspirin. Walking distances on a treadmill were assessed before and after treatment. Policosanol significantly increased the initial and absolute claudication distances, while aspirin changed neither variable. Policosanol, not aspirin, significantly lowered serum low-density lipoprotein-cholesterol and total cholesterol while raising high-density lipoprotein-cholesterol. In conclusion, treatments of policosanol, not aspirin, for 10 weeks significantly increased walking distances, but modestly, in contrast with previous results. Therefore, the duration of treatments at the doses tested was too short for meaningful effects on the treadmill test. [ABSTRACT FROM AUTHOR]

Focuses on the definition of average concept. Implication for Landesman-Lazer condition; Proposition of the proof of the theorem; Use of conditions to study the permanence of class in predatory-prey system; Use for establishing the existence of coexistence states for non-autonomous competition systems of Lotka-Volterra type.

Both hypercholesterolemia (HC) and obesity are coronary risk factors. Clinical studies have shown the benefits of lowering elevated plasma levels of low-density lipoprotein-cholesterol (LDL-C) on clinical end-points. Policosanol is a cholesterol-lowering drug purified from sugar cane wax with a therapeutic range from 5 to 20 mg/day. This randomised, double-blinded, placebo-controlled study was undertaken to investigate the long-term efficacy and safety of policosanol in obese patients (BMI = 30) with Type II hypercholesterolemia. After 5 weeks on step one cholesterol-lowering diet, 129 patients were randomised to policosanol 5 mg or placebo tablets taken once daily with the evening meal for 3 years. Lipid profile variables, safety indicators, adverse events (AE) and compliance with diet counselling and study medications were assessed. Study patiens showed a high frequency of other coronary risk factors, hypertension being the most common. Both groups were well matched at randomisation. After one year on treatment, policosanol significantly (p < 0.01 vs placebo) lowered serum LDL-C, the primary efficacy variable (24.3 %) and total cholesterol (TC) (15.8 %), whereas increased high-density lipoprotein-cholesterol (HDL-C) (21.9 %). Changes of lipid variables in placebo were not significant. Treatment effects were persistent, even slightly enhanced, during the trial. At study completion, policosanol had lowered (p < 0.00001) LDL-C (31.8 %) and TC (20.1 %), while markedly raised (p <0.00001) HDL-C (24.6 %). Thirty patients (18 placebo, 12 policosanol) discontinued the study: 15 (11 placebo, 4 policosanol) due to AE and 12 (9 placebo, 3 policosanol) due to serious adverse events (SAE), most vascular. Policosanol was safe and well tolerated, not impairing significantly any safety indicator. Average body weight was slightly reduced over the study, indicating a general acceptable compliance with dietary recommendations, but policosanol did not show any drug effect on body weight. Overall, 28 placebo and 26 policosanol patients reported some mild or moderate AE during the study. It is concluded that policosanol was effective for lowering cholesterol in obese patients with type II hypercholesterolemia, being also safe and well tolerated. [ABSTRACT FROM AUTHOR]

