Atorvastatin Calcium ; Eosinophilia ; chemically induced ; Heptanoic Acids ; adverse effects ; Humans ; Male ; Middle Aged ; Pyrroles ; adverse effects

Hexanes ; adverse effects ; Humans ; Occupational Injuries ; chemically induced ; Pyrroles ; adverse effects ; Trauma, Nervous System ; chemically induced

No abstract available.
Antineoplastic Agents/*adverse effects ; Female ; Humans ; Indoles/*adverse effects ; Male ; Proteinuria/*chemically induced ; Pyrroles/*adverse effects ; Renal Insufficiency/*chemically induced

This paper presents a case of reversible dysphasia occurring in a patient prescribed atorvastatin in combination with indapamide. A milder dysphasia recurred with the prescription of rosuvastatin and was documented on clinical examination. This resolved following cessation of rosuvastatin. The case highlights both a need for a wider understanding of potential drug interactions through the CYP 450 system and for an increased awareness, questioning and reporting of drug side-effects.
Anticholesteremic Agents/adverse effects/*therapeutic use ; Antihypertensive Agents/therapeutic use ; Anxiety/diagnosis ; Aphasia/diagnosis/*etiology ; Cytochrome P-450 Enzyme System/metabolism ; Depression/diagnosis ; Drug Interactions ; Female ; Fluorobenzenes/adverse effects/*therapeutic use ; Heptanoic Acids/adverse effects/*therapeutic use ; Humans ; Hypercholesterolemia/drug therapy ; Indapamide/therapeutic use ; Middle Aged ; Pyrimidines/adverse effects/*therapeutic use ; Pyrroles/adverse effects/*therapeutic use ; Sulfonamides/adverse effects/*therapeutic use

OBJECTIVETo compare the efficacy and safety of atorvastatin, rosuvastatin and xuezhikang capsule in elderly.

METHODSA total of 314 60-to-94-year-old (average (73.6 ± 7.9) years old) patients who were given different doses and types of statins were divided into three groups: the atorvastatin group (108 patients), the rosuvastatin group (104 patients) and the xuezhikang capsule group (102 patients). The serum TG, TC, LDL-C, HDL-C,ALT and CK were examined before and after the treatment which lasted for at least 4 weeks. All patients were divided into moderate risk group (13, 12 and 21 patients respectively in 3 groups); high risk group (40, 44 and 48 patients respectively in 3 groups) and very high risk group (55, 48 and 33 patients respectively in 3 groups ) according to guidelines on prevention and treatment of dyslipidemia in chinese adults (2007 version). The rate of reaching target goal and the dose when reaching target levels in different risk stratification groups were calculated and compared.

RESULTSSerum TC, LDL-C and non-HDL-C were significantly reduced after the 4-week-treatment in all the three groups (P < 0.01). Serum LDL-C level before and after treatment were (3.14 ± 0.78)mmol/L vs. (2.14 ± 0.65)mmol/L in atorvastatin group (the arevage dose was (16.4 ± 4.8)mg/d), (2.92 ± 0.77)mmol/L vs. (1.96 ± 0.55)mmol/L in rosuvastatin group (the arevage dose was (8.7 ± 3.0) mg/d), and (2.70 ± 0.62)mmol/L vs. (2.16 ± 0.61) mmol/L in xuezhikang capsule group (the arevage dose was (0.9 ± 0.3) g/d ). Among all the three groups of patients, the cases of reaching target levels of LDL-C were 13, 11 and 20 in patients at moderate risk, were 38(95.0%), 38(86.4%) and 40 (83.3%) in patients at high risk, and were 22(40.0%), 30(62.5%) and 17(51.5%) in patients at very high risk. There were no statistical differences in the rate of reaching target levels of LDL-C, non-HDL-C and TC in the three groups and at different risks (P > 0.05). One patient in the atorvastatin group showed ALT level elevation >3 times of the upper limit of normal value, there was no patient with CK level elevation >5 times of the upper limit of normal value.

CONCLUSIONAtorvastatin, rosuvastatin and xuezhikang capsule at low dose and/or standard dose are effective and safety in elderly patients.

Aged ; Aged, 80 and over ; Anticholesteremic Agents ; Atorvastatin Calcium ; Cholesterol, LDL ; Dose-Response Relationship, Drug ; Dyslipidemias ; drug therapy ; Female ; Fluorobenzenes ; adverse effects ; therapeutic use ; Heptanoic Acids ; adverse effects ; therapeutic use ; Humans ; Hydroxymethylglutaryl-CoA Reductase Inhibitors ; adverse effects ; therapeutic use ; Male ; Middle Aged ; Pyrimidines ; adverse effects ; therapeutic use ; Pyrroles ; adverse effects ; therapeutic use ; Rosuvastatin Calcium ; Sulfonamides ; adverse effects ; therapeutic use

OBJECTIVETo evaluate the efficacy of atorvastatin in preventing contrast agent-induced nephropathy (CIN) in patients undergoing coronary angiography and explore the mechanism.

