B1tta/Drug-ACE huggingface dataset:
[Title]: Cholesterol and glycemic effects of Niaspan in patients with type 2 diabetes.
[Abstract]: STUDY OBJECTIVE: To determine the effect of Niaspan--a niacin preparation with both immediate- and extended-release characteristics--on lipid and glycemic control in patients with type 2 diabetes. DESIGN: Retrospective study SETTING: Private-practice endocrinology group. PATIENTS: Thirty-two patients (mean age 60 yrs; 72% men) with type 2 diabetes identified by a computerized text search. INTERVENTION: Patients received Niaspan 1000, 1500, or 2000 mg/day (median daily dosage 1000 mg). MEASUREMENTS AND MAIN RESULTS: Total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density lipoprotein (HDL) cholesterol, triglycerides, hemoglobin A1c, and transaminase levels were compared for each patient before and 6 months after initiation of Niaspan. Niaspan therapy was associated with a significant 34% increase in HDL (p=0.033), a significant 36% reduction of triglycerides (p=0.049), and no significant change in LDL (p=0.236) or total cholesterol (p=0.122). Mean hemoglobin A1c levels significantly decreased from baseline by 0.5 +/- 0.3% (p=0.032), even though dosages and treatment with antidiabetic agents remained constant. There were no significant changes in transaminase levels. Seven patients (21.9%) discontinued Niaspan; one of them experienced an increase in blood glucose while receiving the agent. CONCLUSION: For most patients with type 2 diabetes, Niaspan is a safe and effective therapy for dyslipidemia and does not exacerbate glycemic control.
[Drug-Disease]: Niaspan - dyslipidemia
[Title]: [Clinical study of the month. Nephroprotective role of angiotensin II receptor antagonists in type 2 diabetes: results of the IDNT and RENAAL trials].
[Abstract]: Nephropathy associated with type 2 diabetes mellitus is a rising cause of end-stage renal disease and is a major public health problem. If blocking of the renin angiotensin system has a well established nephroprotective effect in type 1 diabetic nephropathy, this remained to be shown for type 2 diabetes. Two large outcome trials using angiotensin II receptor antagonists (ARA's) in proteinuric chronic renal impairment and hypertensive type 2 diabetic patients have now closed this gap: the Irbesartan Diabetic Nephropathy Trial (IDNT) and the Reduction of Endpoints in NIDDM with Angiotensin II Antagonist Losartan (RENAAL) trial. Both trials showed a significant reduction in the primary pre-specified end-point of death, or worsening of renal function (doubling of serum creatinine) or the development of end-stage renal disease. This effect goes beyond the reduction in blood pressure and makes of ARA's one of the important tools in the treatment of type 2 diabetic nephropathy.
[Drug-Disease]: Losartan - diabetic nephropathy
[Title]: [Clinical study of the month. Nephroprotective role of angiotensin II receptor antagonists in type 2 diabetes: results of the IDNT and RENAAL trials].
[Abstract]: Nephropathy associated with type 2 diabetes mellitus is a rising cause of end-stage renal disease and is a major public health problem. If blocking of the renin angiotensin system has a well established nephroprotective effect in type 1 diabetic nephropathy, this remained to be shown for type 2 diabetes. Two large outcome trials using angiotensin II receptor antagonists (ARA's) in proteinuric chronic renal impairment and hypertensive type 2 diabetic patients have now closed this gap: the Irbesartan Diabetic Nephropathy Trial (IDNT) and the Reduction of Endpoints in NIDDM with Angiotensin II Antagonist Losartan (RENAAL) trial. Both trials showed a significant reduction in the primary pre-specified end-point of death, or worsening of renal function (doubling of serum creatinine) or the development of end-stage renal disease. This effect goes beyond the reduction in blood pressure and makes of ARA's one of the important tools in the treatment of type 2 diabetic nephropathy.
[Drug-Disease]: Losartan - end-stage renal disease
[Title]: Efficacy and tolerability of subcutaneous almotriptan for the treatment of acute migraine: a randomized, double-blind, parallel-group, dose-finding study.
