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Delgado Pertíñez Manuel - One of the best experts on this subject based on the ideXlab platform.
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Physicochemical Composition, Antioxidant Status, Fatty Acid Profile, and Volatile Compounds ofMilk and Fresh and Ripened Ewes’ Cheese from a Sustainable Part-Time Grazing System
'MDPI AG', 2021Co-Authors: Gutiérrez Peña Rosario, Avilés Carmen, Galán Soldevilla Hortensia, Polvillo Oliva, Ruiz Pérez-cacho Pilar, Guzmán Guerrero, José Luis, Horcada Alberto, Delgado Pertíñez ManuelAbstract:We conducted the first nutritional analysis of dairy Products from the traditional Roja Mallorquina sheep breed. Samples of bulk raw milk were taken twice a month from December 2015 to March 2016 from sheep fed using a part-time grazing system, and fresh soft (FC, n = 8) and ripened (RC, n = 8) cheeses were made. The variability in vitamins, total phenolic compounds (TPC), total antioxidant capacity (TAC), and fatty acid (FA) content was influenced by the cheese-making process (differences between the cheese and the original milk) and by the type of cheese-making technology (mainly related to heating, the use of starter culture, and ripening). The most notable physicochemical characteristic of the cheeses was low fat content (24.1 and 29.6 g/100 g for FC and RC). Milk and RC were characterised by major concentrations of retinol (211.4 and 233.6 g/100 g dry matter (DM), respectively) and TPC (18.7 and 54.6 g/100 g DM, respectively), while FC was characterised by major concentrations of retinol (376.4 g) and -tocopherol (361.7 g). The fat soluble components of the FC generally exhibited better nutritional value for human health than those of the milk and RC, with a higher level of retinol and -tocopherol; lower values for saturated FA, atherogenic, and thrombogenic indices; and higher levels of monounsaturated FA, polyunsaturated FA, n-3, and n-6. Acids, alcohols, and ketones comprised almost 95% of the volatile compounds detected. Acetoin and Products of lactose and citrate metabolism played an important role in the development of the aromatic attributes of both kinds of cheese. This preliminary study can contribute to add value to these traditional Products according to healthy nutritional criteria and supports the implementation of strategies to promote their commercialisation and obtain Product Labelling as “pasture-fed” or specific marks
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Physicochemical Composition, Antioxidant Status, Fatty Acid Profile, and Volatile Compounds of Milk and Fresh and Ripened Ewes’ Cheese from a Sustainable Part-Time Grazing System
'MDPI AG', 2021Co-Authors: Gutiérrez Peña Rosario, Avilés Carmen, Galán Soldevilla Hortensia, Ruiz Pérez-cacho Pilar, Polvillo Polo Oliva, Guzmán, José Luis, Horcada Ibáñez, Alberto Luis, Delgado Pertíñez ManuelAbstract:We conducted the first nutritional analysis of dairy Products from the traditional Roja Mallorquina sheep breed. Samples of bulk raw milk were taken twice a month from December 2015 to March 2016 from sheep fed using a part-time grazing system, and fresh soft (FC, n = 8) and ripened (RC, n = 8) cheeses were made. The variability in vitamins, total phenolic compounds (TPC), total antioxidant capacity (TAC), and fatty acid (FA) content was influenced by the cheese-making process (differences between the cheese and the original milk) and by the type of cheese-making technology (mainly related to heating, the use of starter culture, and ripening). The most notable physicochemical characteristic of the cheeses was low fat content (24.1 and 29.6 g/100 g for FC and RC). Milk and RC were characterised by major concentrations of retinol (211.4 and 233.6 μg/100 g dry matter (DM), respectively) and TPC (18.7 and 54.6 μg/100 g DM, respectively), while FC was characterised by major concentrations of retinol (376.4 μg) and α-tocopherol (361.7 μg). The fat-soluble components of the FC generally exhibited better nutritional value for human health than those of the milk and RC, with a higher level of retinol and α-tocopherol; lower values for saturated FA, atherogenic, and thrombogenic indices; and higher levels of monounsaturated FA, polyunsaturated FA, n-3, and n-6. Acids, alcohols, and ketones comprised almost 95% of the volatile compounds detected. Acetoin and Products of lactose and citrate metabolism played an important role in the development of the aromatic attributes of both kinds of cheese. This preliminary study can contribute to add value to these traditional Products according to healthy nutritional criteria and supports the implementation of strategies to promote their commercialisation and obtain Product Labelling as “pasture-fed” or specific marks
Leslie Citrome - One of the best experts on this subject based on the ideXlab platform.
