hydrochlorothiazide

Once-daily polypill shows promise for CV prevention: PolyIran

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A once-daily, fixed-dose polypill including aspirin, atorvastatin, hydrochlorothiazide and enalapril or valsartan was effective for the prevention of major CV events in adults living in low- and middle-income regions, with high adherence and low adverse events.

According to a new study published in The Lancet, in a cohort of participants living in the low- to middle-income Golestan region of Iran (n = 6,838; aged 40-75 years; 50.4% women; 10.8% preexisting CVD; 15% diabetes), a once-daily polypill in combination with educational training on healthy lifestyle, diet, weight control, and abstinence from smoking and opium, resulted in a lower incidence of major CV events (HR = 0.66; 95% CI, 0.55-0.8) compared with participants who did not receive the polypill. Further, the reduction in risk for major CV events improved with greater adherence to the polypill (HR = 0.43; 95% CI, 0.33-0.55).

Additionally, the researchers reported no significant difference in CV outcomes if participants had preexisting CVD (HR = 0.61; 95% CI, 0.49-0.75) or no CVD (HR = 0.80; 95% CI, 0.51-1.12; P = .19).

“For clinical practice, the main message is that we should not wait until heart attack or stroke [occurs] and then start treatment. Rather, we should prevent heart attack and stroke in apparently healthy people who have one or more risk factors by starting prevention with a once-daily polypill, which is very safe,” Reza Malekzadeh, MD, director of the Digestive Disease Research Institute at the Tehran University of Medical Science, Iran, told Cardiology Today. “In low- and middle-income countries, we should [aim to prevent] heart attack and stroke, which is presently one of the major etiologies of premature death and disability. We can do this using polypill.”

A once-daily, fixed-dose polypill including aspirin, atorvastatin, hydrochlorothiazide and enalapril or valsartan was effective for the prevention of major CV events in adults living in low- and middle-income regions, with high adherence and low adverse events.

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In other findings, the overall frequency of adverse CV events was similar between the minimal care group and the polypill group, for incidence of intracranial hemorrhage (polypill group, 0.6% vs. minimal care group, 0.3%) and gastrointestinal bleeding (polypill group, 0.4% vs. minimal care group, 0.3%).

The PolyIran study was a pragmatic, cluster-randomized trial nested in the Golestan Cohort Study. Researchers enrolled participants living in low- to middle-income areas in the Golestan region of Iran and divided participants into two groups: fixed-dose polypill treatment or minimal care. Both groups received educational training on a healthy lifestyle, diet, weight control, and abstinence from smoking and opium, which is a common practice among participants in this cohort. Educational training was provided by PolyIran field visit teams at 3 and 6 months, then every 6 months thereafter, with follow-up for 60 months.

The primary outcome was occurrence of major CV events, which included hospitalization for ACS, fatal MI, sudden death, HF, coronary artery revascularization procedures, and non-fatal and fatal stroke.

The polypill administered to participants contained aspirin 81 mg, atorvastatin 20 mg, hydrochlorothiazide 12.5 mg and enalapril 5 mg, unless a participant developed a cough, in which case he or she was switched to a formula containing valsartan 40 mg instead.

Median adherence to the polypill tablets was 80.5% (interquartile range, 48.5-92.92).

The researchers noted that research and extended follow-up will continue.

“This study was performed in rural North east Iran and 80% of participants were Turkmen,” Malekzadeh said. “We are presently doing another trial in Southern Iran where the ethnicity is 80% Persian, including participants who are somewhat more prone to heart attack and stroke, to ensure that the results of this study is generalizable to different ethnicities.” – byScott Buzby

Common Blood Pressure Drug Tied to Increased Risk of Skin Cancer

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People who take a certain diuretic prescribed to control fluid retention and treat high blood pressure may be more likely to get skin cancer than other individuals, a Danish study suggests.

While the drug, hydrochlorothiazide, has long been linked to an increased risk of sunburns, the current study offers fresh evidence that this commonly prescribed medication may also make people more likely to develop basal cell carcinoma and squamous cell carcinoma.

For the study, researchers examined national prescription registry data on hydrochlorothiazide use from 1995 to 2012 as well as cancer registry records on skin malignancies diagnosed from 2004 to 2012.

Overall, people who took hydrochlorothiazide daily for at least six years were 29% more likely to develop basal cell carcinoma and almost four times more likely to get squamous cell carcinoma than individuals who didn’t take this medication, the study found.

“We already knew that hydrochlorothiazide makes the skin more vulnerable to damage from UV light of sun or sunbeds,” said senior study author Anton Pottegard of the University of Southern Denmark.

“However, we did not know that hydrochlorothiazide use also appears to translate into an increased risk of non-melanoma skin cancer,” Pottegard said by email.

The study included more than 71,000 people with basal cell carcinoma, 8,600 patients with squamous cell carcinoma, and a control group of more than 313,000 people in the Danish population who didn’t have these malignancies but were otherwise similar to the cancer patients.

About 2.7% of patients with basal cell carcinoma and 2.1% of the control group were high users of hydrochlorothiazide, with a lifetime cumulative dose of at least 50,000 mg, or roughly six years of daily use.

