B1tta/Drug-ACE huggingface dataset:
[Title]: Haemodynamic and metabolic effects of rilmenidine in hypertensive patients with metabolic syndrome X. A double-blind parallel study versus amlodipine.
[Abstract]: OBJECTIVE: To compare the effects of rilmenidine with those of amlodipine on blood pressure, glucose metabolism, plasma lipid concentration and fibrinolysis parameters. DESIGN: A four-month randomized double-blind, parallel group study. PATIENTS AND METHODS: Obese hypertensive patients with hypertriglyceridaemia (> or = 2.3 mmol/l) and impaired glucose tolerance (OMS-ADA) were included (n = 52). A placebo run-in period of 2 weeks was followed by 4 months of double-blind treatment with either rilmenidine or amlodipine. Blood pressure was recorded using a mercury sphygmomanometer. Glucose metabolism was evaluated by an oral glucose tolerance test RESULTS: Of the 52 patients recruited, 47 (21 rilmenidine and 26 amlodipine) completed the 4-month treatment period. The intention-to-treat analysis showed a comparable reduction in systolic and diastolic blood pressure (SBP, DBP) with the two anti-hypertensive treatments (rilmenidine -13.9/-13.5 mmHg; amlodipine - 17.6/-15.0 mmHg). Insulin concentrations under basal conditions and 2 h after a standard oral glucose load did not change significantly after treatment in both groups. Plasma glucose under basal conditions and 2 h after a standard oral glucose load as well as the area under the plasma glucose concentration curve tended to decrease in the rilmenidine group and to increase in the amlodipine group so that the changes in these parameters were significantly different between the two study groups (P= 0.041, P = 0.042 and P = 0.015, respectively). Plasminogen activator inhibitor type 1 (PAI-1) antigen and PAI-1 activity were only decreased in the rilmenidine group (not statistically significant). CONCLUSION: Our results demonstrate that rilmenidine and amlodipine have a comparable anti-hypertensive effect but only rilmenidine is able to improve glucose metabolism.
[Drug-Disease]: amlodipine - hypertensive
[Title]: Long-term hydroxyurea in combination with didanosine and stavudine for the treatment of HIV-1 infection. Swiss HIV Cohort Study.
[Abstract]: OBJECTIVE AND METHODS: In 1998 we reported on a randomized comparison between stavudine plus didanosine plus placebo versus stavudine plus didanosine plus hydroxyurea (HU), in patients with a CD4 count of 200-500 x 10(6) cells/l. After 3 months, the HU group had a higher proportion of patients with viral load < 200 x 10 cells/l. At the end of the 3 months blinded period, patients in the placebo group had the option to add HU if their viral load remained > 200 x 10(6) cells/l. We report results after 24 months. RESULTS: Seventy-two patients were randomized to the HU arm, and a further 30 elected to add HU after 12 weeks. Twenty-four months after the start of the trial, only 25% of the 72 patients originally randomized to HU, and 20% of the 30 who added HU after week 12, were still taking it. The reasons for stopping HU were: lack of efficacy (45%), adverse events (37%) and patient or physician preference (18%). Side effects were more frequent in the didanosine/stavudine/HU group than in the didanosine/stavudine group: neuropathy (35 versus 15%, P< 0.02), fatigue (22 versus 7%, P< 0.01), and nausea or vomiting (26 versus 9%, P< 0.01). Of those who had discontinued HU, 73% were taking three drugs including a protease inhibitor. Patients who had started HU were compared with similar patients who had started protease inhibitors in the Swiss cohort. The probability of stopping HU was higher than the probability of stopping nelfinavir or indinavir, and similar to the probability of stopping ritonavir. CONCLUSION: HU increased the antiviral effect of stavudine plus didanosine. However, side effects were more frequent, and after 24 months the majority of patients had switched to protease inhibitor regimens.
[Drug-Disease]: HU - HIV-1 infection
[Title]: Long-term hydroxyurea in combination with didanosine and stavudine for the treatment of HIV-1 infection. Swiss HIV Cohort Study.