[Abstract]: BACKGROUND: The 5-hydroxytryptamine-receptor agonist almotriptan was found to be well tolerated and efficacious when administered orally in clinical trials of migraine treatment. OBJECTIVE: The primary objective of this study was to assess the efficacy and tolerability of 3 different doses of subcutaneous almotriptan in the treatment of acute migraine attacks. METHODS: This was a Phase II multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-finding study conducted over 7 months at 13 practice-oriented centers and 1 larger research-focused center. Patients experiencing moderate to severe migraine with or without aura, as defined by International Headache Society criteria, were randomly assigned to receive a single subcutaneous dose of almotriptan 2, 6, or 10 mg or placebo. The primary end point, pain relief at 2 hours, was self-assessed on a 4-point scale (severe, moderate, mild, or no pain). Patients indicating mild or no pain were considered responders. The analysis was performed on an intent-to-treat basis. RESULTS: A total of 123 patients were enrolled (23 men, 100 women). Overall, almotriptan 6 and 10 mg were significantly more effective than placebo (P &lt; 0.05, Fisher exact test). Response rates for the 6- and 10-mg doses were 96.5% and 90.3%, respectively, compared with 50.0% for placebo (P &lt; 0.05, Fisher exact test). The proportion of patients with pain relief at 2 hours was not significantly different between almotriptan 2 mg and placebo. The response profile for the secondary end points was also better with almotriptan 6 and 10 mg than with placebo. Administration of almotriptan was well tolerated; the most frequently observed drug-associated adverse event was transient local irritation at the injection site. CONCLUSIONS: Almotriptan was well tolerated and significantly more effective than placebo in relieving moderate to severe migraine pain when administered as a single 6- or 10-mg subcutaneous dose.
[Drug-Disease]: Almotriptan - migraine pain
[Title]: A comparison of low versus standard dose pravastatin therapy for the prevention of cardiovascular events in the elderly: the pravastatin anti-atherosclerosis trial in the elderly (PATE).
[Abstract]: Treatment with low drug doses is generally recommended in the elderly. However, the efficacy of low dose 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitor treatment in elderly hypercholesterolemic patients has never been examined. Therefore, we compared the effect of low-dose with standard dose pravastatin, an HMG CoA reductase inhibitor, on the incidence of cardiovascular events (CVEs) in elderly patients with hypercholesterolemia in a randomized prospective trial. Subjects aged &gt; or = 60 years (73 +/- 6 years) with serum total cholesterol (TC) levels of 220-280 mg/dL were randomized to the low-dose (groupL, 5 mg/day; n=334) or standard dose (groupS, 10-20mg/day; n= 331). Baseline TC levels were similar in the 2 groups (253 +/-15 mg/dL). Patients were followed for 3-5 years (mean 3.9 years). TC levels decreased from baseline by 11-13% in group L and by 15-17% in groupS. TC levels at 1 year in S and L group were 209 +/- 2 mg/ dL (16 +/- 1% decrease) and 221+/- 2 mg/dL (12 +/- 1% decrease), respectively. Forty two and 29 CVEs occurred in group L and S, respectively. The incidence of CVEs was significantly lower in group S than in group L (P = 0.046, generalized Wilcoxon test; P = 0.096, log-rank test). The risk ratio for group S compared with group L was 0.674 (95% confidence interval: 0.423-1.074). Subgroup analyses suggested that the difference in the incidence of CVEs between the 2 groups was more clear in subjects without diabetes mellitus, with TC levels of &lt; 253 mg/dL, and with TG levels of &gt; or = 133 mg/dL. The incidence of CVEs in group S was significantly lower than that in group L in subjects without both diabetes mellitus and previous cardiovascular disease (P = 0.026, generalized Wilcoxon test; P = 0.032, log rank test). These findings suggest that standard-dose pravastatin (10-20 mg/day) is more effective in reducing the incidence of CVEs in the elderly than low dose pravastatin (5 mg/ day), especially in nondiabetic elderly patients with mild hypercholesterolemia or previous cardiovascular disease.
[Drug-Disease]: pravastatin - cardiovascular disease
[Title]: A comparison of low versus standard dose pravastatin therapy for the prevention of cardiovascular events in the elderly: the pravastatin anti-atherosclerosis trial in the elderly (PATE).
