(86) BERBERINE (BBR) 500 mg IS MORE EFFECTIVE THAN EZETIMIBE 10 mg IN REDUCING LDL-CHOLESTEROL IN HYPERCHOLESTEROLEMIC PATIENTS INTOLERANT TO STATINS

(86) BERBERINE (BBR) 500 mg IS MORE EFFECTIVE THAN EZETIMIBE 10 mg IN REDUCING LDL-CHOLESTEROL IN... S22 Nutrition, Metabolism & Cardiovascular Diseases (2009) S1–S32 86 BERBERINE (BBR) 500 mg IS MORE EFFECTIVE THAN EZETIMIBE 10 mg IN REDUCING LDL-CHOLESTEROL IN HYPERCHOLESTEROLEMIC PATIENTS INTOLERANT TO STATINS L. Pisciotta, C. Ivaldi, C. Borrini, S. Bertolini. Department of Internal Medicine, University of Genoa, Italy E-mail: livia.pisciotta@unige.it Aim of the study: The primary objective of the study was the comparison of the lipid lowering effects of berberine (BBR) 500 mg/day vs ezetimibe (EZE) 10 mg/day in patients with moderate primary hypercholesterolemia (HCH), possibly poligenic. The secondary objective was to verify the tolerability of the two products. Methods: We enrolled 195 patients over 18 years of age (72 M and 123 F) with HCH, who were randomly assigned with a ratio 1:2 to a treatment with EZE 10 mg/die (N. 65, 25 M and 40 F, 57.9±12.7 years of age, BMI 23.6±2.8 kg/m2 , TC 7.69±0.53, LDL-C 5.33±0.52, HDL-C 1.58±0.33, TG 1.73±0.59 mmol/L) or to a treatment with BBR 500 mg/day (N. 130, 47 M and 83 F, 56.8±13.2 years of age, BMI 24.0±3.0 kg/m2 , TC 7.58±0.47, LDL-C 5.34±0.44, HDL-C 1.55±0.34, TG 1.53±0.52 mmol/L). The two groups were not different for gender distribution, age, TC, LDL-C and HDL-C levels at baseline; the group assigned to EZE treatment had moderately higher TG levels (P < 0.02). After a three months treatment the lipid lowering effects of EZE and BBR were compared. Results: The changes induced by EZE were: TC 21.7±4.7%, LDL-C 29.3±6.9%, TG 16.6±15.7% and by BBR: TC 24.1±6.1% (P 0.002 vs EZE), LDL-C 31.7±8.4% (P 0.03 vs EZE), TG 17.4±16.5% (NS vs EZE). Both treatment had no significant effect on HDL-C levels. Only two patients reported gastrointestinal intolerance to BBR. Conclusions: This study demonstrated that BBR 500 mg/day is more effective than EZE 10 mg/day in reducing TC and LDL-C in HCH patients. No significant adverse effects, including AST, ALT and CPK levels, were observed during the two treatments. 87 PARAMETERS SIGNIFICANTLY ASSOCIATED WITH TENDON XANTHOMATOSIS (Tx) IN 619 GENETICALLY CHARACTERIZED ITALIAN FH PATIENTS L. Pisciotta1 , C. Borrini1 , C. Ivaldi1 , S. Calandra2 , S. Bertolini1 . 1 Dpt of Internal Medicine, Univ.of Genoa, 2 Dpt of Biomedical Science, Univ. of Modena and Reggio Emilia, Italy E-mail: livia.pisciotta@unige.it A recent meta-analysis of 22 studies in FH patients (Oosterveer D et al. Atherosclerosis 2009, on line) has shown a significant association between the presence of Tx and age, male gender, LDL-C and TG levels, and cardiovascular disease (3.2-fold higher risk of CVD in subjects with Tx). We have investigated the parameters associated with Tx in 619 genetically characterized Italian heterozygous FH patients (296 males and 323 females, over 30 years of age; TC 9.84±1.74, LDL-C 7.90±1.69, HDL-C 1.29±0.36, TG 1.48±0.68 mmol/L) by multiple logistic regression analysis. The presence of Tx was found to be independently associated with 5-year increase of age (OR 1.12, 1.03 1.21, P 0.006), 1 mmol/L increase in LDL-C (OR 1.62, 1.43 1.82, P 0.0001) and coronary artery disease (OR 2.24, 1.44 3.47, P 0.0001). No significant associations were found with gender, BMI, arterial hypertension, smoking habits, HDL-C and TG levels. The prevalence of Tx in FH patients carrying LDL receptor-defective mutations (n. 234, TC 9.26±1.63, LDL-C 