[Abstract]: OBJECTIVE AND METHODS: In 1998 we reported on a randomized comparison between stavudine plus didanosine plus placebo versus stavudine plus didanosine plus hydroxyurea (HU), in patients with a CD4 count of 200-500 x 10(6) cells/l. After 3 months, the HU group had a higher proportion of patients with viral load < 200 x 10 cells/l. At the end of the 3 months blinded period, patients in the placebo group had the option to add HU if their viral load remained > 200 x 10(6) cells/l. We report results after 24 months. RESULTS: Seventy-two patients were randomized to the HU arm, and a further 30 elected to add HU after 12 weeks. Twenty-four months after the start of the trial, only 25% of the 72 patients originally randomized to HU, and 20% of the 30 who added HU after week 12, were still taking it. The reasons for stopping HU were: lack of efficacy (45%), adverse events (37%) and patient or physician preference (18%). Side effects were more frequent in the didanosine/stavudine/HU group than in the didanosine/stavudine group: neuropathy (35 versus 15%, P< 0.02), fatigue (22 versus 7%, P< 0.01), and nausea or vomiting (26 versus 9%, P< 0.01). Of those who had discontinued HU, 73% were taking three drugs including a protease inhibitor. Patients who had started HU were compared with similar patients who had started protease inhibitors in the Swiss cohort. The probability of stopping HU was higher than the probability of stopping nelfinavir or indinavir, and similar to the probability of stopping ritonavir. CONCLUSION: HU increased the antiviral effect of stavudine plus didanosine. However, side effects were more frequent, and after 24 months the majority of patients had switched to protease inhibitor regimens.
[Drug-Disease]: didanosine - HIV-1 infection
[Title]: Long-term hydroxyurea in combination with didanosine and stavudine for the treatment of HIV-1 infection. Swiss HIV Cohort Study.
[Abstract]: OBJECTIVE AND METHODS: In 1998 we reported on a randomized comparison between stavudine plus didanosine plus placebo versus stavudine plus didanosine plus hydroxyurea (HU), in patients with a CD4 count of 200-500 x 10(6) cells/l. After 3 months, the HU group had a higher proportion of patients with viral load < 200 x 10 cells/l. At the end of the 3 months blinded period, patients in the placebo group had the option to add HU if their viral load remained > 200 x 10(6) cells/l. We report results after 24 months. RESULTS: Seventy-two patients were randomized to the HU arm, and a further 30 elected to add HU after 12 weeks. Twenty-four months after the start of the trial, only 25% of the 72 patients originally randomized to HU, and 20% of the 30 who added HU after week 12, were still taking it. The reasons for stopping HU were: lack of efficacy (45%), adverse events (37%) and patient or physician preference (18%). Side effects were more frequent in the didanosine/stavudine/HU group than in the didanosine/stavudine group: neuropathy (35 versus 15%, P< 0.02), fatigue (22 versus 7%, P< 0.01), and nausea or vomiting (26 versus 9%, P< 0.01). Of those who had discontinued HU, 73% were taking three drugs including a protease inhibitor. Patients who had started HU were compared with similar patients who had started protease inhibitors in the Swiss cohort. The probability of stopping HU was higher than the probability of stopping nelfinavir or indinavir, and similar to the probability of stopping ritonavir. CONCLUSION: HU increased the antiviral effect of stavudine plus didanosine. However, side effects were more frequent, and after 24 months the majority of patients had switched to protease inhibitor regimens.
[Drug-Disease]: stavudine - HIV-1 infection
[Title]: Renoprotective role of nifedipine during gentamicin therapy: randomized controlled trial.
[Abstract]: AIM: To investigate the protective effect of nifedipine, a dihydropyridine calcium-channel blocker, on renal function (glomerular and tubular) in patients treated with gentamicin, an aminoglycoside antibiotic. METHODS: Thirty-two patients with gentamicin sensitive upper urinary tract infection have been screened and randomized to two groups. The placebo group was given gentamicin and placebo, and the intervention group gentamicin and nifedipine. Gentamicin was given in slow intravenous injection every 12 hours for 10 days, and nifedipine 10 mg orally, 3 times a day. RESULTS: Nifedipine administration during gentamicin therapy promoted primarily the glomerular filtration. In 62% of the patients treated with nifedipine creatinine clearance increased significantly by the end of the study. In the placebo group, 69% of the patients had a creatinine clearance significantly below the baseline at the end of the study. The decrease in creatinine clearance by more than 50% from the initial values was found in 2 patients (1 in each group). There was a significant increase in gammaGT/creatinine clearance ratio in both groups at the end of therapy, indicating that nifedipine did not prevent the brush-border membranous enzyme release caused by gentamicin. CONCLUSION: Nifedipine has positive effects on renal hemodynamics in patients treated with gentamicin. Most likely, the mechanism of action is an increase in glomerular filtration caused by preglomerular vasodilatation.
[Drug-Disease]: gentamicin - upper urinary tract infection
[Title]: Peripheral lidocaine but not ketamine inhibits capsaicin-induced hyperalgesia in humans.