[Abstract]: Treatment with low drug doses is generally recommended in the elderly. However, the efficacy of low dose 3-hydroxy-3-methylglutaryl coenzyme A (HMG CoA) reductase inhibitor treatment in elderly hypercholesterolemic patients has never been examined. Therefore, we compared the effect of low-dose with standard dose pravastatin, an HMG CoA reductase inhibitor, on the incidence of cardiovascular events (CVEs) in elderly patients with hypercholesterolemia in a randomized prospective trial. Subjects aged &gt; or = 60 years (73 +/- 6 years) with serum total cholesterol (TC) levels of 220-280 mg/dL were randomized to the low-dose (groupL, 5 mg/day; n=334) or standard dose (groupS, 10-20mg/day; n= 331). Baseline TC levels were similar in the 2 groups (253 +/-15 mg/dL). Patients were followed for 3-5 years (mean 3.9 years). TC levels decreased from baseline by 11-13% in group L and by 15-17% in groupS. TC levels at 1 year in S and L group were 209 +/- 2 mg/ dL (16 +/- 1% decrease) and 221+/- 2 mg/dL (12 +/- 1% decrease), respectively. Forty two and 29 CVEs occurred in group L and S, respectively. The incidence of CVEs was significantly lower in group S than in group L (P = 0.046, generalized Wilcoxon test; P = 0.096, log-rank test). The risk ratio for group S compared with group L was 0.674 (95% confidence interval: 0.423-1.074). Subgroup analyses suggested that the difference in the incidence of CVEs between the 2 groups was more clear in subjects without diabetes mellitus, with TC levels of &lt; 253 mg/dL, and with TG levels of &gt; or = 133 mg/dL. The incidence of CVEs in group S was significantly lower than that in group L in subjects without both diabetes mellitus and previous cardiovascular disease (P = 0.026, generalized Wilcoxon test; P = 0.032, log rank test). These findings suggest that standard-dose pravastatin (10-20 mg/day) is more effective in reducing the incidence of CVEs in the elderly than low dose pravastatin (5 mg/ day), especially in nondiabetic elderly patients with mild hypercholesterolemia or previous cardiovascular disease.
[Drug-Disease]: pravastatin - hypercholesterolemia
[Title]: Epidural administration of low-dose morphine combined with clonidine for postoperative analgesia after lumbar disc surgery.
[Abstract]: This study evaluates the efficacy and side effects of a low dose of epidural morphine combined with clonidine for postoperative pain relief after lumbar disc surgery. In 36 of 51 patients who accepted the procedure, an epidural catheter was inserted (L1-L2 level). General anesthesia was induced with propofol and sufentanil, and maintained with sevoflurane in O2/N2O. After emergence from anesthesia, epidural analgesia was initiated according to two randomly assigned protocols: 1 mg of morphine with 75 microg of clonidine (Group M) or 12.5 mg of bupivacaine with 75 microg of clonidine (Group B), in 10 mL saline. Piritramide was administered during the first postoperative 24 hours using a patient-controlled analgesia device (PCA). The following parameters were recorded: piritramide consumption during the first 24 hours; pain at rest during the first postoperative hours (D0), during the first night (D1), and during the first mobilization; [visual analogue scale (VAS)]; and the occurrence of drowsiness, motor blockade, respiratory depression, nausea, vomiting, itching, micturition problems, and bladder catheterization during D0 and D1. Epidural administration of morphine-clonidine significantly improved postoperative pain relief and reduced piritramide consumption as compared to epidural bupivacaine-clonidine. Side effects did not differ between groups except for a higher incidence of micturition problems in Group M during D1. The occurrence of bladder catheterization was not significantly higher in that group. We conclude that a low dose of epidural morphine combined with clonidine offers a better postoperative analgesia than does bupivacaine-clonidine. The excellent analgesic conditions were obtained at the expense of a higher incidence of difficulties in initiating micturition.
[Drug-Disease]: clonidine - postoperative pain
[Title]: Epidural administration of low-dose morphine combined with clonidine for postoperative analgesia after lumbar disc surgery.
[Abstract]: This study evaluates the efficacy and side effects of a low dose of epidural morphine combined with clonidine for postoperative pain relief after lumbar disc surgery. In 36 of 51 patients who accepted the procedure, an epidural catheter was inserted (L1-L2 level). General anesthesia was induced with propofol and sufentanil, and maintained with sevoflurane in O2/N2O. After emergence from anesthesia, epidural analgesia was initiated according to two randomly assigned protocols: 1 mg of morphine with 75 microg of clonidine (Group M) or 12.5 mg of bupivacaine with 75 microg of clonidine (Group B), in 10 mL saline. Piritramide was administered during the first postoperative 24 hours using a patient-controlled analgesia device (PCA). The following parameters were recorded: piritramide consumption during the first 24 hours; pain at rest during the first postoperative hours (D0), during the first night (D1), and during the first mobilization; [visual analogue scale (VAS)]; and the occurrence of drowsiness, motor blockade, respiratory depression, nausea, vomiting, itching, micturition problems, and bladder catheterization during D0 and D1. Epidural administration of morphine-clonidine significantly improved postoperative pain relief and reduced piritramide consumption as compared to epidural bupivacaine-clonidine. Side effects did not differ between groups except for a higher incidence of micturition problems in Group M during D1. The occurrence of bladder catheterization was not significantly higher in that group. We conclude that a low dose of epidural morphine combined with clonidine offers a better postoperative analgesia than does bupivacaine-clonidine. The excellent analgesic conditions were obtained at the expense of a higher incidence of difficulties in initiating micturition.