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deutetrabenazine for tardive dyskinesia a systematic review of the efficacy and safety profile for this newly approved novel medication what is the number needed to treat number needed to harm and likelihood to be helped or harmed
International Journal of Clinical Practice, 2017Co-Authors: Leslie CitromeAbstract:SummaryObjective Deutetrabenazine is a deuterated formulation of tetrabenazine. The aim of this systematic review is to describe the efficacy, tolerability and safety of deutetrabenazine for the treatment of tardive dyskinesia (TD). Data sources The pivotal registration trials were accessed by querying http://www.ncbi.nlm.nih.gov/pubmed/ and http://www.clinicaltrials.gov, for the search terms ‘deutetrabenazine’ OR ‘SD-809’, and by also querying the EMBASE (Elsevier) commercial database for clinical poster abstracts, and by asking the manufacturer for copies of posters presented at congresses. Product Labelling provided additional information. Study selection All available clinical reports of studies were identified. Data extraction Descriptions of the principal results and calculation of number needed to treat (NNT) and number needed to harm (NNH) for relevant dichotomous outcomes were extracted from the available study reports and other sources of information. Data synthesis Deutetrabenazine, a reversible inhibitor of vesicular monoamine transporter type 2 (VMAT2), received approval for the treatment of TD in adults based on a clinical trial development programme that included two 12-week parallel group, randomised and placebo-controlled studies. Deutetrabenazine dose is determined individually for each patient based on reduction of TD and tolerability. The recommended starting dose of deutetrabenazine for TD is 6 mg BID, administered with food, and can be increased at weekly intervals in increments of 6 mg/day to a maximum recommended daily dosage of 24 mg BID. The percentage of responders in the fixed-dose Phase III acute study, as defined by a rating of “much improved” or “very much improved” on the clinical global impression of change, was 46% for deutetrabenazine (pooled dose groups 12 and 18 mg BID) vs 26% for placebo, yielding a NNT of 5 (95% CI 3-19); the percentage of responders as defined by an improvement in Abnormal Involuntary Movement Scale (AIMS) severity score (sum of items 1-7) of 50% or more, was 34% for deutetrabenazine (pooled dose groups 12 and 18 mg BID) vs 12% for placebo, yielding a NNT of 5 (95% CI 3-11). Pooling the data across both short-term studies, NNT for AIMS response for the therapeutic doses of deutetrabenazine vs placebo was 7 (95% CI 4-18). Discontinuation because of an adverse event occurred among 3.6% of patients randomised to deutetrabenazine (any dose) vs 3.1% for placebo, yielding a NNH of 189 (not significant). The Likelihood to be Helped or Harmed comparing success (AIMS response) vs discontinuation because of an adverse event is 27. The most common adverse reactions (that occurred in ≥4% of deutetrabenazine-treated patients with TD and greater than placebo) were nasopharyngitis and insomnia, with NNH values of 50 (not significant) and 34 (95% CI 18-725), respectively. Conclusions Deutetrabenazine is the second FDA-approved agent specifically indicated for the treatment of TD. Head-to-head comparisons with other VMAT2 inhibitors among patients with TD in the “real world” are needed.
