B1tta/Drug-ACE huggingface dataset:
[Title]: Safety of controlled-onset extended-release verapamil in middle-aged and older patients with hypertension and coronary artery disease.
[Abstract]: BACKGROUND: Our purpose was to study the safety of controlled-onset, extended-release (COER) verapamil in patients with hypertension or coronary artery disease, with a focus on elderly patients. METHODS: Adverse event data were pooled from 7 double-blind, multicenter, randomized trials including 1999 patients with hypertension or chronic stable angina pectoris. There were 1042 patients who received COER verapamil 180 to 540 mg once daily in the evening for up to 10 weeks, 373 patients who received placebo, and 584 who received an active comparator agent. Data were analyzed according to the following groups: all patients, patients with hypertension, patients with angina, older patients (&gt;/=65 years old), and younger patients (&lt;65 years old). Adverse event rates were compared across the treatment groups by the Fisher exact test. RESULTS: In all patients combined, the incidence of constipation (13% vs 2%), dizziness (6% vs 2%), and back pain (3% vs 1%) was higher in patients treated with COER verapamil than with placebo. Patients with hypertension had more back pain (4% vs 1%) and constipation (12% vs 1%) with COER verapamil than with placebo, whereas patients with angina had more bradycardia (2.6% vs 0%), dizziness (8% vs 2%), and constipation (15% vs 3%). Older patients treated with COER verapamil had more bradycardia, constipation, dizziness, and fatigue and had fewer headaches compared with younger patients treated with COER verapamil. Second- or third-degree atrioventricular block was not observed after administration of COER verapamil in any subgroup. CONCLUSION: These data demonstrate that COER verapamil has an acceptable safety profile that is largely unrelated to age in patients with hypertension or coronary artery disease.
[Drug-Disease]: verapamil - angina
[Title]: Safety of controlled-onset extended-release verapamil in middle-aged and older patients with hypertension and coronary artery disease.
[Abstract]: BACKGROUND: Our purpose was to study the safety of controlled-onset, extended-release (COER) verapamil in patients with hypertension or coronary artery disease, with a focus on elderly patients. METHODS: Adverse event data were pooled from 7 double-blind, multicenter, randomized trials including 1999 patients with hypertension or chronic stable angina pectoris. There were 1042 patients who received COER verapamil 180 to 540 mg once daily in the evening for up to 10 weeks, 373 patients who received placebo, and 584 who received an active comparator agent. Data were analyzed according to the following groups: all patients, patients with hypertension, patients with angina, older patients (&gt;/=65 years old), and younger patients (&lt;65 years old). Adverse event rates were compared across the treatment groups by the Fisher exact test. RESULTS: In all patients combined, the incidence of constipation (13% vs 2%), dizziness (6% vs 2%), and back pain (3% vs 1%) was higher in patients treated with COER verapamil than with placebo. Patients with hypertension had more back pain (4% vs 1%) and constipation (12% vs 1%) with COER verapamil than with placebo, whereas patients with angina had more bradycardia (2.6% vs 0%), dizziness (8% vs 2%), and constipation (15% vs 3%). Older patients treated with COER verapamil had more bradycardia, constipation, dizziness, and fatigue and had fewer headaches compared with younger patients treated with COER verapamil. Second- or third-degree atrioventricular block was not observed after administration of COER verapamil in any subgroup. CONCLUSION: These data demonstrate that COER verapamil has an acceptable safety profile that is largely unrelated to age in patients with hypertension or coronary artery disease.
[Drug-Disease]: verapamil - hypertension
[Title]: Divalproex loading in the treatment of cocaine dependence.
[Abstract]: The current pilot project was designed to evaluate the safety and tolerability of a loading dose of divalproex (DVPX) in subjects with cocaine dependence. Seventeen cocaine-dependent subjects were enrolled in an eight-week, open-label trial of 20 mg/kg/day DVPX. Subjects were seen weekly and urine drug screens were obtained at each visit. Over the eight-week trial, craving intensity and frequency as well as reported time using cocaine decreased significantly. Retention in the current study was 79% at week four and 50% at week eight. The medication and dosing strategy was well tolerated. This pilot study indicates that DVPX loading is well tolerated and may be efficacious in the treatment of cocaine dependence. A placebo-controlled trial would be of interest.
[Drug-Disease]: DVPX - cocaine dependence
[Title]: Preliminary experience with steroidal ovarian suppression for prevention of severe ovarian hyperstimulation syndrome in IVF patients.