Diabetes and hypercholesterolemia are major coronary risk factors. Coronary risk of diabetics is also greater than non-diabetics. The main goal of dyslipidemia control in diabetics is to lower elevated low-density lipoproteincholesterol (LDL-C) levels. Policosanol is a cholesterol-lowering drug purified from sugar cane wax, which significantly reduces LDL-C levels and inhibits platelet aggregation. Previous short-term studies have shown the efficacy and tolerability of policosanol at 10 mg/day on patients with Type 2 diabetes, but no previous study on the effects of long-term treatment or lower doses has been reported. This study was undertaken to investigate the longterm efficacy, safety and tolerability of policosanol on patients with Type 2 diabetes. After 5 weeks on a step one cholesterol lowering diet, 239 patients with Type 2 diabetes were randomized to policosanol 5 mg/day or placebo for 2 years. Analysis was by Intention-to-treat. Baseline characteristics were well matched in both groups. After one year, policosanol reduced significantly (p < 0.0001 versus baseline and placebo) low-density lipoprotein-cholesterol (LDLC) (21.1 %), total cholesterol (TC) (17.5 %) and triglycerides (TG) (16.0 %), whereas increased (p < 0.01 versus baseline and placebo) high-density lipoprotein-cholesterol (HDL-C) levels (10.7 %). Treatment effects on LDL-C, HDL-C and TC persisted, even moderately enhanced, during the study, the effect on TG being persistent too Thus, at study completion, policosanol lowered (p < 0.0001 vs baseline and placebo) LDL-C (29.5 %), TC (21.9 %), TG (16.9 %) and raised (p < 0.0001 vs baseline and placebo) HDL-C (12.4 %). No significant changes on lipid profile variables of placebo group occurred during the study. Of 239 randomized patients, 63 (26.4 %) discontinued the study, 43/120 placebo (35.8 %) and 20/119 policosanol patients (16.8 %). Of them, 35 patients (28 placebo, 7 policosanol) withdrew from the study due to some AE. The frequency of serious adverse events (SAE), most vascular, in policosanol patients (6/119, 5.0 %) was lower than in respective placebo (26/120, 43.3 %). Five patients, all placebo, died during the study, four of them due to myocardial infarction. No drug-related impairment of safety indicators, particularly on glycemic control, was observed. Nevertheless, a reduction of systolic and diastolic blood pressure was observed in policosanol patients compared with placebo. The overall frequency of policosanol patients reporting mild and/or moderate was similar than in placebo. It is concluded that policosanol was long-term effective, safe and well tolerated on patients with dyslipidemia due to Type 2 diabetes. [ABSTRACT FROM AUTHOR]

Introduction: There are clinical and sociodemographic factors that have an impact on the comfort of the critically ill paediatric patient. The main aim of this study was to determine the level of discomfort of paediatric patients admitted to different national hospitals, and to analyse its correlation with sociodemographic and clinical variables, analgosedation, and withdrawal syndrome., Methods: An observational, analytical, cross-sectional, and multicentre study was conducted in five Spanish hospitals. The level of analgosedation was assessed once per shift over a 24 h period, using a BIS sensor, and pain with scales adapted to paediatric age population. The intensity of withdrawal syndrome was determined using the Withdrawal Assessment Tool (WAT-1) scale once per shift for 3 days. Discomfort level was simultaneously assessed using COMFORT Behaviour Scale-Spanish version (CBS-S)., Results: A total of 261 critically ill paediatric patients with median age of 1.61 years (IQR = 0.35-6.55) were included. An overall discomfort score of 10.79 ± 3.7 was observed during morning compared to 10.31 ± 3.3 during the night. When comparing analgosedation and non-analgosedation groups, statistical differences were found in both shifts (χ 2 : 45.48; P = .001). At the same time, an association was observed (P < .001) between low discomfort scores and development of withdrawal syndrome development assessed with WAT-1., Conclusions: As there is a percentage of the studied population with discomfort, specific protocols need to be developed, guided by valuated and clinically tested tools, like the COMFORT Behaviour Scale-Spanish version., (Copyright © 2020 Asociación Española de Pediatría. Published by Elsevier España, S.L.U. All rights reserved.)

Aim: The main aim of this investigation was to analyse the specificity and sensibility of the COMFORT Behaviour Scale (CBS-S) in assessing grade of pain, sedation, and withdrawal syndrome in paediatric critical care patients., Method: An observational, analytical, cross-sectional and multicentre study conducted in Level III Intensive Care Areas of 5 children's university hospitals. Grade of sedation was assessed using the Spanish version of the CBS-S and the Bispectral Index on sedation, once per shift over one day. Grade of withdrawal was determined using the CBS-S and the Withdrawal Assessment Tool-1, once per shift over three days., Results: A total of 261 critically ill paediatric patients with a median age of 5.07 years (P25:0.9-P75:11.7) were included in this study. In terms of the predictive capacity of the CBS-S, it obtained a Receiver Operation Curve of .84 (sensitivity of 81% and specificity of 76%) in relation to pain; .62 (sensitivity of 21% and specificity of 78%) in relation to sedation grade, and .73% (sensitivity of 40% and specificity of 74%) in determining withdrawal syndrome., Conclusions: The Spanish version of the COMFORT Behaviour Scale could be a useful, sensible and easy scale to assess the degree of pain, sedation and pharmacological withdrawal of critically ill paediatric patients., (Copyright © 2021 Sociedad Española de Enfermería Intensiva y Unidades Coronarias (SEEIUC). Publicado por Elsevier España, S.L.U. All rights reserved.)