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lisdexamfetamine for binge eating disorder in adults a systematic review of the efficacy and safety profile for this newly approved indication what is the number needed to treat number needed to harm and likelihood to be helped or harmed
International Journal of Clinical Practice, 2015Co-Authors: Leslie CitromeAbstract:SummaryObjective To describe the efficacy and safety of lisdexamfetamine dimesylate (LDX) for the treatment of binge eating disorder (BED). Data sources The pivotal registration trials were accessed by querying http://www.ncbi.nlm.nih.gov/pubmed/, http://www.clinicaltrials.gov and http://www.clinicaltrialsregister.eu for the search terms ‘lisdexamfetamine’ and ‘binge’, and by also querying the Web of Science (Thomson Reuters) and Embase (Elsevier) commercial databases, and by asking the manufacturer for copies of posters presented at congresses. Product Labelling provided additional information. Study selection All available clinical reports of studies were identified. Data extraction Descriptions of the principal results and calculation of number needed to treat (NNT) and number needed to harm (NNH) for relevant dichotomous outcomes were extracted from the available study reports and other sources of information. Data synthesis LDX is a central nervous system stimulant indicated for the treatment of moderate to severe BED. The recommended dose range is 50–70 mg/day. Approval for the treatment of BED was based on a clinical development programme that included an 11-week Phase II proof-of-concept, placebo-controlled study, testing fixed doses of LDX 30, 50 and 70 mg/day, and two 12-week Phase III placebo-controlled studies examining LDX 50–70 mg/day. Statistically significant reductions in binge eating days/week, the primary outcome measure, were observed for LDX doses of 50 and 70 mg/day, with effect sizes in the Phase III trials ranging from 0.83 to 0.97. The pooled NNT for response across all trials (as defined by a Clinical Global Impressions-Improvement score of ‘very much improved’ or ‘much improved’) for LDX vs. placebo was 3 (95% CI 3–4), and NNT for remission (as defined by 4-week cessation of binge eating) for LDX vs. placebo was 4 (95% CI 4–6). Reductions in weight ranged between 5.2% and 6.25% for LDX 50 or 70 mg/day. Discontinuation rates because of adverse events (AEs) were low; NNH for discontinuation because of an AE for LDX vs. placebo was 44 (95% CI 23–1971). The most commonly encountered AEs (incidence ≥ 10% and greater than the rate for placebo) were dry mouth, decreased appetite, insomnia and headache, with NNH values vs. placebo of 4 (95% CI 3–5), 11 (95% CI 8–17), 11 (95% CI 8–18) and 19 (95% CI 11–75), respectively. Conclusions LDX is the first pharmacological agent that has received regulatory approval for the treatment of BED. LDX 50 or 70 mg/day significantly reduced BED symptoms as measured by the number of binge eating days per week. Effect sizes were highly robust. Pending clinical trials include a long-term study examining maintenance of efficacy.
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suvorexant for insomnia a systematic review of the efficacy and safety profile for this newly approved hypnotic what is the number needed to treat number needed to harm and likelihood to be helped or harmed
International Journal of Clinical Practice, 2014Co-Authors: Leslie CitromeAbstract:SummaryObjective To describe the efficacy and safety of suvorexant for the treatment of insomnia. Data sources The pivotal registration trials were accessed by querying http://www.ncbi.nlm.nih.gov/pubmed/ and http://www.clinicaltrials.gov for the search terms ‘suvorexant’ and ‘MK4305’. Briefing documents from the US Food and Drug Administration Peripheral & Central Nervous System Drugs Advisory Committee and Product Labelling, provided additional information. Study selection All available clinical reports of studies were identified. Data extraction Descriptions of the principal results and calculation of number needed to treat (NNT) and number needed to harm (NNH) for relevant dichotomous outcomes were extracted from the available study reports and other sources of information. Data synthesis Suvorexant (MK4305) is the first orexin receptor antagonist approved for the treatment of insomnia. This approval was based in part on a Phase 3 clinical development programme that included two similarly designed, 3-month, randomised, double-blind, placebo-controlled, parallel-group studies examining suvorexant 40 and 20 mg in non-elderly adults (age < 65 years) and 30 and 15 mg in elderly patients (age ≥ 65 years). Suvorexant was superior to placebo for sleep latency as assessed both objectively by polysomnography and subjectively by patient-estimated sleep latency; suvorexant was also superior to placebo for sleep maintenance, as assessed both objectively by polysomnography and subjectively by patient-estimated total sleep time. NNT vs. placebo for response as measured by a ≥ 6 point improvement on the Insomnia Severity Index at month 3 was 8 (95% CI 6–14) for both the higher and lower dose regimens. The most commonly encountered adverse event (incidence ≥ 5% and at least twice the rate of placebo) as identified in Product Labelling is somnolence, with NNH values vs. placebo of 13 (95% CI 11–18) for suvorexant 40 and 30 mg, and 28 (95% CI 17–82) for suvorexant 20 and 15 mg. The efficacy and tolerability profile of suvorexant is similar for those < 65 and ≥ 65 years of age. Rebound insomnia and withdrawal effects were not observed when suvorexant was discontinued after 3 months or after 12 months of nightly use. Because of concerns about dose-related, next-day effects, including sedation, the recommended dose range is 10–20 mg. Conclusions Suvorexant appears efficacious and relatively tolerable. Its different mechanism of action and potentially different safety and tolerability profile compared with currently available hypnotics represents a new option for the pharmacological treatment of insomnia.