[Abstract]: The purpose of the study was to evaluate the efficiency of administration of high dose progesterone in combination with oestradiol during the luteal phase for the prevention of ovarian hyperstimulation syndrome in a high-risk population of patients undergoing in vitro fertilization. An observational study was carried out involving 21 women (mean age 28.6 years) undergoing controlled ovarian stimulation for in vitro fertilization. The women were identified as at risk of ovarian hyperstimulation syndrome as they had suffered from the condition when hCG was used for luteal phase support in previous cycles. Steroidal suppression of the stimulated ovary on days 2, 6, 10 and 14 after embryo transfer was achieved by intramuscular injections of 500 mg hydroxyprogesterone caproate and 10 mg oestradiol valerate. The incidence of moderate and severe ovarian hyperstimulation syndrome under steroidal ovarian suppression, serum progesterone concentration and pregnancy rates were compared with those in cycles in which human chorionic gonadotrophin was used for luteal phase support. No cases of moderate or severe ovarian hyperstimulation syndrome occurred under steroidal ovarian suppression. Despite low progesterone concentrations (mean 10.7 nmol l(-1), range 2.6-24.5), indicating almost complete ovarian suppression, the pregnancy rate was not impaired. These preliminary results indicate that steroidal ovarian suppression during the luteal phase is a promising tool for reducing the incidence and severity of ovarian hyperstimulation syndrome in a high-risk population, without compromising the pregnancy rate.
[Drug-Disease]: hydroxyprogesterone caproate - ovarian hyperstimulation syndrome
[Title]: Preliminary experience with steroidal ovarian suppression for prevention of severe ovarian hyperstimulation syndrome in IVF patients.
[Abstract]: The purpose of the study was to evaluate the efficiency of administration of high dose progesterone in combination with oestradiol during the luteal phase for the prevention of ovarian hyperstimulation syndrome in a high-risk population of patients undergoing in vitro fertilization. An observational study was carried out involving 21 women (mean age 28.6 years) undergoing controlled ovarian stimulation for in vitro fertilization. The women were identified as at risk of ovarian hyperstimulation syndrome as they had suffered from the condition when hCG was used for luteal phase support in previous cycles. Steroidal suppression of the stimulated ovary on days 2, 6, 10 and 14 after embryo transfer was achieved by intramuscular injections of 500 mg hydroxyprogesterone caproate and 10 mg oestradiol valerate. The incidence of moderate and severe ovarian hyperstimulation syndrome under steroidal ovarian suppression, serum progesterone concentration and pregnancy rates were compared with those in cycles in which human chorionic gonadotrophin was used for luteal phase support. No cases of moderate or severe ovarian hyperstimulation syndrome occurred under steroidal ovarian suppression. Despite low progesterone concentrations (mean 10.7 nmol l(-1), range 2.6-24.5), indicating almost complete ovarian suppression, the pregnancy rate was not impaired. These preliminary results indicate that steroidal ovarian suppression during the luteal phase is a promising tool for reducing the incidence and severity of ovarian hyperstimulation syndrome in a high-risk population, without compromising the pregnancy rate.
[Drug-Disease]: oestradiol valerate - ovarian hyperstimulation syndrome
[Title]: Beneficial effects of diltiazem during myocardial reperfusion: a randomized trial in acute myocardial infarction.