Introduction: There are clinical and sociodemographic factors that have an impact on the comfort of the critically ill paediatric patient. The main aim of this study was to determine the level of discomfort of paediatric patients admitted to different national hospitals, and to analyse its correlation with sociodemographic and clinical variables, analgosedation, and withdrawal syndrome., Methods: An observational, analytical, cross-sectional, and multicentre study was conducted in five Spanish hospitals. The level of analgosedation was assessed once per shift over a 24h period, using a BIS sensor, and pain with scales adapted to paediatric age population. The intensity of withdrawal syndrome was determined using the Withdrawal Assessment Tool (WAT-1) scale once per shift for 3 days. Discomfort level was simultaneous assessed using COMFORT Behaviour Scale-Spanish version (CBS-S)., Results: A total of 261 critically ill paediatric patients with median age of 1.61 years (IQR=0.35-6.55) were included. An overall discomfort score of 10.79±3.7 was observed during morning compared to 10.31±3.3 observed during the night. When comparing analgosedation and non-analgosedation groups, statistically differences were found in both shifts (χ 2 : 45.48; P=.001). At the same time, an association was observed (P<.001) between low discomfort scores and development of withdrawal syndrome development assessed with WAT-1., Conclusions: As there is a percentage of the studied population with discomfort, specific protocols need to be developed, guided by valuated and clinically tested tools, like the COMFORT Behaviour Scale-Spanish version., (Copyright © 2020 Asociación Española de Pediatría. Publicado por Elsevier España, S.L.U. All rights reserved.)

Triple-negative breast cancer (TNBC) represents 15%-20% of all breast cancer types. It is more common among African American (AA) and Hispanic-Latina (HL) women. The biology of TNBC in HL women has been poorly characterized, but some data suggest that the molecular drivers of breast cancer might differ. There are no clinical tools to aid medical oncologists with decisions regarding appropriate individualized therapy, and no way to predict long-term outcomes. The aim of this study was to characterize individual patient gene mutation profiles and to identify the relationship with clinical outcomes. We collected formalin-fixed paraffin-embedded tumors (FFPE) from women with TNBC. We analyzed the gene mutation profiles of the collected tumors and compared the results with individual patient's clinical histories and outcomes. Of 25 patients with TNBC, 24 (96%) identified as HL. Twenty-one (84%) had stage III-IV disease. The most commonly mutated genes were TP53, NOTCH1, NOTCH2, NOTCH3, AKT, MEP3K, PIK3CA, and EGFR. Compared with other international cancer databases, our study demonstrated statistically significant higher frequencies of these genes among HL women. Additionally, a worse clinical course was observed among patients whose tumors had mutations in NOTCH genes and PIK3CA. This study is the first to identify the most common genetic alterations among HL women with TNBC. Our data strongly support the notion that molecular drivers of breast cancer could differ in HL women compared with other ethnic backgrounds. Therefore, a deeper understanding of the biological mechanisms behind NOTCH gene and PIK3CA mutations may lead to a new treatment approach., Competing Interests: The authors have declared that no competing interests exist.

A retrospective analysis of oral fluid drug testing results using LC-MS/MS was performed to determine the prevalence rates in oral fluid for codeine (COD) and 3 COD metabolites-morphine (MOR), norhydrocodone (NHC), and hydrocodone (HCOD). Oral fluid samples were collected using Quantisal oral fluid collection device (Immunalysis Inc.) and submitted to Millennium Health, LLC for the routine drug analysis by LC-MS/MS. Consistent with previously published literature, COD was the primary analyte detected in oral fluid after the use of COD. In COD-positive samples, HCOD, MOR, and NHC were detected at rates of 68.4%, 18.4%, and 6.3%, respectively. Concentration ranges of these analytes were 1.0 to >2000 ng/mL for COD, 1.0-20.2 ng/mL for MOR, 1.0-740.0 ng/mL for HCOD, and 2.1-47.5 ng/mL for NHC. In contrast to urine, where HCOD is typically detected as a minor metabolite of COD, HCOD was the most commonly detected metabolite in oral fluid in samples testing positive for COD with reported prescriptions for COD. This observation suggests that care should be taken when interpreting HCOD positives in oral fluid results, and that the use of COD should be considered as one possible explanation for HCOD positives.