7.25±1.58, HDL-C 1.34±0.38, TG 1.52±0.73 mmol/L) and in those carrying receptor-negative mutations (n. 367, TC 10.22±1.72, LDL-C 8.31±1.65, HDL-C 1.26±0.34, TG 1.44±0.64 mmol/L) was 31.6% and 58.8%, respectively. Removing from the logistic analysis LDL-C level, as independent predictor, and introducing the LDL receptor mutational class we detected, as expected, that patients with receptor-negative mutations vs patients with receptordefective mutations had more than 3-fold higher risk of developing tendon xanthomatosis (OR 3.25, 2.23 4.72, P 0.0001). 88 A NEW PATIENT CARRYING THE R136S MUTATION OF APOE GENE: PHENOTYPIC VARIABILITY OF THIS RECURRENT GENETIC DEFECT L. Pisciotta, A. Bellocchio, S. Airaldi, S. Bertolini. Department of Internal Medicine, University of Genoa, Genoa, Italy E-mail: livia.pisciotta@unige.it The proband was a 54 year-old male (BMI 26 kg/m2 ) with a lipid profile suggestive for dysbetalipoproteinemia (type III): total cholesterol (TC) 10.55, tryglicerides (TG) 4.62 and HDL-cholesterol (HDL-C) 1.14 mmol/L. Ultrasound evaluation of the carotid arteries showed a bilateral IMT of 1.33 mm at common carotids; the patient was apparently free from CAD and PVD. No hypothyroidism, hepatic or renal dysfunctions were found in patient. The proband’s father died for cancer at 79; the mother, 77 year-old, was affected by type 2 diabetes and hypercholesterolemia (TC 7.29, LDL-C 4.96, HDLC 1.63, TG 1.54 mmol/L. Dysbetalipoproteinemia is commonly associated with e2 allele homozygosity (C112, C158) but patient’s APOE genotype resulted to be e3e4 in association with R136S mutation, which was confirmed by direct sequencing. R136S is a rare recurrent defect of APOE gene, located in the receptor-binding domain of the protein. The proband’s mother carried the e3e4 genotype was but did not the R136S mutation. In our lipid clinic we collected 33 cases with dysbetalipoproteinemia; 31 cases were associated 84 PREVALENCE OF MAJOR CARDIOVASCULAR RISK FACTORS AND DISTANCE FROM THE LDL CHOLESTEROL TARGET AMONG DYSLIPIDEMIC SUBJECTS AT DIFFERENT CARDIOVASCULAR RISK M. Pirro, R. Del Giorno, M.R. Mannarino, D. Covelli, G. Schillaci, E. Mannarino. Institute of Internal Medicine, Angiology and Arteriosclerosis Diseases. University of Perugia, Italy E-mail: mpirro@unipg.it Background: Increased lipoprotein levels are considered a determinant of atherosclerosis appearance and progression. Altered lipoprotein profile is frequently part of a constellation of disorders whose combination increases atherosclerotic risk. We investigated among dyslipidemic subjects at different cardiovascular risk the prevalence of major cardiovascular risk factors and the distance from the LDL cholesterol target. Methods: Plasma lipid levels and assessment of major cardiovascular risk factors was performed among 1500 dyslipidemic subjects attending our Lipid Clinic. Traditional cardiovascular risk factors were evaluated and their distribution was studied in the entire cohort and among subjects with cardiovascular disease and/or cardiovascular risk equivalents. The distance of LDL cholesterol levels from reaching its target (target defined according to the number of cardiovascular risk factors and the Framingham risk score assessment: <100 mg/dl; <130 mg/dl; <160 mg/dl) was also evaluated. Results: Mean age of the cohort was 57±12 with a body mass index in the range of overweight (27.1±3.9) and a disturbed lipoprotein profile (total cholesterol 261±51 mg/dl, LDL cholesterol 167±49 mg/dl, triglycerides 197±125 mg/dl, HDL cholesterol 56±16 mg/dl). The prevalence of the