Women were less than half of the people tested for almost all of these common medicines.

High cholesterol

simvastatin

Heart disease is the top cause of death for women, but women were under 40% of the people in its studies.

  • 38.3%

    of the people in the studies were women

  • 55%

    of studies did not allow pregnant women

  • 1%

    looked at results for women separately

Was someone like me tested?

Choose the group that fits you.

Not one of these studies reported results separately for any of the groups below.

Not studied

Pregnant women

55% of studies would not let pregnant women join, and we found no study that tested this medicine in pregnancy.

What do we know?

What the FDA drug label says

Stop taking it when you find out you are pregnant, or ask your doctor. Because of how it works it might harm the baby. It was never tested in pregnant women.

Good to know

Heart disease is the top cause of death for women, yet women were under 40% of the people in these studies.

What women report more

Compared with men taking the same medicine.

  • 3.3×Physical symptoms with no clear cause
  • 2.1×Broken bones
  • 2.1×Problems with skin, tendons and other connective tissue
  • 2.1×Changes to the front of the eye

How many times more often women reported each problem than men taking the same medicine, based on reports to the FDA. This is a warning sign, not proof the medicine caused it.

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Check simvastatin against the medicines, pregnancy and birth control in your profile.

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Women's experiences

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All the details

Every number behind this page.

Who was in the studies

149,396 people in 119 studies

57,193 womenmiddle line = equal numbers92,203 men

Race

  • White92.4%
  • Asian3.9%
  • Black / African American1.9%
  • Other1%
  • Hispanic / Latina0.3%

Studies didn't say how many of the women were Black, Asian or another race — only totals for everyone.

Hispanic or Latina
7.7%
Age 65 or older
68.4%
Studies with men only
3
Studies with women only
4
Rules that kept women out

Share of studies with each rule.

  • 55%

    No pregnant women

    Women who were pregnant could not join.

    See the exact rule
    “Pregnant or lactating woman, or intending to become pregnant” NCT00202878
  • 39%

    No heart disease

    Women with heart disease, heart rhythm problems or a past heart attack were turned away.

    See the exact rule
    “Patients with evidence of a cardiovascular event in the 12-month pre-index period.” NCT01304641
  • 37%

    No diabetes

    Women with diabetes were turned away.

    See the exact rule
    “has Type 1 or Type 2 diabetes mellitus and is on statin therapy, is poorly controlled, is newly diagnosed (within 3 months of Visit 1), has recently experienced repeated hypoglycemia or unstable glycemic control or is taking new or recently…” NCT00479882
  • 34%

    No breastfeeding moms

    Women who were breastfeeding could not join.

    See the exact rule
    “Pregnant or lactating woman, or intending to become pregnant” NCT00202878
  • 27%

    Had to use birth control

    Women who couldn't or didn't want to use birth control were turned away.

    See the exact rule
    “Child-bearing potential (i.e. premenopausal woman who was not using a reliable method of contraception)” NCT00125593
  • 24%

    No cancer

    Women with current or past cancer were turned away.

    See the exact rule
    “…lity to take trial treatments for the duration of the study (e.g. severe respiratory disease, history of cancer or evidence of spread within last 5 years other than non-melanoma skin cancer, or recent history of alcohol or substance misuse)” NCT00461630
What nobody checked

Share of studies that recorded each thing.

  • 1%
    Results shown separately for women
  • 0%
    Whether anyone was pregnant
  • 0%
    Whether women were past menopause
  • 12%
    Body weight (BMI)
  • 15%
    Hispanic / Latina or not
  • 41%
    Race
All 119 studies

Study titles and rules are shown in their original English.

