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Dyspepsia in Medical Technology

AstraZeneca Submits sNDAs for SEROQUEL XR(TM) for the Treatment of Bipolar Mania and Bipolar Depression

... vs 5%-7%), constipation (8%- 10% vs 3%-4%), SGPT increase (5% vs 1%), dyspepsia (5%-7% vs 1%-4%), lethargy (5% vs 2%), and weight gain (5% vs 1%). The ... for schizophrenia were dry mouth (12% vs 1%), constipation (6% vs 5%), dyspepsia (5% vs 2%), sedation (13% vs 7%), somnolence (12% vs 4%), dizziness (10% ...

SEROQUEL XR(TM) Receives Approval From FDA for Maintenance Treatment of Schizophrenia

... vs 5%-7%), constipation (8%- 10% vs 3%-4%), SGPT increase (5% vs 1%), dyspepsia (5%-7% vs 1%-4%), lethargy (5% vs 2%), and weight gain (5% vs 1%). The ... for schizophrenia were dry mouth (12% vs 1%), constipation (6% vs 5%), dyspepsia (5% vs 2%), sedation (13% vs 7%), somnolence (12% vs 4%), dizziness (10% ...

Study Results Present Efficacy and Safety Findings from the PHIRST-1 Study of Patients with Pulmonary Arterial Hypertension Taking Tadalafil Tablets Once Daily

... in the PHIRST-1 clinical trial were headache, myalgia, nasopharyngitis, flushing, respiratory tract infection, extremity pain, nausea, back pain, dyspepsia and nasal congestion. In rare instances, patients taking PDE5 inhibitors (including tadalafil) reported a sudden decrease or loss of vision or ...

Study Demonstrating Lurasidone Is Effective in Patients With Schizophrenia Published in The Journal of Clinical Psychiatry

... subjects) for lurasidone versus placebo were nausea (16% vs. 3%), headache (11.1% vs. 10%), constipation (11.1% vs. 5.6%), vomiting (11.1% vs. 5.6%), dyspepsia (11.1% vs. 3.3%), somnolence (11.1% vs. 3.3%), insomnia (10.0% vs. 3.3%) and sedation (10.0% vs. 4.4%). Lurasidone had a lower overall ...

FDA Approves ADCIRCA(TM) (Tadalafil) Tablets for the Treatment of Pulmonary Arterial Hypertension

... in the PHIRST-1 clinical trial were headache, myalgia, nasopharyngitis, flushing, respiratory tract infection, extremity pain, nausea, back pain, dyspepsia and nasal congestion. In rare instances, patients taking PDE5 inhibitors (including tadalafil) reported a sudden decrease or loss of vision or ...

Results of Two Phase 3 CAPACITY Studies of Pirfenidone in IPF Presented at American Thoracic Society (ATS)

... 2 and 38% vs. 16% in CAPACITY 1), rash (31% vs. 10% and 34% vs. 13%), fatigue (28% vs. 21% and 33% vs. 20%), diarrhea (25% vs. 17% and 33% vs. 21%), dyspepsia (17% vs. 9% and 21% vs. 6%), and dizziness (19% vs. 10% and 18% vs. 10%). Rash was generally mild to moderate in both studies; only 2 patients (1 in ...

Study Reported Tadalafil Taken Once Daily Improved Erectile Function in Men with ED and Sexual Quality of Life in Couples

... with 5 points in the placebo group. Tadalafil 5 mg was generally well-tolerated, and the most frequently reported adverse events were headache, dyspepsia and nasal congestion. Three subjects in the tadalafil group discontinued their participation in the study due to adverse events. About Cialis ...

Continued Overall Survival Advantage Reported From Pivotal Trial of VELCADE(R) (Bortezomib) for Injection Based Therapy in Patients With Previously Untreated Multiple Myeloma

... (13% vs 4%), bronchitis (13% vs 8%), hypokalemia (13% vs 7%), hypertension (13% vs 7%), abdominal pain upper (12% vs 9%), hypotension (12% vs 3%), dyspepsia (11% vs 7%), nasopharyngitis (11% vs 8%), bone pain (11% vs 10%), arthralgia (11% vs 15%) and pruritus (10% vs 5%). About Millennium ...

Prolonged Progression-Free Survival Demonstrated by VELCADE(R) (Bortezomib) for Injection Based Induction Regimens in Transplant-Eligible Previously Untreated Multiple Myeloma Patients

... (13% vs 4%), bronchitis (13% vs 8%), hypokalemia (13% vs 7%), hypertension (13% vs 7%), abdominal pain upper (12% vs 9%), hypotension (12% vs 3%), dyspepsia (11% vs 7%), nasopharyngitis (11% vs 8%), bone pain (11% vs 10%), arthralgia (11% vs 15%) and pruritus (10% vs 5%). About Millennium ...

Long-term Follow Up Interim Data Show Nplate(TM) Increased and Sustained Platelet Counts in Adult Chronic ITP Patients

... (14 percent, 2 percent), Pain in Extremity (13 percent, 5 percent) , Abdominal Pain (11 percent, 0 percent), Shoulder Pain (8 percent, 0 percent), dyspepsia (7 percent, 0 percent), and Paresthesia (6 percent, 0 percent). -- As with all therapeutic proteins, patients may develop antibodies to the ...