[Drug-Disease]: morphine - postoperative pain
[Title]: ACE-inhibitor therapy with spirapril increases nocturnal hypotensive episodes in elderly hypertensive patients.
[Abstract]: The purpose of this double-blind, randomised trial with a 4-week placebo run-in period followed by an active treatment period using either spirapril 3 mg or 6 mg once a day was to clarify the existence of hypotensive episodes in elderly hypertensive patients treated by an ACE-inhibitor. Forty hypertensive patients aged 60-76 years underwent 24-h ABPM at the end of the run-in (week 4) and active treatment (week 9) periods. The mean 24-h systolic blood pressure (SBP) decreased from 161.9 (26.7) mm Hg to 150.6 (29.9) mm Hg (P &lt; 0.001) and diastolic blood pressure (DBP) from 91.70 (14.7) mm Hg to 84.2 (17.3) mm Hg (P &lt; 0.001). No episodes of mean arterial pressure (MAP) &lt;50 mm Hg were seen during the placebo period. Instead 11 episodes were observed during the antihypertensive treatment (one in the 3 mg group and 10 in the 6 mg group, P &lt; 0.01 between the two treatment groups). Fifty-four episodes of MAP &lt;70 mm Hg were observed during the placebo period and 117 during the treatment period (P &lt; 0.001). During the placebo period low MAPs were observed only during night time. During the treatment period they were seen also from 11 am to 4 pm. In conclusion, ACE-inhibitor therapy with spirapril significantly increased hypotensive episodes in elderly hypertensive patients which may worsen their cerebral and myocardial circulation.
[Drug-Disease]: spirapril - hypertensive
[Title]: Effect of risperidone on behavioral and psychological symptoms and cognitive function in dementia.
[Abstract]: AIMS: This open-label study examined the efficacy and tolerability of risperidone in the treatment of aggression, agitation, and psychotic symptoms in dementia. The influence of risperidone on cognitive function was also assessed under conditions reflecting normal, daily clinical care. METHOD: A total of 34 hospital inpatients and outpatients (mean age = 76 years) with DSM-IV dementia disorders were treated with flexible doses of risperidone (0.5-2 mg/day) for 8 weeks. Assessments, conducted at baseline and after weeks 4 and 8, included the Clinical Global Impressions scale (CGI) and Neuropsychiatric Inventory (NPI) ratings. Cognitive function assessments included the Mini-Mental State Examination (MMSE) and specific measures of cognition (Age Concentration Test [AKT] and Brief Syndrome Test [SKT]). Frequency of extrapyramidal symptoms (EPS) was measured according to the Extrapyramidal Symptom Rating Scale (ESRS). RESULTS: At the end of the study, 50% of patients (N = 17) were receiving risperidone, 1 mg/day. 18% (N = 6) were receiving 0.5 mg/day, and 32% (N = 11) received > 1 mg/day (mean dose at endpoint = 1.1 mg/day). An improvement in symptoms, as measured by the CGI-Global Impression of Change scale, was reported for 82% of patients (N = 28) (59% [N = 20] much or very much improved). The frequency and severity of delusions, hallucinations, agitation/aggression, and irritability decreased as measured by the NPI. Multiplication of frequency and severity scores revealed a significant decline during the course of treatment (p < .001, end of study vs. baseline). Caregiver responses on the NPI also showed an improvement, with the mean +/- SD total score decreasing from 24.2 +/- 7.3 at baseline to 21.2 +/- 6.3 at study end (p = .002). MMSE, AKT, and SKT results indicated that there was no decrease in cognitive function during the study. Risperidone treatment was well tolerated, and no clinically relevant changes in EPS. vital signs, or weight were detected. CONCLUSION: During treatment with low-dose risperidone, behavioral and psychological symptoms improved overall in 34 patients with dementia, and cognitive function was maintained throughout the treatment period.
[Drug-Disease]: risperidone - dementia
[Title]: Comparison of alfentanil and morphine in the prehospital treatment of patients with acute ischaemic-type chest pain.