StudyPhasepeople% women
Cardiovascular Events Based On Statin Initiation In The Elderly
NCT01304641
—31,60260.1%
Treatment of HDL to Reduce the Incidence of Vascular Events HPS2-THRIVE
NCT00461630
325,67317.3%
IMPROVE-IT: Examining Outcomes in Subjects With Acute Coronary Syndrome: Vytorin (Ezetimibe/Simvastatin) vs Simvastatin (P04103)
NCT00202878
318,14424.3%
Study of the Effectiveness of Additional Reductions in Cholesterol and Homocysteine
NCT00124072
312,06417%
Action to Control Cardiovascular Risk in Diabetes (ACCORD)
NCT00000620
310,25138.6%
Study of Heart and Renal Protection
NCT00125593
49,27037.4%
Evaluating How the Treatments in the Action to Control Cardiovascular Risk in Diabetes (ACCORD) Study Affect Diabetic Retinopathy (The ACCORD Eye Study)
NCT00542178
35,71238.2%
Post-marketing Surveillance of the Safety, Tolerability and Efficacy of Vytorin (Ezetimibe + Simvastatin) Tablet Among Filipino Patients (Study P05647)
NCT00909389
—4,74850.5%
MK-0524B Lipid Study (MK-0524B-063)
NCT00479882
32,41453.4%
Lipid Efficacy and Safety in Participants With Mixed Hyperlipidemia (MK-0524B-024)
NCT00289900
32,34055.9%
Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia.
NCT00300430
32,20150.9%
LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2
NCT01763866
31,89945.9%
An Investigational Drug on Clinical Outcomes in Patients With Aortic Stenosis (Narrowing of the Major Blood Vessel of the Heart)(MK-0653A-043 AM4)(COMPLETED)
NCT00092677
31,87338.6%
A Study to Assess the Cholesterol Lowering Effect of Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Elderly Patients With High Cholesterol at High or Moderately High Risk for Coronary Heart Disease (0653A-128)
NCT00535405
31,28962.8%
To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)
NCT00271817
31,22049.8%
Study of Extended Release Niacin/Laropiprant on Lipids (0524A-067)
NCT00479388
31,21648.8%
Ezetimibe/Simvastatin in Patients With Metabolic Syndrome (0653A-107)(COMPLETED)
NCT00409773
31,14343.6%
Safety, Tolerability, and Effect of Alirocumab in High Cardiovascular Risk Patients With Severe Hypercholesterolemia Not Adequately Controlled With Conventional Lipid-modifying Therapies (ODYSSEY APPRISE)
NCT02476006
399437.1%
Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin
NCT00309777
384859.2%
12-week Open-label, Phase IIIb Comparing Efficacy and Safety of Rosuvastatin (CRESTOR™) in Combination With Ezetimibe
NCT00525824
383345%
Ezetimibe/Simvastatin (MK-0653A) Versus Rosuvastatin Versus Doubling Statin Dose in Participants With Cardiovascular Disease and Diabetes Mellitus (MK-0653A-133)(COMPLETED)
NCT00862251
380847.8%
A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments (0653A-121)
NCT00462748
378633.5%
Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood
NCT00300456
365051.1%
A Study to Assess the Cholesterol Lowering Effect of an Ezetimibe/Simvastatin Combination Tablet Compared to Another Cholesterol Lowering Drug in Patients With High Cholesterol and With High Cardiovascular Risk (0653A-809)(COMPLETED)
NCT00479713
361840.1%
Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia
NCT02715726
361525%
A 12-week Study to Compare the Efficacy and Safety of Fixed Combinations of Fenofibrate/Simvastatin 145/20mg and Fenofibrate/Simvastatin 145/40mg Tablets Versus Fenofibrate or Simvastatin Monotherapies in Subjects With Abnormal Blood Levels of Fats (Lipids) and at High Risk of Cardiovascular Disease
NCT01674712
355635.6%
A Study of LY3015014 in Participants With High Cholesterol
NCT01890967
251946.4%
Safety and Efficacy Study Comparing ABT-143 to Simvastatin in Subjects With Elevated Levels of Low Density Lipoprotein Cholesterol ("Bad Cholesterol") and Triglycerides
NCT00812955
347453.2%
Nephropathy In Type 2 Diabetes and Cardio-renal Events
NCT00535925
439552.9%
A Study of LY2484595 in Patients With High LDL-C or Low HDL-C
NCT01105975
239356%
Effects of Vytorin Versus Placebo in Subjects With Primary Hypercholesterolemia (Study P04420)
NCT00413972
338963.2%
Study to Compare the Efficacy and Safety of Pitavastatin and Simvastatin
NCT00309738
335231.8%
A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia
NCT00491530
331047.7%
An Efficacy and Safety Study of Alirocumab in Children and Adolescents With Heterozygous Familial Hypercholesterolemia
NCT03510884
330656.9%
Efficacy and Safety Study of MCI-196 Versus Simvastatin for Dyslipidaemia in Chronic Kidney Disease (CKD) Subjects on Dialysis
NCT00858637
325946.3%
A Multicenter, Randomized, Open Label Study to Evaluate the Lipid Lowering Efficacy and Safety of Vytorin® 10/20 vs. Atorvastatin 10mg in Hypercholesterolemia Patients With Metabolic Syndrome in Korea (0653A-129)(COMPLETED)
NCT00496730
325630.9%
Ezetimibe/Simvastatin (10 mg/40 mg) vs. the Doubling of Atorvastatin in High Risk Participants (MK-0653A-134 AM1)(COMPLETED)
NCT00782184
325048.8%
Study of Alirocumab (REGN727/SAR236553) in Patients With heFH (Heterozygous Familial Hypercholesterolemia) Who Are Not Adequately Controlled With Their LMT (Lipid-Modifying Therapy)
NCT01709500
324947.4%
Effects of Ezetimibe With Simvastatin in the Therapy of Adolescents With HeFH (Study P02579)
NCT00129402
324842.7%
Vytorin (10/20 Or 10/40) Compared to Atorvastatin (10 mg or 20 mg) in Patients With Coronary Artery Disease (0653A-126)(COMPLETED)
NCT00442897
422948%