following risk factors was obtained: family and personal history for early major cardiovascular diseases 14% and 6.9% respectively, current smoking 22% (number of cigarettes 14±10), diabetes 6.1% and known hypertension 42%. Statin and/or anti-hypertensive treatment was already prescribed in 22% and 40% subjects respectively. According to the number of cardiovascular risk factors and Framingham risk score assessment, the LDL cholesterol target was reached by 28% of the cohort with a mean distance from the target of 27±51 mg/dl. This distance was higher (32±50 mg/dl) when only subjects not taking statin treatment was considered. Among subjects at high cardiovascular risk, the distance from the target for LDL cholesterol (<100 mg/dl) was 54±60 mg/dl (64±62 mg/dl among high risk patients not taking statins). Conclusions: The presence of non lipid cardiovascular risk factors contributes significantly to increase the burden of risk among dyslipidemic subjects. The relatively high distance from reaching the LDL cholesterol target particularly among high risk, statin-untreated and at a less extent statintreated dyslipidemic subjects warrants a more aggressive LDL cholesterol lowering. 85 CLINICAL AND BIOCHEMICAL FEATURES IN ITALIAN FH AND FDB PATIENTS L. Pisciotta1 , C. Borrini1 , R. Sallo1 , S. Calandra2 , S. Bertolini1 . 1 Dpt. of Internal Medicine, Univ. of Genoa, 2 Department of Biomedical Science, University of Modena and Reggio Emilia, Italy E-mail: livia.pisciotta@unige.it We have genetically characterized 1108 subjects with autosomal dominant hypercholesterolemia (ADH), from 481 unrelated families. Four-hundred and seventy families were carries of LDLR gene mutation (97.7%) and eleven of APOB gene mutations causing FDB (2.3%). In FH patients we found 134 different mutations, including major rearrangements, minute insertions and deletions, point insertions and deletions, nonsense and missense mutations, and splicing mutations. Among families with FDB, 10 were carriers of R3500Q mutation and one of R3500W mutation. The comparison between FH and FDB probands showed no significant differences for age (44.0±17.9 vs 44.8±19.0 years), BMI (24.1±3.8 vs 23.3±4.7), HDL-C (1.33±0.34 vs 1.34±0.34 mmol/L) and TG (1.30±0.60 vs 1.28±0.31 mmol/L) levels, but significantly higher TC (9.30±1.71 vs 7.58±0.75 mmol/L) and LDL-C (7.39±1.67 vs 5.66±0.87 mmol/L) levels in FH patients. FH probands also had a higher prevalence of tendon xanthomas (48.8% vs 27.3%), carotid plaques (56.5% vs 25.0%) and CAD (30.4% vs 18.2%). Similar differences in the lipoprotein profile were detectable considering all FH (n. 1081) and all FDB (n. 27) patients: TC 9.15±1.62 vs 7.72±0.82 mmol/L, LDL-C 7.26±1.57 vs 5.80±0.82 mmol/L (P = 0.0001). Subdividing FH probands in subjects with receptor-negative (FH-RN n. 245) and receptor-defective (FH-RD n. 208) mutations and comparing these subgroups with FDB probands no significant differences among the three groups were detected for gender distributions, age, BMI, HDL-C and TG levels. However, the three groups differ each other for LDL-C levels: FH-RN 7.88±1.68, FH-RD 6.79±1.48, FDB 5.66±0.87 mmol/L (P < 0.01); moreover, FH-RN showed a tendency to lower HDL-C levels in comparison to the other groups: FH-RN 1.28±0.31, FH-RD 1.39±0.36, FDB 1.35±0.35 mmol/L. The prevalences of tendon xanthomas, carotid plaques and CAD were: 61.1%, 33.7% and 27.2%; 64.1%, 46.6% and 25.0%; 37.5%, 21.1% and 18.2% in FH-RN, FH-RD and FDB, respectively. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Nutrition, Metabolism and Cardiovascular Diseases Elsevier