[Abstract]: We examined the effect of the subcutaneous infiltration of ketamine, lidocaine and saline before injury on capsaicin-induced pain and hyperalgesia. Twelve healthy volunteers participated in two separate, randomized, double-blind, placebo-controlled crossover experiments. In experiment 1, 100 micrograms capsaicin was injected intradermally in one volar forearm 10 min after the skin had been pretreated with lidocaine 20.0 mg in 2.0 ml or 0.9% saline 2.0 ml at the capsaicin injection site. In experiment 2, a similar capsaicin test was given 10 min after the skin had been pretreated with ketamine 5 mg in 2.0 ml or 0.9% saline 2.0 ml. To control for possible systemic effects, the capsaicin injection site was pretreated by injection of saline into the skin and the contralateral arm was treated with active drug, and vice versa. Outcome measures were spontaneous pain, pain evoked by punctate and brush stimuli, and areas of brush-evoked and punctate-evoked hyperalgesia. Lidocaine reduced all measures compared with placebo (P < 0.001), whereas ketamine failed to change any measures. Pain scores and areas of hyperalgesia were not affected when the contralateral site was infiltrated with ketamine or lidocaine. Lidocaine produced no side-effects, whereas ketamine produced paraesthesia, dizziness and sleepiness in six out of 24 (25%) cases. Blocking peripheral sodium channels with locally administered lidocaine reduces spontaneous pain and capsaicin-induced hyperalgesia but local block with the NMDA-type glutamate receptor antagonist ketamine has no effect on capsaicin-induced pain and hyperalgesia.
[Drug-Disease]: lidocaine - hyperalgesia
[Title]: Peripheral lidocaine but not ketamine inhibits capsaicin-induced hyperalgesia in humans.
[Abstract]: We examined the effect of the subcutaneous infiltration of ketamine, lidocaine and saline before injury on capsaicin-induced pain and hyperalgesia. Twelve healthy volunteers participated in two separate, randomized, double-blind, placebo-controlled crossover experiments. In experiment 1, 100 micrograms capsaicin was injected intradermally in one volar forearm 10 min after the skin had been pretreated with lidocaine 20.0 mg in 2.0 ml or 0.9% saline 2.0 ml at the capsaicin injection site. In experiment 2, a similar capsaicin test was given 10 min after the skin had been pretreated with ketamine 5 mg in 2.0 ml or 0.9% saline 2.0 ml. To control for possible systemic effects, the capsaicin injection site was pretreated by injection of saline into the skin and the contralateral arm was treated with active drug, and vice versa. Outcome measures were spontaneous pain, pain evoked by punctate and brush stimuli, and areas of brush-evoked and punctate-evoked hyperalgesia. Lidocaine reduced all measures compared with placebo (P < 0.001), whereas ketamine failed to change any measures. Pain scores and areas of hyperalgesia were not affected when the contralateral site was infiltrated with ketamine or lidocaine. Lidocaine produced no side-effects, whereas ketamine produced paraesthesia, dizziness and sleepiness in six out of 24 (25%) cases. Blocking peripheral sodium channels with locally administered lidocaine reduces spontaneous pain and capsaicin-induced hyperalgesia but local block with the NMDA-type glutamate receptor antagonist ketamine has no effect on capsaicin-induced pain and hyperalgesia.
[Drug-Disease]: lidocaine - pain
[Title]: A phase I/II study of multiple-dose intravenous busulfan as myeloablation prior to stem cell transplantation.
[Abstract]: Busulfan has been previously only available in an oral formulation due to its poor water solubility. We report the results of a phase I study of multiple escalating doses of intravenous busulfan (Spartaject Busulfan, Orphan Europe, Paris, France) for myeloablation prior to stem cell transplantation (SCT) in 12 patients with chronic myeloid leukemia, acute myeloid leukemia or acute lymphocytic leukemia. One patient received allogeneic SCT; the other 11 patients received autologous SCT. The first six patients received i.v. busulfan diluted in 50 ml of 0.9% normal saline and the last six patients received busulfan in a 500-ml 5% dextrose solution. All patients experienced profound myelosuppression and all but one demonstrated hematopoietic engraftment. Toxicity was mild or moderate and there were no toxic deaths attributable to busulfan. Of note, there were no cases of veno-occlusive disease of the liver. Busulfan plasma concentrations were determined by gas chromatography with electron capture detection and showed little intrapatient variability. In most cases there was no significant difference between the first and last dose PK parameters. These data suggest that dose adjustment based on first dose PK data could allow uniformity of busulfan dosing for patients receiving SCT.
