The cyclic nucleotide (cGMP) signalling pathway mediates the smooth-muscle relaxing effects of nitric oxide necessary for normal erectile function. Down-regulation of this pathway is the pathophysiological pivot of many forms of erectile dysfunction (ED) and leads to the development of some chronic diseases, such as hypertension and type 2 diabetes mellitus. Therefore, selective inhibition of the enzyme that catalyses the degradation of cGMP promotes erectile responses to sexual stimulation. Recently, a new phosphodiesterase type 5 (PDE-5) inhibitor tadalafil has emerged, which has a prolonged half-life. Here is a review of recent studies on the safety of tadalafil in the treatment of ED.
Back Pain ; chemically induced ; Carbolines ; adverse effects ; therapeutic use ; Erectile Dysfunction ; drug therapy ; Headache ; chemically induced ; Humans ; Male ; Phosphodiesterase Inhibitors ; adverse effects ; therapeutic use ; Tadalafil

BACKGROUND/AIMS: This integrated analysis aimed to identify the factors associated with the most frequently reported treatment-emergent adverse events (TEAEs) in Asian and non-Asian patients with chronic constipation (CC) who receive prucalopride or placebo over 12 weeks. METHODS: Pooled data from four randomized, double-blind, placebo-controlled, multicenter, phase III studies (NCT00488137, NCT00483886, NCT00485940, and NCT01116206) on patients treated with prucalopride 2 mg or placebo were analyzed. The associations between predictors and TEAEs were evaluated based on a logistic regression model. RESULTS: Overall, 1,821 patients (Asian, 26.1%; non-Asian, 73.9%) were analyzed. Prucalopride treatment was significantly associated with diarrhea, headache, and nausea (p<0.001), but not with abdominal pain, compared with placebo. Differences 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 experience 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. CONCLUSIONS: 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.
Abdominal Pain/*chemically induced ; Adult ; Aged ; Aged, 80 and over ; Asian Continental Ancestry Group/statistics & numerical data ; Benzofurans/*adverse effects ; Clinical Trials, Phase III as Topic ; Constipation/*drug therapy/ethnology ; Diarrhea/*chemically induced ; Double-Blind Method ; Female ; Headache/*chemically induced ; Humans ; Male ; Middle Aged ; Multicenter Studies as Topic ; Nausea/chemically induced ; Randomized Controlled Trials as Topic ; Regression Analysis

BACKGROUND/AIMS: This integrated analysis aimed to identify the factors associated with the most frequently reported treatment-emergent adverse events (TEAEs) in Asian and non-Asian patients with chronic constipation (CC) who receive prucalopride or placebo over 12 weeks. METHODS: Pooled data from four randomized, double-blind, placebo-controlled, multicenter, phase III studies (NCT00488137, NCT00483886, NCT00485940, and NCT01116206) on patients treated with prucalopride 2 mg or placebo were analyzed. The associations between predictors and TEAEs were evaluated based on a logistic regression model. RESULTS: Overall, 1,821 patients (Asian, 26.1%; non-Asian, 73.9%) were analyzed. Prucalopride treatment was significantly associated with diarrhea, headache, and nausea (p<0.001), but not with abdominal pain, compared with placebo. Differences 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 experience 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. CONCLUSIONS: 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.
Abdominal Pain/*chemically induced ; Adult ; Aged ; Aged, 80 and over ; Asian Continental Ancestry Group/statistics & numerical data ; Benzofurans/*adverse effects ; Clinical Trials, Phase III as Topic ; Constipation/*drug therapy/ethnology ; Diarrhea/*chemically induced ; Double-Blind Method ; Female ; Headache/*chemically induced ; Humans ; Male ; Middle Aged ; Multicenter Studies as Topic ; Nausea/chemically induced ; Randomized Controlled Trials as Topic ; Regression Analysis

Antiviral Agents ; adverse effects ; therapeutic use ; Drug Therapy, Combination ; Fatigue ; chemically induced ; Fever ; chemically induced ; Headache ; chemically induced ; Hepatitis C ; drug therapy ; Humans ; Interferon-alpha ; adverse effects ; therapeutic use ; Pain ; chemically induced ; Polyethylene Glycols ; chemistry ; Recombinant Proteins ; Ribavirin ; adverse effects ; therapeutic use

OBJECTIVETo evaluate the safety of recombinant human interferon alpha-2b for nasal spray for the prevention of SARS and other upper respiratory viral infections.

METHODSField epidemiologic evaluation was conducted, the design was randomized and had a synchronously parallel control group. In the study, the drugs were given for five days and all subjects were followed up for ten days.

