News | Womens Healthcare | July 07, 2017

Sex-Specific Cardiovascular Drug Dosages Needed to Reduce Adverse Reactions in Women

Position paper notes that current guidelines underestimate or ignore major differences between men and women

Sex-Specific Cardiovascular Drug Dosages Needed to Reduce Adverse Reactions in Women

July 7, 2017 — Sex-specific cardiovascular drug dosages are needed to reduce adverse reactions in women, according to a position paper from the European Society of Cardiology published in the June issue of European Heart Journal - Cardiovascular Pharmacotherapy.

“Cardiovascular diseases kill a greater proportion of women than men in Europe, and they kill twice as many women as all cancers combined,” said lead author Juan Tamargo, M.D., director of the Cardiovascular Pharmacology Research Group, Universidad Complutense, Madrid, Spain.

“Cardiovascular drug recommendations are based on clinical trials in middle-aged men,” continued Tamargo. “Women have more adverse reactions from current dosages and may stop taking preventive medication, leaving them unprotected despite their higher risk.”

The position paper outlines the differences between women and men with respect to cardiovascular medications and gives recommendations on how to improve treatment in women.

Key differences between women and men with respect to cardiovascular diseases and drugs include:

  • Women are at greater risk of cardiovascular disease than men because they live longer;
  • Cardiovascular drug recommendations are based on clinical trials in middle-aged men;
  • Adverse drug reactions are more severe and more common in women than men;
  • Women less often receive preventive treatments and are treated less aggressively than men; and
  • Women and men absorb, distribute, metabolize and excrete drugs differently.

Tamargo said: “Male physicians less often prescribe recommended medications for female patients. Some doctors think cardiovascular disease is not a real issue for women because they are protected by sex hormones, forgetting that this disappears with age and women live longer than men.”

Women have a 1.5 to 1.7-fold greater incidence of adverse reactions to cardiovascular drugs and they tend to be more severe than in men, more often needing hospital admission. For example, women have a higher risk of drug-induced torsades de pointes (an abnormal heart rhythm than can lead to sudden cardiac death) and severe bleeding. Statin-induced myopathy is more common in older women with low body weight.

“Women have more adverse reactions because for many drugs the same dose is recommended for everyone irrespective of body weight,” said Tamargo. “This can lead to higher plasma levels and overdoses in women.”

There are sex-related differences in the pharmacokinetics (the way a drug is absorbed, distributed, biotransformed and excreted) of some widely used cardiovascular drugs. For example, the bioavailability and plasma levels of aspirin are higher in women than men, possibly due to lower activity of the enzyme aspirin esterase, and greater distribution and lower clearance of aspirin. These differences vanish with oral contraceptives and during pregnancy.

Tamargo said: “Sex-related recommendations for drug dosages are not included on labels, even for drugs with a greater than 40 percent difference in pharmacokinetics between men and women.”

Sex-related differences also occur in cardiovascular drug pharmacodynamics (the relationship between drug effect and drug concentration at the site of action). For example, aspirin has a higher protective effect against stroke in women and against heart attack in men. Aspirin is more active in male platelets, and aspirin resistance is more frequent in women.

The paper recommends:

  • Develop and implement sex-specific guidelines for cardiovascular drugs;
  • Include sex-specific dosages on cardiovascular drug labels;
  • Enroll women in clinical trials of cardiovascular drugs; and
  • Educate doctors about sex differences in the pharmacokinetics and pharmacodynamics of cardiovascular drugs.

Tamargo concluded: “The most effective way to minimize adverse drug reactions in women is to develop and implement sex-specific guidelines for cardiovascular drugs.”

This work was supported by CIBERCV (Spanish National Network on Cardiovascular Diseases).

For more information: www.academic.oup.com/ehjcvp

Related Content

Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies| August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
Review Paper Calls for Gender-Specific Heart Health Strategies
News | Womens Healthcare| August 08, 2017
August 8, 2017 — Radical changes to our healthcare system accounting for the unique needs of...
Abbott Initiates XIENCE Short DAPT Clinical Trial
News | Antiplatelet and Anticoagulation Therapies| August 03, 2017
Abbott recently announced the first patient has been enrolled in a clinical study evaluating the short-term use of...
Study Discovers Anticoagulant Drugs Are Being Prescribed Against Safety Advice
News | Antiplatelet and Anticoagulation Therapies| July 25, 2017
July 25, 2017 — A study by researchers at the University of Birmingham has shown that general practitioners (GPs) are
long-duration dual anti-platelet therapy (L-DAPT) compared to short-duration dual antiplatelet (S-DAPT) after DES stent implantation
News | Antiplatelet and Anticoagulation Therapies| July 12, 2017
June 12, 2017 — Researchers have evaluated the long-term efficacy and safety of long-duration dual anti-platelet ther
Greater Emphasis Needed on Preventing, Treating Heart Disease in Women
News | Womens Healthcare| July 06, 2017
Women and physicians do not put enough emphasis on cardiovascular disease in women, and a social stigma regarding body...
Bayer Now Enrolling Patients for Global Pulmonary Arterial Hypertension Study
News | Hypertension| July 05, 2017
Bayer has enrolled the first patient in a global Phase IV study assessing the clinical effects of riociguat in patients...
FDA Grants Priority Review of Xarelto sNDA for 10 mg Dose
News | Antiplatelet and Anticoagulation Therapies| June 29, 2017
Janssen Research & Development LLC announced the U.S. Food and Drug Administration (FDA) accepted for Priority...
radial access, transradial access trial using anticoagulants
News | Radial Access| June 15, 2017
June 15, 2017 — In patients undergoing t...
Cost comparison between NOACs, novel oral anticoagulants
News | Antiplatelet and Anticoagulation Therapies| May 31, 2017
May 31, 2017 – The results from the first real-world, matched head-to-head study comparing all-cause healthcare costs
Overlay Init