[Drug-Disease]: busulfan - chronic myeloid leukemia
[Title]: A phase I/II study of multiple-dose intravenous busulfan as myeloablation prior to stem cell transplantation.
[Abstract]: Busulfan has been previously only available in an oral formulation due to its poor water solubility. We report the results of a phase I study of multiple escalating doses of intravenous busulfan (Spartaject Busulfan, Orphan Europe, Paris, France) for myeloablation prior to stem cell transplantation (SCT) in 12 patients with chronic myeloid leukemia, acute myeloid leukemia or acute lymphocytic leukemia. One patient received allogeneic SCT; the other 11 patients received autologous SCT. The first six patients received i.v. busulfan diluted in 50 ml of 0.9% normal saline and the last six patients received busulfan in a 500-ml 5% dextrose solution. All patients experienced profound myelosuppression and all but one demonstrated hematopoietic engraftment. Toxicity was mild or moderate and there were no toxic deaths attributable to busulfan. Of note, there were no cases of veno-occlusive disease of the liver. Busulfan plasma concentrations were determined by gas chromatography with electron capture detection and showed little intrapatient variability. In most cases there was no significant difference between the first and last dose PK parameters. These data suggest that dose adjustment based on first dose PK data could allow uniformity of busulfan dosing for patients receiving SCT.
[Drug-Disease]: busulfan - acute myeloid leukemia
[Title]: A phase I/II study of multiple-dose intravenous busulfan as myeloablation prior to stem cell transplantation.
[Abstract]: Busulfan has been previously only available in an oral formulation due to its poor water solubility. We report the results of a phase I study of multiple escalating doses of intravenous busulfan (Spartaject Busulfan, Orphan Europe, Paris, France) for myeloablation prior to stem cell transplantation (SCT) in 12 patients with chronic myeloid leukemia, acute myeloid leukemia or acute lymphocytic leukemia. One patient received allogeneic SCT; the other 11 patients received autologous SCT. The first six patients received i.v. busulfan diluted in 50 ml of 0.9% normal saline and the last six patients received busulfan in a 500-ml 5% dextrose solution. All patients experienced profound myelosuppression and all but one demonstrated hematopoietic engraftment. Toxicity was mild or moderate and there were no toxic deaths attributable to busulfan. Of note, there were no cases of veno-occlusive disease of the liver. Busulfan plasma concentrations were determined by gas chromatography with electron capture detection and showed little intrapatient variability. In most cases there was no significant difference between the first and last dose PK parameters. These data suggest that dose adjustment based on first dose PK data could allow uniformity of busulfan dosing for patients receiving SCT.
[Drug-Disease]: busulfan - acute lymphocytic leukemia
[Title]: White matter changes on MRI during treatment in children with acute lymphoblastic leukemia: correlation with neuropsychological findings.
[Abstract]: BACKGROUND: Treatment of childhood acute lymphoblastic leukemia (ALL) may cause structural and functional brain damage. To find out the incidence of white matter changes during therapy, a prospective MRI study was designed, and the findings were correlated with neuropsychological evaluation. PROCEDURE: Thirty-three children with ALL underwent serial cranial MRI before, during, and after therapy. Twenty-eight of these children underwent also neuropsychological assessment at the end of treatment. They all received intravenous and intrathecal methotrexate for central nervous system (CNS) therapy, 15 patients received cranial irradiation in addition. RESULTS: Transient high-intensity white matter changes were observed by MRI in three children 9% (95% CI, 2-24%) who received chemotherapy only. The high-intensity changes were most prominent in the frontal lobes in two of these children. The children with white matter changes were significantly younger than those with normal MRI (2.8 vs. 7.4 years; mean). There was no correlation between neuropsychological tests and white matter changes, except in attention and in tests referring to the frontal areas in general. CONCLUSIONS: White matter changes are occasionally observed during therapy with the current Nordic protocols. Young children may be more susceptible to developing white matter changes after repeated intravenous methotrexate injections. There is no systematic correlation between neuropsychological deficits and MRI findings.
[Drug-Disease]: methotrexate - acute lymphoblastic leukemia
[Title]: Efficacy and safety of Zafirlukast ('Accolate') in the management of patients with mild-to-moderate asthma.