RESULTSDuring the period of using interferon, body temperature of the experimental group was normal compared to the control group. Experimental group had more influenza-like symptoms than the control group (P < 0.05), such as headache (4.83%-7.09%), dizziness (7.17%-11.63%), lassitude (8.55%-15.06%), muscular soreness (4.43%-7.09%), pharynx dryness (12.10%-17.85%), angina (6.25%-8.72%), abdominal pain (2.30%-5.50%) and diarrhea (2.45%-5.66%). Most of side effects reached their peak with in the first 3 days. Except for pharynx dryness, the incidences of all other side effects declined after completion of the use of the trial drug, and incidences of some symptoms in experimental group were lower than those of the control group. There were no significant differences in the symptoms of cough and expectoration between the experimental group and the control group. The incidence of exanthem in the control group was significantly higher than that in the experimental group. The side effect of bloody nasal mucus was not observed in experimental group, which had been reported by other authors in several volunteer studies.

CONCLUSIONUsing recombinant human interferon alpha-2b for nasal spray could lead to some influenza-like symptoms, however, all those symptoms were mild , reversible, and relieved after completion of the use of the trial drug. No serious side effects were found during the period of following up. The authors conclude that the drug is safe.

Abdominal Pain ; chemically induced ; Adolescent ; Adult ; Antiviral Agents ; administration & dosage ; adverse effects ; therapeutic use ; Dizziness ; chemically induced ; Female ; Follow-Up Studies ; Headache ; chemically induced ; Humans ; Interferon-alpha ; administration & dosage ; adverse effects ; therapeutic use ; Male ; Recombinant Proteins ; SARS Virus ; drug effects ; Severe Acute Respiratory Syndrome ; prevention & control ; virology ; Treatment Outcome ; Young Adult

OBJECTIVETo evaluate the efficacy and safety of domestically manufactured recombinant human thrombopoietin (rhTPO) in the treatment for chemotherapy-induced thrombocytopenia in patients with solid tumors.

METHODSA non-randomized controlled study was conducted. Seventy-two patients with platelet count < 75 x 10(9)/L after chemotherapy were enrolled into this study according to the standard criteria of NCI-CTC toxicity stratification. Thirty-five patients in the treatment-group received subcutaneous injection of rhTPO at a dose of 15,000 U/d, another 37 patients in the control group received subcutaneous injection of rhIL-11a at a dose of 3 mg/d as the paralleled control.

RESULTSThe mean minimal platelet count after rhTPO treatment was (46.2 +/- 20.3) x 10(9)/L in the treatment-group versus (37.2 +/- 16.7) x 10(9)/L in the control-group (P < 0.05), while the mean maximal platelet count was (250.2 +/- 159.0) x 10(9)/L versus (160.5 +/- 96.4) x 10(9)/L (P < 0.05). The incidence rate of adverse effects and duration of grade III and IV thrombocytopenia in the treatment-group was also significantly lower than those in the control-group. Furthermore, the patients receiving platelet transfusion were 4/35 in the treatment-group versus 11/37 in the control-group (P > 0.05). The side-effect rate in the treatment-group was significantly lower than that in the control-group (11.4% versus 78.4%, P < 0.01).

CONCLUSIONCompared with rhIL-11, administration of rhTPO after chemotherapy is safe and effective with mild adverse effects in reducing the degree and duration of thrombocytopenia.

Adult ; Aged ; Antineoplastic Combined Chemotherapy Protocols ; adverse effects ; therapeutic use ; Breast Neoplasms ; blood ; drug therapy ; Female ; Fever ; chemically induced ; Headache ; chemically induced ; Humans ; Lung Neoplasms ; blood ; drug therapy ; Male ; Middle Aged ; Platelet Count ; Recombinant Proteins ; adverse effects ; therapeutic use ; Thrombocytopenia ; chemically induced ; drug therapy ; Thrombopoietin ; adverse effects ; therapeutic use

To investigate the efficaciousness of recombinant human granulocyte colony-stimulating factor (G-CSF) combined with recombinant human erythropoietin (EPO) in the treatment of patients with myelodysplastic syndrome (MDS), the hematological changes in the blood and bone marrow along with clinical features after treatment with G-CSF and EPO in 15 patients were observed. Patients were subcutaneously injected with G-CSF 300 microg/d for 10 days, then injected with EPO 100 U/(kg x d) for 10 days. The results showed that the obvious improvements in granulocytes of blood were found in 10 patients with MDS, improvements in erythrocytes of blood were observed in 7 patients with MDS. No serious side effects occured is all treated patients. In conclusion, treatment of G-CSF in combination with EPO is effective for patients with MDS.
Adult ; Aged ; Drug Therapy, Combination ; Erythrocyte Count ; Erythropoietin ; administration & dosage ; adverse effects ; therapeutic use ; Female ; Fever ; chemically induced ; Granulocyte Colony-Stimulating Factor ; administration & dosage ; adverse effects ; therapeutic use ; Headache ; chemically induced ; Humans ; Injections, Subcutaneous ; Leukocyte Count ; Male ; Middle Aged ; Myelodysplastic Syndromes ; drug therapy ; pathology ; Recombinant Proteins ; Treatment Outcome