[Abstract]: Patients with acute myocardial ischaemic pain would benefit from rapid pain relief. The clinical usefulness of alfentanil, which has a rapid onset of action, was therefore assessed as the initial pain relieving opioid in patients suffering from acute myocardial ischaemic pain. The effects of alfentanil were compared with those of morphine in the prehospital treatment of 40 haemodynamically stable patients suffering from acute ischaemic-type chest pain. After initial assessment, the patients were given either 0.5 mg alfentanil or 5 mg morphine intravenously in a randomized double-blind fashion. The dose was repeated 2 minutes later if severe pain persisted. Arterial pressure, heart rate, respiratory rate and pain expressed on a visual analogue scale was measured before and at 2, 4, 6, 10 and 15 minutes after administration of drugs. After randomization, four patients were excluded. Sixteen patients received alfentanil and 20 patients morphine. Pain relief was faster (p &lt; 0.005) in the alfentanil group than in the morphine group. Alfentanil was found to provide effective analgesia during the follow-up period of 15 minutes. No haemodynamic or respiratory side effects occurred. It is concluded that alfentanil is an effective analgesic in the prehospital treatment of myocardial ischaemic pain.
[Drug-Disease]: morphine - ischaemic-type chest pain
[Title]: Comparison of alfentanil and morphine in the prehospital treatment of patients with acute ischaemic-type chest pain.
[Abstract]: Patients with acute myocardial ischaemic pain would benefit from rapid pain relief. The clinical usefulness of alfentanil, which has a rapid onset of action, was therefore assessed as the initial pain relieving opioid in patients suffering from acute myocardial ischaemic pain. The effects of alfentanil were compared with those of morphine in the prehospital treatment of 40 haemodynamically stable patients suffering from acute ischaemic-type chest pain. After initial assessment, the patients were given either 0.5 mg alfentanil or 5 mg morphine intravenously in a randomized double-blind fashion. The dose was repeated 2 minutes later if severe pain persisted. Arterial pressure, heart rate, respiratory rate and pain expressed on a visual analogue scale was measured before and at 2, 4, 6, 10 and 15 minutes after administration of drugs. After randomization, four patients were excluded. Sixteen patients received alfentanil and 20 patients morphine. Pain relief was faster (p &lt; 0.005) in the alfentanil group than in the morphine group. Alfentanil was found to provide effective analgesia during the follow-up period of 15 minutes. No haemodynamic or respiratory side effects occurred. It is concluded that alfentanil is an effective analgesic in the prehospital treatment of myocardial ischaemic pain.
[Drug-Disease]: alfentanil - ischaemic-type chest pain
[Title]: Thalidomide reduces tumour necrosis factor alpha and interleukin 12 production in patients with chronic active Crohn's disease.
[Abstract]: BACKGROUND: Thalidomide improves clinical symptoms in patients with therapy refractory Crohn's disease, as shown in two recent studies. The mechanism of this effect however is still unknown. Suppression of tumour necrosis factor alpha (TNF-alpha) by thalidomide has been suggested as a possible mechanism. However, effects on other cytokines have not been adequately investigated. AIM: The aim of our study was to investigate the effects of thalidomide on cytokine production in patients with inflammatory bowel disease (IBD). METHODS: Ten patients with therapy refractory IBD (nine Crohn's disease, one ulcerative colitis) received thalidomide 300 mg daily in a 12 week open label study. Production of TNF-alpha, interleukin (IL)-1 beta, IL-6, and IL-12 was investigated in short term cultures of stimulated colonic lamina propria mononuclear cells (LPMC) and peripheral blood monocytes (PBMC) before and after 12 weeks of treatment. LPMC were also cultured with graded doses of thalidomide. RESULTS: Three patients discontinued treatment because of sedative side effects. In the other patients, disease activity decreased significantly, with four patients achieving remission. Production of TNF-alpha and IL-12 decreased during treatment with thalidomide: LPMC (TNF-alpha: 42.3 (8.3) pg/ml v 16.4 (6.3); IL-12: 9.7 (3.3) v 5.0 (2.5); p&lt;0.04) and PBMC (TNF-alpha: 62.8 (14.6) v 22.5 (9.2); p&lt;0.02). Production of IL-1 beta and IL-6 did not change significantly. Culturing of LPMC with thalidomide showed a dose dependent decrease in TNF-alpha and IL-12 production. CONCLUSION: The clinical effects of thalidomide in Crohn's disease may be mediated by reduction of both TNF-alpha and IL-12.
[Drug-Disease]: thalidomide - Crohn's disease