Novel VELCADE(R) (Bortezomib) for Injection Based Four-Drug Combination Was Well Tolerated In Previously Untreated Multiple Myeloma Patients

... (13% vs 4%), bronchitis (13% vs 8%), hypokalemia (13% vs 7%), hypertension (13% vs 7%), abdominal pain upper (12% vs 9%), hypotension (12% vs 3%), dyspepsia (11% vs 7%), nasopharyngitis (11% vs 8%), bone pain (11% vs 10%), arthralgia (11% vs 15%) and pruritus (10% vs 5%). About Millennium ...

Long-Term Study Evaluates Boosted PREZISTA(R) Vs. Lopinavir/Ritonavir as Part of HIV Combination Therapy in Treatment-Naive Adults

... abdominal pain (5 percent), rash (6 percent), vomiting (4 percent), asthenia (3 percent), headache (2 percent), abdominal distension (2 percent), and dyspepsia (2 percent). This is not a complete list of all adverse drug reactions reported with the use of PREZISTA/r. Please see full Prescribing ...

Consensus Document Outlines Practical Steps for Reducing Gastrointestinal Risks of Antiplatelet and NSAID Use

... age, previous history of ulcers or bleeding, presence of H. pylori (a common bacteria that contributes to the development of stomach ulcers), dyspepsia or GERD (gastroesophageal reflux disease or "acid reflux") symptoms, as well as the simultaneous use of NSAIDs, anticoagulants and/or ....

New England Journal of Medicine Publishes Phase III Results of VELCADE(R) (Bortezomib) for Injection in Previously Untreated Multiple Myeloma Patients

... (13% vs 4%), bronchitis (13% vs 8%), hypokalemia (13% vs 7%), hypertension (13% vs 7%), abdominal pain upper (12% vs 9%), hypotension (12% vs 3%), dyspepsia (11% vs 7%), nasopharyngitis (11% vs 8%), bone pain (11% vs 10%), arthralgia (11% vs 15%) and pruritus (10% vs 5%). Important Safety Information ...

New Discovery of Key Difference in Bile Acid Metabolism in Patients with Type 2 Diabetes May Suggest Underlying Disorder

... of patients -- and more commonly with Welchol than placebo -- regardless of investigator assessment of causality were constipation (11.0% vs. 7.0%), dyspepsia (8.3% vs. 3.5%), nausea (4.2% vs. 3.9%), accidental injury (3.7% vs. 2.7%), asthenia (3.6% vs. 1.9%), pharyngitis (3.2% vs. 1.9%), flu syndrome (3.2% ...

Welchol(TM) Lowered A1C by a Mean 1 Percent or Greater When Added to Metformin-, Insulin-, or Sulfonylurea-Based Therapy in 47 Percent of Patients Evaluated

... of patients - and more commonly with Welchol than placebo -- regardless of investigator assessment of causality were constipation (11.0% vs. 7.0%), dyspepsia (8.3% vs. 3.5%), nausea (4.2% vs. 3.9%), accidental injury (3.7% vs. 2.7%), asthenia (3.6% vs. 1.9%), pharyngitis (3.2% vs. 1.9%), flu syndrome (3.2% ...

AstraZeneca Submits sNDA for SEROQUEL XR(TM) for the Treatment of Generalized Anxiety Disorder - a First for the Atypical Antipsychotic Class of Medicines

... associated with the use of SEROQUEL XR versus placebo in clinical trials for schizophrenia were dry mouth (12% vs 1%), constipation (6% vs 5%), dyspepsia (5% vs 2%), sedation (13% vs 7%), somnolence (12% vs 4%), dizziness (10% vs 4%), and orthostatic hypotension (7% vs 5%). In long-term clinical ...

New Data on SEROQUEL XR(TM) in Treatment of Both Major Depressive Disorder and Generalized Anxiety Disorder Presented at APA Annual Meeting

... associated with the use of SEROQUEL XR versus placebo in clinical trials for schizophrenia were dry mouth (12% vs 1%), constipation (6% vs 5%), dyspepsia (5% vs 2%), sedation (13% vs 7%), somnolence (12% vs 4%), dizziness (10% vs 4%), and orthostatic hypotension (7% vs 5%). In long-term clinical ...

Pharmasset Presents Results of 4-Week Combination Study of R7128 for the Treatment of Chronic Hepatitis C

... 4-week treatment period, were headache, injection site reaction, myalgia, fatigue, chills, rash, nausea, diarrhea, arthralgia, pyrexia, dizziness, dyspepsia and pruritis. The frequency and severity of these adverse events, as well as any general body system observations, were generally similar to ...

Photo: Welchol(TM) (colesevelam HCl) Receives FDA Approval to Reduce Blood Glucose in Adults with Type 2 Diabetes

... of patients -- and more commonly with Welchol than placebo -- regardless of investigator assessment of causality were constipation (11.0% vs. 7.0%), dyspepsia (8.3% vs. 3.5%), nausea (4.2% vs. 3.9%), accidental injury (3.7% vs. 2.7%), asthenia (3.6% vs. 1.9%), pharyngitis (3.2% vs. 1.9%), flu syndrome (3.2% ...