[Abstract]: BACKGROUND: Although in experimental models of coronary occlusion diltiazem administration has been shown to reduce the degree of stunning and of reperfusion injury, the majority of clinical trials has failed to demonstrate significant benefits. The aim of this study was to evaluate the effect of diltiazem, administered before coronary reperfusion, on infarct size, residual myocardial viability and recovery of left ventricular function. METHODS: We studied 90 patients admitted within 3 hours of the onset of symptoms of acute myocardial infarction. They were immediately randomized to either intravenous diltiazem (10 mg bolus + 10 mg/hour for 3 days) (group 1, n = 43) or placebo (group 2, n = 47) and subsequently treated with recombinant tissue-type plasminogen activator. All underwent serial echocardiograms upon admission, 4 days post-admission during low-dose dobutamine stress echo, at discharge and after 6 months. We calculated the dysfunction score (1 = hypokinesia, 2 = akinesia, 3 = dyskinesia) on admission and its percent reduction after dobutamine (viability) and at follow-up (recovery). The 12-lead electrocardiograms were continuously monitored for 3 days and coronary angioplasty was performed whenever the residual stenosis was &gt; 60%. RESULTS: Upon admission, there were no differences in age, sex, infarct location and size, degree of ST-segment elevation, time from onset of symptoms and dysfunction score. Creatine kinase peaked early in 70% of patients in both groups; the incidences of recurrent ischemia, infarct-related vessel patency and the need for coronary angioplasty were also similar. The creatine kinase peak was significantly higher in group 2 (2931 +/- 2456 vs 1726 +/- 1004 IU/l, p &lt; 0.05). Conversely, in group 1 the residual viability was significantly higher (51 +/- 23 vs 36 +/- 30% improvement in dysfunction score, p &lt; 0.05) and the early recovery of regional function was significantly greater (35 +/- 34 vs 18 +/- 22% at discharge, p &lt; 0.05). On the other hand, the delayed recovery was not significantly different (15 +/- 29 vs 21 +/- 32% from the time of discharge to 6 months of follow-up). CONCLUSIONS: Intravenous diltiazem, started before coronary reperfusion, has beneficial effects on the infarct size, residual viability and recovery of regional function. If confirmed by larger trials, these preliminary results suggest the use of diltiazem as adjunctive therapy in patients with acute myocardial infarction and undergoing reperfusion.
[Drug-Disease]: diltiazem - acute myocardial infarction
[Title]: Dose finding, placebo-controlled study of oral almotriptan in the acute treatment of migraine.
[Abstract]: OBJECTIVE: To assess the efficacy and tolerability of oral almotriptan, a selective serotonin receptor (5-HT1B/1D) agonist, when used at different doses in the treatment of acute migraine. METHODS: This was a placebo controlled, double-blind, parallel-group, dose-finding study. Patients satisfying International Headache Society criteria for acute migraine were randomized to a single dose of placebo or oral almotriptan 2, 6.25, 12.5, or 25 mg at the onset of moderate or severe pain. Patients graded pain intensity on a 4-point verbal scale from 0 (no pain) to 3 (severe pain) and recorded adverse events. The primary efficacy variable was headache response at 2 hours. Data were analyzed on an intent-to-treat basis. RESULTS: Nine hundred and three patients were randomized, and 742 were included in the evaluation of the efficacy and tolerability. Headache response at 2 hours was 32.5% with placebo, and 30%, 56.3%, 58.5%, and 66.5% with almotriptan 2, 6.25, 12.5, and 25 mg doses (p &lt; 0.05 for 6.25, 12.5, and 25 mg vs placebo). A dose-dependent decrease in the incidence of migraine-associated symptoms and the need for escape medication was observed. The incidence of adverse events with the almotriptan 2-mg, 6.25-mg, and 12.5-mg groups was comparable to that with the placebo group. CONCLUSION: Almotriptan 12.5 mg demonstrated the most favorable ratio between efficacy and tolerability, offering equivalent efficacy and better tolerability compared with the 25 mg dose. The minimum effective dose of almotriptan was 6.25 mg.
[Drug-Disease]: almotriptan - migraine
[Title]: [Effect of doxazosin on postural changes in blood pressure using a multibiomedical recorder].
[Abstract]: To investigate the effect of doxazosin on orthostatic blood pressure changes with daily activity, the relationship among blood pressure, physical position and physical activities using an ambulatory multibiomedical monitoring system(TM2425) were studied. The subjects were 22 patients with essential hypertension(EHT group), 23 patients with diabetic mellitus(DM group) and 17 healthy volunteers for the control. Patients were administered doxazosin at 2-8 mg/day for 0.5 month to 12 months. Twenty-four-hour blood pressure, posture and activity were monitored. Systolic blood pressure was higher in the standing position than that in the sitting position in the control group, but there were no differences between these values in the EHT group and DM groups. During the awake, sleep, and standing periods, doxazosin significantly decreased blood pressure in the EHT group; however, it significantly decreased only the standing systolic blood pressure in the DM group. Absolute changes in blood pressure after the administration of doxazosin were not significantly different between the standing and sitting periods in each group. These findings suggest that doxazosin decreases the blood pressure of both patients with essential hypertension and patients with diabetic mellitus without an excessive decrease in standing blood pressure.
[Drug-Disease]: doxazosin - hypertension
[Title]: Clozapine: its impact on aggressive behavior among patients in a state psychiatric hospital.