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vortioxetine for major depressive disorder a systematic review of the efficacy and safety profile for this newly approved antidepressant what is the number needed to treat number needed to harm and likelihood to be helped or harmed
International Journal of Clinical Practice, 2013Co-Authors: Leslie CitromeAbstract:Summary Objective To describe the efficacy and safety of levomilnacipran (extended-release capsules) for the treatment of major depressive disorder (MDD). Data sources The pivotal registration trials were accessed by querying http://www.ncbi.nlm.nih.gov/pubmed/, http://www.clinicaltrialsregister.eu and http://www.clinicaltrials.gov for the search terms ‘levomilnacipran’ and ‘F2695’, and by obtaining posters presented at congresses. Product Labelling provided additional information. Study selection All available clinical reports of studies were identified. Data extraction Descriptions of the principal results and calculation of number needed to treat (NNT) and number needed to harm (NNH) for relevant dichotomous outcomes were extracted from the available study reports and other sources of information. Data synthesis Levomilnacipran (1S, 2R-milnacipran) is a potent and selective serotonin–norepinephrine reuptake inhibitor with greater potency for inhibition of norepinephrine relative to serotonin reuptake. Approval for the treatment of MDD was based on a clinical development program that included one 10-week Phase II and four 8-week Phase III randomised placebo-controlled clinical trials in outpatients with MDD where levomilnacipran was titrated to target doses ranging from 40 to 120 mg taken once daily. Four of the five trials demonstrated efficacy as measured by the Montgomery Asberg Depression Rating Scale, with a NNT for response vs. placebo of 9 (95% CI 7–15), and for remission, 14 (95% CI 10–28). Levomilnacipran also demonstrated superiority over placebo as measured by improvement in the Sheehan Disability Scale functional impairment total score. NNH vs. placebo for discontinuation because an adverse event (AE) across all five trials was 19 (95% CI 14–28). The most commonly encountered AEs (incidence ≥ 5% and at least twice the rate of placebo) as identified in Product Labelling were nausea, hyperhidrosis, constipation, heart rate increased, erectile dysfunction in men, vomiting, tachycardia and palpitations, with NNH values vs. placebo of 10 (95% CI 8–12), 15 (95% CI 12–19), 17 (95% CI 13–24), 21 (95% CI 17–29), 20 (95% CI 14–36), 25 (95% CI 20–37), 25 (95% CI 19–40) and 30 (95% CI 22–49), respectively. Levomilnacipran was not associated with clinically relevant weight change in the short-term trials or in a 48-week open-label extension trial. Mean changes from baseline in systolic blood pressure (BP), diastolic BP and heart rate were +3.0 mmHg, +3.2 mm Hg and +7.4 bpm for levomilnacipran, and −0.4 mmHg, no change and −0.3 bpm for placebo, respectively. Categorical shift in BP from normal or prehypertension at baseline to stage 1 or stage 2 hypertension at end of study was 10.4% for levomilnacipran vs. 7.1% for placebo, for a NNH of 31 (95% CI 18–94). Conclusions Levomilnacipran represents another option for the treatment of MDD. Levomilnacipran appears to have a favourable weight-gain profile. Additional controlled data regarding long-term efficacy and comparative effectiveness will help characterise this new agent.
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vilazodone for major depressive disorder a systematic review of the efficacy and safety profile for this newly approved antidepressant what is the number needed to treat number needed to harm and likelihood to be helped or harmed
International Journal of Clinical Practice, 2012Co-Authors: Leslie CitromeAbstract:Summary Objective To describe the efficacy and safety of levomilnacipran (extended-release capsules) for the treatment of major depressive disorder (MDD). Data sources The pivotal registration trials were accessed by querying http://www.ncbi.nlm.nih.gov/pubmed/, http://www.clinicaltrialsregister.eu and http://www.clinicaltrials.gov for the search terms ‘levomilnacipran’ and ‘F2695’, and by obtaining posters presented at congresses. Product Labelling provided additional information. Study selection All available clinical reports of studies were identified. Data extraction Descriptions of the principal results and calculation of number needed to treat (NNT) and number needed to harm (NNH) for relevant dichotomous outcomes were extracted from the available study reports and other sources of information. Data synthesis Levomilnacipran (1S, 2R-milnacipran) is a potent and selective serotonin–norepinephrine reuptake inhibitor with greater potency for inhibition of norepinephrine relative to serotonin reuptake. Approval for the treatment of MDD was based on a clinical development program that included one 10-week Phase II and four 8-week Phase