METHODSA total of 180 patients undergoing coronary angiography or percutaneous coronary interventions (PCI) were randomized into regular dose and high dose atorvastatin groups (n=90). Serum creatinine (Scr), glomerular filtration rate (GFR), cystatin, peripheral blood levels of myeloperoxidase (MPO), malondialdehyde (MDA), and superoxide dismutase (SOD) before and after the procedure were compared between the two groups.

RESULTSThe incidence of CIN was significantly lower in high-dose atorvastatin group than in the regular dose group. At 48-72 h after the surgery, serum Scr and cystatin levels were significantly lower and eGFR was significantly higher in the high-dose group. At 24 h after the surgery, MPO and MDA levels were significantly lower, and SOD activity was significantly higher in high-dose group than in the regular dose group.

CONCLUSIONHigh-dose atorvastatin used before angiography is more effective than the regular dose in attenuating contrast agent-induced renal dysfunction, and its mechanism is related with the inhibition of oxidative stress.

Aged ; Atorvastatin Calcium ; Contrast Media ; adverse effects ; Coronary Angiography ; adverse effects ; Female ; Heptanoic Acids ; administration & dosage ; pharmacology ; therapeutic use ; Humans ; Kidney Diseases ; chemically induced ; prevention & control ; Male ; Middle Aged ; Oxidative Stress ; drug effects ; Pyrroles ; administration & dosage ; pharmacology ; therapeutic use

BACKGROUNDFamitinib is a novel and potent multitargeting receptor tyrosine kinase inhibitor. The phase I clinical study showed that famitinib was well tolerated and had a broad anti-tumor spectrum. The purpose of this study was to examine the efficacy and safety of famitinib for the treatment of metastatic renal cell carcinoma (mRCC).

METHODSThe data of famitinib in treating patients with mRCC from the single-center phases I and II clinical trials were analyzed. Famitinib was administered orally at the dose of 13-30 mg once daily until tumor progression, occurrence of intolerable adverse reactions or withdrawal of the informed consent.

RESULTSA total of 24 patients with mRCC were treated including 17 patients at a dose of 25 mg once daily, 4 patients at a dose of 27 mg and 1 patient each at a dose of 13 mg, 20 mg and 30 mg, respectively. Twelve (50.0%) patients achieved partial response (PR) and 9 patients achieved stable disease (SD). Progressive disease was found in 3 (12.5%) patients. The disease control rate was 87.5%. The median follow-up time was 17.6 months; the median progression free survival (PFS) was 10.7 (95% CI 7.0-14.4) months; and the estimated median overall survival (OS) time was 33.0 (95% CI 8.7-57.3) months. The adverse drug reactions mainly included hypertension (54.1%), hand-foot skin reactions (45.8%), diarrhea (33.3%), mucositis (29.2%), neutropenia (45.8%), thrombocytopenia (29.2%), hyperlipidemia (41.7%) and proteinuria (41.7%). The incidence rate of grades 3 and 4 adverse events was low, mainly including hypertension 12.5%, hand-foot skin reactions 4.2%, neutropenia 4.2%, thrombocytopenia 4.2%, hyperlipidemia 4.2% and proteinuria 12.5%.

CONCLUSIONSFamitinib has significant anti-tumor activity in mRCC. The common adverse reactions are generally manageable.

Adult ; Aged ; Carcinoma, Renal Cell ; drug therapy ; Female ; Humans ; Indoles ; adverse effects ; therapeutic use ; Kidney Neoplasms ; drug therapy ; Male ; Protein Kinase Inhibitors ; Pyrroles ; adverse effects ; therapeutic use ; Retrospective Studies ; Treatment Outcome ; Young Adult

Background: Tofacitinib is an oral Janus kinase inhibitor for the treatment of rheumatoid arthritis (RA). This study assessed the efficacy and safety of tofacitinib in Chinese patients with RA enrolled in Phase 3 and long-term extension (LTE) studies. Methods: ORAL Sync was a 1-year, randomized, placebo-controlled, Phase 3 trial. Patients received tofacitinib 5 or 10 mg twice daily (BID) or placebo advanced to tofacitinib 5 or 10 mg BID at 3 or 6 months. All patients remained on ≥1 background conventional synthetic disease-modifying antirheumatic drug. ORAL Sequel is an open-label LTE study (data-cut: March 2015; data collection and analyses were ongoing, and study database was not locked at the time of analysis; study was closed in 2017). Efficacy outcomes: American College of Rheumatology (ACR) 20/50/70 response rates and Disease Activity Score in 28 joints using erythrocyte sedimentation rate (DAS28-4 [ESR]). Patient- and physician-reported outcomes: Health Assessment Questionnaire-Disability Index (HAQ-DI), Patient and Physician Global Assessment of Arthritis, and pain (visual analog scale). Safety was assessed throughout. Results: ORAL Sync included 218 patients; 192 were subsequently enrolled into ORAL Sequel. In ORAL Sync, more patients achieved ACR20 (tofacitinib 5 mg BID, 67.4%; 10 mg BID, 70.6%; placebo, 34.1%) and DAS28-4 (ESR) <2.6 (tofacitinib 5 mg BID, 7.1%; 10 mg BID, 13.1%; placebo, 2.3%) with tofacitinib versus placebo at Month 6. Mean changes from baseline in HAQ-DI were greater with tofacitinib versus placebo at Month 6. In ORAL Sequel, efficacy was consistent to Month 48. Incidence rates for adverse events of special interest in tofacitinib-treated patients were similar to the global population. Conclusions: Tofacitinib significantly reduced signs/symptoms and improved physical function and quality of life in Chinese patients with moderate-to-severely active RA up to Month 48. The safety profile was consistent with the global population. Clinical Trial Identifier NCT00856544 and NCT00413699.
Administration, Oral ; Adult ; Aged ; Arthritis, Rheumatoid ; drug therapy ; Asian Continental Ancestry Group ; Female ; Humans ; Male ; Middle Aged ; Piperidines ; adverse effects ; therapeutic use ; Protein Kinase Inhibitors ; adverse effects ; therapeutic use ; Pyrimidines ; adverse effects ; therapeutic use ; Pyrroles ; adverse effects ; therapeutic use ; Surveys and Questionnaires ; Young Adult