Indeterminate cytologic diagnoses in endoscopic ultrasound guided fine needle aspiration biopsy (EUS-FNA) of solid pancreatic lesions include the diagnostic categories "atypical" (ATY) and "suspicious for malignancy" (SUSP), which are used at variable rates and are associated with variable underlying risk of malignancy. The aim of this study was to determine individual cytopathologists' rates of indeterminate diagnoses in EUS-FNA of solid pancreatic lesions and their relationship to cytopathologists' experience and volume of pancreatic EUS-FNA examined, as well as the potential impact of departmental consensus review on indeterminate diagnoses., Design: The diagnostic rates of ATY and SUSP and their underlying risk of malignancy were calculated for six cytopathologists who diagnosed 1,114 of 1,225 EUS-FNA of solid pancreatic lesions from 1/1/2001 to 9/15/2014, and were then compared for the periods before and after the implementation of departmental consensus review during 2009., Results: The six cytopathologists diagnosed 10% of cases as indeterminate; 82 (7.4%) as "atypical" and 29 (2.6%) as "suspicious". The individual cytopathologists' indeterminate diagnosis rates varied twofold (6.67-12.80%) and did not correlate with their experience, total or annual volume of EUS-FNAs. Of the 56/99 (56.57%) cases with follow-up, the underlying rate of malignancy was 47% (35/75; for "atypical" and 87.5% (21/24); for "suspicious"). The underlying rates of malignancy were 33-67% for "atypical" and 80-100% for "suspicious" diagnoses made by individual cytopathologists. The rate of indeterminate diagnoses decreased from 11.55 to 7.88% after the implementation of departmental consensus review., Conclusion: Individual cytopathologists' rates of indeterminate diagnoses and their significance vary; however, consensus review is helpful in reducing these rates. Diagn. Cytopathol. 2017;45:3-13. © 2016 Wiley Periodicals, Inc., (© 2016 Wiley Periodicals, Inc.)

Objectives: Cellular fibroepithelial lesions (CFELs) are a heterogeneous group of tumors encompassing cellular fibroadenoma (CFA) and phyllodes tumor (PT). Distinction between the two is challenging on core needle biopsy (CNB) specimens. The objective of this study was to evaluate histologic features that can help distinguish PT from CFA on CNB specimens., Methods: Records of all patients diagnosed with CFELs on CNB specimens with follow-up excision between January 2002 and December 2012 were retrieved. Histopathologic stromal features were evaluated on CNB specimens, including mitoses per 10 high-power fields (hpf), overgrowth, increased cellularity, fragmentation, adipose tissue infiltration, heterogeneity, subepithelial condensation, and nuclear pleomorphism., Results: Twenty-seven (42.2%) of 64 were diagnosed as PT (24 benign PTs and three borderline PTs) and 37 (57.8%) as CFA on excision. All features except for increased stromal cellularity were statistically significant. The average number of histologic features seen in PT and CFA was 3.9 and 1.4, respectively (odds ratio [OR], 7.27; 95% confidence interval [CI], 2.44-21.69; P = .0004). The average number of mitoses per 10 hpf was 3.0 for PT compared with 0.8 for CFA (OR, 2.14; 95% CI, 1.18-3.86; P = .01)., Conclusions: The presence of mitoses (three or more) and/or total histologic features of three or more on CNB specimens were the most helpful features in predicting PT on excision., (Copyright© by the American Society for Clinical Pathology.)

Background: We sought to determine whether the design of 3 different double-lumen endobronchial tubes (DLT) (Rusch, Mallinckrodt, Fuji) has an effect on the ease of placement over an airway exchange catheter (AEC) using a video laryngoscope., Methods: A convenience sample of 17 anesthesia residents and fellows with at least 3 years of anesthesia training was recruited from teaching hospitals in Toronto for a randomized crossover trial. Each participant passed each DLT over an AEC in an airway simulator, visualized and video recorded via a video laryngoscope (GlideScope). The order of exchange was randomized by blindly pulling the name of the manufacturer of a DLT from a box. The primary outcome was time to intubate, defined as time from the bronchial lumen entering the GlideScope view to the bronchial lumen passing the vocal cords. Also recorded were participants' subjective rating of the ease of use and failure rate, defined as an attempt >150-second duration., Results: Time to intubate was faster with the Fuji-Phycon DLT (median 2 seconds) compared with both the Rusch (median 27 seconds, P = 0.0144) and Mallinckrodt (median 21 seconds, P = 0.0117). On a scale of 1 to 10, with 10 being very easy to use and 1 being very difficult, the Fuji-Phycon was judged to be easier to use (median 10 seconds) compared with the Rusch (median 3, P = 0.0186) and the Mallinckrodt (median 4 seconds, P = 0.0123). The Rusch was associated with significantly more failures than the other DLTs, P = 0.002., Conclusions: The Fuji-Phycon DLT was easier to pass over an AEC in this simulator trial and warrants consideration in patients with difficult airways who require 1-lung ventilation.