[Abstract]: The efficacy and safety of the oral leukotriene receptor antagonist Zafirlukast ('Accolate') was assessed as maintenance therapy for black (Nigerian) patients with mild to moderate asthma. A total of eighty-one patients aged 16-70 years were screened and sixty patients were enrolled in a 7-week multicenter open study to receive 20 mg of 'Accolate' twice daily. Those enrolled had FEV1 > or = 60%, reversibility > or = 15% and cumulative daytime asthma symptoms score > or = 10 over seven consecutive days before visit 2 to be considered eligible to receive trial therapy, and the patients were maintained on as required beta 2-agonist therapy. Efficacy was assessed by changes in symptoms, number of times beta 2-agonist was used and results of pulmonary function tests. Safety was assessed by adverse event experiences, results of laboratory tests and physical examination. At the endpoint, patients reported a statistically significant increase in lung function and a significant reduction in episodes of asthma symptoms either in the morning, day or night. The mean beta 2-agonist use was also statistically reduced over the weeks as treatment progressed while the cumulative daytime total asthma score showed a sharp decline following drug use. Change in symptoms, beta 2-agonist use and pulmonary function occurred within one week of Zafirlukast treatment and continued throughout the trial. Zafirlukast was well tolerated. Headaches and pneumonia were the only side effects in three patients and these were not considered to be related to trial therapy. No clinically significant changes were observed in laboratory test results, or on physical examination. We conclude that Zafirlukast ('Accolate') 20 mg b.d. is an effective and well tolerated medication for maintenance therapy in black (Nigerian) patients with mild-to-moderate asthma.
[Drug-Disease]: Accolate - asthma
[Title]: A randomized, comparative open-label study on the efficacy of latanoprost and timolol in steroid induced ocular hypertension after photorefractive keratectomy.
[Abstract]: PURPOSE: To evaluate the effect of 0.005% latanoprost and 0.50% timolol for the treatment of steroid-induced ocular hypertension (SIOH) after excimer laser photorefractive keratectomy (PRK). METHODS: In this comparative, open-label study we enrolled 29 patients who received steroid therapy after PRK and developed intraocular pressure (IOP) elevation within 30 days of treatment. Fifteen were randomized to 0.005% latanoprost (group A) and 14 to 0.50% timolol (group B). IOP measurements were scheduled at 1, 3, 7, 15, 30, 60, 90 and 120 days of therapy. RESULTS; We did not find any real differences between latanoprost and timolol except at the 7-day and 15-day timepoints, when latanoprost reduced IOP significantly more than timolol (p=0.033, 0.035, respectively). After 7 days of therapy two of the 14 timolol-treated patients had high IOP (24 and 26 mmHg) but these promptly returned to normal when latanoprost was added. No significant differences were observed in the ocular side effects considered. CONCLUSIONS: 0.005% latanoprost is as safe and effective as 0.50% timolol in the treatment of SIOH after PRK. Both drugs provide a significant and stable IOP reduction in the majority of patients after short-term treatment. These findings are encouraging for the use of latanoprost in the management of SIOH after PRK, although further trials are necessary to consider it as a primary treatment.
[Drug-Disease]: latanoprost - ocular hypertension
[Title]: A randomized, comparative open-label study on the efficacy of latanoprost and timolol in steroid induced ocular hypertension after photorefractive keratectomy.
[Abstract]: PURPOSE: To evaluate the effect of 0.005% latanoprost and 0.50% timolol for the treatment of steroid-induced ocular hypertension (SIOH) after excimer laser photorefractive keratectomy (PRK). METHODS: In this comparative, open-label study we enrolled 29 patients who received steroid therapy after PRK and developed intraocular pressure (IOP) elevation within 30 days of treatment. Fifteen were randomized to 0.005% latanoprost (group A) and 14 to 0.50% timolol (group B). IOP measurements were scheduled at 1, 3, 7, 15, 30, 60, 90 and 120 days of therapy. RESULTS; We did not find any real differences between latanoprost and timolol except at the 7-day and 15-day timepoints, when latanoprost reduced IOP significantly more than timolol (p=0.033, 0.035, respectively). After 7 days of therapy two of the 14 timolol-treated patients had high IOP (24 and 26 mmHg) but these promptly returned to normal when latanoprost was added. No significant differences were observed in the ocular side effects considered. CONCLUSIONS: 0.005% latanoprost is as safe and effective as 0.50% timolol in the treatment of SIOH after PRK. Both drugs provide a significant and stable IOP reduction in the majority of patients after short-term treatment. These findings are encouraging for the use of latanoprost in the management of SIOH after PRK, although further trials are necessary to consider it as a primary treatment.
[Drug-Disease]: timolol - ocular hypertension