benzofurans and Headache

Prucalopride is effective at alleviating symptoms of chronic constipation in women. The aim of this study was to assess the efficacy of 12 weeks of prucalopride treatment compared with placebo in men with chronic constipation.. This was a multicenter, stratified, randomized, parallel-group, double-blind, placebo-controlled, phase 3 study (ClinicalTrials.gov identifier: NCT01147926). The primary end point was the proportion of patients with a mean of three or more spontaneous complete bowel movements (SCBMs) per week across the treatment period. Efficacy end points were assessed using daily electronic diaries, global assessment of the severity of constipation and efficacy of treatment, and Patient Assessment of Constipation-Symptoms (PAC-SYM) and Patient Assessment of Constipation-Quality of Life (PAC-QOL) questionnaires.. In total, 374 patients were enrolled in the study. Significantly more patients achieved a mean of three or more SCBMs per week in the prucalopride group (37.9%) than in the placebo group (17.7%, P<0.0001). The proportion of patients rating their constipation treatment as "quite a bit" to "extremely" effective at the final on-treatment visit was 46.7 and 30.4% in the prucalopride and placebo groups, respectively. The difference between treatment groups was statistically significant (P<0.0001). The proportion of patients with an improvement of at least 1 point in PAC-QOL satisfaction subscale score was 52.7 and 38.8% in the prucalopride and placebo groups, respectively (P=0.0035). Prucalopride had a good safety profile and was well tolerated.. Prucalopride is effective, has a good safety profile, and is well tolerated for the treatment of men with chronic constipation.

Topics: Abdominal Pain; Adult; Aged; Benzofurans; Chronic Disease; Defecation; Diarrhea; Double-Blind Method; Headache; Humans; Male; Medical Records; Middle Aged; Nausea; Quality of Life; Serotonin 5-HT4 Receptor Agonists; Severity of Illness Index; Surveys and Questionnaires

Novel interferon- and ribavirin-free regimens are needed to treat hepatitis C virus (HCV) infection.. To evaluate the safety and efficacy of grazoprevir (NS3/4A protease inhibitor) and elbasvir (NS5A inhibitor) in treatment-naive patients.. Randomized, blinded, placebo-controlled trial. (ClinicalTrials.gov: NCT02105467).. 60 centers in the United States, Europe, Australia, Scandinavia, and Asia.. Cirrhotic and noncirrhotic treatment-naive adults with genotype 1, 4, or 6 infection.. Oral, once-daily, fixed-dose grazoprevir 100 mg/elbasvir 50 mg for 12 weeks, stratified by fibrosis and genotype. Patients were randomly assigned 3:1 to immediate or deferred therapy.. Proportion of patients in the immediate-treatment group achieving unquantifiable HCV RNA 12 weeks after treatment (SVR12); adverse events in both groups.. Among 421 participants, 194 (46%) were women, 157 (37%) were nonwhite, 382 (91%) had genotype 1 infection, and 92 (22%) had cirrhosis. Of 316 patients receiving immediate treatment, 299 of 316 (95% [95% CI, 92% to 97%]) achieved SVR12, including 144 of 157 (92% [CI, 86% to 96%]) with genotype 1a, 129 of 131 (99% [CI, 95% to 100%]) with genotype 1b, 18 of 18 (100% [CI, 82% to 100%]) with genotype 4, 8 of 10 (80% [CI, 44% to 98%]) with genotype 6, 68 of 70 (97% [CI, 90% to 100%]) with cirrhosis, and 231 of 246 (94% [CI, 90% to 97%]) without cirrhosis. Virologic failure occurred in 13 patients (4%), including 1 case of breakthrough infection and 12 relapses, and was associated with baseline NS5A polymorphisms and emergent NS3 or NS5A variants or both. Serious adverse events occurred in 9 (2.8%) and 3 (2.9%) patients in the active and placebo groups, respectively (difference <0.05 percentage point [CI, -5.4 to 3.1 percentage points]); none were considered drug related. The most common adverse events in the active group were headache (17%), fatigue (16%), and nausea (9%).. The study lacked an active-comparator control group and included relatively few genotype 4 and 6 infections.. Grazoprevir-elbasvir achieved high SVR12 rates in treatment-naive cirrhotic and noncirrhotic patients with genotype 1, 4, or 6 infection. This once-daily, all-oral, fixed-combination regimen represents a potent new therapeutic option for chronic HCV infection.. Merck & Co.

Topics: Administration, Oral; Adult; Aged; Amides; Antiviral Agents; Benzofurans; Carbamates; Cyclopropanes; Drug Administration Schedule; Drug Therapy, Combination; Fatigue; Female; Genotype; Headache; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazoles; Liver Cirrhosis; Male; Middle Aged; Nausea; Quinoxalines; Sulfonamides; Treatment Outcome; Viral Load; Young Adult

Topics: Amides; Antiviral Agents; Asthenia; Benzofurans; Carbamates; Cyclopropanes; Drug Therapy, Combination; Fatigue; Female; Genotype; Headache; Hepacivirus; Hepatitis C, Chronic; Humans; Imidazoles; Male; Middle Aged; Nausea; Quinoxalines; Randomized Controlled Trials as Topic; Ribavirin; RNA, Viral; Sulfonamides; Sustained Virologic Response; Viral Load