BACKGROUND/AIMS: The aim of this study was to assess the efficacy and safety of tofacitinib (5 and 10 mg twice daily) in patients with active rheumatoid arthritis (RA). METHODS: A systematic review of randomized controlled trials (RCTs) that examined the efficacy and safety of tofacitinib in patients with active RA was performed using the Medline, Embase, and Cochrane Controlled Trials Register databases as well as manual searches. RESULTS: Five RCTs, including three phase-II and two phase-III trials involving 1,590 patients, met the inclusion criteria. The three phase-II RCTs included 452 patients with RA (144 patients randomized to 5 mg of tofacitinib twice daily, 156 patients randomized to 10 mg of tofacitinib twice daily, and 152 patients randomized to placebo) who were included in this meta-analysis. The American College of Rheumatology 20% response rate was significantly higher in the tofacitinib 5- and 10-mg groups than in the control group (relative risk [RR], 2.445; 95% confidence interval [CI], 1.229 to 4.861; p = 0.011; and RR, 2.597; 95% CI, 1.514 to 4.455; p = 0.001, respectively). The safety outcomes did not differ between the tofacitinib 5- and 10-mg groups and placebo groups with the exception of infection in the tofacitinib 10-mg group (RR, 2.133; 95% CI, 1.268 to 3.590; p = 0.004). The results of two phase-III trials (1,123 patients) confirmed the findings in the phase-II studies. CONCLUSIONS: Tofacitinib at dosages of 5 and 10 mg twice daily was found to be effective in patients with active RA that inadequately responded to methotrexate or disease-modifying antirheumatic drugs, and showed a manageable safety profile.
Antirheumatic Agents/administration & dosage/adverse effects/*therapeutic use ; Arthritis, Rheumatoid/*drug therapy ; Clinical Trials, Phase II as Topic ; Clinical Trials, Phase III as Topic ; Humans ; Janus Kinases/antagonists & inhibitors ; Methotrexate/therapeutic use ; Piperidines/administration & dosage/adverse effects/*therapeutic use ; Protein Kinase Inhibitors/administration & dosage/adverse effects/therapeutic use ; Pyrimidines/administration & dosage/adverse effects/*therapeutic use ; Pyrroles/administration & dosage/adverse effects/*therapeutic use ; Randomized Controlled Trials as Topic ; Treatment Outcome

Sunitinib as a multitarget tyrosine kinase inhibitor is one of the anti-tumor agents, approved by the United States Food and Drug Administration to use treat gastrointestinal stromal tumor and metastatic renal cell carcinoma. The agent is known to commonly induce adverse reactions such as fatigue, nausea, diarrhea, stomatitis, esophagitis, hypertension, skin toxicity, reduciton in cardiac output of left ventricle, and hypothyroidism. However, it has been reported to rarely induce adverse reactions such as nephrotic syndrome and irreversible reduction in renal functions, and cases of intestinal perforation or pneumatosis interstinalis as such reactions have been consistently reported. In this report, a 66-year old man showing abdominal pain had renal cell carcinoma and history of sunitinib at a dosage of 50 mg/day on a 4-weeks-on, 2-weeks-off schedule. Seven days after the third cycle he was referred to the hospital because of abdominal pain. Computed tomography showed pneumoperitoneum with linear pneumatosis intestinalis in his small bowel. The patient underwent surgical exploration that confirmed the pneumatosis intestinalis at 100 cm distal to Treitz's ligament. We report a rare case of intestinal perforation with pneumatosis intestinalis after administration of sunitinib to a patient with metastatic renal cell carcinoma.
Aged ; Antineoplastic Agents/adverse effects/*therapeutic use ; Carcinoma, Renal Cell/*drug therapy ; Drug Administration Schedule ; Humans ; Indoles/adverse effects/*therapeutic use ; Intestinal Perforation/*diagnosis/etiology/surgery ; Kidney Neoplasms/*drug therapy ; Lung/radiography ; Male ; Pneumatosis Cystoides Intestinalis/*diagnosis/etiology ; Positron-Emission Tomography ; Pyrroles/adverse effects/*therapeutic use ; Tomography, X-Ray Computed