New Study Shows Once-Monthly Boniva(R) is as Clinically Effective as Once-Weekly Fosamax(R) at Increasing Bone Mineral Density in Postmenopausal Women With Osteoporosis

... with once-monthly Boniva regardless of causality were abdominal pain (Boniva 150 mg 7.8% vs. Boniva 2.5 mg 5.3%), hypertension (6.3% vs. 7.3%), dyspepsia (5.6% vs. 7.1%), arthralgia (5.6% vs. 3.5%), nausea (5.1% vs. 4.8%) and diarrhea (5.1% vs. 4.1%). For complete prescribing information for Boniva, ...

New Phase III Data Presented for Once Monthly Dosing Regimen of Risedronate to Treat Postmenopausal Osteoporosis

... regimens were similar. The most commonly reported adverse events regardless of causality were arthralgia (Actonel 75 mg 10.4% vs Actonel 5 mg 9.5%), dyspepsia (9.1% vs 7.3%), and back pain (8.8% vs 10.8%). Please see full prescribing information for Actonel(R) (risedronate sodium tablets) for additional ...

Trexima (Sumatriptan/Naproxen Sodium) Superior Efficacy Data Published in JAMA

... (5 percent in Study 1; 3 percent in Study 2), somnolence (3 percent/4 percent), nausea (3 percent/4 percent) and paresthesia (3 percent/2 percent), dyspepsia (3 percent in Study 2 only), dry mouth (2 percent/2 percent) and chest discomfort (2 percent in Study 1 only.) About Imitrex(R) (sumatriptan ...

Positive Results Prompt US National Cancer Institute to Make Glivec Available to Patients in Post-Surgical GIST Study

... muscle cramps, skin rash, vomiting, diarrhea, abdominal pain, myalgia, arthralgia, hemorrhage, fatigue, headache, joint pain, cough, dizziness, dyspepsia and dyspnea, dermatitis, eczema, fluid retention, as well as neutropenia, thrombocytopenia and anemia. Glivec was generally well-tolerated in all of ...

Alterations in Intestinal Serotonin in Irritable Bowel Syndrome and Dyspepsia

... were obtained from the stomach and intestines of each patient and serotonin levels were measured. Researchers found that patients with dyspepsia had low levels of a serotonin reuptake transporter in their stomachs and high levels of a molecule that synthesizes serotonin in the small intestine. ...

Six-Week Investigational Study In Adults With Major Depressive Disorder Evaluates The Effectiveness of Adjunctive Aripiprazole Therapy With Antidepressants

... (20% vs 17%), insomnia (19% vs 14%), nausea (16% vs 12%), vomiting (12% vs 6%), dizziness (11% vs 8%), constipation (11% vs 7%), dyspepsia (10% vs 8%), and akathisia (10% vs 4%). Aripiprazole Injection In short-term (24 hour) trials, the following were reported ...

New Study Analyses Confirm Once-Daily Seroquel XR Extended-Release Tablets as Effective Treatment for Schizophrenia

... vs 3-13%), sedation (30% vs 8%), somnolence (18-28% vs 7-8%), dizziness (11-18% vs 5-7%), constipation (8-10% vs 3-4%), SGPT increase (5% vs 1%), dyspepsia (5-7% vs 1-4%), lethargy (5% vs 2%), and weight gain (5% vs 1%). The most commonly observed adverse events associated with the use of SEROQUEL versus ...

Investigational Study Evaluates the Effectiveness of Aripiprazole in Adolescents With Schizophrenia

... anxiety (20% vs 17%), insomnia (19% vs 14%), nausea (16% vs 12%), vomiting (12% vs 6%), dizziness (11% vs 8%), constipation (11% vs 7%), dyspepsia (10% vs 8%), and akathisia (10% vs 4%). Aripiprazole Injection In short-term (24 hour) trials, the following were reported at an ...

Caelyx Delays Time to Disease Progression as Maintenance Therapy in Patients with Metastatic Breast Cancer

... fever, pain, mucous membrane disorder, back pain, infection, headache, nausea, stomatitis (mouth sores), vomiting, constipation, diarrhea, anorexia, dyspepsia (indigestion), intestinal obstruction, peripheral edema (foot, leg, and/or ankle swelling), paresthesia (sensation of tingling, pricking, or numbness ...

Dynogen Reports Positive Results in Phase 1B GERD Study

... the United States. Persistent heartburn is the most common symptom of GERD, but patients may also experience acid regurgitation into the esophagus, dyspepsia (stomach pain) and dysphagia (difficulty swallowing). GERD affects all age groups, although the incidence increases markedly after the age of 40. If ...

Dynogen's DDP733 Reduces Reflux in Phase 1b GERD Study

... the United States. Persistent heartburn is the most common symptom of GERD, but patients may also experience acid regurgitation into the esophagus, dyspepsia (stomach pain) and dysphagia (difficulty swallowing). GERD affects all age groups, although the incidence increases markedly after the age of 40. ...
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