Hormone receptor status determination for breast cancer is an important part of pathologists' daily sign outs and many retrospective and prospective studies. In this study, we compared the estrogen receptor (ER) expression tested on tissue microarray (TMA) sections to those tested on whole sections (WS) to find out concordance and frequency of intratumoral heterogeneity. Five and one-half percent of all tumors showed discrepancy in ER expression between TMA and WS. The rate of discrepancy was lower with increasing number of cores from individual cases. In 1.4% of cases, there was discrepancy in ER expression between cores in which >1 core was available on TMA section. We concluded that TMA can be used to determine ER status with good concordance to ER determination done on WS. Whenever the size of the tumor in the block allows it, more cores should be taken to construct TMAs.

The pattern of immunohistochemical expression of cytokeratins 7 (CK 7) and 20 (CK 20) is commonly used to assess possible primary sites of metastatic carcinomas. Because pituitary tumors are almost always benign, there has been little interest in their cytokeratin profile. However, we recently reported the use of CK 7/20 expression to document malignant progression and metastasis of a pituitary tumor, indicating the potential diagnostic usefulness of the CK 7/20 profile of pituitary adenomas. We analyzed CK 7/20 expression in 97 pituitary adenomas subclassified by immunohistochemical hormone expression. In about 90% of all subtypes, CK 7 was either negative or reactive in only a few scattered cells. Corticotrophs and sparsely granulated growth hormone-positive adenomas were consistently CK 20 positive (and CK 7 negative) whereas all other subtypes were almost always CK 20 negative. This CK 20-positive, CK 7-negative profile is previously described consistently only in colonic adenocarcinomas. This study documents that subtypes of pituitary adenomas have different CK 7/20 profiles. Whereas this pattern is likely to have diagnostic usefulness in only rare adenomas, the presence of a unique CK signature in corticotrophs and sparsely granulated growth hormone-positive adenomas, subtypes particularly noted for invasive and aggressive behavior, merits further investigation.

Background: Policosanol is a drug derived from sugar cane wax that has cholesterol-lowering and antiplatelet properties. Randomized, controlled studies are the gold standard for demonstrating drug efficacy, safety, and tolerability, but postmarketing surveillance studies are encouraged for corroborating drug effects. A valid proof of the safety of a drug is a well-documented, good tolerability profile in older individuals, since this population is more prone to drug-related adverse events (AEs)., Objective: This study investigated the tolerability of policosanol in the elderly population by monitoring the incidence and nature of AEs occurring in older Cuban patients treated with policosanol in routine clinical practice., Methods: All patients aged > or =60 years treated with policosanol at 7 major medical centers from January 2000 to May 2003 were included. Policosanol (5, 10, or 20 mg/d) was prescribed to patients eligible to receive cholesterol-lowering and/or antiplatelet drugs, with the dosage recommended according to their individual atherosclerotic risk. Patients had follow-up visits approximately every 6 months. Data on AEs and other relevant information, including changes in policosanol treatment, concomitant medications, and discontinuations, were recorded on individual case-report forms., Results: This study included 2252 patients (1306 women, 946 men): 647 (28.7%), 244 (10.8%), and 173 (7.7%) patients had coronary, cerebrovascular, and peripheral artery disease, respectively. A total of 1485 patients had hypercholesterolemia (65.9%), 1322 (58.7%) had hypertension, and 323 (14.3%) had diabetes mellitus. Of the enrolled patients, 1123 (49.9%), 644 (28.6%), and 485 (21.5%) received policosanol 5, 10, and 20 mg/d, respectively. Treatment duration varied: 2169 (96.3%), 1861 (82.6%), 1116 (49.6%), and 412 (18.3%) patients were treated for 6, 12, 24, and 36 months, respectively. Thirty-one patients (1.4%) experienced serious AEs, 18 of them fatal. Death was most often due to vascular events: myocardial infarction (4 patients), sudden cardiac arrest (1), ventricular arrhythmia (2), ischemic stroke (1), lung thromboembolism (1), cancer (5), pneumonia (1), peritonitis (1), lung edema (1), and dehydration (1). Another 13 patients (0.6%) were hospitalized, and 61 (2.7%) reported moderate or mild AEs. Overall, 21 patients (0.9%) discontinued prematurely from the study, 18 of them due to a fatal serious AE., Conclusions: Long-term tolerability of policosanol in elderly patients at high vascular risk was very good, as assessed under conditions of routine clinical practice. These results are consistent with those obtained in randomized, double-blind clinical studies of older patients treated with policosanol.