[Abstract]: Clozapine has shown consistent efficacy against positive symptoms of psychoses, and emerging reports indicate improvements in aggression and suicidality. This study evaluated the impact of clozapine aggression in a psychiatric hospital. Over a three year period, 137 subjects with schizophrenia or schizoaffective disorder received clozapine, of whom nearly 50% (n=69) experienced seclusion or restraint. Using a mirror-image study design, seclusion and restraint rates were computed per patient-month pre-clozapine and compared during clozapine treatment to a maximum of 12 months in either direction. The rest of the hospital not receiving clozapine served as a comparator group. Statistically significant reductions occurred in both seclusion (0.44+/-0.46 vs. 0.16+/-0.32, z=-3.91, p=0.0003) and restraint (0.34+/-0.47 vs. 0.08+/-0.23, z=-2.27, p=0.032) during clozapine treatment as compared with the pre-clozapine period. The comparator group experienced a low rate of seclusion and restraint throughout. While there are limitations to a mirror-image design, this study supports the emerging data on the benefits of clozapine for aggressive and violent patients with psychoses. Preliminary data suggests other second generation antipsychotic agents may have similar effects.
[Drug-Disease]: clozapine - schizophrenia or schizoaffective disorder
[Title]: Evaluation of different nebulized bronchodilators on clinical efficacy and hypokalemia in asthmatic children.
[Abstract]: Acute asthma attack continues to be a major cause for children admitted to the emergency room. Nebulized beta 2-adrenergic agonists are still the first-line drugs for a rapid bronchodilation effect and an easily administered drug during acute asthma attack. The bronchodilator-induced hypokalemia is thought significant in adult group, but is often ignored in children group. In this study, we conducted a randomized study to compare the laboratory and clinical effects between nebulized salbutamol and terbutaline. We found that both salbutamol and terbutaline nebulization induced a significant hypokalemia (p &lt; 0.05). Terbutaline nebulization also significantly improved the peak expiratory flow rate (PEFR) and respiratory rate (RR), but not venous partial pressure of oxygen (PvO2), venous carbon dioxide tension (PvCO2) and O2 saturation in venous blood (SvO2). In contrast, salbutamol improved not only PEFR and RR, but also PvO2, PvCO2, and SvO2 30 minutes of administration. In conclusion, the nebulized salbutamol, although induced a hypokalemic effect which is similar to terbutaline group, has a better effect on improving O2 saturation than nebulized terbutaline with the same dose 30 minutes after administered for children with acute asthma attack.
[Drug-Disease]: salbutamol - asthma
[Title]: Evaluation of different nebulized bronchodilators on clinical efficacy and hypokalemia in asthmatic children.
[Abstract]: Acute asthma attack continues to be a major cause for children admitted to the emergency room. Nebulized beta 2-adrenergic agonists are still the first-line drugs for a rapid bronchodilation effect and an easily administered drug during acute asthma attack. The bronchodilator-induced hypokalemia is thought significant in adult group, but is often ignored in children group. In this study, we conducted a randomized study to compare the laboratory and clinical effects between nebulized salbutamol and terbutaline. We found that both salbutamol and terbutaline nebulization induced a significant hypokalemia (p &lt; 0.05). Terbutaline nebulization also significantly improved the peak expiratory flow rate (PEFR) and respiratory rate (RR), but not venous partial pressure of oxygen (PvO2), venous carbon dioxide tension (PvCO2) and O2 saturation in venous blood (SvO2). In contrast, salbutamol improved not only PEFR and RR, but also PvO2, PvCO2, and SvO2 30 minutes of administration. In conclusion, the nebulized salbutamol, although induced a hypokalemic effect which is similar to terbutaline group, has a better effect on improving O2 saturation than nebulized terbutaline with the same dose 30 minutes after administered for children with acute asthma attack.
[Drug-Disease]: terbutaline - asthma
[Title]: [Risperidone in the treatment of psychotic patients with opiate abuse and dependence].