III randomised placebo-controlled clinical trials in outpatients with MDD where levomilnacipran was titrated to target doses ranging from 40 to 120 mg taken once daily. Four of the five trials demonstrated efficacy as measured by the Montgomery Asberg Depression Rating Scale, with a NNT for response vs. placebo of 9 (95% CI 7–15), and for remission, 14 (95% CI 10–28). Levomilnacipran also demonstrated superiority over placebo as measured by improvement in the Sheehan Disability Scale functional impairment total score. NNH vs. placebo for discontinuation because an adverse event (AE) across all five trials was 19 (95% CI 14–28). The most commonly encountered AEs (incidence ≥ 5% and at least twice the rate of placebo) as identified in Product Labelling were nausea, hyperhidrosis, constipation, heart rate increased, erectile dysfunction in men, vomiting, tachycardia and palpitations, with NNH values vs. placebo of 10 (95% CI 8–12), 15 (95% CI 12–19), 17 (95% CI 13–24), 21 (95% CI 17–29), 20 (95% CI 14–36), 25 (95% CI 20–37), 25 (95% CI 19–40) and 30 (95% CI 22–49), respectively. Levomilnacipran was not associated with clinically relevant weight change in the short-term trials or in a 48-week open-label extension trial. Mean changes from baseline in systolic blood pressure (BP), diastolic BP and heart rate were +3.0 mmHg, +3.2 mm Hg and +7.4 bpm for levomilnacipran, and −0.4 mmHg, no change and −0.3 bpm for placebo, respectively. Categorical shift in BP from normal or prehypertension at baseline to stage 1 or stage 2 hypertension at end of study was 10.4% for levomilnacipran vs. 7.1% for placebo, for a NNH of 31 (95% CI 18–94). Conclusions Levomilnacipran represents another option for the treatment of MDD. Levomilnacipran appears to have a favourable weight-gain profile. Additional controlled data regarding long-term efficacy and comparative effectiveness will help characterise this new agent.
Giacomo Calzolari - One of the best experts on this subject based on the ideXlab platform.
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hormone beefs chloridric chicken and international trade can scientific uncertainty be an informational barrier to trade
Social Science Research Network, 2000Co-Authors: Giacomo Calzolari, Giovanni ImmordinoAbstract:We study international trade of innovative goods subject to scientific uncertainty on consumers' health effects. Trade of these goods is often at the centre of international disputes. We show that a new trade protectionism may arise because of the scientific uncertainty. A free riding effect is individuated implying a more conservative behaviour by countries. We also study the informative role played by producers (lobbies) in revealing valuable information. We find that producers reveal more information when the effects of harmful consumption on health are long lasting. Our results are robust to several extensions (e.g. Product Labelling, firm liability).
Gutiérrez Peña Rosario - One of the best experts on this subject based on the ideXlab platform.
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Physicochemical Composition, Antioxidant Status, Fatty Acid Profile, and Volatile Compounds ofMilk and Fresh and Ripened Ewes’ Cheese from a Sustainable Part-Time Grazing System
'MDPI AG', 2021Co-Authors: Gutiérrez Peña Rosario, Avilés Carmen, Galán Soldevilla Hortensia, Polvillo Oliva, Ruiz Pérez-cacho Pilar, Guzmán Guerrero, José Luis, Horcada Alberto, Delgado Pertíñez ManuelAbstract:We conducted the first nutritional analysis of dairy Products from the traditional Roja Mallorquina sheep breed. Samples of bulk raw milk were taken twice a month from December 2015 to March 2016 from sheep fed using a part-time grazing system, and fresh soft (FC, n = 8) and ripened (RC, n = 8) cheeses were made. The variability in vitamins, total phenolic compounds (TPC), total antioxidant capacity (TAC), and fatty acid (FA) content was influenced by the cheese-making process (differences between the cheese and the original milk) and by the type of cheese-making technology (mainly related to heating, the use of starter culture, and ripening). The most notable physicochemical characteristic of the cheeses was low fat content (24.1 and 29.6 g/100 g for FC and RC). Milk and RC were characterised by major concentrations of retinol (211.4 and 233.6 g/100 g dry matter (DM), respectively) and TPC (18.7 and 54.6 g/100 g DM, respectively), while FC was characterised by major concentrations of retinol (376.4 g) and -tocopherol (361.7 g). The fat soluble components of the FC generally exhibited better nutritional value for human health than those of the milk and RC, with a higher level of retinol and -tocopherol; lower values for saturated FA, atherogenic, and thrombogenic indices; and higher levels of monounsaturated FA, polyunsaturated FA, n-3, and n-6. Acids, alcohols, and ketones comprised almost 95% of the volatile compounds detected. Acetoin and Products of lactose and citrate metabolism played an important role in the development of the aromatic attributes of both kinds of cheese. This preliminary study can contribute to add value to these traditional Products according to healthy nutritional criteria and supports the implementation of strategies to promote their commercialisation and obtain Product Labelling as “pasture-fed” or specific marks