This integrated analysis aimed to identify the factors associated with the most frequently re-ported treatment-emergent adverse events (TEAEs) in Asian and non-Asian patients with chronic constipation (CC) who receive prucalopride or placebo over 12 weeks.. Pooled data from four randomized, double-blind, placebo-controlled, multicenter, phase III studies (NCT00488137, NCT00483886, NCT00485940, and NCT01116206) on pa-tients treated with prucalopride 2 mg or placebo were ana-lyzed. The associations between predictors and TEAEs were evaluated based on a logistic regression model.. Overall, 1,821 patients (Asian, 26.1%; non-Asian, 73.9%) were analyzed. Prucalopride treatment was significantly as-sociated with diarrhea, headache, and nausea (p<0.001), but not with abdominal pain, compared with placebo. Differ-ences in the prevalence of TEAEs between prucalopride and placebo decreased greatly after the first day of treatment. Compared with non-Asians, Asians were more likely to expe-rience diarrhea and less likely to develop abdominal pain, headache, and nausea. Prior laxative use, CC duration, and body weight were not predictive of any of these TEAEs. Con-clusions Prucalopride treatment was positively associated with diarrhea, headache, and nausea. Asian patients tended to have a higher frequency of diarrhea but lower frequencies of headache, abdominal pain, and nausea compared with non-Asians. (Gut Liver, 2015;9208-213).

Topics: Abdominal Pain; Adult; Aged; Aged, 80 and over; Asian People; Benzofurans; Clinical Trials, Phase III as Topic; Constipation; Diarrhea; Double-Blind Method; Female; Headache; Humans; Male; Middle Aged; Multicenter Studies as Topic; Nausea; Randomized Controlled Trials as Topic; Regression Analysis

Kanemi Yusho is the name given to a 1968 food poisoning incident resulting from the ingestion of PCB contaminated rice bran oil that had been used as a heating medium. At the time, victims presented with mainly cutaneous manifestations and various other symptoms such as of the eyes and teeth, general fatigue, headaches, and paresthesia of the extremities. The characteristic symptoms then resolved with time. Yusho patients have been followed from immediately after the incident. Blood levels of dioxins such as PeCDF have been measured for those who wishing to since 2001.. The presence or absence of relationships between blood PeCDF level and various examination items/symptoms was investigated in 359 subjects whose blood levels of PCB-related chemical compounds such as PeCDF were measured in the Yusho related examinations between 2001 and 2003. Characteristic symptoms were also compared with the results of examinations done 15 years previously.. The average blood 2,3,4,7,8-PeCDF level in designated Yusho patients was 177.50 pg/g lipids; showing a markedly higher value than that of the normal control group (15.2 pg/g lipids). As well, the blood PeCDF level was related to PCB level, hexachlorobiphenyl level, urinary sugar, erythrocyte sedimetation rate (ESR) (2-hour), thymol and Na. There were also relationships with cutaneous findings (acneiform eruption and comedones), mucosal findings (oral pigmentation), constipation, numbness in the extremities, body weight loss, and abnormal abdominal ultrasonography. Symptoms seen in the skin and eyes in 2001 and 2003 had decreased compared with those in seen 1988. However, PCB and blood PeCDF levels remained high. Patients are continuing to present with mucosal and subjective symptoms as chronic conditions.

Topics: Benzofurans; Eye Diseases; Fatigue; Food Contamination; Headache; Humans; Japan; Oryza; Paresthesia; Plant Oils; Polychlorinated Biphenyls; Skin Diseases; Time Factors; Tooth Diseases

The main objective of this study was to establish background levels of serum PCDD/Fs and biochemistry of residents living near municipal waste incinerators (MWIs) which had been operating between 1 and 8 years, and also to examine the association between the serum PCDD/Fs levels and health outcomes of interest. Information on medical history, life-style, and dietary habits was obtained by questionnaire interview. Significantly elevated levels of glucose and blood urea nitrogen (BUN) were found in those with low to high serum PCDD/Fs levels (p<0.05), and PCDD/Fs levels were found to be positively associated with glucose levels, and marginally with GGT levels even after adjusting for age, sex, BMI and smoking status. Although no conclusive findings on health disorder were associated with the accumulation of serum PCDD/Fs in our study participants, we suggest that the current biochemistry examinations only reflect partially the physiological change in glucose modulation and liver function. However, the low serum PCDD/Fs level does not seem to be sufficient in eliciting pathological process for diabetes or liver-related diseases. The findings suggest that the human body's biochemistry functions such as liver and glucose modulation were affected by PCDD/Fs exposure at even these low serum PCDD/Fs levels found in the general population. Other biochemical functions therefore should be further analyzed, especially for hormone-related and immune functions.

Topics: Adolescent; Adult; Aged; Arrhythmias, Cardiac; Benzofurans; Blood Glucose; Diabetes Mellitus; Dibenzofurans, Polychlorinated; Environmental Monitoring; Environmental Pollutants; Epidemiological Monitoring; Female; gamma-Glutamyltransferase; Headache; Humans; Hypothyroidism; Incineration; Male; Middle Aged; Polychlorinated Dibenzodioxins; Taiwan

Topics: Adult; Aged; Analgesics; Benzofurans; Benzoxepins; Face; Female; Headache; Humans; Male; Middle Aged; Pain; Vascular Headaches

Topics: Adult; Benzofurans; Benzoxepins; Drug Evaluation; Female; Headache; Humans; Male; Middle Aged; Migraine Disorders; Vascular Headaches

Topics: Adolescent; Adult; Benzofurans; Benzoxepins; Drug Evaluation; Female; Headache; Humans; Male; Migraine Disorders; Vascular Headaches