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blog.joliesiam.com
June 25, 2014

The FDA has announced that it has completed its safety review of olmesartan medoxomil and has found no clear evidence of increased cardiovascular risks associated with the use of the drug in patients with diabetes . Olmesartan medoxomil, an angiotensin II receptor blocker, is indicated for the treatment of hypertension and is found in the following brand products: Benicar , Puma Womens Basket Ostrich Sneakers N3ptt0FT
, , and Tribenzor .

The safety review was prompted by the results of the Randomized Olmesartan and Diabetes Microalbuminuria Prevention (ROADMAP) clinical trial, which evaluated the effects of olmesartan medoxomil in delaying kidney damage for patients with type 2 diabetes. An increased risk of cardiovascular mortality was found in the olmesartan group compared to placebo but the risk of non-fatal heart attack was lower in patients treated with olmesartan medoxomil compared to placebo. After reviewing additional studies that included a large study of Medicare patients, the FDA was unable to find clear evidence of increased cardiovascular risk in diabetic patients taking olmesartan medoxomil.

RELATED: FDA Reviews Cardiovascular Mortality Risk Associated with Benicar

While recommendations for olmesartan medoxomil use in patients with diabetes will remain the same for now, the FDA will require information about some of the studies to be included in the drug labels. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program .

For more information visit FDA.gov

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June 28, 2018
No interactions seen for any outcome; log-additive effect on risk of developing cardiovascular disease.

HealthDay News — Genetic risk and lifestyle are independent predictors of incident cardiovascular disease and diabetes, according to a study published online June 27 in JAMA Cardiology .

M. Abdullah Said, from the University of Groningen in the Netherlands, and colleagues examined the correlation of combined health behaviors and factors within genetic risk groups with coronary artery disease, atrial fibrillation, stroke, hypertension, and type 2 diabetes. A total of 339,003 unrelated individuals of white British descent with available genotype and matching genetic data from the UK Biobank cohort study were included in this study. Genetic risk was categorized as low, intermediate, or high; within each group, the risks of incident events associated with ideal, intermediate, or poor combined health behaviors and factors were assessed.

The figure below shows the –time profiles of sildenafil after administration of 50 mg of the drug in the form of slow IV infusion and oral tablet. Determine the absolute bioavailability of the tablets. Determine the Cl from the IV data. Studies with radiolabeled sildenafil have shown that 92% of the drug is absorbed, although much less intact drug is detected in plasma. Can you explain this difference?

The figure below shows the –time profiles of sildenafil after administration of 100 mg of the drug to fasted and fed volunteers. Describe the food effect on the oral bioavailability of sildenafil .

Christopher F. Barnett MD, MPH, Teresa De Marco MD, in Murray and Nadel's Textbook of Respiratory Medicine (Sixth Edition) , 2016

Phosphodiesterase Type 5 Antagonists.

Sildenafil and tadalafil are selective inhibitors of cyclic guanosine monophosphate–specific phosphodiesterase type 5 and cause pulmonary arteriolar smooth muscle cell relaxation and vasodilation. Additionally, sildenafil has antifibrotic activity that has been tested in patients with lung disease.

The acute effects of sildenafil on hemodynamics and oxygenation were studied at rest and with exercise in 20 patients with COPD and mild PH after a single dose of 20 mg or 40 mg of sildenafil . There was a significant 21% reduction in resting 1 hour after sildenafil that was accompanied by worsening gas exchange with a reduction in arterial P o of 9%. A similar reduction in was seen during exercise with no significant change in oxygenation; concomitant studies showed that worsening hypoxemia was related to worsening of ventilation-perfusion matching after sildenafil .

Three studies have attempted to address the effects of sildenafil on exercise tolerance in patients with COPD. In the first, sildenafil was administered to 15 COPD patients for 3 months; compared to baseline, there was no difference in the right ventricular stroke volume measured by MRI or in exercise tolerance measured by cardiopulmonary exercise testing and the 6MWD. The effects of sildenafil on exercise capacity were studied in 10 patients in a randomized double-blind placebo-controlled crossover study. Patients with PH were specifically excluded from this study. After 14 days of sildenafil treatment, there was no difference in exercise capacity, but there was worsening of oxygenation and quality of life with increasing symptoms and adverse events in the sildenafil group. Another study randomized 63 patients with COPD and moderate PH documented by echocardiography to treatment with sildenafil for 3 months during pulmonary rehabilitation; in this study sildenafil had no effect on exercise capacity or oxygenation.

The acute effects of sildenafil have also been evaluated in patients with interstitial lung disease. Sixteen hospitalized patients with pulmonary fibrosis were treated with inhaled NO and then randomized to receive open-label intravenous epoprostenol (mean dose 8 ng/kg/min) or a single dose of oral sildenafil 50 mg. All three agents reduced the PVR index to a similar extent. However, only inhaled NO and sildenafil reduced the PVR-to-SVR ratio. Intravenous epoprostenol also decreased mean systemic arterial pressure and P o values, owing to ventilation-perfusion mismatching. By contrast, during treatment with inhaled NO and sildenafil , ventilation-perfusion matching was maintained. Therefore, among patients in this study, sildenafil exerted a selective pulmonary arterial vasodilatory effect without worsening hypoxemia.

The effects of sildenafil on exercise tolerance in patients with PH-IPF were examined in two studies. In one small open-label study 14 patients with IPF and mild PH received sildenafil 20 to 50 mg three times daily for 12 weeks. At the end of the study, of the 11 patients who completed the 6MWD, 9 demonstrated an improvement in the mean 6MWD of 49 m (90% confidence interval, 17.5 to 84 m). The largest study of sildenafil in patients with IPF to date was STEP-IPF ( Sildenafil Trial of Exercise Performance in Idiopathic Pulmonary Fibrosis). In this study, patients with IPF were randomized to either sildenafil ( = 89) or placebo ( = 91) for 12 weeks of treatment without any assessment for the presence or severity of PH. The primary end point of improvement in 6MWD was not met; however, patients taking sildenafil had improved dyspnea, quality of life, and less deterioration in oxygenation.

Overall, the results of these studies are highly variable but suggest that in certain patients with lung disease sildenafil might confer some early hemodynamic and symptomatic improvement, potentially at the expense of worsening ventilation-perfusion matching and worsening oxygenation and without any clear long-term benefits. Further well-designed studies are needed to determine if there is a role for these agents in PH-LD.

Avinash C. Shukla, ... Francis X. McGowan, in Freestyle Hi Satin Bow Reebok Lifestyle SpExNogNw
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