Ten percent of squamous cell carcinoma cases were high users, as were 2.8% of people in the control group.

With the highest cumulative hydrochlorothiazide exposure – approximately 24 years of daily use – patients were 54% more likely to develop basal cell carcinoma and more than seven times more likely to get squamous cell carcinoma.

The study wasn’t a controlled experiment designed to prove whether or how hydrochlorothiazide might cause skin cancer.

Another limitation is that researchers lacked data on two main factors that influence the risk of skin cancer: ultraviolet light exposure and skin type, the study authors note online December 3 in the Journal of the American Academy of Dermatology.

“There may be a relationship between taking hydrochlorothiazide and risk for skin cancer,” said Dr. Aaron Farberg of the Icahn School of Medicine at Mount Sinai in New York City.

“However, the relationship may not be directly causative,” Farberg, who wasn’t involved in the study, said by email.

Even so, the findings add to the evidence suggesting that patients taking hydrochlorothiazide should take extra precautions to protect their skin from damage caused by the sun, said Dr. Elizabeth Martin, president of Pure Dermatology & Aesthetics in Hoover, Alabama.

“Everyone can reduce their skin cancer risk by avoiding unprotected exposure to UV light,” Martin, who wasn’t involved in the study, said by email. “Don’t use indoor tanning devices, and protect yourself from the sun by seeking sunscreen with an SPF of 30 or higher.”

Patients taking hydrochlorothiazide shouldn’t stop without first seeing a doctor, Pottegard cautioned. While there are other safe, affordable options to manage high blood pressure, patients already taking hydrochlorothiazide won’t meaningfully alter their skin cancer risk by staying on the drug for a few months until a physician can advise them, he said.

“If you are at an increased risk of skin cancer, due to high exposure to sunlight, have already experienced skin cancer, or are otherwise predisposed to skin cancer, you should consider consulting your physician regarding a potential therapy shift,” Pottegard said.

Losartan plus hydrochlorothiazide improves BP control in diabetics with hypertension

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Combination therapy using losartan plus hydrochlorothiazide improves blood pressure control in patients with type 2 diabetes mellitus (T2DM) complicated with hypertension, according to a Japanese study.

The 24-week study recruited 43 Japanese patients with T2DM complicated with treatment-resistant hypertension. Prior to the study, participants were given 12 weeks of continuous treatment with the maximum dosage of angiotensin II receptor blockers (ARBs) as recommended in Japan, but their blood pressure did not reach the target level of systolic ≤130mm Hg and diastolic ≤80mm Hg. [Hypertens Res 2009;32:3-107]

Study participants were assessed for changes in blood pressure and metabolism after switching their treatment plan from maximum dose ARB to a combination of losartan 50 mg/day and hydrochlorothiazide 12.5 mg/day. At the end of the study, participants had significantly lower systolic and diastolic blood pressure. The results also showed that combination therapy did not have any effect on lipid metabolism, serum uric acid and potassium levels. However, HbA1c levels were higher and urinary albumin-creatinine ratios lower, said the researchers. [Intern Med 2014;53:1283-9]

The study found that mean systolic blood pressure dropped from 147±11mmHg at baseline to 133±13 mmHg at the end of the study, while mean diastolic blood pressure fell from 79±8 mmHg to 72±10 mmHg. This significant reduction could be due to the fact that patients with diabetes have enhanced renal tubular reabsorption, leading to the formation of sodium-sensitive hypertension. Diuretics promote sodium excretion, thus increasing the antihypertensive effects of other drugs.

Another explanation for the improved antihypertensive effect is that hydrochlorothiazide probably enhances the antihypertensive effects of ARBs by reducing circulating blood volume and increasing plasma renin activity. As ARBs work by inhibiting the actions of angiotensin II, their effectiveness increases in parallel with plasma renin activity. [J Pharmacol Exp Ther 1990;252:726-32]

Most patients with diabetes complicated by hypertension require multidrug therapy to achieve target blood pressure. Combining a diuretic with ARB and regularly monitoring kidney function, electrolytes and glucose metabolism is a potentially effective option for patients who fail first-line therapy using ARBs. This is particularly apparent in diabetic Japanese patients with treatment-resistant hypertension, summarized the researchers.

 

Certain Antihypertensive Drugs Associated with Risk for Lip Cancer.

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Some commonly used antihypertensive drugs — hydrochlorothiazide and nifedipine — might increase the risk for lip cancer, according to a case-control study in the Archives of Internal Medicine.

Using a California-based cancer registry, researchers matched some 700 non-Hispanic white adults diagnosed with lip cancer to some 23,000 controls free of lip cancer. Patients who filled three or more prescriptions for hydrochlorothiazide, hydrochlorothiazide-triamterene, and nifedipine — all photosensitizing agents — had roughly double the risk for lip cancer relative to those with no prescriptions filled. Risks increased with duration of use. Atenolol, which is non-photosensitizing, was not associated with increased risk.

The authors write that photosensitizing drugs may absorb energy from sunlight, which leads to the release of electrons. This then produces free radicals that can cause inflammation.

An Archives‘ editor writes: “When initiating use of photosensitizing agents for our patients, we need to remind them of … simple measures to avoid sun exposure.”

Source: Archives of Internal Medicine