[Abstract]: INTRODUCTION: 180 psychotic patients with opiate dependence and abuse (ICD-10) were included in an open label study. The study objectives were to evaluate safety and efficacy of risperidone for a six month follow-up period. The total mean dose was 4.4 (SD: 2.4 mg/daily; range: 0.5-12 mg/daily). METHODS: BPRS, CGI and DDS-SV were used to assess efficacy and UKU subscale for neurological side effects and spontaneous reports for safety. RESULTS: Risperidone treatment improved symptoms, disability of the included patients with a significant reduction in the mean total scores of BPRS, CGI and DDS-SV observed from the first month of treatment onwards. Risperidone also reduced illegal opiate abuse patients from 39% basedate to 18% at month 6. There was a significant reduction (p&lt; 0.0001) in the total UKU subscale for neurological side effects scores from visit 1 onwards for studied sample. Risperidone was well tolerated by the study patients. From 165 elegible patients, just 10 (6.1%) discontinued treatment due to adverse reactions, 94% of the patients did not suffer any adverse event; the most frequent adverse events according spontaneous reports were extrapyramidal effects (3%) and anxiety (1.8%). DISCUSSION: Risperidone improved disability, psychotic symptoms and tolerability of these patients. Those results could mean an outstanding breakthrough in the treatment of these type of disorders and, if it is confirmed that risperidone can lead to abstinence, we would be before a new line of treatment for dual pathology.
[Drug-Disease]: risperidone - illegal opiate abuse
[Title]: [Risperidone in the treatment of psychotic patients with opiate abuse and dependence].
[Abstract]: INTRODUCTION: 180 psychotic patients with opiate dependence and abuse (ICD-10) were included in an open label study. The study objectives were to evaluate safety and efficacy of risperidone for a six month follow-up period. The total mean dose was 4.4 (SD: 2.4 mg/daily; range: 0.5-12 mg/daily). METHODS: BPRS, CGI and DDS-SV were used to assess efficacy and UKU subscale for neurological side effects and spontaneous reports for safety. RESULTS: Risperidone treatment improved symptoms, disability of the included patients with a significant reduction in the mean total scores of BPRS, CGI and DDS-SV observed from the first month of treatment onwards. Risperidone also reduced illegal opiate abuse patients from 39% basedate to 18% at month 6. There was a significant reduction (p&lt; 0.0001) in the total UKU subscale for neurological side effects scores from visit 1 onwards for studied sample. Risperidone was well tolerated by the study patients. From 165 elegible patients, just 10 (6.1%) discontinued treatment due to adverse reactions, 94% of the patients did not suffer any adverse event; the most frequent adverse events according spontaneous reports were extrapyramidal effects (3%) and anxiety (1.8%). DISCUSSION: Risperidone improved disability, psychotic symptoms and tolerability of these patients. Those results could mean an outstanding breakthrough in the treatment of these type of disorders and, if it is confirmed that risperidone can lead to abstinence, we would be before a new line of treatment for dual pathology.
[Drug-Disease]: risperidone - psychotic
[Title]: Ketorolac vs tramadol in the treatment of postoperative pain during maxillofacial surgery.
[Abstract]: BACKGROUND: This study aims to assess the best postoperative analgesia during maxillofacial surgery by using small doses of ketorolac or tramadol or their association and evaluates the presence of adverse effects due to NSAID or opioid use. METHODS: After their informed consent, 51 patients ASA I and II undergoing major maxillofacial surgery, were randomised in three groups and the following protocol was used: group K received ketorolac (30 mg i.v.) at the time of skin closure and repeated after 8 hrs and 16 hrs from the end of the operation. Group T received tramadol (100 mg i.v.) in the same condition; and group KT received first tramadol (100 mg i.v.) during surgery and then ketorolac (30 mg) was given in the administrations that followed. Meperidine 50 mg was used in case of unsatisfactory analgesia. Pain was evaluated using pain intensity scores 2, 4, 6, 12 and 24 hours from the end of the operation. Data was analysed using Anova and c2 test. RESULTS: The groups were comparable with regard to age, weight, duration of surgery. Very good postoperative analgesia was recorded in three groups. There is no difference statistically between K, T and KT groups in the pain scores measured. Only a low number of patients required opioids administration to achieve adequate analgesia. The patients were considered to have achieved excellent analgesia in 64.8% in T group, in 41.2% of the K group and in 58.8% of the KT group. There were no cases of insufficient analgesia. We did not find a significant difference considering BP, HR, respiratory depression in the post-operative period. Vomiting was registered in 41.2% of this T group vs 11.2% of the K group and in 35.5% of the KT group. CONCLUSIONS: Ketorolac and Tramadol produced comparable, effective and low cost postoperative analgesia during maxillofacial surgery. There are only statistically significant differences considering side effects.
[Drug-Disease]: Tramadol - postoperative pain