(86) BERBERINE (BBR) 500 mg IS MORE EFFECTIVE THAN EZETIMIBE 10 mg IN REDUCING LDL-CHOLESTEROL IN HYPERCHOLESTEROLEMIC PATIENTS INTOLERANT TO STATINS

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Abstract

S22 Nutrition, Metabolism & Cardiovascular Diseases (2009) S1–S32 86 BERBERINE (BBR) 500 mg IS MORE EFFECTIVE THAN EZETIMIBE 10 mg IN REDUCING LDL-CHOLESTEROL IN HYPERCHOLESTEROLEMIC PATIENTS INTOLERANT TO STATINS L. Pisciotta, C. Ivaldi, C. Borrini, S. Bertolini. Department of Internal Medicine, University of Genoa, Italy E-mail: livia.pisciotta@unige.it Aim of the study: The primary objective of the study was the comparison of the lipid lowering effects of berberine (BBR) 500 mg/day vs ezetimibe (EZE) 10 mg/day in patients with moderate primary hypercholesterolemia (HCH), possibly poligenic. The secondary objective was to verify the tolerability of the two products. Methods: We enrolled 195 patients over 18 years of age (72 M and 123 F) with HCH, who were randomly assigned with a ratio 1:2 to a treatment with EZE 10 mg/die (N. 65, 25 M and 40 F, 57.9±12.7 years of age, BMI 23.6±2.8 kg/m2 , TC 7.69±0.53, LDL-C 5.33±0.52, HDL-C 1.58±0.33, TG 1.73±0.59 mmol/L) or to a treatment with BBR 500 mg/day (N. 130, 47 M and 83 F, 56.8±13.2 years of age, BMI 24.0±3.0 kg/m2 , TC 7.58±0.47, LDL-C 5.34±0.44, HDL-C 1.55±0.34, TG 1.53±0.52 mmol/L). The two groups were not different for gender distribution, age, TC, LDL-C and HDL-C levels at baseline; the group assigned to EZE treatment had moderately higher TG levels (P < 0.02). After a three months treatment the lipid lowering effects of EZE and BBR were compared. Results: The changes induced by EZE were: TC 21.7±4.7%, LDL-C 29.3±6.9%, TG 16.6±15.7% and by BBR: TC 24.1±6.1% (P 0.002 vs EZE), LDL-C 31.7±8.4% (P 0.03 vs EZE), TG 17.4±16.5% (NS vs EZE). Both treatment had no significant effect on HDL-C levels. Only two patients reported gastrointestinal intolerance to BBR. Conclusions: This study demonstrated that BBR 500 mg/day is more effective than EZE 10 mg/day in reducing TC and LDL-C in HCH patients. No significant adverse effects, including AST, ALT and CPK levels, were observed during the two treatments. 87 PARAMETERS SIGNIFICANTLY ASSOCIATED WITH TENDON XANTHOMATOSIS (Tx) IN 619 GENETICALLY CHARACTERIZED ITALIAN FH PATIENTS L. Pisciotta1 , C. Borrini1 , C. Ivaldi1 , S. Calandra2 , S. Bertolini1 . 1 Dpt of Internal Medicine, Univ.of Genoa, 2 Dpt of Biomedical Science, Univ. of Modena and Reggio Emilia, Italy E-mail: livia.pisciotta@unige.it A recent meta-analysis of 22 studies in FH patients (Oosterveer D et al. Atherosclerosis 2009, on line) has shown a significant association between the presence of Tx and age, male gender, LDL-C and TG levels, and cardiovascular disease (3.2-fold higher risk of CVD in subjects with Tx). We have investigated the parameters associated with Tx in 619 genetically characterized Italian heterozygous FH patients (296 males and 323 females, over 30 years of age; TC 9.84±1.74, LDL-C 7.90±1.69, HDL-C 1.29±0.36, TG 1.48±0.68 mmol/L) by multiple logistic regression analysis. The presence of Tx was found to be independently associated with 5-year increase of age (OR 1.12, 1.03 1.21, P 0.006), 1 mmol/L increase in LDL-C (OR 1.62, 1.43 1.82, P 0.0001) and coronary artery disease (OR 2.24, 1.44 3.47, P 0.0001). No significant associations were found with gender, BMI, arterial hypertension, smoking habits, HDL-C and TG levels. The prevalence of Tx in FH patients carrying LDL receptor-defective mutations (n. 234, TC 9.26±1.63, LDL-C 7.25±1.58, HDL-C 1.34±0.38, TG 1.52±0.73 mmol/L) and in those carrying receptor-negative mutations (n. 367, TC 10.22±1.72, LDL-C 8.31±1.65, HDL-C 1.26±0.34, TG 1.44±0.64 mmol/L) was 31.6% and 58.8%, respectively. Removing from the logistic analysis LDL-C level, as independent predictor, and introducing the LDL receptor mutational class we detected, as expected, that patients with receptor-negative mutations vs patients with receptordefective mutations had more than 3-fold higher risk of developing tendon xanthomatosis (OR 3.25, 2.23 4.72, P 0.0001). 