Vigilance urged for women on CVD drugs

Women starting cardiovascular disease medication need closer monitoring than men, experts say

Women starting cardiovascular disease medication need closer monitoring than men as they are at greater risk of side-effects, particularly severe side-effects, experts say.

In their recent position statement, the European Society of Cardiology called on researchers to recognise the pharmacokinetic and pharmacodynamic differences between genders, and develop sex-specific drug doses.

“Cardiovascular drug recommendations are based on clinical trials in middle-aged men,” Spanish cardiologist and lead author Dr Juan Tamargo said.

“Women have more adverse reactions from current dosages and may stop taking preventive medication, leaving them unprotected despite their higher risk.”

The report follows previous research that suggests that cardiovascular disease in women is often under-recognised and undertreated.

Cardiologist Professor Leonard Arnolda, from Wollongong Hospital, said the lack of evidence specific to women meant that the benefit-to-risk ratio on which decisions were based was out of kilter.

Differences in metabolism of cardiovascular drugs may vary more than 40% between the sexes. And women have a risk of adverse events 1.5 to 1.7 times higher than men.

In particular, women were more likely than men to develop torsades de pointes, hepatoxicity, skin disorders, and bleeding complications when taking anticoagulants, platelet antiaggregants or thrombolytics.

Also, women taking diuretics were at an increased risk of electrolyte abnormalities, and cough and a creatine rise was more like among women taking ACE inhibitors compared to their male counterparts.

Clinicians should also be aware that older women with low body weight are at greater risk of statin-induced myopathy, the authors wrote.

They pointed out that eight in 10 drugs withdrawn from the US market between 1997 and 2000 had greater health risks to women compared with men.

Dr Tamargo said that women had more adverse reactions because many drugs were given to people at the same dose, regardless of body weight and gender.

Differences in pharmacokinetics may be the result of differences in body composition, drug absorption, plasma and tissue distribution, metabolising enzymes and transporters, and drug excretion.

“In the end, we’re left with a lot of uncertainty,” Professor Arnolda said, adding that the most important thing for clinicians to do was be aware that this was a risk.

“In practice, it is very hard to change the dosage, because we don’t have the information [from clinical trials] yet,” he said.

The report authors concluded: “A better understanding of these sex-related differences is fundamental to improve the safety and efficacy of cardiovascular drugs and for developing proper individual cardiovascular therapeutic strategies both in men and women.”

EHJ-CVP 2017; 3, 163–182