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Physicochemical Composition, Antioxidant Status, Fatty Acid Profile, and Volatile Compounds of Milk and Fresh and Ripened Ewes’ Cheese from a Sustainable Part-Time Grazing System
'MDPI AG', 2021Co-Authors: Gutiérrez Peña Rosario, Avilés Carmen, Galán Soldevilla Hortensia, Ruiz Pérez-cacho Pilar, Polvillo Polo Oliva, Guzmán, José Luis, Horcada Ibáñez, Alberto Luis, Delgado Pertíñez ManuelAbstract:We conducted the first nutritional analysis of dairy Products from the traditional Roja Mallorquina sheep breed. Samples of bulk raw milk were taken twice a month from December 2015 to March 2016 from sheep fed using a part-time grazing system, and fresh soft (FC, n = 8) and ripened (RC, n = 8) cheeses were made. The variability in vitamins, total phenolic compounds (TPC), total antioxidant capacity (TAC), and fatty acid (FA) content was influenced by the cheese-making process (differences between the cheese and the original milk) and by the type of cheese-making technology (mainly related to heating, the use of starter culture, and ripening). The most notable physicochemical characteristic of the cheeses was low fat content (24.1 and 29.6 g/100 g for FC and RC). Milk and RC were characterised by major concentrations of retinol (211.4 and 233.6 μg/100 g dry matter (DM), respectively) and TPC (18.7 and 54.6 μg/100 g DM, respectively), while FC was characterised by major concentrations of retinol (376.4 μg) and α-tocopherol (361.7 μg). The fat-soluble components of the FC generally exhibited better nutritional value for human health than those of the milk and RC, with a higher level of retinol and α-tocopherol; lower values for saturated FA, atherogenic, and thrombogenic indices; and higher levels of monounsaturated FA, polyunsaturated FA, n-3, and n-6. Acids, alcohols, and ketones comprised almost 95% of the volatile compounds detected. Acetoin and Products of lactose and citrate metabolism played an important role in the development of the aromatic attributes of both kinds of cheese. This preliminary study can contribute to add value to these traditional Products according to healthy nutritional criteria and supports the implementation of strategies to promote their commercialisation and obtain Product Labelling as “pasture-fed” or specific marks
Ranbir Bahra - One of the best experts on this subject based on the ideXlab platform.
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a multinational randomised 12 week study comparing the effects of donepezil and galantamine in patients with mild to moderate alzheimer s disease
International Journal of Geriatric Psychiatry, 2004Co-Authors: Roy W Jones, Hilkka Soininen, Klaus Hager, Dag Aarsland, Peter Passmore, Anita Murthy, Richard Zhang, Ranbir BahraAbstract:Objectives To compare directly, in the same patient cohort, the ease of use and tolerability of donepezil and galantamine in the treatment of Alzheimer's disease (AD), and investigate the effects of both treatments on cognition and activities of daily living (ADL). Methods Patients with mild to moderate AD from 14 European centres were randomised to receive open-label donepezil (up to 10 mg once daily) or galantamine (up to 12 mg twice daily) for 12 weeks, according to the approved Product Labelling. Physicians and caregivers completed questionnaires rating satisfaction with treatment/ease of use in daily practice. Secondary assessments were the ADAS-cog, the MMSE, and the DAD scale to assess ADL. Tolerability was evaluated by reporting adverse events (AEs). Results Both physicians and caregivers reported significantly greater overall satisfaction/ease of use for donepezil (n = 64) compared with galantamine (n = 56) at weeks 4, 12, and endpoint (week 12 LOCF; all p-values <0.05). Significantly greater improvements in cognition were also observed for donepezil versus galantamine on the ADAS-cog at Week 12 and endpoint (p-values <0.05). ADL improved significantly in the donepezil group compared with the galantamine group at weeks 4, 12, and endpoint (p-values <0.05). Most AEs were mild to moderate, however, 46% galantamine-treated patients reported gastrointestinal AEs vs 25% donepezil patients. Conclusions Physician and caregiver ease of use/satisfaction scores, and assessments of cognition and ADL, showed significant benefits for donepezil compared with galantamine in this direct comparative trial. Both treatments were well tolerated, with more gastrointestinal AEs reported for galantamine vs donepezil. Copyright © 2004 John Wiley & Sons, Ltd.