88 A NEW PATIENT CARRYING THE R136S MUTATION OF APOE GENE: PHENOTYPIC VARIABILITY OF THIS RECURRENT GENETIC DEFECT L. Pisciotta, A. Bellocchio, S. Airaldi, S. Bertolini. Department of Internal Medicine, University of Genoa, Genoa, Italy E-mail: livia.pisciotta@unige.it The proband was a 54 year-old male (BMI 26 kg/m2 ) with a lipid profile suggestive for dysbetalipoproteinemia (type III): total cholesterol (TC) 10.55, tryglicerides (TG) 4.62 and HDL-cholesterol (HDL-C) 1.14 mmol/L. Ultrasound evaluation of the carotid arteries showed a bilateral IMT of 1.33 mm at common carotids; the patient was apparently free from CAD and PVD. No hypothyroidism, hepatic or renal dysfunctions were found in patient. The proband’s father died for cancer at 79; the mother, 77 year-old, was affected by type 2 diabetes and hypercholesterolemia (TC 7.29, LDL-C 4.96, HDLC 1.63, TG 1.54 mmol/L. Dysbetalipoproteinemia is commonly associated with e2 allele homozygosity (C112, C158) but patient’s APOE genotype resulted to be e3e4 in association with R136S mutation, which was confirmed by direct sequencing. R136S is a rare recurrent defect of APOE gene, located in the receptor-binding domain of the protein. The proband’s mother carried the e3e4 genotype was but did not the R136S mutation. In our lipid clinic we collected 33 cases with dysbetalipoproteinemia; 31 cases were associated 84 PREVALENCE OF MAJOR CARDIOVASCULAR RISK FACTORS AND DISTANCE FROM THE LDL CHOLESTEROL TARGET AMONG DYSLIPIDEMIC SUBJECTS AT DIFFERENT CARDIOVASCULAR RISK M. Pirro, R. Del Giorno, M.R. Mannarino, D. Covelli, G. Schillaci, E. Mannarino. Institute of Internal Medicine, Angiology and Arteriosclerosis Diseases. University of Perugia, Italy E-mail: mpirro@unipg.it Background: Increased lipoprotein levels are considered a determinant of atherosclerosis appearance and progression. Altered lipoprotein profile is frequently part of a constellation of disorders whose combination increases atherosclerotic risk. We investigated among dyslipidemic subjects at different cardiovascular risk the prevalence of major cardiovascular risk factors and the distance from the LDL cholesterol target. Methods: Plasma lipid levels and assessment of major cardiovascular risk factors was performed among 1500 dyslipidemic subjects attending our Lipid Clinic. Traditional cardiovascular risk factors were evaluated and their distribution was studied in the entire cohort and among subjects with cardiovascular disease and/or cardiovascular risk equivalents. The distance of LDL cholesterol levels from reaching its target (target defined according to the number of cardiovascular risk factors and the Framingham risk score assessment: <100 mg/dl; <130 mg/dl; <160 mg/dl) was also evaluated. Results: Mean age of the cohort was 57±12 with a body mass index in the range of overweight (27.1±3.9) and a disturbed lipoprotein profile (total cholesterol 261±51 mg/dl, LDL cholesterol 167±49 mg/dl, triglycerides 197±125 mg/dl, HDL cholesterol 56±16 mg/dl). The prevalence of the following risk factors was obtained: family and personal history for early major cardiovascular diseases 14% and 6.9% respectively, current smoking 22% (number of cigarettes 14±10), diabetes 6.1% and known hypertension 42%. Statin and/or anti-hypertensive treatment was already prescribed in 22% and 40% subjects respectively. According to the number of cardiovascular risk factors and Framingham risk score assessment, the LDL cholesterol target was reached by 28% of the cohort with a mean distance from the target of 27±51 mg/dl. This distance was higher (32±50 mg/dl) when only subjects not taking statin treatment was considered. Among subjects at high cardiovascular risk, the distance from the target for LDL cholesterol (<100 mg/dl) was 54±60 mg/dl (64±62 mg/dl among high risk patients not taking statins). Conclusions: The presence of non lipid cardiovascular risk factors contributes significantly to increase the burden of risk among dyslipidemic subjects. The relatively high distance from reaching the LDL cholesterol target particularly among high risk, statin-untreated and at a less extent statintreated dyslipidemic subjects warrants a more aggressive LDL cholesterol lowering. 85 CLINICAL AND BIOCHEMICAL FEATURES IN ITALIAN FH AND FDB PATIENTS L. Pisciotta1 , C. Borrini1 , R. Sallo1 , S. Calandra2 , S. Bertolini1 . 1 Dpt. of Internal Medicine, Univ. of Genoa, 2 Department of Biomedical Science, University of Modena and Reggio Emilia, Italy E-mail: livia.pisciotta@unige.it We have genetically characterized 1108 subjects with autosomal dominant hypercholesterolemia (ADH), from 481 unrelated families. Four-hundred and seventy families were carries of LDLR gene mutation (97.7%) and eleven of APOB gene mutations causing FDB (2.3%). In FH patients we found 134 different mutations, including major rearrangements, minute insertions and deletions, point insertions and deletions, nonsense and missense mutations, and splicing mutations. Among families with FDB, 10 were carriers of R3500Q mutation and one of R3500W mutation. The comparison between FH and FDB probands showed no significant differences for age (44.0±17.9 vs 44.8±19.0 years), BMI (24.1±3.8 vs 23.3±4.7), HDL-C (1.33±0.34 vs 1.34±0.34 mmol/L) and TG (1.30±0.60 vs 1.28±0.31 mmol/L) levels, but significantly higher TC (9.30±1.71 vs 7.58±0.75 mmol/L) and LDL-C (7.39±1.67 vs 5.66±0.87 mmol/L) levels in FH patients. FH probands also had a higher prevalence of tendon xanthomas (48.8% vs 27.3%), carotid plaques (56.5% vs 25.0%) and CAD (30.4% vs 18.2%). Similar differences in the lipoprotein profile were detectable considering all FH (n. 1081) and all FDB (n. 27) patients: TC 9.15±1.62 vs 7.72±0.82 mmol/L, LDL-C 7.26±1.57 vs 5.80±0.82 mmol/L (P = 0.0001). Subdividing FH probands in subjects with receptor-negative (FH-RN n. 245) and receptor-defective (FH-RD n. 208) mutations and comparing these subgroups with FDB probands no significant differences among the three groups were detected for gender distributions, age, BMI, HDL-C and TG levels. However, the three groups differ each other for LDL-C levels: FH-RN 7.88±1.68, FH-RD 6.79±1.48, FDB 5.66±0.87 mmol/L (P < 0.01); moreover, FH-RN showed a tendency to lower HDL-C levels in comparison to the other groups: FH-RN 1.28±0.31, FH-RD 1.39±0.36, FDB 1.35±0.35 mmol/L. The prevalences of tendon xanthomas, carotid plaques and CAD were: 61.1%, 33.7% and 27.2%; 64.1%, 46.6% and 25.0%; 37.5%, 21.1% and 18.2% in FH-RN, FH-RD and FDB, respectively.

Journal

Nutrition, Metabolism and Cardiovascular DiseasesElsevier

Published: Nov 1, 2009

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