D-003 is a mixture of long-chain aliphatic primary acids isolated from sugar cane wax with cholesterol-lowering effects proven in animals and healthy human volunteers. D-003 reduced serum total cholesterol (TC) and low-density lipoprotein cholesterol (LDL-C) in rabbits, while it increased high-density lipoprotein cholesterol (HDL-C) and did not affect triglycerides. D-003 inhibits cholesterol synthesis by regulating, instead of directly inhibiting, hydroxamethylglutaryl-CoA (HMGCoA) reductase activity. Although the ways in which D-003 and statins inhibit cholesterol biosynthesis are not identical, the strong competitive inhibition of cholesterol biosynthesis induced by statins suggests that an enhanced decrease of LDL-C and TC caused by the combined therapy D-003 plus statins is not expected. Nevertheless, taking into account the differential effects of D-003 and statins in HDL-C and triglycerides in rabbits, potential benefits of such combined therapy on other lipid variables cannot been discarded. Fluvastatin is a statin that inhibits competitively HMGCoA reductase, like other members of this class. This study was undertaken to compare the cholesterol-lowering effects of D-003, fluvastatin and the combined therapy of D-003 plus fluvastatin in normocholesterolemic rabbits. Animals were randomly distributed into four groups of eight. One control group received the vehicle, two groups were treated with D-003 or fluvastatin at 5 mg/kg/day each, and the fourth group received the combined therapy of both drugs at 5 mg/kg/day each. Treatments were orally administered for 30 days. Body weight, food consumption and overall animal behavior were recorded to detect any warning sign resulting from combined therapy. After treatment, it was found that both D-003 and fluvastatin had significantly lowered LDL-C - D-003 by 81.5% (p < 0.01) and fluvastatin by 61.4% (p < 0.05). Combined therapy reduced LDL-C values (75.9%). Final values and percent changes reached in all groups were different from the control (p < 0.01). The reductions of TC were consistent with LDL-C decreases, so that D-003, fluvastatin and combined therapy significantly lowered TC by 48.4% (p < 0.01), 39.7% (p < 0.05) and 45.3%, respectively, values being different from those of the control (p < 0.01). The responses of LDL-C and TC to combined therapy were statistically similar, but less pronounced than those reached by D-003 alone. D-003 and combined therapy, but not fluvastatin alone, increased HDL-C (+21.5% and + 19.0%, respectively), these changes being significant versus the control (p < 0.05). In turn, fluvastatin and combined therapy, but not D-003 alone, lowered triglycerides (13.6% and 13.0%, respectively, p < 0.05 versus control). The effects of combined therapy on HDL-C were similar to those of D-003 alone, and the effects of combined therapy on triglycerides were similar to those of fluvastatin alone. The only advantage of combined therapy appears to be that it shows better effects on HDL-C than those of fluvastatin alone and better effects on triglycerides than D-003 alone. No significant changes in lipid profile were observed in the control group. All groups showed similar food consumption and body weight gain, health status being unaffected by the treatments. It is concluded that D-003 and fluvastatin at 5 mg/kg/day administered orally for 30 days to normocholesterolemic rabbits lowered LDL-C and TC, D-003 being more effective in increasing HDL-C and fluvastatin in lowering triglycerides. Combined therapy did not improve the response of LDL-C and TC with respect to monotherapies, but induced better responses of HDL-C and triglycerides than fluvastatin alone had on HDL-C or D-003 alone had on triglycerides.