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Abstract

Objective

To assess the efficacy of oral administration of sildenafil citrate and sildenafil citrate + tadalafil in treatment of pulmonary hypertension.

Design

In this retrospective study, we compared the efficacy of sildenafil citrate and sildenafil citrate + tadalafil in the treatment of pulmonary hypertension in patients with no contraindication. Patients aged 40 to 70 years with mild-to-moderate and no contraindication for pulmonary hypertension who met the following criteria were randomly assigned to one of two groups: sildenafil citrate group and tadalafil group.

Patients were followed up for a median of 10 years for the first assessment of pulmonary hypertension, and for the second assessment of pulmonary hypertension. The primary end point was the efficacy of sildenafil citrate treatment. All patients completed the study.

Result

A total of 26 patients with pulmonary hypertension were enrolled in the study, of which two patients met the study criteria, while the remaining four patients met criteria for another study. Patients in the sildenafil citrate group were more likely to have received an inadequate response to sildenafil (26.3%) compared to the tadalafil group (15.7%). In the sildenafil citrate group, more patients in the sildenafil citrate + tadalafil group had an inadequate response to sildenafil (25.4%) compared to the placebo group (13.6%). The most common adverse events were diarrhea, asthenia, headache, myalgia, dyspepsia, and back pain. In the tadalafil group, the most common adverse events were diarrhea, headache, asthenia, myalgia, dyspepsia, and back pain. A total of 6 patients in the sildenafil citrate group and 7 patients in the tadalafil group had no contraindication for pulmonary hypertension.

The safety of the sildenafil citrate group was assessed by a single-blind study, and the sildenafil citrate + tadalafil group was compared with the placebo group. In the sildenafil citrate group, the rates of adverse events were similar to the sildenafil citrate + tadalafil group. The rates of adverse events in the tadalafil group were similar to the sildenafil citrate group. No significant differences were noted between the two groups, which was attributed to a small number of patients in the sildenafil citrate group.

Conclusions

The efficacy of oral administration of sildenafil citrate and tadalafil was similar to that of sildenafil citrate + tadalafil in the treatment of pulmonary hypertension.

This study aimed to assess the efficacy of oral administration of sildenafil citrate and sildenafil citrate + tadalafil in the treatment of pulmonary hypertension in patients with no contraindication for pulmonary hypertension.

Introduction

The safety and efficacy of sildenafil citrate and sildenafil citrate + tadalafil in pulmonary hypertension were assessed in a clinical trial. Sildenafil citrate, the active ingredient in Viagra, is the first-choice agent for the treatment of pulmonary hypertension []. It has been well-established that it has anti-tachycardia, anti-inflammation, and vasodilation effects in different tissues, and a strong effect in skeletal muscle [].

The mechanism of action of sildenafil citrate is vasodilation in the pulmonary vasculature. It increases blood flow into the lungs, which reduces pulmonary vascular resistance and oxygen consumption. However, sildenafil citrate + tadalafil may also enhance the effect of vasodilation. The combination of sildenafil citrate and tadalafil is a newer alternative to sildenafil citrate [].

Sildenafil citrate is a vasodilator. The action of sildenafil citrate is a result of the inhibition of the alpha1 and alpha2 adrenoceptor. The inhibition of the alpha1 adrenoceptors may inhibit vasoconstriction and dilate the blood vessels in pulmonary arterial hypertension, and may also promote vasodilation in other organs, such as in the heart, lungs, and brain [, ].

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The Food and Drug Administration on Tuesday cleared a major health measure that would save millions of dollars in annual sales of erectile dysfunction medications that have been on the market for years.

The move by the Food and Drug Administration gives consumers more options for buying the drugs they need, said Tom Brozkowitz, director of the agency’s Center for Drug Evaluation and Research.

Viagra, Cialis, Levitra and Staxyn all carry a similar warning on their labels — “may interact with nitrate drugs.”

“It’s a serious interaction,” Brozkowitz said. “It could lead to serious health complications for patients and potentially other health care providers.”

The FDA said that its review of the drug’s safety and efficacy found no evidence that Viagra had a significant impact on heart disease or that the drugs were unsafe. But in the case of Cialis, the FDA also concluded that the drug had a “significantly increased risk of serious heart-related side effects, including hypotension, syncope, heart failure, and sudden death.”

The FDA has also said that it believes that the Viagra label has been altered to reflect that Viagra carries a warning on its labels.

“This action is a significant step toward ensuring that our patients have access to safe and effective treatments,” Dr. David Graham, a cardiologist at Mount Sinai School of Medicine in New York, told Fox News.

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Healthcare officials did not immediately return a message seeking comment from The Associated Press.

The Food and Drug Administration on Tuesday cleared a major health measure that would save millions of dollars in annual sales of erectile dysfunction medications that have been on the market for years

The FDA has said that its review of the drug’s safety and efficacy found no evidence that Viagra had a significant impact on heart disease or that the drugs were unsafe.

The FDA has also said that its review of the drug’s safety and efficacy found no evidence that Viagra had a significant impact on heart disease or that the drugs were unsafe.

But in the case of Cialis, the FDA also concluded that the drug had a “significantly increased risk of serious heart-related side effects, including hypotension, syncope, heart failure, and sudden death.